[Congressional Record Volume 153, Number 76 (Wednesday, May 9, 2007)]
[Senate]
[Pages S5759-S5824]
From the Congressional Record Online through the 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
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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 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
[[Page S5761]]
American has access to prescription drugs regardless of whether they
live in 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. 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
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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 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
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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 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
[[Page S5764]]
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 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
[[Page S5765]]
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 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
[[Page S5766]]
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 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
[[Page S5767]]
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 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.
[[Page S5768]]
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
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
[[Page S5769]]
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 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.
[[Page S5770]]
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 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.
[[Page S5771]]
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 depressants 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.
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
[[Page S5772]]
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 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.
[[Page S5773]]
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?
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
[[Page S5774]]
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'';
(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.''.
[[Page S5775]]
(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:
``(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.
[[Page S5776]]
``(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 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.
[[Page S5777]]
``(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.
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--
[[Page S5778]]
``(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 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--
[[Page S5779]]
``(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.
``(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
[[Page S5780]]
(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 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);
[[Page S5781]]
``(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.--
``(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--
[[Page S5782]]
``(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.
``(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'.
[[Page S5783]]
``(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 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
[[Page S5784]]
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.
``(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.
[[Page S5785]]
``(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 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 S5786]]
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 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.
[[Page S5787]]
``(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 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;
[[Page S5788]]
``(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;
``(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
[[Page S5789]]
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 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
[[Page S5790]]
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 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
[[Page S5791]]
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.
(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
[[Page S5792]]
``(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;
(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.''.
[[Page S5793]]
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)--
(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
[[Page S5794]]
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 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
[[Page S5795]]
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, 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
[[Page S5796]]
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 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
[[Page S5797]]
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, 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
[[Page S5798]]
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.--
``(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.
[[Page S5799]]
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;
``(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
[[Page S5800]]
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 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''.
[[Page S5801]]
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 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.
[[Page S5802]]
(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--
(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
[[Page S5803]]
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.
(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
[[Page S5804]]
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 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
[[Page S5805]]
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 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
[[Page S5806]]
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, 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
[[Page S5807]]
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.
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
[[Page S5808]]
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.
``(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;
[[Page S5809]]
(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;
(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
[[Page S5810]]
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 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);
``(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
[[Page S5811]]
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
``(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
[[Page S5812]]
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).
``(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
[[Page S5813]]
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
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--
[[Page S5814]]
``(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).
``(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.
[[Page S5815]]
``(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, 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
[[Page S5816]]
``(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 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:
[[Page S5817]]
``(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
(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
[[Page S5818]]
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
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.
[[Page S5819]]
``(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.
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
[[Page S5820]]
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 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
[[Page S5821]]
$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,
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.
[[Page S5822]]
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.
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
[[Page S5823]]
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 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.
[[Page S5824]]
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 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.
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