[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11662-11730]
[From the U.S. Government Publishing Office, www.gpo.gov]




             PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

  The PRESIDING OFFICER. Under the previous order, the Senate will 
resume consideration of S. 1082, which the clerk will report.
  The bill clerk read as follows:

       A bill (S. 1082) to amend the Federal Food, Drug, and 
     Cosmetic Act to reauthorize and amend the prescription drug 
     user fee provisions, and for other purposes.

  Pending:

       Brown (for Grassley) amendment No. 1039, to clarify the 
     authority of the Office of Surveillance and Epidemiology with 
     respect to postmarket drug safety pursuant to recommendations 
     by the Institute of Medicine.
       Brown (for Grassley) amendment No. 998, to provide for the 
     application of stronger civil penalties for violations of 
     approved risk evaluation and mitigation strategies.
       Brown (for Durbin/Bingaman) amendment No. 1034, to reduce 
     financial conflict of interest in FDA Advisory Panels.

  The PRESIDING OFFICER. Under the previous order, there will be 60 
minutes for debate currently on the bill and remaining amendments, with 
10 minutes under the control of the Senator from Iowa, Mr. Grassley or 
his designee, 5 minutes under the control of the Senator from Illinois, 
Mr. Durbin or his designee, and the remaining time equally divided 
between the chairman and ranking member or their designees.
  The Senator from Massachusetts is recognized.
  Mr. KENNEDY. Madam President, I yield myself 6 minutes of our time.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. Madam President, we will see later this morning the 
successful conclusion of this legislation. We have some important 
matters to consider, which we will do in a very short period of time. 
But as we are coming into the closing time for this amendment, I think 
it is appropriate that we review very quickly what this legislation 
does and what it does not do.
  I am a strong believer in this legislation, which has strong 
bipartisan support. I am enormously grateful to Senator Enzi and 
Members on our side of the aisle as well as those on the other side for 
all of their help and assistance in getting us to the point where we 
are ready to take final action on something that makes a major 
difference to families in America. We ensure the safety of our 
prescription drug system and also are making very important progress in 
the safety of our food supply.
  This is, in an important way, breakthrough legislation. I will review 
quickly what this does and then come back to the amendments that are 
before the Senate and how we think the Senate should dispose of them; 
why this legislation is urgent, why it is extremely important, and why 
the American people deserve the best.
  Very quickly, again, there is strong emphasis on safer food and safer 
medicines for families in this country. We spelled out at the earlier 
part of our presentations the effective systems we have supported to 
make sure we are going to have the safest prescription drug program in 
the world, using different kinds of modern technologies and also modern 
surveillance systems for monitoring postmarketing safety. This will 
ensure in the future we are going to have the safest prescription drug 
program in the world. We will have safer medicines.
  We will also have safer food for families and pets. I think all 
Americans have been alarmed, as they should have been, by what has been 
reported in the news in the last few weeks. Many families have lost 
their pets because the agency lacked the authorities provided in this 
bill.
  We will have earlier warnings on drug safety problems using extremely 
elaborate systems of postmarketing surveillance. These systems will use 
both public and private centers to collect information that the FDA 
will use

[[Page 11663]]

to find early warnings of possible harm. In these cases, the agency 
will be able to take expeditious action. That has never been done 
before.
  We are going to have better medicines for children. We are enormously 
appreciative of the excellent work that has been done by Senator Dodd 
and Senator Clinton. This was done in a bipartisan way with Senator 
DeWine, who is not here. We all realize that children are not little 
people; children are children, and therefore their bodies react 
differently to various kinds of prescription drugs. This legislation 
provides mechanisms to get information on safe and effective use of 
medications in children as well as to promote studies of drugs in 
pediatric populations. In the past few years, we have made enormous 
progress and we believe this legislation will help to an even greater 
extent.
  We are going to have more transparency and stronger science at the 
FDA because of the wonderful work done by Senator Mikulski. She and 
others worked to assure that we have greater awareness by the public of 
what is happening at the agency.
  There is greater focus and attention on making sure the agency is 
going to have the best in terms of the new sciences. We are in the life 
science century at the present time. This has been impressed on the 
country with the extraordinary convention on biosciences that took 
place in Boston in the last few days. There I listened and read about 
the potential the life sciences have, not only in terms of energy and 
agriculture but also in terms of medicines. The United States is 
absolutely poised to continue to be the world leader in these fields, 
with all of its implications of healthier families here and around the 
world.
  We need to make sure we are going to have the best kind of science at 
the FDA. We do that in the way we have given greater authority over the 
development of the science function at FDA. We also provided a rather 
unique foundation that will be able to use public and private funding. 
This foundation will seek out the best and the newest modalities to 
help speed the review of various prescription drugs. That is going to 
be enormously important because time means cost. If we are able to 
resolve these issues more quickly the costs will be more understandable 
and reasonable to consumers and we will get them faster.
  Briefly to comment on some of the amendments, we have taken a 
position in our proposal that both the safety and efficacy of 
particular prescription drugs is a function that ought to be considered 
in tandem. I know there are those who think we ought to separate those 
functions. We can imagine a circumstance, for example, where the side 
reaction of a particular drug is that individuals lose all of their 
hair and they become nauseated. Clearly I am describing the impact of 
methotrexate. That can happen to an individual on many anticancer 
drugs. You wouldn't prescribe that for athlete's foot because the side 
effects are so dramatic, but you would approve that for another kind of 
regime to try to treat cancer.
  We also have items on civil penalties for the first time. There is a 
question of what those civil penalties should be. I want them to be 
higher, but I am mindful as well that this is the first time we are 
going to have those civil penalties. We are going to be working on 
those matters with the House. I basically think they should be a little 
higher, but I listened to my colleague on this issue and we are going 
to try to make sure we get something that is going to be fair and can 
do the job.
  I am also mindful of the concern we have in terms of the potential of 
conflicts of interest. I will reserve my time to be able to deal with 
this issue.
  This is a very important issue. We want to make sure, on the one 
hand, as we have these breakthroughs in science, that we are going to 
have the best experts participating in these review groups. We also 
have to be sensitive to the issues of conflicts of interests. I know 
the Senator from Illinois has a proposal on this.
  I will reserve the rest of my time to be able to discuss that later.


                      elements to assure safe use

  Ms. MURKOWSKI. Madam President I rise to engage in a colloquy with 
the Senator from Wyoming and ranking member of the Senate Health, 
Education, Labor, and Pensions Committee, Senator Enzi.
  First, I would like to thank the chairman and the ranking member of 
the HELP Committee for their efforts to address the issue of access to 
health care in frontier areas. Much of Alaska is a frontier area and it 
is not an easy task to access health care in general, let alone find a 
specialist to obtain needed medications.
  Toward that end, I am pleased that the bill before us today 
recognizes the problem of access and provides a willing provider in a 
frontier area with the ability to receive the training and 
certification necessary to prescribe a drug that has potential serious 
risks. For clarification purposes, I would like to ask the Senator from 
Wyoming if it is the intent of Congress that section 202 of S. 1082, 
the FDA Revitalization Act, allows all physician and nonphysician 
health care providers in frontier areas to be able to receive 
``training or certification'' so that the provider can prescribe or 
dispense a particular drug without the need for an additional degree or 
medical specialty?
  Mr. ENZI. Yes. This is the intent.
  Ms. MURKOWSKI. And under the provisions of section 202, would the 
willing health care provider be able to receive this training or 
certification through remote learning methods so that a provider would 
not need to travel vast distances in order to get the requisite 
training?
  Mr. ENZI. Yes. The language in the bill recognizes that travel in 
frontier areas, particularly in remote places such as Alaska, can be 
time-consuming and expensive, so it specifically notes that the 
training or certification should be available in a widely available 
training or certification method, such as an online course or through 
the mail. This is intended to reduce the amount of travel and expense a 
willing provider in a frontier area must undertake in order to be able 
to prescribe or dispense needed medicines to their
  Ms. MURKOWSKI. I thank the Senator. And since the provider would not 
be required to obtain an additional degree or medical specialty, and 
the training or certification would hopefully be through an online 
course or through the mail, is there any indication of how long such 
training would take for the provider to be deemed sufficiently trained 
to prescribe a specific drug?
  Mr. ENZI. While I cannot give the Senator a guaranteed time frame, I 
would point out that the training and certification is specifically for 
the drug the provider is seeking to prescribe or dispense--not for a 
range of drugs. Thus, the time frame should not be a lengthy one, 
particularly if the training can be conducted online.
  Ms. MURKOWSKI. Now, I understand that many physicians around the 
country are invited to attend conferences or training seminars in order 
to be certified to prescribe certain drugs. Given the low volume of the 
high risk drugs we are talking about that are likely to be dispensed in 
frontier areas, how can we ensure that a willing provider will be able 
to access this training? What is the incentive for a drug manufacturer 
or the FDA to include frontier area among the areas where training and 
certification would be available?
  Mr. ENZI. I thank the Senator for that question. The language in the 
bill specifically says that the training or certification shall be 
available to any willing provider from a frontier area. Shall be 
available--not may be available, but shall. It is the intent of 
Congress in this section to direct the FDA to guarantee that a willing 
provider will have access to the training and certification needed to 
prescribe a particular drug. And again, the language that encourages 
the availability of an online course or course through the mail is one 
way to provide for that training or certification at minimal cost.
  Ms. MURKOWSKI. I thank the Senator for that clarification. I bring 
this colloquy to the Senate floor today because I want to ensure that 
every American has access to prescription drugs regardless of whether 
they live in

[[Page 11664]]

a large urban city like New York, or a frontier community like Bethel, 
AK. I believe that with the modifications that have been made to this 
bill, we will be able to achieve that.
  Mr. FEINGOLD. Madam President, I am pleased to support S. 1082, the 
Food and Drug Administration Revitalization Act of 2007. This much-
needed legislation improves our country's prescription drug and medical 
device safety, and responds to problems that Congress is long overdue 
in addressing. This legislation strengthens the Food and Drug 
Administration, a body that has been continually underfunded and 
weakened by political and corporate interests. While I would like to 
see an even stronger bill passed, this legislation drastically improves 
our current policies that regulate the FDA.
  My constituents in Wisconsin largely trust that their food, 
medications, and medical devices are safe. I generally trust that they 
are as well. We all depend on the FDA to ensure that our lives are not 
jeopardized by faulty products or contaminated food. However, recently 
a steady stream of dangerous drugs, food, and devices have made their 
way into Americans' homes. Vioxx, antidepressant drugs for children, 
salmonella poisoning in food, pet food contaminations--these are just a 
few of the most publicized instances that have harmed and even killed 
people in our country.
  Numerous investigations have been conducted in order to better 
understand why these events have occurred. The conclusions to these 
studies have found that we need a better FDA. We need to provide the 
agency with the legal authority necessary to ensure our safety, and we 
need to provide the FDA with the necessary funding to do its job. It is 
clear that the agency's authority has been watered down over the years 
as a result of corporate influence, and our citizens have suffered the 
consequences. This bill takes important steps to put safety over profit 
margins, and it has been long awaited.
  I commend the immense bipartisan effort that has been put into 
crafting this legislation. This is not an easy topic to tackle. It is a 
complex topic rife with political infighting, but today we have 
legislation that both parties and even many companies are fine with. 
Granted, the bill may be too far-reaching for some, and for others like 
me, it doesn't necessarily go far enough, but this is something that 
will pass that is a vast improvement from current law.
  I was glad to support Senator Durbin's amendment to improve the FDA's 
oversight and ability to respond to contaminated pet food. Like the 
bill as a whole, I think we need to do more to ensure that the 
ingredients used in both pet and human food are free from 
contamination, but this amendment was an important step in the right 
direction. The amendment strengthens the standards for pet food 
processing and ingredients and at the same time improves the FDA's 
ability to react to a problem through better detection, an adulterated 
food registry, and improved communication with the public. I hope this 
will be a platform for improving Federal oversight of the human food 
supply, which has been shown many times over the last year to be at 
risk.
  In my home State of Wisconsin, the outbreak of E.coli last summer, 
later linked to bagged spinach, killed an elderly woman and sickened at 
least fifty others. The spinach was traced back to four fields on four 
ranches in California. The FDA itself admits that ``There has been a 
long history of E. coli O157:H7 outbreaks involving leafy greens from 
the central California region'', and yet mostly depends on the industry 
to self-regulate. In fact, on the FDA Web site about this particular 
outbreak, it says, ``[the] FDA and the State of California expect the 
industry to develop a comprehensive plan which is designed to minimize 
the risk of another outbreak.'' I am concerned that all too often the 
FDA is allowing the food industry to dictate the rules and whether to 
implement food safety protections. This bill is a step in the right 
direction, but more steps are likely needed and I look forward to 
working with my colleagues on these.
  Along these lines, I was glad to offer an amendment and have it 
accepted in the bill that would require the FDA to resume annual 
reports on the level of pesticide residues in domestic and imported 
food and agricultural products. Moreover, my amendment requires the FDA 
to make the report more useful for Congress and the public. 
Specifically the amendment requires the FDA to work with other agencies 
to include similar data collected by other government agencies, conduct 
more advanced statistical analysis, report on efforts to prevent 
smuggling through mislabeling one product as another, and target future 
testing on products or countries, in the case of exports, that show 
relatively more prohibited pesticides. The recent headlines about 
contaminated Chinese wheat gluten clearly show a need to get a better 
handle on food safety. So it clearly wasn't the time for the FDA to end 
reporting on pesticide residues and this amendment follows the larger 
theme of the bill in improving our food safety oversight.
  While this pesticide residue amendment is important to improve 
consumers' confidence in the food they eat, it also can be important 
for U.S. farmers. For example, Wisconsin's ginseng growers have 
suffered a double insult over the past few years--facing unfair 
competition from imported ginseng that was treated with chemicals 
illegal in the U.S. and then often having that ginseng misbranded as 
the superior quality Wisconsin ginseng. My amendment and the improved 
pesticide residue data and ability to focus on certain products should 
help FDA identify and seize unsafe products such as contaminated 
ginseng imports.
  On another note, I am disappointed that the bill does not actually 
allow importing lower cost prescription drugs. While the Dorgan-Snowe 
amendment was accepted in the bill, it was modified and effectively 
nullified by the Cochran amendment, which I strongly opposed
  A competitive marketplace for prescription drugs will help in 
containing the skyrocketing costs of prescription drugs. Over the past 
4 years, I have worked in a bipartisan fashion to allow the safe 
importation of prescription drugs from abroad. I am a proud cosponsor 
of the Pharmaceutical Market Access and Drug Safety Act, which the 
provisions in the Dorgan-Snowe amendment were based on. This 
legislation would have allowed the importation of FDA-approved drugs 
from countries with FDA-comparable regulations, such as Canada. This 
legislation will finally allow the importation of safe and affordable 
prescriptions drugs to the United States.
  As I travel around Wisconsin listening to people's concerns, the high 
cost of health care continues to be at the top of the list, and this 
includes prescription drugs. The strong bipartisan support for 
reimportation makes clear that Americans of all political backgrounds 
want the Federal Government to support consumers, rather than the 
interests of drug companies, and make safe and affordable prescription 
drugs available to those who need them. The failure to include strong 
reimportation legislation in this bill is unfortunate, but we are 
getting closer to enacting reimportation with each vote. I fully expect 
this to pass in the near future, and I urge my colleagues to join me in 
supporting efforts to legalize reimportation. As I stated earlier, I 
will support the final FDA Revitalization Act, but I am disappointed 
that strong reimportation language is not included.
  Mr. COBURN. Madam President, I appreciate the attention to drug 
safety on the part of Senators Kennedy and Enzi. The drug safety 
problems our nation experienced surrounding Vioxx and the SSRIs 
demanded that we take a serious look at the FDA.
  I appreciate the hundreds and hundreds of staff hours that have gone 
into working on this legislation both before and after the HELP 
Committee markup.
  When the Health, Education, Labor, and Pensions Committee marked up 
this legislation, I strongly opposed it. I appreciate the willingness 
of Senators Kennedy and Enzi to listen to my concerns and take action 
to address them.

[[Page 11665]]

Many of the changes I requested are included in the final product that 
we vote on today.
  This bill has come a very long ways since its consideration in the 
HELP Committee. Instead of requiring a risk evaluation and mitigation 
strategy, REMS, for every drug, a REMS may only be requested when there 
is a scientific reason for one. In giving new regulatory authority to 
the FDA, we must be extremely cautious that we do not hurt access to 
new and innovative prescription drugs.
  I appreciate that the concept, introduced by Senators Gregg, Burr, 
and myself, to establish a surveillance system for adverse prescription 
drug events has been included in this legislation. This will now allow 
cooperation with academic institutions that have the expertise to 
evaluate the signals from that surveillance system and ensure that both 
patients and doctors have the information they need to make decisions 
about the risks and benefits of medical drugs.
  As a practicing physician, I know that it is impossible to ever 
completely eliminate drug risks. The right approach is to provide 
accurate risk information and preserve the doctor-patient relationship. 
I appreciate the progress made in the bill towards this end.
  I appreciate the willingness of Senators Kennedy and Enzi to work 
with me on preserving the doctor-patient relationship. The FDA's job is 
to approve drugs as safe and effective--not to dictate which doctors 
can prescribe which drugs to which patients. Medicine is not just a 
science; it is also an art.
  This legislation will ensure that patients have access to potentially 
lifesaving drugs that might not otherwise be approved because of known 
adverse events caused by the drug. This legislation establishes that 
the agency will not limit or restrict distribution or use unless a drug 
has been shown to actually cause an adverse event.
  I also appreciate the efforts of my colleague Senator Roberts in 
preserving the right to commercial free speech, as intended by the 
Constitution, in direct-to-consumer, DTC, advertising. While I am not a 
big fan of DTC, I am a big fan of the Constitution. I am pleased that a 
compromise was reached to remove the ban on DTC from this bill and 
instead ensure that drug companies are held accountable if their 
advertisements are false or misleading.
  I appreciate the willingness of Senators Kennedy and Enzi to accept 
an amendment that will provide a date certain for a safety evaluation 
of the drug RU-486.
  The two user fee agreements for prescription drugs and medical 
devices, PDUFA and MDUFMA, have been negotiated between industry 
representatives and the FDA. The industry indicates what it will pay 
for faster drug approvals and the FDA commits to achievable performance 
goals.
  I appreciate the work of FDA Commissioner Dr. Andrew von Eschenbach 
in crafting fair and reasonable proposals for both prescription drug 
and medical device companies. It is critical that we focus on public 
health and safety, and also hold the FDA accountable for improved 
agency performance goals. Maintaining timely and efficient patient 
access to lifesaving and life-enhancing medical drugs and devices is a 
win for the industry, doctors, and patients. I look forward to seeing 
how the new performance goals in both the PDUFA and MDUFMA agreements 
will both help keep the pipeline of innovation moving forward and 
improve communication and understanding between agency staff and 
manufacturers.
  I can vote in favor of this legislation today because of the enormous 
progress made. However, there are some workability issues with both the 
Best Pharmaceuticals for Children Act and the Pediatric Research 
Improvement Act. These issues need to be resolved so that the FDA has 
the authority to do its job quickly and effectively.
  The Best Pharmaceuticals for Children Act, BPCA, has generated more 
clinical information for the pediatric population than any other 
legislative or regulatory effort to date. I am concerned about this 
reauthorization of the Best Pharmaceuticals for Children Act because 
chips away at incentives that have been getting real results for kids.
  I am also concerned that part of the bill, pediatric medical devices, 
would authorize $30 million in demonstration grants for improving the 
availability of pediatric devices. While this has a worthy goal, more 
accountability is needed for this program to ensure that such grants 
are used for helping save the lives of children. Additionally, the 
bill's sponsors failed to do their homework in examining existing 
Federal programs. The fact is, the National Institutes of Health 
already has a program for this purpose. In order to preserve a heritage 
for our grandchildren, Congress needs to do the hard work of taking an 
inventory of existing programs before we authorize new ones.
  Again, I appreciate the enormous amount of work that has gone into 
improving this legislation. It is critical that in addressing drug 
safety that we do not harm access to new and lifesaving medical 
technologies.
  Mr. DODD. Madam President, I rise to support passage of the committee 
substitute to S. 1082, the Food and Drug Administration Revitalization 
Act, FDARA. This legislation contains tremendous advances for children 
and their families through the reauthorization of the Best 
Pharmaceuticals for Children Act, BPCA, and the Pediatric Medical 
Device Safety and Improvement Act, which I authored, as well as the 
reauthorization of the Pediatric Research Equity Act, PREA, which was 
introduced by my colleague, Senator Clinton.
  I congratulate Chairman Kennedy and Ranking Member Enzi for their 
efforts in putting this complex bill together and thank them both for 
working with me to ensure these vital programs for children can thrive 
well into the future.
  We have had good debate on this legislation. I want to thank my 
friend from Colorado, Senator Allard, for the floor debate we had on 
BPCA. I want to assure him and those that voted for his amendment that 
this bill is about increasing pediatric clinical trials and improving 
our knowledge about products being used in children where previously we 
have had no information. BPCA is and has always been about striking an 
appropriate balance between the cost to consumers and benefits to 
children.
  Ten years ago when Senator Mike DeWine and I undertook this effort, 
only 11 drugs on the market that were being used in children had 
actually been tested and studied for their use. Prior to the enactment 
of BPCA 10 years ago, pediatricians were essentially flying blind 
because they lacked information regarding the safety and effectiveness 
of drugs they were prescribing for children. But it was children who 
suffered the most from taking drugs where so little was known about 
their effects.
  What we have learned over the past 10 years of experience is that 
children have been exposed to ineffective drugs, ineffective dosing, 
overdosing, or side effects from drugs that were previously unknown. In 
10 years, nearly 800 studies involving more than 45,000 children in 
clinical trials have been completed. Useful new pediatric information 
is now part of product labeling for more than 119 drugs. In sum, there 
has been a twentyfold increase in the number of drugs studied in 
infants, children, and adolescents as a result of BPCA since its 
enactment.
  Children with a wide range of diseases such as HIV/AIDS, cancer, 
allergies, asthma, neurological and psychiatric disorders, and obesity 
can now lead healthier, more productive lives as a result of new 
information about the safety and efficacy of drugs they use to treat 
and manage their diseases where previously there was none.
  This successful program for children will expire on September 30 
unless we act to reauthorize it.
  The reauthorization of BPCA contained within S. 1082, makes several 
important improvements to this program which I have spent many months 
developing. It is my belief that these improvements will help ensure 
that this program continues to thrive well

[[Page 11666]]

into the future. I strongly support the 5-year authorization of this 
program so that we can closely monitor how the program is working and 
make improvements as they are needed in the future.
  S. 1082 will increase the amount and quality of pediatric information 
by streamlining BPCA and PREA at the Food and Drug Administration, FDA, 
and ensuring that labeling changes as a result of BPCA are communicated 
to physicians. S. 1082 will improve transparency and accountability by 
making market exclusivity determinations and written requests for 
pediatric studies public within 30 days of exclusivity being awarded. 
It also will improve the accuracy and speed of labeling changes by 
requiring such changes to be made within the FDA's timeline and 
ensuring that labeling reflects the results of the BPCA study that was 
conducted.
  S. 1082 will ensure that BPCA continues to yield more and better drug 
studies in children, while addressing the minority of cases where the 
incentive of 6 months additional market exclusivity has far exceeded 
the ``carrot'' it was intended to provide to drug sponsors. It improves 
market certainty by not allowing pediatric exclusivity to be granted 
within nine months of the end of the drug's patent and increases data 
about the use and applicability of BPCA through reports conducted by 
the Institute of Medicine, IOM, and the Government Accountability 
Office to review the program and assess the impact of the changes made 
within the legislation.
  BPCA has shown us that it is unsafe to simply treat children as 
smaller versions of adults. Children face a similar inequity with 
respect to medical devices. Far too few medical devices are 
specifically designed for children's small and growing bodies. Experts 
say that the development of children's medical devices lags 5 to 10 
years behind that of adults. That is largely due to the limited size of 
the market for pediatric devices.
  When a medical device suitable for a child is needed to save that 
child's life but it does not exist, doctors are often forced to ``jury-
rig'' adult versions of the device or, in some cases, perform a riskier 
surgery on the child. Ventilator masks, for instance, are far too large 
to fit over a baby's mouth. Often, the only alternative is to run an 
invasive tube down the baby's throat.
  Because of what we witnessed over the past ten years with the market 
incentives provided under BPCA, I introduced an initiative called the 
Pediatric Medical Device Safety and Improvement Act to create similar 
incentives for device manufacturers. This legislation also streamlines 
the approval process for cutting-edge technology and establishes grants 
for matchmaking between inventors and manufacturers and the Federal 
Government.
  Balancing incentives with safety, the legislation closely mirrors 
recommendations made by the IOM in its 2005 report on pediatric medical 
device safety to improve the serious flaws in the current postmarket 
safety surveillance of these devices. Specifically, the IOM called for 
and the legislation allows the FDA to require postmarket studies as a 
condition of clearance or approval for certain categories of devices 
and it gives the FDA the ability to require studies longer than 3 years 
with respect to a device that is to have significant use in pediatric 
populations if such studies would be necessary to address longer term 
pediatric questions, such as the impact on growth and development.
  Some in the medical device industry continue to offer proposals to 
chip away at the authorities in the legislation intended to ensure the 
FDA can request manufacturers to conduct postmarket safety 
surveillances and ensure devices used in children are safe. I am 
disheartened by anyone who would attempt to deprive children and 
physicians of information that pertains to device safety and I will 
strongly oppose attempts to weaken the postmarket safety standards 
contained within the legislation as the bill heads to conference.
  The faster we can get new, safe pediatric devices to market, the 
fewer parents have to stake their children's lives on improvisation and 
guesswork.
  I have previously mentioned the broad-ranging support for these 
important initiatives for children but it is worth restating that the 
level of support from pediatricians, patient advocacy organizations, 
drug and device companies, and many others indicates that this 
important legislation will greatly benefit children and their families.
  I want to thank the tremendous work of the staff on this bill. They 
have devoted countless hours and many weekends to working on this 
legislation. Specifically, I want to thank David Bowen and David Dorsey 
with Senator Kennedy and Shana Christrup, Keith Flanagan and Amy 
Muhlberg with Senator Enzi who worked so closely with my office on the 
pediatrics initiatives in title IV of this legislation. I also want to 
thank Kate Leone with Senator Harry Reid whose terrific leadership 
helped guide this legislation to passage.
  I also want to acknowledge the leadership of the American Academy of 
Pediatrics and the Elizabeth Glaser Pediatric AIDS Foundation whose 
staff, Mark Del Monte, Jeanne Ireland and Elaine Vining, have provided 
tremendous technical assistance on the pediatrics initiatives in S. 
1082.
  Before I close I want to address the other provision in this 
legislation which reauthorizes vital user fee programs at the FDA for 
drugs and devices and addresses the important issue of drug safety at 
the FDA, an agency that regulates 25 percent of the products consumed 
by Americans. In recent years, we have witnessed a public crisis of 
confidence in the FDA's ability to ensure that the drugs taken by 
millions of Americans are safe and effective once they are on the 
market. My colleagues and I on the Health, Education, Labor and 
Pensions, HELP, Committee heard testimony about the internal crisis 
within the scientific community at the FDA about inappropriate 
influences on decisionmaking.
  I was deeply troubled by the recent Union of Concerned Scientists 
study showing that of nearly 1,000 FDA scientists questioned, 420 
reported that they knew of cases in which the Department of Health and 
Human Services or FDA political appointees have inappropriately 
injected themselves into FDA determinations or actions. The same study 
also found that 378 FDA scientists disagreed or strongly disagreed that 
the FDA is acting effectively to protect public health. With Vioxx, 
antidepressants in children, and now Ketek, the FDA has repeatedly been 
accused of suppressing internal safety concerns and ignoring repeated 
warnings of safety concerns from the FDA's own scientists.
  We need to restore the public trust in this vital agency, rid it of 
undue influences that benefit a political, rather than a public health, 
agenda, and, above all, we need to adequately fund the FDA through the 
appropriations process so that the agency is less reliant on user fees 
collected from private industry. Congress must act swiftly to give the 
FDA more resources. That, I believe, is how we maintain the FDA as the 
world's gold standard in drug and device safety.
  Senator Grassley and I authored one of the first drug safety and 
clinical trials bills in the Senate in the wake of the Vioxx scandal 
that would have given FDA's office of postmarket drug surveillance the 
independence, stature and funding to take action when a safety problem 
arises. We reintroduced the bill this congress with several colleagues 
on the HELP Committee including Senators Mikulski and Bingaman and I 
thank them for their support. While I do not agree with some of my 
colleagues who have argued that this authority would create a bigger 
bureaucracy at the FDA, our experience showed us that the support to 
move such a proposal simply wasn't there.
  However, I believe that my colleagues and I were able to make 
significant improvements to S. 1082 with respect to drug safety. I 
believe those improvements will strengthen science at the FDA, improve 
transparency of decisionmaking so that dissenting views can be heard, 
and improve safety of drugs once they are on the market.
  The drug safety and clinical trials components of S. 1082 are by no 
means

[[Page 11667]]

perfect. In fact, I have serious concerns about what I view as 
inadequate enforcement authority in the bill and am particularly 
concerned about whether the bill will prevent companies from 
withholding information about clinical trials which were negative or 
were trials that companies abandoned because initial results were 
negative. As demonstrated by Ketek, I am also concerned about whether 
this bill does enough to capture clinical trials conducted overseas. I 
hope we can improve on these provisions when this bill goes to 
conference with the House.
  Today the Senate voted on an important issue dealing with conflicts 
of interest on FDA advisory committees. As demonstrated by the FDA 
advisory committee considering Vioxx, it is clear that the FDA's policy 
with respect to financial conflicts of interest wasn't working. The FDA 
has made modifications to its policy and the underlying legislation 
makes several additional improvements. I believe the amendment offered 
by Senators Durbin and Bingaman would have made great improvements to 
the recruitment of qualified advisory committee members. The amendment 
would have required the FDA to conduct aggressive outreach to 
professional medical and scientific societies to help with recruitment 
for advisory committees, especially ones with the greatest number of 
vacancies. Those are important policy goals and ones that I fully 
support.
  However, I voted against the amendment because I was concerned about 
the impact a hard and fast limit of one waiver per committee meeting 
would have on timely access to drugs and new drug information. 
Specifically, the Pediatric Advisory Committee, a standing FDA advisory 
committee which relies on experts with specific expertise in pediatric 
issues, is an important component of the Best Pharmaceuticals for 
Children Act program. I was concerned that setting an arbitrary limit 
on the number of waivers per committee meeting would further complicate 
an already small pool of qualified individuals in fields such as 
pediatrics.
  I am disappointed that an agreement on the amendment was not reached 
between the bill managers and sponsors of the amendment so that the 
Senate bill could contain the important provisions dealing with 
recruitment and outreach. It is my hope that we can find a way to 
address these issues in the conference with the House.
  Taken as a whole, the underlying legislation is vital to our nation's 
children as well as consumers needing timely access to safe and 
effective drugs. Therefore, it is essential that the House act quickly 
so that we can send a conference report to the President in the coming 
months. I urge the House to pass all of the major provisions contained 
in S. 1082. I support this legislation and look forward to continuing 
to work with my colleagues on both sides of the aisle and in both 
Chambers so that we can send this legislation to the President for his 
signature.
  Mr. KENNEDY. Madam President, I would like to take some time to talk 
about some issues that I haven't spent a great deal of time describing 
to the Senate about S. 1082, the Food and Drug Administration 
Revitalization Act.
  First, I thank Senator Roberts and Senator Harkin for working with 
Senator Enzi and me and with many members of the committee on the 
important issue of direct-to-consumer, or DTC, advertising.
  We have worked together to accomplish our common goal--a 
constitutionally sound, effective, workable way to see that DTC ads 
provide accurate information to patients about the drugs they are 
taking.
  Some have advocated a ban on such advertising altogether, but Senator 
Enzi and I rejected that approach since it failed to meet the 
constitutional test. Instead, we included a more measured provision in 
our legislation that allows FDA to impose a moratorium in extraordinary 
circumstances where needed to protect public health.
  During our committee's consideration of this issue, Senator Roberts 
brought up his concerns that even this limited provision fell afoul of 
recent Supreme Court decisions on free speech. Senator Harkin raised 
his strong interest in seeing that these DTC ads include strong, 
effective safety information that is clearly and prominently presented 
to consumers in a way that does not gloss over important information. 
Senator Enzi and I committed to work with Senator Roberts to see that 
any provision on DTC met the constitutional threshold, and we agreed to 
work with Senator Harkin to make certain that it provided strong safety 
information to consumers. The result of our discussions is an amendment 
that our two colleagues offered. It is a true bipartisan compromise, 
worked out by two Senators committed to making real progress on an 
important issue, and I am pleased to support the amendment.
  Instead of the moratorium included in our original bill, the Roberts-
Harkin amendment puts in place strong safety disclosures for DTC ads, 
coupled with effective enforcement. Under current law, safety 
disclosures can be an afterthought--a rushed disclaimer read by an 
announcer at the conclusion of a TV ad while distracting images help 
gloss over the important information provided. Our proposal requires 
safety announcements to be presented in a manner that is clear and 
conspicuous without distracting imagery.
  We also give FDA the authority to require safety disclosures in DTC 
ads if the risk profile of the drug requires them. Senator Roberts had 
a concern that this authority not be used indiscriminately, so we have 
made clear that the required disclosure must pertain to a specific 
identified risk.
  We have made important improvements in FDA's ability to enforce the 
requirement to provide clear and accurate information to consumers.
  For advertisements, as in so many other areas, FDA's enforcement 
tools are now limited. Although FDA does have the capacity under 
current law to remove a drug from the market for misleading ads, that 
authority is not often used and rightly so, since it punishes patients 
for the transgressions of the manufacturers. Since removing a drug from 
the market is an empty threat, FDA is often left with little option but 
to make polite requests to companies to change their ads. Under the 
Roberts-Harkin amendment, FDA will have the ability to levy fines of up 
to $150,000 for false or misleading ads.
  It is unacceptable for patients to be put at risk by inaccurate ads. 
The Roberts-Harkin amendment makes certain that FDA will have the 
ability to see that this does not occur, in a way that is clearly 
consistent with the Constitution.
  The amendment is a victory for bipartisan common sense on a difficult 
issue.
  I would also like to address the affect of title II of this bill. 
Generally speaking, title II grants the FDA new authority to conduct 
postapproval safety surveillance activity in order to improve drug 
safety.
  In enacting title II, we do not intend to alter existing State law 
duties imposed on the holder of an approved drug application to obtain 
and disclose information regarding drug safety hazards either before or 
after the drug receives FDA approval or labeling. Nor are we expressing 
a belief that the regulatory scheme embodied in the bill is 
comprehensive enough to preempt the field or every aspect of State law. 
FDA's approved label has always been understood to be the minimum 
requirement necessary for approval. In providing the FDA with new tools 
and enhanced authority to determine drug safety, we do not intend to 
convert this minimum requirement into a maximum.
  As the Institute of Medicine and others have found, the FDA's past 
performance has been inadequate. While we fully expect substantial 
improvement as a result of the enactment of this bill, we cannot and do 
not expect the FDA or this new process to identify every drug-specific 
safety concern before a drug manufacturer becomes aware or should have 
become aware of

[[Page 11668]]

such concerns. Nor are the bill's requirements that holders disclose 
certain safety information to the Government intended to substitute for 
the disclosure requirements that may be required under State law.
  I would also like to focus on another aspect of our legislation, the 
Reagan-Udall Foundation.
  During the discussions that led to consideration of this bill, we 
heard time and again that there was a major need for better research 
tools to aid FDA in evaluating the safety of drugs and help researchers 
move through the long process of developing drugs more effectively. 
Every day that a new medicine is needlessly delayed is another day that 
a patient does not receive a treatment that could well mean the 
difference between health and continued illness. If new research tools 
and better ways to evaluate the safety and effectiveness of drugs could 
be developed, patients will benefit from quicker drug development. If 
current procedures can be made more effective, then the cost of 
developing new drugs will drop.
  One area where scientists can make real progress is developing new 
cell lines and new genetic techniques for testing drugs that reduce the 
need for costly forms of testing.
  The Reagan-Udall Foundation sets up a way to develop these new 
tools--not so they can help just one researcher or one company, but so 
they can help the entire research enterprise. New ways to test drugs 
for effectiveness and safety will bring new advances to patients 
quicker and more smoothly. Through the Reagan-Udall Foundation, they 
will be available to the FDA and to the entire research enterprise. 
This new foundation is not many pages in a long bill, but it is an 
important component to help get needed medicines to patients as quickly 
as safety will allow.
  I also wish to mention another critical aspect of our legislation--
its registry of clinical trials.
  This provision serves two essential purposes. First, it allows 
patients who want to enroll in those trials an accessible and central 
Internet site to find out which trials are being conducted and whether 
they might be eligible.
  This provision builds on an existing provision of law to create a 
clinical trials site, but report after report has shown that the 
requirement to list trials has not been complied with. Our legislation 
puts more force in the requirement to list trials so that patients will 
benefit.
  Listing trials is important for patient access--but reporting results 
is critical for safety. Our legislation requires that the results of 
trials be reported. No longer will companies be able to hide the 
outcome of a trial that did not turn out the way they hoped.
  Examples of this kind of abuse are shocking. The manufacturer of the 
antidepressant drug Paxil conducted five clinical trials of the drug in 
adolescents and children, yet published only one study whose mixed 
results it deemed positive. The company sat on two major studies for up 
to 4 years, although the results of one were divulged by a 
whistleblower and all of the studies were submitted to the FDA when the 
company sought approval for new uses of Paxil. At that time it became 
apparent that Paxil was no more effective than a placebo in treating 
adolescent depression.
  Under the bill, these kinds of abuses will not be permitted, since 
clinical trials will have to be reported--no matter what the result.
  Senator Enzi, Senator Dodd and many others in the committee worked 
hard to get this provision right. We require immediate listing of all 
publicly available data and require a negotiated rulemaking, backed by 
the full authority of statute to develop the precise requirements for 
other results information to be included.
  I would like to thank my colleagues for considering these comments as 
they relate to S. 1082, and I urge my colleagues to support the bill.
  Mr. COBURN. Madam President, as we debate the important issue of drug 
safety, I want to address the safety of one drug in particular: RU-486 
or mifepristone. This drug was approved in 2000 under a special 
pathway, subpart H drug approval that is reserved for drugs that treat 
severe or life-threatening illnesses. Subpart H approvals generally 
require a special ``restricted distribution'' approval process. 
Unfortunately some drugs, RU-486 for example, approved under subpart H 
have caused serious adverse health events in women.
  Every drug approved under Subpart H is listed on the Food and Drug 
Administration's Web site. The vast majority of drugs listed combat HIV 
or specific types of cancer. One governs the use of thalidomide in 
treating leprosy. These drugs are supposed to relate to the treatment 
of life-threatening illnesses.
  One example of a subpart H approval makes a mockery of the regulatory 
process by an expedited approval of two extremely risky drugs for 
abortions. Pregnancy is not an illness and certainly not one that is 
life-threatening in the first 7 weeks, unless it is a tubal or ectopic 
pregnancy in which case RU-486 abortions are absolutely 
contraindicated.
  RU-486 was inappropriately approved in 2000. RU-486 was approved 
using special ``subpart H'' regulations to address problems for 
``certain new drug products that have been studied for their safety and 
effectiveness in treating serious or life-threatening illnesses . . .'' 
and under restricted distribution conditions due to serious hazards 
presented by the drug; for example, severe hemorrhage and ectopic 
pregnancies. This was an inappropriate approval of RU-486 as pregnancy 
is not normally a life-threatening condition. Today many health care 
providers do not follow the limited distribution requirements of RU-
486's approval.
  RU-486 has put women's lives at risk. To date there have been six 
North American deaths related to the use of the RU-486 abortion 
regimen: Five Americans and one Canadian have died from septic shock 
stemming from infection by the anaerobic bacteria Clostridium 
sordellii. Five other international deaths have been related to RU-486.
  RU-486 causes serious safety issues. More than 1,000 adverse event 
reports--232 hospitalizations, 116 blood transfusions, and 88 cases of 
infection--have been submitted regarding RU-486 and are significant 
because they confirm that large numbers of mifepristone patients 
require surgical intervention for infection, hemorrhage, complications 
from ectopic pregnancy, and incomplete abortions. While lives have been 
lost from the use of RU-486, not a single case has been documented 
where RU-486 has been used to save a woman's life.
  RU-486 is not always effective and when it is not the consequences 
are dire. I recently learned of a woman who was given RU-486 after she 
had a seizure. Her physicians assumed that the seizure was life-
threatening to the baby she was carrying and gave her RU-486 for a 
therapeutic abortion.
  RU-486 was not effective in her case and the woman carried the baby 
to term. When the baby was born at a low birth weight, it also suffered 
from failure to thrive. That baby has had three subsequent brain 
surgeries due to hydrocephalus. The baby also suffers from idiopathic 
lymphocytocholitis--an inflammatory disease of the colon, which is 
extremely rare in children. It is clear that RU-486 not only is unsafe 
in women, but it is also not completely effective. And when it is not 
effective, the results are devastating.
  I appreciate the desire to effect safer drugs through this bill. 
Senator Kennedy and Senator Enzi have done a great deal of work in 
designing the REMS scheme for certain drugs to ensure that they can be 
safely and effectively used.
  Under the risk evaluation and mitigation system, REMS, provisions of 
this drug safety bill, a drug that has previously been approved under 
subpart H is deemed to have a REMS. Every REMS is subject to a periodic 
review. Therefore, RU-486 is deemed to have a REMS and is subject to 
periodic review.
  I am pleased that the amendment offered by Senator DeMint was 
accepted by the full Senate. Senator DeMint's amendment sets a ``date 
certain'' REMS assessment for RU-486 to properly evaluate its drug 
safety risks in

[[Page 11669]]

women. Women in this country deserve to know the safety risks 
associated with RU-486.
  The PRESIDING OFFICER. Who yields time? The Senator from Illinois.


                           Amendment No. 1034

  Mr. DURBIN. Madam President, I have an amendment pending and 
scheduled for a vote this morning on the conflict of interest 
provision. I believe I have 5 minutes to speak to it.
  The PRESIDING OFFICER. The Senator does have 5 minutes.
  Mr. DURBIN. I ask the chairman and ranking member if this a 
convenient time to raise the issue?
  Thank you very much.
  Yesterday I proposed this amendment with Senator Bingaman. The Food 
and Drug Administration Advisory Committees make important decisions, 
life-and-death decisions. They decide whether the drugs and medical 
devices which are going to be used in America are safe and effective. 
In other words, if a person in America has a prescription from a doctor 
and takes this drug, is it going to be good for their health, or bad?
  This is a critical situation. If they make the wrong decision, if the 
advisory committee turns a dangerous drug loose on the market, it can 
have terrible consequences, so these committees literally have life-
and-death decisions in their hands on approving drugs, on deciding what 
the warning labels say, deciding what you have to say in advertising. 
There might be a danger in these drugs. These advisory committees are 
the juries of scientific experts who have to make these calls. That is 
one of the most important decisions of our Government.
  They are not just life-and-death decisions, they are decisions 
involving millions and millions of dollars. Drug companies spend a 
fortune over a long period of time trying to bring a drug to market. 
They would hope this will be a drug very popular and profitable for 
them and their shareholders. That is a natural inclination of a 
business. So the advisory committee not only decides the safety and 
efficacy of the product, it makes a decision which has a direct impact 
worth millions of dollars to the drug companies involved.
  Do you know what we found out? We found out over the last 10 years 
many people sitting on these advisory committees, those who are 
actually sitting on the so-called juries and deciding the fate of these 
drugs, have a conflict of interest. Some of them were already 
receiving, from the companies that make the drugs, tens of thousands of 
dollars in consulting fees and speaking fees. It turns out they are on 
the payroll, some of them, of the very companies on which they are 
being asked to stand in judgment. That is a conflict of interest which 
people cannot accept and I cannot accept.
  The Food and Drug Administration argues that there are so few experts 
that we have to sometimes turn to those who have a conflict of 
interest; there is no place else to go. So occasionally we have to put 
a waiver in and allow someone to sit on an advisory committee panel who 
frankly has a financial interest in the company they are making a 
decision about.
  That worries me. Because if you are going to have truly objective 
jurisdictions, that are right for the consumers of America, that 
approve drugs or disapprove them on the merits, not because of some 
inclination or prejudice which you might bring to the table, you don't 
need these conflicts of interest.
  So basically what Senator Bingaman and I have said is: Let's 
strengthen the conflict-of-interest provisions on advisory committees. 
Let's make certain that there is confidence in the process. We know 
what happened with Vioxx. There were 10 people sitting on the advisory 
committee who had a financial conflict of interest. Had they been 
removed from the deliberation, the panel would not have recommended 
they go back on the market, endangering the health of thousands of 
Americans.
  How can you ever justify that kind of conflict of interest? Our 
language tightens it. What we are trying to do is to make sure the Food 
and Drug Administration, with this amendment, limits the number of 
waivers to one per each advisory committee meeting, allows advisory 
committees to receive information from guest experts who have a 
financial conflict but prevents those experts from participating in the 
deliberations.
  They can come in and express their point of view and then leave the 
room before the deliberation and the vote take place. And also 
strengthen the provisions to increase the outreach for new experts. The 
Food and Drug Administration has to do a better job of cultivating this 
new cadre of trustworthy experts who can serve on these advisory 
committees.
  We have 125 medical schools in this country, 90 schools of pharmacy, 
40 schools of public health. If the FDA is more aggressive in filling 
the slots on the advisory committees, we can remove this shadow of 
doubt which is over this process.
  Now, some will argue: Well, the FDA has come forward with draft 
guidance to improve this. This is draft guidance. They are suggestions. 
This is law. This tells them they will have to follow the law to avoid 
these conflicts of interest. This is not an idea that Senator Bingaman 
and I bring to the table without support.
  I ask unanimous consent, Madam President, to have printed in the 
Record with my remarks letters from the Consumers Union, the Union of 
Concerned Scientists, and a broader letter from 11 different 
organization that support this amendment, that would reduce and 
eliminate the conflicts of interest when it comes to approving new 
drugs and medical devices. What is at stake is the integrity of the 
Food and Drug Administration, the integrity of the process, and making 
certain we can say, with a straight face to American consumers, the 
products that are coming to the market, the life-and-death decisions 
that are being made that bring them to the market are being made by 
people who do not have a financial conflict of interest with these 
devices. I urge my colleagues to support the Durbin-Bingaman amendment.
  I ask unanimous consent these letters be printed in the Record after 
my remarks.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                              Consumers Union,

                                                      May 8, 2007.
       Dear Senator, Consumers Union, the nonprofit, independent 
     publisher of Consumer Reports, urges you to support the 
     Durbin-Bingaman amendment to S. 1082, the Food and Drug 
     Administration Revitalization Act. This amendment will help 
     ensure that FDA advisory committees responsible for assessing 
     a drug's safety are not inappropriately influenced by 
     scientists or others with financial ties to the affected drug 
     company.
       A recent national survey by Consumer Reports National 
     Research Center found that Americans are extremely concerned 
     about the pharmaceutical industry's influence on the drug 
     safety process, as well as financial conflicts on FDA 
     advisory boards.
       Sixty percent of those surveyed disapproved of allowing 
     doctors and scientists with a conflicting financial interest 
     to participate on advisory boards. And 84 percent of 
     consumers agree that drug companies have too much influence 
     over the government officials who regulate them.
       This amendment would make it more difficult for the FDA to 
     issue financial conflicts of interest waivers to the 
     scientific experts who serve on its advisory committees. The 
     Durbin-Bingaman amendment would: limit the number of waivers 
     to one per advisory committee meeting; establish a specific 
     process to allow experts with a financial conflict to present 
     information to an advisory committee, while not permitting 
     them to deliberate or vote with the committee; and enhance 
     the FDA's outreach activities for identifying non-conflicted 
     experts to participate in advisory committees.
       The integrity of the FDA advisory process is vital to 
     ensuring that decisions by federal policymakers benefit the 
     public, and not the agendas of any special interest.
       Please support the Durbin-Bingaman amendment to S. 1082. If 
     you have any questions, please contact Bill Vaughan.
           Sincerely,
                                                     Bill Vaughan,
     Senior Policy Analyst.
                                  ____

                                                      May 8, 2007.
       Dear Senator: The Union of Concerned Scientists strongly 
     urges you to support the Durbin-Bingaman amendment to the FDA 
     Revitalization Act, S. 1082. This amendment will help ensure 
     that the Food and Drug Agency's assessment of the safety and 
     efficacy of drugs is not inappropriately influenced by 
     scientists with ties to the drug

[[Page 11670]]

     companies affected by an FDA approval decision.
       This amendment would make it more difficult for the FDA to 
     issue financial conflicts of interest waivers to the 
     scientific experts who serve on its 30-plus advisory 
     committees.
       Conflicts of interest can have serious consequences for 
     drug safety. For example, ten of the 32 scientists on the 
     February 2005 advisory committee that considered the safety 
     of Cox-2 inhibitors, including Vioxx, had ties to the drug 
     companies that made the products. The scientists voted to 
     permit the companies to continue marketing the drugs, even 
     though Vioxx had already been withdrawn from the market and 
     had been implicated in tens of thousands of deaths.
       The Durbin-Bingaman amendment would: limit the number of 
     waivers to one per advisory committee meeting; establish a 
     specific process to allow experts with a financial conflict 
     to present information to an advisory committee, while not 
     permitting them to deliberate or vote with the committee; and 
     enhance the FDA's outreach activities for identifying non-
     conflicted experts to participate in advisory committees.
       The integrity of science is vital to ensuring that 
     decisions by federal policymakers benefit the public, and not 
     the agendas of any special interest. We at the Union of 
     Concerned Scientists are working to ensure that federal 
     scientists, and those who advise federal agencies, are free 
     to do their work without interference. This amendment will be 
     a constructive step in addressing the pervasive problem of 
     political interference in government science.
       For all these reasons, we believe that the Durbin-Bingaman 
     amendment merits your support. Please call our Washington 
     Representative Celia Wexler if you'd like more information on 
     either S. 1082 or the amendment.
           Sincerely,

                                          Dr. Francesca Grifo,

                           Director, Scientific Integrity Program,
     Union of Concerned Scientists.
                                  ____

                                                   April 30, 2007.
     Senator Jeff Bingaman,
     Washington, DC.
       Dear Senator Bingaman: We, the undersigned organizations, 
     give our wholehearted support to the amendment to S. 1082 
     that you plan to offer next week that would limit the number 
     of conflict of interest waivers allowed on Food and Drug 
     Administration advisory committees. This amendment would end 
     the vast majority of conflicts of interest while insuring 
     that the FDA has access to the best advice that this nation 
     has to offer.
       The amendment would: require the FDA to engage in greater 
     efforts to find experts without conflicts of interest to 
     serve on its advisory committees; limit the number of waivers 
     that can be granted to one per committee per year; and 
     authorize the FDA to hire experts who have conflicts of 
     interest to make presentations and answer questions at an 
     advisory committee meeting if the FDA believes their 
     expertise is crucial. However, these experts will not be 
     allowed to vote or otherwise participate in the discussions 
     leading up to committee vote.
       The FDA advisory committee process has been severely 
     compromised in recent years. According to the agency's most 
     recent report, one in four experts advising the FDA received 
     waivers because they have financial ties to companies with a 
     stake in the outcome of advisory committee meetings. At the 
     February 2005 meeting which voted to allow continued 
     marketing of Vioxx and Bextra, nearly a third of the advisers 
     had ties to Cox-2 manufacturers and had their votes not been 
     counted, the vote would have been reversed.
       The status quo is undermining the public's faith in the 
     ability of the FDA to protect it from unsafe or ineffective 
     drugs. We believe passing this amendment will help rebuild 
     the public's confidence in the integrity of the scientific 
     process at the FDA. Please circulate this letter among your 
     colleagues and encourage them to vote yes on the Bingaman 
     amendment.
           Sincerely,
         Center for Medical Consumers, Center for Science in the 
           Public Interest, Consumers Union, Government 
           Accountability Project, National Research Center for 
           Women & Families, National Women's Health Network, 
           Reproductive Health Technologies Project, Title II 
           Community AIDS National Network, Union of Concerned 
           Scientists, U.S. PIRG, Woody Matters.

  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Madam President, I wish to thank the Senator from 
Massachusetts, Mr. Kennedy, for the statement he made a little bit 
earlier but mostly for the 2\1/2\ years' worth of effort he and I have 
put into this bill. It has been a very cooperative process between he 
and I and between the Members on both sides of the aisle on the 
committee.
  There have been a lot of points raised about food and drug safety, 
particularly drug safety. It has been a cooperative process, as I 
mentioned. We have had a lot of questions. We have had some 
disagreements. But what that has resulted in is going back and getting 
more information and finding a way that we can come up with a solution 
that will provide more assurance to Americans that their drugs will be 
safe.
  I also wish to thank the people at the Food and Drug Administration 
for their participation in this lengthy process and providing answers. 
It has been a long road for this bill. I do strongly urge my colleagues 
to vote ``yes'' on final passage and endorse the most comprehensive 
drug safety overhaul in more than a decade.
  Completion of this bill marks yet another significant step in the 
process, but there is more work to be done. The House needs to pass 
their version of the legislation, and then the two bodies need to work 
out differences in the conference committee. My hope and expectation is 
that the House will act in a reasonable manner and soon because this is 
widely considered to be must-pass legislation.
  This key FDA package includes four reauthorizations that must be done 
this year, along with the essential new authorities for the FDA to be 
able to react in a timely way to safety problems that arise after a 
drug has been brought to the market.
  I would like to take a couple minutes to recap for my colleagues the 
path this legislation has taken thus far. The Senate Committee on 
Health, Education, Labor, and Pensions conducted a top-to-bottom review 
of the FDA's drug safety and approval processes over 2 years ago. We 
did that at the same time the Finance Committee was doing a review of 
the FDA's safety approval processes.
  We used this information plus information from other Senators to do 
this bill. The bill is a culmination of that review and our continued 
evaluation and analysis of the FDA. The changes made in the drug safety 
components of this legislation are critical to restoring peace of mind 
to Americans who want to be assured the drugs they purchase to treat 
illnesses and chronic medical conditions can be relied upon and 
trusted.
  Given the limitations we identified during our review of the FDA, I 
felt strongly it was necessary to correct those problems and ensure 
that the FDA has the right tools in the toolbox to address drug safety 
after the drug is on the market. That is why this bill creates the Risk 
Evaluation and Mitigation Strategy or REMS. The REMS give the FDA the 
full toolbox of options for dealing with potential safety problems, 
even if they are discovered after the drug is first marketed.
  Our goal is to get the drugs to the market quicker and to discover 
problems faster and get them corrected. With this new toolbox, the FDA 
has the ability to identify side effects after the drug is marketed 
through active surveillance. FDA has the authority to request a 
separate study or clinical trial to learn more about a particular 
potential safety problem.
  FDA can also obtain timely label changes for the first time under 
this Risk Evaluation and Mitigation Strategy System. Through the REMS 
process, the bill also makes several key improvements to how patients 
get their information through advertising and labeling.
  I wish to thank my colleague, Senator Roberts, for his tireless 
efforts to provide an appropriate balance for direct-to-consumer 
advertising. It was not an easy task to reconcile some very different 
opinions. I am so pleased we were able to reach a resolution on this 
issue that we can all support.
  I also thank my colleagues, Senator Harkin and Senator Kennedy, for 
their hard work on this issue. Senator Roberts had planned to vote for 
S. 1082 but cannot be here today because he is in Kansas showing the 
President the damage from the tornadoes. I wish him all the best in 
helping his State recover from that tragedy.
  The FDA currently has very little authority to require labeling 
changes after a drug is brought to market. We have included provisions 
that ensure discussions between FDA and a drug manufacturer regarding 
the labeling

[[Page 11671]]

changes come to a close quickly and effectively, rather than relying on 
FDA's nuclear option, which is pulling the drug completely off the 
market.
  This legislation gives FDA the tools needed to get drugs to the 
market quickly and efficiently and to respond to potential problems the 
same way, especially when lives are on the line and people need new 
drugs and therapies.
  FDA currently has no mechanism from active, routine surveillance of 
potential safety problems. It cannot easily detect safety problems 
after a drug has been put on the market. This legislation fixes that 
challenge and ensures that FDA has the right tools to address drug 
safety after the drug is on the market.
  The legislation allows for routine, active safe monitoring using 
large linked databases, what I call health IT for drug safety. I wish 
to thank Senator Gregg for being the champion of this provision and 
ensuring that we crafted this provision properly.
  Not every drug will need a REMS. However, every drug will need a very 
active FDA, an FDA with all the necessary tools to identify and quickly 
manage additional risks.
  Title IV of the bill before us contains a number of critical 
provisions to improve children's health. Up to 75 percent of drugs used 
by kids have not been tested in kids. Without information from 
pediatric studies, kids are often overdosed, underdosed or receive 
ineffective treatment. They may suffer needlessly or even die. The Best 
Pharmaceuticals for Children Act makes drugs safer for kids by creating 
incentives to perform pediatric drug studies. The incentives have 
produced astonishing results. In the 7 years before BPCA incentives, a 
total of 11 pediatric studies were performed; 7 years, 11 studies.
  In the 10 years since incentives were authorized, at least 132 
studies have been completed and more are underway. As a grandfather, I 
am very happy that the law is in place. If my grandson Trey is sick, I 
want the drugs he needs to have been tested for kids. All of us want 
that for our children and grandchildren.
  The bill also reauthorizes a companion study, the Pediatric Research 
Improvement Act, which enables FDA to require a pediatric study if it 
is not done under the incentive program or through the National 
Institutes of Health. These two laws work together as a carrot and a 
stick. I strongly support their reauthorization and continuing to keep 
them together.
  Now, so far I have only talked about drugs for kids. The bill will 
also make medical devices safer for kids. Devices designed for adults 
might not fit in kids. A scaled-down device might fit at first, but a 
child can grow out of it, so doctors have to jury-rig adult devices, 
improvise or use more invasive treatments. In addition, the market for 
kids' devices is small, and the development costs are very high, so few 
kids' devices get made.
  The bill before us creates new incentives to grow the market for 
kid's medical devices. I am hopeful these new incentives will be as 
helpful as the kids' drug incentive. I would like to thank Senator 
Alexander, Senator Allard, Senator Bond, Senator Dodd, Senator Clinton, 
and others for their leadership on behalf of kids.
  A number of other FDA issues were also addressed during debate of 
this legislation. The legislation was improved when the Senate adopted 
a food safety amendment by a vote of 94 to 0. This amendment adds 
additional food safety provisions to better protect our pet food supply 
and track when food is adulterated. My colleagues and I also reached 
consensus that the issue of follow-on biologics will be addressed in 
the Help Committee early this summer.
  As my colleagues know, I have some concerns with the Dorgan amendment 
on drug importation that was adopted last week. I supported the Cochran 
safety amendment that was also adopted. I did not support the Dorgan 
approach to foreign drug importation because I do not believe it 
adequately ensures the safety of the prescription drug supply.
  I was pleased to work with my colleague, Senator Dorgan, to add some 
very significant anticounterfeiting language to the bill in the 
managers' amendment. But a lot of work still remains. I support the 
process moving forward, and I will continue to work with my colleagues 
and Senator Dorgan and Senator Snowe to improve this language during 
the conference process.
  Finally, I would like to thank Senator Hatch for his work on the 
antibiotics and other Hatch-Waxman issues and the follow-on biologics. 
Senator Hatch was responsible for the first FDA Revitalization Act in 
1990, before I was even elected a Member of the Senate. I would like to 
thank him for helping me to bring that full circle and for the 
mentoring he has done as a former chairman of the committee.
  I will have a lot more thank-yous to deliver after the votes, but 
right now we have a bit of business left to conduct.
  I yield the floor and retain the remainder of my time.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Madam President, how much time remains?
  The PRESIDING OFFICER. The managers have 14 minutes.
  Mr. KENNEDY. Madam President, I yield myself 4 minutes.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized 
for 4 minutes.
  Mr. KENNEDY. Madam President, I commend my colleague from Illinois 
and my colleague from New Mexico for their amendment on the conflicts 
of interest and for working with us to address these issues in 
appropriations bills during the past year.
  Their amendment includes many thoughtful proposals I support: 
including the right to call for the FDA to improve its outreach to 
experts who have no conflicts of interest and their right to call for 
greater transparency in the process of waivers.
  But where I disagree with my friend from Illinois and New Mexico is 
that there should be an inflexible cap on the number of waivers for 
conflicts of interests an advisory committee can grant, no matter what 
the expertise of the scientists involved.
  The amendment would impose a one-size-fits all, one waiver per 
conflict, per committee, relegating any additional members with 
conflicts to a secondary guest status on the committee.
  The FDA has recently issued a policy not to grant a waiver for a 
financial interest that exceeds $50,000 and will allow those who 
receive a waiver for a lesser conflict to serve only as members who can 
participate in committee discussions but not vote.
  The hallmark of this proposal is the flexibility it gives to ensure 
the committees will have the adequate expertise. If one or more experts 
with financial conflicts in excess of $50,000 have expertise that is 
essential to a committee, the Commissioner can grant the needed 
waivers. This is expected to be rare, but it can happen if needed.
  Under the Durbin amendment, by contrast, the FDA can grant only one 
waiver per meeting. There is no flexibility on this point.
  The FDA is already experiencing difficulty in filling vacancies on 
advisory committees. The Durbin amendment, no matter how well-
intentioned, would worsen the problems, making it harder to fill 
critical vacancies and slowing the process of reviewing new medicines.
  Let's look at the problem FDA is facing now. The Antiviral Drugs 
Advisory Committee needs six experts with specialized knowledge in the 
fields of clinical pharmacology, internal medicine, infectious 
diseases, microbiology, virology, immunology, pediatrics, and other 
specialties. These experts are needed to review the safety and 
effectiveness of new medicines for pandemic flu, HIV/AIDS, and other 
serious infections. The Anesthesiology and Respiratory Therapy Devices 
Panel has nine vacancies. The Ophthalmology Panel is in need of nine 
experts. The Advisory Committee on Peripheral and Central Nervous 
System Drugs needs six members--on and on down the list, the story is 
the same, critical vacancies, missed opportunities, and missed

[[Page 11672]]

expertise. I am not for conflicts of interest. I am against them. But 
they are a fact of life.
  We need policies that reflect the current reality of research in the 
life sciences. We have increased transparency in this legislation so 
there will be wide understanding of exactly how decisions are made. 
This is the most important. In the time of life sciences, we are 
talking about cross-fertilization of different ideas. Visit the 
Institute of Medicine. They are talking about the life sciences and 
work that is taking place. Flip a molecule and it could be relevant to 
alternative fuels. Flip it again and it can be relevant to agriculture. 
Flip it again and it can be relevant to the health sciences. We need 
all of these disciplines working together. To take one particular 
requirement and exclude the possibility of getting the best in terms of 
future scientists, we need integrity in the FDA, integrity in 
decisionmaking, integrity when they grant waivers. The public ought to 
have the right to know. We have a balance in here. Hopefully, we will 
retain it.
  I withhold the remainder of my time.


                           Amendment No. 1039

  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. GRASSLEY. Madam President, I yield myself 5 minutes out of the 10 
allotted to me.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GRASSLEY. I am going to speak about amendment No. 1039. I ask 
unanimous consent that Senators Mikulski, Brown, Snowe, and Bingaman be 
added as cosponsors.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GRASSLEY. This amendment is important because S. 1082 does not 
sufficiently address the underlying problems I have found existing at 
the Food and Drug Administration during my tenure as chairman of the 
Senate Finance Committee looking into the problems of the Food and Drug 
Administration, with the goal in mind that the Federal Government 
should only be paying for drugs that are safe. That problem is the lack 
of equality between the Office of New Drugs, which reviews drug 
applications and decides whether to approve a drug for marketing, and 
the Office of Surveillance and Epidemiology, the office which monitors 
and assesses the safety of drugs postmarketing.
  Many times I quote the Institute of Medicine as justification for my 
amendment. They recognize this problem. The Institute of Medicine 
recognizes joint authority between these two offices for postapproval 
regulatory action related to safety. Even the Consumers Union supports 
this amendment.
  Having equality between preapproval and postapproval offices at the 
FDA is fundamental to real reform. Concentrating on the entire life 
cycle of drugs is critical. After all, the vast majority of a drug's 
life cycle is spent postapproval. In essence, the bill before us 
promotes the status quo when it comes to the specific role played by 
the Office of Surveillance. That means the Office of Surveillance and 
Epidemiology will remain nothing more than a mere consultant to the 
Office of New Drugs. This is not acceptable.
  Amendment 1039 gives the Office of Surveillance sign-off authority. 
They are experts in postmarketing safety. Even the Institute of 
Medicine recognized that through their recommendations. Let me be 
clear: This is not the amendment Senator Dodd and I originally 
proposed. I still believe an independent postmarketing safety center 
would be best to solve the problem. But under the process, that is not 
going to happen. Through this amendment, at least joint postmarketing 
decisionmaking between the Office of Surveillance and the Office of New 
Drugs will allow the office with the postmarketing safety expertise to 
have a say in what drug safety action will be taken by the FDA.
  The problem is not only the FDA having enough tools--this bill gives 
additional tools--it is about FDA managers disregarding concerns raised 
by its own scientists in the Office of Surveillance and not taking 
prompt action. This amendment makes common sense when you weigh the 
evidence I presented over the last 3 years about these problems at the 
FDA.
  Opponents of this amendment say it is unnecessary because the bill 
includes a dispute resolution process with strict deadlines. But that 
process is for disputes between the FDA and the drug company, not 
internal disagreements between FDA offices.
  Getting down to brass tacks, when the office that looks at 
postmarketing surveillance is under the thumb of the Office of New 
Drugs, and the Office of New Drugs says: This drug is safe, they aren't 
going to want to get egg on their faces by listening to the advice of 
the Office of Postmarketing Surveillance. If that had been the case, 
Dr. Graham, in the case of Vioxx, and Dr. Mosholder, in the case of 
antidepressant drugs, when kids were committing suicide, would have 
been listened to, but they weren't until they came as whistleblowers to 
the Congress.
  We have to have it so that we have enough independent decisionmaking 
within the FDA to make sure these drugs are safe.
  This amendment provides an approach with checks and balances between 
the office that approves a drug for marketing and the office that 
watches a drug once it is on the market.
  The PRESIDING OFFICER. The Senator has used 5 minutes.
  Who yields time?
  The Senator from Wyoming.
  Mr. ENZI. Madam President, I yield myself such time as I need.
  I rise in opposition to the amendment offered by my colleague from 
Iowa, Senator Grassley, No. 1039, regarding the joint signing authority 
under the Office of New Drugs and the Office of Surveillance and 
Epidemiology. This amendment would add an unnecessary layer of 
bureaucracy into an agency that we have designed to be nimble and 
responsive in their process to deal with emerging drug safety issues.
  Before the bill is passed, the option after market is to suggest 
changes or pull the drug off the market, kind of a nuclear option. The 
underlying bill has surveillance and techniques to notice problems 
quicker. That is why we will be able to get drugs on to the market 
faster. The underlying bill does have a dispute resolution process with 
firm and tight deadlines. There is both one with companies and with 
staff disputes. It requires by its very nature close collaboration 
between the two offices. This amendment only serves to separate what 
should be a together process and delay what should be a rapid process.
  I urge my colleagues to oppose the amendment. The tools we have put 
in the toolbox will do what the Senator from Iowa wants to have done, 
which is quick response when there is a problem. I hope we don't add 
this extra layer of bureaucracy. We looked at this problem through a 
number of hearings and a number of concerns by members on the committee 
from both sides and came up with this third way for being able to do it 
that had not been polarized and that had some agreement. I hope people 
will stick with what is in the bill.
  I yield the floor and reserve the remainder of my time.
  The PRESIDING OFFICER. The Senator from Iowa.


                           Amendment No. 998

  Mr. GRASSLEY. Madam President, I yield myself such time as I consume 
on amendment No. 998. I ask unanimous consent that Senators Dodd, 
Snowe, and Bingaman be added as cosponsors.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GRASSLEY. This amendment provides for the application of stronger 
civil monetary penalties for violations of approved risk evaluation and 
mitigation strategies. Currently, the bill before us contains 
penalties, but those penalties won't mean much to large global 
corporations. In fact, the penalties amount to the cost of doing 
business. This amendment is intended, then, to give the Food and Drug 
Administration, the watchdog, some bite along with its bark.
  There is opposition to having strong civil monetary penalties, but 
that does

[[Page 11673]]

not make sense to this Senator. Even the Consumers Union supports this 
amendment. The reality is, drug companies provide lifesaving 
pharmaceuticals throughout the world. The pharmaceutical companies make 
miracles happen. Before a drug is approved, a drug company has an 
incentive to provide evidence of a drug's effectiveness to the Food and 
Drug Administration. Without it, they can't sell drugs in this country. 
However, once a drug is already being sold in the marketplace, drug 
companies have almost no incentive to look for and evaluate safety 
issues. The bottom line is, sometimes market forces guide businesses in 
a way that may be contrary to the public interest.
  We have seen this happen many times. For the Food and Drug 
Administration's new authorities to be meaningful in this legislation, 
there must be stronger civil monetary penalties in the underlying bill; 
hence, my amendment. Fines are nothing more than the cost of doing 
business, and we can't change behavior. More importantly, we can't even 
deter bad behavior. If a company does what it is supposed to do, a drug 
company doesn't need to fear any penalties. It is that simple.
  I ask Members of the Senate to support this amendment because it adds 
real teeth to the FDA's bite.
  I thank Senators Kennedy and Enzi for the tremendous efforts they 
went to in bringing this bill to the Senate floor. Again, I want to 
make this bill even better. They have already included several ideas 
Senator Dodd and I have shared with them.
  I reserve the remainder of my time.
  The PRESIDING OFFICER. Who yields time?
  Mr. ENZI. Madam President, I yield myself such time as I need.
  I thank the Senator from Iowa, Mr. Grassley, for his participation in 
this bill. It has been tremendous. I mentioned the hearings he held, as 
we were holding hearings, as there were some crises with food and 
drugs. The valuable information he shared with us, as well as 
amendments, as he has correctly stated, are already a part of the bill.
  With respect to amendment No. 998, I also have to oppose this 
amendment regarding the level of civil monetary penalties that can be 
assessed for violations of the drug safety plan.
  I appreciate Senator Kennedy's earlier comments. The level of civil 
penalties in the underlying bill was carefully crafted to reflect 
existing FDA policies for other regulated products. This is the first 
time we have had civil penalties in this portion covering the area of 
food and drugs. It was no small feat to get a consensus position so 
that we could have civil penalties in the bill, and I think that is 
necessary.
  There is a precedent for the levels that we have selected, the 
current levels. Medical devices has the same levels. I reiterate that 
has never before been available to the FDA as a tool on drug safety 
issues, but we are providing it as a tool. Furthermore, I believe the 
very threat of a civil penalty is sufficient to deter bad behavior. 
This is the name-and-shame principle. The fine may be affordable to the 
company, but the loss of reputation is not.
  I urge my colleagues to oppose this amendment as well. This is not 
the end of the process. I suspect the House will have something to say 
on it, as I have mentioned to the Senator from Iowa before. There will 
be additional negotiations, I am certain, on civil penalties. I hope we 
will stick with the civil penalties that have a basis in the medical 
devices as some basis from which to negotiate and would hope that the 
Senate position will be the one that is in the bill. I ask people to 
oppose the amendment.
  I yield the floor and reserve the remainder of my time.
  The PRESIDING OFFICER (Mr. Casey). The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, how much time do I have?
  The PRESIDING OFFICER. The Senator has 10 minutes remaining.
  Mr. KENNEDY. Mr. President, I yield myself 5 minutes.
  I support the comments Senator Enzi has made about the fines. We are 
going to have to look at this in conference, and it is clear the House 
is going to raise the fines, it seems to me, as Senator Enzi pointed 
out. So we will have a chance to look at it in conference. I think that 
is probably the best way to do it.
  Let me point out two other items--something I think most Americans 
have been concerned about in recent times. It was reported today that 
China has detained managers from two companies linked to contaminated 
foods. As a first step, we need to determine the extent of the 
contamination and see how far into the food supply this internal 
adulteration has gone.
  Yesterday's report from the FDA that contaminated wheat flour from 
China was fed to fish raised for human consumption is another example 
of the need for a comprehensive examination of our food safety system. 
We also found out yesterday that what we thought was contaminated 
highly processed wheat gluten was actually unprocessed wheat flour 
spiked with melamine to make it appear to be higher quality.
  A month ago, the FDA warned that certain types of pet food were 
suspected of being contaminated. Then, there were more kinds of pet 
food. Then it was hogs being fed the contaminated food, but those had 
been caught before human consumption. Then we found out that tens of 
millions of chickens eaten by people had been fed the tainted food. 
Yesterday, we were informed that fish raised for human consumption had 
been fed contaminated food.
  The incremental expansion of this crisis raises serious concerns 
about the FDA's ability to rapidly identify the source of food-related 
problems and bring to bear the effective tools. We know the issue of 
food safety is divided into different kinds of committees, but it has 
to be of concern to American families.
  We have included strong new protections to allow FDA to better ensure 
the safety of human and pet foods, but this is a first step. Senator 
Enzi and Senator Durbin have joined with me and others and we are 
committed to taking a comprehensive look at the safety of our food 
supply and we are committed to taking the actions, with our colleagues, 
needed to ensure that the foods our families and pets eat are as safe 
as possible.
  As part of the managers' package adopted last night, we included 
important new provisions to allow the FDA to oversee the safety of 
farm-raised fish. We owe this--this is a story in the paper today--to 
Senators Lincoln and Pryor and Sessions on this important proposal.
  This morning's newspaper talks about doctors reaping millions for the 
use of anemia drugs. People are going to wonder what we are doing in 
this bill, if anything, on this issue. Well, this is not what the FDA 
does exactly. It is safety and efficacy. But there are different 
agencies in what they call health research and quality. AHRQ has 
responsibility for this. We will be in touch with them to examine this 
issue and provide better guidance and recommendations to doctors and 
patients.
  The FDA does not practice medicine. But this kind of action has to be 
of concern because it reflects itself in increased costs to the 
American consumer, and it does raise health issues as well.
  So this is illustrative of the range of different areas of concerns 
the American families have. We believe we have made very important and 
substantial progress in trying to address those questions.
  Mr. President, at this time I will withhold the remainder of my time.
  The PRESIDING OFFICER. Who yields time?
  The Senator from Wyoming.


                           Amendment No. 1034

  Mr. ENZI. Mr. President, I have to make some comments in regard to 
the other amendment we will be voting on this morning, which I also 
hope people will oppose, and that is amendment No. 1034, offered by my 
colleague from Illinois, Senator Durbin.
  The FDA relies on 30 advisory committees to provide independent 
expert advice, which lends credibility to the product review process 
and informs

[[Page 11674]]

consumers of trends and product development. Given the complex issues 
that are considered by the FDA, outside help is needed and beneficial, 
and it is advisory. The decisions are not made by the committees. They 
advise. But any scientist who is expert enough to merit interest by the 
FDA has almost certainly merited interest by other entities, such as 
granting agencies and companies involved in the field.
  This amendment would seriously limit the FDA's ability to access the 
best experts in the field to assist the Agency with its decisionmaking 
process. It would restrict FDA to granting only one waiver per 
committee meeting.
  How would the FDA decide who gets that one waiver? Who is more 
worthy, the toxicologist, the drug safety expert, the specialist in 
women's health? These are not easy answers.
  The FDA, in March, released a guidance document outlining strict new 
limits on evaluating advisory personnel committee members for service. 
The comment period on this guidance has not even closed. It is 
premature to void that guidance before we even know whether and how it 
will work.
  Let's take a step back and think about what might happen if we do not 
allow people who have worked with or for industry to be involved in an 
advisory committee meeting.
  Louis Pasteur was a brilliant microbiologist who revolutionized human 
food and health safety. Every time you buy milk in the grocery store, 
you are benefiting from his contributions to society. But under the 
Durbin amendment, Pasteur would probably not have been able to serve on 
any advisory committee. You see, Pasteur's research was funded by the 
wine industry.
  Now, do you want to prevent the FDA from benefiting from the advice 
of the best and the brightest they have to offer? We do want to move so 
there are not conflicts of interest. I think the guidelines that are 
out there, if finalized, will do that. The amendment almost gets into a 
position of not conflicts of interest but biases--much harder to 
determine. If we are going to do that, we will never be able to have 
anybody on any of the committees, particularly with the expertise we 
need.
  So I ask we oppose that amendment as well.
  I yield time to the Republican leader.
  The PRESIDING OFFICER. The Republican leader is recognized.
  Mr. McCONNELL. Mr. President, I thank my friend from Wyoming.
  I wish to take a moment to congratulate Senator Enzi on this 
wonderful, bipartisan effort he has been engaged in with our friend 
from Massachusetts, Senator Kennedy. They have worked tirelessly for 
the past 3 weeks, through markup and floor consideration.
  I also wish to commend Senator Gregg, who worked very hard with 
Senator Enzi to reach a bipartisan compromise on this important 
measure.
  I particularly wish to note Senator Roberts was instrumental in 
working out the problems with direct-to-consumer advertising 
provisions. I know he would have liked to have been here today to 
support this bill, but he is out in Kansas with the President touring 
hurricane damage in his State.
  Also, I wish to commend Senator Cochran. We appreciate his efforts to 
ensure that any proposal to bring drugs in from other countries must be 
certified by the Secretary of Health and Human Services as safe for the 
American people.
  So again, I thank the Senator from Wyoming for his extraordinary 
accomplishment in moving this important, bipartisan legislation 
forward.
  With that, I yield the floor.
  The PRESIDING OFFICER. Who yields time?
  The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I think we are about--I see my friend 
from Iowa on his feet so I will withhold. I will make a very brief 
comment at the very end, so I withhold.
  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. GRASSLEY. Mr. President, I yield myself such time as I might 
consume. I only have 2\1/2\ minutes.


                           Amendment No. 1039

  On the very important amendment about making sure there is adequate 
cooperation and dialog between the Office of New Drugs and the Office 
of Postmarket Surveillance, I wish to make clear this amendment is not, 
as some have characterized it, about process. It seems to me this is 
the ultimate of insurance to do the right thing to protect the American 
people on the safety of drugs. It is based on so many examples I found 
over the last 3 years, where there was not the respect for the Office 
of Postmarketing Surveillance there ought to be from the Office of New 
Drugs.
  A lot of safety issues would not have gotten out if we had not had a 
lot of red-blooded, patriotic whistleblowers who would come to 
Congress, such as Dr. Graham, for instance, in the case of Vioxx, such 
as Dr. Mosholder, in the case of antidepressant drugs for children who 
were committing suicide. This ended up with Vioxx coming off the 
market. This ended up with black-box safety measures in the case of the 
antidepressants.
  The Institute of Medicine has recognized the importance of these two 
groups within the FDA working very closely together on making a 
determination on postmarketing surveillance. That is what my amendment 
does. It makes sure this process works the way the Institute of 
Medicine indicated it should.
  So as you consider voting on this amendment, I ask my colleagues--
himself or herself--one basic question before voting: Since the 
Institute of Medicine recommends equality between the preapproval 
process--in other words, before a drug is marketed--and the 
postapproval process at the FDA, why not vote for this amendment and 
improve postmarketing safety for the American people?
  I yield the floor.
  The PRESIDING OFFICER. Who yields time?
  The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, in a few minutes, we will be prepared to 
vote. I yield myself 3 or 4 minutes.
  I will include in the Record, at the conclusion of this debate, the 
names of the staff on our committee who have done superb work. It has 
been extraordinary and on both sides of the aisle. We are enormously 
appreciative and grateful.
  I am also personally appreciative of the work of my friend and 
colleague, the Senator from Ohio, Mr. Brown, who was here yesterday and 
filled in. I had the opportunity to travel to Ireland, where they 
signed and put in place, after 400 years of struggle, the democratic 
institutions over there, in a very moving ceremony, which President 
Bush had supported--a very special day.
  This legislation is a reflection of 2\1/2\ years of hearings under 
the leadership of Senator Enzi, when he was chair of the committee, and 
myself. It incorporates the Institute of Medicine's recommendations, by 
and large, after they had months and months of hearings. The American 
people ought to understand the legislation, which reflects bipartisan 
support in the Senate, is a reflection of the best judgments we could 
have as a result of months and years of working on this issue and of 
the membership on it. We are enormously grateful.
  This legislation is going to make the prescription drugs our families 
take safer and our food safer. That is very important. It is going to 
ensure that the Agency has resources to do follow-on reviews to 
continue its important function to be the world leader, the gold 
standard, for safety for our people and the example for the rest of the 
world. So this is very important legislation.
  We are reminded every day of the additional kinds of challenges we 
are facing in terms of safety for our families. We are very aware of 
it. Senator Enzi and I and the members of our committee are going to 
continue our study, our review, and continue our activity to ensure we 
are going to have the best in terms of a safe and secure food supply, 
pharmaceutical supply, and take advantage of this life science century 
so every American is going to have the best and, hopefully, at the most 
reasonable price, so they can have healthier and stronger families.

[[Page 11675]]

  Mr. President, I yield back my remaining time.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Mr. President, I have a number of people I need to thank 
for their efforts on this bill, and I will do that following the vote 
so that we don't hold up the vote.
  There has been tremendous cooperation, effort, knowledge, and 
capability that has been involved, not just of the Senators but also of 
the staffs. The staffs on both sides of the aisle have spent countless 
hours on this, even on weekends. In fact, I know of one day on one 
weekend they worked about 20 hours together to pull this thing together 
and get some of the final issues worked out. But they worked the entire 
weekend for at least the last three weekends. They will look forward to 
a little time to rest, and we will probably give them a day. That is 
because we have so many things happening in the committee, and Senator 
Kennedy and I are determined to get a lot of that done to help the 
American people with their health and with their education and in the 
area of workplace safety and training and pensions.
  But on this bill, I hope people will join us in supporting it. Of 
course I hope they will join us in maintaining a balance to take it to 
conference committee and to defeat the three amendments that are before 
us this morning.
  I yield back the remainder of my time.


                           Amendment No. 1039

  The PRESIDING OFFICER. Under the previous order, there will be 2 
minutes for debate equally divided prior to a vote in relation to 
amendment No. 1039.
  Who yields time?
  Mr. GRASSLEY. Mr. President, I will speak in favor of 1039. I have 30 
seconds, did you say, or 1 minute?
  The PRESIDING OFFICER. The Senator has 1 minute.
  Mr. GRASSLEY. Mr. President, one of the issues that has been very 
much a shortcoming within the FDA besides lack of respect for the 
scientific process, but it is involved in the issue of this amendment 
as well, is whether scientists in the FDA who have the responsibility 
of postmarketing surveillance get the respect they ought to from the 
Office of New Drugs that previously had approved the drug. We have 
found in the case of Vioxx, in the case of antidepressants for 
children, and in a lot of other areas as well that this has just not 
been the case.
  My amendment will follow the Institute of Medicine recommendation and 
make sure there is adequate time and consideration given to 
postmarketing surveillance, the same as there is to the approval of the 
drug in the first place. So I ask for approval of this amendment. It is 
backed by the Institute of Medicine.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Mr. President, I oppose the amendment. I appreciate the 
thought that went into it, and I know that before we did this bill and 
put into place some of the processes we have in the toolbox for 
postapproval--which, nevertheless, existed before for the FDA--this 
amendment would have been necessary. But in light of the toolbox we 
provide and the dispute resolution we have, it would add an unnecessary 
layer of bureaucracy.
  We have designed the bill to be a nimble and responsive process to 
deal with emerging drug safety issues. We want drugs on the market 
faster, we want to know about anything that goes wrong faster, and we 
think that is built into it. We do have a dispute resolution in the 
bill with tight guidelines that will result in rapid approvals. We 
don't need the additional process.
  The amendment separates what should be together and delays what 
should be rapid. So I urge my colleagues to oppose the amendment.
  Mr. GRASSLEY. Mr. President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second? There appears to 
be a sufficient second.
  Mr. KENNEDY. Mr. President, parliamentary inquiry: Could we ask 
unanimous consent that we have the yeas and nays on the other two 
amendments? I ask unanimous consent that it be in order now for the 
yeas and nays on the other two amendments and then on final passage.
  The PRESIDING OFFICER. Is there objection? Without objection, it is 
so ordered.
  Mr. KENNEDY. I thank the Chair.
  The PRESIDING OFFICER. Is there a sufficient second on the remaining 
amendments? There appears to be a sufficient second. The yeas and nays 
are ordered on the remaining amendments as well.
  The question is on agreeing to amendment No. 1039.
  The clerk will call the roll.
  The legislative clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Indiana (Mr. Bayh) and 
the Senator from South Dakota (Mr. Johnson) are necessarily absent.
  Mr. LOTT. The following Senators are necessarily absent: the Senator 
from Kansas (Mr. Brownback), the Senator from Idaho (Mr. Crapo), the 
Senator from Arizona (Mr. McCain), the Senator from Kansas (Mr. 
Roberts), and the Senator from Louisiana (Mr. Vitter).
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The result was announced--yeas 46, nays 47, as follows:

                      [Rollcall Vote No. 154 Leg.]

                                YEAS--46

     Baucus
     Biden
     Bingaman
     Boxer
     Brown
     Byrd
     Cantwell
     Cardin
     Carper
     Casey
     Clinton
     Conrad
     Corker
     Dodd
     Dorgan
     Durbin
     Feingold
     Feinstein
     Grassley
     Harkin
     Hutchison
     Klobuchar
     Kohl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Lugar
     Menendez
     Mikulski
     Nelson (FL)
     Obama
     Pryor
     Reed
     Reid
     Rockefeller
     Sanders
     Schumer
     Snowe
     Stabenow
     Tester
     Webb
     Whitehouse
     Wyden

                                NAYS--47

     Akaka
     Alexander
     Allard
     Bennett
     Bond
     Bunning
     Burr
     Chambliss
     Coburn
     Cochran
     Coleman
     Collins
     Cornyn
     Craig
     DeMint
     Dole
     Domenici
     Ensign
     Enzi
     Graham
     Gregg
     Hagel
     Hatch
     Inhofe
     Inouye
     Isakson
     Kennedy
     Kerry
     Kyl
     Lott
     Martinez
     McCaskill
     McConnell
     Murkowski
     Murray
     Nelson (NE)
     Salazar
     Sessions
     Shelby
     Smith
     Specter
     Stevens
     Sununu
     Thomas
     Thune
     Voinovich
     Warner

                             NOT VOTING--7

     Bayh
     Brownback
     Crapo
     Johnson
     McCain
     Roberts
     Vitter
  The amendment (No. 1039) was rejected.
  Mr. ENZI. I move to reconsider the vote, and I move to lay that 
motion on the table.
  The motion to lay on the table was agreed to.


                           Amendment No. 998

  The PRESIDING OFFICER. Under the previous order, there will be 2 
minutes for debate equally divided prior to a vote in relation to 
amendment No. 998.
  The Senator from Iowa.
  Mr. GRASSLEY. I have 1 minute?
  The PRESIDING OFFICER. One minute.
  Mr. GRASSLEY. Mr. President, the issue is the level of civil and 
monetary penalties. If the fines are nothing more than the cost of 
doing business, you can't change behavior and you can't deter bad 
behavior. My feeling is the levels in this underlying bill are not high 
enough to get the attention of the drug companies. After all, if a 
company does what it is supposed to do, a drug company doesn't need to 
fear any penalties. It is that simple.
  I ask my colleagues to support my amendment so it has real teeth.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Mr. President, I have to oppose this amendment in keeping 
with having a balance in the bill that we have agreed on. This is the 
first time civil monetary penalties have been assessed for violations 
of the drug safety plan. That is what is in our bill. We do have civil 
penalties in the bill. The civil penalties are the same as the

[[Page 11676]]

medical devices. That is how we decided at what level to do it.
  We added civil penalties, and there will be more work done on this 
issue probably as we get to conference. I want to establish the fact 
that civil penalties are in the bill. I want to arrive at the level 
that the civil penalties are assessed with more consideration and with 
debate with the House. This amendment could burden small businesses and 
create problems there.
  Civil penalties are part of the bill we put together with a 
compromise. I ask that my colleagues vote against the amendment.
  The PRESIDING OFFICER. The question is on agreeing to amendment No. 
998. The yeas and nays have been ordered. The clerk will call the roll.
  The assistant legislative clerk called the roll.
  Mr. DURBIN. I announce that the Senator from South Dakota (Mr. 
Johnson) is necessarily absent
  Mr. LOTT. The following Senators are necessarily absent: the Senator 
from Kansas (Mr. Brownback), the Senator from Idaho (Mr. Crapo), the 
Senator from Arizona (Mr. McCain), the Senator from Kansas (Mr. 
Roberts), and the Senator from Louisiana (Mr. Vitter).
  The PRESIDING OFFICER (Mr. Menendez). Are there any other Senators in 
the Chamber desiring to vote?
  The result was announced--yeas 64, nays 30, as follows:

                      [Rollcall Vote No. 155 Leg.]

                                YEAS--64

     Akaka
     Baucus
     Biden
     Bingaman
     Boxer
     Brown
     Byrd
     Cantwell
     Cardin
     Carper
     Casey
     Clinton
     Coleman
     Collins
     Conrad
     Corker
     Cornyn
     Dodd
     Dorgan
     Durbin
     Ensign
     Feingold
     Feinstein
     Graham
     Grassley
     Harkin
     Hutchison
     Klobuchar
     Kohl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Lott
     Lugar
     Martinez
     McCaskill
     Menendez
     Mikulski
     Murray
     Nelson (FL)
     Nelson (NE)
     Obama
     Pryor
     Reed
     Reid
     Rockefeller
     Salazar
     Sanders
     Schumer
     Sessions
     Smith
     Snowe
     Specter
     Stabenow
     Sununu
     Tester
     Thune
     Warner
     Webb
     Whitehouse
     Wyden

                                NAYS--30

     Alexander
     Allard
     Bayh
     Bennett
     Bond
     Bunning
     Burr
     Chambliss
     Coburn
     Cochran
     Craig
     DeMint
     Dole
     Domenici
     Enzi
     Gregg
     Hagel
     Hatch
     Inhofe
     Inouye
     Isakson
     Kennedy
     Kerry
     Kyl
     McConnell
     Murkowski
     Shelby
     Stevens
     Thomas
     Voinovich

                             NOT VOTING--6

     Brownback
     Crapo
     Johnson
     McCain
     Roberts
     Vitter
  The amendment (No. 998) was agreed to.
  Mr. GRASSLEY. Mr. President, I move to reconsider the vote and to lay 
that motion on the table.
  The motion to lay on the table was agreed to.


                           Amendment No. 1034

  The PRESIDING OFFICER. Under the previous order, there will be 2 
minutes of debate, equally divided, prior to a vote in relation to 
amendment No. 1034.
  The Senator from Illinois is recognized.
  Mr. DURBIN. Mr. President, 2 years ago, an advisory committee of the 
FDA sat down to judge painkiller drugs and whether they were safe to 
sell to America. They made the recommendation that selling Vioxx to 
America was safe. Ten of the members of that advisory committee had a 
financial conflict of interest when they made the decision. Had those 
10 members with the conflict not been there, the panel would not have 
recommended keeping those drugs on the market.
  This amendment Senator Bingaman and I offer will take the conflict of 
interest out of the advisory committees. We will allow one waiver for 
someone with a conflict of interest, and we will say that others who 
participate as guest experts have to leave the room before any 
deliberation or vote.
  We will hear from the other side that the Food and Drug 
Administration has an idea of how they are going to change this rule at 
some future time. This is not an idea we are proposing, it is a law--a 
law to protect the integrity of the advisory committees and the drugs 
and medical devices which are sold across America.
  I urge my colleagues to support this amendment.
  Mr. KENNEDY. Mr. President, the FDA has a new policy, a new procedure 
out there.
  Basically, what the Durbin amendment says is, one size fits all. That 
concept has been rejected by the Europeans, rejected by the Canadians, 
and basically rejected by the Institute of Medicine. In this life 
science century, researchers who are looking at cancer drugs may be 
examining 15 different components. Are we going to say that if a 
conflict exists with one of those components that they meet the Durbin 
amendment standard. This would exclude some of the most knowledgeable 
people in this country from participating in the review of breakthrough 
drugs.
  The FDA says they have adopted transparency. Everyone in the Senate 
is going to know who sits on the advisory committees. There is a 
financial limitation of $50,000 at the FDA now. Everyone is going to 
know the existence of any conflicts. It is a new day out there. We have 
now have transparency, but virtually everyone who understands that we 
are in the life science century says we have to have the best 
scientific minds at the table, and so the Institute of Medicine said: 
Don't go with a one-size-fits-all, which the Durbin amendment does.
  The PRESIDING OFFICER. All time has expired.
  The question is on agreeing to amendment No. 1034. The yeas and nays 
have been ordered.
  The clerk will call the roll.
  The assistant legislative clerk called the roll.
  Mr. DURBIN. I announce that the Senator from South Dakota (Mr. 
Johnson) is necessarily absent.
  Mr. LOTT. The following Senators are necessarily absent: the Senator 
from Kansas (Mr. Brownback), the Senator from Idaho (Mr. Crapo), the 
Senator from Arizona (Mr. McCain), the Senator from Kansas (Mr. 
Roberts), and the Senator from Louisiana (Mr. Vitter).
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The result was announced--yeas 47, nays 47, as follows:

                      [Rollcall Vote No. 156 Leg.]

                                YEAS--47

     Akaka
     Baucus
     Bayh
     Biden
     Bingaman
     Boxer
     Brown
     Cantwell
     Cardin
     Carper
     Casey
     Clinton
     Collins
     Conrad
     Dorgan
     Durbin
     Feingold
     Feinstein
     Grassley
     Harkin
     Inouye
     Klobuchar
     Kohl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     McCaskill
     Menendez
     Mikulski
     Murray
     Nelson (FL)
     Obama
     Pryor
     Reed
     Reid
     Salazar
     Sanders
     Schumer
     Snowe
     Stabenow
     Tester
     Webb
     Whitehouse
     Wyden

                                NAYS--47

     Alexander
     Allard
     Bennett
     Bond
     Bunning
     Burr
     Byrd
     Chambliss
     Coburn
     Cochran
     Coleman
     Corker
     Cornyn
     Craig
     DeMint
     Dodd
     Dole
     Domenici
     Ensign
     Enzi
     Graham
     Gregg
     Hagel
     Hatch
     Hutchison
     Inhofe
     Isakson
     Kennedy
     Kerry
     Kyl
     Lott
     Lugar
     Martinez
     McConnell
     Murkowski
     Nelson (NE)
     Rockefeller
     Sessions
     Shelby
     Smith
     Specter
     Stevens
     Sununu
     Thomas
     Thune
     Voinovich
     Warner

                             NOT VOTING--6

     Brownback
     Crapo
     Johnson
     McCain
     Roberts
     Vitter
  The amendment (No. 1034) was rejected.
  The PRESIDING OFFICER. Under the previous order, the committee 
substitute amendment, as modified and amended, is agreed to, the motion 
to reconsider is considered made and laid upon the table, and the 
cloture motion on the bill is withdrawn.
  Under the previous order, the clerk will read the bill for the third 
time.
  The bill was ordered to be engrossed for a third reading and was read 
the third time.
  The PRESIDING OFFICER. The bill having been read the third time, the 
question is, Shall the bill, as modified and amended, pass?

[[Page 11677]]


  Mr. KENNEDY. I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second? There is a 
sufficient second.
  The clerk will call the roll.
  The legislative clerk called the roll.
  Mr. DURBIN. I announce that the Senator from South Dakota (Mr. 
Johnson) is necessarily absent.
  Mr. LOTT. The following Senators are necessarily absent: the Senator 
from Kansas (Mr. Brownback), the Senator from Idaho (Mr. Crapo), the 
Senator from Arizona (Mr. McCain), the Senator from Kansas (Mr. 
Roberts), and the Senator from Louisiana (Mr. Vitter).
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The result was announced--yeas 93, nays 1, as follows:

                      [Rollcall Vote No. 157 Leg.]

                                YEAS--93

     Akaka
     Alexander
     Allard
     Baucus
     Bayh
     Bennett
     Biden
     Bingaman
     Bond
     Boxer
     Brown
     Bunning
     Burr
     Byrd
     Cantwell
     Cardin
     Carper
     Casey
     Chambliss
     Clinton
     Coburn
     Cochran
     Coleman
     Collins
     Conrad
     Corker
     Cornyn
     Craig
     DeMint
     Dodd
     Dole
     Domenici
     Dorgan
     Durbin
     Ensign
     Enzi
     Feingold
     Feinstein
     Graham
     Grassley
     Gregg
     Hagel
     Harkin
     Hatch
     Hutchison
     Inhofe
     Inouye
     Isakson
     Kennedy
     Kerry
     Klobuchar
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Lott
     Lugar
     Martinez
     McCaskill
     McConnell
     Menendez
     Mikulski
     Murkowski
     Murray
     Nelson (FL)
     Nelson (NE)
     Obama
     Pryor
     Reed
     Reid
     Rockefeller
     Salazar
     Schumer
     Sessions
     Shelby
     Smith
     Snowe
     Specter
     Stabenow
     Stevens
     Sununu
     Tester
     Thomas
     Thune
     Voinovich
     Warner
     Webb
     Whitehouse
     Wyden

                                NAYS--1

       
     Sanders
       

                             NOT VOTING--6

     Brownback
     Crapo
     Johnson
     McCain
     Roberts
     Vitter
  The bill (S. 1082) as modified and amended, was passed, as follows:

                                S. 1082

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Food and Drug Administration 
     Revitalization Act''.

                  TITLE I--PRESCRIPTION DRUG USER FEES

     SEC. 101. SHORT TITLE; REFERENCES IN TITLE.

       (a) Short Title.--This title may be cited as the 
     ``Prescription Drug User Fee Amendments of 2007''.
       (b) References in Title.--Except as otherwise specified, 
     whenever in this title an amendment is expressed in terms of 
     an amendment to a section or other provision, the reference 
     shall be considered to be made to a section or other 
     provision of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.).

     SEC. 102. DRUG FEES.

       Section 735 (21 U.S.C. 379g) is amended--
       (1) by striking the section designation and all that 
     follows through ``For purposes of this subchapter:'' and 
     inserting the following:

     ``SEC. 735. DRUG FEES.

       ``(a) Purpose.--It is the purpose of this part that the 
     fees authorized under this part be dedicated toward 
     expediting the drug development process, the process for the 
     review of human drug applications, and postmarket drug 
     safety, as set forth in the goals identified for purposes of 
     this part in the letters from the Secretary to the Chairman 
     of the Committee on Health, Education, Labor, and Pensions of 
     the Senate and the Chairman of the Committee on Energy and 
     Commerce of the House of Representatives, as set forth in the 
     Congressional Record.
       ``(b) Reports.--
       ``(1) Performance report.--For fiscal years 2008 through 
     2012, not later than 120 days after the end of each fiscal 
     year during which fees are collected under this part, the 
     Secretary shall prepare and submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, a report concerning the progress of the Food 
     and Drug Administration in achieving the goals identified in 
     the letters described in subsection (a) during such fiscal 
     year and the future plans of the Food and Drug Administration 
     for meeting the goals. The report for a fiscal year shall 
     include information on all previous cohorts for which the 
     Secretary has not given a complete response on all human drug 
     applications and supplements in the cohort.
       ``(2) Fiscal report.--For fiscal years 2008 through 2012, 
     not later than 120 days after the end of each fiscal year 
     during which fees are collected under this part, the 
     Secretary shall prepare and submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, a report on the implementation of the 
     authority for such fees during such fiscal year and the use, 
     by the Food and Drug Administration, of the fees collected 
     during such fiscal year for which the report is made.
       ``(3) Public availability.--The Secretary shall make the 
     reports required under paragraphs (1) and (2) available to 
     the public on the Internet website of the Food and Drug 
     Administration.
       ``(c) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to Congress with respect to the goals, and plans for 
     meeting the goals, for the process for the review of human 
     drug applications for the first 5 fiscal years after fiscal 
     year 2012, and for the reauthorization of this part for such 
     fiscal years, the Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the regulated industry.
       ``(2) Public review of recommendations.--After negotiations 
     with the regulated industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the Congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(3) Transmittal of recommendations.--Not later than 
     January 15, 2012, the Secretary shall transmit to Congress 
     the revised recommendations under paragraph (2), a summary of 
     the views and comments received under such paragraph, and any 
     changes made to the recommendations in response to such views 
     and comments.
       ``(d) Definitions.--For purposes of this part:'';
       (2) in subsection (d)--
       (A) in paragraph (1)--
       (i) in subparagraph (A), by striking ``505(b)(1),'' and 
     inserting ``505(b), or'';
       (ii) by striking subparagraph (B);
       (iii) by redesignating subparagraph (C) as subparagraph 
     (B); and
       (iv) in the matter following subparagraph (B), as so 
     redesignated, by striking ``subparagraph (C)'' and inserting 
     ``subparagraph (B)'';
       (B) in paragraph (3)(C), by--
       (i) striking ``the list'' and inserting ``the list (not 
     including the discontinued section of such list)''; and
       (ii) striking ``a list'' and inserting ``a list (not 
     including the discontinued section of such a list)'';
       (C) in paragraph (4), by inserting before the period at the 
     end the following: ``(such as capsules, tablets, and 
     lyophilized products before reconstitution)'';
       (D) by amending paragraph (6)(F) to read as follows:
       ``(F) In the case of drugs approved under human drug 
     applications or supplements, postmarket safety activities, 
     including--
       ``(i) collecting, developing, and reviewing safety 
     information on approved drugs (including adverse event 
     reports);
       ``(ii) developing and using improved adverse event data 
     collection systems (including information technology 
     systems); and
       ``(iii) developing and using improved analytical tools to 
     assess potential safety problems (including by accessing 
     external data bases).'';
       (E) in paragraph (8)--
       (i) by striking ``April of the preceding fiscal year'' and 
     inserting ``October of the preceding fiscal year''; and
       (ii) by striking ``April 1997'' and inserting ``October 
     1996'';
       (F) by redesignating paragraph (9) as paragraph (10); and
       (G) by inserting after paragraph (8) the following:
       ``(9) The term `person' includes an affiliate of such 
     person.''.

     SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

       (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
     amended--
       (1) in the matter preceding paragraph (1), by striking 
     ``2003'' and inserting ``2008'';
       (2) in paragraph (1)--
       (A) in subparagraph (D)--
       (i) in the heading, by inserting ``or withdrawn before 
     filing'' after ``refund of fee if application refused for 
     filing''; and
       (ii) by inserting before the period at the end the 
     following: ``or withdrawn without a waiver before filing'';

[[Page 11678]]

       (B) by redesignating subparagraphs (E) and (F) as 
     subparagraphs (F) and (G), respectively; and
       (C) by inserting after subparagraph (D) the following:
       ``(E) Fee for application previously refused for filing or 
     withdrawn before filing.--An application or supplement that 
     has been refused for filing or that was withdrawn before 
     filing, if filed under protest or resubmitted, shall be 
     subject to the fee under subparagraph (A) (unless an 
     exception under subparagraph (C) or (F) applies or the fee is 
     waived or reduced under subsection (d)), without regard to 
     previous payment of such a fee and the refund of 75 percent 
     of that fee under subparagraph (D).''; and
       (3) in paragraph (2)--
       (A) in subparagraph (A), by striking ``subparagraph (B)'' 
     and inserting ``subparagraphs (B) and (C)''; and
       (B) by adding at the end the following:
       ``(C) Special rules for compounded positron emission 
     tomography drugs.--
       ``(i) In general.--Except as provided in clause (ii), each 
     person who is named as the applicant in an approved human 
     drug application for a compounded positron emission 
     tomography drug shall be subject under subparagraph (A) to 
     one-fifth of an annual establishment fee with respect to each 
     such establishment identified in the application as producing 
     compounded positron emission tomography drugs under the 
     approved application.
       ``(ii) Exception from annual establishment fee.--Each 
     person who is named as the applicant in an application 
     described in clause (i) shall not be assessed an annual 
     establishment fee for a fiscal year if the person certifies 
     to the Secretary, at a time specified by the Secretary and 
     using procedures specified by the Secretary, that--

       ``(I) the person is a not-for-profit medical center that 
     has only 1 establishment for the production of compounded 
     positron emission tomography drugs; and
       ``(II) at least 95 percent of the total number of doses of 
     each compounded positron emission tomography drug produced by 
     such establishment during such fiscal year will be used 
     within the medical center.''.

       (b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C. 
     379h(b)) is amended to read as follows:
       ``(b) Fee Revenue Amounts.--Except as provided in 
     subsections (c), (d), (f), and (g), fees under subsection (a) 
     shall be established to generate the following revenue 
     amounts, in each fiscal year beginning with fiscal year 2008 
     and continuing through fiscal year 2012: $392,783,000, plus 
     an adjustment for workload on $354,893,000 of this amount. 
     Such adjustment shall be made in accordance with the workload 
     adjustment provisions in effect for fiscal year 2007, except 
     that instead of commercial investigational new drug 
     applications submitted to the Secretary, all commercial 
     investigational new drug applications with a submission 
     during the previous 12-month period shall be used in the 
     determination. One-third of the revenue amount shall be 
     derived from application fees, one-third from establishment 
     fees, and one-third from product fees.''.
       (c) Adjustments to Fees.--
       (1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C. 
     379h(c)(1)) is amended--
       (A) in the matter preceding subparagraph (A) by striking 
     ``The revenues established in subsection (b)'' and inserting 
     ``Beginning with fiscal year 2009, the revenues established 
     in subsection (b)'';
       (B) in subparagraph (A) by striking ``or'' at the end;
       (C) in subparagraph (B) by striking the period at the end 
     and inserting ``, or,'';
       (D) by inserting after subparagraph (B) the following:
       ``(C) the average annual change in the cost, per full-time 
     equivalent position of the Food and Drug Administration, of 
     all personnel compensation and benefits paid with respect to 
     such positions, for the first 5 fiscal years of the previous 
     6 fiscal years.''; and
       (E) in the matter following subparagraph (C) (as added by 
     this paragraph), by striking ``fiscal year 2003'' and 
     inserting ``fiscal year 2008''.
       (2) Workload adjustment.--Section 736(c)(2) (21 U.S.C. 
     379h(c)(2)) is amended--
       (A) in the matter preceding subparagraph (A,) by striking 
     ``2004'' and inserting ``2009'';
       (B) in the first sentence of subparagraph (A)--
       (i) by striking ``, commercial investigational new drug 
     applications'' and inserting ``(adjusted for changes in 
     review activities)''; and
       (ii) by inserting before the period at the end ``, and the 
     change in the number of commercial investigational new drug 
     applications with a submission during the previous 12-month 
     period (adjusted for changes in review activities)'';
       (C) in subparagraph (B), by adding at the end the following 
     new sentence: ``Further, any adjustment for changes in review 
     activities made in setting fees and fee revenue amounts for 
     fiscal year 2009 may not result in the total workload 
     adjustment being more than 2 percentage points higher than it 
     would be absent the adjustment for changes in review 
     activities.''; and
       (D) by adding at the end the following:
       ``(C) The Secretary shall contract with an independent 
     accounting firm to study the adjustment for changes in review 
     activities applied in setting fees for fiscal year 2009 and 
     to make recommendations, if warranted, on future changes in 
     the methodology for calculating the adjustment for changes in 
     review activity. After review of the recommendations by the 
     independent accounting firm, the Secretary shall make 
     appropriate changes to the workload adjustment methodology in 
     setting fees for fiscal years 2010 through 2012. If the study 
     is not conducted, no adjustment for changes in review 
     activities shall be made after fiscal year 2009.''.
       (3) Rent and rent-related cost adjustment.--Section 736(c) 
     (21 U.S.C. 379h(c)) is amended--
       (A) by redesignating paragraphs (3), (4), and (5) as 
     paragraphs (4), (5), and (6), respectively; and
       (B) by inserting after paragraph (2) the following:
       ``(3) Rent and rent-related cost adjustment.--Beginning 
     with fiscal year 2010, the Secretary shall, before making the 
     adjustments under paragraphs (1) and (2), reduce the fee 
     amounts established in subsection (b), if actual costs paid 
     for rent and rent-related expenses are less than $11,721,000. 
     The reductions made under this paragraph, if any, shall not 
     exceed the amounts by which costs fell below $11,721,000, and 
     shall not exceed $11,721,000 in any fiscal year.''.
       (4) Final year adjustment.--Section 736(c) (21 U.S.C. 
     379h(c)) is amended--
       (A) in paragraph (4), as redesignated by this subsection--
       (i) by striking ``2007'' each place it appears and 
     inserting ``2012''; and
       (ii) by striking ``2008'' and inserting ``2013''; and
       (B) in paragraph (5), as redesignated by this subsection, 
     by striking ``2002'' and inserting ``2007''.
       (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 
     379h(d)) is amended--
       (1) in paragraph (1), in the matter preceding subparagraph 
     (A), by--
       (A) inserting ``to a person who is named as the applicant'' 
     after ``The Secretary shall grant'';
       (B) inserting ``to that person'' after ``a waiver from or a 
     reduction of one or more fees assessed''; and
       (C) striking ``finds'' and inserting ``determines'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively;
       (3) by inserting after paragraph (1) the following:
       ``(2) Evaluation.--For the purpose of determining whether 
     to grant a waiver or reduction of a fee under paragraph (1), 
     the Secretary shall consider only the circumstances and 
     assets of the applicant and any affiliate of the 
     applicant.''; and
       (4) in paragraph (4), as redesignated by this subsection, 
     in subparagraph (A), by inserting before the period at the 
     end ``, and that does not have a drug product that has been 
     approved under a human drug application and introduced or 
     delivered for introduction into interstate commerce''.
       (e) Crediting and Availability of Fees.--
       (1) Authorization of appropriations.--Section 736(g)(3) (21 
     U.S.C. 379h(g)(3)) is amended to read as follows:
       ``(3) Authorization of appropriations.--There are 
     authorized to be appropriated for fees under this section 
     such sums as are authorized to be assessed and collected 
     under this section in each of fiscal years 2008 through 
     2012.''.
       (2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 
     amended to read as follows:
       ``(4) Offset.--If the cumulative amount of fees collected 
     during fiscal years 2008, 2009, and 2010, plus the amount 
     estimated to be collected for fiscal year 2011, exceeds the 
     amount of fees specified in aggregate in appropriation Acts 
     for such fiscal years, the aggregate amount in excess shall 
     be credited to the appropriation account of the Food and Drug 
     Administration as provided in paragraph (1), and shall be 
     subtracted from the amount of fees that would otherwise be 
     authorized to be collected under this section pursuant to 
     appropriation Acts for fiscal year 2012.''.
       (f) Conforming Amendments.--
       (1) Section 736(a) (21 U.S.C. 379h(a)), as amended by this 
     section, is amended--
       (A) in paragraph (1)(A), by striking ``subsection (c)(4)'' 
     each place it appears and inserting ``subsection (c)(5)'';
       (B) in paragraph (2), by striking ``subsection (c)(4)'' and 
     inserting ``subsection (c)(5)''; and
       (C) in paragraph (3), by striking ``subsection (c)(4)'' and 
     inserting ``subsection (c)(5)''.
       (2) Section 736A(h)(3), as added by section 104 of this 
     title, is amended by striking ``735(3)'' and inserting 
     ``735(d)(3)''.

     SEC. 104. AUTHORITY TO ASSESS AND USE PRESCRIPTION DRUG 
                   ADVERTISING FEES.

       Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et seq.) 
     is amended by adding after section 736 the following new 
     section:

     ``SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE ADVISORY 
                   REVIEW OF PRESCRIPTION DRUG ADVERTISING.

       ``(a) Types of Direct-to-Consumer Television Advertisement 
     Review Fees.--Beginning with fiscal year 2008, the Secretary 
     shall assess and collect fees in accordance with this section 
     as follows:

[[Page 11679]]

       ``(1) Advisory review fee.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     each person that on or after October 1, 2007, submits a 
     proposed direct-to-consumer television advertisement for 
     advisory review by the Secretary prior to its initial public 
     dissemination shall be subject to a fee established under 
     subsection (c)(3).
       ``(B) Exception for required submissions.--A direct-to-
     consumer television advertisement that is required to be 
     submitted to the Secretary prior to initial public 
     dissemination shall not be assessed a fee unless the sponsor 
     designates it as a submission for advisory review.
       ``(C) Payment.--The fee required by subparagraph (A) shall 
     be due not later than October 1 of the fiscal year in which 
     the direct-to-consumer television advertisement shall be 
     submitted to the Secretary for advisory review.
       ``(D) Modification of advisory review fee.--
       ``(i) Late payment.--If, on or before November 1 of the 
     fiscal year in which the fees are due, a person has not paid 
     all fees that were due and payable for advisory reviews 
     identified in response to the Federal Register notice 
     described in subsection (c)(3)(A), the fees shall be regarded 
     as late. Such fees shall be due and payable 20 days before 
     any direct-to-consumer television advertisement is submitted 
     by such person to the Secretary for advisory review. 
     Notwithstanding any other provision of this section, such 
     fees shall be due and payable for each of those advisory 
     reviews in the amount of 150 percent of the advisory review 
     fee established for that fiscal year pursuant to subsection 
     (c)(3).
       ``(ii) Late notice of submission.--If any person submits 
     any direct-to-consumer television advertisements for advisory 
     review that are in excess of the number identified by that 
     person in response to the Federal Register notice described 
     in subsection (c)(3)(A), that person must pay a fee for each 
     of those advisory reviews in the amount of 150 percent of the 
     advisory review fee established for that fiscal year pursuant 
     to subsection (c)(3). Fees under this subparagraph shall be 
     due 20 days before the direct-to-consumer television 
     advertisement is submitted by such person to the Secretary 
     for advisory review.
       ``(E) Limits.--
       ``(i) In general.--The payment of a fee under this 
     paragraph for a fiscal year entitles the person that pays the 
     fee to acceptance for advisory review by the Secretary of 1 
     direct-to-consumer television advertisement and acceptance of 
     1 resubmission for advisory review of the same advertisement. 
     The advertisement shall be submitted for review in the fiscal 
     year for which the fee was assessed, except that a person may 
     carry over no more than 1 paid advisory review submission to 
     the next fiscal year. Resubmissions may be submitted without 
     regard to the fiscal year of the initial advisory review 
     submission.
       ``(ii) No refund.--Except as provided by subsection (f), 
     fees paid under this paragraph shall not be refunded.
       ``(iii) No waiver, exemption, or reduction.--The Secretary 
     shall not grant a waiver, exemption, or reduction of any fees 
     due or payable under this section.
       ``(iv) Non-transferability.--The right to an advisory 
     review is not transferable, except to a successor in 
     interest.
       ``(2) Operating reserve fee.--
       ``(A) In general.--Each person that, on or after October 1, 
     2007, is assessed an advisory review fee under paragraph (1) 
     shall be subject to an operating reserve fee established 
     under subsection (d)(2) only in the first fiscal year in 
     which an advisory review fee is assessed.
       ``(B) Payment.--Except as provided in subparagraph (C), the 
     fee required by subparagraph (A) shall be due not later than 
     October 1 of the first fiscal year in which the person is 
     required to pay an advisory review fee under paragraph (1).
       ``(C) Late notice of submission.--If, in the first fiscal 
     year of a person's participation in the Program, that person 
     submits any direct-to-consumer television advertisements for 
     advisory review that are in excess of the number identified 
     by that person in response to the Federal Register notice 
     described in subsection (c)(3)(A), that person must pay an 
     operating reserve fee for each of those advisory reviews 
     equal to the advisory review fee for each submission 
     established under paragraph (1)(D)(ii). Fees required by this 
     subparagraph shall be in addition to the fees required under 
     subparagraph (B), if any. Fees under this subparagraph shall 
     be due 20 days before any direct-to-consumer television 
     advertisement is submitted by such person to the Secretary 
     for advisory review.
       ``(b) Advisory Review Fee Revenue Amounts.--Fees under 
     subsection (a)(1) shall be established to generate revenue 
     amounts of $6,250,000 for each of fiscal years 2008 through 
     2012, as adjusted pursuant to subsection (c).
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--Beginning with fiscal year 
     2009, the revenues established in subsection (b) shall be 
     adjusted by the Secretary by notice, published in the Federal 
     Register, for a fiscal year to reflect the greater of--
       ``(A) the total percentage change that occurred in the 
     Consumer Price Index for all urban consumers (all items; 
     United States city average), for the 12-month period ending 
     June 30 preceding the fiscal year for which fees are being 
     established;
       ``(B) the total percentage change for the previous fiscal 
     year in basic pay under the General Schedule in accordance 
     with section 5332 of title 5, as adjusted by any locality-
     based comparability payment pursuant to section 5304 of such 
     title for Federal employees stationed in the District of 
     Columbia; or
       ``(C) the average annual change in the cost, per full-time 
     equivalent position of the Food and Drug Administration, of 
     all personnel compensation and benefits paid with respect to 
     such positions, for the first 5 fiscal years of the previous 
     6 fiscal years.

     The adjustment made each fiscal year by this paragraph shall 
     be added on a compounded basis to the sum of all adjustments 
     made each fiscal year after fiscal year 2008 under this 
     subsection.
       ``(2) Workload adjustment.--
       ``(A) In general.--Beginning with fiscal year 2009, after 
     the fee revenues established in subsection (b) of this 
     section are adjusted for a fiscal year for inflation in 
     accordance with paragraph (1), the fee revenues shall be 
     adjusted further for such fiscal year to reflect changes in 
     the workload of the Secretary with respect to the submission 
     of proposed direct-to-consumer television advertisements for 
     advisory review prior to initial broadcast.
       ``(B) Determination of workload adjustment.--
       ``(i) In general.--The workload adjustment under this 
     paragraph for a fiscal year shall be determined by the 
     Secretary--

       ``(I) based upon the number of direct-to-consumer 
     television advertisements identified pursuant to paragraph 
     (3)(A) for that fiscal year, excluding allowable previously 
     paid carry over submissions; and
       ``(II) by multiplying the number of such advertisements 
     projected for that fiscal year that exceeds 150 by $27,600 
     (adjusted each year beginning with fiscal year 2009 for 
     inflation in accordance with paragraph (1)).

       ``(ii) Publication in federal register.--The Secretary 
     shall publish in the Federal Register, as part of the notice 
     described in paragraph (1), the fee revenues and fees 
     resulting from the adjustment made under this paragraph and 
     the supporting methodologies.
       ``(C) Limitation.--Under no circumstances shall the 
     adjustment made under this paragraph result in fee revenues 
     for a fiscal year that are less than the fee revenues 
     established for the prior fiscal year.
       ``(3) Annual fee setting.--
       ``(A) Number of advertisements.--The Secretary shall, 120 
     days before the start of each fiscal year, publish a notice 
     in the Federal Register requesting any person to notify the 
     Secretary within 30 days of the number of direct-to-consumer 
     television advertisements the person intends to submit for 
     advisory review by the Secretary in the next fiscal year. 
     Notification to the Secretary of the number of advertisements 
     a person intends to submit for advisory review prior to 
     initial broadcast shall be a legally binding commitment by 
     that person to pay the annual advisory review fee for that 
     number of submissions on or before October 1 of the fiscal 
     year in which the advertisement is intended to be submitted. 
     A person shall at the same time also notify the Secretary if 
     such person intends to use a paid submission from the 
     previous fiscal year under subsection (a)(1)(E)(i). If such 
     person does not so notify the Secretary, all submissions for 
     advisory review shall be subject to advisory review fees.
       ``(B) Annual fee.--The Secretary shall, 60 days before the 
     start of each fiscal year, establish, for the next fiscal 
     year, the direct-to-consumer television advertisement 
     advisory review fee under subsection (a)(1), based on the 
     revenue amounts established under subsection (b), the 
     adjustments provided under this subsection and the number of 
     direct-to-consumer television advertisements identified 
     pursuant to subparagraph (A), excluding allowable previously 
     paid carry over submissions. The annual advisory review fee 
     shall be established by dividing the fee revenue for a fiscal 
     year (as adjusted pursuant to this subsection) by the number 
     of direct-to-consumer television advertisements identified 
     pursuant to subparagraph (A), excluding allowable previously 
     paid carry over submissions.
       ``(C) Fiscal year 2008 fee limit.--Notwithstanding 
     subsection (b), the fee established under subparagraph (B) 
     for fiscal year 2008 may not be more than $83,000 per 
     submission for advisory review.
       ``(D) Annual fee limit.--Notwithstanding subsection (b), 
     the fee established under subparagraph (B) for a fiscal year 
     after fiscal year 2008 may not be more than 50 percent more 
     than the fee established for the prior fiscal year.
       ``(E) Limit.--The total amount of fees obligated for a 
     fiscal year may not exceed the total costs for such fiscal 
     year for the resources allocated for the process for the 
     advisory review of prescription drug advertising.
       ``(d) Operating Reserves.--
       ``(1) In general.--The Secretary shall establish in the 
     Food and Drug Administration salaries and expenses 
     appropriation account

[[Page 11680]]

     without fiscal year limitation a Direct-to-Consumer Advisory 
     Review Operating Reserve, of at least $6,250,000 in fiscal 
     year 2008, to continue the Program in the event the fees 
     collected in any subsequent fiscal year pursuant to 
     subsection (c)(3) do not generate the fee revenue amount 
     established for that fiscal year.
       ``(2) Fee setting.--The Secretary shall establish the 
     operating reserve fee under subsection (a)(2)(A) for each 
     person required to pay the fee by multiplying the number of 
     direct-to-consumer television advertisements identified by 
     that person pursuant to subsection (c)(3)(A) by the advisory 
     review fee established pursuant to subsection (c)(3) for that 
     fiscal year. In no case shall the operating reserve fee 
     assessed be less than the operating reserve fee assessed if 
     the person had first participated in the Program in fiscal 
     year 2008.
       ``(3) Use of operating reserve.--The Secretary may use 
     funds from the reserves under this subsection only to the 
     extent necessary in any fiscal year to make up the difference 
     between the fee revenue amount established for that fiscal 
     year under subsection (b) and the amount of fees collected 
     for that fiscal year pursuant to subsection (a), or to pay 
     costs of ending the Program if it is terminated pursuant to 
     subsection (f) or if it is not reauthorized after fiscal year 
     2012.
       ``(4) Refund of operating reserves.--Within 120 days of the 
     end of fiscal year 2012, or if the Program is terminated 
     pursuant to subsection (f), the Secretary, after setting 
     aside sufficient operating reserve amounts to terminate the 
     Program, shall refund all amounts remaining in the operating 
     reserve on a pro rata basis to each person that paid an 
     operating reserve fee assessment. In no event shall the 
     refund to any person exceed the total amount of operating 
     reserve fees paid by such person pursuant to subsection 
     (a)(2).
       ``(e) Effect of Failure To Pay Fees.--Notwithstanding any 
     other law or regulation of the Secretary, a submission for 
     advisory review of a direct-to-consumer television 
     advertisement submitted by a person subject to fees under 
     subsection (a) shall be considered incomplete and shall not 
     be accepted for review by the Secretary until all fees owed 
     by such person under this section have been paid.
       ``(f) Effect of Inadequate Funding of Program.--
       ``(1) First fiscal year.--If on November 1, 2007, or 120 
     days after enactment of the Prescription Drug User Fee 
     Amendments of 2007, whichever is later, the Secretary has 
     received less than $11,250,000 in advisory review fees and 
     operating reserve fees combined, the Program shall be 
     terminated and all collected fees shall be refunded.
       ``(2) Subsequent fiscal years.--Beginning in fiscal year 
     2009, if, on November 1 of a fiscal year, the combination of 
     the operating reserves, annual fee revenues from that fiscal 
     year, and unobligated fee revenues from prior fiscal years is 
     less than $9,000,000, adjusted for inflation (in accordance 
     with subsection (c)(1)), the Program shall be terminated, and 
     the Secretary shall notify all participants, retain any money 
     from the unused advisory review fees and the operating 
     reserves needed to terminate the Program, and refund the 
     remainder of the unused fees and operating reserves. To the 
     extent required to terminate the Program, the Secretary shall 
     first use unobligated advisory review fee revenues from prior 
     fiscal years, then the operating reserves, and then unused 
     advisory review fees from the relevant fiscal year.
       ``(g) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts. Such fees are authorized to remain 
     available until expended. Such sums as may be necessary may 
     be transferred from the Food and Drug Administration salaries 
     and expenses appropriation account without fiscal year 
     limitation to such appropriation account for salaries and 
     expenses with such fiscal year limitation. The sums 
     transferred shall be available solely for the process for the 
     advisory review of prescription drug advertising.
       ``(2) Collections and appropriation acts.--The fees 
     authorized by this section--
       ``(A) shall be retained in each fiscal year in an amount 
     not to exceed the amount specified in appropriation Acts, or 
     otherwise made available for obligation for such fiscal year; 
     and
       ``(B) shall be available for obligation only if 
     appropriated budget authority continues to support at least 
     the total combined number of full-time equivalent employees 
     in the Food and Drug Administration, Center for Drug 
     Evaluation and Research, Division of Drug Marketing, 
     Advertising, and Communications, and the Center for Biologics 
     Evaluation and Research, Advertising and Promotional Labeling 
     Branch supported in fiscal year 2007.
       ``(3) Authorization of appropriations.--There are 
     authorized to be appropriated for fees under this section not 
     less than $6,250,000 for each of fiscal years 2008, 2009, 
     2010, 2011, and 2012, as adjusted to reflect adjustments in 
     the total fee revenues made under this section, plus amounts 
     collected for the reserve fund under subsection (d).
       ``(4) Offset.--Any amount of fees collected for a fiscal 
     year under this section that exceeds the amount of fees 
     specified in appropriation Acts for such fiscal year shall be 
     credited to the appropriation account of the Food and Drug 
     Administration as provided in paragraph (1), and shall be 
     subtracted from the amount of fees that would otherwise be 
     collected under this section pursuant to appropriation Acts 
     for a subsequent fiscal year.
       ``(h) Definitions.--For purposes of this section:
       ``(1) The term `advisory review' means reviewing and 
     providing advisory comments regarding compliance of a 
     proposed advertisement with the requirements of this Act 
     prior to its initial public dissemination.
       ``(2) The term `carry over submission' means a submission 
     for an advisory review for which a fee was paid in a fiscal 
     year that is submitted for review in the following fiscal 
     year.
       ``(3) The term `direct-to-consumer television 
     advertisement' means an advertisement for a prescription drug 
     product as defined in section 735(3) intended to be displayed 
     on any television channel for less than 2 minutes.
       ``(4) The term `person' includes an individual, a 
     partnership, a corporation, and an association, and any 
     affiliate thereof or successor in interest.
       ``(5) The term `process for the advisory review of 
     prescription drug advertising' means the activities necessary 
     to review and provide advisory comments on proposed direct-
     to-consumer television advertisements prior to public 
     dissemination and, to the extent the Secretary has additional 
     staff resources available under the Program that are not 
     necessary for the advisory review of direct-to-consumer 
     television advertisements, the activities necessary to review 
     and provide advisory comments on other proposed 
     advertisements and promotional material prior to public 
     dissemination.
       ``(6) The term `Program' means the Program to assess, 
     collect, and use fees for the advisory review of prescription 
     drug advertising established by this section.
       ``(7) The term `resources allocated for the process for the 
     advisory review of prescription drug advertising' means the 
     expenses incurred in connection with the process for the 
     advisory review of prescription drug advertising for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers, employees, and committees, and to contracts 
     with such contractors;
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources;
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies;
       ``(D) collection of fees under this section and accounting 
     for resources allocated for the advisory review of 
     prescription drug advertising; and
       ``(E) terminating the Program under subsection (f)(2), if 
     necessary.
       ``(8) The term `resubmission' means a subsequent submission 
     for advisory review of a direct-to-consumer television 
     advertisement that has been revised in response to the 
     Secretary's comments on an original submission. A 
     resubmission may not introduce significant new concepts or 
     creative themes into the television advertisement.
       ``(9) The term `submission for advisory review' means an 
     original submission of a direct-to-consumer television 
     advertisement for which the sponsor voluntarily requests 
     advisory comments before the advertisement is publicly 
     disseminated.

     ``SEC. 736B. SUNSET.

       ``This part shall cease to be effective on October 1, 2012, 
     except that subsection (b) of section 736 with respect to 
     reports shall cease to be effective on January 31, 2013.''.

     SEC. 105. SAVINGS CLAUSE.

       Notwithstanding section 509 of the Prescription Drug User 
     Fee Amendments of 2002 (21 U.S.C. 379g note), and 
     notwithstanding the amendments made by this title, part 2 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act, as in effect on the day before the date of 
     enactment of this title, shall continue to be in effect with 
     respect to human drug applications and supplements (as 
     defined in such part as of such day) that on or after October 
     1, 2002, but before October 1, 2007, were accepted by the 
     Food and Drug Administration for filing with respect to 
     assessing and collecting any fee required by such part for a 
     fiscal year prior to fiscal year 2008.

     SEC. 106. TECHNICAL AMENDMENT.

       Section 739 (21 U.S.C. 379j-11) is amended in the matter 
     preceding paragraph (1), by striking ``subchapter'' and 
     inserting ``part''.

     SEC. 107. EFFECTIVE DATES.

       (a) In General.--Except as provided in subsection (b), the 
     amendments made by this title shall take effect October 1, 
     2007.
       (b) Exception.--The amendment made by section 104 of this 
     title shall take effect on the date of enactment of this 
     title.

[[Page 11681]]



                         TITLE II--DRUG SAFETY

     SEC. 200. SHORT TITLE.

       This title may be cited as the ``Enhancing Drug Safety and 
     Innovation Act of 2007''.

         Subtitle A--Risk Evaluation and Mitigation Strategies

     SEC. 201. ROUTINE ACTIVE SURVEILLANCE AND ASSESSMENT.

       (a) In General.--Subsection (k) of section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is 
     amended by adding at the end the following:
       ``(3) Routine active surveillance and assessment.--
       ``(A) Development of the postmarket risk identification and 
     analysis system.--The Secretary shall, not later than 2 years 
     after the date of enactment of the Enhancing Drug Safety and 
     Innovation Act of 2007, act in collaboration with academic 
     institutions and private entities to--
       ``(i) establish minimum standards for collection and 
     transmission of postmarketing data elements from electronic 
     health data systems; and
       ``(ii) establish, through partnerships, a validated and 
     integrated postmarket risk identification and analysis system 
     to integrate and analyze safety data from multiple sources, 
     with the goals of including, in aggregate--

       ``(I) at least 25,000,000 patients by July 1, 2010; and
       ``(II) at least 100,000,000 patients by July 1, 2012.

       ``(B) Data collection activities.--
       ``(i) In general.--The Secretary shall, not later than 1 
     year after the establishment of the minimum standards and the 
     identification and analysis system under subparagraph (A), 
     establish and maintain an active surveillance 
     infrastructure--

       ``(I) to collect and report data for pharmaceutical 
     postmarket risk identification and analysis, in compliance 
     with the regulations promulgated under section 264(c) of the 
     Health Insurance Portability and Accountability Act of 1996; 
     and
       ``(II) that includes, in addition to the collection and 
     monitoring (in a standardized form) of data on all serious 
     adverse drug experiences (as defined in subsection (o)(2)(C)) 
     required to be submitted to the Secretary under paragraph 
     (1), and those events voluntarily submitted from patients, 
     providers, and drug, when appropriate, procedures to--

       ``(aa) provide for adverse event surveillance by collecting 
     and monitoring Federal health-related electronic data (such 
     as data from the Medicare program and the health systems of 
     the Department of Veterans Affairs);
       ``(bb) provide for adverse event surveillance by collecting 
     and monitoring private sector health-related electronic data 
     (such as pharmaceutical purchase data and health insurance 
     claims data);
       ``(cc) provide for adverse event surveillance by monitoring 
     standardized electronic health records, as available;
       ``(dd) provide for adverse event surveillance by collecting 
     and monitoring other information as the Secretary deems 
     necessary to create a robust system to identify adverse 
     events and potential drug safety signals;
       ``(ee) enable the program to identify certain trends and 
     patterns with respect to data reported to the program;
       ``(ff) enable the program to provide regular reports to the 
     Secretary concerning adverse event trends, adverse event 
     patterns, incidence and prevalence of adverse events, 
     laboratory data, and other information determined 
     appropriate, which may include data on comparative national 
     adverse event trends; and
       ``(gg) enable the program to export data in a form 
     appropriate for further aggregation, statistical analysis, 
     and reporting.
       ``(ii) Timeliness of reporting.--The procedures developed 
     under clause (i) shall ensure that such data are collected, 
     monitored, and reported in a timely, routine, and automatic 
     manner, taking into consideration the need for data 
     completeness, coding, cleansing, and transmission.
       ``(iii) Private sector resources.--To ensure the 
     establishment of the active surveillance infrastructure by 
     the date described under clause (i), the Secretary may, on a 
     temporary or permanent basis, implement systems or products 
     developed by private entities.
       ``(iv) Complementary approaches.--To the extent the active 
     surveillance infrastructure established under clause (i) is 
     not sufficient to gather data and information relevant to 
     priority drug safety questions, the Secretary shall develop, 
     support, and participate in complementary approaches to 
     gather and analyze such data and information, including--

       ``(I) approaches that are complementary with respect to 
     assessing the safety of use of a drug in domestic populations 
     not included in the trials used to approve the drug (such as 
     older people, people with comorbidities, pregnant women, or 
     children); and
       ``(II) existing approaches such as the Vaccine Adverse 
     Event Reporting System and the Vaccine Safety Datalink or 
     successor databases.

       ``(v) Authority for contracts.--The Secretary may enter 
     into contracts with public and private entities to fulfill 
     the requirements of this subparagraph.
       ``(C) Risk identification and analysis.--
       ``(i) Purpose.--To carry out this paragraph, the Secretary 
     shall establish collaborations with other Government, 
     academic, and private entities, including the Centers for 
     Education and Research on Therapeutics under section 912 of 
     the Public Health Service Act, to provide for the risk 
     identification and analysis of the data collected under 
     subparagraph (B) and data that is publicly available or is 
     provided by the Secretary, in order to--

       ``(I) improve the quality and efficiency of postmarket drug 
     safety risk-benefit analysis;
       ``(II) provide the Secretary with routine access to 
     expertise to study advanced drug safety data; and
       ``(III) enhance the ability of the Secretary to make timely 
     assessments based on drug safety data.

       ``(ii) Public process for priority questions.--At least 
     biannually, the Secretary shall seek recommendations from the 
     Drug Safety and Risk Management Advisory Committee (or 
     successor committee) and from other advisory committees, as 
     appropriate, to the Food and Drug Administration on--

       ``(I) priority drug safety questions; and
       ``(II) mechanisms for answering such questions, including 
     through--

       ``(aa) routine active surveillance under subparagraph (B); 
     and
       ``(bb) when such surveillance is not sufficient, postmarket 
     studies under subsection (o)(4)(B) and postapproval clinical 
     trials under subsection (o)(4)(C).
       ``(iii) Procedures for the development of drug safety 
     collaborations.--

       ``(I) In general.--Not later than 180 days after the date 
     of the establishment of the active surveillance 
     infrastructure under subparagraph (B), the Secretary shall 
     establish and implement procedures under which the Secretary 
     may routinely collaborate with a qualified entity to--

       ``(aa) clean, classify, or aggregate data collected under 
     subparagraph (B) and data that is publicly available or is 
     provided by the Secretary;
       ``(bb) allow for prompt investigation of priority drug 
     safety questions, including--
       ``(AA) unresolved safety questions for drugs or classes of 
     drugs; and
       ``(BB) for a newly-approved drug: safety signals from 
     clinical trials used to approve the drug and other 
     preapproval trials; rare, serious drug side effects; and the 
     safety of use in domestic populations not included in the 
     trials used to approve the drug (such as older people, people 
     with comorbidities, pregnant women, or children);
       ``(cc) perform advanced research and analysis on identified 
     drug safety risks;
       ``(dd) convene an expert advisory committee to oversee the 
     establishment of standards for the ethical and scientific 
     uses for, and communication of, postmarketing data collected 
     under subparagraph (B), including advising on the development 
     of effective research methods for the study of drug safety 
     questions;
       ``(ee) focus postmarket studies under subsection (o)(4)(B) 
     and postapproval clinical trials under subsection (o)(4)(C) 
     more effectively on cases for which reports under paragraph 
     (1) and other safety signal detection is not sufficient to 
     resolve whether there is an elevated risk of a serious 
     adverse event associated with the use of a drug; and
       ``(ff) carry out other activities as the Secretary deems 
     necessary to carry out the purposes of this paragraph.

       ``(II) Request for specific methodology.--The procedures 
     described in subclause (I) shall permit the Secretary to 
     request that a specific methodology be used by the qualified 
     entity. The qualified entity shall work with the Secretary to 
     finalize the methodology to be used.

       ``(iv) Use of analyses.--The Secretary shall provide the 
     analyses described under this subparagraph, including the 
     methods and results of such analyses, about a drug to the 
     sponsor or sponsors of such drug.
       ``(v) Qualified entities.--

       ``(I) In general.--The Secretary shall enter into contracts 
     with a sufficient number of qualified entities to develop and 
     provide information to the Secretary in a timely manner.
       ``(II) Qualification.--The Secretary shall enter into a 
     contract with an entity under subclause (I) only if the 
     Secretary determines that the entity--

       ``(aa) has the research capability and expertise to conduct 
     and complete the activities under this paragraph;
       ``(bb) has in place an information technology 
     infrastructure to support adverse event surveillance data and 
     operational standards to provide security for such data;
       ``(cc) has experience with, and expertise on, the 
     development of drug safety and effectiveness research using 
     electronic population data;
       ``(dd) has an understanding of drug development and risk/
     benefit balancing in a clinical setting; and
       ``(ee) has a significant business presence in the United 
     States.
       ``(vi) Contract requirements.--Each contract with a 
     qualified entity shall contain the following requirements:

       ``(I) Ensuring privacy.--The qualified entity shall provide 
     assurances that the entity

[[Page 11682]]

     will not use the data provided by the Secretary in a manner 
     that violates--

       ``(aa) the regulations promulgated under section 264(c) of 
     the Health Insurance Portability and Accountability Act of 
     1996; or
       ``(bb) sections 552 or 552a of title 5, United States Code, 
     with regard to the privacy of individually-identifiable 
     beneficiary health information.

       ``(II) Component of another organization.--If a qualified 
     entity is a component of another organization--

       ``(aa) the qualified entity shall maintain the data related 
     to the activities carried out under this paragraph separate 
     from the other components of the organization and establish 
     appropriate security measures to maintain the confidentiality 
     and privacy of such data; and
       ``(bb) the entity shall not make an unauthorized disclosure 
     of such data to the other components of the organization in 
     breach of such confidentiality and privacy requirement.

       ``(III) Termination or nonrenewal.--If a contract with a 
     qualified entity under this subparagraph is terminated or not 
     renewed, the following requirements shall apply:

       ``(aa) Confidentiality and privacy protections.--The entity 
     shall continue to comply with the confidentiality and privacy 
     requirements under this paragraph with respect to all data 
     disclosed to the entity.
       ``(bb) Disposition of data.--The entity shall return to the 
     Secretary all data disclosed to the entity or, if returning 
     the data is not practicable, destroy the data.
       ``(vii) Competitive procedures.--The Secretary shall use 
     competitive procedures (as defined in section 4(5) of the 
     Federal Procurement Policy Act) to enter into contracts under 
     clause (v).
       ``(viii) Review of contract in the even of a merger or 
     acquisition.--The Secretary shall review the contract with a 
     qualified entity under this paragraph in the event of a 
     merger or acquisition of the entity in order to ensure that 
     the requirements under this subparagraph will continue to be 
     met.
       ``(D) Coordination.--In carrying out this paragraph, the 
     Secretary shall provide for appropriate communications to the 
     public, scientific, public health, and medical communities, 
     and other key stakeholders, and provide for the coordination 
     of the activities of private entities, professional 
     associations, or other entities that may have sources of 
     surveillance data.''.
       (b) Authorization of Appropriations.--To carry out 
     activities under the amendment made by this section for which 
     funds are made available under section 736 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379h), there are 
     authorized to be appropriated to carry out the amendment made 
     by this section, in addition to such funds, $25,000,000 for 
     each of fiscal years 2008 through 2012.

     SEC. 202. RISK EVALUATION AND MITIGATION STRATEGIES.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355) is amended by adding at the end the following:
       ``(o) Risk Evaluation and Mitigation Strategy.--
       ``(1) In general.--In the case of any drug subject to 
     subsection (b) or to section 351 of the Public Health Service 
     Act for which a risk evaluation and mitigation strategy is 
     approved as provided for in this subsection, the applicant 
     shall comply with the requirements of such strategy.
       ``(2) Definitions.--In this subsection:
       ``(A) Adverse drug experience.--The term `adverse drug 
     experience' means any adverse event associated with the use 
     of a drug in humans, whether or not considered drug related, 
     including--
       ``(i) an adverse event occurring in the course of the use 
     of the drug in professional practice;
       ``(ii) an adverse event occurring from an overdose of the 
     drug, whether accidental or intentional;
       ``(iii) an adverse event occurring from abuse of the drug;
       ``(iv) an adverse event occurring from withdrawal of the 
     drug; and
       ``(v) any failure of expected pharmacological action of the 
     drug.
       ``(B) New safety information.--The term `new safety 
     information' with respect to a drug means information about--
       ``(i) a serious risk or an unexpected serious risk with use 
     of the drug that the Secretary has become aware of since the 
     later of--

       ``(I) the date of initial approval of the drug under this 
     section or initial licensure of the drug under section 351 of 
     the Public Health Service Act; or
       ``(II) if applicable, the last assessment of the approved 
     risk evaluation and mitigation strategy for the drug; or

       ``(ii) the effectiveness of the approved risk evaluation 
     and mitigation strategy for the drug obtained since the later 
     of--

       ``(I) the approval of such strategy; or
       ``(II) the last assessment of such strategy.

       ``(C) Serious adverse drug experience.--The term `serious 
     adverse drug experience' is an adverse drug experience that--
       ``(i) results in--

       ``(I) death;
       ``(II) the placement of the patient at immediate risk of 
     death from the adverse drug experience as it occurred (not 
     including an adverse drug experience that might have caused 
     death had it occurred in a more severe form);
       ``(III) inpatient hospitalization or prolongation of 
     existing hospitalization;
       ``(IV) a persistent or significant incapacity or 
     substantial disruption of the ability to conduct normal life 
     functions; or
       ``(V) a congenital anomaly or birth defect; or

       ``(ii) based on appropriate medical judgment, may 
     jeopardize the patient and may require a medical or surgical 
     intervention to prevent an outcome described under clause 
     (i).
       ``(D) Serious risk.--The term `serious risk' means a risk 
     of a serious adverse drug experience.
       ``(E) Signal of a serious risk.--The term `signal of a 
     serious risk' means information related to a serious adverse 
     drug experience derived from--
       ``(i) a clinical trial;
       ``(ii) adverse event reports under subsection (k)(1);
       ``(iii) routine active surveillance under subsection 
     (k)(3);
       ``(iv) a postapproval study, including a study under 
     paragraph (4)(B); or
       ``(v) peer-reviewed biomedical literature.
       ``(F) Unexpected serious risk.--The term `unexpected 
     serious risk' means a serious adverse drug experience that--
       ``(i) is not listed in the labeling of a drug; or
       ``(ii) is symptomatically and pathophysiologically related 
     to an adverse drug experience listed in the labeling of the 
     drug, but differs from such adverse drug experience because 
     of greater severity, specificity, or prevalence.
       ``(3) Required elements of a risk evaluation and mitigation 
     strategy.--If a risk evaluation and mitigation strategy for a 
     drug is required, such strategy shall include--
       ``(A) the labeling for the drug for use by health care 
     providers as approved under subsection (c);
       ``(B) a timetable for submission of assessments of the 
     strategy, that--
       ``(i) for a drug no active ingredient (including any ester 
     or salt of the active ingredient) of which has been approved 
     in any other application under this section or section 351 of 
     the Public Health Service Act--

       ``(I) shall be no less frequently than 18 months and 3 
     years after the drug is initially approved and at a frequency 
     specified in the strategy for subsequent years; and
       ``(II) may be eliminated after the first 3 years if the 
     Secretary determines that serious risks of the drug have been 
     adequately identified and assessed and are being adequately 
     managed;

       ``(ii) for a drug other than a drug described under clause 
     (i), shall occur at a frequency determined by the Secretary; 
     and
       ``(iii) may be increased or reduced in frequency as 
     necessary as provided for in paragraph (7)(B)(v)(VI).
       ``(4) Additional potential evaluation elements of a risk 
     evaluation and mitigation strategy.--
       ``(A) Risk evaluation.--If a risk evaluation and mitigation 
     strategy for a drug is required, such strategy may include 1 
     or more of the additional evaluation elements described in 
     this paragraph, so long as the Secretary makes the 
     determination required with respect to each additional 
     included element.
       ``(B) Postapproval studies.--If the Secretary determines 
     that the reports under subsection (k)(1) and routine active 
     surveillance as available under subsection (k)(3) (including 
     available complementary approaches under subsection 
     (k)(3)(B)(iv)) will not be sufficient to--
       ``(i) assess a signal of a serious risk with use of a drug; 
     or
       ``(ii) identify, based on a review of a demonstrated 
     pattern of use of the drug, unexpected serious risks in a 
     domestic population, including older people, people with 
     comorbidities, pregnant women, or children,

     the risk evaluation and mitigation strategy for the drug may 
     require that the applicant conduct an appropriate 
     postapproval study, such as a prospective or retrospective 
     observational study, of the drug (which shall include a 
     timeframe specified by the Secretary for completing the study 
     and reporting the results to the Secretary).
       ``(C) Postapproval clinical trials.--If the Secretary 
     determines that the reports under subsection (k)(1), routine 
     active surveillance as available under subsection (k)(3) 
     (including available complementary approaches under 
     subsection (k)(3)(B)(iv)), and a study or studies under 
     subparagraph (B) will likely be inadequate to assess a signal 
     of a serious risk with use of a drug, and there is no 
     effective approved application for the drug under subsection 
     (j) as of the date that the requirement is first imposed, the 
     risk evaluation and mitigation strategy for the drug may 
     require that the applicant conduct an appropriate 
     postapproval clinical trial of the drug (which shall include 
     a timeframe specified by the Secretary for completing the 
     clinical trial and reporting the results to the Secretary) to 
     be included in the clinical trial registry data bank provided 
     for under subsections (i) and (j) of section 402 of the 
     Public Health Service Act.

[[Page 11683]]

       ``(5) Additional potential communication elements of a risk 
     evaluation and mitigation strategy.--
       ``(A) Risk communication.--If a risk evaluation and 
     mitigation strategy for a drug is required, such strategy may 
     include 1 or more of the additional communication elements 
     described in this paragraph, so long as the Secretary makes 
     the determination required with respect to each additional 
     included element.
       ``(B) Medguide; patient package insert.--The risk 
     evaluation and mitigation strategy for a drug may require 
     that the applicant develop for distribution to each patient 
     when the drug is dispensed either or both of the following:
       ``(i) A Medication Guide, as provided for under part 208 of 
     title 21, Code of Federal Regulations (or any successor 
     regulations).
       ``(ii) A patient package insert, if the Secretary 
     determines that such insert may help mitigate a serious risk 
     listed in the labeling of the drug.
       ``(C) Communication plan.--If the Secretary determines that 
     a communication plan to health care providers may support 
     implementation of an element of the risk evaluation and 
     mitigation strategy for a drug, such as a labeling change, 
     the strategy may require that the applicant conduct such a 
     plan, which may include--
       ``(i) sending letters to health care providers;
       ``(ii) disseminating information about the elements of the 
     strategy to encourage implementation by health care providers 
     of components that apply to such health care providers, or to 
     explain certain safety protocols (such as medical monitoring 
     by periodic laboratory tests); or
       ``(iii) disseminating information to health care providers 
     through professional societies about any serious risks of the 
     drug and any protocol to assure safe use.
       ``(D) Prereview.--
       ``(i) In general.--If the Secretary determines that 
     prereview of advertisements is necessary to ensure the 
     inclusion of a true statement in such advertisements of 
     information in brief summary relating to a serious risk 
     listed in the labeling of a drug, or relating to a protocol 
     to ensure the safe use described in the labeling of the drug, 
     the risk evaluation and mitigation strategy for the drug may 
     require that the applicant submit to the Secretary 
     advertisements of the drug for prereview not later than 45 
     days before dissemination of the advertisement
       ``(ii) Specification of advertisements.--The Secretary may 
     specify the advertisements required to be submitted under 
     clause (i).
       ``(E) Specific disclosures.--
       ``(i) Serious risk; safety protocol.--If the Secretary 
     determines that advertisements lacking a specific disclosure 
     about a serious risk listed in the labeling of a drug or 
     about a protocol to ensure safe use described in the labeling 
     of the drug would be false or misleading, the risk evaluation 
     and mitigation strategy for the drug may require that the 
     applicant include in advertisements of the drug such 
     disclosure.
       ``(ii) Date of approval.--If the Secretary determines that 
     advertisements lacking a specific disclosure of the date a 
     drug was approved and disclosure of a serious risk would be 
     false or misleading, the risk evaluation and mitigation 
     strategy for the drug may require that the applicant include 
     in advertisements of the drug such disclosure.
       ``(iii) Specification of advertisements.--The Secretary may 
     specify the advertisements required to include a specific 
     disclosure under clause (i) or (ii).
       ``(iv) Required safety surveillance.--If the approved risk 
     evaluation and mitigation strategy for a drug requires the 
     specific disclosure under clause (ii), the Secretary shall--

       ``(I) consider identifying and assessing all serious risks 
     of using the drug to be a priority safety question under 
     subsection (k)(3)(B);
       ``(II) not less frequently than every 3 months, evaluate 
     the reports under subsection (k)(1) and the routine active 
     surveillance as available under subsection (k)(3) with 
     respect to such priority drug safety question to determine 
     whether serious risks that might occur among patients 
     expected to be treated with the drug have been adequately 
     identified and assessed;
       ``(III) remove such specific disclosure requirement as an 
     element of such strategy if such serious risks have been 
     adequately identified and assessed; and
       ``(IV) consider whether a specific disclosure under clause 
     (i) should be required.

       ``(6) Providing safe access for patients to drugs with 
     known serious risks that would otherwise be unavailable.--
       ``(A) Allowing safe access to drugs with known serious 
     risks.--The Secretary may require that the risk evaluation 
     and mitigation strategy for a drug include such elements as 
     are necessary to assure safe use of the drug, because of its 
     inherent toxicity or potential harmfulness, if the Secretary 
     determines that--
       ``(i) the drug, which has been shown to be effective, but 
     is associated with a serious adverse drug experience, can be 
     approved only if, or would be withdrawn unless, such elements 
     are required as part of such strategy to mitigate a specific 
     serious risk listed in the labeling of the drug; and
       ``(ii) for a drug initially approved without elements to 
     assure safe use, other elements under paragraphs (3), (4), 
     and (5) are not sufficient to mitigate such serious risk.
       ``(B) Assuring access and minimizing burden.--Such elements 
     to assure safe use under subparagraph (A) shall--
       ``(i) be commensurate with the specific serious risk listed 
     in the labeling of the drug;
       ``(ii) within 30 days of the date on which any element 
     under subparagraph (A) is imposed, be posted publicly by the 
     Secretary with an explanation of how such elements will 
     mitigate the observed safety risk;
       ``(iii) considering such risk, not be unduly burdensome on 
     patient access to the drug, considering in particular--

       ``(I) patients with serious or life-threatening diseases or 
     conditions; and
       ``(II) patients who have difficulty accessing health care 
     (such as patients in rural or medically underserved areas); 
     and

       ``(iv) to the extent practicable, so as to minimize the 
     burden on the health care delivery system--

       ``(I) conform with elements to assure safe use for other 
     drugs with similar, serious risks; and
       ``(II) be designed to be compatible with established 
     distribution, procurement, and dispensing systems for drugs.

       ``(C) Elements to assure safe use.--The elements to assure 
     safe use under subparagraph (A) shall include 1 or more goals 
     to mitigate a specific serious risk listed in the labeling of 
     the drug and, to mitigate such risk, may require that--
       ``(i) health care providers who prescribe the drug have 
     particular training or experience, or are specially certified 
     (which training or certification with respect to the drug 
     shall be available to any willing provider from a frontier 
     area in a widely available training or certification method 
     (including an on-line course or via mail) as approved by the 
     Secretary at minimal cost to the provider);
       ``(ii) pharmacies, practitioners, or health care settings 
     that dispense the drug are specially certified (which 
     certification shall be available to any willing provider from 
     a frontier area);
       ``(iii) the drug be dispensed to patients only in certain 
     health care settings, such as hospitals;
       ``(iv) the drug be dispensed to patients with evidence or 
     other documentation of safe-use conditions, such as 
     laboratory test results;
       ``(v) each patient using the drug be subject to certain 
     monitoring; or
       ``(vi) each patient using the drug be enrolled in a 
     registry.
       ``(D) Implementation system.--The elements to assure safe 
     use under subparagraph (A) that are described in clauses 
     (ii), (iii), or (iv) of subparagraph (C) may include a system 
     through which the applicant is able to take reasonable steps 
     to--
       ``(i) monitor and evaluate implementation of such elements 
     by health care providers, pharmacists, and other parties in 
     the health care system who are responsible for implementing 
     such elements; and
       ``(ii) work to improve implementation of such elements by 
     such persons.
       ``(E) Evaluation of elements to assure safe use.--The 
     Secretary, through the Drug Safety and Risk Management 
     Advisory Committee (or successor committee) of the Food and 
     Drug Administration, shall--
       ``(i) seek input from patients, physicians, pharmacists, 
     and other health care providers about how elements to assure 
     safe use under this paragraph for 1 or more drugs may be 
     standardized so as not to be--

       ``(I) unduly burdensome on patient access to the drug; and
       ``(II) to the extent practicable, minimize the burden on 
     the health care delivery system;

       ``(ii) at least annually, evaluate, for 1 or more drugs, 
     the elements to assure safe use of such drug to assess 
     whether the elements--

       ``(I) assure safe use of the drug;
       ``(II) are not unduly burdensome on patient access to the 
     drug; and
       ``(III) to the extent practicable, minimize the burden on 
     the health care delivery system; and

       ``(iii) considering such input and evaluations--

       ``(I) issue or modify agency guidance about how to 
     implement the requirements of this paragraph; and
       ``(II) modify elements under this paragraph for 1 or more 
     drugs as appropriate.

       ``(F) Additional mechanisms to assure access.--The 
     mechanisms under section 561 to provide for expanded access 
     for patients with serious or life-threatening diseases or 
     conditions may be used to provide access for patients with a 
     serious or life-threatening disease or condition, the 
     treatment of which is not an approved use for the drug, to a 
     drug that is subject to elements to assure safe use under 
     this paragraph. The Secretary shall promulgate regulations 
     for how a physician may provide the drug under the mechanisms 
     of section 561.
       ``(G) Waiver in public health emergencies.--The Secretary 
     may waive any requirement of this paragraph during the period 
     described in section 319(a) of the Public

[[Page 11684]]

     Health Service Act with respect to a qualified countermeasure 
     described under section 319F-1(a)(2) of such Act, to which a 
     requirement under this paragraph has been applied, if the 
     Secretary has--
       ``(i) declared a public health emergency under such section 
     319; and
       ``(ii) determined that such waiver is required to mitigate 
     the effects of, or reduce the severity of, such public health 
     emergency.
       ``(7) Submission and review of risk evaluation and 
     mitigation strategy.--
       ``(A) Proposed risk evaluation and mitigation strategy.--
       ``(i) Voluntary proposal.--If there is a signal of a 
     serious risk with a drug, an applicant may include a proposed 
     risk evaluation and mitigation strategy for the drug in an 
     application, including in a supplemental application, for the 
     drug under subsection (b) or section 351 of the Public Health 
     Service Act.
       ``(ii) Required proposal.--

       ``(I) Determination necessary to require a proposal.--

       ``(aa) In general.--The Secretary may require that the 
     applicant for a drug submit a proposed risk evaluation and 
     mitigation strategy for a drug if the Secretary (acting 
     through the office responsible for reviewing the drug and the 
     office responsible for postapproval safety with respect to 
     the drug) determines that, based on a signal of a serious 
     risk with the drug, a risk evaluation and mitigation strategy 
     is necessary to assess such signal or mitigate such serious 
     risk.
       ``(bb) Non-delegation.--A determination under item (aa) for 
     a drug shall be made by individuals at or above the level of 
     individuals empowered to approve a drug (such as division 
     directors within the Center for Drug Evaluation and 
     Research).

       ``(II) Circumstances in which a proposal may be required.--
     The applicant shall submit a proposed risk evaluation and 
     mitigation strategy for a drug--

       ``(aa) in response to a letter from the Secretary (acting 
     through the office responsible for reviewing the drug and the 
     office responsible for postapproval safety with respect to 
     the drug) sent regarding an application, including a 
     supplemental application, for the drug, if the Secretary 
     determines that data or information in the application 
     indicates that an element under paragraph (4), (5), or (6) 
     should be included in a strategy for the drug;
       ``(bb) within a timeframe specified by the Secretary, not 
     to be less than 45 days, when ordered by the Secretary 
     (acting through such offices), if the Secretary determines 
     that new safety information indicates that--
       ``(AA) the labeling of the drug should be changed; or
       ``(BB) an element under paragraph (4) or (5) should be 
     included in a strategy for the drug; or
       ``(cc) within 90 days when ordered by the Secretary (acting 
     through such offices), if the Secretary determines that new 
     safety information indicates that an element under paragraph 
     (6) should be included in a strategy for the drug.
       ``(iii) Content of letter.--A letter under clause 
     (ii)(II)(aa) shall describe--

       ``(I) the data or information in the application that 
     warrants the proposal of a risk evaluation and mitigation 
     strategy for the drug; and
       ``(II) what elements under paragraphs (4), (5), or (6) 
     should be included in a strategy for the drug.

       ``(iv) Content of order.--An order under item (aa) or (bb) 
     of clause (ii)(II) shall describe--

       ``(I) the new safety information with respect to the drug 
     that warrants the proposal of a risk evaluation and 
     mitigation strategy for the drug; and
       ``(II) whether and how the labeling of the drug should be 
     changed and what elements under paragraphs (4), (5), or (6) 
     should be included in a strategy for the drug.

       ``(v) Content of proposal.--A proposed risk evaluation and 
     mitigation strategy--

       ``(I) shall include a timetable as described under 
     paragraph (3)(B); and
       ``(II) may also include additional elements as provided for 
     under paragraphs (4), (5), and (6).

       ``(B) Assessment and modification of a risk evaluation and 
     mitigation strategy.--
       ``(i) Voluntary assessments.--If a risk evaluation and 
     mitigation strategy for a drug is required, the applicant may 
     submit to the Secretary an assessment of, and propose a 
     modification to, such approved strategy for the drug at any 
     time.
       ``(ii) Required assessments.--If a risk evaluation and 
     mitigation strategy for a drug is required, the applicant 
     shall submit an assessment of, and may propose a modification 
     to, such approved strategy for the drug--

       ``(I) when submitting an application, including a 
     supplemental application, for a new indication under 
     subsection (b) or section 351 of the Public Health Service 
     Act;
       ``(II) when required by the strategy, as provided for in 
     the timetable under paragraph (3)(B);
       ``(III) within a timeframe specified by the Secretary, not 
     to be less than 45 days, when ordered by the Secretary 
     (acting through the offices described in subparagraph 
     (A)(ii)(I)), if the Secretary determines that new safety 
     information indicates that an element under paragraph (3) or 
     (4) should be modified or added to the strategy;
       ``(IV) within 90 days when ordered by the Secretary (acting 
     through such offices), if the Secretary determines that new 
     safety information indicates that an element under paragraph 
     (6) should be modified or added to the strategy; or
       ``(V) within 15 days when ordered by the Secretary (acting 
     through such offices), if the Secretary determines that there 
     may be a cause for action by the Secretary under subsection 
     (e).

       ``(iii) Content of order.--An order under subclauses (III), 
     (IV), or (V) of clause (ii) shall describe--

       ``(I) the new safety information with respect to the drug 
     that warrants an assessment of the approved risk evaluation 
     and mitigation strategy for the drug; and
       ``(II) whether and how such strategy should be modified 
     because of such information.

       ``(iv) Assessment.--An assessment of the approved risk 
     evaluation and mitigation strategy for a drug shall include--

       ``(I) a description of new safety information, if any, with 
     respect to the drug;
       ``(II) whether and how to modify such strategy because of 
     such information;
       ``(III) with respect to any postapproval study required 
     under paragraph (4)(B) or otherwise undertaken by the 
     applicant to investigate a safety issue, the status of such 
     study, including whether any difficulties completing the 
     study have been encountered;
       ``(IV) with respect to any postapproval clinical trial 
     required under paragraph (4)(C) or otherwise undertaken by 
     the applicant to investigate a safety issue, the status of 
     such clinical trial, including whether enrollment has begun, 
     the number of participants enrolled, the expected completion 
     date, whether any difficulties completing the clinical trial 
     have been encountered, and registration information with 
     respect to requirements under subsections (i) and (j) of 
     section 402 of the Public Health Service Act; and
       ``(V) with respect to any goal under paragraph (6) and 
     considering input and evaluations, if applicable, under 
     paragraph (6)(E), an assessment of how well the elements to 
     assure safe use are meeting the goal of increasing safe 
     access to drugs with known serious risks or whether the goal 
     or such elements should be modified.

       ``(v) Modification.--A modification (whether an enhancement 
     or a reduction) to the approved risk evaluation and 
     mitigation strategy for a drug may include the addition or 
     modification of any element under subparagraph (A) or (B) of 
     paragraph (3) or the addition, modification, or removal of 
     any element under paragraph (4), (5), or (6), such as--

       ``(I) a labeling change, including the addition of a boxed 
     warning;
       ``(II) adding a postapproval study or clinical trial 
     requirement;
       ``(III) modifying a postapproval study or clinical trial 
     requirement (such as a change in trial design due to 
     legitimate difficulties recruiting participants);
       ``(IV) adding, modifying, or removing an element on 
     advertising under subparagraph (D), (E), or (F) of paragraph 
     (5);
       ``(V) adding, modifying, or removing an element to assure 
     safe use under paragraph (6); or
       ``(VI) modifying the timetable for assessments of the 
     strategy under paragraph (3)(B), including to eliminate 
     assessments.

       ``(C) Review.--The Secretary (acting through the offices 
     described in subparagraph (A)(ii)(I)) shall promptly review 
     the proposed risk evaluation and mitigation strategy for a 
     drug submitted under subparagraph (A), or an assessment of 
     the approved risk evaluation and mitigation strategy for a 
     drug submitted under subparagraph (B).
       ``(D) Discussion.--The Secretary (acting through the 
     offices described in subparagraph (A)(ii)(I)) shall initiate 
     discussions of the proposed risk evaluation and mitigation 
     strategy for a drug submitted under subparagraph (A), or of 
     an assessment of the approved risk evaluation and mitigation 
     strategy for a drug submitted under subparagraph (B), with 
     the applicant to determine a strategy--
       ``(i) if the proposed strategy or assessment is submitted 
     as part of an application (including a supplemental 
     application) under subparagraph (A)(i), (A)(ii)(II)(aa), or 
     (B)(ii)(I), by the target date for communication of feedback 
     from the review team to the applicant regarding proposed 
     labeling and postmarketing study commitments, as set forth in 
     the letters described in section 735(a);
       ``(ii) if the proposed strategy is submitted under 
     subparagraph (A)(ii)(II)(bb) or the assessment is submitted 
     under subclause (II) or (III) of subparagraph (B)(ii), not 
     later than 20 days after such submission;
       ``(iii) if the proposed strategy is submitted under 
     subparagraph (A)(ii)(II)(cc) or the assessment is submitted 
     under subparagraph (B)(i) or under subparagraph (B)(ii)(IV), 
     not later than 30 days after such submission; or
       ``(iv) if the assessment is submitted under subparagraph 
     (B)(ii)(V), not later than 10 days after such submission.
       ``(E) Action.--

[[Page 11685]]

       ``(i) In general.--Unless the applicant requests the 
     dispute resolution process as described under subparagraph 
     (F) or (G), the Secretary (acting through the offices 
     described in subparagraph (A)(ii)(I)) shall approve and 
     include the risk evaluation and mitigation strategy for a 
     drug, or any modification to the strategy (including a 
     timeframe for implementing such modification), with--

       ``(I) the action letter on the application, if a proposed 
     strategy is submitted under subparagraph (A)(i) or 
     (A)(ii)(II)(aa) or an assessment of the strategy is submitted 
     under subparagraph (B)(ii)(I); or
       ``(II) an order, which shall be made public, issued not 
     later than 50 days after the date discussions of such 
     proposed strategy or modification begin under subparagraph 
     (D), if a proposed strategy is submitted under item (bb) or 
     (cc) of subparagraph (A)(ii)(II) or an assessment of the 
     strategy is submitted under subparagraph (B)(i) or under 
     subclause (II), (III), (IV), or (V) of subparagraph (B)(ii).

       ``(ii) Inaction.--An approved risk evaluation and 
     mitigation strategy shall remain in effect until the 
     Secretary acts, if the Secretary fails to act as provided 
     under clause (i).
       ``(F) Dispute resolution at initial approval.--If a 
     proposed risk evaluation and mitigation strategy is submitted 
     under subparagraph (A)(i) or (A)(ii)(II)(aa) in an 
     application for initial approval of a drug and there is a 
     dispute about the strategy, the applicant shall use the major 
     dispute resolution procedures as set forth in the letters 
     described in section 735(a).
       ``(G) Dispute resolution in all other cases.--
       ``(i) Request for review.--In any case other than a 
     submission under subparagraph (A)(i) or (A)(ii)(II)(aa) in an 
     application for initial approval of a drug if there is a 
     dispute about the strategy, not earlier than 15 days, and not 
     later than 35 days, after discussions under subparagraph (D) 
     have begun, the applicant shall request in writing that the 
     dispute be reviewed by the Drug Safety Oversight Board.
       ``(ii) Scheduling review.--If the applicant requests review 
     under clause (i), the Secretary--

       ``(I)(aa) shall schedule the dispute for review at 1 of the 
     next 2 regular meetings of the Drug Safety Oversight Board, 
     whichever meeting date is more practicable; or
       ``(bb) may convene a special meeting of the Drug Safety 
     Oversight Board to review the matter more promptly, including 
     to meet an action deadline on an application (including a 
     supplemental application);
       ``(II) shall give advance notice to the public through the 
     Federal Register and on the Internet website of the Food and 
     Drug Administration--

       ``(aa) that the drug is to be discussed by the Drug Safety 
     Oversight Board; and
       ``(bb) of the date on which the Drug Safety Oversight Board 
     shall discuss such drug; and

       ``(III) shall apply section 301(j), section 552 of title 5, 
     and section 1905 of title 18, United States Code, to any 
     request for information about such review.

       ``(iii) Agreement after discussion or administrative 
     appeals.--

       ``(I) Further discussion or administrative appeals.--A 
     request for review under clause (i) shall not preclude--

       ``(aa) further discussions to reach agreement on the risk 
     evaluation and mitigation strategy; or
       ``(bb) the use of administrative appeals within the Food 
     and Drug Administration to reach agreement on the strategy, 
     including the major dispute resolution procedures as set 
     forth in the letters described in section 735(a).

       ``(II) Agreement terminates dispute resolution.--At any 
     time before a decision and order is issued under clause (vi), 
     the Secretary (acting through the offices described in 
     subparagraph (A)(ii)(I)) and the applicant may reach an 
     agreement on the risk evaluation and mitigation strategy 
     through further discussion or administrative appeals, 
     terminating the dispute resolution process, and the Secretary 
     shall issue an action letter or order, as appropriate, that 
     describes the strategy.

       ``(iv) Meeting of the board.--At the meeting of the Drug 
     Safety Oversight Board described in clause (ii), the Board 
     shall--

       ``(I) hear from both parties; and
       ``(II) review the dispute.

       ``(v) Recommendation of the board.--Not later than 5 days 
     after such meeting of the Drug Safety Oversight Board, the 
     Board shall provide a written recommendation on resolving the 
     dispute to the Secretary.
       ``(vi) Action by the secretary.--

       ``(I) Action letter.--With respect to a proposed risk 
     evaluation and mitigation strategy submitted under 
     subparagraph (A)(i) or (A)(ii)(II)(aa) or to an assessment of 
     the strategy submitted under subparagraph (B)(ii)(I), the 
     Secretary shall issue an action letter that resolves the 
     dispute not later than the later of--

       ``(aa) the action deadline for the action letter on the 
     application; or
       ``(bb) 7 days after receiving the recommendation of the 
     Drug Safety Oversight Board.

       ``(II) Order.--With respect to a proposed risk evaluation 
     and mitigation strategy submitted under item (bb) or (cc) of 
     subparagraph (A)(ii)(II) or an assessment of the risk 
     evaluation and mitigation strategy under subparagraph (B)(i) 
     or under subclause (II), (III), (IV), or (V) of subparagraph 
     (B)(ii), the Secretary shall issue an order, which (with the 
     recommendation of the Drug Safety Oversight Board) shall be 
     made public, that resolves the dispute not later than 7 days 
     after receiving the recommendation of the Drug Safety 
     Oversight Board.

       ``(vii) Inaction.--An approved risk evaluation and 
     mitigation strategy shall remain in effect until the 
     Secretary acts, if the Secretary fails to act as provided for 
     under clause (vi).
       ``(viii) Effect on action deadline.--With respect to the 
     application or supplemental application in which a proposed 
     risk evaluation and mitigation strategy is submitted under 
     subparagraph (A)(i) or (A)(ii)(II)(aa) or in which an 
     assessment of the strategy is submitted under subparagraph 
     (B)(ii)(I), the Secretary shall be considered to have met the 
     action deadline for the action letter on such application if 
     the applicant requests the dispute resolution process 
     described in this subparagraph and if the Secretary--

       ``(I) has initiated the discussions described under 
     subparagraph (D) by the target date referred to in 
     subparagraph (D)(i); and
       ``(II) has complied with the timing requirements of 
     scheduling review by the Drug Safety Oversight Board, 
     providing a written recommendation, and issuing an action 
     letter under clauses (ii), (v), and (vi), respectively.

       ``(ix) Disqualification.--No individual who is an employee 
     of the Food and Drug Administration and who reviews a drug or 
     who participated in an administrative appeal under clause 
     (iii)(I) with respect to such drug may serve on the Drug 
     Safety Oversight Board at a meeting under clause (iv) to 
     review a dispute about the risk evaluation and mitigation 
     strategy for such drug.
       ``(x) Additional expertise.--The Drug Safety Oversight 
     Board may add members with relevant expertise from the Food 
     and Drug Administration, including the Office of Pediatrics, 
     the Office of Women's Health, or the Office of Rare Diseases, 
     or from other Federal public health or health care agencies, 
     for a meeting under clause (iv) of the Drug Safety Oversight 
     Board.
       ``(H) Use of advisory committees.--The Secretary (acting 
     through the offices described in subparagraph (A)(ii)(I)) may 
     convene a meeting of 1 or more advisory committees of the 
     Food and Drug Administration to--
       ``(i) review a concern about the safety of a drug or class 
     of drugs, including before an assessment of the risk 
     evaluation and mitigation strategy or strategies of such drug 
     or drugs is required to be submitted under subclause (II), 
     (III), (IV), or (V) of subparagraph (B)(ii);
       ``(ii) review the risk evaluation and mitigation strategy 
     or strategies of a drug or group of drugs; or
       ``(iii) with the consent of the applicant, review a dispute 
     under subparagraph (G).
       ``(I) Process for addressing drug class effects.--
       ``(i) In general.--When a concern about a serious risk of a 
     drug may be related to the pharmacological class of the drug, 
     the Secretary (acting through the offices described in 
     subparagraph (A)(ii)(I)) may defer assessments of the 
     approved risk evaluation and mitigation strategies for such 
     drugs until the Secretary has--

       ``(I) convened, after appropriate public notice, 1 or more 
     public meetings to consider possible responses to such 
     concern; or
       ``(II) gathered additional information or data about such 
     concern.

       ``(ii) Public meetings.--Such public meetings may include--

       ``(I) 1 or more meetings of the applicants for such drugs;
       ``(II) 1 or more meetings of 1 or more advisory committees 
     of the Food and Drug Administration, as provided for under 
     subparagraph (H); or
       ``(III) 1 or more workshops of scientific experts and other 
     stakeholders.

       ``(iii) Action.--After considering the discussions from any 
     meetings under clause (ii), the Secretary may--

       ``(I) announce in the Federal Register a planned regulatory 
     action, including a modification to each risk evaluation and 
     mitigation strategy, for drugs in the pharmacological class;
       ``(II) seek public comment about such action; and
       ``(III) after seeking such comment, issue an order 
     addressing such regulatory action.

       ``(J) International coordination.--The Secretary (acting 
     through the offices described in subparagraph (A)(ii)(I)) may 
     coordinate the timetable for submission of assessments under 
     paragraph (3)(B), a study under paragraph (4)(B), or a 
     clinical trial under paragraph (4)(C), with efforts to 
     identify and assess the serious risks of such drug by the 
     marketing authorities of other countries whose drug approval 
     and risk management processes the Secretary deems comparable 
     to the drug approval and risk management processes of the 
     United States.
       ``(K) Effect.--Use of the processes described in 
     subparagraphs (I) and (J) shall not delay action on an 
     application or a supplement to an application for a drug.

[[Page 11686]]

       ``(L) No effect on labeling changes that do not require 
     preapproval.--In the case of a labeling change to which 
     section 314.70 of title 21, Code of Federal Regulations (or 
     any successor regulation), applies for which the submission 
     of a supplemental application is not required or for which 
     distribution of the drug involved may commence upon the 
     receipt by the Secretary of a supplemental application for 
     the change, the submission of an assessment of the approved 
     risk evaluation and mitigation strategy for the drug under 
     this subsection is not required.
       ``(8) Drug safety oversight board.--
       ``(A) In general.--There is established a Drug Safety 
     Oversight Board.
       ``(B) Composition; meetings.--The Drug Safety Oversight 
     Board shall--
       ``(i) be composed of scientists and health care 
     practitioners appointed by the Secretary, each of whom is an 
     employee of the Federal Government;
       ``(ii) include representatives from offices throughout the 
     Food and Drug Administration (including the offices 
     responsible for postapproval safety of drugs);
       ``(iii) include at least 1 representative each from the 
     National Institutes of Health, the Department of Health and 
     Human Services (other than the Food and Drug Administration), 
     and the Veterans Health Administration; and
       ``(iv) meet at least monthly to provide oversight and 
     advice to the Secretary on the management of important drug 
     safety issues.
       ``(9) Civil monetary penalty.--Notwithstanding any other 
     provision of this Act, an applicant (as such term is defined 
     for purposes of this section) that knowingly fails to comply 
     with a requirement of an approved risk evaluation and 
     mitigation strategy under this subsection shall be subject to 
     a civil money penalty of $250,000 for the first 30-day period 
     that the applicant is in noncompliance, and such amount shall 
     double for every 30-day period thereafter that the 
     requirement is not complied with, not to exceed 
     $2,000,000.''.

     SEC. 203. ENFORCEMENT.

       (a) Misbranding.--Section 502 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352) is amended by adding at the 
     end the following:
       ``(x) If it is a drug subject to an approved risk 
     evaluation and mitigation strategy under section 505(o) and 
     the applicant for such drug fails to--
       ``(1) make a labeling change required by such strategy 
     after the Secretary has approved such strategy or completed 
     review of, and acted on, an assessment of such strategy under 
     paragraph (7) of such section; or
       ``(2) comply with a requirement of such strategy with 
     respect to advertising as provided for under subparagraph 
     (D), (E), or (F) of paragraph (5) of such section.''.
       (b) Civil Penalties.--Section 303(f) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended--
       (1) by redesignating paragraphs (3), (4), and (5) as 
     paragraphs (4), (5), and (6), respectively;
       (2) by inserting after paragraph (2) the following:
       ``(3) An applicant (as such term is used in section 505(o)) 
     who knowingly fails to comply with a requirement of an 
     approved risk evaluation and mitigation strategy under such 
     section 505(o) shall be subject to a civil money penalty of 
     not less than $15,000 and not more than $250,000 per 
     violation, and not to exceed $1,000,000 for all such 
     violations adjudicated in a single proceeding.'';
       (3) in paragraph (2)(C), by striking ``paragraph (3)(A)'' 
     and inserting ``paragraph (4)(A)'';
       (4) in paragraph (4), as so redesignated, by striking 
     ``paragraph (1) or (2)'' each place it appears and inserting 
     ``paragraph (1), (2), or (3)''; and
       (5) in paragraph (6), as so redesignated, by striking 
     ``paragraph (4)'' each place it appears and inserting 
     ``paragraph (5)''.

     SEC. 204. REGULATION OF DRUGS THAT ARE BIOLOGICAL PRODUCTS.

       Section 351 of the Public Health Service Act (42 U.S.C. 
     262) is amended--
       (1) in subsection (a)(2), by adding at the end the 
     following:
       ``(D) Risk Evaluation and Mitigation Strategy.--A person 
     that submits an application for a license for a drug under 
     this paragraph may submit to the Secretary as part of the 
     application a proposed risk evaluation and mitigation 
     strategy as described under section 505(o) of the Federal 
     Food, Drug, and Cosmetic Act.''; and
       (2) in subsection (j), by inserting ``, including the 
     requirements under section 505(o) of such Act,'' after ``, 
     and Cosmetic Act''.

     SEC. 205. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.

       Section 505(e) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(e)) is amended by adding at the end the 
     following: ``The Secretary may withdraw the approval of an 
     application submitted under this section, or suspend the 
     approval of such an application, as provided under this 
     subsection, without first ordering the applicant to submit an 
     assessment of the approved risk evaluation and mitigation 
     strategy for the drug under subsection (o)(7)(B)(ii)(V).''.

     SEC. 206. DRUGS SUBJECT TO AN ABBREVIATED NEW DRUG 
                   APPLICATION.

       Section 505(j)(2) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)(2)) is amended by adding at the end the 
     following:
       ``(E) Risk Evaluation and Mitigation Strategy 
     Requirement.--
       ``(i) In general.--A drug that is the subject of an 
     abbreviated new drug application under this subsection shall 
     be subject to only the following elements of the approved 
     risk evaluation and mitigation strategy if required under 
     subsection (o) for the applicable listed drug:
       ``(I) Labeling, as required under subsection (o)(3)(A) for 
     the applicable listed drug.
       ``(II) A Medication Guide or patient package insert, if 
     required under subsection (o)(5)(B) for the applicable listed 
     drug.
       ``(III) Prereview of advertising, if required under 
     subsection (o)(5)(D) for the applicable listed drug.
       ``(IV) Specific disclosures in advertising, if required 
     under subsection (o)(5)(E) for the applicable listed drug.
       ``(V) Elements to assure safe use, if required under 
     subsection (o)(6) for the applicable listed drug, except that 
     such drug may use a different, comparable aspect of such 
     elements as are necessary to assure safe use of such drug 
     if--
       ``(aa) the corresponding aspect of the elements to assure 
     safe use for the applicable listed drug is claimed by a 
     patent that has not expired or is a method or process that as 
     a trade secret is entitled to protection; and
       ``(bb) the applicant certifies that it has sought a license 
     for use of such aspect of the elements to assure safe use for 
     the applicable listed drug.
       ``(ii) Action by secretary.--For an applicable listed drug 
     for which a drug is approved under this subsection, the 
     Secretary--
       ``(I) shall undertake any communication plan to health care 
     providers required under section (o)(5)(C) for the applicable 
     listed drug;
       ``(II) shall conduct, or contract for, any postapproval 
     study required under subsection (o)(4)(B) for the applicable 
     listed drug;
       ``(III) shall inform the applicant for a drug approved 
     under this subsection if the approved risk evaluation and 
     mitigation strategy for the applicable listed drug is 
     modified; and
       ``(IV) in order to minimize the burden on the health care 
     delivery system of different elements to assure safe use for 
     the drug approved under this subsection and the applicable 
     listed drug, may seek to negotiate a voluntary agreement with 
     the owner of the patent, method, or process for a license 
     under which the applicant for such drug may use an aspect of 
     the elements to assure safe use, if required under subsection 
     (o)(6) for the applicable listed drug, that is claimed by a 
     patent that has not expired or is a method or process that as 
     a trade secret is entitled to protection.''.

     SEC. 207. RESOURCES.

       (a) User Fees.--Subparagraph (F) of section 735(d)(6) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379g(d)(6)), as amended by section 103, is amended--
       (1) in clause (ii), by striking ``systems); and'' and 
     inserting ``systems);''
       (2) in clause (iii), by striking ``bases).'' and inserting 
     ``bases); and''; and
       (3) by adding at the end the following:
       ``(iv) reviewing, implementing, and ensuring compliance 
     with risk evaluation and mitigation strategies.''.
       (b) Additional Fee Revenues for Drug Safety.--Section 736 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), 
     as amended by section 103, is amended by--
       (1) striking the subsection designation and all that 
     follows through ``.--Except'' and inserting the following:
       ``(b) Fee Revenue Amounts.--
       ``(1) In general.--Except''; and
       (2) adding at the end the following:
       ``(2) Additional fee revenues for drug safety.--
       ``(A) In general.--Subject to subparagraph (C), in each of 
     fiscal years 2008 through 2012, paragraph (1) shall be 
     applied by substituting the amount determined under 
     subparagraph (B) for `$392,783,000'.
       ``(B) Amount determined.--For any fiscal year 2008 through 
     2012, the amount determined under this subparagraph is the 
     sum of--
       ``(i) $392,783,000; plus
       ``(ii) the amount equal to--

       ``(I)(aa) for fiscal year 2008, $25,000,000;
       ``(bb) for fiscal year 2009, $35,000,000;
       ``(cc) for fiscal year 2010, $45,000,000;
       ``(dd) for fiscal year 2011, $55,000,000; and
       ``(ee) for fiscal year 2012, $65,000,000; minus

       ``(II) the amount equal to one-fifth of the excess amount 
     in item (bb), provided that--

       ``(aa) the amount of the total appropriation for the Food 
     and Drug Administration for such fiscal year (excluding the 
     amount of fees appropriated for such fiscal year) exceeds the 
     amount of the total appropriation for the Food and Drug 
     Administration for fiscal year 2007 (excluding the amount of 
     fees appropriated for such fiscal year), adjusted as provided 
     under subsection (c)(1); and
       ``(bb) the amount of the total appropriations for the 
     process of human drug review at the Food and Drug 
     Administration for such fiscal year (excluding the amount of 
     fees appropriated for such fiscal year) exceeds the amount of 
     appropriations for the

[[Page 11687]]

     process of human drug review at the Food and Drug 
     Administration for fiscal year 2007 (excluding the amount of 
     fees appropriated for such fiscal year), adjusted as provided 
     under subsection (c)(1).

     In making the adjustment under subclause (II) for any fiscal 
     year 2008 through 2012, subsection (c)(1) shall be applied by 
     substituting `2007' for `2008.'
       ``(C) Limitation.--This paragraph shall not apply for any 
     fiscal year if the amount described under subparagraph 
     (B)(ii) is less than 0.''.
       (c) Strategic Plan for Information Technology.--Not later 
     than 1 year after the date of enactment of this title, the 
     Secretary of Health and Human Services (referred to in this 
     title as the ``Secretary'') shall submit to the Committee on 
     Health, Education, Labor, and Pensions and the Committee on 
     Appropriations of the Senate and the Committee on Energy and 
     Commerce and the Committee on Appropriations of the House of 
     Representatives, a strategic plan on information technology 
     that includes--
       (1) an assessment of the information technology 
     infrastructure, including systems for data collection, access 
     to data in external health care databases, data mining 
     capabilities, personnel, and personnel training programs, 
     needed by the Food and Drug Administration to--
       (A) comply with the requirements of this subtitle (and the 
     amendments made by this subtitle);
       (B) achieve interoperability within and among the centers 
     of the Food and Drug Administration and between the Food and 
     Drug Administration and product application sponsors;
       (C) utilize electronic health records;
       (D) implement routine active surveillance under section 
     505(k)(3) (including complementary approaches under 
     subsection (c) of such section) of the Federal Food, Drug, 
     and Cosmetic Act, as added by section 201 of this Act; and
       (E) communicate drug safety information to physicians and 
     other health care providers;
       (2) an assessment of the extent to which the current 
     information technology assets of the Food and Drug 
     Administration are sufficient to meet the needs assessments 
     under paragraph (1);
       (3) a plan for enhancing the information technology assets 
     of the Food and Drug Administration toward meeting the needs 
     assessments under paragraph (1); and
       (4) an assessment of additional resources needed to so 
     enhance the information technology assets of the Food and 
     Drug Administration.

     SEC. 208. SAFETY LABELING CHANGES.

       (a) In General.--Subchapter A of chapter V of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is 
     amended by inserting after section 506C the following:

     ``SEC. 506D. SAFETY LABELING CHANGES.

       ``(a) New Safety Information.--
       ``(1) Notification.--The holder of an approved application 
     under section 505 of this Act or a license under section 351 
     of the Public Health Service Act (referred to in this section 
     as a `holder') shall promptly notify the Secretary if the 
     holder becomes aware of new safety information that the 
     holder believes should be included in the labeling of the 
     drug. The Secretary shall promptly notify the holder if the 
     Secretary becomes aware of new safety information that the 
     Secretary believes should be included in the labeling of the 
     drug.
       ``(2) Discussion regarding labeling changes.--Following 
     notification pursuant to paragraph (1), the Secretary and 
     holder shall initiate discussions of the new safety 
     information in order to reach agreement on whether the 
     labeling for the drug should be modified to reflect the new 
     safety information and, if so, on the contents of such 
     labeling changes.
       ``(3) Supplement.--If the Secretary determines that there 
     is reasonable scientific evidence that an adverse event is 
     associated with use of the drug, the Secretary may request 
     the holder to submit a supplement to an application under 
     section 505 of this Act or to a license under section 351 of 
     the Public Health Service Act (referred to in this section as 
     a `supplement') proposing changes to the approved labeling to 
     reflect the new safety information, including changes to 
     boxed warnings, contraindications, warnings, precautions, or 
     adverse reactions (referred to in this section as a `safety 
     labeling change'). If the Secretary determines that no safety 
     labeling change is necessary or appropriate based upon the 
     new safety information, the Secretary shall notify the holder 
     of this determination in writing.
       ``(b) Labeling Supplements.--
       ``(1) In general.--The holder shall submit a supplement 
     whenever the holder seeks, either at the holder's own 
     initiative or at the request of the Secretary, to make a 
     safety labeling change.
       ``(2) Nonaccelerated process.--Unless the accelerated 
     labeling review process described in subsection (c) is 
     initiated, any supplement proposing a safety labeling change 
     shall be reviewed and acted upon by the Secretary not later 
     than 30 days after the date the Secretary receives the 
     supplement. Until the Secretary acts on such a supplement 
     proposing a safety labeling change, the existing approved 
     labeling shall remain in effect and be distributed by the 
     holder without change.
       ``(3) New safety information.--Nothing in this section 
     shall prohibit the Secretary from informing health care 
     professionals or the public about new safety information 
     prior to approval of a supplement proposing a safety labeling 
     change.
       ``(c) Accelerated Labeling Review Process.--An accelerated 
     labeling review process shall be available to resolve 
     disagreements in a timely manner between the Secretary and a 
     holder about the need for, or content of, a safety labeling 
     change, as follows:
       ``(1) Request to initiate accelerated process.--The 
     accelerated labeling review process shall be initiated upon 
     the written request of either the Secretary or the holder. 
     Such request may be made at any time after the notification 
     described in subsection (a)(1), including during the 
     Secretary's review of a supplement proposing a safety 
     labeling change.
       ``(2) Scientific discussion and meetings.--
       ``(A) In general.--Following initiation of the accelerated 
     labeling review process, the Secretary and holder shall 
     immediately initiate discussions to review and assess the new 
     safety information and to reach agreement on whether safety 
     labeling changes are necessary and appropriate and, if so, 
     the content of such safety labeling changes.
       ``(B) Time period.--The discussions under this paragraph 
     shall not extend for more than 45 calendar days after the 
     initiation of the accelerated labeling review process.
       ``(C) Dispute proceedings.--If the Secretary and holder do 
     not reach an agreement regarding the safety labeling changes 
     by not later than 25 calendar days after the initiation of 
     the accelerated labeling review process, the dispute 
     automatically shall be referred to the director of the drug 
     evaluation office responsible for the drug under 
     consideration, who shall be required to take an active role 
     in such discussions.
       ``(3) Request for safety labeling change and failure to 
     agree.--If the Secretary and holder fail to reach an 
     agreement on appropriate safety labeling changes by not later 
     than 45 calendar days after the initiation of the accelerated 
     labeling review process--
       ``(A) on the next calendar day (other than a weekend or 
     Federal holiday) after such period, the Secretary shall--
       ``(i) request in writing that the holder make any safety 
     labeling change that the Secretary determines to be necessary 
     and appropriate based upon the new safety information; or
       ``(ii) notify the holder in writing that the Secretary has 
     determined that no safety labeling change is necessary or 
     appropriate; and
       ``(B) if the Secretary fails to act within the specified 
     time, or if the holder does not agree to make a safety 
     labeling change requested by the Secretary or does not agree 
     with the Secretary's determination that no labeling change is 
     necessary or appropriate, the Secretary (on his own 
     initiative or upon request by the holder) shall refer the 
     matter for expedited review to the Drug Safety Oversight 
     Board.
       ``(4) Action by the drug safety oversight board.--Not later 
     than 45 days after receiving a referral under paragraph 
     (3)(B), the Drug Safety Oversight Board shall--
       ``(A) review the new safety information;
       ``(B) review all written material submitted by the 
     Secretary and the holder;
       ``(C) convene a meeting to hear oral presentations and 
     arguments from the Secretary and holder; and
       ``(D) make a written recommendation to the Secretary--
       ``(i) concerning appropriate safety labeling changes, if 
     any; or
       ``(ii) stating that no safety labeling changes are 
     necessary or appropriate based upon the new safety 
     information.
       ``(5) Consideration of recommendations.--
       ``(A) Action by the secretary.--The Secretary shall 
     consider the recommendation of the Drug Safety Oversight 
     Board made under paragraph (4)(D) and, not later than 20 days 
     after receiving the recommendation--
       ``(i) issue an order requiring the holder to make any 
     safety labeling change that the Secretary determines to be 
     necessary and appropriate; or
       ``(ii) if the Secretary determines that no safety labeling 
     change is necessary or appropriate, the Secretary shall 
     notify the holder of this determination in writing.
       ``(B) Failure to act.--If the Secretary fails to act by not 
     later than 20 days after receiving the recommendation of the 
     Drug Safety Oversight Board, the written recommendation of 
     the Drug Safety Oversight Board shall be considered the order 
     of the Secretary under this paragraph.
       ``(C) Nondelegation.--The Secretary's authority under this 
     paragraph shall not be redelegated to an individual below the 
     level of the Director of the Center for Drug Evaluation and 
     Research, or the Director of the Center for Biologics 
     Evaluation and Research, of the Food and Drug Administration.
       ``(6) Misbranding.--If the holder, not later than 10 days 
     after receiving an order under subparagraph (A) or (B) of 
     paragraph (5), does not agree to make a safety labeling 
     change ordered by the Secretary, the Secretary may deem the 
     drug that is the subject of the request to be misbranded.

[[Page 11688]]

       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed to change the standards in existence on the date 
     of enactment of this section for determining whether safety 
     labeling changes are necessary or appropriate.''.
       (b) Conforming Amendment.--Section 502 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 352 et seq.), as amended by 
     section 203, is further amended by adding at the end the 
     following:
       ``(y) If it is a drug and the holder does not agree to make 
     a safety labeling change ordered by the Secretary under 
     section 506D(c) within 10 days after issuance of such an 
     order.''.

     SEC. 209. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND 
                   PROVIDERS.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by section 251, is amended by adding 
     at the end the following:
       ``(r) Postmarket Drug Safety Information for Patients and 
     Providers.--
       ``(1) Establishment.--Not later than 1 year after the date 
     of enactment of the Enhancing Drug Safety and Innovation Act 
     of 2007, the Secretary shall improve the transparency of 
     pharmaceutical data and allow patients and health care 
     providers better access to pharmaceutical data by developing 
     and maintaining an Internet website that--
       ``(A) provides comprehensive drug safety information for 
     prescription drugs that are approved by the Secretary under 
     this section or licensed under section 351 of the Public 
     Health Service Act; and
       ``(B) improves communication of drug safety information to 
     patients and providers.
       ``(2) Internet website.--The Secretary shall carry out 
     paragraph (1) by--
       ``(A) developing and maintaining an accessible, 
     consolidated Internet website with easily searchable drug 
     safety information, including the information found on United 
     States Government Internet websites, such as the United 
     States National Library of Medicine's Daily Med and Medline 
     Plus websites, in addition to other such websites maintained 
     by the Secretary;
       ``(B) ensuring that the information provided on the 
     Internet website is comprehensive and includes, when 
     available and appropriate--
       ``(i) patient labeling and patient packaging inserts;
       ``(ii) a link to a list of each drug, whether approved 
     under this section or licensed under such section 351, for 
     which a Medication Guide, as provided for under part 208 of 
     title 21, Code of Federal Regulations (or any successor 
     regulations), is required;
       ``(iii) a link to the clinical trial registry data bank 
     provided for under subsections (i) and (j) of section 402 of 
     the Public Health Service Act;
       ``(iv) the most recent safety information and alerts issued 
     by the Food and Drug Administration for drugs approved by the 
     Secretary under this section, such as product recalls, 
     warning letters, and import alerts;
       ``(v) publicly available information about implemented 
     RiskMAPs and risk evaluation and mitigation strategies under 
     subsection (o);
       ``(vi) guidance documents and regulations related to drug 
     safety; and
       ``(vii) other material determined appropriate by the 
     Secretary;
       ``(C) including links to non-Food and Drug Administration 
     Internet resources that provide access to relevant drug 
     safety information, such as medical journals and studies;
       ``(D) providing access to summaries of the assessed and 
     aggregated data collected from the active surveillance 
     infrastructure under subsection (k)(3) to provide information 
     of known and serious side-effects for drugs approved by the 
     Secretary under this section or licensed under such section 
     351;
       ``(E) enabling patients, providers, and drug sponsors to 
     submit adverse event reports through the Internet website;
       ``(F) providing educational materials for patients and 
     providers about the appropriate means of disposing of 
     expired, damaged, or unusable medications; and
       ``(G) supporting initiatives that the Secretary determines 
     to be useful to fulfill the purposes of the Internet website.
       ``(3) Posting of drug labeling.--The Secretary shall post 
     on the Internet website established under paragraph (1) the 
     approved professional labeling and any required patient 
     labeling of a drug approved under this section or licensed 
     under such section 351 not later than 21 days after the date 
     the drug is approved or licensed, including in a supplemental 
     application with respect to a labeling change.
       ``(4) Private sector resources.--To ensure development of 
     the Internet website by the date described in paragraph (1), 
     the Secretary may, on a temporary or permanent basis, 
     implement systems or products developed by private entities.
       ``(5) Authority for contracts.--The Secretary may enter 
     into contracts with public and private entities to fulfill 
     the requirements of this subsection.
       ``(6) Review.--The Advisory Committee on Risk Communication 
     under section 566 shall, on a regular basis, perform a 
     comprehensive review and evaluation of the types of risk 
     communication information provided on the Internet website 
     established under paragraph (1) and, through other means, 
     shall identify, clarify, and define the purposes and types of 
     information available to facilitate the efficient flow of 
     information to patients and providers, and shall recommend 
     ways for the Food and Drug Administration to work with 
     outside entities to help facilitate the dispensing of risk 
     communication information to patients and providers.''.

     SEC. 210. ACTION PACKAGE FOR APPROVAL.

       Section 505(l) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(l)) is amended by--
       (1) redesignating paragraphs (1), (2), (3), (4), and (5) as 
     subparagraphs (A), (B), (C), (D), and (E), respectively;
       (2) striking ``(l) Safety and'' and inserting ``(l)(1) 
     Safety and''; and
       (3) adding at the end the following:
       ``(2) Action Package for Approval.--
       ``(A) Action package.--The Secretary shall publish the 
     action package for approval of an application under 
     subsection (b) or section 351 of the Public Health Service 
     Act on the Internet website of the Food and Drug 
     Administration--
       ``(i) not later than 30 days after the date of approval of 
     such application for a drug no active ingredient (including 
     any ester or salt of the active ingredient) of which has been 
     approved in any other application under this section or 
     section 351 of the Public Health Service Act; and
       ``(ii) not later than 30 days after the third request for 
     such action package for approval received under section 552 
     of title 5, United States Code, for any other drug.
       ``(B) Immediate publication of summary review.--
     Notwithstanding subparagraph (A), the Secretary shall 
     publish, on the Internet website of the Food and Drug 
     Administration, the materials described in subparagraph 
     (C)(iv) not later than 48 hours after the date of approval of 
     the drug, except where such materials require redaction by 
     the Secretary.
       ``(C) Contents.--An action package for approval of an 
     application under subparagraph (A) shall be dated and shall 
     include the following:
       ``(i) Documents generated by the Food and Drug 
     Administration related to review of the application.
       ``(ii) Documents pertaining to the format and content of 
     the application generated during drug development.
       ``(iii) Labeling submitted by the applicant.
       ``(iv) A summary review that documents conclusions from all 
     reviewing disciplines about the drug, noting any critical 
     issues and disagreements with the applicant and how they were 
     resolved, recommendation for action, and an explanation of 
     any nonconcurrence with review conclusions.
       ``(v) If applicable, a separate review from a supervisor 
     who does not concur with the summary review.
       ``(vi) Identification by name of each officer or employee 
     of the Food and Drug Administration who--
       ``(I) participated in the decision to approve the 
     application; and
       ``(II) consents to have his or her name included in the 
     package.
       ``(D) Disagreements.--A scientific review of an application 
     is considered the work of the reviewer and shall not be 
     altered by management or the reviewer once final. 
     Disagreements by team leaders, division directors, or office 
     directors with any or all of the major conclusions of a 
     reviewer shall be document in a separate review or in an 
     addendum to the review.
       ``(E) Confidential information.--This paragraph does not 
     authorize the disclosure of any trade secret or confidential 
     commercial or financial information described in section 
     552(b)(4) of title 5, United States Code, unless the 
     Secretary declares an emergency under section 319 of the 
     Public Health Service Act and such disclosure is necessary to 
     mitigate the effects of such emergency.''.

     SEC. 211. RISK COMMUNICATION.

       Subchapter E of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding 
     at the end the following:

     ``SEC. 566. RISK COMMUNICATION.

       ``(a) Advisory Committee on Risk Communication.--
       ``(1) In general.--The Secretary shall establish an 
     advisory committee to be known as the `Advisory Committee on 
     Risk Communication' (referred to in this section as the 
     `Committee').
       ``(2) Duties of committee.--The Committee shall advise the 
     Commissioner on methods to effectively communicate risks 
     associated with the products regulated by the Food and Drug 
     Administration.
       ``(3) Members.--The Secretary shall ensure that the 
     Committee is composed of experts on risk communication, 
     experts on the risks described in subsection (b), and 
     representatives of patient, consumer, and health professional 
     organizations.
       ``(4) Permanence of committee.--Section 14 of the Federal 
     Advisory Committee Act shall not apply to the Committee 
     established under this subsection.
       ``(b) Partnerships for Risk Communication.--
       ``(1) In general.--The Secretary shall partner with 
     professional medical societies, medical schools, academic 
     medical centers, and

[[Page 11689]]

     other stakeholders to develop robust and multi-faceted 
     systems for communication to health care providers about 
     emerging postmarket drug risks.
       ``(2) Partnerships.--The systems developed under paragraph 
     (1) shall--
       ``(A) account for the diversity among physicians in terms 
     of practice, affinity for technology, and focus; and
       ``(B) include the use of existing communication channels, 
     including electronic communications, in place at the Food and 
     Drug Administration.''.

     SEC. 212. REFERRAL TO ADVISORY COMMITTEE.

       Section 505 of the Federal Food, Drug, and Cosmetic Act, as 
     amended by section 202, is further amended by adding at the 
     end the following:
       ``(p) Referral to Advisory Committee.--
       ``(1) In general.--Prior to the approval of a drug no 
     active ingredient (including any ester or salt of the active 
     ingredient) of which has been approved in any other 
     application under this section or section 351 of the Public 
     Health Service Act, the Secretary shall refer such drug to a 
     Food and Drug Administration advisory committee for review at 
     a meeting of such advisory committee.
       ``(2) Exception.--Notwithstanding paragraph (1), an 
     advisory committee review of a drug described under such 
     paragraph may occur within 1 year after approval of such a 
     drug if--
       ``(A) the clinical trial that formed the primary basis of 
     the safety and efficacy determination was halted by a drug 
     safety monitoring board or an Institutional Review Board 
     before its scheduled completion due to early unanticipated 
     therapeutic results; or
       ``(B) the Secretary determines that it would be beneficial 
     to the public health.''.

     SEC. 213. RESPONSE TO THE INSTITUTE OF MEDICINE.

       (a) In General.--Not later than 1 year after the date of 
     enactment of this title, the Secretary shall issue a report 
     responding to the 2006 report of the Institute of Medicine 
     entitled ``The Future of Drug Safety--Promoting and 
     Protecting the Health of the Public''.
       (b) Content of Report.--The report issued by the Secretary 
     under subsection (a) shall include--
       (1) an update on the implementation by the Food and Drug 
     Administration of its plan to respond to the Institute of 
     Medicine report described under such subsection; and
       (2) an assessment of how the Food and Drug Administration 
     has implemented--
       (A) the recommendations described in such Institute of 
     Medicine report; and
       (B) the requirement under paragraph (7) of section 505(o) 
     of the Federal Food, Drug, and Cosmetic Act (as added by this 
     title), that the appropriate office responsible for reviewing 
     a drug and the office responsible for postapproval safety 
     with respect to the drug act together to assess, implement, 
     and ensure compliance with the requirements of such section 
     505(o).

     SEC. 214. EFFECTIVE DATE AND APPLICABILITY.

       (a) Effective Dates.--
       (1) In general.--Except as provided in paragraph (2), this 
     subtitle shall take effect 180 days after the date of 
     enactment of this title.
       (2) User fees.--The amendments made by subsections (a) 
     through (c) of section 207 shall take effect on October 1, 
     2007.
       (b) Drugs Deemed To Have Risk Evaluation and Mitigation 
     Strategies.--
       (1) In general.--A drug that was approved before the 
     effective date of this subtitle shall be deemed to have an 
     approved risk evaluation and mitigation strategy under 
     section 505(o) of the Federal Food, Drug, and Cosmetic Act 
     (as added by this subtitle) if there are in effect on the 
     effective date of this subtitle restrictions on distribution 
     or use--
       (A) required under section 314.520 or section 601.42 of 
     title 21, Code of Federal Regulations; or
       (B) otherwise agreed to by the applicant and the Secretary 
     for such drug.
       (2) Risk evaluation and mitigation strategy.--The approved 
     risk evaluation and mitigation strategy deemed in effect for 
     a drug under paragraph (1) shall consist of the elements 
     described in subparagraphs (A) and (B) of paragraph (3) of 
     such section 505(o) and any other additional elements under 
     paragraphs (4), (5), and (6) in effect for such drug on the 
     effective date of this subtitle.
       (3) Notification.--Not later than 30 days after the 
     effective date of this subtitle, the Secretary shall notify 
     the applicant for each drug described in paragraph (1)--
       (A) that such drug is deemed to have an approved risk 
     evaluation and mitigation strategy pursuant to such 
     paragraph; and
       (B) of the date, which, unless a safety issue with the drug 
     arises, shall be no earlier than 6 months after the applicant 
     is so notified, by which the applicant shall submit to the 
     Secretary an assessment of such approved strategy under 
     paragraph (7)(B) of such section 505(o), except with respect 
     to the drug Mifeprex (mifepristone), such assessment shall be 
     submitted 6 months after the applicant is so notified.
       (4) Enforcement only after assessment and review.--Neither 
     the Secretary nor the Attorney General may seek to enforce a 
     requirement of a risk evaluation and mitigation strategy 
     deemed in effect under paragraph (1) before the Secretary has 
     completed review of, and acted on, the first assessment of 
     such strategy under such section 505(o).
       (c) No Effect on Veterinary Medicine.--This subtitle, and 
     the amendments made by this subtitle, shall have no effect on 
     the use of drugs approved under section 505 of the Federal 
     Food, Drug, and Cosmetic Act by, or on the lawful written or 
     oral order of, a licensed veterinarian within the context of 
     a veterinarian-client-patient relationship, as provided for 
     under section 512(a)(5) of such Act.

       Subtitle B--Reagan-Udall Foundation for the Food and Drug 
                             Administration

     SEC. 221. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
                   ADMINISTRATION.

       (a) In General.--Chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at 
     the end the following:

     ``Subchapter I--Reagan-Udall Foundation for the Food and Drug 
                             Administration

     ``SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.

       ``(a) In General.--A nonprofit corporation to be known as 
     the Reagan-Udall Foundation for the Food and Drug 
     Administration (referred to in this subchapter as the 
     `Foundation') shall be established in accordance with this 
     section. The Foundation shall be headed by an Executive 
     Director, appointed by the members of the Board of Directors 
     under subsection (e). The Foundation shall not be an agency 
     or instrumentality of the United States Government.
       ``(b) Purpose of Foundation.--The purpose of the Foundation 
     is to advance the mission of the Food and Drug Administration 
     to modernize medical, veterinary, food, food ingredient, and 
     cosmetic product development, accelerate innovation, and 
     enhance product safety.
       ``(c) Duties of the Foundation.--The Foundation shall--
       ``(1) taking into consideration the Critical Path reports 
     and priorities published by the Food and Drug Administration, 
     identify unmet needs in the development, manufacture, and 
     evaluation of the safety and effectiveness, including 
     postapproval, of devices, including diagnostics, biologics, 
     and drugs, and the safety of food, food ingredients, and 
     cosmetics;
       ``(2) establish goals and priorities in order to meet the 
     unmet needs identified in paragraph (1);
       ``(3) in consultation with the Secretary, identify existing 
     and proposed Federal intramural and extramural research and 
     development programs relating to the goals and priorities 
     established under paragraph (2), coordinate Foundation 
     activities with such programs, and minimize Foundation 
     duplication of existing efforts;
       ``(4) award grants to, or enter into contracts, memoranda 
     of understanding, or cooperative agreements with, scientists 
     and entities, which may include the Food and Drug 
     Administration, university consortia, public-private 
     partnerships, institutions of higher education, entities 
     described in section 501(c)(3) of the Internal Revenue Code 
     (and exempt from tax under section 501(a) of such Code), and 
     industry, to efficiently and effectively advance the goals 
     and priorities established under paragraph (2);
       ``(5) recruit meeting participants and hold or sponsor (in 
     whole or in part) meetings as appropriate to further the 
     goals and priorities established under paragraph (2);
       ``(6) release and publish information and data and, to the 
     extent practicable, license, distribute, and release 
     material, reagents, and techniques to maximize, promote, and 
     coordinate the availability of such material, reagents, and 
     techniques for use by the Food and Drug Administration, 
     nonprofit organizations, and academic and industrial 
     researchers to further the goals and priorities established 
     under paragraph (2);
       ``(7) ensure that--
       ``(A) action is taken as necessary to obtain patents for 
     inventions developed by the Foundation or with funds from the 
     Foundation;
       ``(B) action is taken as necessary to enable the licensing 
     of inventions developed by the Foundation or with funds from 
     the Foundation; and
       ``(C) executed licenses, memoranda of understanding, 
     material transfer agreements, contracts, and other such 
     instruments, promote, to the maximum extent practicable, the 
     broadest conversion to commercial and noncommercial 
     applications of licensed and patented inventions of the 
     Foundation to further the goals and priorities established 
     under paragraph (2);
       ``(8) provide objective clinical and scientific information 
     to the Food and Drug Administration and, upon request, to 
     other Federal agencies to assist in agency determinations of 
     how to ensure that regulatory policy accommodates scientific 
     advances and meets the agency's public health mission;
       ``(9) conduct annual assessments of the unmet needs 
     identified in paragraph (1); and
       ``(10) carry out such other activities consistent with the 
     purposes of the Foundation as the Board determines 
     appropriate.
       ``(d) Board of Directors.--
       ``(1) Establishment.--
       ``(A) In general.--The Foundation shall have a Board of 
     Directors (referred to in this subchapter as the `Board'), 
     which shall be composed of ex officio and appointed members 
     in accordance with this subsection. All

[[Page 11690]]

      appointed members of the Board shall be voting members.
       ``(B) Ex officio members.--The ex officio members of the 
     Board shall be the following individuals or their designees:
       ``(i) The Commissioner.
       ``(ii) The Director of the National Institutes of Health.
       ``(iii) The Director of the Centers for Disease Control and 
     Prevention.
       ``(iv) The Director of the Agency for Healthcare Research 
     and Quality.
       ``(C) Appointed members.--
       ``(i) In general.--The ex officio members of the Board 
     under subparagraph (B) shall, by majority vote, appoint to 
     the Board 12 individuals, from a list of candidates to be 
     provided by the National Academy of Sciences. Of such 
     appointed members--

       ``(I) 4 shall be representatives of the general 
     pharmaceutical, device, food, cosmetic, and biotechnology 
     industries;
       ``(II) 3 shall be representatives of academic research 
     organizations;
       ``(III) 2 shall be representatives of Government agencies, 
     including the Food and Drug Administration and the National 
     Institutes of Health;
       ``(IV) 2 shall be representatives of patient or consumer 
     advocacy organizations; and
       ``(V) 1 shall be a representative of health care providers.

       ``(ii) Requirement.--The ex officio members shall ensure 
     the Board membership includes individuals with expertise in 
     areas including the sciences of developing, manufacturing, 
     and evaluating the safety and effectiveness of devices, 
     including diagnostics, biologics, and drugs, and the safety 
     of food, food ingredients, and cosmetics.
       ``(D) Initial meeting.--
       ``(i) In general.--Not later than 30 days after the date of 
     the enactment of the Enhancing Drug Safety and Innovation Act 
     of 2007, the Secretary shall convene a meeting of the ex 
     officio members of the Board to--

       ``(I) incorporate the Foundation; and
       ``(II) appoint the members of the Board in accordance with 
     subparagraph (C).

       ``(ii) Service of ex officio members.--Upon the appointment 
     of the members of the Board under clause (i)(II), the terms 
     of service of the ex officio members of the Board as members 
     of the Board shall terminate.
       ``(iii) Chair.--The ex officio members of the Board under 
     subparagraph (B) shall designate an appointed member of the 
     Board to serve as the Chair of the Board.
       ``(2) Duties of board.--The Board shall--
       ``(A) establish bylaws for the Foundation that--
       ``(i) are published in the Federal Register and available 
     for public comment;
       ``(ii) establish policies for the selection of the 
     officers, employees, agents, and contractors of the 
     Foundation;
       ``(iii) establish policies, including ethical standards, 
     for the acceptance, solicitation, and disposition of 
     donations and grants to the Foundation and for the 
     disposition of the assets of the Foundation, including 
     appropriate limits on the ability of donors to designate, by 
     stipulation or restriction, the use or recipient of donated 
     funds;
       ``(iv) establish policies that would subject all employees, 
     fellows, and trainees of the Foundation to the conflict of 
     interest standards under section 208 of title 18, United 
     States Code;
       ``(v) establish licensing, distribution, and publication 
     policies that support the widest and least restrictive use by 
     the public of information and inventions developed by the 
     Foundation or with Foundation funds to carry out the duties 
     described in paragraphs (6) and (7) of subsection (c), and 
     may include charging cost-based fees for published material 
     produced by the Foundation;
       ``(vi) specify principles for the review of proposals and 
     awarding of grants and contracts that include peer review and 
     that are consistent with those of the Foundation for the 
     National Institutes of Health, to the extent determined 
     practicable and appropriate by the Board;
       ``(vii) specify a cap on administrative expenses for 
     recipients of a grant, contract, or cooperative agreement 
     from the Foundation;
       ``(viii) establish policies for the execution of memoranda 
     of understanding and cooperative agreements between the 
     Foundation and other entities, including the Food and Drug 
     Administration;
       ``(ix) establish policies for funding training fellowships, 
     whether at the Foundation, academic or scientific 
     institutions, or the Food and Drug Administration, for 
     scientists, doctors, and other professionals who are not 
     employees of regulated industry, to foster greater 
     understanding of and expertise in new scientific tools, 
     diagnostics, manufacturing techniques, and potential barriers 
     to translating basic research into clinical and regulatory 
     practice;
       ``(x) specify a process for annual Board review of the 
     operations of the Foundation; and
       ``(xi) establish specific duties of the Executive Director;
       ``(B) prioritize and provide overall direction to the 
     activities of the Foundation;
       ``(C) evaluate the performance of the Executive Director; 
     and
       ``(D) carry out any other necessary activities regarding 
     the functioning of the Foundation.
       ``(3) Terms and vacancies.--
       ``(A) Term.--The term of office of each member of the Board 
     appointed under paragraph (1)(C) shall be 4 years, except 
     that the terms of offices for the initial appointed members 
     of the Board shall expire on a staggered basis as determined 
     by the ex officio members.
       ``(B) Vacancy.--Any vacancy in the membership of the 
     Board--
       ``(i) shall not affect the power of the remaining members 
     to execute the duties of the Board; and
       ``(ii) shall be filled by appointment by the appointed 
     members described in paragraph (1)(C) by majority vote.
       ``(C) Partial term.--If a member of the Board does not 
     serve the full term applicable under subparagraph (A), the 
     individual appointed under subparagraph (B) to fill the 
     resulting vacancy shall be appointed for the remainder of the 
     term of the predecessor of the individual.
       ``(D) Serving past term.--A member of the Board may 
     continue to serve after the expiration of the term of the 
     member until a successor is appointed.
       ``(4) Compensation.--Members of the Board may not receive 
     compensation for service on the Board. Such members may be 
     reimbursed for travel, subsistence, and other necessary 
     expenses incurred in carrying out the duties of the Board, as 
     set forth in the bylaws issued by the Board.
       ``(e) Incorporation.--The ex officio members of the Board 
     shall serve as incorporators and shall take whatever actions 
     necessary to incorporate the Foundation.
       ``(f) Nonprofit Status.--The Foundation shall be considered 
     to be a corporation under section 501(c) of the Internal 
     Revenue Code of 1986, and shall be subject to the provisions 
     of such section.
       ``(g) Executive Director.--
       ``(1) In general.--The Board shall appoint an Executive 
     Director who shall serve at the pleasure of the Board. The 
     Executive Director shall be responsible for the day-to-day 
     operations of the Foundation and shall have such specific 
     duties and responsibilities as the Board shall prescribe.
       ``(2) Compensation.--The compensation of the Executive 
     Director shall be fixed by the Board but shall not be greater 
     than the compensation of the Commissioner.
       ``(h) Administrative Powers.--In carrying out this 
     subchapter, the Board, acting through the Executive Director, 
     may--
       ``(1) adopt, alter, and use a corporate seal, which shall 
     be judicially noticed;
       ``(2) hire, promote, compensate, and discharge 1 or more 
     officers, employees, and agents, as may be necessary, and 
     define their duties;
       ``(3) prescribe the manner in which--
       ``(A) real or personal property of the Foundation is 
     acquired, held, and transferred;
       ``(B) general operations of the Foundation are to be 
     conducted; and
       ``(C) the privileges granted to the Board by law are 
     exercised and enjoyed;
       ``(4) with the consent of the applicable executive 
     department or independent agency, use the information, 
     services, and facilities of such department or agencies in 
     carrying out this section;
       ``(5) enter into contracts with public and private 
     organizations for the writing, editing, printing, and 
     publishing of books and other material;
       ``(6) hold, administer, invest, and spend any gift, devise, 
     or bequest of real or personal property made to the 
     Foundation under subsection (i);
       ``(7) enter into such other contracts, leases, cooperative 
     agreements, and other transactions as the Board considers 
     appropriate to conduct the activities of the Foundation;
       ``(8) modify or consent to the modification of any contract 
     or agreement to which it is a party or in which it has an 
     interest under this subchapter;
       ``(9) take such action as may be necessary to obtain 
     patents and licenses for devices and procedures developed by 
     the Foundation and its employees;
       ``(10) sue and be sued in its corporate name, and complain 
     and defend in courts of competent jurisdiction;
       ``(11) appoint other groups of advisors as may be 
     determined necessary to carry out the functions of the 
     Foundation; and
       ``(12) exercise other powers as set forth in this section, 
     and such other incidental powers as are necessary to carry 
     out its powers, duties, and functions in accordance with this 
     subchapter.
       ``(i) Acceptance of Funds From Other Sources.--The 
     Executive Director may solicit and accept on behalf of the 
     Foundation, any funds, gifts, grants, devises, or bequests of 
     real or personal property made to the Foundation, including 
     from private entities, for the purposes of carrying out the 
     duties of the Foundation.
       ``(j) Service of Federal Employees.--Federal Government 
     employees may serve on committees advisory to the Foundation 
     and otherwise cooperate with and assist the Foundation in 
     carrying out its functions, so long as such employees do not 
     direct or control Foundation activities.
       ``(k) Detail of Government Employees; Fellowships.--
       ``(1) Detail from federal agencies.--Federal Government 
     employees may be detailed

[[Page 11691]]

     from Federal agencies with or without reimbursement to those 
     agencies to the Foundation at any time, and such detail shall 
     be without interruption or loss of civil service status or 
     privilege. Each such employee shall abide by the statutory, 
     regulatory, ethical, and procedural standards applicable to 
     the employees of the agency from which such employee is 
     detailed and those of the Foundation.
       ``(2) Voluntary service; acceptance of federal employees.--
       ``(A) Foundation.--The Executive Director of the Foundation 
     may accept the services of employees detailed from Federal 
     agencies with or without reimbursement to those agencies.
       ``(B) Food and drug administration.--The Commissioner may 
     accept the uncompensated services of Foundation fellows or 
     trainees. Such services shall be considered to be undertaking 
     an activity under contract with the Secretary as described in 
     section 708.
       ``(l) Annual Reports.--
       ``(1) Reports to foundation.--Any recipient of a grant, 
     contract, fellowship, memorandum of understanding, or 
     cooperative agreement from the Foundation under this section 
     shall submit to the Foundation a report on an annual basis 
     for the duration of such grant, contract, fellowship, 
     memorandum of understanding, or cooperative agreement, that 
     describes the activities carried out under such grant, 
     contract, fellowship, memorandum of understanding, or 
     cooperative agreement.
       ``(2) Report to congress and the fda.--Beginning with 
     fiscal year 2009, the Executive Director shall submit to 
     Congress and the Commissioner an annual report that--
       ``(A) describes the activities of the Foundation and the 
     progress of the Foundation in furthering the goals and 
     priorities established under subsection (c)(2), including the 
     practical impact of the Foundation on regulated product 
     development;
       ``(B) provides a specific accounting of the source and use 
     of all funds used by the Foundation to carry out such 
     activities; and
       ``(C) provides information on how the results of Foundation 
     activities could be incorporated into the regulatory and 
     product review activities of the Food and Drug 
     Administration.
       ``(m) Separation of Funds.--The Executive Director shall 
     ensure that the funds received from the Treasury are held in 
     separate accounts from funds received from entities under 
     subsection (i).
       ``(n) Funding.--From amounts appropriated to the Food and 
     Drug Administration for each fiscal year, the Commissioner 
     shall transfer not less than $500,000 and not more than 
     $1,250,000, to the Foundation to carry out subsections (a), 
     (b), and (d) through (m).''.
       (b) Other Foundation Provisions.--Chapter VII (21 U.S.C. 
     371 et seq.) (as amended by subsection (a)) is amended by 
     adding at the end the following:

     ``SEC. 771. LOCATION OF FOUNDATION.

       ``The Foundation shall, if practicable, be located not more 
     than 20 miles from the District of Columbia.

     ``SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.

       ``(a) In General.--The Commissioner shall receive and 
     assess the report submitted to the Commissioner by the 
     Executive Director of the Foundation under section 770(l)(2).
       ``(b) Report to Congress.--Beginning with fiscal year 2009, 
     the Commissioner shall submit to Congress an annual report 
     summarizing the incorporation of the information provided by 
     the Foundation in the report described under section 
     770(l)(2) and by other recipients of grants, contracts, 
     memoranda of understanding, or cooperative agreements into 
     regulatory and product review activities of the Food and Drug 
     Administration.
       ``(c) Extramural Grants.--The provisions of this subchapter 
     shall have no effect on any grant, contract, memorandum of 
     understanding, or cooperative agreement between the Food and 
     Drug Administration and any other entity entered into before, 
     on, or after the date of enactment of the Enhancing Drug 
     Safety and Innovation Act of 2007.''.
       (c) Conforming Amendment.--Section 742(b) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended 
     by adding at the end the following: ``Any such fellowships 
     and training programs under this section or under section 
     770(d)(2)(A)(ix) may include provision by such scientists and 
     physicians of services on a voluntary and uncompensated 
     basis, as the Secretary determines appropriate. Such 
     scientists and physicians shall be subject to all legal and 
     ethical requirements otherwise applicable to officers or 
     employees of the Department of Health and Human Services.''.

     SEC. 222. OFFICE OF THE CHIEF SCIENTIST.

       Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 391 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 910. OFFICE OF THE CHIEF SCIENTIST.

       ``(a) Establishment; Appointment.--The Secretary shall 
     establish within the Office of the Commissioner an office to 
     be known as the Office of the Chief Scientist. The Secretary 
     shall appoint a Chief Scientist to lead such Office.
       ``(b) Duties of the Office.--The Office of the Chief 
     Scientist shall--
       ``(1) oversee, coordinate, and ensure quality and 
     regulatory focus of the intramural research programs of the 
     Food and Drug Administration;
       ``(2) track and, to the extent necessary, coordinate 
     intramural research awards made by each center of the 
     Administration or science-based office within the Office of 
     the Commissioner, and ensure that there is no duplication of 
     research efforts supported by the Reagan-Udall Foundation for 
     the Food and Drug Administration;
       ``(3) develop and advocate for a budget to support 
     intramural research;
       ``(4) develop a peer review process by which intramural 
     research can be evaluated; and
       ``(5) identify and solicit intramural research proposals 
     from across the Food and Drug Administration through an 
     advisory board composed of employees of the Administration 
     that shall include--
       ``(A) representatives of each of the centers and the 
     science-based offices within the Office of the Commissioner; 
     and
       ``(B) experts on trial design, epidemiology, demographics, 
     pharmacovigilance, basic science, and public health.''.

                      Subtitle C--Clinical Trials

     SEC. 231. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

       (a) In General.--Section 402 of the Public Health Service 
     Act (42 U.S.C. 282) is amended by--
       (1) redesignating subsections (j) and (k) as subsections 
     (k) and (l), respectively; and
       (2) inserting after subsection (i) the following:
       ``(j) Expanded Clinical Trial Registry Data Bank.--
       ``(1) Definitions; requirement.--
       ``(A) Definitions.--In this subsection:
       ``(i) Applicable device clinical trial.--The term 
     `applicable device clinical trial' means--

       ``(I) a prospective study of health outcomes comparing an 
     intervention against a control in human subjects intended to 
     support an application under section 515 or 520(m), or a 
     report under section 510(k), of the Federal Food, Drug, and 
     Cosmetic Act (other than a limited study to gather essential 
     information used to refine the device or design a pivotal 
     trial and that is not intended to determine safety and 
     effectiveness of a device); and
       ``(II) a pediatric postmarket surveillance as required 
     under section 522 of the Federal Food, Drug, and Cosmetic 
     Act.

       ``(ii) Applicable drug clinical trial.--

       ``(I) In general.--The term `applicable drug clinical 
     trial' means a controlled clinical investigation, other than 
     a phase I clinical investigation, of a product subject to 
     section 505 of the Federal Food, Drug, and Cosmetic Act or to 
     section 351 of this Act.
       ``(II) Clinical investigation.--For purposes of subclause 
     (I), the term `clinical investigation' has the meaning given 
     that term in section 312.3 of title 21, Code of Federal 
     Regulations.
       ``(III) Phase i.--The term `phase I' has the meaning given 
     that term in section 312.21 of title 21, Code of Federal 
     Regulations.

       ``(iii) Clinical trial information.--The term `clinical 
     trial information' means those data elements that are 
     necessary to complete an entry in the clinical trial registry 
     data bank under paragraph (2).
       ``(iv) Completion date.--The term `completion date' means, 
     with respect to an applicable drug clinical trial or an 
     applicable device clinical trial, the date on which the last 
     patient enrolled in the clinical trial has completed his or 
     her last medical visit of the clinical trial, whether the 
     clinical trial concluded according to the prespecified 
     protocol plan or was terminated.
       ``(v) Device.--The term `device' means a device as defined 
     in section 201(h) of the Federal Food, Drug, and Cosmetic 
     Act.
       ``(vi) Drug.--The term `drug' means a drug as defined in 
     section 201(g) of the Federal Food, Drug, and Cosmetic Act or 
     a biological product as defined in section 351 of this Act.
       ``(vii) Responsible party.--The term `responsible party', 
     with respect to a clinical trial of a drug or device, means--

       ``(I) the sponsor of the clinical trial (as defined in 
     section 50.3 of title 21, Code of Federal Regulations (or any 
     successor regulations)) or the principal investigator of such 
     clinical trial if so designated by such sponsor; or
       ``(II) if no sponsor exists, the grantee, contractor, or 
     awardee for a trial funded by a Federal agency or the 
     principal investigator of such clinical trial if so 
     designated by such grantee, contractor, or awardee.

       ``(B) Requirement.--The Secretary shall develop a mechanism 
     by which--
       ``(i) the responsible party for each applicable drug 
     clinical trial and applicable device clinical trial shall 
     submit the identity and contact information of such 
     responsible party to the Secretary at the time of submission 
     of clinical trial information under paragraph (2); and
       ``(ii) other Federal agencies may identify the responsible 
     party for an applicable drug clinical trial or applicable 
     device clinical trial.
       ``(2) Expansion of clinical trial registry data bank with 
     respect to clinical trial information.--
       ``(A) In general.--
       ``(i) Expansion of data bank.--To enhance patient 
     enrollment and provide a mechanism to track subsequent 
     progress of clinical

[[Page 11692]]

     trials, the Secretary, acting through the Director of NIH, 
     shall expand, in accordance with this subsection, the 
     clinical trials registry of the data bank described under 
     subsection (i)(3)(A) (referred to in this subsection as the 
     `registry data bank'). The Director of NIH shall ensure that 
     the registry data bank is made publicly available through the 
     Internet.
       ``(ii) Content.--Not later than 18 months after the date of 
     enactment of the Enhancing Drug Safety and Innovation Act of 
     2007, and after notice and comment, the Secretary shall 
     promulgate regulations to expand the registry data bank to 
     require the submission to the registry data bank of clinical 
     trial information for applicable drug clinical trials and 
     applicable device clinical trials that--

       ``(I) conforms to the International Clinical Trials 
     Registry Platform trial registration data set of the World 
     Health Organization;
       ``(II) includes the city, State, and zip code for each 
     clinical trial location, or a toll-free number through which 
     such location information may be accessed;
       ``(III) if the drug is not approved under section 505 of 
     the Federal Food, Drug, and Cosmetic Act or licensed under 
     section 351 of this Act, specifies whether or not there is 
     expanded access to the drug under section 561 of the Federal 
     Food, Drug, and Cosmetic Act for those who do not qualify for 
     enrollment in the clinical trial and how to obtain 
     information about such access;
       ``(IV) requires the inclusion of such other data elements 
     to the registry data bank as appropriate; and
       ``(V) becomes effective 90 days after issuance of the final 
     rule.

       ``(B) Format and structure.--
       ``(i) Searchable categories.--The Director of NIH shall 
     ensure that the public may search the entries in the registry 
     data bank by 1 or more of the following criteria:

       ``(I) The disease or condition being studied in the 
     clinical trial, using Medical Subject Headers (MeSH) 
     descriptors.
       ``(II) The treatment being studied in the clinical trial.
       ``(III) The location of the clinical trial.
       ``(IV) The age group studied in the clinical trial, 
     including pediatric subpopulations.
       ``(V) The study phase of the clinical trial.
       ``(VI) The source of support for the clinical trial, which 
     may be the National Institutes of Health or other Federal 
     agency, a private industry source, or a university or other 
     organization.
       ``(VII) The recruitment status of the clinical trial.
       ``(VIII) The National Clinical Trial number or other study 
     identification for the clinical trial.

       ``(ii) Format.--The Director of the NIH shall ensure that 
     the registry data bank is easily used by the public, and that 
     entries are easily compared.
       ``(C) Data submission.--The responsible party for an 
     applicable drug clinical trial shall submit to the Director 
     of NIH for inclusion in the registry data bank the clinical 
     trial information described in subparagraph (A)(ii).
       ``(D) Truthful clinical trial information.--
       ``(i) In general.--The clinical trial information submitted 
     by a responsible party under this paragraph shall not be 
     false or misleading in any particular.
       ``(ii) Effect.--Clause (i) shall not have the effect of 
     requiring clinical trial information with respect to an 
     applicable drug clinical trial or an applicable device 
     clinical trial to include information from any source other 
     than such clinical trial involved.
       ``(E) Changes in clinical trial status.--
       ``(i) Enrollment.--The responsible party for an applicable 
     drug clinical trial or an applicable device clinical trial 
     shall update the enrollment status not later than 30 days 
     after the enrollment status of such clinical trial changes.
       ``(ii) Completion.--The responsible party for an applicable 
     drug clinical trial or applicable device clinical trial shall 
     report to the Director of NIH that such clinical trial is 
     complete not later than 30 days after the completion date of 
     the clinical trial.
       ``(F) Timing of submission.--The clinical trial information 
     for an applicable drug clinical trial or an applicable device 
     clinical trial required to be submitted under this paragraph 
     shall be submitted not later than 21 days after the first 
     patient is enrolled in such clinical trial.
       ``(G) Posting of data.--
       ``(i) Applicable drug clinical trial.--The Director of NIH 
     shall ensure that clinical trial information for an 
     applicable drug clinical trial submitted in accordance with 
     this paragraph is posted publicly within 30 days of such 
     submission.
       ``(ii) Applicable device clinical trial.--The Director of 
     NIH shall ensure that clinical trial information for an 
     applicable device clinical trial submitted in accordance with 
     this paragraph is posted publicly within 30 days of clearance 
     under section 510(k) of the Federal Food, Drug, and Cosmetic 
     Act, or approval under section 515 or section 520(m) of such 
     Act, as applicable.
       ``(H) Voluntary submissions.--A responsible party for a 
     clinical trial that is not an applicable drug clinical trial 
     or an applicable device clinical trial may submit clinical 
     trial information to the registry data bank in accordance 
     with this subsection.
       ``(3) Expansion of registry data bank to include results of 
     clinical trials.--
       ``(A) Linking registry data bank to existing results.--
       ``(i) In general.--Beginning not later than 90 days after 
     the date of enactment of the Enhancing Drug Safety and 
     Innovation Act of 2007, for those clinical trials that form 
     the primary basis of an efficacy claim or are conducted after 
     the drug involved is approved or after the device involved is 
     cleared or approved, the Secretary shall ensure that the 
     registry data bank includes links to results information for 
     such clinical trial--

       ``(I) not earlier than 30 days after the date of the 
     approval of the drug involved or clearance or approval of the 
     device involved; or
       ``(II) not later than 30 days after such information 
     becomes publicly available, as applicable.

       ``(ii) Required information.--

       ``(I) FDA information.--The Secretary shall ensure that the 
     registry data bank includes links to the following 
     information:

       ``(aa) If an advisory committee considered at a meeting an 
     applicable drug clinical trial or an applicable device 
     clinical trial, any posted Food and Drug Administration 
     summary document regarding such applicable drug clinical 
     trial or applicable clinical device trial.
       ``(bb) If an applicable drug clinical trial was conducted 
     under section 505A or 505B of the Federal Food, Drug, and 
     Cosmetic Act, a link to the posted Food and Drug 
     Administration assessment of the results of such trial.
       ``(cc) Food and Drug Administration public health 
     advisories regarding the drug or device that is the subject 
     of the applicable drug clinical trial or applicable device 
     clinical trial, respectively, if any.
       ``(dd) For an applicable drug clinical trial, the Food and 
     Drug Administration action package for approval document 
     required under section 505(l)(2) of the Food Drug and 
     Cosmetic Act.
       ``(ee) For an applicable device clinical trial, in the case 
     of a premarket application, the detailed summary of 
     information respecting the safety and effectiveness of the 
     device required under section 520(h)(1) of the Federal Food, 
     Drug, and Cosmetic Act, or, in the case of a report under 
     section 510(k) of such Act, the section 510(k) summary of the 
     safety and effectiveness data required under section 
     807.95(d) of title 21, Code of Federal Regulations (or any 
     successor regulations).

       ``(II) NIH information.--The Secretary shall ensure that 
     the registry data bank includes links to the following 
     information:

       ``(aa) Medline citations to any publications regarding each 
     applicable drug clinical trial and applicable device clinical 
     trial.
       ``(bb) The entry for the drug that is the subject of an 
     applicable drug clinical trial in the National Library of 
     Medicine database of structured product labels, if available.
       ``(iii) Results for existing data bank entries.--The 
     Secretary may include the links described in clause (ii) for 
     data bank entries for clinical trials submitted to the data 
     bank prior to enactment of the Enhancing Drug Safety and 
     Innovation Act of 2007, as available.
       ``(B) Feasibility study.--The Director of NIH shall--
       ``(i) conduct a study to determine the best, validated 
     methods of making the results of clinical trials publicly 
     available after the approval of the drug that is the subject 
     of an applicable drug clinical trial; and
       ``(ii) not later than 18 months after initiating such 
     study, submit to the Secretary any findings and 
     recommendations of such study.
       ``(C) Negotiated rulemaking.--
       ``(i) In general.--The Secretary shall establish a 
     negotiated rulemaking process pursuant to subchapter IV of 
     chapter 5 of title 5, United States Code, to determine, for 
     applicable drug clinical trials--

       ``(I) how to ensure quality and validate methods of 
     expanding the registry data bank to include clinical trial 
     results information for trials not within the scope of this 
     Act;
       ``(II) the clinical trials of which the results information 
     is appropriate for adding to the expanded registry data bank; 
     and
       ``(III) the appropriate timing of the posting of such 
     results information.

       ``(ii) Time requirement.--The process described in 
     paragraph (1) shall be conducted in a timely manner to ensure 
     that--

       ``(I) any recommendation for a proposed rule--

       ``(aa) is provided to the Secretary not later than 21 
     months after the date of the enactment of the Enhancing Drug 
     Safety and Innovation Act of 2007; and
       ``(bb) includes an assessment of the benefits and costs of 
     the recommendation; and

       ``(II) a final rule is promulgated not later than 30 months 
     after the date of the enactment of the Enhancing Drug Safety 
     and Innovation Act of 2007, taking into account the 
     recommendations under subclause (I) and the results of the 
     feasibility study conducted under subparagraph (B).

       ``(iii) Representation on negotiated rulemaking 
     committee.--The negotiated rulemaking committee established 
     by the Secretary pursuant to clause (i) shall include members 
     representing--

       ``(I) the Food and Drug Administration;
       ``(II) the National Institutes of Health;

[[Page 11693]]

       ``(III) other Federal agencies as the Secretary determines 
     appropriate;
       ``(IV) patient advocacy and health care provider groups;
       ``(V) the pharmaceutical industry;
       ``(VI) contract clinical research organizations;
       ``(VII) the International Committee of Medical Journal 
     Editors; and
       ``(VIII) other interested parties, including experts in 
     privacy protection, pediatrics, health information 
     technology, health literacy, communication, clinical trial 
     design and implementation, and health care ethics.

       ``(iv) Content of regulations.--The regulations promulgated 
     pursuant to clause (i) shall establish--

       ``(I) procedures to determine which clinical trials results 
     information data elements shall be included in the registry 
     data bank, taking into account the needs of different 
     populations of users of the registry data bank;
       ``(II) a standard format for the submission of clinical 
     trials results to the registry data bank;
       ``(III) a standard procedure for the submission of clinical 
     trial results information, including the timing of submission 
     and the timing of posting of results information, to the 
     registry data bank, taking into account the possible impacts 
     on publication of manuscripts based on the clinical trial;
       ``(IV) a standard procedure for the verification of 
     clinical trial results information, including ensuring that 
     free text data elements are non-promotional; and
       ``(V) an implementation plan for the prompt inclusion of 
     clinical trials results information in the registry data 
     bank.

       ``(D) Consideration of world health organization data 
     set.--The Secretary shall consider the status of the 
     consensus data elements set for reporting clinical trial 
     results of the World Health Organization when promulgating 
     the regulations under subparagraph (C).
       ``(E) Truthful clinical trial information.--
       ``(i) In general.--The clinical trial information submitted 
     by a responsible party under this paragraph shall not be 
     false or misleading in any particular.
       ``(ii) Effect.--Clause (i) shall not have the effect of 
     requiring clinical trial information with respect to an 
     applicable drug clinical trial or an applicable device 
     clinical trial to include information from any source other 
     than such clinical trial involved.
       ``(F) Waivers regarding certain clinical trial results.--
     The Secretary may waive any applicable requirements of this 
     paragraph for an applicable drug clinical trial or an 
     applicable device clinical trial, upon a written request from 
     the responsible person, if the Secretary determines that 
     extraordinary circumstances justify the waiver and that 
     providing the waiver is in the public interest, consistent 
     with the protection of public health, or in the interest of 
     national security. Not later than 30 days after any part of a 
     waiver is granted, the Secretary shall notify, in writing, 
     the appropriate committees of Congress of the waiver and 
     provide an explanation for why the waiver was granted.
       ``(4) Coordination and compliance.--
       ``(A) Clinical trials supported by grants from federal 
     agencies.--
       ``(i) In general.--No Federal agency may release funds 
     under a research grant to an awardee who has not complied 
     with paragraph (2) for any applicable drug clinical trial or 
     applicable device clinical trial for which such person is the 
     responsible party.
       ``(ii) Grants from certain federal agencies.--If an 
     applicable drug clinical trial or applicable device clinical 
     trial is funded in whole or in part by a grant from the Food 
     and Drug Administration, National Institutes of Health, the 
     Agency for Healthcare Research and Quality, or the Department 
     of Veterans Affairs, any grant or progress report forms 
     required under such grant shall include a certification that 
     the responsible party has made all required submissions to 
     the Director of NIH under paragraph (2).
       ``(iii) Verification by federal agencies.--The heads of the 
     agencies referred to in clause (ii), as applicable, shall 
     verify that the clinical trial information for each 
     applicable drug clinical trial or applicable device clinical 
     trial for which a grantee is the responsible party has been 
     submitted under paragraph (2) before releasing any remaining 
     funding for a grant or funding for a future grant to such 
     grantee.
       ``(iv) Notice and opportunity to remedy.--If the head of an 
     agency referred to in clause (ii), as applicable, verifies 
     that a grantee has not submitted clinical trial information 
     as described in clause (iii), such agency head shall provide 
     notice to such grantee of such non-compliance and allow such 
     grantee 30 days to correct such non-compliance and submit the 
     required clinical trial information.
       ``(v) Consultation with other federal agencies.--The 
     Secretary shall--

       ``(I) consult with other agencies that conduct research 
     involving human subjects in accordance with any section of 
     part 46 of title 45, Code of Federal Regulations (or any 
     successor regulations), to determine if any such research is 
     an applicable drug clinical trial or an applicable device 
     clinical trial under paragraph (1); and
       ``(II) develop with such agencies procedures comparable to 
     those described in clauses (ii), (iii), and (iv) to ensure 
     that clinical trial information for such applicable drug 
     clinical trials and applicable device clinical trial is 
     submitted under paragraph (2).

       ``(B) Certification to accompany drug, biological product, 
     and device submissions.--At the time of submission of an 
     application under section 505 of the Federal Food, Drug, and 
     Cosmetic Act, section 515 of such Act, section 520(m) of such 
     Act, or section 351 of this Act, or submission of a report 
     under section 510(k) of such Act, such application or 
     submission shall be accompanied by a certification that all 
     applicable requirements of this subsection have been met. 
     Where available, such certification shall include the 
     appropriate National Clinical Trial control numbers.
       ``(C) Verification of submission prior to posting.--In the 
     case of clinical trial information that is submitted under 
     paragraph (2), but is not made publicly available pending 
     regulatory approval or clearance, as applicable, the Director 
     of NIH shall respond to inquiries from other Federal agencies 
     and peer-reviewed scientific journals to confirm that such 
     clinical trial information has been submitted but has not yet 
     been posted.
       ``(5) Limitation on disclosure of clinical trial 
     information.--
       ``(A) In general.--Nothing in this subsection (or under 
     section 552 of title 5, United States Code) shall require the 
     Secretary to publicly disclose, from any record or source 
     other than the registry data bank expanded under this 
     subsection, information described in subparagraph (B).
       ``(B) Information described.--Information described in this 
     subparagraph is--
       ``(i) information submitted to the Director of NIH under 
     this subsection, or information of the same general nature as 
     (or integrally associated with) the information so submitted; 
     and
       ``(ii) not otherwise publicly available, including because 
     it is protected from disclosure under section 552 of title 5, 
     United States Code.
       ``(6) Authorization of appropriations.--There are 
     authorized to be appropriated to carry out this subsection 
     $10,000,000 for each fiscal year.''.
       (b) Conforming Amendments.--
       (1) Prohibited acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding 
     at the end the following:
       ``(jj)(1) The failure to submit the certification required 
     by section 402(j)(4)(B) of the Public Health Service Act, or 
     knowingly submitting a false certification under such 
     section.
       ``(2) The submission of clinical trial information under 
     subsection (i) or (j) of section 402 of the Public Health 
     Service Act that is promotional or false or misleading in any 
     particular under paragraph (2) or (3) of such subsection 
     (j).''.
       (2) Civil money penalties.--Section 303(f) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)), as amended 
     by section 203, is further amended by--
       (A) redesignating paragraphs (4), (5), and (6) as 
     paragraphs (5), (6), and (7), respectively;
       (B) inserting after paragraph (3) the following:
       ``(4) Any person who violates section 301(jj) shall be 
     subject to a civil monetary penalty of not more than $10,000 
     for the first violation, and not more than $20,000 for each 
     subsequent violation.'';
       (C) in paragraph (2)(C), by striking ``paragraph (4)(A)'' 
     and inserting ``paragraph (5)(A)'';
       (D) in paragraph (5), as so redesignated, by striking 
     ``paragraph (1), (2), or (3)'' each place it appears and 
     inserting ``paragraph (1), (2), (3), or (4)''; and
       (E) in paragraph (7), as so redesignated, by striking 
     ``paragraph (5)'' each place it appears and inserting 
     ``paragraph (6)''.
       (3) New drugs and devices.--
       (A) Investigational new drugs.--Section 505(i) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is 
     amended in paragraph (4), by adding at the end the following: 
     ``The Secretary shall update such regulations to require 
     inclusion in the informed consent form a statement that 
     clinical trial information for such clinical investigation 
     has been or will be submitted for inclusion in the registry 
     data bank pursuant to subsections (i) and (j) of section 402 
     of the Public Health Service Act.''.
       (B) New drug applications.--Section 505(b) of the Federal, 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by 
     adding at the end the following:
       ``(6) An application submitted under this subsection shall 
     be accompanied by the certification required under section 
     402(j)(4)(B) of the Public Health Service Act. Such 
     certification shall not be considered an element of such 
     application.''.
       (C) Device reports under section 510(k).--Section 510(k) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) 
     is amended by adding at the end the following:

     ``A notification submitted under this subsection that 
     contains clinical trial data for an applicable device 
     clinical trial (as defined in section 402(j)(1) of the Public 
     Health Service Act) shall be accompanied by the certification 
     required under section 402(j)(4)(B) of

[[Page 11694]]

     such Act. Such certification shall not be considered an 
     element of such notification.''.
       (D) Device premarket approval application.--Section 515(c) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360e(c)) is amended--
       (i) in subparagraph (F), by striking ``; and'' and 
     inserting a semicolon;
       (ii) by redesignating subparagraph (G) as subparagraph (H); 
     and
       (iii) by inserting after subparagraph (F) the following:
       ``(G) the certification required under section 402(j)(4)(B) 
     of the Public Health Service Act (which shall not be 
     considered an element of such application); and''.
       (E) Humanitarian device exemption.--Section 520(m)(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) 
     is amended in the first sentence in the matter following 
     subparagraph (C), by inserting at the end before the period 
     ``and such application shall include the certification 
     required under section 402(j)(4)(B) of the Public Health 
     Service Act (which shall not be considered an element of such 
     application)''.
       (c) Preemption.--
       (1) In general.--No State or political subdivision of a 
     State may establish or continue in effect any requirement for 
     the registration of clinical trials or for the inclusion of 
     information relating to the results of clinical trials in a 
     database.
       (2) Rule of construction.--The fact of submission of 
     clinical trial information, if submitted in compliance with 
     subsection (i) and (j) of section 402 of the Public Health 
     Service Act (as amended by this section), that relates to a 
     use of a drug or device not included in the official labeling 
     of the approved drug or device shall not be construed by the 
     Secretary or in any administrative or judicial proceeding, as 
     evidence of a new intended use of the drug or device that is 
     different from the intended use of the drug or device set 
     forth in the official labeling of the drug or device. The 
     availability of clinical trial information through the data 
     bank under such subsections (i) and (j), if submitted in 
     compliance with such subsections, shall not be considered as 
     labeling, adulteration, or misbranding of the drug or device 
     under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
     et seq.).
       (d) Transition Rule; Effective Date of Funding 
     Restrictions.--
       (1) Transition rule for clinical trials initiated prior to 
     expansion of registry data bank.--The responsible party (as 
     defined in paragraph (1) of section 402(j) of the Public 
     Health Service Act (as added by this section)) for an 
     applicable drug clinical trial or applicable device clinical 
     trial (as defined under such paragraph (1)) that is initiated 
     after the date of enactment of this subtitle and before the 
     effective date of the regulations promulgated under paragraph 
     (2) of such section 402(j), shall submit required clinical 
     trial information under such section not later than 120 days 
     after such effective date.
       (2) Funding restrictions.--Subparagraph (A) of paragraph 
     (4) of such section 402(j) shall take effect 210 days after 
     the effective date of the regulations promulgated under 
     paragraph (2) of such section 402(j).
       (e) Effective Date.--
       (1) In general.--Beginning 90 days after the date of 
     enactment of this title, the responsible party for an 
     applicable drug clinical trial or an applicable device 
     clinical trial (as that term is defined in such section 
     402(j)) that is initiated after the date of enactment of this 
     title and before the effective date of the regulations issued 
     under subparagraph (A) of paragraph (2) of such subsection, 
     shall submit clinical trial information under such paragraph 
     (2).
       (2) Rulemaking.--
       (A) In general.--Except as provided in subparagraph (B), 
     subsection (c)(1) shall become effective on the date on which 
     the regulation promulgated pursuant to section 
     402(j)(3)(C)(i) of the Public Health Service Act, as added by 
     this section, becomes effective.
       (B) Exception.--Subsection (c)(1) shall apply with respect 
     to any clinical trial for which the registry data bank 
     includes links to results information, as provided for under 
     section 402(j)(3)(A) of such Act, as added by this section.

                   Subtitle D--Conflicts of Interest

     SEC. 241. CONFLICTS OF INTEREST.

       (a) In General.--Subchapter A of chapter VII of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is 
     amended by inserting at the end the following:

     ``SEC. 712. CONFLICTS OF INTEREST.

       ``(a) Definitions.--For purposes of this section:
       ``(1) Advisory committee.--The term `advisory committee' 
     means an advisory committee under the Federal Advisory 
     Committee Act that provides advice or recommendations to the 
     Secretary regarding activities of the Food and Drug 
     Administration.
       ``(2) Financial interest.--The term `financial interest' 
     means a financial interest under section 208(a) of title 18, 
     United States Code.
       ``(b) Appointments to Advisory Committees.--
       ``(1) Recruitment.--
       ``(A) In general.--Given the importance of advisory 
     committees to the review process at the Food and Drug 
     Administration, the Secretary shall carry out informational 
     and recruitment activities for purposes of recruiting 
     individuals to serve as advisory committee members. The 
     Secretary shall seek input from professional medical and 
     scientific societies to determine the most effective 
     informational and recruitment activities. The Secretary shall 
     also take into account the advisory committees with the 
     greatest number of vacancies.
       ``(B) Recruitment activities.--The recruitment activities 
     under subparagraph (A) may include--
       ``(i) advertising the process for becoming an advisory 
     committee member at medical and scientific society 
     conferences;
       ``(ii) making widely available, including by using existing 
     electronic communications channels, the contact information 
     for the Food and Drug Administration point of contact 
     regarding advisory committee nominations; and
       ``(iii) developing a method through which an entity 
     receiving National Institutes of Health funding can identify 
     a person who the Food and Drug Administration can contact 
     regarding the nomination of individuals to serve on advisory 
     committees.
       ``(2) Evaluation and criteria.--When considering a term 
     appointment to an advisory committee, the Secretary shall 
     review the expertise of the individual and the financial 
     disclosure report filed by the individual pursuant to the 
     Ethics in Government Act of 1978 for each individual under 
     consideration for the appointment, so as to reduce the 
     likelihood that an appointed individual will later require a 
     written determination as referred to in section 208(b)(1) of 
     title 18, United States Code, a written certification as 
     referred to in section 208(b)(3) of title 18, United States 
     Code, or a waiver as referred to in subsection (c)(3) of this 
     section for service on the committee at a meeting of the 
     committee.
       ``(c) Granting and Disclosure of Waivers.--
       ``(1) In general.--Prior to a meeting of an advisory 
     committee regarding a `particular matter' (as that term is 
     used in section 208 of title 18, United States Code), each 
     member of the committee who is a full-time Government 
     employee or special Government employee shall disclose to the 
     Secretary financial interests in accordance with subsection 
     (b) of such section 208.
       ``(2) Financial interest of advisory committee member or 
     family member.--No member of an advisory committee may vote 
     with respect to any matter considered by the advisory 
     committee if such member (or an immediate family member of 
     such member) has a financial interest that could be affected 
     by the advice given to the Secretary with respect to such 
     matter, excluding interests exempted in regulations issued by 
     the Director of the Office of Government Ethics as too remote 
     or inconsequential to affect the integrity of the services of 
     the Government officers or employees to which such 
     regulations apply.
       ``(3) Waiver.--The Secretary may grant a waiver of the 
     prohibition in paragraph (2) if such waiver is necessary to 
     afford the advisory committee essential expertise.
       ``(4) Limitation.--The Secretary may not grant a waiver 
     under paragraph (3) for a member of an advisory committee 
     when the member's own scientific work is involved.
       ``(5) Disclosure of waiver.--Notwithstanding section 
     107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), 
     the following shall apply:
       ``(A) 15 or more days in advance.--As soon as practicable, 
     but in no case later than 15 days prior to a meeting of an 
     advisory committee to which a written determination as 
     referred to in section 208(b)(1) of title 18, United States 
     Code, a written certification as referred to in section 
     208(b)(3) of title 18, United States Code, or a waiver as 
     referred to in paragraph (3) applies, the Secretary shall 
     disclose (other than information exempted from disclosure 
     under section 552 of title 5, United States Code, and section 
     552a of title 5, United States Code (popularly known as the 
     Freedom of Information Act and the Privacy Act of 1974, 
     respectively)) on the Internet website of the Food and Drug 
     Administration--
       ``(i) the type, nature, and magnitude of the financial 
     interests of the advisory committee member to which such 
     determination, certification, or waiver applies; and
       ``(ii) the reasons of the Secretary for such determination, 
     certification, or waiver.
       ``(B) Less than 30 days in advance.--In the case of a 
     financial interest that becomes known to the Secretary less 
     than 30 days prior to a meeting of an advisory committee to 
     which a written determination as referred to in section 
     208(b)(1) of title 18, United States Code, a written 
     certification as referred to in section 208(b)(3) of title 
     18, United States Code, or a waiver as referred to in 
     paragraph (3) applies, the Secretary shall disclose (other 
     than information exempted from disclosure under section 552 
     of title 5, United States Code, and section 552a of title 5, 
     United States Code) on the Internet website of the Food and 
     Drug Administration, the information described in clauses (i) 
     and (ii) of subparagraph (A) as soon as practicable after the 
     Secretary makes such

[[Page 11695]]

     determination, certification, or waiver, but in no case later 
     than the date of such meeting.
       ``(d) Public Record.--The Secretary shall ensure that the 
     public record and transcript of each meeting of an advisory 
     committee includes the disclosure required under subsection 
     (c)(5) (other than information exempted from disclosure under 
     section 552 of title 5, United States Code, and section 552a 
     of title 5, United States Code).
       ``(e) Annual Report.--Not later than February 1 of each 
     year, the Secretary shall submit to the Inspector General of 
     the Department of Health and Human Services, the Committee on 
     Appropriations and the Committee on Health, Education, Labor, 
     and Pensions of the Senate, and the Committee on 
     Appropriations and the Committee on Energy and Commerce of 
     the House of Representatives, a report that describes--
       ``(1) with respect to the fiscal year that ended on 
     September 30 of the previous year, the number of vacancies on 
     each advisory committee, the number of nominees received for 
     each committee, and the number of such nominees willing to 
     serve;
       ``(2) with respect to such year, the aggregate number of 
     disclosures required under subsection (c)(5) for each meeting 
     of each advisory committee and the percentage of individuals 
     to whom such disclosures did not apply who served on such 
     committee for each such meeting;
       ``(3) with respect to such year, the number of times the 
     disclosures required under subsection (c)(5) occurred under 
     subparagraph (B) of such subsection; and
       ``(4) how the Secretary plans to reduce the number of 
     vacancies reported under paragraph (1) during the fiscal year 
     following such year, and mechanisms to encourage the 
     nomination of individuals for service on an advisory 
     committee, including those who are classified by the Food and 
     Drug Administration as academicians or practitioners.
       ``(f) Periodic Review of Guidance.--Not less than once 
     every 5 years, the Secretary shall review guidance of the 
     Food and Drug Administration regarding conflict of interest 
     waiver determinations with respect to advisory committees and 
     update such guidance as necessary.''.
       (b) Conforming Amendment.--Section 505(n) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended 
     by--
       (1) striking paragraph (4); and
       (2) redesignating paragraphs (5), (6), (7), and (8) as 
     paragraphs (4), (5), (6), and (7), respectively.
       (c) Effective Date.--The amendments made by this section 
     shall take effect on October 1, 2007.

                Subtitle E--Other Drug Safety Provisions

     SEC. 251. DATABASE FOR AUTHORIZED GENERIC DRUGS.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by this title, is further amended by 
     adding at the end the following:
       ``(q) Database for Authorized Generic Drugs.--
       ``(1) In general.--
       ``(A) Publication.--The Commissioner shall--
       ``(i) not later than 9 months after the date of enactment 
     of the Enhancing Drug Safety and Innovation Act of 2007, 
     publish a complete list on the Internet website of the Food 
     and Drug Administration of all authorized generic drugs 
     (including drug trade name, brand company manufacturer, and 
     the date the authorized generic drug entered the market); and
       ``(ii) update the list quarterly to include each authorized 
     generic drug included in an annual report submitted to the 
     Secretary by the sponsor of a listed drug during the 
     preceding 3-month period.
       ``(B) Notification.--The Commissioner shall notify relevant 
     Federal agencies, including the Centers for Medicare & 
     Medicaid Services and the Federal Trade Commission, any time 
     the Commissioner updates the information described in 
     subparagraph (A).
       ``(2) Inclusion.--The Commissioner shall include in the 
     list described in paragraph (1) each authorized generic drug 
     included in an annual report submitted to the Secretary by 
     the sponsor of a listed drug after January 1, 1999.
       ``(3) Authorized generic drug.--In this section, the term 
     `authorized generic drug' means a listed drug (as that term 
     is used in subsection (j)) that--
       ``(A) has been approved under subsection (c); and
       ``(B) is marketed, sold, or distributed directly or 
     indirectly to retail class of trade under a different 
     labeling, packaging (other than repackaging as the listed 
     drug in blister packs, unit doses, or similar packaging for 
     use in institutions), product code, labeler code, trade name, 
     or trade mark than the listed drug.''.

     SEC. 252. MEDICAL MARIJUANA.

       The Secretary shall require that State-legalized medical 
     marijuana be subject to the full regulatory requirements of 
     the Food and Drug Administration, including a risk evaluation 
     and mitigation strategy and all other requirements and 
     penalties of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.) regarding safe and effective reviews, 
     approval, sale, marketing, and use of pharmaceuticals.

              Subtitle F--Antibiotic Access and Innovation

     SEC. 261. INCENTIVES FOR THE DEVELOPMENT OF, AND ACCESS TO, 
                   CERTAIN ANTIBIOTICS.

       (a) In General.--Section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355), as amended by this Act, is 
     further amended by adding at the end the following:
       ``(s) Antibiotic Drugs Submitted Before November 21, 
     1997.--
       ``(1) Antibiotic drugs approved before november 21, 1997.--
       ``(A) In general.--Notwithstanding any provision of the 
     Food and Drug Administration Modernization Act of 1997 or any 
     other provision of law, a sponsor of a drug that is the 
     subject of an application described in subparagraph (B)(i) 
     shall be eligible for, with respect to the drug, the 3-year 
     exclusivity period referred to under clauses (iii) and (iv) 
     of subsection (c)(3)(E) and under clauses (iii) and (iv) of 
     subsection (j)(5)(F), subject to the requirements of such 
     clauses, as applicable.
       ``(B) Application; antibiotic drug described.--
       ``(i) Application.--An application described in this clause 
     is an application for marketing submitted under this section 
     after the date of enactment of this subsection in which the 
     drug that is the subject of the application contains an 
     antibiotic drug described in clause (ii).
       ``(ii) Antibiotic drug.--An antibiotic drug described in 
     this clause is an antibiotic drug that was the subject of an 
     application approved by the Secretary under section 507 of 
     this Act (as in effect before November 21, 1997).
       ``(2) Antibiotic drugs submitted before november 21, 1997, 
     but not approved.--
       ``(A) In general.--Notwithstanding any provision of the 
     Food and Drug Administration Modernization Act of 1997 or any 
     other provision of law, a sponsor of a drug that is the 
     subject of an application described in subparagraph (B)(i) 
     may elect to be eligible for, with respect to the drug--
       ``(i)(I) the 3-year exclusivity period referred to under 
     clauses (iii) and (iv) of subsection (c)(3)(E) and under 
     clauses (iii) and (iv) of subsection (j)(5)(F), subject to 
     the requirements of such clauses, as applicable; and
       ``(II) the 5-year exclusivity period referred to under 
     clause (ii) of subsection (c)(3)(E) and under clause (ii) of 
     subsection (j)(5)(F), subject to the requirements of such 
     clauses, as applicable; or
       ``(ii) a patent term extension under section 156 of title 
     35, United States Code, subject to the requirements of such 
     section.
       ``(B) Application; antibiotic drug described.--
       ``(i) Application.--An application described in this clause 
     is an application for marketing submitted under this section 
     after the date of enactment of this subsection in which the 
     drug that is the subject of the application contains an 
     antibiotic drug described in clause (ii).
       ``(ii) Antibiotic drug.--An antibiotic drug described in 
     this clause is an antibiotic drug that was the subject of 1 
     or more applications received by the Secretary under section 
     507 of this Act (as in effect before November 21, 1997), none 
     of which was approved by the Secretary under such section.
       ``(3) Limitations.--
       ``(A) Exclusivities and extensions.--Paragraphs (1)(A) and 
     (2)(A) shall not be construed to entitle a drug that is the 
     subject of an approved application described in subparagraphs 
     (1)(B)(i) or (2)(B)(i), as applicable, to any market 
     exclusivities or patent extensions other than those 
     exclusivities or extensions described in paragraph (1)(A) or 
     (2)(A).
       ``(B) Conditions of use.--Paragraphs (1)(A) and (2)(A)(i) 
     shall not apply to any condition of use for which the drug 
     referred to in subparagraph (1)(B)(i) or (2)(B)(i), as 
     applicable, was approved before the date of enactment of this 
     subsection.
       ``(4) Application of certain provisions.--Notwithstanding 
     section 125, or any other provision, of the Food and Drug 
     Administration Modernization Act of 1997, or any other 
     provision of law, and subject to the limitations in 
     paragraphs (1), (2), and (3), the provisions of the Drug 
     Price Competition and Patent Term Restoration Act of 1984 
     shall apply to any drug subject to paragraph (1) or any drug 
     with respect to which an election is made under paragraph 
     (2)(A).''.
       (b) Transition Rule.--With respect to a patent issued on or 
     before the date of enactment of this Act, any patent 
     information required to be filed with the Secretary under 
     subsection (b)(1) or (c)(2) of section 505 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355) to be listed on 
     a drug to which subsection (s)(1) of such section 505 (as 
     added by this section) applies shall be filed with such 
     Secretary not later than 60 days after the date of enactment 
     of this Act.

     SEC. 262. ANTIBIOTICS AS ORPHAN PRODUCTS.

       (a) Public Meeting.--The Commissioner of Food and Drugs 
     shall convene a public meeting and, if appropriate, issue 
     guidance, regarding which serious and life-threatening 
     infectious diseases, such as diseases due to gram-negative 
     bacteria and other diseases due to antibiotic-resistant 
     bacteria, potentially qualify for available grants and 
     contracts under subsection (a) of section 5 of the Orphan 
     Drug Act (21 U.S.C. 360ee(a)) or other incentives for 
     development.

[[Page 11696]]

       (b) Grants and Contracts for the Development of Orphan 
     Drugs.--Subsection (c) of section 5 of the Orphan Drug Act 
     (21 U.S.C. 360ee(c)) is amended to read as follows:
       ``(c) For grants and contracts under subsection (a) there 
     are authorized to be appropriated--
       ``(1) such sums as already have been appropriated for 
     fiscal year 2007; and
       ``(2) $35,000,000 for each of fiscal years 2008 through 
     2012.''.

     SEC. 263. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE 
                   CONCENTRATIONS OF ANTIMICROBIALS.

       (a) Definition.--In this section, the term ``clinically 
     susceptible concentrations'' means specific values which 
     characterize bacteria as clinically susceptible, 
     intermediate, or resistant to the drug (or drugs) tested.
       (b) Identification.--The Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary''), 
     through the Commissioner of Food and Drugs, shall identify 
     and periodically update clinically susceptible 
     concentrations.
       (c) Public Availability.--The Secretary, through the 
     Commissioner of Food and Drugs, shall make such clinically 
     susceptible concentrations publicly available within 30 days 
     of the date of identification and any update under this 
     section.
       (d) Effect.--Nothing in this section shall be construed to 
     restrict, in any manner, the prescribing of antibiotics by 
     physicians, or to limit the practice of medicine, including 
     for diseases such as Lyme and tick-borne diseases.

     SEC. 264. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE 
                   ENANTIOMERS.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S. C. 355), as amended by this subtitle, is amended by 
     adding at the end the following:
       ``(t) Certain Drugs Containing Single Enantiomers.--
       ``(1) In general.--For purposes of subsections 
     (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is 
     submitted under subsection (b) for a non-racemic drug 
     containing as an active ingredient a single enantiomer that 
     is contained in a racemic drug approved in another 
     application under subsection (b), the applicant may, in the 
     application for such non-racemic drug, elect to have the 
     single enantiomer not be considered the same active 
     ingredient as that contained in the approved racemic drug, 
     if--
       ``(A)(i) the single enantiomer has not been previously 
     approved except in the approved racemic drug; and
       ``(ii) the application submitted under subsection (b) for 
     such non-racemic drug--
       ``(I) includes full reports of new clinical investigations 
     (other than bioavailability studies)--

       ``(aa) necessary for the approval of the application under 
     subsections (c) and (d); and
       ``(bb) conducted or sponsored by the applicant; and

       ``(II) does not rely on any investigations that are part of 
     an application submitted under subsection (b) for approval of 
     the approved racemic drug; and
       ``(B) the application submitted under subsection (b) for 
     such non-racemic drug is not submitted for approval of a 
     condition of use--
       ``(i) in a therapeutic category in which the approved 
     racemic drug has been approved; or
       ``(ii) for which any other enantiomer of the racemic drug 
     has been approved.
       ``(2) Limitation.--
       ``(A) No approval in certain therapeutic categories.--Until 
     the date that is 10 years after the date of approval of a 
     non-racemic drug described in paragraph (1) and with respect 
     to which the applicant has made the election provided for by 
     such paragraph, the Secretary shall not approve such non-
     racemic drug for any condition of use in the therapeutic 
     category in which the racemic drug has been approved.
       ``(B) Labeling.--If applicable, the labeling of a non-
     racemic drug described in paragraph (1) and with respect to 
     which the applicant has made the election provided for by 
     such paragraph shall include a statement that the non-racemic 
     drug is not approved, and has not been shown to be safe and 
     effective, for any condition of use of the racemic drug.
       ``(3) Definition.--
       ``(A) In general.--For purposes of this subsection, the 
     term `therapeutic category' means a therapeutic category 
     identified in the list developed by the United States 
     Pharmacopeia pursuant to section 1860D-4(b)(3)(C)(ii) of the 
     Social Security Act and as in effect on the date of enactment 
     of this subsection.
       ``(B) Publication by secretary.--The Secretary shall 
     publish the list described in subparagraph (A) and may amend 
     such list by regulation.
       ``(4) Availability.--The election referred to in paragraph 
     (1) may be made only in an application that is submitted to 
     the Secretary after the date of enactment of this subsection 
     and before October 1, 2012.''.

     SEC. 265. REPORT.

       Not later than January 1, 2012, the Comptroller General of 
     the United States shall submit a report to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives that examines whether and how this subtitle 
     has--
       (1) encouraged the development of new antibiotics and other 
     drugs; and
       (2) prevented or delayed timely generic drug entry into the 
     market.

                       TITLE III--MEDICAL DEVICES

     SEC. 300. REFERENCES.

       Except as otherwise specified, whenever in this title an 
     amendment is expressed in terms of an amendment to a section 
     or other provision, the reference shall be considered to be 
     made to a section or other provision of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

                      Subtitle A--Device User Fees

     SEC. 301. SHORT TITLE.

       This subtitle may be cited as the ``Medical Device User Fee 
     Amendments of 2007''.

     SEC. 302. DEVICE FEES.

       Section 737 (21 U.S.C. 379i) is amended--
       (1) by striking the section designation and all that 
     follows through ``For purposes of this subchapter'' and 
     inserting the following:

     ``SEC. 737. DEVICE FEES.

       ``(a) Purpose.--It is the purpose of this part that the 
     fees authorized under this part be dedicated toward 
     expediting the process for the review of device applications 
     and for assuring the safety and effectiveness of devices, as 
     set forth in the goals identified for purposes of this part 
     in the letters from the Secretary to the Chairman of the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Chairman of the Committee on Energy and 
     Commerce of the House of Representatives, as set forth in the 
     Congressional Record.
       ``(b) Reports.--
       ``(1) Performance report.--For fiscal years 2008 through 
     2012, not later than 120 days after the end of each fiscal 
     year during which fees are collected under this part, the 
     Secretary shall prepare and submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, a report concerning the progress of the Food 
     and Drug Administration in achieving the goals identified in 
     the letters described in subsection (a) during such fiscal 
     year and the future plans of the Food and Drug Administration 
     for meeting the goals. The report for a fiscal year shall 
     include information on all previous cohorts for which the 
     Secretary has not given a complete response on all device 
     premarket applications, supplements, and premarket 
     notifications in the cohort.
       ``(2) Fiscal report.--For fiscal years 2008 through 2012, 
     not later than 120 days after the end of each fiscal year 
     during which fees are collected under this part, the 
     Secretary shall prepare and submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, a report on the implementation of the 
     authority for such fees during such fiscal year and the use, 
     by the Food and Drug Administration, of the fees collected 
     during such fiscal year for which the report is made.
       ``(3) Public availability.--The Secretary shall make the 
     reports required under paragraphs (1) and (2) available to 
     the public on the Internet website of the Food and Drug 
     Administration.
       ``(c) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to Congress with respect to the goals, and plans for 
     meeting the goals, for the process for the review of device 
     applications for the first 5 fiscal years after fiscal year 
     2012, and for the reauthorization of this part for such 
     fiscal years, the Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the regulated industry.
       ``(2) Public review of recommendations.--After negotiations 
     with the regulated industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the Congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(3) Transmittal of recommendations.--Not later than 
     January 15, 2012, the Secretary shall transmit to Congress 
     the revised recommendations under paragraph (2), a summary of 
     the views and comments received under such paragraph, and any 
     changes made to the recommendations in response to such views 
     and comments.
       ``(d) Definitions.--For purposes of this part:'';
       (2) by redesignating paragraphs (5), (6), (7), and (8), as 
     paragraphs (7), (8), (9), and (11), respectively;

[[Page 11697]]

       (3) in paragraph (4)--
       (A) in subparagraph (A), by striking ``or an efficacy 
     supplement,'' and inserting ``an efficacy supplement, or a 
     30-day notice,''; and
       (B) by adding at the end the following:
       ``(F) The term `30-day notice' means a supplement to an 
     approved premarket application or premarket report under 
     section 515 that is limited to a request to make 
     modifications to manufacturing procedures or methods of 
     manufacture affecting the safety and effectiveness of the 
     device.'';
       (4) by inserting after paragraph (4) the following:
       ``(5) The term `request for classification information' 
     means a request made under section 513(g) for information 
     respecting the class in which a device has been classified or 
     the requirements applicable to a device.
       ``(6) The term `annual fee for periodic reporting 
     concerning a class III device' means the fee associated with 
     reports imposed by a premarket application approval order (as 
     described in section 814.82(a)(7) of title 21, Code of 
     Federal Regulations), usually referred to as `annual 
     reports.''';
       (5) in paragraph (9), as redesignated by paragraph (2)--
       (A) by striking ``April of'' and inserting ``October of''; 
     and
       (B) by striking ``April 2002'' and inserting ``October 
     2001'';
       (6) by inserting after paragraph (9), as redesignated by 
     paragraph (2), the following:
       ``(10) The term `person' includes an affiliate of such 
     person.''; and
       (7) by adding at the end the following:
       ``(12) The term `establishment subject to a registration 
     fee' means an establishment required to register with the 
     Secretary under section 510 at which any of the following 
     types of activities are conducted:
       ``(A) Manufacturer.--An establishment that makes by any 
     means any article that is a device including an establishment 
     that sterilizes or otherwise makes such article for or on 
     behalf of a specification developer or any other person.
       ``(B) Single-use device reprocessor.--An establishment that 
     performs manufacturing operations on a single-use device that 
     has previously been used on a patient.
       ``(C) Specification developer.--An establishment that 
     develops specifications for a device that is distributed 
     under the establishment's name but that performs no 
     manufacturing, including establishments that, in addition to 
     developing specifications, arrange for the manufacturing of 
     devices labeled with another establishment's name by a 
     contract manufacturer.
       ``(13) The term `establishment registration fee' means a 
     fee assessed under section 738(a)(3) for the registration of 
     an establishment subject to a registration fee.
       ``(e) Sunset.--This part shall cease to be effective on 
     October 1, 2012, except that subsection (b) with respect to 
     reports shall cease to be effective January 31, 2013.''.

     SEC. 303. AUTHORITY TO ASSESS AND USE DEVICE FEES.

       Section 738 (21 U.S.C. 379j) is amended--
       (1) in subsection (a)--
       (A) in paragraph (2)--
       (i) in the header, by inserting ``, and annual fee for 
     periodic reporting concerning a class iii device'' after 
     ``fee'';
       (ii) in subparagraph (A)--

       (I) in clause (iii), by inserting ``75 percent of'' after 
     ``a fee equal to'';
       (II) in clause (iv), by striking ``21.5'' and inserting 
     ``15'';
       (III) in clause (v), by striking ``7.2'' and inserting 
     ``7'';
       (IV) by redesignating clauses (vi) and (vii) as clauses 
     (vii) and (viii), respectively;
       (V) by inserting after clause (v) the following:

       ``(vi) For a 30-day notice, a fee equal to 1.6 percent of 
     the fee that applies under clause (i).'';

       (VI) in clause (viii), as redesignated by subclause (IV)--

       (aa) by striking ``1.42'' and inserting ``1.84''; and
       (bb) by striking ``, subject to any adjustment under 
     subsection (e)(2)(C)(ii)''; and

       (VII) by adding at the end the following:

       ``(ix) For a request for classification information, a fee 
     equal to 1.35 percent of the fee that applies under clause 
     (i).
       ``(x) For periodic reporting concerning a class III device, 
     the annual fee shall be equal to 3.5 percent of the fee that 
     applies under clause (i).'';
       (iii) in subparagraph (C)--

       (I) in the first sentence--

       (aa) by striking ``or''; and
       (bb) by striking ``except that'' and all that follows 
     through the period and inserting ``, 30-day notice, request 
     for classification information, or periodic report concerning 
     a class III device.''; and

       (II) by striking the third sentence; and

       (iv) in subparagraph (D)--

       (I) in clause (iii), by striking the last two sentences; 
     and
       (II) by adding at the end the following:

       ``(iv) Modular application withdrawn before first action.--
     The Secretary shall refund 75 percent of the application fee 
     paid for a modular application submitted under section 
     515(c)(4) that is withdrawn before a second module is 
     submitted and before a first action on the first module. If 
     the modular application is withdrawn after a second or 
     subsequent module is submitted but before any first action, 
     the Secretary may return a portion of the fee. The amount of 
     refund, if any, shall be based on the level of effort already 
     expended on the review of the modules submitted.
       ``(v) Sole discretion to refund.--The Secretary shall have 
     sole discretion to refund a fee or portion of the fee under 
     this subparagraph. A determination by the Secretary 
     concerning a refund under this paragraph shall not be 
     reviewable.''; and
       (B) by adding at the end the following:
       ``(3) Annual establishment registration fee.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     each establishment subject to a registration fee shall be 
     subject to a fee for each initial or annual registration 
     beginning with its registration for fiscal year 2008.
       ``(B) Exception for federal or state government 
     establishment.--No fee shall be required under subparagraph 
     (A) for an establishment operated by a Federal or State 
     government entity unless a device manufactured by the 
     establishment is to be distributed commercially.
       ``(C) Payment.--The annual establishment registration fee 
     shall be due once each fiscal year, upon the initial 
     registration of the establishment or upon the annual 
     registration under section 510.'';
       (2) by striking subsection (b) and inserting the following:
       ``(b) Fee Amounts.--Except as provided in subsections (c), 
     (d), and (e), the fees under subsection (a) shall be based on 
     the following fee amounts:


----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                         Fee Type                          Year 2008  Year 2009  Year 2010  Year 2011  Year 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application                                       $185,000   $200,725   $217,787   $236,298   $256,384
----------------------------------------------------------------------------------------------------------------
Establishment Registration Fee                                $1,706     $1,851     $2,008     $2,179  $2,364'';
----------------------------------------------------------------------------------------------------------------

       (3) in subsection (c)--
       (A) in the heading, by striking ``Annual Fee Setting.--'' 
     and inserting ``Annual Fee Setting.--'';
       (B) in paragraph (1), by striking the second sentence;
       (C) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively;
       (D) by inserting after paragraph (1) the following:
       ``(2) Adjustment of annual establishment registration 
     fee.--
       ``(A) In general.--When setting the fees for fiscal year 
     2010, the Secretary may increase the establishment 
     registration fee specified in subsection (b) only if the 
     Secretary estimates that the number of establishments 
     submitting fees for fiscal year 2009 is less than 12,250. The 
     percent increase shall be the percent by which the estimate 
     of establishments submitting fees in fiscal year 2009 is less 
     than 12,750, but in no case shall the percent increase be 
     more than 8.5 percent over the amount for such fee specified 
     in subsection (b) for fiscal year 2010. If the Secretary 
     makes any adjustment to the establishment registration fee 
     for fiscal year 2010, then the establishment registration fee 
     for fiscal years 2011 and 2012 under subsection (b) shall be 
     adjusted as follows: the fee for fiscal year 2011 shall be 
     equal to the adjusted fee for fiscal year 2010, increased by 
     8.5 percent, and the fee for fiscal year 2012 shall be equal 
     to the adjusted fee for fiscal year 2011, increased by 8.5 
     percent.
       ``(B) Publication in the federal register.--The Secretary 
     shall publish any determination with respect to any 
     establishment registration fee adjustment made under 
     subparagraph (A), and the rationale for such determination, 
     in the Federal Register.''; and
       (E) in paragraph (4)(A), as so redesignated--
       (i) by striking ``For fiscal years 2006 and 2007, the'' and 
     inserting ``The''; and
       (ii) by striking ``of fiscal year 2008'' and inserting ``of 
     the next fiscal year'';
       (4) in subsection (d)--
       (A) in paragraph (1), by striking ``, partners, and parent 
     firms'';
       (B) in paragraph (2)--

[[Page 11698]]

       (i) in subparagraph (A), by striking ``, partners, and 
     parent firms'';
       (ii) in subparagraph (B)--

       (I) by striking ``An applicant shall'' and inserting the 
     following:

       ``(i) In general.--An applicant shall'';

       (II) by striking ``The applicant shall support'' and 
     inserting the following:

       ``(ii) Firms submitting tax returns to the united states 
     internal revenue service.--The applicant shall support'';

       (III) by striking ``, partners, and parent firms'' both 
     places the term appears;
       (IV) by striking ``partners, or parent firms, the'' and 
     inserting ``the'';
       (V) by striking ``, partners, or parent firms, 
     respectively''; and
       (VI) by adding at the end the following:

       ``(iii) Firms not submitting tax returns to the united 
     states internal revenue service.--The applicant shall support 
     its claim that it meets the definition under subparagraph (A) 
     by submission of the following:

       ``(I) A signed certification, in such form as the Secretary 
     may direct through a notice published in the Federal 
     Register, that the applicant meets the criteria for a small 
     business.
       ``(II) A certification, in English, from the national 
     taxing authority of the country in which it is headquartered. 
     Such certification shall provide the applicant's gross 
     receipts and sales for the most recent year, in both the 
     local currency and in United States dollars, the exchange 
     rate used in making this conversion to dollars, and the dates 
     during which these receipts and sales were collected, and it 
     shall bear the official seal of the national taxing 
     authority.
       ``(III) Identical certifications shall be provided for each 
     of the applicant's affiliates.
       ``(IV) A statement signed by the head of the applicant or 
     its chief financial officer that it has submitted 
     certifications for all of its affiliates, or that it had no 
     affiliates, whichever is applicable.''; and

       (iii) in subparagraph (C)--

       (I) by striking ``reduced rate of'' and inserting ``reduced 
     rate of--''; and
       (II) by striking ``38 percent'' and all that follows 
     through the period and inserting the following:

       ``(i) 25 percent of the fee established under such 
     subsection for a premarket application, a premarket report, a 
     supplement, or a periodic report concerning a class III 
     device; and
       ``(ii) 50 percent of the fee established under such 
     subsection for a 30-day notice or a request for 
     classification information.'';
       (5) in subsection (e)--
       (A) in paragraph (1), by striking ``2004'' and inserting 
     ``2008''; and
       (B) in paragraph (2)--
       (i) in subparagraph (A), by striking ``, partners, and 
     parent firms'';
       (ii) by striking subparagraph (B) and inserting the 
     following:
       ``(B) Evidence of qualification.--
       ``(i) In general.--An applicant shall pay the higher fees 
     established by the Secretary each year unless the applicant 
     submits evidence that it qualifies for the lower fee rate.
       ``(ii) Firms submitting tax returns to the united states 
     internal revenue service.--The applicant shall support its 
     claim that it meets the definition under subparagraph (A) by 
     submission of a copy of its most recent Federal income tax 
     return for a taxable year, and a copy of such returns of its 
     affiliates, which show an amount of gross sales or receipts 
     that is less than the maximum established in subparagraph 
     (A). The applicant, and each of such affiliates, shall 
     certify that the information provided is a true and accurate 
     copy of the actual tax forms they submitted to the Internal 
     Revenue Service. If no tax forms are submitted for 
     affiliates, the applicant shall certify that the applicant 
     has no affiliates.
       ``(iii) Firms not submitting tax returns to the united 
     states internal revenue service.--The applicant shall support 
     its claim that it meets the definition under subparagraph (A) 
     by submission of the following:

       ``(I) A signed certification, in such form as the Secretary 
     may direct through a notice published in the Federal 
     Register, that the applicant meets the criteria for a small 
     business.
       ``(II) A certification, in English, from the national 
     taxing authority of the country in which it is headquartered. 
     Such certification shall provide the applicant's gross 
     receipts and sales for the most recent year, in both the 
     local currency and in United States dollars, and the exchange 
     rate used in making such conversion to dollars, and the dates 
     during which such receipts and sales were collected, and it 
     shall bear the official seal of the national taxing 
     authority.
       ``(III) Identical certifications shall be provided for each 
     of the applicant's affiliates.
       ``(IV) A statement signed by the head of the applicant or 
     its chief financial officer that it has submitted 
     certifications for all of its affiliates, or that it had no 
     affiliates, whichever is applicable.''; and

       (iii) by striking subparagraph (C) and inserting the 
     following:
       ``(C) Reduced fees.--For fiscal year 2008 and each 
     subsequent fiscal year, where the Secretary finds that the 
     applicant involved meets the definition under subparagraph 
     (A), the fee for a premarket notification submission may be 
     paid at 50 percent of the fee that applies under subsection 
     (a)(2)(A)(viii) and as established under subsection 
     (c)(1).'';
       (6) by striking subsection (f) and inserting the following:
       ``(f) Effect of Failure To Pay Fees.--
       ``(1) In general.--A premarket application, premarket 
     report, supplement, or premarket notification submission, 30-
     day notice, request for classification information, or 
     periodic report concerning a class III device submitted by a 
     person subject to fees under paragraphs (2) and (3) of 
     subsection (a) shall be considered incomplete and shall not 
     be accepted by the Secretary until all fees owed by such 
     person have been paid.
       ``(2) Registration information.--Registration information 
     submitted by an establishment subject to a registration fee 
     under subsection (a)(3) shall be considered incomplete and 
     shall not be accepted by the Secretary until the registration 
     fee owed for the establishment has been paid. Until the fee 
     is paid and the registration is complete, the establishment 
     shall be deemed to have failed to register in accordance with 
     section 510.'';
       (7) in subsection (g)--
       (A) by striking paragraph (1) and inserting the following:
       ``(1) Performance goals; termination of program.--With 
     respect to the amount that, under the salaries and expenses 
     account of the Food and Drug Administration, is appropriated 
     for a fiscal year for devices and radiological products, fees 
     may not be assessed under subsection (a) for the fiscal year, 
     and the Secretary is not expected to meet any performance 
     goals identified for the fiscal year, if--
       ``(A) the amount so appropriated for the fiscal year, 
     excluding the amount of fees appropriated for the fiscal 
     year, is more than 1 percent less than $205,720,000 
     multiplied by the adjustment factor applicable to such fiscal 
     year; or
       ``(B) fees were not assessed under subsection (a) for the 
     previous fiscal year.''; and
       (B) in paragraph (2), by striking ``and premarket 
     notification submissions, and'' and inserting ``premarket 
     notification submissions, 30-day notices, requests for 
     classification information, periodic reports concerning a 
     class III device, and establishment registrations''; and
       (8) in subsection (h), by striking paragraphs (3) and (4) 
     and inserting the following:
       ``(3) Authorization of appropriations.--There are 
     authorized to be appropriated for fees under this section--
       ``(A) $48,431,000 for fiscal year 2008;
       ``(B) $52,547,000 for fiscal year 2009;
       ``(C) $57,014,000 for fiscal year 2010;
       ``(D) $61,860,000 for fiscal year 2011; and
       ``(E) $67,118,000 for fiscal year 2012.
       ``(4) Offset.--If the cumulative amount of fees collected 
     during fiscal years 2008, 2009, and 2010, added to the amount 
     estimated to be collected for fiscal year 2011 (which 
     estimate shall be based upon the amount of fees received by 
     the Secretary through June 30, 2011), exceeds the amount of 
     fees specified in aggregate in paragraph (3) for such 4 
     fiscal years, the aggregate amount in excess shall be 
     credited to the appropriation account of the Food and Drug 
     Administration as provided in paragraph (1), and shall be 
     subtracted from the amount of fees that would otherwise be 
     authorized to be collected under this section pursuant to 
     appropriation Acts for fiscal year 2012.''.

     SEC. 304. SAVINGS CLAUSE.

       Notwithstanding section 107 of the Medical Device User Fee 
     and Modernization Act of 2002 (Public Law 107-250), and 
     notwithstanding the amendments made by this subtitle, part 3 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act, as in effect on the day before the date of 
     enactment of this subtitle, shall continue to be in effect 
     with respect to premarket applications, premarket reports, 
     premarket notification submissions, and supplements (as 
     defined in such part as of such day) that on or after October 
     1, 2002, but before October 1, 2007, were accepted by the 
     Food and Drug Administration for filing with respect to 
     assessing and collecting any fee required by such part for a 
     fiscal year prior to fiscal year 2008.

     SEC. 305. EFFECTIVE DATE.

       The amendments made by this subtitle shall take effect on 
     October 1, 2007.

     Subtitle B--Amendments Regarding Regulation of Medical Devices

     SEC. 311. INSPECTIONS BY ACCREDITED PERSONS.

       Section 704(g) (21 U.S.C. 374(g)) is amended--
       (1) in paragraph (1), by striking ``Not later than one year 
     after the date of enactment of this subsection, the 
     Secretary'' and inserting ``The Secretary'';
       (2) in paragraph (2), by--
       (A) striking ``Not later than 180 days after the date of 
     enactment of this subsection, the'' and inserting ``The 
     Secretary''; and
       (B) striking the fifth sentence;
       (3) in paragraph (3), by adding at the end the following:
       ``(F) Such person shall notify the Secretary of any 
     withdrawal, suspension, restriction, or expiration of 
     certificate of conformance with the quality systems standard 
     referred to in paragraph (7) for any device establishment 
     that such person inspects under this subsection not later 
     than 30 days after

[[Page 11699]]

     such withdrawal, suspension, restriction, or expiration.
       ``(G) Such person may conduct audits to establish 
     conformance with the quality systems standard referred to in 
     paragraph (7).'';
       (4) by amending paragraph (6) to read as follows:
       ``(6)(A) Subject to subparagraphs (B) and (C), a device 
     establishment is eligible for inspection by persons 
     accredited under paragraph (2) if the following conditions 
     are met:
       ``(i) The Secretary classified the results of the most 
     recent inspection of the establishment as `no action 
     indicated' or `voluntary action indicated'.
       ``(ii) With respect to inspections of the establishment to 
     be conducted by an accredited person, the owner or operator 
     of the establishment submits to the Secretary a notice that--
       ``(I) provides the date of the last inspection of the 
     establishment by the Secretary and the classification of that 
     inspection;
       ``(II) states the intention of the owner or operator to use 
     an accredited person to conduct inspections of the 
     establishment;
       ``(III) identifies the particular accredited person the 
     owner or operator intends to select to conduct such 
     inspections; and
       ``(IV) includes a certification that, with respect to the 
     devices that are manufactured, prepared, propagated, 
     compounded, or processed in the establishment--
       ``(aa) at least 1 of such devices is marketed in the United 
     States; and
       ``(bb) at least 1 of such devices is marketed, or is 
     intended to be marketed, in 1 or more foreign countries, 1 of 
     which countries certifies, accredits, or otherwise recognizes 
     the person accredited under paragraph (2) and identified 
     under subclause (III) as a person authorized to conduct 
     inspections of device establishments.
       ``(B)(i) Except with respect to the requirement of 
     subparagraph (A)(i), a device establishment is deemed to have 
     clearance to participate in the program and to use the 
     accredited person identified in the notice under subparagraph 
     (A)(ii) for inspections of the establishment unless the 
     Secretary, not later than 30 days after receiving such 
     notice, issues a response that--
       ``(I) denies clearance to participate as provided under 
     subparagraph (C); or
       ``(II) makes a request under clause (ii).
       ``(ii) The Secretary may request from the owner or operator 
     of a device establishment in response to the notice under 
     subparagraph (A)(ii) with respect to the establishment, or 
     from the particular accredited person identified in such 
     notice--
       ``(I) compliance data for the establishment in accordance 
     with clause (iii)(I); or
       ``(II) information concerning the relationship between the 
     owner or operator of the establishment and the accredited 
     person identified in such notice in accordance with clause 
     (iii)(II).

     The owner or operator of the establishment, or such 
     accredited person, as the case may be, shall respond to such 
     a request not later than 60 days after receiving such 
     request.
       ``(iii)(I) The compliance data to be submitted by the owner 
     or operation of a device establishment in response to a 
     request under clause (ii)(I) are data describing whether the 
     quality controls of the establishment have been sufficient 
     for ensuring consistent compliance with current good 
     manufacturing practice within the meaning of section 501(h) 
     and with other applicable provisions of this Act. Such data 
     shall include complete reports of inspectional findings 
     regarding good manufacturing practice or other quality 
     control audits that, during the preceding 2-year period, were 
     conducted at the establishment by persons other than the 
     owner or operator of the establishment, together with all 
     other compliance data the Secretary deems necessary. Data 
     under the preceding sentence shall demonstrate to the 
     Secretary whether the establishment has facilitated 
     consistent compliance by promptly correcting any compliance 
     problems identified in such inspections.
       ``(II) A request to an accredited person under clause 
     (ii)(II) may not seek any information that is not required to 
     be maintained by such person in records under subsection 
     (f)(1).
       ``(iv) A device establishment is deemed to have clearance 
     to participate in the program and to use the accredited 
     person identified in the notice under subparagraph (A)(ii) 
     for inspections of the establishment unless the Secretary, 
     not later than 60 days after receiving the information 
     requested under clause (ii), issues a response that denies 
     clearance to participate as provided under subparagraph (C).
       ``(C)(i) The Secretary may deny clearance to a device 
     establishment if the Secretary has evidence that the 
     certification under subparagraph (A)(ii)(IV) is untrue and 
     the Secretary provides to the owner or operator of the 
     establishment a statement summarizing such evidence.
       ``(ii) The Secretary may deny clearance to a device 
     establishment if the Secretary determines that the 
     establishment has failed to demonstrate consistent compliance 
     for purposes of subparagraph (B)(iii)(I) and the Secretary 
     provides to the owner or operator of the establishment a 
     statement of the reasons for such determination.
       ``(iii)(I) The Secretary may reject the selection of the 
     accredited person identified in the notice under subparagraph 
     (A)(ii) if the Secretary provides to the owner or operator of 
     the establishment a statement of the reasons for such 
     rejection. Reasons for the rejection may include that the 
     establishment or the accredited person, as the case may be, 
     has failed to fully respond to the request, or that the 
     Secretary has concerns regarding the relationship between the 
     establishment and such accredited person.
       ``(II) If the Secretary rejects the selection of an 
     accredited person by the owner or operator of a device 
     establishment, the owner or operator may make an additional 
     selection of an accredited person by submitting to the 
     Secretary a notice that identifies the additional selection. 
     Clauses (i) and (ii) of subparagraph (B), and subclause (I) 
     of this clause, apply to the selection of an accredited 
     person through a notice under the preceding sentence in the 
     same manner and to the same extent as such provisions apply 
     to a selection of an accredited person through a notice under 
     subparagraph (A)(ii).
       ``(iv) In the case of a device establishment that is denied 
     clearance under clause (i) or (ii) or with respect to which 
     the selection of the accredited person is rejected under 
     clause (iii), the Secretary shall designate a person to 
     review the statement of reasons, or statement summarizing 
     such evidence, as the case may be, of the Secretary under 
     such clause if, during the 30-day period beginning on the 
     date on which the owner or operator of the establishment 
     receives such statement, the owner or operator requests the 
     review. The review shall commence not later than 30 days 
     after the owner or operator requests the review, unless the 
     Secretary and the owner or operator otherwise agree.'';
       (5) in paragraph (7)--
       (A) by amending subparagraph (A) to read as follows:
       ``(A) Persons accredited under paragraph (2) to conduct 
     inspections shall record in writing their inspection 
     observations and shall present the observations to the device 
     establishment's designated representative and describe each 
     observation. Additionally, such accredited person shall 
     prepare an inspection report in a form and manner designated 
     by the Secretary to conduct inspections, taking into 
     consideration the goals of international harmonization of 
     quality systems standards. Any official classification of the 
     inspection shall be determined by the Secretary.''; and
       (B) by adding at the end the following:
       ``(F) For the purpose of setting risk-based inspectional 
     priorities, the Secretary shall accept voluntary submissions 
     of reports of audits assessing conformance with appropriate 
     quality systems standards set by the International 
     Organization for Standardization (ISO) and identified by the 
     Secretary in public notice. If the owner or operator of an 
     establishment elects to submit audit reports under this 
     subparagraph, the owner or operator shall submit all such 
     audit reports with respect to the establishment during the 
     preceding 2-year periods.''; and
       (6) in paragraphs (10)(C)(iii), by striking ``based'' and 
     inserting ``base''.

     SEC. 312. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF 
                   PREMARKET NOTIFICATION.

       Section 523(c) (21 U.S.C. 360m(c)) is amended by striking 
     ``2007'' and inserting ``2012''.

     SEC. 313. REGISTRATION.

       (a) Annual Registration of Producers of Drugs and 
     Devices.--Section 510(b) (21 U.S.C. 359(b)) is amended--
       (1) by redesignating the existing text as paragraph (1), 
     and indenting and relocating it appropriately;
       (2) in paragraph (1), as so redesignated, by striking ``or 
     a device or devices''; and
       (3) by adding at the end the following new paragraph:
       ``(2) Between October 1 and December 31 of each year every 
     person who owns or operates any establishment in any State 
     engaged in the manufacture, preparation, propagation, 
     compounding, or processing of a device or devices shall 
     register with the Secretary his name, places of business, and 
     all such establishments.''.
       (b) Registration of Foreign Establishments.--Section 
     510(i)(1) (21 U.S.C. 359(i)(1)) is amended--
       (1) by redesignating the existing text as subparagraph (A), 
     and indenting and relocating it appropriately;
       (2) in subparagraph (A), as so redesignated--
       (A) by striking ``processing of a drug or a device that is 
     imported'' and inserting ``processing of a drug that is 
     imported''; and
       (B) by striking ``or device'' each place it appears; and
       (3) by adding after such subparagraph (A) the following new 
     subparagraph:
       ``(B) Between October 1 and December 31 of each year, any 
     establishment within any foreign country engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a device that is imported or offered for import 
     into the United States shall, through electronic means in 
     accordance with the criteria of the Secretary, register with 
     the Secretary the name and place of business of the 
     establishment, the name of the United States agent for the 
     establishment, the name of each importer of such device in 
     the United States that is known to the establishment,

[[Page 11700]]

     and the name of each person who imports or offers for import 
     such device to the United States for purposes of 
     importation.''.

     SEC. 314. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED 
                   PREPARED, PROPAGATED AND COMPOUNDED BY 
                   REGISTRANTS; STATEMENTS; ACCOMPANYING 
                   DISCLOSURES.

       Section 510(j)(2) (21 U.S.C. 360(j)(2) is amended, in the 
     matter preceding subparagraph (A), to read as follows:
       ``(2) Each person who registers with the Secretary under 
     this section shall report to the Secretary (i) with regard to 
     drugs, once during the month of June of each year and once 
     during the month of December of each year, and (ii) with 
     regard to devices, once each year between October 1 and 
     December 31, the following information:''.

     SEC. 315. ELECTRONIC REGISTRATION AND LISTING.

       Section 510(p) (21 U.S.C. 360(p)) is amended to read as 
     follows:
       ``(p)(1) With regard to any establishment engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug, registrations under subsections (b), 
     (c), (d), and (i) of this section (including the submission 
     of updated information) shall be submitted to the Secretary 
     by electronic means, upon a finding by the Secretary that the 
     electronic receipt of such registrations is feasible, unless 
     the Secretary grants a request for waiver of such requirement 
     because use of electronic means is not reasonable for the 
     person requesting such waiver.
       ``(2) With regard to any establishment engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a device, the registration and listing 
     information required by this section shall be submitted to 
     the Secretary by electronic means, unless the Secretary 
     grants a waiver because electronic registration and listing 
     is not reasonable for the person requesting such waiver.''.

                  TITLE IV--PEDIATRIC MEDICAL PRODUCTS

             Subtitle A--Best Pharmaceuticals for Children

     SEC. 401. SHORT TITLE.

       This subtitle may be cited as the ``Best Pharmaceuticals 
     for Children Amendments of 2007''.

     SEC. 402. PEDIATRIC STUDIES OF DRUGS.

       (a) In General.--Section 505A of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355a) is amended--
       (1) in subsection (a), by inserting before the period at 
     the end the following: ``, and, at the discretion of the 
     Secretary, may include preclinical studies'';
       (2) in subsection (b)--
       (A) in paragraph (1)(A)(i), by striking ``(D)'' both places 
     it appears and inserting ``(E)'';
       (B) in paragraph (1)(A)(ii), by striking ``(D)'' and 
     inserting ``(E)'';
       (C) by striking ``(1)(A)(i)'' and inserting ``(A)(i)(I)'';
       (D) by striking ``(ii) the'' and inserting ``(II) the'';
       (E) by striking ``(B) if the drug is designated'' and 
     inserting ``(ii) if the drug is designated'';
       (F) by striking ``(2)(A)'' and inserting ``(B)(i)'';
       (G) by striking ``(i) a listed patent'' and inserting ``(I) 
     a listed patent'';
       (H) by striking ``(ii) a listed patent'' and inserting 
     ``(II) a listed patent'';
       (I) by striking ``(B) if the drug is the subject'' and 
     inserting ``(ii) if the drug is the subject'';
       (J) by striking ``If'' and all that follows through 
     ``subsection (d)(3)'' and inserting the following:
       ``(1) In general.--Except as provided in paragraph (2), if, 
     prior to approval of an application that is submitted under 
     section 505(b)(1), the Secretary determines that information 
     relating to the use of a new drug in the pediatric population 
     may produce health benefits in that population, the Secretary 
     makes a written request for pediatric studies (which shall 
     include a timeframe for completing such studies), the 
     applicant agrees to the request, such studies are completed 
     using appropriate formulations for each age group for which 
     the study is requested within any such timeframe, and the 
     reports thereof are submitted and accepted in accordance with 
     subsection (d)(3), and if the Secretary determines that 
     labeling changes are appropriate, such changes are made 
     within the timeframe requested by the Secretary--''; and
       (K) by adding at the end the following:
       ``(2) Exception.--The Secretary shall not extend a period 
     referred to in paragraph (1)(A) or in paragraph (1)(B) if the 
     determination made under subsection (d)(3) is made less than 
     9 months prior to the expiration of such period.'';
       (3) in subsection (c)--
       (A) in paragraph (1)(A)(i), by striking ``(D)'' both places 
     it appears and inserting ``(E)'';
       (B) in paragraph (1)(A)(ii), by striking ``(D)'' and 
     inserting ``(E)'';
       (C) by striking ``(1)(A)(i)'' and inserting ``(A)(i)(I)'';
       (D) by striking ``(ii) the'' and inserting ``(II) the'';
       (E) by striking ``(B) if the drug is designated'' and 
     inserting ``(ii) if the drug is designated'';
       (F) by striking ``(2)(A)'' and inserting ``(B)(i)'';
       (G) by striking ``(i) a listed patent'' and inserting ``(I) 
     a listed patent'';
       (H) by striking ``(ii) a listed patent'' and inserting 
     ``(II) a listed patent'';
       (I) by striking ``(B) if the drug is the subject'' and 
     inserting ``(ii) if the drug is the subject'';
       (J) by striking ``If'' and all that follows through 
     ``subsection (d)(3)'' and inserting the following:
       ``(1) In general.--Except as provided in paragraph (2), if 
     the Secretary determines that information relating to the use 
     of an approved drug in the pediatric population may produce 
     health benefits in that population and makes a written 
     request to the holder of an approved application under 
     section 505(b)(1) for pediatric studies (which shall include 
     a timeframe for completing such studies), the holder agrees 
     to the request, such studies are completed using appropriate 
     formulations for each age group for which the study is 
     requested within any such timeframe, and the reports thereof 
     are submitted and accepted in accordance with subsection 
     (d)(3), and if the Secretary determines that labeling changes 
     are appropriate, such changes are made within the timeframe 
     requested by the Secretary--''; and
       (K) by adding at the end the following:
       ``(2) Exception.--The Secretary shall not extend a period 
     referred to in paragraph (1)(A) or in paragraph (1)(B) if the 
     determination made under subsection (d)(3) is made less than 
     9 months prior to the expiration of such period.'';
       (4) by striking subsection (d) and inserting the following:
       ``(d) Conduct of Pediatric Studies.--
       ``(1) Request for studies.--
       ``(A) In general.--The Secretary may, after consultation 
     with the sponsor of an application for an investigational new 
     drug under section 505(i), the sponsor of an application for 
     a new drug under section 505(b)(1), or the holder of an 
     approved application for a drug under section 505(b)(1), 
     issue to the sponsor or holder a written request for the 
     conduct of pediatric studies for such drug. In issuing such 
     request, the Secretary shall take into account adequate 
     representation of children of ethnic and racial minorities. 
     Such request to conduct pediatric studies shall be in writing 
     and shall include a timeframe for such studies and a request 
     to the sponsor or holder to propose pediatric labeling 
     resulting from such studies.
       ``(B) Single written request.--A single written request--
       ``(i) may relate to more than 1 use of a drug; and
       ``(ii) may include uses that are both approved and 
     unapproved.
       ``(2) Written request for pediatric studies.--
       ``(A) Request and response.--
       ``(i) In general.--If the Secretary makes a written request 
     for pediatric studies (including neonates, as appropriate) 
     under subsection (b) or (c), the applicant or holder, not 
     later than 180 days after receiving the written request, 
     shall respond to the Secretary as to the intention of the 
     applicant or holder to act on the request by--

       ``(I) indicating when the pediatric studies will be 
     initiated, if the applicant or holder agrees to the request; 
     or
       ``(II) indicating that the applicant or holder does not 
     agree to the request and the reasons for declining the 
     request.

       ``(ii) Disagree with request.--If, on or after the date of 
     enactment of the Best Pharmaceuticals for Children Amendments 
     of 2007, the applicant or holder does not agree to the 
     request on the grounds that it is not possible to develop the 
     appropriate pediatric formulation, the applicant or holder 
     shall submit to the Secretary the reasons such pediatric 
     formulation cannot be developed.
       ``(B) Adverse event reports.--An applicant or holder that, 
     on or after the date of enactment of the Best Pharmaceuticals 
     for Children Amendments of 2007, agrees to the request for 
     such studies shall provide the Secretary, at the same time as 
     submission of the reports of such studies, with all 
     postmarket adverse event reports regarding the drug that is 
     the subject of such studies and are available prior to 
     submission of such reports.
       ``(3) Meeting the studies requirement.--Not later than 180 
     days after the submission of the reports of the studies, the 
     Secretary shall accept or reject such reports and so notify 
     the sponsor or holder. The Secretary's only responsibility in 
     accepting or rejecting the reports shall be to determine, 
     within the 180 days, whether the studies fairly respond to 
     the written request, have been conducted in accordance with 
     commonly accepted scientific principles and protocols, and 
     have been reported in accordance with the requirements of the 
     Secretary for filing.
       ``(4) Effect of subsection.--Nothing in this subsection 
     alters or amends section 301(j) of this Act or section 552 of 
     title 5 or section 1905 of title 18, United States Code.'';
       (5) by striking subsections (e) and (f) and inserting the 
     following:
       ``(e) Notice of Determinations on Studies Requirement.--
       ``(1) In general.--The Secretary shall publish a notice of 
     any determination, made on or after the date of enactment of 
     the Best Pharmaceuticals for Children Amendments of 2007, 
     that the requirements of subsection (d) have been met and 
     that submissions and

[[Page 11701]]

     approvals under subsection (b)(2) or (j) of section 505 for a 
     drug will be subject to the provisions of this section. Such 
     notice shall be published not later than 30 days after the 
     date of the Secretary's determination regarding market 
     exclusivity and shall include a copy of the written request 
     made under subsection (b) or (c).
       ``(2) Identification of certain drugs.--The Secretary shall 
     publish a notice identifying any drug for which, on or after 
     the date of enactment of the Best Pharmaceuticals for 
     Children Amendments of 2007, a pediatric formulation was 
     developed, studied, and found to be safe and effective in the 
     pediatric population (or specified subpopulation) if the 
     pediatric formulation for such drug is not introduced onto 
     the market within 1 year of the date that the Secretary 
     publishes the notice described in paragraph (1). Such notice 
     identifying such drug shall be published not later than 30 
     days after the date of the expiration of such 1 year period.
       ``(f) Internal Review of Written Requests and Pediatric 
     Studies.--
       ``(1) Internal review.--
       ``(A) In general.--The Secretary shall create an internal 
     review committee to review all written requests issued and 
     all reports submitted on or after the date of enactment of 
     the Best Pharmaceuticals for Children Amendments of 2007, in 
     accordance with paragraphs (2) and (3).
       ``(B) Members.--The committee under subparagraph (A) shall 
     include individuals, each of whom is an employee of the Food 
     and Drug Administration, with the following expertise:
       ``(i) Pediatrics.
       ``(ii) Biopharmacology.
       ``(iii) Statistics.
       ``(iv) Drugs and drug formulations.
       ``(v) Legal issues.
       ``(vi) Appropriate expertise, such as expertise in child 
     and adolescent psychiatry, pertaining to the pediatric 
     product under review.
       ``(vii) One or more experts from the Office of Pediatric 
     Therapeutics, which may include an expert in pediatric 
     ethics.
       ``(viii) Other individuals as designated by the Secretary.
       ``(C) Action by committee.--The committee established under 
     this paragraph may perform a function under this section 
     using appropriate members of the committee under subparagraph 
     (B) and need not convene all members of the committee under 
     subparagraph (B) in order to perform a function under this 
     section.
       ``(D) Documentation of committee action.--The committee 
     established under this paragraph shall document for each 
     function under paragraphs (2) and (3), which members of the 
     committee participated in such function.
       ``(2) Review of written requests.--All written requests 
     under this section shall be reviewed and approved by the 
     committee established under paragraph (1) prior to being 
     issued.
       ``(3) Review of pediatric studies.--The committee 
     established under paragraph (1) shall review all studies 
     conducted pursuant to this section to make a recommendation 
     to the Secretary whether to accept or reject such reports 
     under subsection (d)(3).
       ``(4) Tracking pediatric studies and labeling changes.--The 
     committee established under paragraph (1) shall be 
     responsible for tracking and making available to the public, 
     in an easily accessible manner, including through posting on 
     the website of the Food and Drug Administration--
       ``(A) the number of studies conducted under this section;
       ``(B) the specific drugs and drug uses, including labeled 
     and off-labeled indications, studied under this section;
       ``(C) the types of studies conducted under this section, 
     including trial design, the number of pediatric patients 
     studied, and the number of centers and countries involved;
       ``(D) the number of pediatric formulations developed and 
     the number of pediatric formulations not developed and the 
     reasons such formulations were not developed;
       ``(E) the labeling changes made as a result of studies 
     conducted under this section;
       ``(F) an annual summary of labeling changes made as a 
     result of studies conducted under this section for 
     distribution pursuant to subsection (k)(2);
       ``(G) information regarding reports submitted on or after 
     the date of enactment of the Best Pharmaceuticals for 
     Children Amendments of 2007; and
       ``(H) the number of times the committee established under 
     paragraph (1) made a recommendation to the Secretary under 
     paragraph (3), the number of times the Secretary did not 
     follow such a recommendation to accept reports under 
     subsection (d)(3), and the number of times the Secretary did 
     not follow such a recommendation to reject such reports under 
     section (d)(3).
       ``(5) Committee.--The committee established under paragraph 
     (1) is the committee established under section 505B(f)(1).'';
       (6) in subsection (g)--
       (A) in paragraph (1)--
       (i) by striking ``(c)(1)(A)(ii)'' and inserting 
     ``(c)(1)(A)(i)(II)''; and
       (ii) by striking ``(c)(2)'' and inserting ``(c)(1)(B)'';
       (B) in paragraph (2), by striking ``(c)(1)(B)'' and 
     inserting ``(c)(1)(A)(ii)'';
       (C) by redesignating paragraphs (1) and (2) as 
     subparagraphs (A) and (B), respectively;
       (D) by striking ``Limitations.--A drug'' and inserting 
     ``Limitations.--
       ``(1) In general.--Notwithstanding subsection (c)(2), a 
     drug''; and
       (E) by adding at the end the following:
       ``(2) Exclusivity adjustment.--
       ``(A) Adjustment.--
       ``(i) In general.--With respect to any drug, if the 
     organization designated under subparagraph (B) notifies the 
     Secretary that the combined annual gross sales for all drugs 
     with the same active moiety exceeded $1,000,000,000 in any 
     calendar year prior to the time the sponsor or holder agrees 
     to the initial written request pursuant to subsection (d)(2), 
     then each period of market exclusivity deemed or extended 
     under subsection (b) or (c) shall be reduced by 3 months for 
     such drug.
       ``(ii) Determination.--The determination under clause (i) 
     of the combined annual gross sales shall be determined--

       ``(I) taking into account only those sales within the 
     United States; and
       ``(II) taking into account only the sales of all drugs with 
     the same active moiety of the sponsor or holder and its 
     affiliates.

       ``(B) Designation.--The Secretary shall designate an 
     organization other than the Food and Drug Administration to 
     evaluate whether the combined annual gross sales for all 
     drugs with the same active moiety exceeded $1,000,000,000 in 
     a calendar year as described in subparagraph (A). Prior to 
     designating such organization, the Secretary shall determine 
     that such organization is independent and is qualified to 
     evaluate the sales of pharmaceutical products. The Secretary 
     shall re-evaluate the designation of such organization once 
     every 3 years.
       ``(C) Notification.--Once a year at a time designated by 
     the Secretary, the organization designated under subparagraph 
     (B) shall notify the Food and Drug Administration of all 
     drugs with the same active moiety with combined annual gross 
     sales that exceed $1,000,000,000 during the previous calendar 
     year.'';
       (7) in subsection (i)--
       (A) in the heading, by striking ``Supplements'' and 
     inserting ``Changes'';
       (B) in paragraph (1)--
       (i) in the heading, by inserting ``applications and'' after 
     ``pediatric'';
       (ii) by inserting ``application or'' after ``Any'';
       (iii) by striking ``change pursuant to a report on a 
     pediatric study under'' and inserting ``change as a result of 
     any pediatric study conducted pursuant to''; and
       (iv) by inserting ``application or'' after ``to be a 
     priority''; and
       (C) in paragraph (2)(A), by--
       (i) striking ``If the Commissioner'' and inserting ``If, on 
     or after the date of enactment of the Best Pharmaceuticals 
     for Children Amendments of 2007, the Commissioner''; and
       (ii) striking ``an application with'' and all that follows 
     through ``on appropriate'' and inserting ``the sponsor and 
     the Commissioner have been unable to reach agreement on 
     appropriate'';
       (8) by striking subsection (m);
       (9) by redesignating subsections (j), (k), (l), and (n), as 
     subsections (k), (m), (o), and (p), respectively;
       (10) by inserting after subsection (i) the following:
       ``(j) Other Labeling Changes.--If, on or after the date of 
     enactment of the Best Pharmaceuticals for Children Amendments 
     of 2007, the Secretary determines that a pediatric study 
     conducted under this section does or does not demonstrate 
     that the drug that is the subject of the study is safe and 
     effective, including whether such study results are 
     inconclusive, in pediatric populations or subpopulations, the 
     Secretary shall order the labeling of such product to include 
     information about the results of the study and a statement of 
     the Secretary's determination.'';
       (11) in subsection (k), as redesignated by paragraph (9)--
       (A) in paragraph (1)--
       (i) by striking ``a summary of the medical and'' and 
     inserting ``the medical, statistical, and''; and
       (ii) by striking ``for the supplement'' and all that 
     follows through the period and inserting ``under subsection 
     (b) or (c).'';
       (B) by redesignating paragraph (2) as paragraph (3); and
       (C) by inserting after paragraph (1) the following:
       ``(2) Dissemination of information regarding labeling 
     changes.--Beginning on the date of enactment of the Best 
     Pharmaceuticals for Children Amendments of 2007, the 
     Secretary shall require that the sponsors of the studies that 
     result in labeling changes that are reflected in the annual 
     summary developed pursuant to subsection (f)(4)(F) 
     distribute, at least annually (or more frequently if the 
     Secretary determines that it would be beneficial to the 
     public health), such information to physicians and other 
     health care providers.'';
       (12) by inserting after subsection (k), as redesignated by 
     paragraph (9), the following:
       ``(l) Adverse Event Reporting.--
       ``(1) Reporting in year one.--Beginning on the date of 
     enactment of the Best Pharmaceuticals for Children Amendments 
     of 2007,

[[Page 11702]]

     during the 1-year period beginning on the date a labeling 
     change is made pursuant to subsection (i), the Secretary 
     shall ensure that all adverse event reports that have been 
     received for such drug (regardless of when such report was 
     received) are referred to the Office of Pediatric 
     Therapeutics established under section 6 of the Best 
     Pharmaceuticals for Children Act (Public Law 107-109). In 
     considering such reports, the Director of such Office shall 
     provide for the review of the report by the Pediatric 
     Advisory Committee, including obtaining any recommendations 
     of such Committee regarding whether the Secretary should take 
     action under this section in response to such reports.
       ``(2) Reporting in subsequent years.--Following the 1-year 
     period described in paragraph (1), the Secretary shall, as 
     appropriate, refer to the Office of Pediatric Therapeutics 
     all pediatric adverse event reports for a drug for which a 
     pediatric study was conducted under this section. In 
     considering such reports, the Director of such Office may 
     provide for the review of such reports by the Pediatric 
     Advisory Committee, including obtaining any recommendation of 
     such Committee regarding whether the Secretary should take 
     action in response to such reports.
       ``(3) Effect.--The requirements of this subsection shall 
     supplement, not supplant, other review of such adverse event 
     reports by the Secretary.'';
       (13) by inserting after subsection (m), as redesignated by 
     paragraph (9), the following:
       ``(n) Referral if Pediatric Studies Not Completed.--
       ``(1) In general.--Beginning on the date of enactment of 
     the Best Pharmaceuticals for Children Amendments of 2007, if 
     pediatric studies of a drug have not been completed under 
     subsection (d) and if the Secretary, through the committee 
     established under subsection (f), determines that there is a 
     continuing need for information relating to the use of the 
     drug in the pediatric population (including neonates, as 
     appropriate), the Secretary shall carry out the following:
       ``(A) For a drug for which a listed patent has not expired, 
     make a determination regarding whether an assessment shall be 
     required to be submitted under section 505B. Prior to making 
     such determination, the Secretary may take not more than 60 
     days to certify whether the Foundation for the National 
     Institutes of Health has sufficient funding at the time of 
     such certification to initiate 1 or more of the pediatric 
     studies of such drug referred to in the sentence preceding 
     this paragraph and fund 1 or more of such studies in their 
     entirety. Only if the Secretary makes such certification in 
     the affirmative, the Secretary shall refer such pediatric 
     study or studies to the Foundation for the National 
     Institutes of Health for the conduct of such study or 
     studies.
       ``(B) For a drug that has no listed patents or has 1 or 
     more listed patents that have expired, the Secretary shall 
     refer the drug for inclusion on the list established under 
     section 409I of the Public Health Service Act for the conduct 
     of studies.
       ``(2) Public notice.--The Secretary shall give the public 
     notice of--
       ``(A) a decision under paragraph (1)(A) not to require an 
     assessment under section 505B and the basis for such 
     decision; and
       ``(B) any referral under paragraph (1)(B) of a drug for 
     inclusion on the list established under section 409I of the 
     Public Health Service Act.
       ``(3) Effect of subsection.--Nothing in this subsection 
     alters or amends section 301(j) of this Act or section 552 of 
     title 5 or section 1905 of title 18, United States Code.''; 
     and
       (14) in subsection (p), as redesignated by paragraph (9)--
       (A) striking ``6-month period'' and inserting ``3-month or 
     6-month period'';
       (B) by striking ``subsection (a)'' and inserting 
     ``subsection (b)''; and
       (C) by striking ``2007'' both places it appears and 
     inserting ``2012''.
       (b) Effective Date.--Except as otherwise provided in the 
     amendments made by subsection (a), such amendments shall 
     apply to written requests under section 505A of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355a) made after the 
     date of enactment of this subtitle.

     SEC. 403. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

       Section 409I of the Public Health Service Act (42 U.S.C. 
     284m) is amended--
       (1) by striking subsections (a) and (b) and inserting the 
     following:
       ``(a) List of Priority Issues in Pediatric Therapeutics.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of the Best Pharmaceuticals for Children Amendments 
     of 2007, the Secretary, acting through the Director of the 
     National Institutes of Health and in consultation with the 
     Commissioner of Food and Drugs and experts in pediatric 
     research, shall develop and publish a priority list of needs 
     in pediatric therapeutics, including drugs or indications 
     that require study. The list shall be revised every 3 years.
       ``(2) Consideration of available information.--In 
     developing and prioritizing the list under paragraph (1), the 
     Secretary shall consider--
       ``(A) therapeutic gaps in pediatrics that may include 
     developmental pharmacology, pharmacogenetic determinants of 
     drug response, metabolism of drugs and biologics in children, 
     and pediatric clinical trials;
       ``(B) particular pediatric diseases, disorders or 
     conditions where more complete knowledge and testing of 
     therapeutics, including drugs and biologics, may be 
     beneficial in pediatric populations; and
       ``(C) the adequacy of necessary infrastructure to conduct 
     pediatric pharmacological research, including research 
     networks and trained pediatric investigators.
       ``(b) Pediatric Studies and Research.--The Secretary, 
     acting through the National Institutes of Health, shall award 
     funds to entities that have the expertise to conduct 
     pediatric clinical trials or other research (including 
     qualified universities, hospitals, laboratories, contract 
     research organizations, practice groups, federally funded 
     programs such as pediatric pharmacology research units, other 
     public or private institutions, or individuals) to enable the 
     entities to conduct the drug studies or other research on the 
     issues described in subsection (a). The Secretary may use 
     contracts, grants, or other appropriate funding mechanisms to 
     award funds under this subsection.'';
       (2) in subsection (c)--
       (A) in the heading, by striking ``Contracts'' and inserting 
     ``Proposed Pediatric Study Requests'';
       (B) by striking paragraphs (4) and (12);
       (C) by redesignating paragraphs (1), (2), and (3), as 
     paragraphs (2), (3), and (4);
       (D) by inserting before paragraph (2), as redesignated by 
     subparagraph (C), the following:
       ``(1) Submission of proposed pediatric study request.--The 
     Director of the National Institutes of Health shall, as 
     appropriate, submit proposed pediatric study requests for 
     consideration by the Commissioner of Food and Drugs for 
     pediatric studies of a specific pediatric indication 
     identified under subsection (a). Such a proposed pediatric 
     study request shall be made in a manner equivalent to a 
     written request made under subsection (b) or (c) of section 
     505A of the Federal Food, Drug, and Cosmetic Act, including 
     with respect to the information provided on the pediatric 
     studies to be conducted pursuant to the request. The Director 
     of the National Institutes of Health may submit a proposed 
     pediatric study request for a drug for which--
       ``(A)(i) there is an approved application under section 
     505(j) of the Federal Food, Drug, and Cosmetic Act; or
       ``(ii) there is a submitted application that could be 
     approved under the criteria of section 505(j) of the Federal 
     Food, Drug, and Cosmetic Act;
       ``(B) there is no patent protection or market exclusivity 
     protection for at least 1 form of the drug under the Federal 
     Food, Drug, and Cosmetic Act; and
       ``(C) additional studies are needed to assess the safety 
     and effectiveness of the use of the drug in the pediatric 
     population.'';
       (E) in paragraph (2), as redesignated by subparagraph (C)--
       (i) by inserting ``based on the proposed pediatric study 
     request for the indication or indications submitted pursuant 
     to paragraph (1)'' after ``issue a written request'';
       (ii) by striking ``in the list described in subsection 
     (a)(1)(A) (except clause (iv))'' and inserting ``under 
     subsection (a)''; and
       (iii) by inserting ``and using appropriate formulations for 
     each age group for which the study is requested'' before the 
     period at the end;
       (F) in paragraph (3), as redesignated by subparagraph (C)--
       (i) in the heading, by striking ``contract'';
       (ii) by striking ``paragraph (1)'' and inserting 
     ``paragraph (2)'';
       (iii) by striking ``or if a referral described in 
     subsection (a)(1)(A)(iv) is made,'';
       (iv) by striking ``for contract proposals'' and inserting 
     ``for proposals''; and
       (v) by inserting ``in accordance with subsection (b)'' 
     before the period at the end;
       (G) in paragraph (4), as redesignated by subparagraph (C)--
       (i) by striking ``contract''; and
       (ii) by striking ``paragraph (2)'' and inserting 
     ``paragraph (3)'';
       (H) in paragraph (5)--
       (i) by striking the heading and inserting ``Contracts, 
     grants, or other funding mechanisms''; and
       (ii) by striking ``A contract'' and all that follows 
     through ``is submitted'' and inserting ``A contract, grant, 
     or other funding may be awarded under this section only if a 
     proposal is submitted'';
       (I) in paragraph (6)(A)--
       (i) by striking ``a contract awarded'' and inserting ``an 
     award''; and
       (ii) by inserting ``, including a written request if 
     issued'' after ``with the study''; and
       (3) by inserting after subsection (c) the following:
       ``(d) Dissemination of Pediatric Information.--Not later 
     than 1 year after the date of enactment of the Best 
     Pharmaceuticals for Children Amendments of 2007, the 
     Secretary, acting through the Director of the National 
     Institutes of Health, shall study the feasibility of 
     establishing a compilation of information on pediatric drug 
     use and report the findings to Congress.''
       ``(e) Authorization of Appropriations.--

[[Page 11703]]

       ``(1) In general.--There are authorized to be appropriated 
     to carry out this section--
       ``(A) $200,000,000 for fiscal year 2008; and
       ``(B) such sums as are necessary for each of the 4 
     succeeding fiscal years.
       ``(2) Availability.--Any amount appropriated under 
     paragraph (1) shall remain available to carry out this 
     section until expended.''.

     SEC. 404. REPORTS AND STUDIES.

       (a) GAO Report.--Not later than January 31, 2011, the 
     Comptroller General of the United States, in consultation 
     with the Secretary of Health and Human Services, shall submit 
     to Congress a report that addresses the effectiveness of 
     section 505A of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355a) in ensuring that medicines used by children are 
     tested and properly labeled, including--
       (1) the number and importance of drugs for children that 
     are being tested as a result of the amendments made by this 
     subtitle and the importance for children, health care 
     providers, parents, and others of labeling changes made as a 
     result of such testing;
       (2) the number and importance of drugs for children that 
     are not being tested for their use notwithstanding the 
     provisions of this subtitle and the amendments made by this 
     subtitle, and possible reasons for the lack of testing, 
     including whether the number of written requests declined by 
     sponsors or holders of drugs subject to section 505A(g)(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355a(g)(2)), has increased or decreased as a result of the 
     amendments made by this subtitle;
       (3) the number of drugs for which testing is being done and 
     labeling changes required, including the date labeling 
     changes are made and which labeling changes required the use 
     of the dispute resolution process established pursuant to the 
     amendments made by this subtitle, together with a description 
     of the outcomes of such process, including a description of 
     the disputes and the recommendations of the Pediatric 
     Advisory Committee;
       (4) any recommendations for modifications to the programs 
     established under section 505A of the Federal Food, Drug and 
     Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public 
     Health Service Act (42 U.S.C. 284m) that the Secretary 
     determines to be appropriate, including a detailed rationale 
     for each recommendation; and
       (5)(A) the efforts made by the Secretary to increase the 
     number of studies conducted in the neonate population; and
       (B) the results of those efforts, including efforts made to 
     encourage the conduct of appropriate studies in neonates by 
     companies with products that have sufficient safety and other 
     information to make the conduct of the studies ethical and 
     safe.
       (b) IOM Study.--Not later than 3 years after the date of 
     enactment of this subtitle, the Secretary of Health and Human 
     Services shall enter into a contract with the Institute of 
     Medicine to conduct a study and report to Congress regarding 
     the written requests made and the studies conducted pursuant 
     to section 505A of the Federal Food, Drug, and Cosmetic Act. 
     The Institute of Medicine may devise an appropriate mechanism 
     to review a representative sample of requests made and 
     studies conducted pursuant to such section in order to 
     conduct such study. Such study shall--
       (1) review such representative written requests issued by 
     the Secretary since 1997 under subsections (b) and (c) of 
     such section 505A;
       (2) review and assess such representative pediatric studies 
     conducted under such subsections (b) and (c) since 1997 and 
     labeling changes made as a result of such studies; and
       (3) review the use of extrapolation for pediatric 
     subpopulations, the use of alternative endpoints for 
     pediatric populations, neonatal assessment tools, and ethical 
     issues in pediatric clinical trials.

     SEC. 405. TRAINING OF PEDIATRIC PHARMACOLOGISTS.

       (a) Investment in Tomorrow's Pediatric Researchers.--
     Section 452G(2) of the Public Health Service Act (42 U.S.C. 
     285g-10(2)) is amended by adding before the period at the end 
     the following: ``, including pediatric pharmacological 
     research''.
       (b) Pediatric Research Loan Repayment Program.--Section 
     487F(a)(1) of the Public Health Service Act (42 U.S.C. 288-
     6(a)(1)) is amended by inserting ``including pediatric 
     pharmacological research,'' after ``pediatric research,''.

     SEC. 406. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.

       Section 499(c)(1)(C) of the Public Health Service Act (42 
     U.S.C. 290b(c)(1)(C)) is amended by striking ``and studies 
     listed by the Secretary pursuant to section 409I(a)(1)(A) of 
     the is Act and referred under section 505A(d)(4)(C) of the 
     Federal Food, Drug and Cosmetic Act (21 U.S.C. 
     355(a)(d)(4)(C)'' and inserting ``and studies for which the 
     Secretary issues a certification under section 505A(n)(1)(A) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355a(n)(1)(A))''.

     SEC. 407. CONTINUATION OF OPERATION OF COMMITTEE.

       Section 14 of the Best Pharmaceuticals for Children Act (42 
     U.S.C. 284m note) is amended by adding at the end the 
     following:
       ``(d) Continuation of Operation of Committee.--
     Notwithstanding section 14 of the Federal Advisory Committee 
     Act (5 U.S.C. App.), the advisory committee shall continue to 
     operate during the 5-year period beginning on the date of 
     enactment of the Best Pharmaceuticals for Children Amendments 
     of 2007.''.

     SEC. 408. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS 
                   ADVISORY COMMITTEE.

       Section 15 of the Best Pharmaceuticals for Children Act (42 
     U.S.C. 284m note) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1)--
       (i) in subparagraph (B), by striking ``and'' after the 
     semicolon;
       (ii) in subparagraph (C), by striking the period at the end 
     and inserting ``; and''; and
       (iii) by adding at the end the following:
       ``(D) provide recommendations to the internal review 
     committee created under section 505A(f) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355a(f)) regarding the 
     implementation of amendments to sections 505A and 505B of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a and 
     355c) with respect to the treatment of pediatric cancers.''; 
     and
       (B) by adding at the end the following:
       ``(3) Continuation of operation of subcommittee.--
     Notwithstanding section 14 of the Federal Advisory Committee 
     Act (5 U.S.C. App.), the Subcommittee shall continue to 
     operate during the 5-year period beginning on the date of 
     enactment of the Best Pharmaceuticals for Children Amendments 
     of 2007.''; and
       (2) in subsection (d), by striking ``2003'' and inserting 
     ``2009''.

     SEC. 409. EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO 
                   TOLL-FREE NUMBER FOR ADVERSE EVENTS ON LABELING 
                   FOR HUMAN DRUG PRODUCTS.

       (a) In General.--Notwithstanding subchapter II of chapter 
     5, and chapter 7, of title 5, United States Code (commonly 
     known as the ``Administrative Procedure Act'') and any other 
     provision of law, the proposed rule issued by the 
     Commissioner of Food and Drugs entitled ``Toll-Free Number 
     for Reporting Adverse Events on Labeling for Human Drug 
     Products'', 69 Fed. Reg. 21778, (April 22, 2004) shall take 
     effect on January 1, 2008, unless such Commissioner issues 
     the final rule before such date.
       (b) Limitation.--The proposed rule that takes effect under 
     subsection (a), or the final rule described under subsection 
     (a), shall, notwithstanding section 17(a) of the Best 
     Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not 
     apply to a drug--
       (1) for which an application is approved under section 505 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
       (2) that is not described under section 503(b)(1) of such 
     Act (21 U.S.C. 353(b)(1)); and
       (3) the packaging of which includes a toll-free number 
     through which consumers can report complaints to the 
     manufacturer or distributor of the drug.

               Subtitle B--Pediatric Research Improvement

     SEC. 411. SHORT TITLE.

       This subtitle may be cited as the ``Pediatric Research 
     Improvement Act''.

     SEC. 412. PEDIATRIC FORMULATIONS, EXTRAPOLATIONS, AND 
                   DEFERRALS.

       Section 505B(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355c(a)) is amended--
       (1) in paragraph (4)(C), by adding at the end the 
     following: ``An applicant seeking either a partial or full 
     waiver on this ground shall submit to the Secretary 
     documentation detailing why a pediatric formulation cannot be 
     developed, and, if the waiver is granted, the applicant's 
     submission shall promptly be made available to the public in 
     an easily accessible manner, including through posting on the 
     website of the Food and Drug Administration'';
       (2) in paragraph (2)(B), by adding at the end the 
     following:
       ``(iii) Information on extrapolation.--A brief 
     documentation of the scientific data supporting the 
     conclusion under clauses (i) and (ii) shall be included in 
     any pertinent reviews for the application under section 505 
     or section 351 of the Public Health Service Act.''; and
       (3) by striking paragraph (3) and inserting the following:
       ``(3) Deferral.--
       ``(A) In general.--On the initiative of the Secretary or at 
     the request of the applicant, the Secretary may defer 
     submission of some or all assessments required under 
     paragraph (1) until a specified date after approval of the 
     drug or issuance of the license for a biological product if--
       ``(i) the Secretary finds that--

       ``(I) the drug or biological product is ready for approval 
     for use in adults before pediatric studies are complete;
       ``(II) pediatric studies should be delayed until additional 
     safety or effectiveness data have been collected; or
       ``(III) there is another appropriate reason for deferral; 
     and

       ``(ii) the applicant submits to the Secretary--

       ``(I) certification of the grounds for deferring the 
     assessments;

[[Page 11704]]

       ``(II) a description of the planned or ongoing studies;
       ``(III) evidence that the studies are being conducted or 
     will be conducted with due diligence and at the earliest 
     possible time; and
       ``(IV) a timeline for the completion of such studies.

       ``(B) Annual review.--
       ``(i) In general.--On an annual basis following the 
     approval of a deferral under subparagraph (A), the applicant 
     shall submit to the Secretary the following information:

       ``(I) Information detailing the progress made in conducting 
     pediatric studies.
       ``(II) If no progress has been made in conducting such 
     studies, evidence and documentation that such studies will be 
     conducted with due diligence and at the earliest possible 
     time.

       ``(ii) Public availability.--The information submitted 
     through the annual review under clause (i) shall promptly be 
     made available to the public in an easily accessible manner, 
     including through the website of the Food and Drug 
     Administration.''.

     SEC. 413. IMPROVING AVAILABILITY OF PEDIATRIC DATA FOR 
                   ALREADY MARKETED PRODUCTS.

       Section 505B(b) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355c(b)) is amended--
       (1) by striking paragraph (1) and inserting the following:
       ``(1) In general.--After providing notice in the form of a 
     written request under section 505A that was declined by the 
     sponsor or holder, or a letter referencing such declined 
     written request, and an opportunity for written response and 
     a meeting, which may include an advisory committee meeting, 
     the Secretary may (by order in the form of a letter) require 
     the sponsor or holder of an approved application for a drug 
     under section 505 or the holder of a license for a biological 
     product under section 351 of the Public Health Service Act 
     (42 U.S.C. 262) to submit by a specified date the assessments 
     described in subsection (a)(2) and the written request, as 
     appropriate, for the labeled indication or indications, if 
     the Secretary finds that--
       ``(A)(i) the drug or biological product is used for a 
     substantial number of pediatric patients for the labeled 
     indications; and
       ``(ii) adequate pediatric labeling could confer a benefit 
     on pediatric patients;
       ``(B) there is reason to believe that the drug or 
     biological product would represent a meaningful therapeutic 
     benefit over existing therapies for pediatric patients for 1 
     or more of the claimed indications; or
       ``(C) the absence of adequate pediatric labeling could pose 
     a risk to pediatric patients.'';
       (2) in paragraph (2)(C), by adding at the end the 
     following: ``An applicant seeking either a partial or full 
     waiver shall submit to the Secretary documentation detailing 
     why a pediatric formulation cannot be developed, and, if the 
     waiver is granted, the applicant's submission shall promptly 
     be made available to the public in an easily accessible 
     manner, including through posting on the website of the Food 
     and Drug Administration.''; and
       (3) by striking paragraph (3) and inserting the following:
       ``(3) Effect of subsection.--Nothing in this subsection 
     alters or amends section 301(j) of this Act or section 552 of 
     title 5 or section 1905 of title 18, United States Code.''.

     SEC. 414. SUNSET; REVIEW OF PEDIATRIC ASSESSMENTS; ADVERSE 
                   EVENT REPORTING; LABELING CHANGES; AND 
                   PEDIATRIC ASSESSMENTS.

       Section 505B of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355c) is amended--
       (1) redesignating subsection (h) as subsection (j);
       (2) in subsection (j), as so redesignated, by striking 
     ``505A(n)'' and inserting ``505A(p)'';
       (3) by redesignating subsection (f) as subsection (k);
       (4) by redesignating subsection (g) as subsection (l); and
       (5) by inserting after subsection (e) the following:
       ``(f) Review of Pediatric Assessment Requests, Pediatric 
     Assessments, Deferrals, and Waivers.--
       ``(1) Review.--The Secretary shall create an internal 
     committee to review all pediatric assessment requests issued 
     under this section, all pediatric assessments conducted under 
     this section, and all deferral and waiver requests made 
     pursuant to this section. Such internal committee shall 
     include individuals, each of whom is an employee of the Food 
     and Drug Administration, with the following expertise:
       ``(A) Pediatrics.
       ``(B) Biopharmacology.
       ``(C) Statistics.
       ``(D) Drugs and drug formulations.
       ``(E) Pediatric ethics.
       ``(F) Legal issues.
       ``(G) Appropriate expertise, such as expertise in child and 
     adolescent psychiatry, pertaining to the pediatric product 
     under review.
       ``(H) 1 or more experts from the Office of Pediatric 
     Therapeutics.
       ``(I) Other individuals as designated by the Secretary.
       ``(2) Action by the committee.--The committee established 
     under paragraph (1) may perform a function under this section 
     using appropriate members of the committee under paragraph 
     (1) and need not convene all members of the committee under 
     paragraph (1) in order to perform a function under this 
     section.
       ``(3) Documentation of committee action.--For each drug or 
     biological product, the committee established under this 
     paragraph shall document for each function under paragraph 
     (4) or (5), which members of the committee participated in 
     such function.
       ``(4) Review of requests for pediatric assessments, 
     deferrals, and waivers.--All written requests for a pediatric 
     assessment issued pursuant to this section and all requests 
     for deferrals and waivers from the requirement to conduct a 
     pediatric assessment under this section shall be reviewed and 
     approved by the committee established under paragraph (1).
       ``(5) Review of assessments.--The committee established 
     under paragraph (1) shall review all assessments conducted 
     under this section to determine whether such assessments meet 
     the requirements of this section.
       ``(6) Tracking of assessments and labeling changes.--The 
     committee established under paragraph (1) is responsible for 
     tracking and making public in an easily accessible manner, 
     including through posting on the website of the Food and Drug 
     Administration--
       ``(A) the number of assessments conducted under this 
     section;
       ``(B) the specific drugs and drug uses assessed under this 
     section;
       ``(C) the types of assessments conducted under this 
     section, including trial design, the number of pediatric 
     patients studied, and the number of centers and countries 
     involved;
       ``(D) the total number of deferrals requested and granted 
     under this section, and, if granted, the reasons for such 
     deferrals, the timeline for completion, and the number 
     completed and pending by the specified date, as outlined in 
     subsection (a)(3);
       ``(E) the number of waivers requested and granted under 
     this section, and, if granted, the reasons for the waivers;
       ``(F) the number of pediatric formulations developed and 
     the number of pediatric formulations not developed and the 
     reasons any such formulations were not developed;
       ``(G) the labeling changes made as a result of assessments 
     conducted under this section;
       ``(H) an annual summary of labeling changes made as a 
     result of assessments conducted under this section for 
     distribution pursuant to subsection (i)(2); and
       ``(I) an annual summary of the information submitted 
     pursuant to subsection (a)(3)(B).
       ``(7) Committee.--The committee established under paragraph 
     (1) is the committee established under section 505A(f)(1).
       ``(g) Labeling Changes.--
       ``(1) Priority status for pediatric supplement.--Any 
     supplement to an application under section 505 and section 
     351 of the Public Health Service Act proposing a labeling 
     change as a result of any pediatric assessments conducted 
     pursuant to this section--
       ``(A) shall be considered a priority supplement; and
       ``(B) shall be subject to the performance goals established 
     by the Commissioner for priority drugs.
       ``(2) Dispute resolution.--
       ``(A) Request for labeling change and failure to agree.--If 
     the Commissioner determines that a sponsor and the 
     Commissioner have been unable to reach agreement on 
     appropriate changes to the labeling for the drug that is the 
     subject of the application or supplement, not later than 180 
     days after the date of the submission of the application or 
     supplement--
       ``(i) the Commissioner shall request that the sponsor make 
     any labeling change that the Commissioner determines to be 
     appropriate; and
       ``(ii) if the sponsor does not agree to make a labeling 
     change requested by the Commissioner, the Commissioner shall 
     refer the matter to the Pediatric Advisory Committee.
       ``(B) Action by the pediatric advisory committee.--Not 
     later than 90 days after receiving a referral under 
     subparagraph (A)(ii), the Pediatric Advisory Committee 
     shall--
       ``(i) review the pediatric study reports; and
       ``(ii) make a recommendation to the Commissioner concerning 
     appropriate labeling changes, if any.
       ``(C) Consideration of recommendations.--The Commissioner 
     shall consider the recommendations of the Pediatric Advisory 
     Committee and, if appropriate, not later than 30 days after 
     receiving the recommendation, make a request to the sponsor 
     of the application or supplement to make any labeling changes 
     that the Commissioner determines to be appropriate.
       ``(D) Misbranding.--If the sponsor, within 30 days after 
     receiving a request under subparagraph (C), does not agree to 
     make a labeling change requested by the Commissioner, the 
     Commissioner may deem the drug that is the subject of the 
     application or supplement to be misbranded.
       ``(E) No effect on authority.--Nothing in this subsection 
     limits the authority of the

[[Page 11705]]

     United States to bring an enforcement action under this Act 
     when a drug lacks appropriate pediatric labeling. Neither 
     course of action (the Pediatric Advisory Committee process or 
     an enforcement action referred to in the preceding sentence) 
     shall preclude, delay, or serve as the basis to stay the 
     other course of action.
       ``(3) Other labeling changes.--If the Secretary makes a 
     determination that a pediatric assessment conducted under 
     this section does or does not demonstrate that the drug that 
     is the subject of such assessment is safe and effective, 
     including whether such assessment results are inconclusive, 
     in pediatric populations or subpopulations, the Secretary 
     shall order the labeling of such product to include 
     information about the results of the assessment and a 
     statement of the Secretary's determination.
       ``(h) Dissemination of Pediatric Information.--
       ``(1) In general.--Not later than 180 days after the date 
     of submission of a pediatric assessment under this section, 
     the Secretary shall make available to the public in an easily 
     accessible manner the medical, statistical, and clinical 
     pharmacology reviews of such pediatric assessments and shall 
     post such assessments on the website of the Food and Drug 
     Administration.
       ``(2) Dissemination of information regarding labeling 
     changes.--The Secretary shall require that the sponsors of 
     the assessments that result in labeling changes that are 
     reflected in the annual summary developed pursuant to 
     subsection (f)(4)(H) distribute such information to 
     physicians and other health care providers.
       ``(3) Effect of subsection.--Nothing in this subsection 
     shall alter or amend section 301(j) of this Act or section 
     552 of title 5, United States Code, or section 1905 of title 
     18, United States Code.
       ``(i) Adverse Event Reporting.--
       ``(1) Reporting in year 1.--During the 1-year period 
     beginning on the date a labeling change is made pursuant to 
     subsection (g), the Secretary shall ensure that all adverse 
     event reports that have been received for such drug 
     (regardless of when such report was received) are referred to 
     the Office of Pediatric Therapeutics. In considering such 
     reports, the Director of such Office shall provide for the 
     review of the report by the Pediatric Advisory Committee, 
     including obtaining any recommendations of such committee 
     regarding whether the Secretary should take action under this 
     Act in response to such report.
       ``(2) Reporting in subsequent years.--Following the 1-year 
     period described in paragraph (1), the Secretary shall, as 
     appropriate, refer to the Office of Pediatric Therapeutics 
     with all pediatric adverse event reports for a drug for which 
     a pediatric study was conducted under this section. In 
     considering such reports, the Director of such Office may 
     provide for the review of such reports by the Pediatric 
     Advisory Committee, including obtaining any recommendation of 
     such Committee regarding whether the Secretary should take 
     action in response to such report.
       ``(3) Effect.--The requirements of this subsection shall 
     supplement, not supplant, other review of such adverse event 
     reports by the Secretary.''.

     SEC. 415. MEANINGFUL THERAPEUTIC BENEFIT.

       Section 505B(c) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355c) is amended--
       (1) by striking ``estimates'' and inserting ``determines''; 
     and
       (2) by striking ``would'' and inserting ``could''.

     SEC. 416. REPORTS.

       (a) Institute of Medicine Study.--
       (1) In general.--Not later than 3 years after the date of 
     enactment of this subtitle, the Secretary shall contract with 
     the Institute of Medicine to conduct a study and report to 
     Congress regarding the pediatric studies conducted pursuant 
     to section 505B of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355c) since 1997.
       (2) Content of study.--The study under paragraph (1) shall 
     review and assess--
       (A) pediatric studies conducted pursuant to section 505B of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) 
     since 1997 and labeling changes made as a result of such 
     studies; and
       (B) the use of extrapolation for pediatric subpopulations, 
     the use of alternative endpoints for pediatric populations, 
     neonatal assessment tools, number and type of pediatric 
     adverse events, and ethical issues in pediatric clinical 
     trials.
       (3) Representative sample.--The Institute of Medicine may 
     devise an appropriate mechanism to review a representative 
     sample of studies conducted pursuant to section 505B of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) from 
     each review division within the Center for Drug Evaluation 
     and Research and the Center for Biologics Evaluation and 
     Research in order to make the required assessment.
       (b) GAO Report.--Not later than September 1, 2010, the 
     Comptroller General of the United States, in consultation 
     with the Secretary of Health and Human Services, shall submit 
     to Congress a report that addresses the effectiveness of 
     section 505B of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355a) in ensuring that medicines used by children are 
     tested and properly labeled, including--
       (1) the number and importance of drugs for children that 
     are being tested as a result of this provision and the 
     importance for children, health care providers, parents, and 
     others of labeling changes made as a result of such testing;
       (2) the number and importance of drugs for children that 
     are not being tested for their use notwithstanding the 
     provisions of such section 505B, and possible reasons for the 
     lack of testing; and
       (3) the number of drugs for which testing is being done and 
     labeling changes required, including the date labeling 
     changes are made and which labeling changes required the use 
     of the dispute resolution process established under such 
     section 505B, together with a description of the outcomes of 
     such process, including a description of the disputes and the 
     recommendations of the Pediatric Advisory Committee.

     SEC. 417. TECHNICAL CORRECTIONS.

       Section 505B(a)(2)(B)(ii) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355c(a)(2)(B)(ii)) is amended by 
     striking ``one'' and inserting ``1''.

                 Subtitle C--Pediatric Medical Devices

     SEC. 421. SHORT TITLE.

       This subtitle may be cited as the ``Pediatric Medical 
     Device Safety and Improvement Act of 2007''.

     SEC. 422. TRACKING PEDIATRIC DEVICE APPROVALS.

       Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 351 et seq.) is amended by inserting after section 515 
     the following:

     ``SEC. 515A. PEDIATRIC USES OF DEVICES.

       ``(a) New Devices.--
       ``(1) In general.--A person that submits to the Secretary 
     an application under section 520(m), or an application (or 
     supplement to an application) or a product development 
     protocol under section 515, shall include in the application 
     or protocol the information described in paragraph (2).
       ``(2) Required information.--The application or protocol 
     described in paragraph (1) shall include, with respect to the 
     device for which approval is sought and if readily 
     available--
       ``(A) a description of any pediatric subpopulations that 
     suffer from the disease or condition that the device is 
     intended to treat, diagnose, or cure; and
       ``(B) the number of affected pediatric patients.
       ``(3) Annual report.--Not later than 18 months after the 
     date of enactment of this section, and annually thereafter, 
     the Secretary shall submit to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report that includes--
       ``(A) the number of devices approved in the year preceding 
     the year in which the report is submitted, for which there is 
     a pediatric subpopulation that suffers from the disease or 
     condition that the device is intended to treat, diagnose, or 
     cure;
       ``(B) the number of devices approved in the year preceding 
     the year in which the report is submitted, labeled for use in 
     pediatric patients;
       ``(C) the number of pediatric devices approved in the year 
     preceding the year in which the report is submitted, exempted 
     from a fee pursuant to section 738(a)(2)(B)(v); and
       ``(D) the review time for each device described in 
     subparagraphs (A), (B), and (C).
       ``(b) Determination of Pediatric Effectiveness Based on 
     Similar Course of Disease or Condition or Similar Effect of 
     Device on Adults.--
       ``(1) In general.--If the course of the disease or 
     condition and the effects of the device are sufficiently 
     similar in adults and pediatric patients, the Secretary may 
     conclude that adult data may be used to support a 
     determination of a reasonable assurance of effectiveness in 
     pediatric populations, as appropriate.
       ``(2) Extrapolation between subpopulations.--A study may 
     not be needed in each pediatric subpopulation if data from 
     one subpopulation can be extrapolated to another 
     subpopulation.
       ``(c) Pediatric Subpopulation.--In this section, the term 
     `pediatric subpopulation' has the meaning given the term in 
     section 520(m)(6)(E)(ii).''.

     SEC. 423. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.

       (a) In General.--Section 520(m) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360j(m)) is amended--
       (1) in paragraph (3), by striking ``No'' and inserting 
     ``Except as provided in paragraph (6), no'';
       (2) in paragraph (5)--
       (A) by inserting ``, if the Secretary has reason to believe 
     that the requirements of paragraph (6) are no longer met,'' 
     after ``public health''; and
       (B) by adding at the end the following: ``If the person 
     granted an exemption under paragraph (2) fails to demonstrate 
     continued compliance with the requirements of this 
     subsection, the Secretary may suspend or withdraw the 
     exemption from the effectiveness requirements of sections 514 
     and 515 for

[[Page 11706]]

     a humanitarian device only after providing notice and an 
     opportunity for an informal hearing.'';
       (3) by striking paragraph (6) and inserting the following:
       ``(6)(A) Except as provided in subparagraph (D), the 
     prohibition in paragraph (3) shall not apply with respect to 
     a person granted an exemption under paragraph (2) if each of 
     the following conditions apply:
       ``(i)(I) The device with respect to which the exemption is 
     granted is intended for the treatment or diagnosis of a 
     disease or condition that occurs in pediatric patients or in 
     a pediatric subpopulation, and such device is labeled for use 
     in pediatric patients or in a pediatric subpopulation in 
     which the disease or condition occurs.
       ``(II) The device was not previously approved under this 
     subsection for the pediatric patients or the pediatric 
     subpopulation described in subclause (I) prior to the date of 
     enactment of the Pediatric Medical Device Safety and 
     Improvement Act of 2007.
       ``(ii) During any calendar year, the number of such devices 
     distributed during that year does not exceed the annual 
     distribution number specified by the Secretary when the 
     Secretary grants such exemption. The annual distribution 
     number shall be based on the number of individuals affected 
     by the disease or condition that such device is intended to 
     treat, diagnose, or cure, and of that number, the number of 
     individuals likely to use the device, and the number of 
     devices reasonably necessary to treat such individuals. In no 
     case shall the annual distribution number exceed the number 
     identified in paragraph (2)(A).
       ``(iii) Such person immediately notifies the Secretary if 
     the number of such devices distributed during any calendar 
     year exceeds the annual distribution number referred to in 
     clause (ii).
       ``(iv) The request for such exemption is submitted on or 
     before October 1, 2012.
       ``(B) The Secretary may inspect the records relating to the 
     number of devices distributed during any calendar year of a 
     person granted an exemption under paragraph (2) for which the 
     prohibition in paragraph (3) does not apply.
       ``(C) A person may petition the Secretary to modify the 
     annual distribution number specified by the Secretary under 
     subparagraph (A)(ii) with respect to a device if additional 
     information on the number of individuals affected by the 
     disease or condition arises, and the Secretary may modify 
     such number but in no case shall the annual distribution 
     number exceed the number identified in paragraph (2)(A).
       ``(D) If a person notifies the Secretary, or the Secretary 
     determines through an inspection under subparagraph (B), that 
     the number of devices distributed during any calendar year 
     exceeds the annual distribution number, as required under 
     subparagraph (A)(iii), and modified under subparagraph (C), 
     if applicable, then the prohibition in paragraph (3) shall 
     apply with respect to such person for such device for any 
     sales of such device after such notification.
       ``(E)(i) In this subsection, the term `pediatric patients' 
     means patients who are 21 years of age or younger at the time 
     of the diagnosis or treatment.
       ``(ii) In this subsection, the term `pediatric 
     subpopulation' means 1 of the following populations:
       ``(I) Neonates.
       ``(II) Infants.
       ``(III) Children.
       ``(IV) Adolescents.''; and
       (4) by adding at the end the following:
       ``(7) The Secretary shall refer any report of an adverse 
     event regarding a device for which the prohibition under 
     paragraph (3) does not apply pursuant to paragraph (6)(A) 
     that the Secretary receives to the Office of Pediatric 
     Therapeutics, established under section 6 of the Best 
     Pharmaceuticals for Children Act (Public Law 107-109)). In 
     considering the report, the Director of the Office of 
     Pediatric Therapeutics, in consultation with experts in the 
     Center for Devices and Radiological Health, shall provide for 
     periodic review of the report by the Pediatric Advisory 
     Committee, including obtaining any recommendations of such 
     committee regarding whether the Secretary should take action 
     under this Act in response to the report.''.
       (b) Report.--Not later than January 1, 2012, the 
     Comptroller General of the United States shall submit to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives a report on the impact of allowing persons 
     granted an exemption under section 520(m)(2) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with 
     respect to a device to profit from such device pursuant to 
     section 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as 
     amended by subsection (a)), including--
       (1) an assessment of whether such section 520(m)(6) (as 
     amended by subsection (a)) has increased the availability of 
     pediatric devices for conditions that occur in small numbers 
     of children, including any increase or decrease in the number 
     of--
       (A) exemptions granted under such section 520(m)(2) for 
     pediatric devices; and
       (B) applications approved under section 515 of such Act (21 
     U.S.C. 360e) for devices intended to treat, diagnose, or cure 
     conditions that occur in pediatric patients or for devices 
     labeled for use in a pediatric population;
       (2) the conditions or diseases the pediatric devices were 
     intended to treat or diagnose and the estimated size of the 
     pediatric patient population for each condition or disease;
       (3) the costs of the pediatric devices, based on a survey 
     of children's hospitals;
       (4) the extent to which the costs of such devices are 
     covered by health insurance;
       (5) the impact, if any, of allowing profit on access to 
     such devices for patients;
       (6) the profits made by manufacturers for each device that 
     receives an exemption;
       (7) an estimate of the extent of the use of the pediatric 
     devices by both adults and pediatric populations for a 
     condition or disease other than the condition or disease on 
     the label of such devices;
       (8) recommendations of the Comptroller General of the 
     United States regarding the effectiveness of such section 
     520(m)(6) (as amended by subsection (a)) and whether any 
     modifications to such section 520(m)(6) (as amended by 
     subsection (a)) should be made;
       (9) existing obstacles to pediatric device development; and
       (10) an evaluation of the demonstration grants described in 
     section 425, which shall include an evaluation of the number 
     of pediatric medical devices--
       (A) that have been or are being studied in children; and
       (B) that have been submitted to the Food and Drug 
     Administration for approval, clearance, or review under such 
     section 520(m) (as amended by this Act) and any regulatory 
     actions taken.
       (c) Guidance.--Not later than 180 days after the date of 
     enactment of this subtitle, the Commissioner of Food and 
     Drugs shall issue guidance for institutional review 
     committees on how to evaluate requests for approval for 
     devices for which a humanitarian device exemption under 
     section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360j(m)(2)) has been granted.

     SEC. 424. CONTACT POINT FOR AVAILABLE FUNDING.

       Section 402(b) of the Public Health Service Act (42 U.S.C. 
     282(b)) is amended--
       (1) in paragraph (21), by striking ``and'' after the 
     semicolon at the end;
       (2) in paragraph (22), by striking the period at the end 
     and inserting ``; and''; and
       (3) by inserting after paragraph (22) the following:
       ``(23) shall designate a contact point or office to help 
     innovators and physicians identify sources of funding 
     available for pediatric medical device development.''.

     SEC. 425. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE 
                   AVAILABILITY.

       (a) In General.--
       (1) Request for proposals.--Not later than 90 days after 
     the date of enactment of this subtitle, the Secretary of 
     Health and Human Services shall issue a request for proposals 
     for 1 or more grants or contracts to nonprofit consortia for 
     demonstration projects to promote pediatric device 
     development.
       (2) Determination on grants or contracts.--Not later than 
     180 days after the date the Secretary of Health and Human 
     Services issues a request for proposals under paragraph (1), 
     the Secretary shall make a determination on the grants or 
     contracts under this section.
       (b) Application.--A nonprofit consortium that desires to 
     receive a grant or contract under this section shall submit 
     an application to the Secretary of Health and Human Services 
     at such time, in such manner, and containing such information 
     as the Secretary may require.
       (c) Use of Funds.--A nonprofit consortium that receives a 
     grant or contract under this section shall facilitate the 
     development, production, and distribution of pediatric 
     medical devices by--
       (1) encouraging innovation and connecting qualified 
     individuals with pediatric device ideas with potential 
     manufacturers;
       (2) mentoring and managing pediatric device projects 
     through the development process, including product 
     identification, prototype design, device development, and 
     marketing;
       (3) connecting innovators and physicians to existing 
     Federal and non-Federal resources, including resources from 
     the Food and Drug Administration, the National Institutes of 
     Health, the Small Business Administration, the Department of 
     Energy, the Department of Education, the National Science 
     Foundation, the Department of Veterans Affairs, the Agency 
     for Healthcare Research and Quality, and the National 
     Institute of Standards and Technology;
       (4) assessing the scientific and medical merit of proposed 
     pediatric device projects; and
       (5) providing assistance and advice as needed on business 
     development, personnel training, prototype development, 
     postmarket needs, and other activities consistent with the 
     purposes of this section.
       (d) Coordination.--
       (1) National institutes of health.--Each consortium that 
     receives a grant or contract under this section shall--

[[Page 11707]]

       (A) coordinate with the National Institutes of Health's 
     pediatric device contact point or office, designated under 
     section 424; and
       (B) provide to the National Institutes of Health any 
     identified pediatric device needs that the consortium lacks 
     sufficient capacity to address or those needs in which the 
     consortium has been unable to stimulate manufacturer 
     interest.
       (2) Food and drug administration.--Each consortium that 
     receives a grant or contract under this section shall 
     coordinate with the Commissioner of Food and Drugs and device 
     companies to facilitate the application for approval or 
     clearance of devices labeled for pediatric use.
       (3) Effectiveness and outcomes.--Each consortium that 
     receives a grant or contract under this section shall 
     annually report to the Secretary of Health and Human Services 
     on--
       (A) the effectiveness of activities conducted under 
     subsection (c);
       (B) the impact of activities conducted under subsection (c) 
     on pediatric device development; and
       (C) the status of pediatric device development that has 
     been facilitated by the consortium.
       (e) Authorization of Appropriations.--There are authorized 
     to be appropriated to carry out this section $6,000,000 for 
     each of fiscal years 2008 through 2012.

     SEC. 426. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND 
                   PEDIATRIC ADVISORY COMMITTEE.

       (a) In General.--
       (1) Office of pediatric therapeutics.--Section 6(b) of the 
     Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is 
     amended by inserting ``, including increasing pediatric 
     access to medical devices'' after ``pediatric issues''.
       (2) Plan for pediatric medical device research.--
       (A) In general.--Not later than 270 days after the date of 
     enactment of this subtitle, the Office of Pediatric 
     Therapeutics, in collaboration with the Director of the 
     National Institutes of Health and the Director of the Agency 
     for Healthcare Research and Quality, shall submit to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives a plan for expanding pediatric medical 
     device research and development. In developing such plan, the 
     Commissioner of Food and Drugs shall consult with individuals 
     and organizations with appropriate expertise in pediatric 
     medical devices.
       (B) Contents.--The plan under subparagraph (A) shall 
     include--
       (i) the current status of federally funded pediatric 
     medical device research;
       (ii) any gaps in such research, which may include a survey 
     of pediatric medical providers regarding unmet pediatric 
     medical device needs, as needed; and
       (iii) a research agenda for improving pediatric medical 
     device development and Food and Drug Administration clearance 
     or approval of pediatric medical devices, and for evaluating 
     the short- and long-term safety and effectiveness of 
     pediatric medical devices.
       (b) Pediatric Advisory Committee.--Section 14 of the Best 
     Pharmaceuticals for Children Act (42 U.S.C. 284m note) is 
     amended--
       (1) in subsection (a), by inserting ``(including drugs and 
     biological products) and medical devices'' after 
     ``therapeutics''; and
       (2) in subsection (b)--
       (A) in paragraph (1), by inserting ``(including drugs and 
     biological products) and medical devices'' after 
     ``therapeutics''; and
       (B) in paragraph (2)--
       (i) in subparagraph (A), by striking ``and 505B'' and 
     inserting ``505B, 510(k), 515, and 520(m)'';
       (ii) by striking subparagraph (B) and inserting the 
     following:
       ``(B) identification of research priorities related to 
     therapeutics (including drugs and biological products) and 
     medical devices for pediatric populations and the need for 
     additional diagnostics and treatments for specific pediatric 
     diseases or conditions; and''; and
       (iii) in subparagraph (C), by inserting ``(including drugs 
     and biological products) and medical devices'' after 
     ``therapeutics''.

     SEC. 427. POSTMARKET SURVEILLANCE.

       (a) Postmarket Surveillance.--Section 522 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is amended--
       (1) by striking subsection (a) and inserting the following:
       ``(a) Postmarket Surveillance.--
       ``(1) In general.--
       ``(A) Conduct.--The Secretary may by order require a 
     manufacturer to conduct postmarket surveillance for any 
     device of the manufacturer that is a class II or class III 
     device--
       ``(i) the failure of which would be reasonably likely to 
     have serious adverse health consequences;
       ``(ii) that is expected to have significant use in 
     pediatric populations; or
       ``(iii) that is intended to be--

       ``(I) implanted in the human body for more than 1 year; or
       ``(II) a life-sustaining or life-supporting device used 
     outside a device user facility.

       ``(B) Condition.--The Secretary may order a postmarket 
     surveillance under subparagraph (A) as a condition to 
     approval or clearance of a device described in subparagraph 
     (A)(ii).
       ``(2) Rule of construction.--The provisions of paragraph 
     (1) shall have no effect on authorities otherwise provided 
     under the Act or regulations issued under this Act.''; and
       (2) in subsection (b)--
       (A) by striking ``(b) Surveillance Approval.--Each'' and 
     inserting the following:
       ``(b) Surveillance Approval.--
       ``(1) In general.--Each'';
       (B) by striking ``The Secretary, in consultation'' and 
     inserting ``Except as provided in paragraph (2), the 
     Secretary, in consultation'';
       (C) by striking ``Any determination'' and inserting 
     ``Except as provided in paragraph (2), any determination''; 
     and
       (D) by adding at the end the following:
       ``(2) Longer surveillances for pediatric devices.--The 
     Secretary may by order require a prospective surveillance 
     period of more than 36 months with respect to a device that 
     is expected to have significant use in pediatric populations 
     if such period of more than 36 months is necessary in order 
     to assess the impact of the device on growth and development, 
     or the effects of growth, development, activity level, or 
     other factors on the safety of the device.''.

                       TITLE V--OTHER PROVISIONS

     SEC. 501. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC 
                   ARTICLES PUBLISHED BY FDA EMPLOYEES.

       Subchapter A of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 371 et seq.), as amended by section 
     241, is further amended by adding at the end the following:

     ``SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC 
                   ARTICLES PUBLISHED BY FDA EMPLOYEES.

       ``(a) Definition.--In this section, the term `article' 
     means a paper, poster, abstract, book, book chapter, or other 
     published writing.
       ``(b) Policies.--The Secretary, through the Commissioner of 
     Food and Drugs, shall establish and make publicly available 
     clear written policies to implement this section and govern 
     the timely submission, review, clearance, and disclaimer 
     requirements for articles.
       ``(c) Timing of Submission for Review.--If an officer or 
     employee, including a Staff Fellow and a contractor who 
     performs staff work, of the Food and Drug Administration is 
     required by the policies established under subsection (b) to 
     submit an article to the supervisor of such officer or 
     employee, or to some other official of the Food and Drug 
     Administration, for review and clearance before such officer 
     or employee may seek to publish or present such an article at 
     a conference, such officer or employee shall submit such 
     article for such review and clearance not less than 30 days 
     before submitting the article for publication or 
     presentation.
       ``(d) Timing for Review and Clearance.--The supervisor or 
     other reviewing official shall review such article and 
     provide written clearance, or written clearance on the 
     condition of specified changes being made, to such officer or 
     employee not later than 30 days after such officer or 
     employee submitted such article for review.
       ``(e) Non-Timely Review.--If, 31 days after such submission 
     under subsection (c), the supervisor or other reviewing 
     official has not cleared or has not reviewed such article and 
     provided written clearance, such officer or employee may 
     consider such article not to have been cleared and may submit 
     the article for publication or presentation with an 
     appropriate disclaimer as specified in the policies 
     established under subsection (b).''.

     SEC. 502. TECHNICAL AMENDMENTS.

       The Public Health Service Act (42 U.S.C. 201 et seq.) is 
     amended--
       (1) in section 319C-2(j)(3)(B), by striking ``section 319C-
     1(h)'' and inserting ``section 319C-1(i)'';
       (2) in section 402(b)(4), by inserting ``minority and 
     other'' after ``reducing'';
       (3) in section 403(a)(4)(C)(iv)(III), by inserting ``and 
     post doctoral training funded through investigator-initiated 
     research grant awards'' before the semicolon; and
       (4) in section 403C(a)--
       (A) in the matter preceding paragraph (1), by inserting 
     ``graduate students supported by NIH for'' after ``with 
     respect to'';
       (B) in paragraph (1), by inserting ``such'' after 
     ``percentage of''; and
       (C) in paragraph (2), by inserting ``(not including any 
     leaves of absence)'' after ``average time''.

     SEC. 503. SEVERABILITY CLAUSE.

       If any provision of this Act, an amendment made this Act, 
     or the application of such provision or amendment to any 
     person or circumstance is held to be unconstitutional, the 
     remainder of this Act, the amendments made by this Act, and 
     the application of the provisions of such to any person or 
     circumstances shall not be affected thereby.

     SEC. 504. SENSE OF THE SENATE WITH RESPECT TO FOLLOW-ON 
                   BIOLOGICS.

       (a) Findings.--The Senate finds the following:
       (1) The Food and Drug Administration has stated that it 
     requires legislative authority to review follow-on biologics.

[[Page 11708]]

       (2) Business, consumer, and government purchasers require 
     competition and choice to ensure more affordable prescription 
     drug options.
       (3) Well-constructed policies that balance the needs of 
     innovation and affordability have broad bipartisan support.
       (b) Sense of the Senate.--It is the sense of the Senate 
     that legislation should be enacted to--
       (1) provide the Food and Drug Administration with the 
     authority and flexibility to approve biopharmaceuticals 
     subject to an abbreviated approval pathway;
       (2) ensure that patient safety remains paramount in the 
     system;
       (3) establish a regulatory pathway that is efficient, 
     effective, and scientifically-grounded and that also includes 
     measures to ensure timely resolution of patent disputes; and
       (4) provide appropriate incentives to facilitate the 
     research and development of innovative biopharmaceuticals.

     SEC. 505. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR 
                   TROPICAL DISEASES.

       Subchapter A of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR 
                   TROPICAL DISEASES.

       ``(a) Definitions.--In this section:
       ``(1) AIDS.--The term `AIDS' means the acquired immune 
     deficiency syndrome.
       ``(2) AIDS drug.--The term `AIDS drug' means a drug 
     indicated for treating HIV.
       ``(3) HIV.--The term `HIV' means the human immunodeficiency 
     virus, the pathogen that causes AIDS.
       ``(4) Neglected or tropical disease.--The term `neglected 
     or tropical disease' means--
       ``(A) HIV, malaria, tuberculosis, and related diseases; or
       ``(B) any other infectious disease that disproportionately 
     affects poor and marginalized populations, including those 
     diseases targeted by the Special Programme for Research and 
     Training in Tropical Diseases cosponsored by the United 
     Nations Development Program, UNICEF, the World Bank, and the 
     World Health Organization.
       ``(5) Priority review.--The term `priority review', with 
     respect to a new drug application described in paragraph (6), 
     means review and action by the Secretary on such application 
     not later than 180 days after receipt by the Secretary of 
     such application, pursuant to the Manual of Policies and 
     Procedures of the Food and Drug Administration.
       ``(6) Priority review voucher.--The term `priority review 
     voucher' means a voucher issued by the Secretary to the 
     sponsor of a tropical disease product that entitles such 
     sponsor, or a person described under subsection (b)(2), to 
     priority review of a new drug application submitted under 
     section 505(b)(1) after the date of approval of the tropical 
     disease product.
       ``(7) Tropical disease product.--The term `tropical disease 
     product' means a product that--
       ``(A) is a new drug, antibiotic drug, biological product, 
     vaccine, device, diagnostic, or other tool for treatment of a 
     neglected or tropical disease; and
       ``(B) is approved by the Secretary for use in the treatment 
     of a neglected or tropical disease.
       ``(b) Priority Review Voucher.--
       ``(1) In general.--The Secretary shall award a priority 
     review voucher to the sponsor of a tropical disease product 
     upon approval by the Secretary of such tropical disease 
     product.
       ``(2) Transferability.--The sponsor of a tropical disease 
     product that receives a priority review voucher under this 
     section may transfer (including by sale) the entitlement to 
     such voucher to a sponsor of a new drug for which an 
     application under section 505(b)(1) will be submitted after 
     the date of the approval of the tropical disease product.
       ``(3) Limitation.--A sponsor of a tropical disease product 
     may not receive a priority review voucher under this section 
     if the tropical disease product was approved by the Secretary 
     prior to the date of enactment of this section.
       ``(c) Priority Review User Fee.--
       ``(1) In general.--The Secretary shall establish a user fee 
     program under which a sponsor of a drug that is the subject 
     of a priority review voucher shall pay to the Secretary a fee 
     determined under paragraph (2). Such fee shall be in addition 
     to any fee required to be submitted by the sponsor under 
     chapter VII.
       ``(2) Fee amount.--The amount of the priority review user 
     fee shall be determined each fiscal year by the Secretary and 
     based on the anticipated costs to the Secretary of 
     implementing this section.
       ``(3) Annual fee setting.--The Secretary shall establish, 
     before the beginning of each fiscal year beginning after 
     September 30, 2007, for that fiscal year, the amount of the 
     priority review user fee.
       ``(4) Payment.--
       ``(A) In general.--The fee required by this subsection 
     shall be due upon the filing of the new drug application 
     under section 505(b)(1) for which the voucher is used.
       ``(B) Complete application.--An application described under 
     subparagraph (A) for which the sponsor requests the use of a 
     priority review voucher shall be considered incomplete if the 
     fee required by this subsection is not included in such 
     application.
       ``(5) Offsetting collections.--Fees collected pursuant to 
     this subsection for any fiscal year--
       ``(A) shall be deposited and credited as offsetting 
     collections to the account providing appropriations to the 
     Food and Drug Administration; and
       ``(B) shall not be collected for any fiscal year except to 
     the extent provided in advance in appropriation Acts.''.

     SEC. 506. CITIZENS PETITIONS AND PETITIONS FOR STAY OF AGENCY 
                   ACTION.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by this Act, is amended by adding at 
     the end the following:
       ``(s) Citizen Petitions and Petitions for Stay of Agency 
     Action.--
       ``(1) In general.--
       ``(A) No delay of consideration or approval.--
       ``(i) In general.--With respect to a pending application 
     submitted under subsection (b)(2) or (j), if a petition is 
     submitted to the Secretary that seeks to have the Secretary 
     take, or refrain from taking, any form of action relating to 
     the approval of the application, including a delay in the 
     effective date of the application, clauses (ii) and (iii) 
     shall apply.
       ``(ii) No delay of consideration or approval.--Except as 
     provided in clause (iii), the receipt and consideration of a 
     petition described in clause (i) shall not delay 
     consideration or approval of an application submitted under 
     subsection (b)(2) or (j).
       ``(iii) No delay of approval without determination.--The 
     Secretary shall not delay approval of an application 
     submitted under subsection (b)(2) or (j) while a petition 
     described in clause (i) is reviewed and considered unless the 
     Secretary determines, not later than 25 business days after 
     the submission of the petition, that a delay is necessary to 
     protect the public health.
       ``(B) Determination of delay.--With respect to a 
     determination by the Secretary under subparagraph (A)(iii) 
     that a delay is necessary to protect the public health the 
     following shall apply:
       ``(i) Not later than 5 days after making such 
     determination, the Secretary shall publish on the Internet 
     website of the Food and Drug Administration a detailed 
     statement providing the reasons underlying the determination. 
     The detailed statement shall include a summary of the 
     petition and comments and supplements, the specific 
     substantive issues that the petition raises which need to be 
     considered prior to approving a pending application submitted 
     under subsection (b)(2) or (j), and any clarifications and 
     additional data that is needed by the Secretary to promptly 
     review the petition.
       ``(ii) Not later than 10 days after making such 
     determination, the Secretary shall provide notice to the 
     sponsor of the pending application submitted under subsection 
     (b)(2) or (j) and provide an opportunity for a meeting with 
     appropriate staff as determined by the Commissioner to 
     discuss the determination.
       ``(2) Timing of final agency action on petitions.--
       ``(A) In general.--Notwithstanding a determination made by 
     the Secretary under paragraph (1)(A)(iii), the Secretary 
     shall take final agency action with respect to a petition not 
     later than 180 days of submission of that petition unless the 
     Secretary determines, prior to the date that is 180 days 
     after the date of submission of the petition, that a delay is 
     necessary to protect the public health.
       ``(B) Determination of delay.--With respect to a 
     determination by the Secretary under subparagraph (A) that a 
     delay is necessary to protect the public health the following 
     shall apply:
       ``(i) Not later than 5 days after making the determination 
     under subparagraph (A), the Secretary shall publish on the 
     Internet website of the Food and Drug Administration a 
     detailed statement providing the reasons underlying the 
     determination. The detailed statement should include the 
     state of the review of the petition, the specific outstanding 
     issues that still need to be resolved, a proposed timeframe 
     to resolve the issues, and any additional information that 
     has been requested by the Secretary of the petitioner or 
     needed by the Secretary in order to resolve the petition and 
     not further delay an application filed under subsection 
     (b)(2) or (j).
       ``(ii) Not later than 10 days after making the 
     determination under subparagraph (A), the Secretary shall 
     provide notice to the sponsor of the pending application 
     submitted under subsection (b)(2) or (j) and provide an 
     opportunity for a meeting with appropriate staff as 
     determined by the Commissioner to discuss the determination.
       ``(3) Verifications.--
       ``(A) Petitions for review.--The Secretary shall not accept 
     a petition for review unless it is signed and contains the 
     following verification: `I certify that, to my best knowledge 
     and belief: (a) this petition includes all information and 
     views upon which the petition relies; (b) this petition 
     includes representative data and/or information

[[Page 11709]]

     known to the petitioner which are unfavorable to the 
     petition; and (c) information upon which I have based the 
     action requested herein first became known to the party on 
     whose behalf this petition is filed on or about __________. I 
     received or expect to receive payments, including cash and 
     other forms of consideration, from the following persons or 
     organizations to file this petition: ________. I verify under 
     penalty of perjury that the foregoing is true and correct.', 
     with the date of the filing of such petition and the 
     signature of the petitioner inserted in the first and second 
     blank space, respectively.
       ``(B) Supplemental information.--The Secretary shall not 
     accept for review any supplemental information or comments on 
     a petition unless the party submitting such information or 
     comments does so in written form and that the subject 
     document is signed and contains the following verification: 
     `I certify that, to my best knowledge and belief: (a) I have 
     not intentionally delayed submission of this document or its 
     contents; and (b) the information upon which I have based the 
     action requested herein first became known to me on or about 
     __________. I received or expect to receive payments, 
     including cash and other forms of consideration, from the 
     following persons or organizations to submit this information 
     or its contents: _____. I verify under penalty of perjury 
     that the foregoing is true and correct.', with the date of 
     the submission of such document and the signature of the 
     petitioner inserted in the first and second blank space, 
     respectively.
       ``(4) Annual report on delays in approvals per petition.--
     The Secretary shall annually submit to the Congress a report 
     that specifies--
       ``(A) the number of applications under subsection (b)(2) 
     and (j) that were approved during the preceding 1-year 
     period;
       ``(B) the number of petitions that were submitted during 
     such period;
       ``(C) the number of applications whose effective dates were 
     delayed by petitions during such period and the number of 
     days by which the applications were so delayed; and
       ``(D) the number of petitions that were filed under this 
     subsection that were deemed by the Secretary under paragraph 
     (1)(A)(iii) to require delaying an application under 
     subsection (b)(2) or (j) and the number of days by which the 
     applications were so delayed.
       ``(5) Exception.--This subsection does not apply to a 
     petition that is made by the sponsor of the application under 
     subsection (b)(2) or (j) and that seeks only to have the 
     Secretary take or refrain from taking any form of action with 
     respect to that application.
       ``(6) Report by inspector general.--The Office of Inspector 
     General of the Department of Health and Human Services shall 
     issue a report not later than 2 years after the date of 
     enactment of this subsection evaluating evidence of the 
     compliance of the Food and Drug Administration with the 
     requirement that the consideration by the Secretary of 
     petitions that do not raise public health concerns remain 
     separate and apart from the review and approval of an 
     application submitted under subsection (b)(2) or (j).
       ``(7) Definition.--For purposes of this subsection, the 
     term `petition' includes any request for an action described 
     in paragraph (1)(A)(i) to the Secretary, without regard to 
     whether the request is characterized as a petition.''.

     SEC. 507. PUBLICATION OF ANNUAL REPORTS.

       (a) In General.--The Commissioner on Food and Drugs shall 
     annually submit to Congress and publish on the Internet 
     website of the Food and Drug Administration, a report 
     concerning the results of the Administration's pesticide 
     residue monitoring program, that includes--
       (1) information and analysis similar to that contained in 
     the report entitled ``Food and Drug Administration Pesticide 
     Program Residue Monitoring 2003'' as released in June of 
     2005;
       (2) based on an analysis of previous samples, an 
     identification of products or countries (for imports) that 
     require special attention and additional study based on a 
     comparison with equivalent products manufactured, 
     distributed, or sold in the United States (including details 
     on the plans for such additional studies), including in the 
     initial report (and subsequent reports as determined 
     necessary) the results and analysis of the Ginseng Dietary 
     Supplements Special Survey as described on page 13 of the 
     report entitled ``Food and Drug Administration Pesticide 
     Program Residue Monitoring 2003'';
       (3) information on the relative number of interstate and 
     imported shipments of each tested commodity that were 
     sampled, including recommendations on whether sampling is 
     statistically significant, provides confidence intervals or 
     other related statistical information, and whether the number 
     of samples should be increased and the details of any plans 
     to provide for such increase; and
       (4) a description of whether certain commodities are being 
     improperly imported as another commodity, including a 
     description of additional steps that are being planned to 
     prevent such smuggling.
       (b) Initial Reports.--Annual reports under subsection (a) 
     for fiscal years 2004 through 2006 may be combined into a 
     single report, by not later than June 1, 2008, for purposes 
     of publication under subsection (a). Thereafter such reports 
     shall be completed by June 1 of each year for the data 
     collected for the year that was 2-years prior to the year in 
     which the report is published.
       (c) Memorandum of Understanding.--The Commissioner of Food 
     and Drugs, the Administrator of the Food Safety and 
     Inspection Service, the Department of Commerce, and the head 
     of the Agricultural Marketing Service shall enter into a 
     memorandum of understanding to permit inclusion of data in 
     the reports under subsection (a) relating to testing carried 
     out by the Food Safety and Inspection Service and the 
     Agricultural Marketing Service on meat, poultry, eggs, and 
     certain raw agricultural products, respectively.

     SEC. 508. HEAD START ACT AMENDMENT IMPOSING PARENTAL CONSENT 
                   REQUIREMENT FOR NONEMERGENCY INTRUSIVE PHYSICAL 
                   EXAMINATIONS.

       The Head Start Act (42 U.S.C. 9831 et seq.) is amended by 
     adding at the end the following:

     ``SEC. 657A. PARENTAL CONSENT REQUIREMENT FOR NONEMERGENCY 
                   INTRUSIVE PHYSICAL EXAMINATIONS.

       ``(a) In General.--A Head Start agency shall obtain written 
     parental consent before administration of any nonemergency 
     intrusive physical examination of a child in connection with 
     participation in a program under this subchapter.
       ``(b) Definition.--The term `nonemergency intrusive 
     physical examination' means, with respect to a child, a 
     physical examination that--
       ``(1) is not immediately necessary to protect the health or 
     safety of the child involved or the health or safety of 
     another individual; and
       ``(2) requires incision or is otherwise invasive, or 
     involves exposure of private body parts.
       ``(c) Rule of Construction.--Nothing in this section shall 
     be construed to prohibit agencies from using established 
     methods, for handling cases of suspected or known child abuse 
     and neglect, that are in compliance with applicable Federal, 
     State, or tribal law.''.

     SEC. 509. SAFETY OF FOOD ADDITIVES.

       Not later than 90 days after the date of enactment of this 
     Act, the Food and Drug Administration shall issue a report on 
     the question of whether substances used to preserve the 
     appearance of fresh meat may create any health risks, or 
     mislead consumers.

     SEC. 510. IMPROVING GENETIC TEST SAFETY AND QUALITY.

       Not later than 30 days after the date of enactment of this 
     Act, the Secretary shall enter into a contract with the 
     Institute of Medicine to conduct a study to assess the 
     overall safety and quality of genetic tests and prepare a 
     report that includes recommendations to improve Federal 
     oversight and regulation of genetic tests. Such study shall 
     take into consideration relevant reports by the Secretary's 
     Advisory Committee on Genetic Testing and other groups and 
     shall be completed not later than 1 year after the date on 
     which the Secretary entered into such contract.

     SEC. 511. ORPHAN DISEASE TREATMENT IN CHILDREN.

       (a) Finding.--The Senate finds that parents of children 
     suffering from rare genetic diseases known as orphan diseases 
     face multiple obstacles in obtaining safe and effective 
     treatment for their children due mainly to the fact that many 
     Food and Drug Administration-approved drugs used in the 
     treatment of orphan diseases in children may not be approved 
     for pediatric indications.
       (b) Sense of the Senate.--It is the sense of the Senate 
     that the Food and Drug Administration should enter into a 
     contract with the Institute of Medicine for the conduct of a 
     study concerning measures that may be taken to improve the 
     likelihood that Food and Drug Administration-approved drugs 
     that are safe and effective in treating children with orphan 
     diseases are made available and affordable for pediatric 
     indications.

     SEC. 512. COLOR CERTIFICATION REPORTS.

       Section 721 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379e) is amended by adding at the end the following:
       ``(g) Color Certification Reports.--Not later than--
       ``(1) 90 days after the close of a fiscal year in which 
     color certification fees are collected, the Secretary shall 
     submit to Congress a performance report for such fiscal year 
     on the number of batches of color additives approved, the 
     average turn around time for approval, and quantifiable goals 
     for improving laboratory efficiencies; and
       ``(2) 120 days after the close of a fiscal year in which 
     color certification fees are collected, the Secretary shall 
     submit to Congress a financial report for such fiscal year 
     that includes all fees and expenses of the color 
     certification program, the balance remaining in the fund at 
     the end of the fiscal year, and anticipated costs during the 
     next fiscal year for equipment needs and laboratory 
     improvements of such program.''.

     SEC. 513. PROHIBITION ON IMPORTATION FROM A FOREIGN FOOD 
                   FACILITY THAT DENIES ACCESS TO FOOD INSPECTORS.

       Notwithstanding any other provision of law, no food product 
     may be imported into

[[Page 11710]]

     the United States that is the product of a foreign facility 
     registered under section 415 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 350d) that refuses to permit United 
     States inspectors, upon request, to inspect such facility or 
     that unduly delays access to United States inspectors.

     SEC. 514. COUNTERFEIT-RESISTANT TECHNOLOGIES.

       Notwithstanding any other provision of this Act, the 
     requirement that the Secretary of Health and Human Services 
     certify that the implementation of the title of this Act 
     relating to the Importation of Prescription Drugs will pose 
     no additional risk to the public's health and safety and will 
     result in a significant reduction in the cost of covered 
     products to the American consumer shall not apply to the 
     requirement that the Secretary require that the packaging of 
     any prescription drug incorporates--
       (1) not later than 18 months after the date of enactment of 
     this Act, a standardized numerical identifier (which, to the 
     extent practicable, shall be harmonized with international 
     consensus standards for such an identifier) unique to each 
     package of such drug, applied at the point of manufacturing 
     and repackaging (in which case the numerical identifier shall 
     be linked to the numerical identifier applied at the point of 
     manufacturing); and
       (2) not later than 24 months after the date of enactment of 
     this Act for the 50 prescription drugs with the highest 
     dollar volume of sales in the United States, based on the 
     calendar year that ends of December 31, 2007, and, not later 
     than 30 months after the date of enactment of this Act for 
     all other prescription drugs--
       (A) overt optically variable counterfeit-resistant 
     technologies that--
       (i) are visible to the naked eye, providing for visual 
     identification of product authenticity without the need for 
     readers, microscopes, lighting devices, or scanners;
       (ii) are similar to that used by the Bureau of Engraving 
     and Printing to secure United States currency;
       (iii) are manufactured and distributed in a highly secure, 
     tightly controlled environment; and
       (iv) incorporate additional layers of nonvisible convert 
     security features up to and including forensic capability; or
       (B) technologies that have a function of security 
     comparable to that described in subparagraph (A), as 
     determined by the Secretary.

     SEC. 515. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.

       (a) Findings.--Congress finds the following:
       (1) In 2007, there has been an overwhelming increase in the 
     volume of aquaculture and seafood that has been found to 
     contain substances that are not approved for use in food in 
     the United States.
       (2) As of May 2007, inspection programs are not able to 
     satisfactorily accomplish the goals of ensuring the food 
     safety of the United States.
       (3) To protect the health and safety of consumers in the 
     United States, the ability of the Secretary of Health and 
     Human Services to perform inspection functions must be 
     enhanced.
       (b) Heightened Inspections.--The Secretary of Health and 
     Human Services (referred to in this section as the 
     ``Secretary'') is authorized to, by regulation, enhance, as 
     necessary, the inspection regime of the Food and Drug 
     Administration for aquaculture and seafood, consistent with 
     obligations of the United States under international 
     agreements and United States law.
       (c) Report to Congress.--Not later than 90 days after the 
     date of enactment of this Act, the Secretary shall submit to 
     Congress a report that--
       (1) describes the specifics of the aquaculture and seafood 
     inspection program;
       (2) describes the feasibility of developing a traceability 
     system for all catfish and seafood products, both domestic 
     and imported, for the purpose of identifying the processing 
     plant of origin of such products; and
       (3) provides for an assessment of the risks associated with 
     particular contaminants and banned substances.
       (d) Partnerships With States.--Upon the request by any 
     State, the Secretary may enter into partnership agreements, 
     as soon as practicable after the request is made, to 
     implement inspection programs regarding the importation of 
     aquaculture and seafood.
       (e) Authorization of Appropriations.--There are authorized 
     to be appropriated such sums as may be necessary to carry out 
     this section.

     SEC. 516. SENSE OF THE SENATE REGARDING CERTAIN PATENT 
                   INFRINGEMENTS.

       (a) Findings.--The Senate makes the following findings:
       (1) Innovation in developing life-saving prescription drugs 
     saves millions of lives around the world each year.
       (2) The responsible protection of intellectual property is 
     vital to the continued development of new and life-saving 
     drugs and future growth of the United States economy.
       (3) In order to maintain the global competitiveness of the 
     United States, the United States Trade Representative's 
     Office of Intellectual Property and Innovation develops and 
     implements trade policy in support of vital American 
     innovations, including innovation in the pharmaceutical and 
     medical technology industries.
       (4) The United States Trade Representative also provides 
     trade policy leadership and expertise across the full range 
     of interagency initiatives to enhance protection and 
     enforcement of intellectual property rights.
       (5) Strong and fair intellectual property protection, 
     including patent, copyright, trademark, and data protection 
     plays an integral role in fostering economic growth and 
     development and ensuring patient access to the most effective 
     medicines around the world.
       (6) There are concerns that certain countries have engaged 
     in unfair price manipulation and abuse of compulsory 
     licensing. Americans bear the majority of research and 
     development costs for the world, which could undermine the 
     value of existing United States pharmaceutical patents and 
     could impede access to important therapies.
       (7) There is a growing global threat of counterfeit 
     medicines and increased need for the United States Trade 
     Representative and other United States agencies to use 
     available trade policy measures to strengthen laws and 
     enforcement abroad to prevent harm to United States patients 
     and patients around the world.
       (b) Sense of the Senate.--It is the sense of the Senate 
     that--
       (1) the United States Trade Representative should use all 
     the tools at the disposal of the Trade Representative to 
     address violations and other concerns with intellectual 
     property, including through--
       (A) bilateral engagement with United States trading 
     partners;
       (B) transparency and balance of the annual ``Special 301'' 
     review and reviews of compliance with the intellectual 
     property requirements of countries with respect to which the 
     United States grants trade preferences;
       (C) negotiation of responsible and fair intellectual 
     property provisions as part of bilateral and regional trade 
     agreements; and
       (D) multilateral engagement through the World Trade 
     Organization (WTO); and
       (2) the United States Trade Representative should develop 
     and submit to Congress a strategic plan to address the 
     problem of countries that infringe upon American 
     pharmaceutical intellectual property rights and the problem 
     of countries that engage in price manipulation.

     SEC. 517. CONSULTATION REGARDING GENETICALLY ENGINEERED 
                   SEAFOOD PRODUCTS.

       The Commissioner of Food and Drugs shall consult with the 
     Assistant Administrator of the National Marine Fisheries 
     Service of the National Oceanic and Atmospheric 
     Administration to produce a report on any environmental risks 
     associated with genetically engineered seafood products, 
     including the impact on wild fish stocks.

     SEC. 518. REPORT ON THE MARKETING OF CERTAIN CRUSTACEANS.

       Not later than 30 days after the date of enactment of this 
     Act, the Secretary of Health and Human Services, in 
     consultation with the Secretary of Commerce, shall submit to 
     the Health, Education, Labor, and Pensions Committee and the 
     Committee on Commerce, Science, and Transportation of the 
     Senate, a report on the differences between taxonomy of 
     species of lobster in the subfamily Nephropinae, and species 
     of langostino, specifically from the infraorder Caridea or 
     Anomura. This report shall also describe the differences in 
     consumer perception of such species, including such factors 
     as taste, quality, and value of the species.

     SEC. 519. CIVIL PENALTIES; DIRECT-TO-CONSUMER ADVERTISEMENT.

       (a) Civil Penalties.--Section 303 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding 
     at the end the following:
       ``(g)(1) Any applicant (as such term is used in section 
     505(o)) who disseminates a direct-to-consumer advertisement 
     for a prescription drug that is false or misleading and a 
     violation of section 502(n) shall be liable to the United 
     States for a civil penalty in an amount not to exceed 
     $150,000 for the first such violation in any 3-year period, 
     and not to exceed $300,000 for each subsequent violation 
     committed after the applicant has been penalized under this 
     paragraph any time in the preceding 3-year period. For the 
     purposes of this paragraph, repeated dissemination of the 
     same or similar advertisement prior to the receipt of the 
     written notice referred to in paragraph (2) for such 
     advertisements shall be considered as 1 violation.
       ``(2) A civil penalty under paragraph (1) shall be assessed 
     by the Secretary by an order made on the record after 
     providing written notice to the applicant to be assessed a 
     civil penalty and an opportunity for a hearing in accordance 
     with this paragraph and section 554 of title 5, United States 
     Code. If upon receipt of the written notice, the applicant to 
     be assessed a civil penalty objects and requests a hearing, 
     then in the course of any investigation related to such 
     hearing, the Secretary may issue subpoenas requiring the 
     attendance and testimony of witnesses and the production of 
     evidence that relates to the matter under investigation, 
     including information pertaining to the factors described in 
     paragraph (3).
       ``(3) Upon the request of the applicant to be assessed a 
     civil penalty, the Secretary, in determining the amount of a 
     civil penalty,

[[Page 11711]]

     shall take into account the nature, circumstances, extent, 
     and gravity of the violation or violations, including the 
     following factors:
       ``(A) Whether the applicant submitted the advertisement or 
     a similar advertisement for review under section 736A.
       ``(B) Whether the applicant submitted the advertisement for 
     prereview if required under section 505(o)(5)(D).
       ``(C) Whether, after submission of the advertisement as 
     described in subparagraph (A) or (B), the applicant 
     disseminated the advertisement before the end of the 45-day 
     comment period.
       ``(D) Whether the applicant failed to incorporate any 
     comments made by the Secretary with regard to the 
     advertisement or a similar advertisement into the 
     advertisement prior to its dissemination.
       ``(E) Whether the applicant ceased distribution of the 
     advertisement upon receipt of the written notice referred to 
     in paragraph (2) for such advertisement.
       ``(F) Whether the applicant had the advertisement reviewed 
     by qualified medical, regulatory, and legal reviewers prior 
     to its dissemination.
       ``(G) Whether the violations were material.
       ``(H) Whether the applicant who created the advertisement 
     acted in good faith.
       ``(I) Whether the applicant who created the advertisement 
     has been assessed a civil penalty under this provision within 
     the previous 1-year period.
       ``(J) The scope and extent of any voluntary, subsequent 
     remedial action by the applicant.
       ``(K) Such other matters, as justice may require.
       ``(4)(A) Subject to subparagraph (B), no applicant shall be 
     required to pay a civil penalty under paragraph (1) if the 
     applicant submitted the advertisement to the Secretary and 
     disseminated such advertisement after incorporating any 
     comment received from the Secretary.
       ``(B) The Secretary may retract or modify any prior 
     comments the Secretary has provided to an advertisement 
     submitted to the Secretary based on new information or 
     changed circumstances, so long as the Secretary provides 
     written notice to the applicant of the new views of the 
     Secretary on the advertisement and provides a reasonable time 
     for modification or correction of the advertisement prior to 
     seeking any civil penalty under paragraph (1).
       ``(5) The Secretary may compromise, modify, remit, with or 
     without conditions, any civil penalty which may be assessed 
     under paragraph (1). The amount of such penalty, when finally 
     determined, or the amount charged upon in compromise, may be 
     deducted from any sums owned by the United States to the 
     applicant charged.
       ``(6) Any applicant who requested, in accordance with 
     paragraph (2), a hearing with respect to the assessment of a 
     civil penalty and who is aggrieved by an order assessing a 
     civil penalty, may file a petition for de novo judicial 
     review of such order with the United States Court of Appeals 
     for the District of Columbia Circuit or for any other circuit 
     in which such applicant resides or transacts business. Such a 
     petition may only be filed within the 60-day period beginning 
     on the date the order making such assessments was issued.
       ``(7) If any applicant fails to pay an assessment of a 
     civil penalty--
       ``(A) after the order making the assessment becomes final, 
     and if such applicant does not file a petition for judicial 
     review of the order in accordance with paragraph (6); or
       ``(B) after a court in an action brought under paragraph 
     (6) has entered a final judgment in favor of the Secretary,
     the Attorney General shall recover the amount assessed (plus 
     interest at currently prevailing rates from the date of the 
     expiration of the 60-day period referred to in paragraph (6) 
     or date of such final judgment, as the case may be) in an 
     action brought in any appropriate district court of the 
     United States. In such an action, the validity, amount, and 
     appropriateness of such penalty shall not be subject to 
     review.''.
       (b) Direct-to-Consumer Advertisement.--
       (1) In general.--Section 502(n) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352(n)) is amended by inserting 
     after the first sentence the following: ``In the case of an 
     advertisement for a prescription drug presented directly to 
     consumers in television or radio format that states the name 
     of the drug and its conditions of use, the major statement 
     relating to side effects, contraindications, and 
     effectiveness referred to in the previous sentence shall be 
     stated in a clear and conspicuous (neutral) manner.''.
       (2) Regulations to determine neutral manner.--The Secretary 
     of Health and Human Services shall by regulation establish 
     standards for determining whether a major statement, relating 
     to side effects, contraindications, and effectiveness of a 
     drug, described in section 502(n) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352(n)) (as amended by paragraph 
     (1)) is presented in the manner required under such section.

     SEC. 520. REPORT BY THE FOOD AND DRUG ADMINISTRATION 
                   REGARDING LABELING INFORMATION ON THE 
                   RELATIONSHIP BETWEEN THE USE OF INDOOR TANNING 
                   DEVICES AND DEVELOPMENT OF SKIN CANCER OR OTHER 
                   SKIN DAMAGE.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary''), acting 
     through the Commissioner of Food and Drugs, shall determine--
       (1) whether the labeling requirements for indoor tanning 
     devices, including the positioning requirements, provide 
     sufficient information to consumers regarding the risks that 
     the use of such devices pose for the development of 
     irreversible damage to the eyes and skin, including skin 
     cancer; and
       (2)(A) whether modifying the warning label required on 
     tanning beds to read, ``Ultraviolet radiation can cause skin 
     cancer'', or any other additional warning, would communicate 
     the risks of indoor tanning more effectively; or
       (B) whether there is no warning that would be capable of 
     adequately communicating such risks.
       (b) Consumer Testing.--In making the determinations under 
     subsection (a), the Secretary shall conduct appropriate 
     consumer testing, using the best available methods for 
     determining consumer understanding of label warnings.
       (c) Public Hearings; Public Comment.--The Secretary shall 
     hold public hearings and solicit comments from the public in 
     making the determinations under subsection (a).
       (d) Report.--Not later than 1 year after the date of the 
     enactment of this Act, the Secretary shall submit to the 
     Congress a report that provides the determinations under 
     subsection (a). In addition, the Secretary shall include in 
     the report the measures being implemented by the Secretary to 
     significantly reduce the risks associated with indoor tanning 
     devices.

                         TITLE VI--FOOD SAFETY

     SEC. 601. FINDINGS.

       (a) Findings.--Congress finds that--
       (1) the safety and integrity of the United States food 
     supply is vital to the public health, to public confidence in 
     the food supply, and to the success of the food sector of the 
     Nation's economy;
       (2) illnesses and deaths of individuals and companion 
     animals caused by contaminated food--
       (A) have contributed to a loss of public confidence in food 
     safety; and
       (B) have caused significant economic losses to 
     manufacturers and producers not responsible for contaminated 
     food items;
       (3) the task of preserving the safety of the food supply of 
     the United States faces tremendous pressures with regard to--
       (A) emerging pathogens and other contaminants and the 
     ability to detect all forms of contamination; and
       (B) an increasing volume of imported food from a wide 
     variety of countries; and
       (C) a shortage of adequate resources for monitoring and 
     inspection;
       (4) the United States is increasing the amount of food that 
     it imports such that--
       (A) from 2003 to the present, the value of food imports has 
     increased from $45,600,000,000 to $64,000,000,000; and
       (B) imported food accounts for 13 percent of the average 
     Americans diet including 31 percent of fruits, juices, and 
     nuts, 9.5 percent of red meat and 78.6 percent of fish and 
     shellfish; and
       (5) the number of full time equivalent Food and Drug 
     Administration employees conducting inspections has decreased 
     from 2003 to 2007.

     SEC. 602. ENSURING THE SAFETY OF PET FOOD.

       (a) Processing and Ingredient Standards.--Not later than 18 
     months after the date of enactment of this Act, the Secretary 
     of Health and Human Services (referred to in this title as 
     the ``Secretary''), in consultation with the Association of 
     American Feed Control Officials, and other relevant 
     stakeholder groups, including veterinary medical 
     associations, animal health organizations, and pet food 
     manufacturers, shall by regulation establish--
       (1) processing and ingredient standards with respect to pet 
     food, animal waste, and ingredient definitions; and
       (2) updated standards for the labeling of pet food that 
     includes nutritional information and ingredient information.
       (b) Early Warning Surveillance Systems and Notification 
     During Pet Food Recalls.--Not later than 180 days after the 
     date of enactment of this Act, the Secretary shall by 
     regulation establish an early warning and surveillance system 
     to identify adulteration of the pet food supply and outbreaks 
     of illness associated with pet food. In establishing such 
     system, the Secretary shall--
       (1) use surveillance and monitoring mechanisms similar to, 
     or in coordination with, those mechanisms used by the Centers 
     for Disease Control and Prevention to monitor human health, 
     such as the Foodborne Diseases Active Surveillance Network 
     (FoodNet) and PulseNet;
       (2) consult with relevant professional associations and 
     private sector veterinary hospitals; and
       (3) work with the Health Alert Network and other 
     notification networks to inform veterinarians and relevant 
     stakeholders during any recall of pet food.

[[Page 11712]]



     SEC. 603. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS 
                   DURING A RECALL.

       The Secretary shall, during an ongoing recall of human or 
     pet food--
       (1) work with companies, relevant professional 
     associations, and other organizations to collect and 
     aggregate information pertaining to the recall;
       (2) use existing networks of communication including 
     electronic forms of information dissemination to enhance the 
     quality and speed of communication with the public; and
       (3) post information regarding recalled products on the 
     Internet website of the Food and Drug Administration in a 
     consolidated, searchable form that is easily accessed and 
     understood by the public.

     SEC. 604. STATE AND FEDERAL COOPERATION.

       (a) In General.--The Secretary shall work with the States 
     in undertaking activities and programs that assist in 
     improving the safety of fresh and processed produce so that 
     State food safety programs involving the safety of fresh and 
     processed produce and activities conducted by the Secretaries 
     function in a coordinated and cost-effective manner. With the 
     assistance provided under subsection (b), the Secretary shall 
     encourage States to--
       (1) establish, continue, or strengthen State food safety 
     programs, especially with respect to the regulation of retail 
     commercial food establishments; and
       (2) establish procedures and requirements for ensuring that 
     processed produce under the jurisdiction of the State food 
     safety programs is not unsafe for human consumption.
       (b) Assistance.--The Secretary may provide to a State, for 
     planning, developing, and implementing such a food safety 
     program--
       (1) advisory assistance;
       (2) technical assistance, training, and laboratory 
     assistance (including necessary materials and equipment); and
       (3) financial and other assistance.
       (c) Service Agreements.--The Secretary may, under an 
     agreement entered into with a Federal, State, or local 
     agency, use, on a reimbursable basis or otherwise, the 
     personnel, services, and facilities of the agency to carry 
     out the responsibilities of the agency under this section. An 
     agreement entered into with a State agency under this 
     subsection may provide for training of State employees.

     SEC. 605. ADULTERATED FOOD REGISTRY.

       (a) Findings.--Congress makes the following findings:
       (1) In 1994, Congress passed the Dietary Supplement Health 
     and Education Act (P.L. 103-417) to provide the Food and Drug 
     Administration with the legal framework to ensure that 
     dietary supplements are safe and properly labeled foods.
       (2) In 2006, Congress passed the Dietary Supplement and 
     Nonprescription Drug Consumer Protection Act (P.L. 109-462) 
     to establish a mandatory reporting system of serious adverse 
     events for non-prescription drugs and dietary supplements 
     sold and consumed in the United States.
       (3) The adverse event reporting system created under the 
     Dietary Supplement and Nonprescription Drug Consumer 
     Protection Act will serve as the early warning system for any 
     potential public health issues associated with the use of 
     these food products.
       (4) A reliable mechanism to track patterns of adulteration 
     in food would support efforts by the Food and Drug 
     Administration to effectively target limited inspection 
     resources to protect the public health.
       (b) In General.--Chapter IV of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 417. ADULTERATED FOOD REGISTRY.

       ``(a) Definitions.--In this section:
       ``(1) Importer.--The term `importer', with respect to an 
     article of food, means the person who submitted the notice 
     with respect to such article of food under section 801(m).
       ``(2) Responsible party.--The term `responsible party', 
     with respect to an article of food, means any registered food 
     facility under section 415(a), including those responsible 
     for the manufacturing, processing, packaging or holding of 
     such food for consumption in the United States.
       ``(3) Reportable adulterated food.--The term `reportable 
     adulterated food' for purposes of this section means a food 
     that is adulterated or--
       ``(A) presents a situation in which there is a reasonable 
     probability that the use of, or exposure to, a violative 
     product will cause serious adverse health consequences or 
     death as defined in section 7.3(m)(1) of title, Code of 
     Federal Regulations (or any successor regulations); or
       ``(B) meets the threshold established in section 304(h).
       ``(b) Establishment.--
       ``(1) In general.--Not later than 180 days after the date 
     of enactment of this section, the Secretary shall establish 
     within the Food and Drug Administration an Adulterated Food 
     Registry to which instances of reportable adulterated food 
     may be submitted by the Food and Drug Administration after 
     receipt of reports of adulteration, via an electronic portal, 
     from--
       ``(A) Federal, State, and local public health officials;
       ``(B) an importer;
       ``(C) a responsible party; or
       ``(D) a consumer or other individual.
       ``(2) Review by secretary.--The Secretary shall review and 
     determine the validity of the information submitted under 
     paragraph (1) for the purposes of identifying adulterated 
     food, submitting entries to the Adulterated Food Registry, 
     acting under subsection (c), and exercising other existing 
     food safety authorities under the Act to protect the public 
     health.
       ``(c) Issuance of an Alert by the Secretary.--
       ``(1) In general.--The Secretary shall issue an alert with 
     respect to an adulterated food if the Adulterated Food 
     Registry shows that the food--
       ``(A) has been associated with repeated and separate 
     outbreaks of illness or has been repeatedly determined to be 
     adulterated; or
       ``(B) is a reportable adulterated food.
       ``(2) Scope of alert.--An alert under paragraph (1) may 
     apply to a particular food or to food from a particular 
     producer, manufacturer, shipper, growing area, or country, to 
     the extent that elements in subparagraph (A) or (B) of 
     paragraph (1) are associated with the particular food, 
     producer, manufacturer, shipper, growing area, or country.
       ``(d) Submission by a Consumer or Other Individual.--A 
     consumer or other individual may submit a report to the Food 
     and Drug Administration using the electronic portal data 
     elements described in subsection (e). Such reports shall be 
     evaluated by the Secretary as specified in subsection (b)(2).
       ``(e) Notification and Reporting of Adulteration.--
       ``(1) Determination by responsible party or importer.--If a 
     responsible party or importer determines that an article of 
     food it produced, processed, manufactured, distributed, or 
     otherwise handled is a reportable adulterated food, the 
     responsible party shall provide the notifications described 
     under paragraph (2).
       ``(2) Notification of adulteration.--
       ``(A) In general.--Not later than 5 days after a 
     responsible party or importer receives a notification, the 
     responsible party or importer, as applicable, shall review 
     whether the food referenced in the report described in 
     paragraph (1) is a reportable adulterated food.
       ``(B) Notification.--If a determination is made by such 
     responsible party or importer that the food is a reportable 
     adulterated food, such responsible party or importer shall, 
     no later than 2 days after such determination is made, notify 
     other responsible parties directly linked in the supply chain 
     to which and from which the article of reportable adulterated 
     food was transferred.
       ``(3) Submission of reports to the food and drug 
     administration by a responsible party or importer.--The 
     responsible party or importer, as applicable, shall submit a 
     report to the Food and Drug Administration through the 
     electronic portal using the data elements described in 
     subsection (f) not later than 2 days after a responsible 
     party or importer--
       ``(A) makes a notification under paragraph (2)(B); or
       ``(B) determines that an article of food it produced, 
     processed, manufactured, distributed, imported, or otherwise 
     handled is a reportable adulterated food, except that if such 
     adulteration was initiated with such responsible party or 
     importer, was detected prior to any transfer of such article 
     of food, and was destroyed, no report is necessary.
       ``(f) Data Elements in the Registry.--A report submitted to 
     the Food and Drug Administration electronic portal under 
     subsection (e) shall include the following data elements:
       ``(1) Contact information for the individual or entity 
     submitting the report.
       ``(2) The date on which an article of food was determined 
     to be adulterated or suspected of being adulterated.
       ``(3) A description of the article of food including the 
     quantity or amount.
       ``(4) The extent and nature of the adulteration.
       ``(5) The disposition of the article.
       ``(6) Product information typically found on packaging 
     including product codes, use by dates, and names of 
     manufactures or distributors.
       ``(7) Information about the place of purchase or process by 
     which the consumer or other individual acquired the article 
     of adulterated food.
       ``(8) In the case of a responsible party or an importer, 
     the elements required for the registration of food facilities 
     under section 415(a).
       ``(9) The contact information for parties directly linked 
     in the supply chain and notified under subsection (e)(2).
       ``(10) In the case of an importer, the elements required 
     for the prior notice of imported food shipments under section 
     801(m).
       ``(g) Maintenance and Inspection of Records.--The 
     responsible person or importer shall maintain records related 
     to each report received, notification made, and report 
     submitted to the Food and Drug Administration under this 
     section and permit inspection of such records as provided for 
     in section 414. Such records shall also be made available 
     during an inspection under section 704.

[[Page 11713]]

       ``(h) Request for Information.--Section 552 of title 5, 
     United States Code, shall apply to any request for 
     information regarding a record in the Adulterated Food 
     Registry.
       ``(i) Homeland Security Notification.--If, after receiving 
     a report under subsection (e), the Secretary suspects such 
     food may have been deliberately adulterated, the Secretary 
     shall immediately notify the Secretary of Homeland Security. 
     The Secretary shall make the data in the Adulterated Imported 
     Food Registry available to the Secretary of Homeland 
     Security.''.
       (c) Definition.--Section 201(ff) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking 
     ``section 201(g)'' and inserting ``sections 201(g) and 417''.
       (d) Prohibited Acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331), as amended by this 
     Act, is further amended by adding at the end the following:
       ``(kk) The failure to provide a report as required under 
     section 417(e)(3).
       ``(ll) The falsification a report as required under section 
     417(e)(3).''.
       (e) Suspected Food Adulteration Regulations.--The Secretary 
     shall, within 180 days of enactment of this Act, promulgate 
     regulations that establish standards and thresholds by which 
     importers and responsible parties shall be required and 
     consumers may be able to, under section 417 of the Federal 
     Food, Drug, and Cosmetic Act (as added by this section)--
       (1) report instances of suspected reportable adulteration 
     of food to the Food and Drug Administration for possible 
     inclusion in the Adulterated Food Registry after evaluation 
     of such report; and
       (2) notify, in keeping with subsection (e)(2) of such 
     section 417, other responsible parties directly linked in the 
     supply chain, including establishments as defined in section 
     415(b) of such Act.
       (f) Effective Date.--The requirements of section 417(e) of 
     the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (a), shall become effective 180 days after the 
     date of enactment of this Act.

     SEC. 606. SENSE OF THE SENATE.

       It is the sense of the Senate that--
       (1) it is vital for Congress to provide the Food and Drug 
     Administration with additional resources, authorities, and 
     direction with respect to ensuring the safety of the food 
     supply of the United States;
       (2) additional inspectors are required to improve the Food 
     and Drug Administration's ability to safeguard the food 
     supply of the United States;
       (3) because of the increasing volume of international trade 
     in food products the Secretary of Health and Human Services 
     should make it a priority to enter into agreements with the 
     trading partners of the United States with respect to food 
     safety; and
       (4) the Senate should work to develop a comprehensive 
     response to the issue of food safety.

     SEC. 607. ANNUAL REPORT TO CONGRESS.

       The Secretary shall, on an annual basis, submit to the 
     Committee on Health, Education, Labor, and Pensions and the 
     Committee on Appropriations of the Senate and the Committee 
     on Energy and Commerce and the Committee on Appropriations of 
     the House of Representatives a report that includes, with 
     respect to the preceding 1-year period--
       (1) the number and amount of food products regulated by the 
     Food and Drug Administration imported into the United States, 
     aggregated by country and type of food;
       (2) a listing of the number of Food and Drug Administration 
     inspectors of imported food products referenced in paragraph 
     (1) and the number of Food and Drug Administration 
     inspections performed on such products; and
       (3) aggregated data on the findings of such inspections, 
     including data related to violations of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 201 et seq.), and 
     enforcement actions used to follow-up on such findings and 
     violations.

     SEC. 608. RULE OF CONSTRUCTION.

       Nothing in this title (or an amendment made by this title) 
     shall be construed to affect--
       (1) the regulation of dietary supplements under the Dietary 
     Supplement Health and Education Act; or
       (2) the adverse event reporting system for dietary 
     supplements created under the Dietary Supplement and 
     Nonprescription Drug Consumer Protection Act.

     SEC. 609. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated to carry out this 
     title (and the amendments made by this title) such sums as 
     may be necessary.

              TITLE VII--DOMESTIC PET TURTLE MARKET ACCESS

     SEC. 701. SHORT TITLE.

       This title may be cited as the ``Domestic Pet Turtle Market 
     Access Act of 2007''.

     SEC. 702. FINDINGS.

       Congress makes the following findings:
       (1) Pet turtles less than 10.2 centimeters in diameter have 
     been banned for sale in the United States by the Food and 
     Drug Administration since 1975 due to health concerns.
       (2) The Food and Drug Administration does not ban the sale 
     of iguanas or other lizards, snakes, frogs, or other 
     amphibians or reptiles that are sold as pets in the United 
     States that also carry salmonella bacteria. The Food and Drug 
     Administration also does not require that these animals be 
     treated for salmonella bacteria before being sold as pets.
       (3) The technology to treat turtles for salmonella, and 
     make them safe for sale, has greatly advanced since 1975. 
     Treatments exist that can nearly eradicate salmonella from 
     turtles, and individuals are more aware of the causes of 
     salmonella, how to treat salmonella poisoning, and the 
     seriousness associated with salmonella poisoning.
       (4) University research has shown that these turtles can be 
     treated in such a way that they can be raised, shipped, and 
     distributed without having a recolonization of salmonella.
       (5) University research has also shown that pet owners can 
     be equipped with a treatment regiment that allows the turtle 
     to be maintained safe from salmonella.
       (6) The Food and Drug Administration should allow the sale 
     of turtles less than 10.2 centimeters in diameter as pets as 
     long as the sellers are required to use proven methods to 
     treat these turtles for salmonella.

     SEC. 703. SALE OF BABY TURTLES.

       Notwithstanding any other provision of law, the Food and 
     Drug Administration shall not restrict the sale by a turtle 
     farmer, wholesaler, or commercial retail seller of a turtle 
     that is less than 10.2 centimeters in diameter as a pet if--
       (1) the State or territory in which such farmer is located 
     has developed a regulatory process by which pet turtle 
     farmers are required to have a State license to breed, hatch, 
     propagate, raise, grow, receive, ship, transport, export, or 
     sell pet turtles or pet turtle eggs;
       (2) such State or territory requires certification of 
     sanitization that is signed by a veterinarian who is licensed 
     in the State or territory, and approved by the State or 
     territory agency in charge of regulating the sale of pet 
     turtles;
       (3) the certification of sanitization requires each turtle 
     to be sanitized or treated for diseases, including 
     salmonella, and is dependant upon using the Siebeling method, 
     or other such proven non-antibiotic method, to make the 
     turtle salmonella-free; and
       (4) the turtle farmer or commercial retail seller includes, 
     with the sale of such a turtle, a disclosure to the buyer 
     that includes--
       (A) information regarding--
       (i) the possibility that salmonella can re-colonize in 
     turtles;
       (ii) the dangers, including possible severe illness or 
     death, especially for at-risk people who may be susceptible 
     to salmonella poisoning, such as children, pregnant women, 
     and others who may have weak immune systems, that could 
     result if the turtle is not properly handled and safely 
     maintained;
       (iii) the proper handling of the turtle, including an 
     explanation of proper hygiene such as handwashing after 
     handling a turtle; and
       (iv) the proven methods of treatment that, if properly 
     applied, keep the turtle safe from salmonella;
       (B) a detailed explanation of how to properly treat the 
     turtle to keep it safe from salmonella, using the proven 
     methods of treatment referred to under subparagraph (A), and 
     how the buyer can continue to purchase the tools, treatments, 
     or any other required item to continually treat the turtle; 
     and
       (C) a statement that buyers of pet turtles should not 
     abandon the turtle or abandon it outside, as the turtle may 
     become an invasive species to the local community, but should 
     instead return them to a commercial retail pet seller or 
     other organization that would accept turtles no longer wanted 
     as pets.

     SEC. 704. FDA REVIEW OF STATE PROTECTIONS.

       The Commissioner of Food and Drugs may, after providing an 
     opportunity for the affected State to respond, restrict the 
     sale of a turtle only if the Secretary of Health and Human 
     Services determines that the actual implementation of State 
     health protections described in this title are insufficient 
     to protect consumers against infectious diseases acquired 
     from such turtle at the time of sale.

             TITLE VIII--IMPORTATION OF PRESCRIPTION DRUGS

     SEC. 801. SHORT TITLE.

       This title may be cited as the ``Pharmaceutical Market 
     Access and Drug Safety Act of 2007''.

     SEC. 802. FINDINGS.

       Congress finds that--
       (1) Americans unjustly pay up to 5 times more to fill their 
     prescriptions than consumers in other countries;
       (2) the United States is the largest market for 
     pharmaceuticals in the world, yet American consumers pay the 
     highest prices for brand pharmaceuticals in the world;
       (3) a prescription drug is neither safe nor effective to an 
     individual who cannot afford it;
       (4) allowing and structuring the importation of 
     prescription drugs to ensure access to safe and affordable 
     drugs approved by the Food and Drug Administration will 
     provide a level of safety to American consumers that they do 
     not currently enjoy;
       (5) American spend more than $200,000,000,000 on 
     prescription drugs every year;

[[Page 11714]]

       (6) the Congressional Budget Office has found that the cost 
     of prescription drugs are between 35 to 55 percent less in 
     other highly-developed countries than in the United States; 
     and
       (7) promoting competitive market pricing would both 
     contribute to health care savings and allow greater access to 
     therapy, improving health and saving lives.

     SEC. 803. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF 
                   PRESCRIPTION DRUGS.

       Chapter VIII of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 381 et seq.) is amended by striking section 804.

     SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF 
                   CERTAIN IMPORT RESTRICTIONS.

       (a) In General.--Chapter VIII of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by 
     section 803, is further amended by inserting after section 
     803 the following:

     ``SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF 
                   PRESCRIPTION DRUGS.

       ``(a) Importation of Prescription Drugs.--
       ``(1) In general.--In the case of qualifying drugs imported 
     or offered for import into the United States from registered 
     exporters or by registered importers--
       ``(A) the limitation on importation that is established in 
     section 801(d)(1) is waived; and
       ``(B) the standards referred to in section 801(a) regarding 
     admission of the drugs are subject to subsection (g) of this 
     section (including with respect to qualifying drugs to which 
     section 801(d)(1) does not apply).
       ``(2) Importers.--A qualifying drug may not be imported 
     under paragraph (1) unless--
       ``(A) the drug is imported by a pharmacy, group of 
     pharmacies, or a wholesaler that is a registered importer; or
       ``(B) the drug is imported by an individual for personal 
     use or for the use of a family member of the individual (not 
     for resale) from a registered exporter.
       ``(3) Rule of construction.--This section shall apply only 
     with respect to a drug that is imported or offered for import 
     into the United States--
       ``(A) by a registered importer; or
       ``(B) from a registered exporter to an individual.
       ``(4) Definitions.--
       ``(A) Registered exporter; registered importer.--For 
     purposes of this section:
       ``(i) The term `registered exporter' means an exporter for 
     which a registration under subsection (b) has been approved 
     and is in effect.
       ``(ii) The term `registered importer' means a pharmacy, 
     group of pharmacies, or a wholesaler for which a registration 
     under subsection (b) has been approved and is in effect.
       ``(iii) The term `registration condition' means a condition 
     that must exist for a registration under subsection (b) to be 
     approved.
       ``(B) Qualifying drug.--For purposes of this section, the 
     term `qualifying drug' means a drug for which there is a 
     corresponding U.S. label drug.
       ``(C) U.S. label drug.--For purposes of this section, the 
     term `U.S. label drug' means a prescription drug that--
       ``(i) with respect to a qualifying drug, has the same 
     active ingredient or ingredients, route of administration, 
     dosage form, and strength as the qualifying drug;
       ``(ii) with respect to the qualifying drug, is manufactured 
     by or for the person that manufactures the qualifying drug;
       ``(iii) is approved under section 505(c); and
       ``(iv) is not--

       ``(I) a controlled substance, as defined in section 102 of 
     the Controlled Substances Act (21 U.S.C. 802);
       ``(II) a biological product, as defined in section 351 of 
     the Public Health Service Act (42 U.S.C. 262), including--

       ``(aa) a therapeutic DNA plasmid product;
       ``(bb) a therapeutic synthetic peptide product;
       ``(cc) a monoclonal antibody product for in vivo use; and
       ``(dd) a therapeutic recombinant DNA-derived product;

       ``(III) an infused drug, including a peritoneal dialysis 
     solution;
       ``(IV) an injected drug;
       ``(V) a drug that is inhaled during surgery;
       ``(VI) a drug that is the listed drug referred to in 2 or 
     more abbreviated new drug applications under which the drug 
     is commercially marketed; or
       ``(VII) a sterile opthlamic drug intended for topical use 
     on or in the eye.

       ``(D) Other definitions.--For purposes of this section:
       ``(i)(I) The term `exporter' means a person that is in the 
     business of exporting a drug to individuals in the United 
     States from Canada or from a permitted country designated by 
     the Secretary under subclause (II), or that, pursuant to 
     submitting a registration under subsection (b), seeks to be 
     in such business.
       ``(II) The Secretary shall designate a permitted country 
     under subparagraph (E) (other than Canada) as a country from 
     which an exporter may export a drug to individuals in the 
     United States if the Secretary determines that--

       ``(aa) the country has statutory or regulatory standards 
     that are equivalent to the standards in the United States and 
     Canada with respect to--

       ``(AA) the training of pharmacists;
       ``(BB) the practice of pharmacy; and
       ``(CC) the protection of the privacy of personal medical 
     information; and

       ``(bb) the importation of drugs to individuals in the 
     United States from the country will not adversely affect 
     public health.

       ``(ii) The term `importer' means a pharmacy, a group of 
     pharmacies, or a wholesaler that is in the business of 
     importing a drug into the United States or that, pursuant to 
     submitting a registration under subsection (b), seeks to be 
     in such business.
       ``(iii) The term `pharmacist' means a person licensed by a 
     State to practice pharmacy, including the dispensing and 
     selling of prescription drugs.
       ``(iv) The term `pharmacy' means a person that--

       ``(I) is licensed by a State to engage in the business of 
     selling prescription drugs at retail; and
       ``(II) employs 1 or more pharmacists.

       ``(v) The term `prescription drug' means a drug that is 
     described in section 503(b)(1).
       ``(vi) The term `wholesaler'--

       ``(I) means a person licensed as a wholesaler or 
     distributor of prescription drugs in the United States under 
     section 503(e)(2)(A); and
       ``(II) does not include a person authorized to import drugs 
     under section 801(d)(1).

       ``(E) Permitted country.--The term `permitted country' 
     means--
       ``(i) Australia;
       ``(ii) Canada;
       ``(iii) a member country of the European Union, but does 
     not include a member country with respect to which--

       ``(I) the country's Annex to the Treaty of Accession to the 
     European Union 2003 includes a transitional measure for the 
     regulation of human pharmaceutical products that has not 
     expired; or
       ``(II) the Secretary determines that the requirements 
     described in subclauses (I) and (II) of clause (vii) will not 
     be met by the date on which such transitional measure for the 
     regulation of human pharmaceutical products expires;

       ``(iv) Japan;
       ``(v) New Zealand;
       ``(vi) Switzerland; and
       ``(vii) a country in which the Secretary determines the 
     following requirements are met:

       ``(I) The country has statutory or regulatory 
     requirements--

       ``(aa) that require the review of drugs for safety and 
     effectiveness by an entity of the government of the country;
       ``(bb) that authorize the approval of only those drugs that 
     have been determined to be safe and effective by experts 
     employed by or acting on behalf of such entity and qualified 
     by scientific training and experience to evaluate the safety 
     and effectiveness of drugs on the basis of adequate and well-
     controlled investigations, including clinical investigations, 
     conducted by experts qualified by scientific training and 
     experience to evaluate the safety and effectiveness of drugs;
       ``(cc) that require the methods used in, and the facilities 
     and controls used for the manufacture, processing, and 
     packing of drugs in the country to be adequate to preserve 
     their identity, quality, purity, and strength;
       ``(dd) for the reporting of adverse reactions to drugs and 
     procedures to withdraw approval and remove drugs found not to 
     be safe or effective; and
       ``(ee) that require the labeling and promotion of drugs to 
     be in accordance with the approval of the drug.

       ``(II) The valid marketing authorization system in the 
     country is equivalent to the systems in the countries 
     described in clauses (i) through (vi).
       ``(III) The importation of drugs to the United States from 
     the country will not adversely affect public health.

       ``(b) Registration of Importers and Exporters.--
       ``(1) Registration of importers and exporters.--A 
     registration condition is that the importer or exporter 
     involved (referred to in this subsection as a `registrant') 
     submits to the Secretary a registration containing the 
     following:
       ``(A)(i) In the case of an exporter, the name of the 
     exporter and an identification of all places of business of 
     the exporter that relate to qualifying drugs, including each 
     warehouse or other facility owned or controlled by, or 
     operated for, the exporter.
       ``(ii) In the case of an importer, the name of the importer 
     and an identification of the places of business of the 
     importer at which the importer initially receives a 
     qualifying drug after importation (which shall not exceed 3 
     places of business except by permission of the Secretary).
       ``(B) Such information as the Secretary determines to be 
     necessary to demonstrate that the registrant is in compliance 
     with registration conditions under--
       ``(i) in the case of an importer, subsections (c), (d), 
     (e), (g), and (j) (relating to the sources of imported 
     qualifying drugs; the inspection of facilities of the 
     importer; the payment of fees; compliance with the standards 
     referred to in section 801(a); and maintenance of records and 
     samples); or
       ``(ii) in the case of an exporter, subsections (c), (d), 
     (f), (g), (h), (i), and (j) (relating to the

[[Page 11715]]

     sources of exported qualifying drugs; the inspection of 
     facilities of the exporter and the marking of compliant 
     shipments; the payment of fees; and compliance with the 
     standards referred to in section 801(a); being licensed as a 
     pharmacist; conditions for individual importation; and 
     maintenance of records and samples).
       ``(C) An agreement by the registrant that the registrant 
     will not under subsection (a) import or export any drug that 
     is not a qualifying drug.
       ``(D) An agreement by the registrant to--
       ``(i) notify the Secretary of a recall or withdrawal of a 
     qualifying drug distributed in a permitted country that the 
     registrant has exported or imported, or intends to export or 
     import, to the United States under subsection (a);
       ``(ii) provide for the return to the registrant of such 
     drug; and
       ``(iii) cease, or not begin, the exportation or importation 
     of such drug unless the Secretary has notified the registrant 
     that exportation or importation of such drug may proceed.
       ``(E) An agreement by the registrant to ensure and monitor 
     compliance with each registration condition, to promptly 
     correct any noncompliance with such a condition, and to 
     promptly report to the Secretary any such noncompliance.
       ``(F) A plan describing the manner in which the registrant 
     will comply with the agreement under subparagraph (E).
       ``(G) An agreement by the registrant to enforce a contract 
     under subsection (c)(3)(B) against a party in the chain of 
     custody of a qualifying drug with respect to the authority of 
     the Secretary under clauses (ii) and (iii) of that 
     subsection.
       ``(H) An agreement by the registrant to notify the 
     Secretary not more than 30 days before the registrant intends 
     to make the change, of--
       ``(i) any change that the registrant intends to make 
     regarding information provided under subparagraph (A) or (B); 
     and
       ``(ii) any change that the registrant intends to make in 
     the compliance plan under subparagraph (F).
       ``(I) In the case of an exporter--
       ``(i) An agreement by the exporter that a qualifying drug 
     will not under subsection (a) be exported to any individual 
     not authorized pursuant to subsection (a)(2)(B) to be an 
     importer of such drug.
       ``(ii) An agreement to post a bond, payable to the Treasury 
     of the United States that is equal in value to the lesser 
     of--

       ``(I) the value of drugs exported by the exporter to the 
     United States in a typical 4-week period over the course of a 
     year under this section; or
       ``(II) $1,000,000;

       ``(iii) An agreement by the exporter to comply with 
     applicable provisions of Canadian law, or the law of the 
     permitted country designated under subsection 
     (a)(4)(D)(i)(II) in which the exporter is located, that 
     protect the privacy of personal information with respect to 
     each individual importing a prescription drug from the 
     exporter under subsection (a)(2)(B).
       ``(iv) An agreement by the exporter to report to the 
     Secretary--

       ``(I) not later than August 1 of each fiscal year, the 
     total price and the total volume of drugs exported to the 
     United States by the exporter during the 6-month period from 
     January 1 through June 30 of that year; and
       ``(II) not later than January 1 of each fiscal year, the 
     total price and the total volume of drugs exported to the 
     United States by the exporter during the previous fiscal 
     year.

       ``(J) In the case of an importer, an agreement by the 
     importer to report to the Secretary--
       ``(i) not later than August 1 of each fiscal year, the 
     total price and the total volume of drugs imported to the 
     United States by the importer during the 6-month period from 
     January 1 through June 30 of that fiscal year; and
       ``(ii) not later than January 1 of each fiscal year, the 
     total price and the total volume of drugs imported to the 
     United States by the importer during the previous fiscal 
     year.
       ``(K) Such other provisions as the Secretary may require by 
     regulation to protect the public health while permitting--
       ``(i) the importation by pharmacies, groups of pharmacies, 
     and wholesalers as registered importers of qualifying drugs 
     under subsection (a); and
       ``(ii) importation by individuals of qualifying drugs under 
     subsection (a).
       ``(2) Approval or disapproval of registration.--
       ``(A) In general.--Not later than 90 days after the date on 
     which a registrant submits to the Secretary a registration 
     under paragraph (1), the Secretary shall notify the 
     registrant whether the registration is approved or is 
     disapproved. The Secretary shall disapprove a registration if 
     there is reason to believe that the registrant is not in 
     compliance with one or more registration conditions, and 
     shall notify the registrant of such reason. In the case of a 
     disapproved registration, the Secretary shall subsequently 
     notify the registrant that the registration is approved if 
     the Secretary determines that the registrant is in compliance 
     with such conditions.
       ``(B) Changes in registration information.--Not later than 
     30 days after receiving a notice under paragraph (1)(H) from 
     a registrant, the Secretary shall determine whether the 
     change involved affects the approval of the registration of 
     the registrant under paragraph (1), and shall inform the 
     registrant of the determination.
       ``(3) Publication of contact information for registered 
     exporters.--Through the Internet website of the Food and Drug 
     Administration and a toll-free telephone number, the 
     Secretary shall make readily available to the public a list 
     of registered exporters, including contact information for 
     the exporters. Promptly after the approval of a registration 
     submitted under paragraph (1), the Secretary shall update the 
     Internet website and the information provided through the 
     toll-free telephone number accordingly.
       ``(4) Suspension and termination.--
       ``(A) Suspension.--With respect to the effectiveness of a 
     registration submitted under paragraph (1):
       ``(i) Subject to clause (ii), the Secretary may suspend the 
     registration if the Secretary determines, after notice and 
     opportunity for a hearing, that the registrant has failed to 
     maintain substantial compliance with a registration 
     condition.
       ``(ii) If the Secretary determines that, under color of the 
     registration, the exporter has exported a drug or the 
     importer has imported a drug that is not a qualifying drug, 
     or a drug that does not comply with subsection (g)(2)(A) or 
     (g)(4), or has exported a qualifying drug to an individual in 
     violation of subsection (i)(2)(F), the Secretary shall 
     immediately suspend the registration. A suspension under the 
     preceding sentence is not subject to the provision by the 
     Secretary of prior notice, and the Secretary shall provide to 
     the registrant an opportunity for a hearing not later than 10 
     days after the date on which the registration is suspended.
       ``(iii) The Secretary may reinstate the registration, 
     whether suspended under clause (i) or (ii), if the Secretary 
     determines that the registrant has demonstrated that further 
     violations of registration conditions will not occur.
       ``(B) Termination.--The Secretary, after notice and 
     opportunity for a hearing, may terminate the registration 
     under paragraph (1) of a registrant if the Secretary 
     determines that the registrant has engaged in a pattern or 
     practice of violating 1 or more registration conditions, or 
     if on 1 or more occasions the Secretary has under 
     subparagraph (A)(ii) suspended the registration of the 
     registrant. The Secretary may make the termination permanent, 
     or for a fixed period of not less than 1 year. During the 
     period in which the registration is terminated, any 
     registration submitted under paragraph (1) by the registrant, 
     or a person that is a partner in the export or import 
     enterprise, or a principal officer in such enterprise, and 
     any registration prepared with the assistance of the 
     registrant or such a person, has no legal effect under this 
     section.
       ``(5) Default of bond.--A bond required to be posted by an 
     exporter under paragraph (1)(I)(ii) shall be defaulted and 
     paid to the Treasury of the United States if, after 
     opportunity for an informal hearing, the Secretary determines 
     that the exporter has--
       ``(A) exported a drug to the United States that is not a 
     qualifying drug or that is not in compliance with subsection 
     (g)(2)(A), (g)(4), or (i); or
       ``(B) failed to permit the Secretary to conduct an 
     inspection described under subsection (d).
       ``(c) Sources of Qualifying Drugs.--A registration 
     condition is that the exporter or importer involved agrees 
     that a qualifying drug will under subsection (a) be exported 
     or imported into the United States only if there is 
     compliance with the following:
       ``(1) The drug was manufactured in an establishment--
       ``(A) required to register under subsection (h) or (i) of 
     section 510; and
       ``(B)(i) inspected by the Secretary; or
       ``(ii) for which the Secretary has elected to rely on a 
     satisfactory report of a good manufacturing practice 
     inspection of the establishment from a permitted country 
     whose regulatory system the Secretary recognizes as 
     equivalent under a mutual recognition agreement, as provided 
     for under section 510(i)(3), section 803, or part 26 of title 
     21, Code of Federal Regulations (or any corresponding 
     successor rule or regulation).
       ``(2) The establishment is located in any country, and the 
     establishment manufactured the drug for distribution in the 
     United States or for distribution in 1 or more of the 
     permitted countries (without regard to whether in addition 
     the drug is manufactured for distribution in a foreign 
     country that is not a permitted country).
       ``(3) The exporter or importer obtained the drug--
       ``(A) directly from the establishment; or
       ``(B) directly from an entity that, by contract with the 
     exporter or importer--
       ``(i) provides to the exporter or importer a statement (in 
     such form and containing such information as the Secretary 
     may require) that, for the chain of custody from the 
     establishment, identifies each prior sale, purchase, or trade 
     of the drug (including the date of the transaction and the 
     names and addresses of all parties to the transaction);

[[Page 11716]]

       ``(ii) agrees to permit the Secretary to inspect such 
     statements and related records to determine their accuracy;
       ``(iii) agrees, with respect to the qualifying drugs 
     involved, to permit the Secretary to inspect warehouses and 
     other facilities, including records, of the entity for 
     purposes of determining whether the facilities are in 
     compliance with any standards under this Act that are 
     applicable to facilities of that type in the United States; 
     and
       ``(iv) has ensured, through such contractual relationships 
     as may be necessary, that the Secretary has the same 
     authority regarding other parties in the chain of custody 
     from the establishment that the Secretary has under clauses 
     (ii) and (iii) regarding such entity.
       ``(4)(A) The foreign country from which the importer will 
     import the drug is a permitted country; or
       ``(B) The foreign country from which the exporter will 
     export the drug is the permitted country in which the 
     exporter is located.
       ``(5) During any period in which the drug was not in the 
     control of the manufacturer of the drug, the drug did not 
     enter any country that is not a permitted country.
       ``(6) The exporter or importer retains a sample of each lot 
     of the drug for testing by the Secretary.
       ``(d) Inspection of Facilities; Marking of Shipments.--
       ``(1) Inspection of facilities.--A registration condition 
     is that, for the purpose of assisting the Secretary in 
     determining whether the exporter involved is in compliance 
     with all other registration conditions--
       ``(A) the exporter agrees to permit the Secretary--
       ``(i) to conduct onsite inspections, including monitoring 
     on a day-to-day basis, of places of business of the exporter 
     that relate to qualifying drugs, including each warehouse or 
     other facility owned or controlled by, or operated for, the 
     exporter;
       ``(ii) to have access, including on a day-to-day basis, 
     to--

       ``(I) records of the exporter that relate to the export of 
     such drugs, including financial records; and
       ``(II) samples of such drugs;

       ``(iii) to carry out the duties described in paragraph (3); 
     and
       ``(iv) to carry out any other functions determined by the 
     Secretary to be necessary regarding the compliance of the 
     exporter; and
       ``(B) the Secretary has assigned 1 or more employees of the 
     Secretary to carry out the functions described in this 
     subsection for the Secretary randomly, but not less than 12 
     times annually, on the premises of places of businesses 
     referred to in subparagraph (A)(i), and such an assignment 
     remains in effect on a continuous basis.
       ``(2) Marking of compliant shipments.--A registration 
     condition is that the exporter involved agrees to affix to 
     each shipping container of qualifying drugs exported under 
     subsection (a) such markings as the Secretary determines to 
     be necessary to identify the shipment as being in compliance 
     with all registration conditions. Markings under the 
     preceding sentence shall--
       ``(A) be designed to prevent affixation of the markings to 
     any shipping container that is not authorized to bear the 
     markings; and
       ``(B) include anticounterfeiting or track-and-trace 
     technologies, taking into account the economic and technical 
     feasibility of those technologies.
       ``(3) Certain duties relating to exporters.--Duties of the 
     Secretary with respect to an exporter include the following:
       ``(A) Inspecting, randomly, but not less than 12 times 
     annually, the places of business of the exporter at which 
     qualifying drugs are stored and from which qualifying drugs 
     are shipped.
       ``(B) During the inspections under subparagraph (A), 
     verifying the chain of custody of a statistically significant 
     sample of qualifying drugs from the establishment in which 
     the drug was manufactured to the exporter, which shall be 
     accomplished or supplemented by the use of anticounterfeiting 
     or track-and-trace technologies, taking into account the 
     economic and technical feasibility of those technologies, 
     except that a drug that lacks such technologies from the 
     point of manufacture shall not for that reason be excluded 
     from importation by an exporter.
       ``(C) Randomly reviewing records of exports to individuals 
     for the purpose of determining whether the drugs are being 
     imported by the individuals in accordance with the conditions 
     under subsection (i). Such reviews shall be conducted in a 
     manner that will result in a statistically significant 
     determination of compliance with all such conditions.
       ``(D) Monitoring the affixing of markings under paragraph 
     (2).
       ``(E) Inspecting as the Secretary determines is necessary 
     the warehouses and other facilities, including records, of 
     other parties in the chain of custody of qualifying drugs.
       ``(F) Determining whether the exporter is in compliance 
     with all other registration conditions.
       ``(4) Prior notice of shipments.--A registration condition 
     is that, not less than 8 hours and not more than 5 days in 
     advance of the time of the importation of a shipment of 
     qualifying drugs, the importer involved agrees to submit to 
     the Secretary a notice with respect to the shipment of drugs 
     to be imported or offered for import into the United States 
     under subsection (a). A notice under the preceding sentence 
     shall include--
       ``(A) the name and complete contact information of the 
     person submitting the notice;
       ``(B) the name and complete contact information of the 
     importer involved;
       ``(C) the identity of the drug, including the established 
     name of the drug, the quantity of the drug, and the lot 
     number assigned by the manufacturer;
       ``(D) the identity of the manufacturer of the drug, 
     including the identity of the establishment at which the drug 
     was manufactured;
       ``(E) the country from which the drug is shipped;
       ``(F) the name and complete contact information for the 
     shipper of the drug;
       ``(G) anticipated arrival information, including the port 
     of arrival and crossing location within that port, and the 
     date and time;
       ``(H) a summary of the chain of custody of the drug from 
     the establishment in which the drug was manufactured to the 
     importer;
       ``(I) a declaration as to whether the Secretary has ordered 
     that importation of the drug from the permitted country cease 
     under subsection (g)(2)(C) or (D); and
       ``(J) such other information as the Secretary may require 
     by regulation.
       ``(5) Marking of compliant shipments.--A registration 
     condition is that the importer involved agrees, before 
     wholesale distribution (as defined in section 503(e)) of a 
     qualifying drug that has been imported under subsection (a), 
     to affix to each container of such drug such markings or 
     other technology as the Secretary determines necessary to 
     identify the shipment as being in compliance with all 
     registration conditions, except that the markings or other 
     technology shall not be required on a drug that bears 
     comparable, compatible markings or technology from the 
     manufacturer of the drug. Markings or other technology under 
     the preceding sentence shall--
       ``(A) be designed to prevent affixation of the markings or 
     other technology to any container that is not authorized to 
     bear the markings; and
       ``(B) shall include anticounterfeiting or track-and-trace 
     technologies, taking into account the economic and technical 
     feasibility of such technologies.
       ``(6) Certain duties relating to importers.--Duties of the 
     Secretary with respect to an importer include the following:
       ``(A) Inspecting, randomly, but not less than 12 times 
     annually, the places of business of the importer at which a 
     qualifying drug is initially received after importation.
       ``(B) During the inspections under subparagraph (A), 
     verifying the chain of custody of a statistically significant 
     sample of qualifying drugs from the establishment in which 
     the drug was manufactured to the importer, which shall be 
     accomplished or supplemented by the use of anticounterfeiting 
     or track-and-trace technologies, taking into account the 
     economic and technical feasibility of those technologies, 
     except that a drug that lacks such technologies from the 
     point of manufacture shall not for that reason be excluded 
     from importation by an importer.
       ``(C) Reviewing notices under paragraph (4).
       ``(D) Inspecting as the Secretary determines is necessary 
     the warehouses and other facilities, including records of 
     other parties in the chain of custody of qualifying drugs.
       ``(E) Determining whether the importer is in compliance 
     with all other registration conditions.
       ``(e) Importer Fees.--
       ``(1) Registration fee.--A registration condition is that 
     the importer involved pays to the Secretary a fee of $10,000 
     due on the date on which the importer first submits the 
     registration to the Secretary under subsection (b).
       ``(2) Inspection fee.--A registration condition is that the 
     importer involved pays a fee to the Secretary in accordance 
     with this subsection. Such fee shall be paid not later than 
     October 1 and April 1 of each fiscal year in the amount 
     provided for under paragraph (3).
       ``(3) Amount of inspection fee.--
       ``(A) Aggregate total of fees.--Not later than 30 days 
     before the start of each fiscal year, the Secretary, in 
     consultation with the Secretary of Homeland Security and the 
     Secretary of the Treasury, shall establish an aggregate total 
     of fees to be collected under paragraph (2) for importers for 
     that fiscal year that is sufficient, and not more than 
     necessary, to pay the costs for that fiscal year of 
     administering this section with respect to registered 
     importers, including the costs associated with--
       ``(i) inspecting the facilities of registered importers, 
     and of other entities in the chain of custody of a qualifying 
     drug as necessary, under subsection (d)(6);
       ``(ii) developing, implementing, and operating under such 
     subsection an electronic system for submission and review of 
     the notices required under subsection (d)(4) with respect to 
     shipments of qualifying drugs under subsection (a) to assess 
     compliance with all registration conditions when such 
     shipments are offered for import into the United States; and

[[Page 11717]]

       ``(iii) inspecting such shipments as necessary, when 
     offered for import into the United States to determine if 
     such a shipment should be refused admission under subsection 
     (g)(5).
       ``(B) Limitation.--Subject to subparagraph (C), the 
     aggregate total of fees collected under paragraph (2) for a 
     fiscal year shall not exceed 2.5 percent of the total price 
     of qualifying drugs imported during that fiscal year into the 
     United States by registered importers under subsection (a).
       ``(C) Total price of drugs.--
       ``(i) Estimate.--For the purposes of complying with the 
     limitation described in subparagraph (B) when establishing 
     under subparagraph (A) the aggregate total of fees to be 
     collected under paragraph (2) for a fiscal year, the 
     Secretary shall estimate the total price of qualifying drugs 
     imported into the United States by registered importers 
     during that fiscal year by adding the total price of 
     qualifying drugs imported by each registered importer during 
     the 6-month period from January 1 through June 30 of the 
     previous fiscal year, as reported to the Secretary by each 
     registered importer under subsection (b)(1)(J).
       ``(ii) Calculation.--Not later than March 1 of the fiscal 
     year that follows the fiscal year for which the estimate 
     under clause (i) is made, the Secretary shall calculate the 
     total price of qualifying drugs imported into the United 
     States by registered importers during that fiscal year by 
     adding the total price of qualifying drugs imported by each 
     registered importer during that fiscal year, as reported to 
     the Secretary by each registered importer under subsection 
     (b)(1)(J).
       ``(iii) Adjustment.--If the total price of qualifying drugs 
     imported into the United States by registered importers 
     during a fiscal year as calculated under clause (ii) is less 
     than the aggregate total of fees collected under paragraph 
     (2) for that fiscal year, the Secretary shall provide for a 
     pro-rata reduction in the fee due from each registered 
     importer on April 1 of the subsequent fiscal year so that the 
     limitation described in subparagraph (B) is observed.
       ``(D) Individual importer fee.--Subject to the limitation 
     described in subparagraph (B), the fee under paragraph (2) to 
     be paid on October 1 and April 1 by an importer shall be an 
     amount that is proportional to a reasonable estimate by the 
     Secretary of the semiannual share of the importer of the 
     volume of qualifying drugs imported by importers under 
     subsection (a).
       ``(4) Use of fees.--
       ``(A) In general.--Subject to appropriations Acts, fees 
     collected by the Secretary under paragraphs (1) and (2) shall 
     be credited to the appropriation account for salaries and 
     expenses of the Food and Drug Administration until expended 
     (without fiscal year limitation), and the Secretary may, in 
     consultation with the Secretary of Homeland Security and the 
     Secretary of the Treasury, transfer some proportion of such 
     fees to the appropriation account for salaries and expenses 
     of the Bureau of Customs and Border Protection until expended 
     (without fiscal year limitation).
       ``(B) Sole purpose.--Fees collected by the Secretary under 
     paragraphs (1) and (2) are only available to the Secretary 
     and, if transferred, to the Secretary of Homeland Security, 
     and are for the sole purpose of paying the costs referred to 
     in paragraph (3)(A).
       ``(5) Collection of fees.--In any case where the Secretary 
     does not receive payment of a fee assessed under paragraph 
     (1) or (2) within 30 days after it is due, such fee shall be 
     treated as a claim of the United States Government subject to 
     subchapter II of chapter 37 of title 31, United States Code.
       ``(f) Exporter Fees.--
       ``(1) Registration fee.--A registration condition is that 
     the exporter involved pays to the Secretary a fee of $10,000 
     due on the date on which the exporter first submits that 
     registration to the Secretary under subsection (b).
       ``(2) Inspection fee.--A registration condition is that the 
     exporter involved pays a fee to the Secretary in accordance 
     with this subsection. Such fee shall be paid not later than 
     October 1 and April 1 of each fiscal year in the amount 
     provided for under paragraph (3).
       ``(3) Amount of inspection fee.--
       ``(A) Aggregate total of fees.--Not later than 30 days 
     before the start of each fiscal year, the Secretary, in 
     consultation with the Secretary of Homeland Security and the 
     Secretary of the Treasury, shall establish an aggregate total 
     of fees to be collected under paragraph (2) for exporters for 
     that fiscal year that is sufficient, and not more than 
     necessary, to pay the costs for that fiscal year of 
     administering this section with respect to registered 
     exporters, including the costs associated with--
       ``(i) inspecting the facilities of registered exporters, 
     and of other entities in the chain of custody of a qualifying 
     drug as necessary, under subsection (d)(3);
       ``(ii) developing, implementing, and operating under such 
     subsection a system to screen marks on shipments of 
     qualifying drugs under subsection (a) that indicate 
     compliance with all registration conditions, when such 
     shipments are offered for import into the United States; and
       ``(iii) screening such markings, and inspecting such 
     shipments as necessary, when offered for import into the 
     United States to determine if such a shipment should be 
     refused admission under subsection (g)(5).
       ``(B) Limitation.--Subject to subparagraph (C), the 
     aggregate total of fees collected under paragraph (2) for a 
     fiscal year shall not exceed 2.5 percent of the total price 
     of qualifying drugs imported during that fiscal year into the 
     United States by registered exporters under subsection (a).
       ``(C) Total price of drugs.--
       ``(i) Estimate.--For the purposes of complying with the 
     limitation described in subparagraph (B) when establishing 
     under subparagraph (A) the aggregate total of fees to be 
     collected under paragraph (2) for a fiscal year, the 
     Secretary shall estimate the total price of qualifying drugs 
     imported into the United States by registered exporters 
     during that fiscal year by adding the total price of 
     qualifying drugs exported by each registered exporter during 
     the 6-month period from January 1 through June 30 of the 
     previous fiscal year, as reported to the Secretary by each 
     registered exporter under subsection (b)(1)(I)(iv).
       ``(ii) Calculation.--Not later than March 1 of the fiscal 
     year that follows the fiscal year for which the estimate 
     under clause (i) is made, the Secretary shall calculate the 
     total price of qualifying drugs imported into the United 
     States by registered exporters during that fiscal year by 
     adding the total price of qualifying drugs exported by each 
     registered exporter during that fiscal year, as reported to 
     the Secretary by each registered exporter under subsection 
     (b)(1)(I)(iv).
       ``(iii) Adjustment.--If the total price of qualifying drugs 
     imported into the United States by registered exporters 
     during a fiscal year as calculated under clause (ii) is less 
     than the aggregate total of fees collected under paragraph 
     (2) for that fiscal year, the Secretary shall provide for a 
     pro-rata reduction in the fee due from each registered 
     exporter on April 1 of the subsequent fiscal year so that the 
     limitation described in subparagraph (B) is observed.
       ``(D) Individual exporter fee.--Subject to the limitation 
     described in subparagraph (B), the fee under paragraph (2) to 
     be paid on October 1 and April 1 by an exporter shall be an 
     amount that is proportional to a reasonable estimate by the 
     Secretary of the semiannual share of the exporter of the 
     volume of qualifying drugs exported by exporters under 
     subsection (a).
       ``(4) Use of fees.--
       ``(A) In general.--Subject to appropriations Acts, fees 
     collected by the Secretary under paragraphs (1) and (2) shall 
     be credited to the appropriation account for salaries and 
     expenses of the Food and Drug Administration until expended 
     (without fiscal year limitation), and the Secretary may, in 
     consultation with the Secretary of Homeland Security and the 
     Secretary of the Treasury, transfer some proportion of such 
     fees to the appropriation account for salaries and expenses 
     of the Bureau of Customs and Border Protection until expended 
     (without fiscal year limitation).
       ``(B) Sole purpose.--Fees collected by the Secretary under 
     paragraphs (1) and (2) are only available to the Secretary 
     and, if transferred, to the Secretary of Homeland Security, 
     and are for the sole purpose of paying the costs referred to 
     in paragraph (3)(A).
       ``(5) Collection of fees.--In any case where the Secretary 
     does not receive payment of a fee assessed under paragraph 
     (1) or (2) within 30 days after it is due, such fee shall be 
     treated as a claim of the United States Government subject to 
     subchapter II of chapter 37 of title 31, United States Code.
       ``(g) Compliance With Section 801(a).--
       ``(1) In general.--A registration condition is that each 
     qualifying drug exported under subsection (a) by the 
     registered exporter involved or imported under subsection (a) 
     by the registered importer involved is in compliance with the 
     standards referred to in section 801(a) regarding admission 
     of the drug into the United States, subject to paragraphs 
     (2), (3), and (4).
       ``(2) Section 505; approval status.--
       ``(A) In general.--A qualifying drug that is imported or 
     offered for import under subsection (a) shall comply with the 
     conditions established in the approved application under 
     section 505(b) for the U.S. label drug as described under 
     this subsection.
       ``(B) Notice by manufacturer; general provisions.--
       ``(i) In general.--The person that manufactures a 
     qualifying drug that is, or will be, introduced for 
     commercial distribution in a permitted country shall in 
     accordance with this paragraph submit to the Secretary a 
     notice that--

       ``(I) includes each difference in the qualifying drug from 
     a condition established in the approved application for the 
     U.S. label drug beyond--

       ``(aa) the variations provided for in the application; and
       ``(bb) any difference in labeling (except ingredient 
     labeling); or

       ``(II) states that there is no difference in the qualifying 
     drug from a condition established in the approved application 
     for the U.S. label drug beyond--

       ``(aa) the variations provided for in the application; and
       ``(bb) any difference in labeling (except ingredient 
     labeling).

[[Page 11718]]

       ``(ii) Information in notice.--A notice under clause (i)(I) 
     shall include the information that the Secretary may require 
     under section 506A, any additional information the Secretary 
     may require (which may include data on bioequivalence if such 
     data are not required under section 506A), and, with respect 
     to the permitted country that approved the qualifying drug 
     for commercial distribution, or with respect to which such 
     approval is sought, include the following:

       ``(I) The date on which the qualifying drug with such 
     difference was, or will be, introduced for commercial 
     distribution in the permitted country.
       ``(II) Information demonstrating that the person submitting 
     the notice has also notified the government of the permitted 
     country in writing that the person is submitting to the 
     Secretary a notice under clause (i)(I), which notice 
     describes the difference in the qualifying drug from a 
     condition established in the approved application for the 
     U.S. label drug.
       ``(III) The information that the person submitted or will 
     submit to the government of the permitted country for 
     purposes of obtaining approval for commercial distribution of 
     the drug in the country which, if in a language other than 
     English, shall be accompanied by an English translation 
     verified to be complete and accurate, with the name, address, 
     and a brief statement of the qualifications of the person 
     that made the translation.

       ``(iii) Certifications.--The chief executive officer and 
     the chief medical officer of the manufacturer involved shall 
     each certify in the notice under clause (i) that--

       ``(I) the information provided in the notice is complete 
     and true; and
       ``(II) a copy of the notice has been provided to the 
     Federal Trade Commission and to the State attorneys general.

       ``(iv) Fee.--If a notice submitted under clause (i) 
     includes a difference that would, under section 506A, require 
     the submission of a supplemental application if made as a 
     change to the U.S. label drug, the person that submits the 
     notice shall pay to the Secretary a fee in the same amount as 
     would apply if the person were paying a fee pursuant to 
     section 736(a)(1)(A)(ii). Subject to appropriations Acts, 
     fees collected by the Secretary under the preceding sentence 
     are available only to the Secretary and are for the sole 
     purpose of paying the costs of reviewing notices submitted 
     under clause (i).
       ``(v) Timing of submission of notices.--

       ``(I) Prior approval notices.--A notice under clause (i) to 
     which subparagraph (C) applies shall be submitted to the 
     Secretary not later than 120 days before the qualifying drug 
     with the difference is introduced for commercial distribution 
     in a permitted country, unless the country requires that 
     distribution of the qualifying drug with the difference begin 
     less than 120 days after the country requires the difference.
       ``(II) Other approval notices.--A notice under clause (i) 
     to which subparagraph (D) applies shall be submitted to the 
     Secretary not later than the day on which the qualifying drug 
     with the difference is introduced for commercial distribution 
     in a permitted country.

       ``(III) Other notices.--A notice under clause (i) to which 
     subparagraph (E) applies shall be submitted to the Secretary 
     on the date that the qualifying drug is first introduced for 
     commercial distribution in a permitted country and annually 
     thereafter.

       ``(vi) Review by secretary.--

       ``(I) In general.--In this paragraph, the difference in a 
     qualifying drug that is submitted in a notice under clause 
     (i) from the U.S. label drug shall be treated by the 
     Secretary as if it were a manufacturing change to the U.S. 
     label drug under section 506A.
       ``(II) Standard of review.--Except as provided in subclause 
     (III), the Secretary shall review and approve or disapprove 
     the difference in a notice submitted under clause (i), if 
     required under section 506A, using the safe and effective 
     standard for approving or disapproving a manufacturing change 
     under section 506A.
       ``(III) Bioequivalence.--If the Secretary would approve the 
     difference in a notice submitted under clause (i) using the 
     safe and effective standard under section 506A and if the 
     Secretary determines that the qualifying drug is not 
     bioequivalent to the U.S. label drug, the Secretary shall--

       ``(aa) include in the labeling provided under paragraph (3) 
     a prominent advisory that the qualifying drug is safe and 
     effective but is not bioequivalent to the U.S. label drug if 
     the Secretary determines that such an advisory is necessary 
     for health care practitioners and patients to use the 
     qualifying drug safely and effectively; or
       ``(bb) decline to approve the difference if the Secretary 
     determines that the availability of both the qualifying drug 
     and the U.S. label drug would pose a threat to the public 
     health.

       ``(IV) Review by the secretary.--The Secretary shall review 
     and approve or disapprove the difference in a notice 
     submitted under clause (i), if required under section 506A, 
     not later than 120 days after the date on which the notice is 
     submitted.
       ``(V) Establishment inspection.--If review of such 
     difference would require an inspection of the establishment 
     in which the qualifying drug is manufactured--

       ``(aa) such inspection by the Secretary shall be 
     authorized; and
       ``(bb) the Secretary may rely on a satisfactory report of a 
     good manufacturing practice inspection of the establishment 
     from a permitted country whose regulatory system the 
     Secretary recognizes as equivalent under a mutual recognition 
     agreement, as provided under section 510(i)(3), section 803, 
     or part 26 of title 21, Code of Federal Regulations (or any 
     corresponding successor rule or regulation).
       ``(vii) Publication of information on notices.--

       ``(I) In general.--Through the Internet website of the Food 
     and Drug Administration and a toll-free telephone number, the 
     Secretary shall readily make available to the public a list 
     of notices submitted under clause (i).
       ``(II) Contents.--The list under subclause (I) shall 
     include the date on which a notice is submitted and whether--

       ``(aa) a notice is under review;
       ``(bb) the Secretary has ordered that importation of the 
     qualifying drug from a permitted country cease; or
       ``(cc) the importation of the drug is permitted under 
     subsection (a).

       ``(III) Update.--The Secretary shall promptly update the 
     Internet website with any changes to the list.

       ``(C) Notice; drug difference requiring prior approval.--In 
     the case of a notice under subparagraph (B)(i) that includes 
     a difference that would, under section 506A(c) or 
     (d)(3)(B)(i), require the approval of a supplemental 
     application before the difference could be made to the U.S. 
     label drug the following shall occur:
       ``(i) Promptly after the notice is submitted, the Secretary 
     shall notify registered exporters, registered importers, the 
     Federal Trade Commission, and the State attorneys general 
     that the notice has been submitted with respect to the 
     qualifying drug involved.
       ``(ii) If the Secretary has not made a determination 
     whether such a supplemental application regarding the U.S. 
     label drug would be approved or disapproved by the date on 
     which the qualifying drug involved is to be introduced for 
     commercial distribution in a permitted country, the Secretary 
     shall--

       ``(I) order that the importation of the qualifying drug 
     involved from the permitted country not begin until the 
     Secretary completes review of the notice; and
       ``(II) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the order.

       ``(iii) If the Secretary determines that such a 
     supplemental application regarding the U.S. label drug would 
     not be approved, the Secretary shall--

       ``(I) order that the importation of the qualifying drug 
     involved from the permitted country cease, or provide that an 
     order under clause (ii), if any, remains in effect;
       ``(II) notify the permitted country that approved the 
     qualifying drug for commercial distribution of the 
     determination; and
       ``(III) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the determination.

       ``(iv) If the Secretary determines that such a supplemental 
     application regarding the U.S. label drug would be approved, 
     the Secretary shall--

       ``(I) vacate the order under clause (ii), if any;
       ``(II) consider the difference to be a variation provided 
     for in the approved application for the U.S. label drug;
       ``(III) permit importation of the qualifying drug under 
     subsection (a); and
       ``(IV) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the determination.

       ``(D) Notice; drug difference not requiring prior 
     approval.--In the case of a notice under subparagraph (B)(i) 
     that includes a difference that would, under section 
     506A(d)(3)(B)(ii), not require the approval of a supplemental 
     application before the difference could be made to the U.S. 
     label drug the following shall occur:
       ``(i) During the period in which the notice is being 
     reviewed by the Secretary, the authority under this 
     subsection to import the qualifying drug involved continues 
     in effect.
       ``(ii) If the Secretary determines that such a supplemental 
     application regarding the U.S. label drug would not be 
     approved, the Secretary shall--

       ``(I) order that the importation of the qualifying drug 
     involved from the permitted country cease;
       ``(II) notify the permitted country that approved the 
     qualifying drug for commercial distribution of the 
     determination; and
       ``(III) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the determination.

       ``(iii) If the Secretary determines that such a 
     supplemental application regarding the U.S. label drug would 
     be approved, the difference shall be considered to be a 
     variation provided for in the approved application for the 
     U.S. label drug.
       ``(E) Notice; drug difference not requiring approval; no 
     difference.--In the case of a notice under subparagraph 
     (B)(i) that includes a difference for which, under section

[[Page 11719]]

     506A(d)(1)(A), a supplemental application would not be 
     required for the difference to be made to the U.S. label 
     drug, or that states that there is no difference, the 
     Secretary--
       ``(i) shall consider such difference to be a variation 
     provided for in the approved application for the U.S. label 
     drug;
       ``(ii) may not order that the importation of the qualifying 
     drug involved cease; and
       ``(iii) shall promptly notify registered exporters and 
     registered importers.
       ``(F) Differences in active ingredient, route of 
     administration, dosage form, or strength.--
       ``(i) In general.--A person who manufactures a drug 
     approved under section 505(b) shall submit an application 
     under section 505(b) for approval of another drug that is 
     manufactured for distribution in a permitted country by or 
     for the person that manufactures the drug approved under 
     section 505(b) if--

       ``(I) there is no qualifying drug in commercial 
     distribution in permitted countries whose combined population 
     represents at least 50 percent of the total population of all 
     permitted countries with the same active ingredient or 
     ingredients, route of administration, dosage form, and 
     strength as the drug approved under section 505(b); and
       ``(II) each active ingredient of the other drug is related 
     to an active ingredient of the drug approved under section 
     505(b), as defined in clause (v).

       ``(ii) Application under section 505(b).--The application 
     under section 505(b) required under clause (i) shall--

       ``(I) request approval of the other drug for the indication 
     or indications for which the drug approved under section 
     505(b) is labeled;
       ``(II) include the information that the person submitted to 
     the government of the permitted country for purposes of 
     obtaining approval for commercial distribution of the other 
     drug in that country, which if in a language other than 
     English, shall be accompanied by an English translation 
     verified to be complete and accurate, with the name, address, 
     and a brief statement of the qualifications of the person 
     that made the translation;
       ``(III) include a right of reference to the application for 
     the drug approved under section 505(b); and
       ``(IV) include such additional information as the Secretary 
     may require.

       ``(iii) Timing of submission of application.--An 
     application under section 505(b) required under clause (i) 
     shall be submitted to the Secretary not later than the day on 
     which the information referred to in clause (ii)(II) is 
     submitted to the government of the permitted country.
       ``(iv) Notice of decision on application.--The Secretary 
     shall promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of a determination to approve or to 
     disapprove an application under section 505(b) required under 
     clause (i).
       ``(v) Related active ingredients.--For purposes of clause 
     (i)(II), 2 active ingredients are related if they are--

       ``(I) the same; or
       ``(II) different salts, esters, or complexes of the same 
     moiety.

       ``(3) Section 502; labeling.--
       ``(A) Importation by registered importer.--
       ``(i) In general.--In the case of a qualifying drug that is 
     imported or offered for import by a registered importer, such 
     drug shall be considered to be in compliance with section 502 
     and the labeling requirements under the approved application 
     for the U.S. label drug if the qualifying drug bears--

       ``(I) a copy of the labeling approved for the U.S. label 
     drug under section 505, without regard to whether the copy 
     bears any trademark involved;
       ``(II) the name of the manufacturer and location of the 
     manufacturer;
       ``(III) the lot number assigned by the manufacturer;
       ``(IV) the name, location, and registration number of the 
     importer; and
       ``(V) the National Drug Code number assigned to the 
     qualifying drug by the Secretary.

       ``(ii) Request for copy of the labeling.--The Secretary 
     shall provide such copy to the registered importer involved, 
     upon request of the importer.
       ``(iii) Requested labeling.--The labeling provided by the 
     Secretary under clause (ii) shall--

       ``(I) include the established name, as defined in section 
     502(e)(3), for each active ingredient in the qualifying drug;
       ``(II) not include the proprietary name of the U.S. label 
     drug or any active ingredient thereof;
       ``(III) if required under paragraph (2)(B)(vi)(III), a 
     prominent advisory that the qualifying drug is safe and 
     effective but not bioequivalent to the U.S. label drug; and
       ``(IV) if the inactive ingredients of the qualifying drug 
     are different from the inactive ingredients for the U.S. 
     label drug, include--

       ``(aa) a prominent notice that the ingredients of the 
     qualifying drug differ from the ingredients of the U.S. label 
     drug and that the qualifying drug must be dispensed with an 
     advisory to people with allergies about this difference and a 
     list of ingredients; and
       ``(bb) a list of the ingredients of the qualifying drug as 
     would be required under section 502(e).
       ``(B) Importation by individual.--
       ``(i) In general.--In the case of a qualifying drug that is 
     imported or offered for import by a registered exporter to an 
     individual, such drug shall be considered to be in compliance 
     with section 502 and the labeling requirements under the 
     approved application for the U.S. label drug if the packaging 
     and labeling of the qualifying drug complies with all 
     applicable regulations promulgated under sections 3 and 4 of 
     the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 
     et seq.) and the labeling of the qualifying drug includes--

       ``(I) directions for use by the consumer;
       ``(II) the lot number assigned by the manufacturer;
       ``(III) the name and registration number of the exporter;
       ``(IV) if required under paragraph (2)(B)(vi)(III), a 
     prominent advisory that the drug is safe and effective but 
     not bioequivalent to the U.S. label drug;
       ``(V) if the inactive ingredients of the drug are different 
     from the inactive ingredients for the U.S. label drug--

       ``(aa) a prominent advisory that persons with an allergy 
     should check the ingredient list of the drug because the 
     ingredients of the drug differ from the ingredients of the 
     U.S. label drug; and
       ``(bb) a list of the ingredients of the drug as would be 
     required under section 502(e); and

       ``(VI) a copy of any special labeling that would be 
     required by the Secretary had the U.S. label drug been 
     dispensed by a pharmacist in the United States, without 
     regard to whether the special labeling bears any trademark 
     involved.

       ``(ii) Packaging.--A qualifying drug offered for import to 
     an individual by an exporter under this section that is 
     packaged in a unit-of-use container (as those items are 
     defined in the United States Pharmacopeia and National 
     Formulary) shall not be repackaged, provided that--

       ``(I) the packaging complies with all applicable 
     regulations under sections 3 and 4 of the Poison Prevention 
     Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
       ``(II) the consumer consents to waive the requirements of 
     such Act, after being informed that the packaging does not 
     comply with such Act and that the exporter will provide the 
     drug in packaging that is compliant at no additional cost.

       ``(iii) Request for copy of special labeling and ingredient 
     list.--The Secretary shall provide to the registered exporter 
     involved a copy of the special labeling, the advisory, and 
     the ingredient list described under clause (i), upon request 
     of the exporter.
       ``(iv) Requested labeling and ingredient list.--The 
     labeling and ingredient list provided by the Secretary under 
     clause (iii) shall--

       ``(I) include the established name, as defined in section 
     502(e)(3), for each active ingredient in the drug; and
       ``(II) not include the proprietary name of the U.S. label 
     drug or any active ingredient thereof.

       ``(4) Section 501; adulteration.--A qualifying drug that is 
     imported or offered for import under subsection (a) shall be 
     considered to be in compliance with section 501 if the drug 
     is in compliance with subsection (c).
       ``(5) Standards for refusing admission.--A drug exported 
     under subsection (a) from a registered exporter or imported 
     by a registered importer may be refused admission into the 
     United States if 1 or more of the following applies:
       ``(A) The drug is not a qualifying drug.
       ``(B) A notice for the drug required under paragraph (2)(B) 
     has not been submitted to the Secretary.
       ``(C) The Secretary has ordered that importation of the 
     drug from the permitted country cease under paragraph (2)(C) 
     or (D).
       ``(D) The drug does not comply with paragraph (3) or (4).
       ``(E) The shipping container appears damaged in a way that 
     may affect the strength, quality, or purity of the drug.
       ``(F) The Secretary becomes aware that--
       ``(i) the drug may be counterfeit;
       ``(ii) the drug may have been prepared, packed, or held 
     under insanitary conditions; or
       ``(iii) the methods used in, or the facilities or controls 
     used for, the manufacturing, processing, packing, or holding 
     of the drug do not conform to good manufacturing practice.
       ``(G) The Secretary has obtained an injunction under 
     section 302 that prohibits the distribution of the drug in 
     interstate commerce.
       ``(H) The Secretary has under section 505(e) withdrawn 
     approval of the drug.
       ``(I) The manufacturer of the drug has instituted a recall 
     of the drug.
       ``(J) If the drug is imported or offered for import by a 
     registered importer without submission of a notice in 
     accordance with subsection (d)(4).
       ``(K) If the drug is imported or offered for import from a 
     registered exporter to an individual and 1 or more of the 
     following applies:
       ``(i) The shipping container for such drug does not bear 
     the markings required under subsection (d)(2).

[[Page 11720]]

       ``(ii) The markings on the shipping container appear to be 
     counterfeit.
       ``(iii) The shipping container or markings appear to have 
     been tampered with.
       ``(h) Exporter Licensure in Permitted Country.--A 
     registration condition is that the exporter involved agrees 
     that a qualifying drug will be exported to an individual only 
     if the Secretary has verified that--
       ``(1) the exporter is authorized under the law of the 
     permitted country in which the exporter is located to 
     dispense prescription drugs; and
       ``(2) the exporter employs persons that are licensed under 
     the law of the permitted country in which the exporter is 
     located to dispense prescription drugs in sufficient number 
     to dispense safely the drugs exported by the exporter to 
     individuals, and the exporter assigns to those persons 
     responsibility for dispensing such drugs to individuals.
       ``(i) Individuals; Conditions for Importation.--
       ``(1) In general.--For purposes of subsection (a)(2)(B), 
     the importation of a qualifying drug by an individual is in 
     accordance with this subsection if the following conditions 
     are met:
       ``(A) The drug is accompanied by a copy of a prescription 
     for the drug, which prescription--
       ``(i) is valid under applicable Federal and State laws; and
       ``(ii) was issued by a practitioner who, under the law of a 
     State of which the individual is a resident, or in which the 
     individual receives care from the practitioner who issues the 
     prescription, is authorized to administer prescription drugs.
       ``(B) The drug is accompanied by a copy of the 
     documentation that was required under the law or regulations 
     of the permitted country in which the exporter is located, as 
     a condition of dispensing the drug to the individual.
       ``(C) The copies referred to in subparagraphs (A)(i) and 
     (B) are marked in a manner sufficient--
       ``(i) to indicate that the prescription, and the equivalent 
     document in the permitted country in which the exporter is 
     located, have been filled; and
       ``(ii) to prevent a duplicative filling by another 
     pharmacist.
       ``(D) The individual has provided to the registered 
     exporter a complete list of all drugs used by the individual 
     for review by the individuals who dispense the drug.
       ``(E) The quantity of the drug does not exceed a 90-day 
     supply.
       ``(F) The drug is not an ineligible subpart H drug. For 
     purposes of this section, a prescription drug is an 
     `ineligible subpart H drug' if the drug was approved by the 
     Secretary under subpart H of part 314 of title 21, Code of 
     Federal Regulations (relating to accelerated approval), with 
     restrictions under section 520 of such part to assure safe 
     use, and the Secretary has published in the Federal Register 
     a notice that the Secretary has determined that good cause 
     exists to prohibit the drug from being imported pursuant to 
     this subsection.
       ``(2) Notice regarding drug refused admission.--If a 
     registered exporter ships a drug to an individual pursuant to 
     subsection (a)(2)(B) and the drug is refused admission to the 
     United States, a written notice shall be sent to the 
     individual and to the exporter that informs the individual 
     and the exporter of such refusal and the reason for the 
     refusal.
       ``(j) Maintenance of Records and Samples.--
       ``(1) In general.--A registration condition is that the 
     importer or exporter involved shall--
       ``(A) maintain records required under this section for not 
     less than 2 years; and
       ``(B) maintain samples of each lot of a qualifying drug 
     required under this section for not more than 2 years.
       ``(2) Place of record maintenance.--The records described 
     under paragraph (1) shall be maintained--
       ``(A) in the case of an importer, at the place of business 
     of the importer at which the importer initially receives the 
     qualifying drug after importation; or
       ``(B) in the case of an exporter, at the facility from 
     which the exporter ships the qualifying drug to the United 
     States.
       ``(k) Drug Recalls.--
       ``(1) Manufacturers.--A person that manufactures a 
     qualifying drug imported from a permitted country under this 
     section shall promptly inform the Secretary--
       ``(A) if the drug is recalled or withdrawn from the market 
     in a permitted country;
       ``(B) how the drug may be identified, including lot number; 
     and
       ``(C) the reason for the recall or withdrawal.
       ``(2) Secretary.--With respect to each permitted country, 
     the Secretary shall--
       ``(A) enter into an agreement with the government of the 
     country to receive information about recalls and withdrawals 
     of qualifying drugs in the country; or
       ``(B) monitor recalls and withdrawals of qualifying drugs 
     in the country using any information that is available to the 
     public in any media.
       ``(3) Notice.--The Secretary may notify, as appropriate, 
     registered exporters, registered importers, wholesalers, 
     pharmacies, or the public of a recall or withdrawal of a 
     qualifying drug in a permitted country.
       ``(l) Drug Labeling and Packaging.--
       ``(1) In general.--When a qualifying drug that is imported 
     into the United States by an importer under subsection (a) is 
     dispensed by a pharmacist to an individual, the pharmacist 
     shall provide that the packaging and labeling of the drug 
     complies with all applicable regulations promulgated under 
     sections 3 and 4 of the Poison Prevention Packaging Act of 
     1970 (15 U.S.C. 1471 et seq.) and shall include with any 
     other labeling provided to the individual the following:
       ``(A) The lot number assigned by the manufacturer.
       ``(B) The name and registration number of the importer.
       ``(C) If required under paragraph (2)(B)(vi)(III) of 
     subsection (g), a prominent advisory that the drug is safe 
     and effective but not bioequivalent to the U.S. label drug.
       ``(D) If the inactive ingredients of the drug are different 
     from the inactive ingredients for the U.S. label drug--
       ``(i) a prominent advisory that persons with allergies 
     should check the ingredient list of the drug because the 
     ingredients of the drug differ from the ingredients of the 
     U.S. label drug; and
       ``(ii) a list of the ingredients of the drug as would be 
     required under section 502(e).
       ``(2) Packaging.--A qualifying drug that is packaged in a 
     unit-of-use container (as those terms are defined in the 
     United States Pharmacopeia and National Formulary) shall not 
     be repackaged, provided that--
       ``(A) the packaging complies with all applicable 
     regulations under sections 3 and 4 of the Poison Prevention 
     Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
       ``(B) the consumer consents to waive the requirements of 
     such Act, after being informed that the packaging does not 
     comply with such Act and that the pharmacist will provide the 
     drug in packaging that is compliant at no additional cost.
       ``(m) Charitable Contributions.--Notwithstanding any other 
     provision of this section, this section does not authorize 
     the importation into the United States of a qualifying drug 
     donated or otherwise supplied for free or at nominal cost by 
     the manufacturer of the drug to a charitable or humanitarian 
     organization, including the United Nations and affiliates, or 
     to a government of a foreign country.
       ``(n) Unfair and Discriminatory Acts and Practices.--
       ``(1) In general.--It is unlawful for a manufacturer, 
     directly or indirectly (including by being a party to a 
     licensing agreement or other agreement), to--
       ``(A) discriminate by charging a higher price for a 
     prescription drug sold to a registered exporter or other 
     person in a permitted country that exports a qualifying drug 
     to the United States under this section than the price that 
     is charged, inclusive of rebates or other incentives to the 
     permitted country or other person, to another person that is 
     in the same country and that does not export a qualifying 
     drug into the United States under this section;
       ``(B) discriminate by charging a higher price for a 
     prescription drug sold to a registered importer or other 
     person that distributes, sells, or uses a qualifying drug 
     imported into the United States under this section than the 
     price that is charged to another person in the United States 
     that does not import a qualifying drug under this section, or 
     that does not distribute, sell, or use such a drug;
       ``(C) discriminate by denying, restricting, or delaying 
     supplies of a prescription drug to a registered exporter or 
     other person in a permitted country that exports a qualifying 
     drug to the United States under this section or to a 
     registered importer or other person that distributes, sells, 
     or uses a qualifying drug imported into the United States 
     under this section;
       ``(D) discriminate by publicly, privately, or otherwise 
     refusing to do business with a registered exporter or other 
     person in a permitted country that exports a qualifying drug 
     to the United States under this section or with a registered 
     importer or other person that distributes, sells, or uses a 
     qualifying drug imported into the United States under this 
     section;
       ``(E) knowingly fail to submit a notice under subsection 
     (g)(2)(B)(i), knowingly fail to submit such a notice on or 
     before the date specified in subsection (g)(2)(B)(v) or as 
     otherwise required under subsection (e)(3), (4), and (5) of 
     section 4 of the Pharmaceutical Market Access and Drug Safety 
     Act of 2007, knowingly submit such a notice that makes a 
     materially false, fictitious, or fraudulent statement, or 
     knowingly fail to provide promptly any information requested 
     by the Secretary to review such a notice;
       ``(F) knowingly fail to submit an application required 
     under subsection (g)(2)(F), knowingly fail to submit such an 
     application on or before the date specified in subsection 
     (g)(2)(F)(ii), knowingly submit such an application that 
     makes a materially false, fictitious, or fraudulent 
     statement, or knowingly fail to provide promptly any 
     information requested by the Secretary to review such an 
     application;
       ``(G) cause there to be a difference (including a 
     difference in active ingredient, route of administration, 
     dosage form, strength, formulation, manufacturing 
     establishment,

[[Page 11721]]

     manufacturing process, or person that manufactures the drug) 
     between a prescription drug for distribution in the United 
     States and the drug for distribution in a permitted country;
       ``(H) refuse to allow an inspection authorized under this 
     section of an establishment that manufactures a qualifying 
     drug that is, or will be, introduced for commercial 
     distribution in a permitted country;
       ``(I) fail to conform to the methods used in, or the 
     facilities used for, the manufacturing, processing, packing, 
     or holding of a qualifying drug that is, or will be, 
     introduced for commercial distribution in a permitted country 
     to good manufacturing practice under this Act;
       ``(J) become a party to a licensing agreement or other 
     agreement related to a qualifying drug that fails to provide 
     for compliance with all requirements of this section with 
     respect to such drug;
       ``(K) enter into a contract that restricts, prohibits, or 
     delays the importation of a qualifying drug under this 
     section;
       ``(L) engage in any other action to restrict, prohibit, or 
     delay the importation of a qualifying drug under this 
     section; or
       ``(M) engage in any other action that the Federal Trade 
     Commission determines to discriminate against a person that 
     engages or attempts to engage in the importation of a 
     qualifying drug under this section.
       ``(2) Referral of potential violations.--The Secretary 
     shall promptly refer to the Federal Trade Commission each 
     potential violation of subparagraph (E), (F), (G), (H), or 
     (I) of paragraph (1) that becomes known to the Secretary.
       ``(3) Affirmative defense.--
       ``(A) Discrimination.--It shall be an affirmative defense 
     to a charge that a manufacturer has discriminated under 
     subparagraph (A), (B), (C), (D), or (M) of paragraph (1) that 
     the higher price charged for a prescription drug sold to a 
     person, the denial, restriction, or delay of supplies of a 
     prescription drug to a person, the refusal to do business 
     with a person, or other discriminatory activity against a 
     person, is not based, in whole or in part, on--
       ``(i) the person exporting or importing a qualifying drug 
     into the United States under this section; or
       ``(ii) the person distributing, selling, or using a 
     qualifying drug imported into the United States under this 
     section.
       ``(B) Drug differences.--It shall be an affirmative defense 
     to a charge that a manufacturer has caused there to be a 
     difference described in subparagraph (G) of paragraph (1) 
     that--
       ``(i) the difference was required by the country in which 
     the drug is distributed;
       ``(ii) the Secretary has determined that the difference was 
     necessary to improve the safety or effectiveness of the drug;
       ``(iii) the person manufacturing the drug for distribution 
     in the United States has given notice to the Secretary under 
     subsection (g)(2)(B)(i) that the drug for distribution in the 
     United States is not different from a drug for distribution 
     in permitted countries whose combined population represents 
     at least 50 percent of the total population of all permitted 
     countries; or
       ``(iv) the difference was not caused, in whole or in part, 
     for the purpose of restricting importation of the drug into 
     the United States under this section.
       ``(4) Effect of subsection.--
       ``(A) Sales in other countries.--This subsection applies 
     only to the sale or distribution of a prescription drug in a 
     country if the manufacturer of the drug chooses to sell or 
     distribute the drug in the country. Nothing in this 
     subsection shall be construed to compel the manufacturer of a 
     drug to distribute or sell the drug in a country.
       ``(B) Discounts to insurers, health plans, pharmacy benefit 
     managers, and covered entities.--Nothing in this subsection 
     shall be construed to--
       ``(i) prevent or restrict a manufacturer of a prescription 
     drug from providing discounts to an insurer, health plan, 
     pharmacy benefit manager in the United States, or covered 
     entity in the drug discount program under section 340B of the 
     Public Health Service Act (42 U.S.C. 256b) in return for 
     inclusion of the drug on a formulary;
       ``(ii) require that such discounts be made available to 
     other purchasers of the prescription drug; or
       ``(iii) prevent or restrict any other measures taken by an 
     insurer, health plan, or pharmacy benefit manager to 
     encourage consumption of such prescription drug.
       ``(C) Charitable contributions.--Nothing in this subsection 
     shall be construed to--
       ``(i) prevent a manufacturer from donating a prescription 
     drug, or supplying a prescription drug at nominal cost, to a 
     charitable or humanitarian organization, including the United 
     Nations and affiliates, or to a government of a foreign 
     country; or
       ``(ii) apply to such donations or supplying of a 
     prescription drug.
       ``(5) Enforcement.--
       ``(A) Unfair or deceptive act or practice.--A violation of 
     this subsection shall be treated as a violation of a rule 
     defining an unfair or deceptive act or practice prescribed 
     under section 18(a)(1)(B) of the Federal Trade Commission Act 
     (15 U.S.C. 57a(a)(1)(B)).
       ``(B) Actions by the commission.--The Federal Trade 
     Commission--
       ``(i) shall enforce this subsection in the same manner, by 
     the same means, and with the same jurisdiction, powers, and 
     duties as though all applicable terms and provisions of the 
     Federal Trade Commission Act (15 U.S.C. 41 et seq.) were 
     incorporated into and made a part of this section; and
       ``(ii) may seek monetary relief threefold the damages 
     sustained, in addition to any other remedy available to the 
     Federal Trade Commission under the Federal Trade Commission 
     Act (15 U.S.C. 41 et seq.).
       ``(6) Actions by states.--
       ``(A) In general.--
       ``(i) Civil actions.--In any case in which the attorney 
     general of a State has reason to believe that an interest of 
     the residents of that State have been adversely affected by 
     any manufacturer that violates paragraph (1), the attorney 
     general of a State may bring a civil action on behalf of the 
     residents of the State, and persons doing business in the 
     State, in a district court of the United States of 
     appropriate jurisdiction to--

       ``(I) enjoin that practice;
       ``(II) enforce compliance with this subsection;
       ``(III) obtain damages, restitution, or other compensation 
     on behalf of residents of the State and persons doing 
     business in the State, including threefold the damages; or
       ``(IV) obtain such other relief as the court may consider 
     to be appropriate.

       ``(ii) Notice.--

       ``(I) In general.--Before filing an action under clause 
     (i), the attorney general of the State involved shall provide 
     to the Federal Trade Commission--

       ``(aa) written notice of that action; and
       ``(bb) a copy of the complaint for that action.

       ``(II) Exemption.--Subclause (I) shall not apply with 
     respect to the filing of an action by an attorney general of 
     a State under this paragraph, if the attorney general 
     determines that it is not feasible to provide the notice 
     described in that subclause before filing of the action. In 
     such case, the attorney general of a State shall provide 
     notice and a copy of the complaint to the Federal Trade 
     Commission at the same time as the attorney general files the 
     action.

       ``(B) Intervention.--
       ``(i) In general.--On receiving notice under subparagraph 
     (A)(ii), the Federal Trade Commission shall have the right to 
     intervene in the action that is the subject of the notice.
       ``(ii) Effect of intervention.--If the Federal Trade 
     Commission intervenes in an action under subparagraph (A), it 
     shall have the right--

       ``(I) to be heard with respect to any matter that arises in 
     that action; and
       ``(II) to file a petition for appeal.

       ``(C) Construction.--For purposes of bringing any civil 
     action under subparagraph (A), nothing in this subsection 
     shall be construed to prevent an attorney general of a State 
     from exercising the powers conferred on the attorney general 
     by the laws of that State to--
       ``(i) conduct investigations;
       ``(ii) administer oaths or affirmations; or
       ``(iii) compel the attendance of witnesses or the 
     production of documentary and other evidence.
       ``(D) Actions by the commission.--In any case in which an 
     action is instituted by or on behalf of the Federal Trade 
     Commission for a violation of paragraph (1), a State may not, 
     during the pendency of that action, institute an action under 
     subparagraph (A) for the same violation against any defendant 
     named in the complaint in that action.
       ``(E) Venue.--Any action brought under subparagraph (A) may 
     be brought in the district court of the United States that 
     meets applicable requirements relating to venue under section 
     1391 of title 28, United States Code.
       ``(F) Service of process.--In an action brought under 
     subparagraph (A), process may be served in any district in 
     which the defendant--
       ``(i) is an inhabitant; or
       ``(ii) may be found.
       ``(G) Measurement of damages.--In any action under this 
     paragraph to enforce a cause of action under this subsection 
     in which there has been a determination that a defendant has 
     violated a provision of this subsection, damages may be 
     proved and assessed in the aggregate by statistical or 
     sampling methods, by the computation of illegal overcharges 
     or by such other reasonable system of estimating aggregate 
     damages as the court in its discretion may permit without the 
     necessity of separately proving the individual claim of, or 
     amount of damage to, persons on whose behalf the suit was 
     brought.
       ``(H) Exclusion on duplicative relief.--The district court 
     shall exclude from the amount of monetary relief awarded in 
     an action under this paragraph brought by the attorney 
     general of a State any amount of monetary relief which 
     duplicates amounts which have been awarded for the same 
     injury.
       ``(7) Effect on antitrust laws.--Nothing in this subsection 
     shall be construed to modify, impair, or supersede the 
     operation of the antitrust laws. For the purpose of this 
     subsection, the term `antitrust laws' has the meaning given 
     it in the first section of the

[[Page 11722]]

     Clayton Act, except that it includes section 5 of the Federal 
     Trade Commission Act to the extent that such section 5 
     applies to unfair methods of competition.
       ``(8) Manufacturer.--In this subsection, the term 
     `manufacturer' means any entity, including any affiliate or 
     licensee of that entity, that is engaged in--
       ``(A) the production, preparation, propagation, 
     compounding, conversion, or processing of a prescription 
     drug, either directly or indirectly by extraction from 
     substances of natural origin, or independently by means of 
     chemical synthesis, or by a combination of extraction and 
     chemical synthesis; or
       ``(B) the packaging, repackaging, labeling, relabeling, or 
     distribution of a prescription drug.''.
       (b) Prohibited Acts.--The Federal Food, Drug, and Cosmetic 
     Act is amended--
       (1) in section 301 (21 U.S.C. 331), by striking paragraph 
     (aa) and inserting the following:
       ``(aa)(1) The sale or trade by a pharmacist, or by a 
     business organization of which the pharmacist is a part, of a 
     qualifying drug that under section 804(a)(2)(A) was imported 
     by the pharmacist, other than--
       ``(A) a sale at retail made pursuant to dispensing the drug 
     to a customer of the pharmacist or organization; or
       ``(B) a sale or trade of the drug to a pharmacy or a 
     wholesaler registered to import drugs under section 804.
       ``(2) The sale or trade by an individual of a qualifying 
     drug that under section 804(a)(2)(B) was imported by the 
     individual.
       ``(3) The making of a materially false, fictitious, or 
     fraudulent statement or representation, or a material 
     omission, in a notice under clause (i) of section 
     804(g)(2)(B) or in an application required under section 
     804(g)(2)(F), or the failure to submit such a notice or 
     application.
       ``(4) The importation of a drug in violation of a 
     registration condition or other requirement under section 
     804, the falsification of any record required to be 
     maintained, or provided to the Secretary, under such section, 
     or the violation of any registration condition or other 
     requirement under such section.''; and
       (2) in section 303(a) (21 U.S.C. 333(a)), by striking 
     paragraph (6) and inserting the following:
       ``(6) Notwithstanding subsection (a), any person that 
     knowingly violates section 301(i) (2) or (3) or section 
     301(aa)(4) shall be imprisoned not more than 10 years, or 
     fined in accordance with title 18, United States Code, or 
     both.''.
       (c) Amendment of Certain Provisions.--
       (1) In general.--Section 801 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 381) is amended by striking 
     subsection (g) and inserting the following:
       ``(g) With respect to a prescription drug that is imported 
     or offered for import into the United States by an individual 
     who is not in the business of such importation, that is not 
     shipped by a registered exporter under section 804, and that 
     is refused admission under subsection (a), the Secretary 
     shall notify the individual that--
       ``(1) the drug has been refused admission because the drug 
     was not a lawful import under section 804;
       ``(2) the drug is not otherwise subject to a waiver of the 
     requirements of subsection (a);
       ``(3) the individual may under section 804 lawfully import 
     certain prescription drugs from exporters registered with the 
     Secretary under section 804; and
       ``(4) the individual can find information about such 
     importation, including a list of registered exporters, on the 
     Internet website of the Food and Drug Administration or 
     through a toll-free telephone number required under section 
     804.''.
       (2) Establishment registration.--Section 510(i) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is 
     amended in paragraph (1) by inserting after ``import into the 
     United States'' the following: ``, including a drug that is, 
     or may be, imported or offered for import into the United 
     States under section 804,''.
       (3) Effective date.--The amendments made by this subsection 
     shall take effect on the date that is 90 days after the date 
     of enactment of this title.
       (d) Exhaustion.--
       (1) In general.--Section 271 of title 35, United States 
     Code, is amended--
       (A) by redesignating subsections (h) and (i) as (i) and 
     (j), respectively; and
       (B) by inserting after subsection (g) the following:
       ``(h) It shall not be an act of infringement to use, offer 
     to sell, or sell within the United States or to import into 
     the United States any patented invention under section 804 of 
     the Federal Food, Drug, and Cosmetic Act that was first sold 
     abroad by or under authority of the owner or licensee of such 
     patent.''.
       (2) Rule of construction.--Nothing in the amendment made by 
     paragraph (1) shall be construed to affect the ability of a 
     patent owner or licensee to enforce their patent, subject to 
     such amendment.
       (e) Effect of Section 804.--
       (1) In general.--Section 804 of the Federal Food, Drug, and 
     Cosmetic Act, as added by subsection (a), shall permit the 
     importation of qualifying drugs (as defined in such section 
     804) into the United States without regard to the status of 
     the issuance of implementing regulations--
       (A) from exporters registered under such section 804 on the 
     date that is 90 days after the date of enactment of this 
     title; and
       (B) from permitted countries, as defined in such section 
     804, by importers registered under such section 804 on the 
     date that is 1 year after the date of enactment of this 
     title.
       (2) Review of registration by certain exporters.--
       (A) Review priority.--In the review of registrations 
     submitted under subsection (b) of such section 804, 
     registrations submitted by entities in Canada that are 
     significant exporters of prescription drugs to individuals in 
     the United States as of the date of enactment of this title 
     will have priority during the 90 day period that begins on 
     such date of enactment.
       (B) Period for review.--During such 90-day period, the 
     reference in subsection (b)(2)(A) of such section 804 to 90 
     days (relating to approval or disapproval of registrations) 
     is, as applied to such entities, deemed to be 30 days.
       (C) Limitation.--That an exporter in Canada exports, or has 
     exported, prescription drugs to individuals in the United 
     States on or before the date that is 90 days after the date 
     of enactment of this title shall not serve as a basis, in 
     whole or in part, for disapproving a registration under such 
     section 804 from the exporter.
       (D) First year limit on number of exporters.--During the 1-
     year period beginning on the date of enactment of this title, 
     the Secretary of Health and Human Services (referred to in 
     this section as the ``Secretary'') may limit the number of 
     registered exporters under such section 804 to not less than 
     50, so long as the Secretary gives priority to those 
     exporters with demonstrated ability to process a high volume 
     of shipments of drugs to individuals in the United States.
       (E) Second year limit on number of exporters.--During the 
     1-year period beginning on the date that is 1 year after the 
     date of enactment of this title, the Secretary may limit the 
     number of registered exporters under such section 804 to not 
     less than 100, so long as the Secretary gives priority to 
     those exporters with demonstrated ability to process a high 
     volume of shipments of drugs to individuals in the United 
     States.
       (F) Further limit on number of exporters.--During any 1-
     year period beginning on a date that is 2 or more years after 
     the date of enactment of this title, the Secretary may limit 
     the number of registered exporters under such section 804 to 
     not less than 25 more than the number of such exporters 
     during the previous 1-year period, so long as the Secretary 
     gives priority to those exporters with demonstrated ability 
     to process a high volume of shipments of drugs to individuals 
     in the United States.
       (3) Limits on number of importers.--
       (A) First year limit on number of importers.--During the 1-
     year period beginning on the date that is 1 year after the 
     date of enactment of this title, the Secretary may limit the 
     number of registered importers under such section 804 to not 
     less than 100 (of which at least a significant number shall 
     be groups of pharmacies, to the extent feasible given the 
     applications submitted by such groups), so long as the 
     Secretary gives priority to those importers with demonstrated 
     ability to process a high volume of shipments of drugs 
     imported into the United States.
       (B) Second year limit on number of importers.--During the 
     1-year period beginning on the date that is 2 years after the 
     date of enactment of this title, the Secretary may limit the 
     number of registered importers under such section 804 to not 
     less than 200 (of which at least a significant number shall 
     be groups of pharmacies, to the extent feasible given the 
     applications submitted by such groups), so long as the 
     Secretary gives priority to those importers with demonstrated 
     ability to process a high volume of shipments of drugs into 
     the United States.
       (C) Further limit on number of importers.--During any 1-
     year period beginning on a date that is 3 or more years after 
     the date of enactment of this title, the Secretary may limit 
     the number of registered importers under such section 804 to 
     not less than 50 more (of which at least a significant number 
     shall be groups of pharmacies, to the extent feasible given 
     the applications submitted by such groups) than the number of 
     such importers during the previous 1-year period, so long as 
     the Secretary gives priority to those importers with 
     demonstrated ability to process a high volume of shipments of 
     drugs to the United States.
       (4) Notices for drugs for import from canada.--The notice 
     with respect to a qualifying drug introduced for commercial 
     distribution in Canada as of the date of enactment of this 
     title that is required under subsection (g)(2)(B)(i) of such 
     section 804 shall be submitted to the Secretary not later 
     than 30 days after the date of enactment of this title if--
       (A) the U.S. label drug (as defined in such section 804) 
     for the qualifying drug is 1 of the 100 prescription drugs 
     with the highest dollar volume of sales in the United States 
     based on the 12 calendar month period most recently completed 
     before the date of enactment of this Act; or

[[Page 11723]]

       (B) the notice is a notice under subsection 
     (g)(2)(B)(i)(II) of such section 804.
       (5) Notice for drugs for import from other countries.--The 
     notice with respect to a qualifying drug introduced for 
     commercial distribution in a permitted country other than 
     Canada as of the date of enactment of this title that is 
     required under subsection (g)(2)(B)(i) of such section 804 
     shall be submitted to the Secretary not later than 180 days 
     after the date of enactment of this title if--
       (A) the U.S. label drug for the qualifying drug is 1 of the 
     100 prescription drugs with the highest dollar volume of 
     sales in the United States based on the 12 calendar month 
     period that is first completed on the date that is 120 days 
     after the date of enactment of this title; or
       (B) the notice is a notice under subsection 
     (g)(2)(B)(i)(II) of such section 804.
       (6) Notice for other drugs for import.--
       (A) Guidance on submission dates.--The Secretary shall by 
     guidance establish a series of submission dates for the 
     notices under subsection (g)(2)(B)(i) of such section 804 
     with respect to qualifying drugs introduced for commercial 
     distribution as of the date of enactment of this title and 
     that are not required to be submitted under paragraph (4) or 
     (5).
       (B) Consistent and efficient use of resources.--The 
     Secretary shall establish the dates described under 
     subparagraph (A) so that such notices described under 
     subparagraph (A) are submitted and reviewed at a rate that 
     allows consistent and efficient use of the resources and 
     staff available to the Secretary for such reviews. The 
     Secretary may condition the requirement to submit such a 
     notice, and the review of such a notice, on the submission by 
     a registered exporter or a registered importer to the 
     Secretary of a notice that such exporter or importer intends 
     to import such qualifying drug to the United States under 
     such section 804.
       (C) Priority for drugs with higher sales.--The Secretary 
     shall establish the dates described under subparagraph (A) so 
     that the Secretary reviews the notices described under such 
     subparagraph with respect to qualifying drugs with higher 
     dollar volume of sales in the United States before the 
     notices with respect to drugs with lower sales in the United 
     States.
       (7) Notices for drugs approved after effective date.--The 
     notice required under subsection (g)(2)(B)(i) of such section 
     804 for a qualifying drug first introduced for commercial 
     distribution in a permitted country (as defined in such 
     section 804) after the date of enactment of this title shall 
     be submitted to and reviewed by the Secretary as provided 
     under subsection (g)(2)(B) of such section 804, without 
     regard to paragraph (4), (5), or (6).
       (8) Report.--Beginning with the first full fiscal year 
     after the date of enactment of this title, not later than 90 
     days after the end of each fiscal year during which the 
     Secretary reviews a notice referred to in paragraph (4), (5), 
     or (6), the Secretary shall submit a report to Congress 
     concerning the progress of the Food and Drug Administration 
     in reviewing the notices referred to in paragraphs (4), (5), 
     and (6).
       (9) User fees.--
       (A) Exporters.--When establishing an aggregate total of 
     fees to be collected from exporters under subsection (f)(2) 
     of such section 804, the Secretary shall, under subsection 
     (f)(3)(C)(i) of such section 804, estimate the total price of 
     drugs imported under subsection (a) of such section 804 into 
     the United States by registered exporters during the first 
     fiscal year in which this title takes effect to be an amount 
     equal to the amount which bears the same ratio to 
     $1,000,000,000 as the number of days in such fiscal year 
     during which this title is effective bears to 365.
       (B) Importers.--When establishing an aggregate total of 
     fees to be collected from importers under subsection (e)(2) 
     of such section 804, the Secretary shall, under subsection 
     (e)(3)(C)(i) of such section 804, estimate the total price of 
     drugs imported under subsection (a) of such section 804 into 
     the United States by registered importers during--
       (i) the first fiscal year in which this title takes effect 
     to be an amount equal to the amount which bears the same 
     ratio to $1,000,000,000 as the number of days in such fiscal 
     year during which this title is effective bears to 365; and
       (ii) the second fiscal year in which this title is in 
     effect to be $3,000,000,000.
       (C) Second year adjustment.--
       (i) Reports.--Not later than February 20 of the second 
     fiscal year in which this title is in effect, registered 
     importers shall report to the Secretary the total price and 
     the total volume of drugs imported to the United States by 
     the importer during the 4-month period from October 1 through 
     January 31 of such fiscal year.
       (ii) Reestimate.--Notwithstanding subsection (e)(3)(C)(ii) 
     of such section 804 or subparagraph (B), the Secretary shall 
     reestimate the total price of qualifying drugs imported under 
     subsection (a) of such section 804 into the United States by 
     registered importers during the second fiscal year in which 
     this title is in effect. Such reestimate shall be equal to--

       (I) the total price of qualifying drugs imported by each 
     importer as reported under clause (i); multiplied by
       (II) 3.

       (iii) Adjustment.--The Secretary shall adjust the fee due 
     on April 1 of the second fiscal year in which this title is 
     in effect, from each importer so that the aggregate total of 
     fees collected under subsection (e)(2) for such fiscal year 
     does not exceed the total price of qualifying drugs imported 
     under subsection (a) of such section 804 into the United 
     States by registered importers during such fiscal year as 
     reestimated under clause (ii).
       (D) Failure to pay fees.--Notwithstanding any other 
     provision of this section, the Secretary may prohibit a 
     registered importer or exporter that is required to pay user 
     fees under subsection (e) or (f) of such section 804 and that 
     fails to pay such fees within 30 days after the date on which 
     it is due, from importing or offering for importation a 
     qualifying drug under such section 804 until such fee is 
     paid.
       (E) Annual report.--
       (i) Food and drug administration.--Not later than 180 days 
     after the end of each fiscal year during which fees are 
     collected under subsection (e), (f), or (g)(2)(B)(iv) of such 
     section 804, the Secretary shall prepare and submit to the 
     House of Representatives and the Senate a report on the 
     implementation of the authority for such fees during such 
     fiscal year and the use, by the Food and Drug Administration, 
     of the fees collected for the fiscal year for which the 
     report is made and credited to the Food and Drug 
     Administration.
       (ii) Customs and border control.--Not later than 180 days 
     after the end of each fiscal year during which fees are 
     collected under subsection (e) or (f) of such section 804, 
     the Secretary of Homeland Security, in consultation with the 
     Secretary of the Treasury, shall prepare and submit to the 
     House of Representatives and the Senate a report on the use, 
     by the Bureau of Customs and Border Protection, of the fees, 
     if any, transferred by the Secretary to the Bureau of Customs 
     and Border Protection for the fiscal year for which the 
     report is made.
       (10) Special rule regarding importation by individuals.--
       (A) In general.--Notwithstanding any provision of this 
     title (or an amendment made by this title), the Secretary 
     shall expedite the designation of any additional countries 
     from which an individual may import a qualifying drug into 
     the United States under such section 804 if any action 
     implemented by the Government of Canada has the effect of 
     limiting or prohibiting the importation of qualifying drugs 
     into the United States from Canada.
       (B) Timing and criteria.--The Secretary shall designate 
     such additional countries under subparagraph (A)--
       (i) not later than 6 months after the date of the action by 
     the Government of Canada described under such subparagraph; 
     and
       (ii) using the criteria described under subsection 
     (a)(4)(D)(i)(II) of such section 804.
       (f) Implementation of Section 804.--
       (1) Interim rule.--The Secretary may promulgate an interim 
     rule for implementing section 804 of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a) of this section.
       (2) No notice of proposed rulemaking.--The interim rule 
     described under paragraph (1) may be developed and 
     promulgated by the Secretary without providing general notice 
     of proposed rulemaking.
       (3) Final rule.--Not later than 1 year after the date on 
     which the Secretary promulgates an interim rule under 
     paragraph (1), the Secretary shall, in accordance with 
     procedures under section 553 of title 5, United States Code, 
     promulgate a final rule for implementing such section 804, 
     which may incorporate by reference provisions of the interim 
     rule provided for under paragraph (1), to the extent that 
     such provisions are not modified.
       (g) Consumer Education.--The Secretary shall carry out 
     activities that educate consumers--
       (1) with regard to the availability of qualifying drugs for 
     import for personal use from an exporter registered with and 
     approved by the Food and Drug Administration under section 
     804 of the Federal Food, Drug, and Cosmetic Act, as added by 
     this section, including information on how to verify whether 
     an exporter is registered and approved by use of the Internet 
     website of the Food and Drug Administration and the toll-free 
     telephone number required by this title;
       (2) that drugs that consumers attempt to import from an 
     exporter that is not registered with and approved by the Food 
     and Drug Administration can be seized by the United States 
     Customs Service and destroyed, and that such drugs may be 
     counterfeit, unapproved, unsafe, or ineffective;
       (3) with regard to the suspension and termination of any 
     registration of a registered importer or exporter under such 
     section 804; and
       (4) with regard to the availability at domestic retail 
     pharmacies of qualifying drugs imported under such section 
     804 by domestic wholesalers and pharmacies registered with 
     and approved by the Food and Drug Administration.
       (h) Effect on Administration Practices.--Notwithstanding 
     any provision of this title (and the amendments made by this

[[Page 11724]]

     title), the practices and policies of the Food and Drug 
     Administration and Bureau of Customs and Border Protection, 
     in effect on January 1, 2004, with respect to the importation 
     of prescription drugs into the United States by an 
     individual, on the person of such individual, for personal 
     use, shall remain in effect.
       (i) Report to Congress.--The Federal Trade Commission 
     shall, on an annual basis, submit to Congress a report that 
     describes any action taken during the period for which the 
     report is being prepared to enforce the provisions of section 
     804(n) of the Federal Food, Drug, and Cosmetic Act (as added 
     by this title), including any pending investigations or civil 
     actions under such section.

     SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO 
                   UNITED STATES.

       (a) In General.--Chapter VIII of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by 
     section 804, is further amended by adding at the end the 
     following section:

     ``SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.

       ``(a) In General.--The Secretary of Homeland Security shall 
     deliver to the Secretary a shipment of drugs that is imported 
     or offered for import into the United States if--
       ``(1) the shipment has a declared value of less than 
     $10,000; and
       ``(2)(A) the shipping container for such drugs does not 
     bear the markings required under section 804(d)(2); or
       ``(B) the Secretary has requested delivery of such shipment 
     of drugs.
       ``(b) No Bond or Export.--Section 801(b) does not authorize 
     the delivery to the owner or consignee of drugs delivered to 
     the Secretary under subsection (a) pursuant to the execution 
     of a bond, and such drugs may not be exported.
       ``(c) Destruction of Violative Shipment.--The Secretary 
     shall destroy a shipment of drugs delivered by the Secretary 
     of Homeland Security to the Secretary under subsection (a) 
     if--
       ``(1) in the case of drugs that are imported or offered for 
     import from a registered exporter under section 804, the 
     drugs are in violation of any standard described in section 
     804(g)(5); or
       ``(2) in the case of drugs that are not imported or offered 
     for import from a registered exporter under section 804, the 
     drugs are in violation of a standard referred to in section 
     801(a) or 801(d)(1).
       ``(d) Certain Procedures.--
       ``(1) In general.--The delivery and destruction of drugs 
     under this section may be carried out without notice to the 
     importer, owner, or consignee of the drugs except as required 
     by section 801(g) or section 804(i)(2). The issuance of 
     receipts for the drugs, and recordkeeping activities 
     regarding the drugs, may be carried out on a summary basis.
       ``(2) Objective of procedures.--Procedures promulgated 
     under paragraph (1) shall be designed toward the objective of 
     ensuring that, with respect to efficiently utilizing Federal 
     resources available for carrying out this section, a 
     substantial majority of shipments of drugs subject to 
     described in subsection (c) are identified and destroyed.
       ``(e) Evidence Exception.--Drugs may not be destroyed under 
     subsection (c) to the extent that the Attorney General of the 
     United States determines that the drugs should be preserved 
     as evidence or potential evidence with respect to an offense 
     against the United States.
       ``(f) Rule of Construction.--This section may not be 
     construed as having any legal effect on applicable law with 
     respect to a shipment of drugs that is imported or offered 
     for import into the United States and has a declared value 
     equal to or greater than $10,000.''.
       (b) Procedures.--Procedures for carrying out section 805 of 
     the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (a), shall be established not later than 90 days 
     after the date of the enactment of this title.
       (c) Effective Date.--The amendments made by this section 
     shall take effect on the date that is 90 days after the date 
     of enactment of this title.

     SEC. 806. WHOLESALE DISTRIBUTION OF DRUGS; STATEMENTS 
                   REGARDING PRIOR SALE, PURCHASE, OR TRADE.

       (a) Striking of Exemptions; Applicability to Registered 
     Exporters.--Section 503(e) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 353(e)) is amended--
       (1) in paragraph (1)--
       (A) by striking ``and who is not the manufacturer or an 
     authorized distributor of record of such drug'';
       (B) by striking ``to an authorized distributor of record 
     or''; and
       (C) by striking subparagraph (B) and inserting the 
     following:
       ``(B) The fact that a drug subject to subsection (b) is 
     exported from the United States does not with respect to such 
     drug exempt any person that is engaged in the business of the 
     wholesale distribution of the drug from providing the 
     statement described in subparagraph (A) to the person that 
     receives the drug pursuant to the export of the drug.
       ``(C)(i) The Secretary shall by regulation establish 
     requirements that supersede subparagraph (A) (referred to in 
     this subparagraph as `alternative requirements') to identify 
     the chain of custody of a drug subject to subsection (b) from 
     the manufacturer of the drug throughout the wholesale 
     distribution of the drug to a pharmacist who intends to sell 
     the drug at retail if the Secretary determines that the 
     alternative requirements, which may include standardized 
     anti-counterfeiting or track-and-trace technologies, will 
     identify such chain of custody or the identity of the 
     discrete package of the drug from which the drug is dispensed 
     with equal or greater certainty to the requirements of 
     subparagraph (A), and that the alternative requirements are 
     economically and technically feasible.
       ``(ii) When the Secretary promulgates a final rule to 
     establish such alternative requirements, the final rule in 
     addition shall, with respect to the registration condition 
     established in clause (i) of section 804(c)(3)(B), establish 
     a condition equivalent to the alternative requirements, and 
     such equivalent condition may be met in lieu of the 
     registration condition established in such clause (i).'';
       (2) in paragraph (2)(A), by adding at the end the 
     following: ``The preceding sentence may not be construed as 
     having any applicability with respect to a registered 
     exporter under section 804.''; and
       (3) in paragraph (3), by striking ``and subsection (d)--'' 
     in the matter preceding subparagraph (A) and all that follows 
     through ``the term `wholesale distribution' means'' in 
     subparagraph (B) and inserting the following: ``and 
     subsection (d), the term `wholesale distribution' means''.
       (b) Conforming Amendment.--Section 503(d) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 353(d)) is amended by 
     adding at the end the following:
       ``(4) Each manufacturer of a drug subject to subsection (b) 
     shall maintain at its corporate offices a current list of the 
     authorized distributors of record of such drug.
       ``(5) For purposes of this subsection, the term `authorized 
     distributors of record' means those distributors with whom a 
     manufacturer has established an ongoing relationship to 
     distribute such manufacturer's products.''.
       (c) Effective Date.--
       (1) In general.--The amendments made by paragraphs (1) and 
     (3) of subsection (a) and by subsection (b) shall take effect 
     on January 1, 2010.
       (2) Drugs imported by registered importers under section 
     804.--Notwithstanding paragraph (1), the amendments made by 
     paragraphs (1) and (3) of subsection (a) and by subsection 
     (b) shall take effect on the date that is 90 days after the 
     date of enactment of this title with respect to qualifying 
     drugs imported under section 804 of the Federal Food, Drug, 
     and Cosmetic Act, as added by section 804.
       (3) Effect with respect to registered exporters.--The 
     amendment made by subsection (a)(2) shall take effect on the 
     date that is 90 days after the date of enactment of this 
     title.
       (4) Alternative requirements.--The Secretary shall issue 
     regulations to establish the alternative requirements, 
     referred to in the amendment made by subsection (a)(1), that 
     take effect not later than January 1, 2010.
       (5) Intermediate requirements.--The Secretary shall by 
     regulation require the use of standardized anti-
     counterfeiting or track-and-trace technologies on 
     prescription drugs at the case and pallet level effective not 
     later than 1 year after the date of enactment of this title.
       (6) Additional requirements.--
       (A) In general.--Notwithstanding any other provision of 
     this section, the Secretary shall, not later than 18 months 
     after the date of enactment of this title, require that the 
     packaging of any prescription drug incorporates--
       (i) a standardized numerical identifier unique to each 
     package of such drug, applied at the point of manufacturing 
     and repackaging (in which case the numerical identifier shall 
     be linked to the numerical identifier applied at the point of 
     manufacturing); and
       (ii)(I) overt optically variable counterfeit-resistant 
     technologies that--

       (aa) are visible to the naked eye, providing for visual 
     identification of product authenticity without the need for 
     readers, microscopes, lighting devices, or scanners;
       (bb) are similar to that used by the Bureau of Engraving 
     and Printing to secure United States currency;
       (cc) are manufactured and distributed in a highly secure, 
     tightly controlled environment; and
       (dd) incorporate additional layers of nonvisible convert 
     security features up to and including forensic capability, as 
     described in subparagraph (B); or

       (II) technologies that have a function of security 
     comparable to that described in subclause (I), as determined 
     by the Secretary.
       (B) Standards for packaging.--For the purpose of making it 
     more difficult to counterfeit the packaging of drugs subject 
     to this paragraph, the manufacturers of such drugs shall 
     incorporate the technologies described in subparagraph (A) 
     into at least 1 additional element of the physical packaging 
     of the drugs, including blister packs, shrink wrap, package 
     labels, package seals, bottles, and boxes.

[[Page 11725]]



     SEC. 807. INTERNET SALES OF PRESCRIPTION DRUGS.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 503A the following:

     ``SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.

       ``(a) Requirements Regarding Information on Internet 
     Site.--
       ``(1) In general.--A person may not dispense a prescription 
     drug pursuant to a sale of the drug by such person if--
       ``(A) the purchaser of the drug submitted the purchase 
     order for the drug, or conducted any other part of the sales 
     transaction for the drug, through an Internet site;
       ``(B) the person dispenses the drug to the purchaser by 
     mailing or shipping the drug to the purchaser; and
       ``(C) such site, or any other Internet site used by such 
     person for purposes of sales of a prescription drug, fails to 
     meet each of the requirements specified in paragraph (2), 
     other than a site or pages on a site that--
       ``(i) are not intended to be accessed by purchasers or 
     prospective purchasers; or
       ``(ii) provide an Internet information location tool within 
     the meaning of section 231(e)(5) of the Communications Act of 
     1934 (47 U.S.C. 231(e)(5)).
       ``(2) Requirements.--With respect to an Internet site, the 
     requirements referred to in subparagraph (C) of paragraph (1) 
     for a person to whom such paragraph applies are as follows:
       ``(A) Each page of the site shall include either the 
     following information or a link to a page that provides the 
     following information:
       ``(i) The name of such person.
       ``(ii) Each State in which the person is authorized by law 
     to dispense prescription drugs.
       ``(iii) The address and telephone number of each place of 
     business of the person with respect to sales of prescription 
     drugs through the Internet, other than a place of business 
     that does not mail or ship prescription drugs to purchasers.
       ``(iv) The name of each individual who serves as a 
     pharmacist for prescription drugs that are mailed or shipped 
     pursuant to the site, and each State in which the individual 
     is authorized by law to dispense prescription drugs.
       ``(v) If the person provides for medical consultations 
     through the site for purposes of providing prescriptions, the 
     name of each individual who provides such consultations; each 
     State in which the individual is licensed or otherwise 
     authorized by law to provide such consultations or practice 
     medicine; and the type or types of health professions for 
     which the individual holds such licenses or other 
     authorizations.
       ``(B) A link to which paragraph (1) applies shall be 
     displayed in a clear and prominent place and manner, and 
     shall include in the caption for the link the words 
     `licensing and contact information'.
       ``(b) Internet Sales Without Appropriate Medical 
     Relationships.--
       ``(1) In general.--Except as provided in paragraph (2), a 
     person may not dispense a prescription drug, or sell such a 
     drug, if--
       ``(A) for purposes of such dispensing or sale, the 
     purchaser communicated with the person through the Internet;
       ``(B) the patient for whom the drug was dispensed or 
     purchased did not, when such communications began, have a 
     prescription for the drug that is valid in the United States;
       ``(C) pursuant to such communications, the person provided 
     for the involvement of a practitioner, or an individual 
     represented by the person as a practitioner, and the 
     practitioner or such individual issued a prescription for the 
     drug that was purchased;
       ``(D) the person knew, or had reason to know, that the 
     practitioner or the individual referred to in subparagraph 
     (C) did not, when issuing the prescription, have a qualifying 
     medical relationship with the patient; and
       ``(E) the person received payment for the dispensing or 
     sale of the drug.

     For purposes of subparagraph (E), payment is received if 
     money or other valuable consideration is received.
       ``(2) Exceptions.--Paragraph (1) does not apply to--
       ``(A) the dispensing or selling of a prescription drug 
     pursuant to telemedicine practices sponsored by--
       ``(i) a hospital that has in effect a provider agreement 
     under title XVIII of the Social Security Act (relating to the 
     Medicare program); or
       ``(ii) a group practice that has not fewer than 100 
     physicians who have in effect provider agreements under such 
     title; or
       ``(B) the dispensing or selling of a prescription drug 
     pursuant to practices that promote the public health, as 
     determined by the Secretary by regulation.
       ``(3) Qualifying medical relationship.--
       ``(A) In general.--With respect to issuing a prescription 
     for a drug for a patient, a practitioner has a qualifying 
     medical relationship with the patient for purposes of this 
     section if--
       ``(i) at least one in-person medical evaluation of the 
     patient has been conducted by the practitioner; or
       ``(ii) the practitioner conducts a medical evaluation of 
     the patient as a covering practitioner.
       ``(B) In-person medical evaluation.--A medical evaluation 
     by a practitioner is an in-person medical evaluation for 
     purposes of this section if the practitioner is in the 
     physical presence of the patient as part of conducting the 
     evaluation, without regard to whether portions of the 
     evaluation are conducted by other health professionals.
       ``(C) Covering practitioner.--With respect to a patient, a 
     practitioner is a covering practitioner for purposes of this 
     section if the practitioner conducts a medical evaluation of 
     the patient at the request of a practitioner who has 
     conducted at least one in-person medical evaluation of the 
     patient and is temporarily unavailable to conduct the 
     evaluation of the patient. A practitioner is a covering 
     practitioner without regard to whether the practitioner has 
     conducted any in-person medical evaluation of the patient 
     involved.
       ``(4) Rules of construction.--
       ``(A) Individuals represented as practitioners.--A person 
     who is not a practitioner (as defined in subsection (e)(1)) 
     lacks legal capacity under this section to have a qualifying 
     medical relationship with any patient.
       ``(B) Standard practice of pharmacy.--Paragraph (1) may not 
     be construed as prohibiting any conduct that is a standard 
     practice in the practice of pharmacy.
       ``(C) Applicability of requirements.--Paragraph (3) may not 
     be construed as having any applicability beyond this section, 
     and does not affect any State law, or interpretation of State 
     law, concerning the practice of medicine.
       ``(c) Actions by States.--
       ``(1) In general.--Whenever an attorney general of any 
     State has reason to believe that the interests of the 
     residents of that State have been or are being threatened or 
     adversely affected because any person has engaged or is 
     engaging in a pattern or practice that violates section 
     301(l), the State may bring a civil action on behalf of its 
     residents in an appropriate district court of the United 
     States to enjoin such practice, to enforce compliance with 
     such section (including a nationwide injunction), to obtain 
     damages, restitution, or other compensation on behalf of 
     residents of such State, to obtain reasonable attorneys fees 
     and costs if the State prevails in the civil action, or to 
     obtain such further and other relief as the court may deem 
     appropriate.
       ``(2) Notice.--The State shall serve prior written notice 
     of any civil action under paragraph (1) or (5)(B) upon the 
     Secretary and provide the Secretary with a copy of its 
     complaint, except that if it is not feasible for the State to 
     provide such prior notice, the State shall serve such notice 
     immediately upon instituting such action. Upon receiving a 
     notice respecting a civil action, the Secretary shall have 
     the right--
       ``(A) to intervene in such action;
       ``(B) upon so intervening, to be heard on all matters 
     arising therein; and
       ``(C) to file petitions for appeal.
       ``(3) Construction.--For purposes of bringing any civil 
     action under paragraph (1), nothing in this chapter shall 
     prevent an attorney general of a State from exercising the 
     powers conferred on the attorney general by the laws of such 
     State to conduct investigations or to administer oaths or 
     affirmations or to compel the attendance of witnesses or the 
     production of documentary and other evidence.
       ``(4) Venue; service of process.--Any civil action brought 
     under paragraph (1) in a district court of the United States 
     may be brought in the district in which the defendant is 
     found, is an inhabitant, or transacts business or wherever 
     venue is proper under section 1391 of title 28, United States 
     Code. Process in such an action may be served in any district 
     in which the defendant is an inhabitant or in which the 
     defendant may be found.
       ``(5) Actions by other state officials.--
       ``(A) Nothing contained in this section shall prohibit an 
     authorized State official from proceeding in State court on 
     the basis of an alleged violation of any civil or criminal 
     statute of such State.
       ``(B) In addition to actions brought by an attorney general 
     of a State under paragraph (1), such an action may be brought 
     by officers of such State who are authorized by the State to 
     bring actions in such State on behalf of its residents.
       ``(d) Effect of Section.--This section shall not apply to a 
     person that is a registered exporter under section 804.
       ``(e) General Definitions.--For purposes of this section:
       ``(1) The term `practitioner' means a practitioner referred 
     to in section 503(b)(1) with respect to issuing a written or 
     oral prescription.
       ``(2) The term `prescription drug' means a drug that is 
     described in section 503(b)(1).
       ``(3) The term `qualifying medical relationship', with 
     respect to a practitioner and a patient, has the meaning 
     indicated for such term in subsection (b).
       ``(f) Internet-Related Definitions.--
       ``(1) In general.--For purposes of this section:
       ``(A) The term `Internet' means collectively the myriad of 
     computer and telecommunications facilities, including 
     equipment and operating software, which comprise the 
     interconnected world-wide network

[[Page 11726]]

     of networks that employ the transmission control protocol/
     internet protocol, or any predecessor or successor protocols 
     to such protocol, to communicate information of all kinds by 
     wire or radio.
       ``(B) The term `link', with respect to the Internet, means 
     one or more letters, words, numbers, symbols, or graphic 
     items that appear on a page of an Internet site for the 
     purpose of serving, when activated, as a method for executing 
     an electronic command--
       ``(i) to move from viewing one portion of a page on such 
     site to another portion of the page;
       ``(ii) to move from viewing one page on such site to 
     another page on such site; or
       ``(iii) to move from viewing a page on one Internet site to 
     a page on another Internet site.
       ``(C) The term `page', with respect to the Internet, means 
     a document or other file accessed at an Internet site.
       ``(D)(i) The terms `site' and `address', with respect to 
     the Internet, mean a specific location on the Internet that 
     is determined by Internet Protocol numbers. Such term 
     includes the domain name, if any.
       ``(ii) The term `domain name' means a method of 
     representing an Internet address without direct reference to 
     the Internet Protocol numbers for the address, including 
     methods that use designations such as `.com', `.edu', `.gov', 
     `.net', or `.org'.
       ``(iii) The term `Internet Protocol numbers' includes any 
     successor protocol for determining a specific location on the 
     Internet.
       ``(2) Authority of secretary.--The Secretary may by 
     regulation modify any definition under paragraph (1) to take 
     into account changes in technology.
       ``(g) Interactive Computer Service; Advertising.--No 
     provider of an interactive computer service, as defined in 
     section 230(f)(2) of the Communications Act of 1934 (47 
     U.S.C. 230(f)(2)), or of advertising services shall be liable 
     under this section for dispensing or selling prescription 
     drugs in violation of this section on account of another 
     person's selling or dispensing such drugs, provided that the 
     provider of the interactive computer service or of 
     advertising services does not own or exercise corporate 
     control over such person.''.
       (b) Inclusion as Prohibited Act.--Section 301 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is 
     amended by inserting after paragraph (k) the following:
       ``(l) The dispensing or selling of a prescription drug in 
     violation of section 503B.''.
       (c) Internet Sales of Prescription Drugs; Consideration by 
     Secretary of Practices and Procedures for Certification of 
     Legitimate Businesses.--In carrying out section 503B of the 
     Federal Food, Drug, and Cosmetic Act (as added by subsection 
     (a) of this section), the Secretary of Health and Human 
     Services shall take into consideration the practices and 
     procedures of public or private entities that certify that 
     businesses selling prescription drugs through Internet sites 
     are legitimate businesses, including practices and procedures 
     regarding disclosure formats and verification programs.
       (d) Reports Regarding Internet-Related Violations of 
     Federal and State Laws on Dispensing of Drugs.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this subsection as the ``Secretary'') shall, 
     pursuant to the submission of an application meeting the 
     criteria of the Secretary, make an award of a grant or 
     contract to the National Clearinghouse on Internet 
     Prescribing (operated by the Federation of State Medical 
     Boards) for the purpose of--
       (A) identifying Internet sites that appear to be in 
     violation of Federal or State laws concerning the dispensing 
     of drugs;
       (B) reporting such sites to State medical licensing boards 
     and State pharmacy licensing boards, and to the Attorney 
     General and the Secretary, for further investigation; and
       (C) submitting, for each fiscal year for which the award 
     under this subsection is made, a report to the Secretary 
     describing investigations undertaken with respect to 
     violations described in subparagraph (A).
       (2) Authorization of appropriations.--For the purpose of 
     carrying out paragraph (1), there is authorized to be 
     appropriated $100,000 for each of the first 3 fiscal years in 
     which this section is in effect.
       (e) Effective Date.--The amendments made by subsections (a) 
     and (b) take effect 90 days after the date of enactment of 
     this title, without regard to whether a final rule to 
     implement such amendments has been promulgated by the 
     Secretary of Health and Human Services under section 701(a) 
     of the Federal Food, Drug, and Cosmetic Act. The preceding 
     sentence may not be construed as affecting the authority of 
     such Secretary to promulgate such a final rule.

     SEC. 808. PROHIBITING PAYMENTS TO UNREGISTERED FOREIGN 
                   PHARMACIES.

       (a) In General.--Section 303 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 333) is amended by adding at the end 
     the following:
       ``(g) Restricted Transactions.--
       ``(1) In general.--The introduction of restricted 
     transactions into a payment system or the completion of 
     restricted transactions using a payment system is prohibited.
       ``(2) Payment system.--
       ``(A) In general.--The term `payment system' means a system 
     used by a person described in subparagraph (B) to effect a 
     credit transaction, electronic fund transfer, or money 
     transmitting service that may be used in connection with, or 
     to facilitate, a restricted transaction, and includes--
       ``(i) a credit card system;
       ``(ii) an international, national, regional, or local 
     network used to effect a credit transaction, an electronic 
     fund transfer, or a money transmitting service; and
       ``(iii) any other system that is centrally managed and is 
     primarily engaged in the transmission and settlement of 
     credit transactions, electronic fund transfers, or money 
     transmitting services.
       ``(B) Persons described.--A person referred to in 
     subparagraph (A) is--
       ``(i) a creditor;
       ``(ii) a credit card issuer;
       ``(iii) a financial institution;
       ``(iv) an operator of a terminal at which an electronic 
     fund transfer may be initiated;
       ``(v) a money transmitting business; or
       ``(vi) a participant in an international, national, 
     regional, or local network used to effect a credit 
     transaction, electronic fund transfer, or money transmitting 
     service.
       ``(3) Restricted transaction.--The term `restricted 
     transaction' means a transaction or transmittal, on behalf of 
     an individual who places an unlawful drug importation request 
     to any person engaged in the operation of an unregistered 
     foreign pharmacy, of--
       ``(A) credit, or the proceeds of credit, extended to or on 
     behalf of the individual for the purpose of the unlawful drug 
     importation request (including credit extended through the 
     use of a credit card);
       ``(B) an electronic fund transfer or funds transmitted by 
     or through a money transmitting business, or the proceeds of 
     an electronic fund transfer or money transmitting service, 
     from or on behalf of the individual for the purpose of the 
     unlawful drug importation request;
       ``(C) a check, draft, or similar instrument which is drawn 
     by or on behalf of the individual for the purpose of the 
     unlawful drug importation request and is drawn on or payable 
     at or through any financial institution; or
       ``(D) the proceeds of any other form of financial 
     transaction (identified by the Board by regulation) that 
     involves a financial institution as a payor or financial 
     intermediary on behalf of or for the benefit of the 
     individual for the purpose of the unlawful drug importation 
     request.
       ``(4) Unlawful drug importation request.--The term 
     `unlawful drug importation request' means the request, or 
     transmittal of a request, made to an unregistered foreign 
     pharmacy for a prescription drug by mail (including a private 
     carrier), facsimile, phone, or electronic mail, or by a means 
     that involves the use, in whole or in part, of the Internet.
       ``(5) Unregistered foreign pharmacy.--The term 
     `unregistered foreign pharmacy' means a person in a country 
     other than the United States that is not a registered 
     exporter under section 804.
       ``(6) Other definitions.--
       ``(A) Credit; creditor; credit card.--The terms `credit', 
     `creditor', and `credit card' have the meanings given the 
     terms in section 103 of the Truth in Lending Act (15 U.S.C. 
     1602).
       ``(B) Access device; electronic fund transfer.--The terms 
     `access device' and `electronic fund transfer'--
       ``(i) have the meaning given the term in section 903 of the 
     Electronic Fund Transfer Act (15 U.S.C. 1693a); and
       ``(ii) the term `electronic fund transfer' also includes 
     any fund transfer covered under Article 4A of the Uniform 
     Commercial Code, as in effect in any State.
       ``(C) Financial institution.--The term `financial 
     institution'--
       ``(i) has the meaning given the term in section 903 of the 
     Electronic Transfer Fund Act (15 U.S.C. 1693a); and
       ``(ii) includes a financial institution (as defined in 
     section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
       ``(D) Money transmitting business; money transmitting 
     service.--The terms `money transmitting business' and `money 
     transmitting service' have the meaning given the terms in 
     section 5330(d) of title 31, United States Code.
       ``(E) Board.--The term `Board' means the Board of Governors 
     of the Federal Reserve System.
       ``(7) Policies and procedures required to prevent 
     restricted transactions.--
       ``(A) Regulations.--The Board shall promulgate regulations 
     requiring--
       ``(i) an operator of a credit card system;
       ``(ii) an operator of an international, national, regional, 
     or local network used to effect a credit transaction, an 
     electronic fund transfer, or a money transmitting service;
       ``(iii) an operator of any other payment system that is 
     centrally managed and is primarily engaged in the 
     transmission and settlement of credit transactions, 
     electronic transfers or money transmitting services where at 
     least one party to the transaction or transfer is an 
     individual; and
       ``(iv) any other person described in paragraph (2)(B) and 
     specified by the Board in such regulations,


[[Page 11727]]


     to establish policies and procedures that are reasonably 
     designed to prevent the introduction of a restricted 
     transaction into a payment system or the completion of a 
     restricted transaction using a payment system.
       ``(B) Requirements for policies and procedures.--In 
     promulgating regulations under subparagraph (A), the Board 
     shall--
       ``(i) identify types of policies and procedures, including 
     nonexclusive examples, that shall be considered to be 
     reasonably designed to prevent the introduction of restricted 
     transactions into a payment system or the completion of 
     restricted transactions using a payment system; and
       ``(ii) to the extent practicable, permit any payment 
     system, or person described in paragraph (2)(B), as 
     applicable, to choose among alternative means of preventing 
     the introduction or completion of restricted transactions.
       ``(C) No liability for blocking or refusing to honor 
     restricted transaction.--
       ``(i) In general.--A payment system, or a person described 
     in paragraph (2)(B) that is subject to a regulation issued 
     under this subsection, and any participant in such payment 
     system that prevents or otherwise refuses to honor 
     transactions in an effort to implement the policies and 
     procedures required under this subsection or to otherwise 
     comply with this subsection shall not be liable to any party 
     for such action.
       ``(ii) Compliance.--A person described in paragraph (2)(B) 
     meets the requirements of this subsection if the person 
     relies on and complies with the policies and procedures of a 
     payment system of which the person is a member or in which 
     the person is a participant, and such policies and procedures 
     of the payment system comply with the requirements of the 
     regulations promulgated under subparagraph (A).
       ``(D) Enforcement.--
       ``(i) In general.--This section shall be enforced by the 
     Federal functional regulators and the Federal Trade 
     Commission under applicable law in the manner provided in 
     section 505(a) of the Gramm-Leach-Bliley Act (15 U.S.C. 
     6805(a)).
       ``(ii) Factors to be considered.--In considering any 
     enforcement action under this subsection against a payment 
     system or person described in paragraph (2)(B), the Federal 
     functional regulators and the Federal Trade Commission shall 
     consider the following factors:

       ``(I) The extent to which the payment system or person 
     knowingly permits restricted transactions.
       ``(II) The history of the payment system or person in 
     connection with permitting restricted transactions.
       ``(III) The extent to which the payment system or person 
     has established and is maintaining policies and procedures in 
     compliance with regulations prescribed under this subsection.

       ``(8) Transactions permitted.--A payment system, or a 
     person described in paragraph (2)(B) that is subject to a 
     regulation issued under this subsection, is authorized to 
     engage in transactions with foreign pharmacies in connection 
     with investigating violations or potential violations of any 
     rule or requirement adopted by the payment system or person 
     in connection with complying with paragraph (7). A payment 
     system, or such a person, and its agents and employees shall 
     not be found to be in violation of, or liable under, any 
     Federal, State or other law by virtue of engaging in any such 
     transaction.
       ``(9) Relation to state laws.--No requirement, prohibition, 
     or liability may be imposed on a payment system, or a person 
     described in paragraph (2)(B) that is subject to a regulation 
     issued under this subsection, under the laws of any state 
     with respect to any payment transaction by an individual 
     because the payment transaction involves a payment to a 
     foreign pharmacy.
       ``(10) Timing of requirements.--A payment system, or a 
     person described in paragraph (2)(B) that is subject to a 
     regulation issued under this subsection, must adopt policies 
     and procedures reasonably designed to comply with any 
     regulations required under paragraph (7) within 60 days after 
     such regulations are issued in final form.''.
       (b) Effective Date.--The amendment made by this section 
     shall take effect on the day that is 90 days after the date 
     of enactment of this Act.
       (c) Implementation.--The Board of Governors of the Federal 
     Reserve System shall promulgate regulations as required by 
     subsection (g)(7) of section 303 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 333), as added by subsection (a), 
     not later than 90 days after the date of enactment of this 
     title.

     SEC. 809. IMPORTATION EXEMPTION UNDER CONTROLLED SUBSTANCES 
                   IMPORT AND EXPORT ACT.

       Section 1006(a)(2) of the Controlled Substances Import and 
     Export Act (21 U.S.C. 956(a)(2)) is amended by striking ``not 
     import the controlled substance into the United States in an 
     amount that exceeds 50 dosage units of the controlled 
     substance.'' and inserting ``import into the United States 
     not more than 10 dosage units combined of all such controlled 
     substances.''.

     SEC. 810. SEVERABILITY.

       If any provision of this title, an amendment by this title, 
     or the application of such provision or amendment to any 
     person or circumstance is held to be unconstitutional, the 
     remainder of this title, the amendments made by this title, 
     and the application of the provisions of such to any person 
     or circumstance shall not affected thereby.

     SEC. 811. PROTECTION OF HEALTH AND SAFETY.

       This title, and the amendments made by this title, shall 
     become effective only if the Secretary of Health and Human 
     Services certifies to Congress that the implementation of 
     this title (and amendments) will--
       (1) pose no additional risk to the public's health and 
     safety; and
       (2) result in a significant reduction in the cost of 
     covered products to the American consumer.
  The PRESIDING OFFICER. Under the previous order, the motion to 
reconsider is considered made and laid upon the table, and the title 
amendment which is at the desk is agreed to, and the motion to 
reconsider is considered made and laid upon the table.
  The title was amended so as to read:

       To amend the Federal Food, Drug, and Cosmetic Act and the 
     Public Health Service Act to reauthorize drug and device user 
     fees and ensure the safety of medical products, and for other 
     purposes.

  The Senator from Wyoming.
  Mr. ENZI. Mr. President, I ask unanimous consent that Senator Kennedy 
and I have a few minutes here to thank some of the people involved. I 
have checked with the people who would be involved with the judges, and 
they have no objection.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. ENZI. Mr. President, I do want to take a few minutes to thank the 
leaders, particularly the majority leader, who, after some difficulties 
last week, helped to smooth some things out and make it possible for us 
to move on a little bit on the bill. His coordination and leadership 
were indispensable.
  I thank the Republican leader for the way he participated in the bill 
and, again, made sure we were working across the aisle and getting 
difficulties smoothed out.
  I definitely wish to thank the chairman of the committee for the 
outstanding work he did through the entire process. As we mentioned a 
number of times, it has been a very lengthy process, but he has always 
been so forthright and knowledgeable and willing to work under all 
kinds of circumstances and difficulties. Because of his dedication and 
abilities, I have learned a lot about running the committee from him 
and I have learned a lot about getting a bill passed from him and have 
enjoyed working with him over the last 2 years on a number of bills.
  I thank the staff people who have worked so hard. They have spent 
many evenings and even weekends away from their homes. They worked 
virtually through the night to get some of these issues worked out. The 
way we work a bill, it is a work in progress until it is finished. It 
is not finished yet; we have got to work with the House side yet, and 
we will do that.
  This is such an important bill for the country. My HELP team worked 
overtime to get this bill to the floor and passed in the Senate.
  I would first like to thank my health policy director, Shana 
Christrup. Shana was promoted to her leadership position in January of 
this year. She took ahold of the reins, has incredible knowledge, 
dedication, and negotiating experience and expertise that helped bring 
this bill to fruition.
  I also want to greatly thank Amy Muhlberg, our crackerjack expert who 
knows all things FDA. Her knowledge and drafting skills were central to 
this bill.
  I thank Keith Flanagan for his work on the children's statutes in 
this bill, and Dave Schmickel, who is our resident drug patent expert, 
for his ongoing work on follow-on biologics.
  Others on the team I would like to thank include Todd Spangler and 
Brittany Moore, who provided the required backup that goes with moving 
a bill of this magnitude.
  Finally, I thank my staff director, Katherine McGuire, whose steady 
hand in negotiating and communication skills and ability to juggle a 
number of issues at the same time and tap dance and do all sorts of 
things that make these bills possible provided the cement for the 
entire process.
  I would also like to thank Ilyse Schuman, my chief counsel, for her 
precision and attention to detail.

[[Page 11728]]

  I thank Amy Angelier Shank for her great work on the budget aspects 
of the bill; my press team, Craig Orfield and Mike Mahaffey; and my 
chief of staff, Flip McConnaughey, who was good at putting out 
brushfires throughout the process and kind of maintaining the core to 
our whole process.
  On Senator Kennedy's staff, I would like to thank Michael Myers, 
David Bowen, David Dorsey, Missy Rohrbach, Jeff Teitz, David Noll, and 
Tom Kraus. Senator Kennedy's staffers were reasonable negotiators 
throughout the process and open and patient to hearing all sides of any 
issue.
  As I mentioned before, Senator Hatch was responsible for the first 
FDA Revitalization Act, and I would like to thank him and his staff, 
Patty DeLoatche and Trish Knight, for helping me with the second FDA 
Revitalization Act.
  With Senator Gregg's office, and for his assistance with the health 
IT for drug safety, I thank Dave Fisher and Liz Wroe.
  Stephanie Carlton from Senator Coburn's staff and Jenny Ware with 
Senator Burr were also integral to many parts of the bill.
  I would like to thank my colleague from Kansas, Senator Roberts, and 
his staff, Jennifer Swenson, Kate Anderson, and Mike Seyfert, for their 
incredible work on our direct-to-consumer advertising.
  I also thank my colleague, Senator Harkin, and his staffer, Mike 
Woody, for his hard work on the issue.
  I thank Meghan Hauck, who is with Senator McConnell, for her great 
assistance throughout the process and her tireless hours.
  I thank Isaac Edwards, Amanda Makki, Tyler Thompson, Jennifer 
Claypool, and Mary-Sumpter Johnson.
  Finally, there is a group of people without whom none of this would 
have happened. They work behind the scenes and make the rest of us look 
good. I am talking about the dedicated folks at legislative counsel, 
Stacy Kern-Scheerer, Bill Baird, Amy Gaynor, and the rest of the 
legislative counsel team. They have drafted forever on this, and 
redrafted, helped make this concept a reality. They did it with class, 
grace, patience, kindness, and I cannot thank them enough.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Brown). The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, one of the great joys of serving in the 
Senate has been working with my friend and colleague from Wyoming, 
Senator Enzi, on different legislation. He does it the old-fashioned 
way. He believes that what we ought to do is have the hearings on the 
problem and then listen to various alternatives and then try to work 
out a solution and carry the process forward. That is the old-fashioned 
way. Today people look at different issues, file bills, and try and 
ward off interventions. He has a deep-seated conservative philosophical 
commitment. He and I differ on some matters, but we always try to find 
common ground. We have been able to find it certainly on this 
legislation and many other pieces of legislation. I look forward to 
continuing this tradition. I am personally grateful to him for all his 
help in guiding us. You can see the closeness of these votes. This is 
enormously important legislation to bring the Food and Drug 
Administration into the 21st century. But there are strong feelings, 
strong opinions, strong arguments on different ways to do so. We have 
legislation. It is solid legislation. We are proud of it. I think the 
overwhelming, virtually unanimous vote of the Senate on both sides is a 
vindication of the efforts our committee has made. It starts with 
Senator Enzi. I am grateful to him.
  I see Sherrod Brown, the Senator from Ohio, was kind enough yesterday 
to stand in for me when I had the great honor to witness the coming 
together in Northern Ireland after 400 years of conflict and the 
establishment of democratic institutions in a very momentous historical 
moment. When I left Monday night, there was a certain element of chaos 
surrounding this bill, and coming back early this morning, under the 
great work of Senator Enzi and Senator Brown, we had an orderly path to 
proceed. He is knowledgeable about health issues and had a very 
distinguished record on health policy before he came to the Senate. He 
has not missed a beat in working through the issues. He has been 
invaluable to me personally and to our committee. I thank Senator Brown 
for all of his good work.
  Quickly: I would like to thank my friend, Senator Dodd for his work 
on all of the issues that affect kids' drugs and devices; Senator 
Clinton for her work on drugs and devices; Senator Mikulski for her 
work on the issues of transparency, enormously important provisions on 
which this legislation depends; Senator Hatch for his work on 
antibiotics; Senator Gregg for his work on the databases and Web 
portal; Senators Roberts and Harkin for their work on the direct to 
consumer advertising issue, which involves a lot of different policy 
issues and a lot of emotion and feeling. They worked very hard with the 
staff, we had very solid recommendations on this; Senator Stabenow for 
her work on the citizens' petitions in order to help get product onto 
the markets in a quicker way. I would also like to thank Senator Brown 
and Senator Brownback, for their enormously creative innovative idea 
with regard to neglected diseases. This is something the United States 
should be doing more of, and they have been very creative in coming up 
with an idea; Senator Coburn on the doctor-patient relationship, a 
subject matter he feels intensely about and has been helpful to us on 
the legislation; Senator Durbin on food safety provisions, very 
important and helpful; Senator Alexander on the children's drugs; 
Senator Allard on food safety issues; Senator Lincoln on food safety 
including the raised-fish issue.
  These are some of the items. Again, we thank staff members: From my 
staff, Dave Bowen, David Dorsey, David Noll, and Caya Lewis, all who 
have spent a great deal of time and effort over these past weeks, 
Michael Myers and Carmel Martin and Missy Rohrbach, Tom Kraus, I thank 
them enormously.
  I express appreciation to Senator Enzi's staff. If people try to find 
solutions, rather than perpetuate differences, it makes an enormous 
difference. That was certainly true of all the staffs on our committee. 
I thank Amy Muhlberg and David Schmickel and Keith Flanagan and 
Katherine McGuire, Shana Christrup; Senator Brown's staff: Ellie 
Dehoney; Senator Dodd: Tamar Magarik; Senator Mikulski: Ellen-Marie 
Whelan; Senator Hatch's staff: Patty DeLoatche, and Trisha Knight; Mike 
Woody from Senator Harkin; Senator Gregg: Liz Wroe; Senator Roberts: 
Jennifer Swenson, Mike Seyfert, and Kate Anderson; Senator Clinton's 
staff: Ann Gavaghan and Andrea Palm. I am sure I might have missed 
someone, but we will make sure they are included in the Record.
  We thank all our colleagues and friends. We look forward to meeting 
with the House and reflecting the Senate's best judgment on the 
legislation.
  Mr. President, over the past 10 days we have had a good debate about 
important issues affecting the safety of our Nation's citizens, about 
the drugs they use when they are ill, and about the food they eat every 
day.
  S. 1082 will reauthorize two important user fee programs at the FDA. 
First among these is the prescription drug user fee program. In 2008, 
the program is projected to supply the FDA with nearly $400 million to 
help support new drug reviews and monitor the safety of drugs once they 
are approved and on the market. Additionally, the bill will reauthorize 
the medical device user fee program, which subsidizes the medical 
device review process. Both these programs speed new medical products 
to patients by enhancing the resources the FDA can devote to medical 
product review, without changing the standards that must be met for FDA 
approval or clearance.
  These resources to enhance speedy access to drugs and biologics are 
balanced with several significant provisions that will improve 
postapproval drug safety. A public-private partnership involving the 
FDA will build a network of health care databases to

[[Page 11729]]

gather far better information about the safety risks of prescription 
drugs. Expanded drug user fees would also be used to develop this 
active surveillance system for all FDA approved drugs.
  The bill will create an additional risk-based method for approving 
and monitoring new drugs and biologics, called risk evaluation and 
mitigation strategies, or REMS. A REMS consists of a flexible 
collection of tools that the agency can apply to address the unique 
risks associated with a new drug. From labeling changes to postapproval 
safety studies to measures to assure safe use of a drug, the bill gives 
FDA important new authorities to address safety issues that arise after 
a drug is approved. For the first time, civil money penalties will 
deter noncompliance. The bill increases drug user fees to implement the 
REMS and enhance the postapproval drug safety system.
  Furthermore, this legislation would improve transparency, strengthen 
the agency's science-based culture, and inspire the trust of the 
American public. For example, it would require the FDA to identify and 
disclose conflicts of interest among advisory committee members who 
provide the agency expert scientific recommendations.
  It would also improve access to information for patients and health 
care providers by launching a pubic database with the results of 
clinical trials. A clinical trials registry would enhance patient 
enrollment and provide a mechanism to track the progress of clinical 
trials.
  Finally, the legislation would establish the Reagan-Udall Foundation 
for the FDA to head collaborative research projects, among the FDA, 
academic institutions, and industry intended to improve medical product 
development and evaluation.
  I appreciate Senator Dodd and Senator Clinton's leadership to promote 
the safety of drugs and devices used to treat children.
  I thank Senator Roberts and Senator Harkin for working with Senator 
Enzi and me to design constitutionally sound, effective, and feasible 
controls on DTC advertising. The amendment we produced will ensure the 
information that ads provide is accurate, clear, and conspicuous 
without imposing a moratorium.
  I commend Senators Stabenow, Brown, Lott, Thune, Coburn, and Hatch 
for coming to a solution on the issue of citizens' petitions. They were 
able to craft an amendment that ensures that only citizens' petitions 
with meritorious claims could delay approval of a generic drug and that 
frivolous petitions will not lead to unwarranted delays in the approval 
of new generic drugs.
  I applaud Senator Brownback and Senator Brown for their novel 
proposal to encourage investment in new medicines for neglected 
tropical diseases. Their proposal entitles companies that develop new 
therapies or vaccines to a voucher allowing them a priority review at 
the FDA for a product of their choosing. It would provide 
pharmaceutical manufacturers a significant incentive without raising 
costs to consumers or relaxing the safety standards applied to the drug 
given priority review.
  I would also like to draw attention to the essential amendment 
introduced by Senator Hatch, with important contributions from Senators 
Brown, Burr, Stabenow, and others. The amendment would close a loophole 
that did away with the incentive to bring old but never approved 
antibiotics to market. It would also establish a public process to 
identify drug-resistant infections that are orphan diseases and that 
could be treated with orphan drugs. Additionally, the amendment would 
make certain molecules that are a part of old active ingredients 
eligible for recognition as new active ingredients, provided they will 
be used for a new indication. This provision includes limits that would 
prevent pharmaceutical manufacturers from abusing the process to extend 
the life of old active ingredient drugs.
  Finally, I am grateful to my friend, Senator Enzi, for his leadership 
and commitment to addressing prescription drug safety. We have worked 
together for over 2\1/2\ years to develop this legislation, and I am 
proud of where we are today.
  I have already thanked a number of people, and I would also like to 
thank, on Senator Enzi's staff, Ilyse Schuman, and on my own staff, 
Stacy Sachs, Molly Nicholson, Jeff Teitz, and Charlotte Burrows, and 
two of my interns, Ashley Bennett and Lara Mounir.
  I would also like to thank the many other staff members, both on and 
off the committee, who did such great work on this bill: Carmen Green, 
Nancy Hardt, Paula Burg, Lisa German, Jessica Gerrity, Dora Hughes, Ed 
Ramos, Ben Klein, Jim Esquea, David Lazarus, Lisa Layman, Jenny Ware, 
Mary-Sumpter Johnson, Stephanie Carlton, and Jennifer Claypool.
  I would also like to thank the legislative counsels Bill Baird, Amy 
Gaynor, and Stacey Kern-Scheerer for all of their hard work on this 
bill.
  Mr. ROBERTS. Mr. President, today the Senate voted to approve S. 
1082, the Food and Drug Administration Revitalization Act. I am very 
pleased the Senate took this action and I now look forward to its 
consideration in the House.
  Unfortunately, I was not present to vote for the bill, but I would 
like the record to reflect that I had planned to vote in favor of this 
legislation. Just last weekend, Kansas experienced a horrible disaster 
when a tornado devastated an entire community and took the lives of 
several Kansans.
  Late last Friday evening, the town of Greensburg, KS, was literally 
wiped off the map by an enormous tornado. As a result of this and 
storms associated with the system, 12 Kansans are confirmed dead, and 
all of the 1500 residents of Greensburg have been displaced. What we 
have experienced in Greensburg is unlike any other event in recent 
Kansas history. The hospital is gone, the schools are gone, every 
church is gone, virtually every business in the community is gone, 
including all of Main Street. Estimates are that fully 95 percent of 
the structures in the town are damaged or destroyed. Because of this 
devastation, I invited President Bush to come to Greensburg, KS, and 
view the damage from this unspeakable disaster. Today, President Bush 
is in Greensburg, and I, along with other members of the Kansas 
congressional delegation, are showing him the devastation this 
community has experienced, so I could not be present to vote for S. 
1082.
  However, I want my colleagues to know that I support this legislation 
and would have voted in favor of the bill if I were present. I believe 
S. 1082 will give FDA the tools to ensure drug safety and will renew 
some very important prescription drug and medical device programs. I am 
also pleased the bill includes an amendment I sponsored with Senators 
Harkin, Burr, and Coburn to improve the drug advertisement provisions 
in the underlying bill. This amendment was accepted unanimously by the 
Senate.
  Our amendment addresses the first amendment concerns with the 
advertising provisions in the original bill and gives the FDA the tools 
they need to protect the public from false or misleading prescription 
drug advertisements. We believe this amendment is a more commonsense 
approach to dealing with prescription drug advertisements and ensures 
the public will get truthful and accurate information about new 
prescription drugs.
  I especially want to thank Chairman Kennedy, Ranking Member Enzi, and 
Senator Harkin for their leadership and hard work on this issue. I also 
thank Senators Burr and Coburn for their cooperation and cosponsorship 
of my amendment. This amendment represents the result of our efforts to 
achieve an outcome that is acceptable to all of us. The agreement that 
was accepted today is a fair compromise that addresses the concerns of 
all of the Members involved
  Mr. BYRD. Mr. President, I voted against Senator Durbin's amendment 
because it would have forced the removal of the best scientific minds 
from the oversight of the safety of our Nation's food and prescription 
drug approval process. Though well intentioned, the Durbin amendment 
would have limited the advice available to the Food and Drug 
Administration for critical decisions pertaining to consumer safety. I 
will support the efforts

[[Page 11730]]

to ensure that conflicts of interest do not interfere with the safety 
of the American people, and I will work to ensure that the country's 
best experts continue to secure our medications and food supply.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. LEAHY. I ask unanimous consent that the order for the quorum call 
be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

                          ____________________