[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 10914-10964]
[From the U.S. Government Publishing Office, www.gpo.gov]




             PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

  The PRESIDING OFFICER. Under the previous order, the Senate will 
resume consideration of S. 1082, which the clerk will report.
  The assistant legislative 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:

       Landrieu amendment No. 1004, to require the Food and Drug 
     Administration to permit the sale of baby turtles as pets so 
     long as the seller uses proven methods to effectively treat 
     salmonella.
       Dorgan amendment No. 990, to provide for the importation of 
     prescription drugs.


                Amendment No. 1010 to Amendment No. 990

       (Purpose: To protect the health and safety of the public)

  Mr. COCHRAN. Mr. President, I send an amendment to the desk and ask 
that it be stated.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Mississippi [Mr. Cochran], for himself, 
     Mr. Carper, Mr. Nelson of Nebraska, Mr. Hatch, Mr. Bennett, 
     Mr. Enzi, Mr. Burr, and Mr. Menendez, proposes an amendment 
     numbered 1010 to amendment 990.
       At the end of the amendment, add the following:

     SEC. __. 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. The Senator from Mississippi.
  Mr. COCHRAN. Mr. President, I am offering this amendment for myself, 
as well as for these cosponsors: Mr. Carper, Mr. Nelson of Nebraska, 
Mr. Hatch, Mr. Bennett, Mr. Enzi, Mr. Burr, and Mr. Menendez. This is 
an amendment to the amendment proposed by Mr. Dorgan.
  Improving the health and quality of life for Americans is very 
important to all of us, and access to safe and effective prescription 
drugs is a major step in accomplishing these goals. With recent 
scientific advances, a number of medical therapies have been made 
available to treat and, in some cases, to cure diseases. We want 
Americans to continue to have access to safe and effective drugs that 
are approved by the Food and Drug Administration.
  But we must not create opportunities for potentially dangerous drug 
products from foreign countries to reach the American consumer. For 
example, counterfeit products, those that have been tampered with or 
those of unknown origin, should not be brought into this country. I am 
concerned that allowing the importation of prescription drugs would 
allow such risks to become more likely.
  The amendment proposed by the Senator from North Dakota will put in 
jeopardy the process we now have to ensure the safety of prescription 
medications and protect the health of the American people.
  I am offering this second-degree amendment to require the Secretary 
of Health and Human Services to certify that the importation of drug 
products will not pose additional risks to Americans and will, indeed, 
lower costs to consumers.
  If, as some argue, a policy of importation is safe and will reduce 
costs, this amendment should not be a problem.
  We have debated this issue before on several previous occasions. For 
example, during the consideration of annual appropriations bills for 
the Department of Agriculture, the Food and Drug Administration, and 
related agencies, when considering the Greater Access to 
Pharmaceuticals Act, and even during the debate and passage of the 
Medicare Modernization Act of 2003, a similar amendment to require the 
safety of imported drugs was considered and unanimously approved each 
time.
  In all these instances, the Senate has adopted this amendment by a 
unanimous vote. The safety of the American consumer must be our No. 1 
priority. These safeguards should also be applied to this proposal.
  We should be certain that any change we make in the law does not 
result in less protection in terms of the safety of the drugs supplied 
to the American people and will, indeed, make prescription drugs more 
affordable. Liberalization of protections that are designed to keep 
unsafe drugs out of this country, especially considering the terrorist 
threats we face now, should occur only if the necessary safeguards are 
in place. This amendment will ensure that the concerns of the last two 
administrations regarding safety and cost-effectiveness are addressed 
prior to the implementation of this proposal.
  Counterfeiting of drugs has become a more common practice throughout 
the world, and the transshipment of these counterfeit products through 
Canada is one of the most serious dangers we face. The Canadian 
Government itself has said that drug products shipped to Canada for 
resale in other countries do not fall under the Canadian regulatory 
system, and they can provide no assurance as to the safety or 
authenticity of such drugs.
  In fact, President Bush yesterday released a Statement of 
Administration Policy strongly opposing any provision that allows the 
importation of drug products outside the current safety

[[Page 10915]]

system of the Food and Drug Administration. The statement declares that 
the President's senior advisers would recommend that he veto the bill 
if this provision is included.
  Mr. President, I ask unanimous consent that a copy of the Statement 
of Administration Policy be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         Executive Office of the President, Office of Management 
           and Budget,
                                      Washington, DC, May 1, 2007.

                   Statement of Administration Policy


        s. 1082--food and drug administration revitalization act

                         (Sen. Kennedy (D)-MA)

       The Administration strongly supports reauthorization of the 
     Prescription Drug User Fee Act (PDUFA) and the Medical Device 
     User Fee and Modernization Act (MDUFMA). These two programs 
     account for nearly one quarter of the Food and Drug 
     Administration's (FDA) annual budget and support more than 
     2,000 Agency employees who work diligently to ensure the 
     safety and efficacy of the medical products on which the 
     American people rely. Reauthorizing PDUFA and MDUFMA will 
     enhance FDA's ability to more efficiently and effectively 
     regulate drugs, biological products, and medical devices, a 
     critical component of the Agency's public health mission. 
     Additionally, the Administration is committed to 
     reauthorizing the Best Pharmaceuticals for Children Act 
     (BPCA) and the Pediatric Research Equity Act (PREA), which 
     have provided invaluable information to the Agency about 
     medical products' interaction with pediatric populations.
       The Administration shares the goal of S. 1082 to provide 
     FDA with the appropriate tools and resources to enhance the 
     safety and efficacy of the products the agency regulates. 
     However, the Administration has serious concerns with S. 1082 
     in its current form and will work with Congress to address 
     them as the legislative process moves forward.
       The Administration appreciates that portions of S. 1082 are 
     consistent with the Administration's recommendations for 
     reauthorization, which strengthen FDA's ability to ensure the 
     safety and availability of new drugs and medical devices, 
     create a new program for review of television advertisements, 
     and strengthen post-market review. These user fee programs 
     expire at the end of the current fiscal year, and their 
     timely reauthorization is critical to the ability of FDA to 
     continue to carefully and expeditiously review and approve 
     new drugs and devices to benefit the health of the American 
     people.
       The Administration is committed to further improving drug 
     safety through better tools for surveillance of drug events, 
     improved scientific tools for evaluating drug safety 
     problems, and better means of communicating drug safety 
     problems to providers and patients. However, the 
     Administration is concerned that the bill, as written, would 
     require significant resources to implement burdensome process 
     changes that will not contribute meaningfully to improving 
     drug safety. For example, the prescriptive timeframes to 
     develop and process Risk Evaluation and Mitigation Strategies 
     are particularly burdensome and are not likely to contribute 
     to improving drug safety. Additionally, the Administration is 
     concerned about the provision in S. 1082 that would use 
     increased user fees to fund certain additional drug safety 
     activities that were not agreed to during the statutorily 
     required Agency-industry negotiations. This provision reopens 
     and is inconsistent with the Administration PDUFA proposal 
     that was developed through extensive consultation.
       There are other provisions in S. 1082 that also raise 
     serious concerns. Specifically, the bill would make changes 
     to the BPCA and PREA to reduce the incentives to conduct 
     clinical trials for children, thus reducing the effectiveness 
     of the program. It also would impose administrative burdens 
     that would make the programs inefficient and in many ways 
     unworkable. These provisions would reduce the flexibility the 
     agency needs to conduct these programs, require an 
     inefficient duplication of scientific expertise, and cause 
     delays in the review of pediatric assessments. Both BPCA and 
     PREA have been very successful in providing the necessary 
     incentives for drug companies to conduct pediatric clinical 
     trials to improve our understanding of how drugs work in 
     children, thus enhancing the quality of their medical care. 
     BPCA and PREA should be extended without modification.
     Potential Amendments: Follow-on Protein Products and 
         Importation of Prescription Drugs
       The Administration supports the goal of making safe and 
     effective drugs available and affordable for American 
     consumers. While some in Congress may be interested in 
     attaching legislation related to follow-on protein products 
     to this bill, the Administration believes that these complex 
     issues should be considered thoroughly through a robust 
     scientific, regulatory, and legal discussion. Sufficient 
     discussion has not yet occurred and should not be abbreviated 
     for the convenience of a particular legislative vehicle. Any 
     legislative proposal considered to authorize a regulatory 
     pathway for follow-on protein products must, as a first 
     priority, ensure the safety and efficacy of the resulting 
     products, thus protecting patient safety. Furthermore, it 
     should also include adequate intellectual property 
     protections for innovators, in order to maintain the research 
     enterprise that has generated life-saving medications. The 
     Administration believes further discussion must take place 
     before addressing these issues in legislation. The 
     Administration strongly opposes the inclusion in this bill of 
     any provision related to follow-on protein products.
       The Administration would also strongly oppose any provision 
     that might be added on the Senate Floor regarding the 
     importation of prescription drugs that does not address the 
     serious safety concerns identified in the December 2004 
     Department of Health and Human Services Task Force Report on 
     Prescription Drug Importation. The Administration believes 
     that allowing importation of drugs outside the current safety 
     system established by the FDA without addressing these 
     serious safety concerns would threaten public health and 
     result in unsafe, unapproved, and counterfeit drugs being 
     imported into the United States. As a result, if any such 
     importation provision were included in the final version of 
     the bill presented to the President, the President's senior 
     advisors would recommend that he veto the bill.
       The Administration strongly opposes the inclusion of any 
     unrelated provisions that would disrupt the timely 
     reauthorization of the user fee program. The Administration 
     looks forward to working with Congress to reauthorize PDUFA 
     and MDUFMA expeditiously to avoid any disruptions to these 
     successful programs.

  Mr. COCHRAN. Mr. President, these conditions contained in this 
amendment are the same as those the Senate has previously adopted on 
other occasions on other bills. I urge the Senate to again support this 
language and approve this amendment.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I thank the Senator from Mississippi for 
his cooperation. For the information of our colleagues, if we get 
cloture on the Dorgan amendment tomorrow, sometime prior to the 
expiration of the 30 hours, we will vote on the Cochran amendment. That 
is a notice for Members about when we will address this issue. I thank 
the Senator.
  The Senator from Colorado raised important issues during the markup, 
and he has a very significant amendment to offer to the Senate. I hope 
we will hear from him at this time.
  The PRESIDING OFFICER. The Senator from Colorado.


                           Amendment No. 982

  Mr. ALLARD. Mr. President, I ask unanimous consent to lay aside the 
pending amendment, and I call up amendment No. 982.
  The PRESIDING OFFICER. Without objection, it is so ordered. The clerk 
will report.
  The assistant legislative clerk read as follows:

       The Senator from Colorado [Mr. Allard] proposes an 
     amendment numbered 982.

  Mr. ALLARD. Mr. President, I ask unanimous consent that the reading 
of the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

     (Purpose: To strike provisions related to market exclusivity)

       Strike subparagraphs (D) and (E) of section 402(a)(6).

  Mr. ALLARD. Mr. President, first, I thank the chairman, Senator 
Kennedy, and the ranking Republican, Senator Enzi, for the bipartisan 
way in which they have worked in the committee, of which I am a new 
member. It is the HELP Committee, standing for Health, Education, 
Labor, and Pensions. I appreciate the opportunity to have offered this 
amendment in committee, as well the opportunity to offer it on the 
floor. It is a very important committee.
  The bill, coming out of committee, can withstand some improvement. I 
know both Senator Enzi and Senator Kennedy have sat down and made many 
changes that I think will help relieve some of the concerns we have 
about the bill. That is now in the form of a managers' amendment which 
is before the Senate.
  The issue I remain concerned about is an issue that was in the 
original bill.

[[Page 10916]]

 It remains in the bill, in the managers' amendment, and that is an 
amendment to the Best Pharmaceuticals for Children Act passed in 1997. 
This is an incentive program we put in place for the last decade that 
says to the pharmaceutical industry that if you would put some effort 
into getting children's medications, pediatric medications properly 
labeled for the market, then we will give you, in effect, an extension 
of 6 months on your patent rights. This has been an extremely 
successful program. For the life of me, I don't understand why the 
bill's sponsors feel it is important to put this provision in the bill.
  This is a chart that reflects the drug studies that have been 
completed for kids, which equates to more drugs available for 
pediatricians to use in treating childhood diseases. As one can see, 
the red square on the chart is with no incentives, and very little 
effort was being made. But when the 6-month exclusivity provision was 
provided in the Best Pharmaceuticals for Children Act, we can see how 
dramatic the increase was and how the marketplace responded to this 
incentive.
  In my view, we should not be removing or reducing the incentive for 
any pharmaceutical company to invest in children. Right now, with what 
the current managers' amendment has in it, it takes the 6-month 
exclusivity and reduces it to 3 months, and it has it applied to those 
that are referred to as the blockbuster drugs. In my view, I think we 
need to make sure everybody understands how very important this program 
is. If we go messing with it, we are going to reduce the incentives 
that are in it that have been working so well.
  The Best Pharmaceuticals for Children Act allows the FDA to grant 
drug sponsors pediatric exclusivity. This is 6 months of additional 
market exclusivity--as I said, an extension basically of the patent 
rights--in exchange for conducting and submitting reports on pediatric 
drug studies. Current law is working. There is no reason I see to 
change significantly a program that is working.
  The goal of the program is to develop additional health information 
on the use of such drugs in pediatric populations so they can be 
administered safely and effectively to children. This goal is reflected 
on this chart as being reached. Also, using pediatric research and 
development legislation to attack large pharmaceutical companies, in my 
view, is an abuse of power at the expense of kids. The data shows 
pediatric legislation has resulted in a substantial increase in 
pediatric prescribing information on the labels of those products, 
which have fulfilled the requirements necessary to be granted the 
pediatric exclusivity extension.
  Here is what the GAO study on the Best Pharmaceuticals for Children 
Act has said about how the program has been working for the last 
decade. This study was issued on March 22 of 2007, so it is a current 
evaluation, and here is what they say:

       Prior to enactment of the Food and Drug Administration 
     Modernization Act of 1997, which first established incentives 
     for conducting pediatric drug studies in the form of 
     additional market exclusivity, few drugs were studied for 
     pediatric use.

  Very few were done, as reflected on the chart.

       As a result, there was a lack of information on optimal 
     dosage, possible side effects, and the effectiveness of drugs 
     for pediatric use. Almost all the drugs--about 87 percent--
     that have been granted pediatric exclusivity under the Best 
     Pharmaceuticals for Children Act have had important labeling 
     changes as a result of pediatric drug studies conducted under 
     this Act.

  As a result, exclusivity is working. In fact, it is working so well 
that, in my view, with increased exclusivity we may have even had more 
research and development in the area of pediatric pharmaceuticals. But 
that issue is for another day.
  My amendment doesn't request an increase in what has been working. We 
merely ask that we return in this piece of legislation to that 
exclusivity-linked period, which is 6 months, which has been working so 
very well under current law.
  Some Members want to try to damage the blockbuster drug companies by 
reducing the exclusivity for those businesses, but in reality the ones 
who are really being hurt are our kids because we take away the number 
of choices a pediatrician has in providing drug therapy for those kids 
who could be seriously ill.
  I ask my colleagues to support me in my amendment and to return us to 
the 6-month exclusivity and away from the 3-month exclusivity period we 
currently have in the managers' amendment.
  Mr. President, I yield the floor.
  Mr. KENNEDY. Mr. President, in a few moments we will hear from 
Senator Dodd, who was the architect for the whole undertaking in terms 
of testing for children, and also for the children's prescription drug 
program which has been immensely successful. He deserves great credit 
for it. I am sure he gets a great deal of satisfaction from it. It was 
bipartisan, with Senator DeWine, going back many years, and certainly 
Senator Clinton has added an additional dimension to this whole 
proposal. But Senator Dodd has studied this issue very carefully, and 
he really is the originator of the concept. He has followed it closely, 
and he will speak to the Senate on this matter in a very short time.
  I see my friend from Ohio on the Senate floor, who also wishes to 
address it, but I will just say a brief word. I believe what we have in 
the legislation, which was earlier fashioned by the Senator from 
Connecticut, is the way to go, and I would hope the Allard amendment 
will not be accepted.
  One of the major elements in the FDA bill is the program providing 
incentives for developing the new drugs, and Senator Dodd, Senator 
Clinton, Senator Alexander, and many others have been champions of this 
program, as was our former colleague, Senator DeWine. The 
reauthorization of an effective program is an opportunity to strengthen 
those aspects that work well and to improve those that need adjustment. 
Senator Dodd took up this challenge and renewed the information about 
how the program has worked over the years since Congress last reviewed 
it.
  He found that companies were sometimes rewarded with billions of 
dollars in additional sales in return for doing studies that cost them 
only a few million. Clearly, one must provide incentives to develop new 
drugs for children, but we must be responsible in doing so. That is why 
in this reauthorization, Senator Dodd included a proposal to adjust the 
period of market exclusivity for drugs that generate over a billion 
dollars in sales. If they generate over a billion dollars in sales, 
these blockbuster drugs will receive only 3 months of exclusivity 
instead of 6 months, available to other drugs.
  The Allard amendment would delete this sensible provision and give 
all drugs the full 6 months. That could be worth billions of dollars 
for a major medication. Those extra 6 months don't just apply to sales 
for use in children, they apply to all sales. That means a heart drug 
tested in children would get 6 months protection from competition, so 
it can wrack up big returns.
  The amendment we face embodies a policy that has no proportionality. 
It gives the same broad protection to a drug such as Lipitor or Xanax 
as it does to a specialty drug that might be helpful in treating ear 
infections in children. Senator Dodd's proposal has that sense of 
proportional reward, but the amendment overturns it. That is the wrong 
approach, and I hope the Senate will reject it.
  Mr. President, I see my friend and colleague from Ohio wishes to 
address this issue, and I yield the floor.
  Mr. BROWN. Mr. President, I thank Senator Kennedy, and I want to join 
my colleagues, and I will precede Senator Dodd and join him and Senator 
Kennedy and others in urging a ``no'' vote on the amendment offered by 
the Senator from Colorado.
  Drugmakers, as we know, have exclusive rights to market a 
prescription drug under a patent. That means no generic drugs are 
allowed on the market. There is no price competition and nothing to 
prevent drugmakers from charging top dollar for their products. Top 
dollar, as many of our constituents

[[Page 10917]]

know all too well, for a prescription drug can be breathtaking. A 30-
day supply of Nexium, the little purple pill, costs about $193; a 30-
day supply of Exelon, an Alzheimer's drug, is $214; a 30-day supply of 
Pravachol, a statin drug, is $168. Under current law--under current 
law--drugmakers are rewarded an additional 6 months of competition- 
free time on the market when they agree to evaluate a prescription drug 
for use in children--6 months.
  That is a tradeoff. It is a tradeoff the House and Senate agreed to, 
where adult consumers of this drug--adult consumers of the drug--are 
denied a less costly generic version of, for example, Prilosec, for an 
additional 6 months. This means their out-of-pocket health care costs--
or their employer, or their insurance company, or the government--are 
significantly higher than they otherwise would be. That is the 
tradeoff.
  At the same time, drugmakers agree to conduct pediatric testing they 
wouldn't have done voluntarily, sometimes for reasons all their own, 
and those tests provide invaluable information to pediatricians for the 
proper use and dose of medicines prescribed to children. That was the 
agreement--the 6-month exclusivity agreement. That incentive has worked 
to increase, we all agree, the number of pediatric tests drugmakers 
conduct. That is important. Pediatricians now have access to new 
information that has enabled them to make better use of prescription 
drugs to help our Nation's children.
  My colleague, Senator Dodd, championed the 6-month exclusivity law in 
his efforts in this area, as did my predecessor in the Senate, and so 
many others, and their work has improved the lives of children. 
Needless to say, the Senator from Connecticut would not arbitrarily or 
recklessly make changes to the pediatric exclusivity law. It was his 
idea and his work. He clearly isn't going to compromise it. But he is 
recommending one change, and this amendment, the Allard amendment, 
undoes that change, which is included in S. 1082.
  He is recommending if a drug generates more than $1 billion in 
revenues--that is, it is a blockbuster drug--if the drug generates more 
than $1 billion in revenue, that drug should receive an additional 3 
months of market exclusivity instead of 6 months. The reason is both 
simple and compelling.
  It costs about $13 million--think about these numbers--it costs about 
$13 million to conduct pediatric testing on a new drug. If a drugmaker 
is taking in $1 billion a year on that drug, $13 million is about 1 
percent of their revenues on that drug. Giving that drugmaker an 
additional 6 months of market exclusivity on a $1 billion drug costs 
health care consumers and taxpayers--the taxpayers who cover the cost 
of public health programs such as Medicare, Medicaid, and the VA--it 
costs them millions of dollars each day.
  This is not, as Senator Allard said, a provision to punish the drug 
companies. It is a provision to help people with their out-of-pocket 
drug costs. It is a provision to help taxpayers who fund Medicare, 
Medicaid, and the VA. It is a provision to help those businesses that 
are funding health care and drug plans for their employees.
  The Federal Government could do it another away. The Federal 
Government could reimburse drugmakers for the cost of pediatric tests. 
It could reward them with a 600-percent profit on conducting those 
tests, and it would still cost appreciably less than rewarding them an 
additional 6 months of exclusivity. That is why we made the decision 
not to do it that way. But in light of the astounding imbalance between 
the cost of conducting a pediatric test--$13 million--and the reward 
that 6 months of exclusivity provides when it comes to a $1 billion 
drug, Senator Dodd recommended we cut that in half. We provide 3 months 
of exclusivity for billion-dollar drugs instead.
  It is still a breathtaking reward: A $1 billion drug gets a 3-month 
exclusivity instead of a 6-month exclusivity for a $13 million test--a 
breathtaking reward for one pediatric test, but it is measurably more 
justifiable than the 6-month moratorium on price competition.
  Common sense, fiscal responsibility, and the fact that all of us in 
this Chamber report to U.S. taxpayers dictate that we support Senator 
Dodd on this modest change in his own program. The Allard amendment 
gives $1 billion drugs a 6-month exclusivity instead of 3. The logic 
is, if 6 months of market exclusivity is working to prompt drugmakers 
to conduct pediatric testing, we shouldn't change it. By that logic, we 
might as well give drugmakers 100 years of market exclusivity. I am 
sure that would work, too.
  The point is, we have to draw the line to encourage pediatric 
testing, which this will, and to save money for our employers, for our 
taxpayers, and for senior citizens' out-of-pocket costs. When a 
drugmaker earns hundreds of millions of dollars, in many cases out of 
the pockets of U.S. taxpayers, for a pediatric test that costs about 
$10 million, that is unnecessary, it is unjustifiable, and it is 
outright wrong.
  Please vote for common sense, for protecting our children, for U.S. 
taxpayers, for consumers, and against the Allard amendment.
  Mr. ALLARD. Mr. President, the Senator from Wyoming, who is managing 
the time, has granted permission for me to speak for 5 minutes.
  Mr. President, I forgot to ask unanimous consent that the following 
individuals be added as cosponsors on my amendment: Senator Bond, 
Senator Hatch, and Senator Alexander.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. ALLARD. Mr. President, I would like to respond to this concern 
about drug companies investing relatively little and having huge 
returns. That doesn't apply to every drug.
  Obviously, when you are developing a product for the market, there 
will be some that work out rather easily and the development costs may 
not be too much. But there are other drugs that require a substantial 
amount of work and analysis, and a considerable amount of thought has 
to go into the labeling. When those costs get high and when you hit 
those, the profit margin is not so large. I hate to see us pick out a 
few companies that may have had a windfall and then punish our children 
and say we are going to take away an incentive that has resulted in 80 
percent of the children's drugs that have come to the market being 
approved and getting the proper licensing they require.
  In my view, we pick out a few outrageous circumstances and then we 
try and take away an incentive that has been working so well for us.
  My point, again, is why mess with that incentive when it is working 
so very well? As I had indicated here on the charts, we had such 
tremendous results in getting children's pediatric drugs to the market. 
This allows the pediatrician more choice in selecting therapies for 
their patients. It means better medicine. I also believe that the more 
products you have on the market, the more competition you have, and the 
more competition you have, that then holds down the price of drugs. 
What we need to do is rely on the markets to control the price of 
drugs, to control supply. I hate to see the Government or this Congress 
try to apply any kind of artificial parameters that somehow or other 
would mean we would have fewer drugs for the treatment of our kids and 
their ailments.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Mr. President, I rise today in support of this amendment by 
Senator Allard which would strike a cap on pediatric research 
incentives for blockbuster drugs with more than $1 billion in annual 
sales. That sounds like a lot. We are going to quibble here about 
whether they get 3 months of additional time or 6 months of additional 
time. They have had 6 months of additional time.
  Incidentally, this is one time per drug. This is not every time they 
can come up with a child's use they can extend another 3 months or 6 
months; this is one time on any drug, they can get an extension of 6 
months.
  Now we are going to decide that a company that comes up with a really 
great drug is only going to get 3 months versus 6 months because they

[[Page 10918]]

make $1 billion in annual sales? Three months' worth would be $250 
million in annual sales, and that sounds like a lot, but when you 
figure out what is profit out of that, it is a much smaller number.
  I congratulate Senator Dodd for originally coming up with this 
incentive. He came up with the idea for 6 months, and it worked. You 
have seen the chart that shows how dramatically there was an increase 
in the number of drugs that were studied for kids and how proper doses 
were derived for kids. The Allard amendment ensures that pediatric 
studies that are essential to our children's health and well-being will 
continue to take place, that they will continue the same as they have 
with the same incentives and the same requirements. Under current law, 
in exchange for performing a pediatric study, a manufacturer can 
receive an additional 6 months of market exclusivity, one time per 
drug. This is a powerful incentive to ensure pediatric studies are 
completed. The substitute amendment we are debating today limits this 
exclusivity to just 3 months, and I am concerned that this will reduce 
or limit the number of pediatric studies. Senator Allard's amendment 
would revert back to current law. If we support and pass the amendment 
of Senator Allard, we go to current law, so manufacturers can receive 
the additional 6 months of market exclusivity.
  Before incentives, there were very few pediatric studies. In the 7 
years before Congress authorized incentives, only 11 pediatric studies 
were completed; 7 years, 11 studies--embarrassing. But at least 132 
pediatric studies were completed, and more are ongoing. The current 
incentive system works.
  This is not an abstract policy issue. Pediatric drug studies can mean 
the difference between life and death for our children. For example, 
initial research indicates that Viagra, which is a blockbuster drug, 
can work miracles for children with pulmonary fibrosis, a rare and 
potentially fatal lung disorder. Viagra seems to relax and expand blood 
vessels in afflicted children's lungs. Incentives spurred Pfizer to 
perform studies that are now underway and could save approximately 
28,000 children who might otherwise die or suffer greatly. Without 
powerful incentives, such studies might not get done.
  The Democratic witnesses at the HELP Committee's--the Health, 
Education, Labor, and Pension Committee--recent hearing agreed that 
caps are a risky experiment. The number--zero incentives, 11 studies; 
strong incentives, 132 studies--that speaks for itself. Reducing 
incentives will certainly reduce the number of pediatric studies. We 
should not undercut a system that is proven to help kids and then say 
we are improving the program. I don't think so.
  I strongly agree we need to do everything we can to make health care 
more affordable and accessible, but harming a worthwhile program that 
saves kids' lives is the wrong way to do it. It is wrong to play the 
politics of drug pricing at the expense of our kids. We should protect 
these incentives which are proven to work.
  Again, I congratulate Senator Dodd for coming up with the idea of 
providing these incentives. I wish to note for the record it was at 6 
months that we provided that. I ask that you support the Allard 
amendment.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Brown). The senior Senator from 
Connecticut is recognized.
  Mr. DODD. Mr. President, let me first begin by thanking Senator 
Kennedy and Senator Enzi for including the Best Pharmaceuticals for 
Children Act and the Pediatric Medical Device Safety and Improvement 
Act in the bill before us. I congratulate them, particularly Senator 
Kennedy for his efforts of putting all this together, this major 
legislation which is going to be so important for the health and well-
being of all our citizenry. I am very grateful to him, and to Senator 
Enzi as well, for leading the minority on this issue and making it 
possible for us to be here today to discuss these issues.
  My friend from Colorado and I worked together on this issue. I 
appreciate the comments about the effort we made over the past decade 
or more to try to do what this bill was designed to do and has done, 
and that is to increase the clinical trials and testing of products 
used in our younger Americans--children.
  In too many cases, prescription drugs were being tested for adults, 
and there was an assumption that a smaller dosage of that product would 
be all that was necessary to take care of children. Obviously, that was 
not the case, as we heard in significant testimony over the years.
  Countless hours have gone into the work on this legislation. The 
Presiding Officer has been a tremendous help. I thank him for his 
efforts, along with others on this committee helping us put this 
together.
  It must be an Ohio tradition. As he has heard me say on occasion, 
Senator Brown has been tremendously supportive, working on this issue. 
He was active on the issue when he served in the other body, and he 
brought his talents and knowledge to the issue when he arrived here 
recently. His predecessor, Senator DeWine, was my cosponsor on this 
bill for a decade, on a bipartisan basis putting the legislation 
together that has produced the results which have been identified by 
Senator Allard and Senator Enzi already this morning.
  We find ourselves here having worked very carefully together on a 
bipartisan basis for more than a decade to craft legislation. None of 
us are claiming perfection here. The idea was to try to induce the 
industry to step forward and do something they had not done before--to 
test their products in children. We were not certain when we started 
out how this would actually work. Ten years ago, we saw a situation 
where the majority of drugs being used in children were not being 
tested for their use.
  Children are not simply little adults. The results of drug studies 
conducted under the Best Pharmaceuticals for Children Act have shown 
they should not be treated as such. The initiative contained in the 
bill before us on pediatric medical devices is a similar effort to 
ensure children are not left behind as cutting-edge research and 
revolutionary technologies for medical devices advance.
  Senator DeWine, as I mentioned, and I authored this bill more than a 
decade ago, at a time when only 11 drugs on the market that were being 
used for children had actually been tested and studied for that use. 
Prior to the enactment of this legislation a decade ago, pediatricians 
were essentially flying blind because they lacked information regarding 
the safety and effectiveness of drugs they were prescribing. It was 
often the children who suffered the most.
  What we have learned over this past decade after 10 years of 
experience is that children have been exposed to ineffective drugs, 
ineffective dosing, overdosing, or drug side effects that were 
previously unknown. In 10 years, nearly 800 studies involving more than 
45,000 children in clinical trials have been completed as a result of 
this legislation. Useful new pediatric information is now part of 
product labeling for more than 119 drugs.
  In sum, there has been a 20-fold increase in drugs studied in 
infants, children, and adolescents as a result of the legislation I 
authored 10 years ago. Children with a wide range of diseases such as 
HIV/AIDS, cancer, allergies, asthma, neurological and psychological 
disorders, and obesity can now lead healthier and more productive lives 
as a result of new information about the safety and efficacy of drugs 
they use to treat and manage their diseases when previously there was 
none. This successful program for children will expire on the 30th of 
September unless we reauthorize it.
  I have spent months crafting a proposal to reauthorize this 
legislation, which is now reflected in the underlying bill. It had been 
my hope that this initiative would continue in that bipartisan 
tradition that began more than a decade ago. Fashioning legislation 
when there are 100 of us here, trying to come up with ideas, and yet 
balance disparate views and opinions. There are some, frankly, who 
would

[[Page 10919]]

have no periods of exclusivity and believe the industry ought to be 
doing this as a matter of obligation to one out of four Americans. You 
have heard from others who think we ought to provide extended periods 
of exclusivity, longer than 6 months. It is not easy to fashion these 
compromises here, where you can put something together that does what 
we want to do, all the while ensuring that the program can continue to 
generate more benefits than were originally contemplated. There has to 
be some limitation in terms of how we deal with all this.
  I thank Senators Kennedy, Harkin, Bingaman, Murray, Reed, Clinton, 
and Brown, who all cosponsored the legislation I introduced which, as I 
previously mentioned, has been incorporated on this bill.
  Mr. President, I will ask unanimous consent that these letters be 
printed in the Record so my colleagues will know the bill we are 
considering is not something we threw together haphazardly. This was 
major, extensive work with major organizations in this country that 
spend every waking hour working on children's diseases and issues that 
affect their health. I am grateful to the AIDS Alliance for Children, 
Youth & Families; the American Academy of Child and Adolescent 
Psychiatry; American Academy of Pediatrics; the American Brain 
Coalition; American Pediatric Society; the American Psychiatric 
Association; the American Thoracic Society; the Arthritis Foundation; 
the Association of Medical School Pediatric Department Chairs; 
Children's Cause for Cancer Advocacy; Elizabeth Glaser Pediatric AIDS 
Foundation; National Association of Children's Hospitals; National 
Organization for Rare Disorders; Society for Pediatric Research--the 
list goes on.
  I ask unanimous consent to have printed in the Record two letters 
from this myriad of organizations which every day are involved with 
children's health and are strong advocates of what we are doing here 
and respectfully disagree with the amendment offered by Senator Allard 
today.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                   April 17, 2007.
     Hon. Edward Kennedy,
     Hon. Christopher J. Dodd,
     Hon. Michael B. Enzi,
     Hon. Hillary Rodham Clinton,
     U.S. Senate,
     Washington, DC.
       Dear Senators Kennedy, Enzi, Dodd and Clinton:  As 
     organizations working to ensure better health care for the 
     nation's children, we write to thank you for your 
     longstanding commitment to children's health and to express 
     our support for legislation to reauthorize the Best 
     Pharmaceuticals for Children Act (BPCA) and the Pediatric 
     Research Equity Act (PREA) and to improve children's access 
     to safe medical devices. We are very pleased that BPCA and 
     PREA reauthorization language and S. 830, the Pediatric 
     Medical Device Safety and Improvement Act, have been included 
     in the Chairman's mark of S. 1082, the ``Food and Drug 
     Administration Revitalization Act,'' for consideration by the 
     Senate Health, Education, Labor and Pensions Committee 
     tomorrow.
       Over the past decade, Congress has enacted bipartisan 
     legislation that has dramatically increased the number of 
     drugs tested and labeled for children. The results from BPCA 
     are extraordinary--over 336 requests have been generated for 
     over 780 pediatric studies, resulting in over 115 new drug 
     labels for children. Sen. Dodd's BPCA reauthorization 
     language strengthens this very successful existing program in 
     several important ways, including ensuring prompt label 
     changes, requiring that all study protocols and results be 
     made public, improving adverse events reporting for children, 
     and identifying and addressing important gaps in treatments 
     for children's diseases. In addition, the BPCA language 
     includes a reasoned approach to address the small percentage 
     of drugs for which the exclusivity provision has far exceeded 
     the incentive it was intended to provide pharmaceutical 
     companies.
       S. 993, the Pediatric Research Improvement Act (PRIA), 
     introduced by Sen. Clinton and included in the Chairman's 
     mark, reauthorizes the Pediatric Research Equity Act of 2003 
     (PREA), which requires drug manufacturers to test their 
     products for use in children. This law ensures that children 
     are not a therapeutic afterthought and has generated 
     impressive and invaluable safety and dosing information for 
     children. Since the 2003 passage of PREA, 55 drugs have new 
     or improved pediatric labeling. These drugs range from 
     treatment of ear infections to the prevention of rejection of 
     organ transplants. S. 993 places children on equal 
     therapeutic footing with adults by creating the presumption 
     that medicines coming onto the market for illnesses and 
     conditions that occur in children will be labeled for 
     pediatric use and be available in formulations (e.g., 
     liquids, chewable tablets) that children can take.
       The Pediatric Medical Device Safety and Improvement Act of 
     2007 provides a comprehensive approach to ensuring that 
     children are not left behind as cutting-edge research and 
     revolutionary technologies for medical devices advance. Like 
     drugs, where for too long children were treated like small 
     adults, many essential medical devices used extensively by 
     pediatricians are not designed or sized for children. 
     According to pediatricians, the development of new medical 
     devices suitable for children's smaller and growing bodies 
     can lag 5-10 years behind those for adults. S. 830 improves 
     incentives for devices for small markets--while still 
     preserving the ability to ensure the safety of new products 
     once on the market. It provides assistance to innovators, 
     streamlines regulatory processes, and elevates pediatric 
     device issues at the Food and Drug Administration (FDA) and 
     the National Institutes of Health.
       Despite support for the Chairman's mark, we are 
     disappointed that a key provision to make PRIA permanent has 
     been omitted. As this legislation moves to the floor of the 
     Senate, we urge you to restore the permanent authority of the 
     FDA to ensure that children have properly studied medications 
     as a matter of fact, not chance.
       We are grateful for your longstanding leadership and 
     commitment to improving the health of our nation's children 
     and look forward to working with you toward swift Committee 
     action and passage of these pediatric therapeutic bills by 
     the full Senate.
           Sincerely,
         American Academy of Pediatrics; Elizabeth Glaser 
           Pediatric AIDS Foundation; AIDS Alliance for Children, 
           Youth & Families; American Academy of Child and 
           Adolescent Psychiatry; American Brain Coalition; 
           American Pediatric Society; American Psychiatric 
           Association; American Thoracic Society; Arthritis 
           Foundation; Association of Medical School Pediatric 
           Department Chairs; Children's Cause for Cancer 
           Advocacy; National Association of Children's Hospitals 
           (N.A.C.H.); National Organization for Rare Disorders; 
           National Research Center for Women and Families; 
           Society for Pediatric Research.
                                  ____

                                                      May 1, 2007.
     Hon. Christopher J. Dodd,
     U.S. Senate,
     Washington, DC.
       Dear Senator Dodd: As organizations working to ensure 
     better health care for the nation's children, we write to 
     express our support for your legislation to reauthorize the 
     Best Pharmaceuticals for Children Act (BPCA), which has been 
     included in S. 1082, the ``Food and Drug Administration 
     Revitalization Act.'' Since its original enactment in 1997, 
     this legislation has directly resulted in an extraordinary 
     increase in the number of drugs tested and labeled for 
     children. In the past ten years, BPCA has prompted over 780 
     pediatric studies and yielded 115 new drug labels for 
     children, fundamentally changing the practice of pediatric 
     medicine and the quality of health care for our nation's 
     children.
       Since the inception of BPCA, Congress has recognized the 
     need to ensure that it strikes the appropriate balance 
     between cost to consumers and benefits to children. This year 
     we have the data to show that we can adjust the exclusivity 
     provision without losing pediatric studies. In February, the 
     Journal of the American Medical Association (JAMA) published 
     a study of the profits drug manufacturers received from the 
     additional 6 months of pediatric exclusivity. The study found 
     that ``the Pediatric Exclusivity Program overcompensates 
     blockbuster products for performing clinical trials in 
     children.''
       The approach taken by your BPCA reauthorization legislation 
     appropriately addresses the small number of products for 
     which the benefit of additional exclusivity has far exceeded 
     the incentive it was intended to provide. By limiting 
     exclusivity only for those products with sales over $1 
     billion, your proposal can address concerns about excessive 
     profits without jeopardizing the extraordinary benefits of 
     BPCA for children's health. The adjustment will significantly 
     reduce the overall cost of pediatric exclusivity to 
     consumers. We therefore oppose Senator Allard's amendment to 
     strike this reasonable exclusivity adjustment from S. 1082.
       We are grateful for your leadership and commitment to 
     improving the health of our nation's children and look 
     forward to swift passage of BPCA by the full Senate.
           Sincerely,
         AIDS Alliance for Children, Youth & Families; American 
           Academy of Child and Adolescent Psychiatry; American 
           Academy of Pediatrics; American Brain Coalition; 
           American Pediatric Society; American Psychiatric 
           Association; American Thoracic Society;

[[Page 10920]]

           Arthritis Foundation; Association of Medical School 
           Pediatric Department Chairs; Children's Cause for 
           Cancer Advocacy; Elizabeth Glaser Pediatric AIDS 
           Foundation; National Association of Children's 
           Hospitals (N.A.C.H.); National Organization for Rare 
           Disorders; Society for Pediatric Research.

  Mr. DODD. To anyone offering to flyspeck this proposal and offer 
variations to it, I would say that months and months have gone into 
this legislation which we think has had the dual effect of ensuring 
that the ramifications of expanding the length of exclusivity, as some 
have proposed, have been carefully considered along with proposals to 
limit the length of exclusivity to 3 months for all drugs, as others 
have proposed. The bill before us balances many viewpoints on this 
program and is a proposal that 15 major organizations involved with the 
effort strongly support.
  Throughout the 10-year history of the Best Pharmaceuticals for 
Children Act, Congress has recognized the need to ensure it strikes the 
appropriate balance between the cost to consumers and benefits to 
children. By instituting a 5-year sunset in both the original 
legislation in 1997 and the first reauthorization in 2002, Congress was 
acknowledging the ongoing need to evaluate the cost of the incentive 
under this act to consumers in relation to the benefit of having 
medications properly studied and labeled for children.
  The 6-month incentive of exclusivity has been very successful in 
generating pediatric studies. Yet after 10 years, experience and data 
have shown us that for a small number of drugs, pediatric exclusivity 
has far exceeded the carrot that was designed to encourage people to 
move forward.
  In February of this year, the Journal of the American Medical 
Association published a study of the profits drug manufacturers 
received from the additional 6 months of pediatric exclusivity.
  The study found that most of the drugs studied under the Best 
Pharmaceuticals for Children Act in recent years received relatively 
modest returns. In fact, data shows that many drugs came close to 
breaking even with respect to financial returns on investment for 
conducting pediatric trials. In one place they may have had a negative 
return.
  However, the study also found, and I quote them here, that ``the 
pediatric exclusivity program overcompensates blockbuster products from 
performing clinical trials in children.''
  S. 1082 contains a very reasonable, workable mechanism to address 
cost concerns. By adjusting exclusivity from 6 months to 3 months only 
for those products with U.S. sales over $1 billion, I think S. 1082 can 
address consumer concerns about excessive profits without jeopardizing 
the extraordinary benefits of this legislation.
  I don't think it is too much to ask. That is why we have the sunset 
provisions in this program, to be able to go back and analyze how this 
is working every 5 years. So for those products in excess of a $1 
billion, we shorten exclusivity. I am satisfied.
  Pfizer, a leading drug company in this country, supports this 
proposal. The producer of the largest blockbuster drug in the world 
says this is a good compromise. Why are my colleagues having a hard 
time? If a major drug company who has benefitted under this exclusivity 
and manufactured blockbuster drugs says this bill is a sound 
compromise, what is the problem my colleagues have with this proposal?
  If Pfizer, a company that has benefitted from this program says this 
balance is a healthy one, why can't my colleagues be happy with it?
  This bill is a good bill. It has done a good job for people. But 
let's remind ourselves that we also have a responsibility to consumers. 
And when consumers find themselves in a situation where they can't 
afford lifesaving medicines, then it is time for us to strike a 
balance. This bill has a sunset provision in it. I am for the sunset 
provision. I am for it because we need to come back again in 5 years 
and assess where we are on this issue rather than make a determination 
that in perpetuity this is a program and a balance that makes sense 
forever.
  According to the Congressional Budget Office, eliminating the 
exclusivity adjustment, as the amendment offered by my colleague from 
Colorado would do, would increase the cost of exclusivity to the 
Federal Government by $50 million over 10 years. So in addition to the 
consumers, taxpayers are going to be asked to pay an additional $50 
million under the Allard amendment.
  Again, if we have drug companies saying they think this proposal is a 
good balance, why are we adding a $50 million pricetag to the taxpayers 
with the Allard amendment, not to mention the cost of these drugs 
increasing as a result of extending exclusivity from 3 months to 6 
months for products with sales in excess of $1 billion?
  As I said, this is something I have worked on for a long time in a 
bipartisan fashion: to strike a balance as we've tried to do for 10 
years between benefits to children and cost to consumers. To now say 
all of us who have worked on this program are wrong, all of the 
organizations involved with children's health are wrong, and drug 
companies that have benefitted from this program are wrong--but we know 
best. We know best. We think those billion-dollar products deserve to 
be protected. We think the taxpayers should foot the $50 million bill 
and the cost of these drugs are irrelevant in this debate. Well, they 
are not irrelevant.
  We may do great damage to something we are trying to achieve after a 
decade of hard work on a bipartisan basis to put this together. I say 
respectfully to my friend from Colorado and the Senator from Wyoming, 
we have worked hard to strike these balances. It is not easy. These are 
complicated issues. It requires cooperation on both sides of the aisle 
to get the job done. That is what I have done for a decade with Members 
of that side of the aisle to see to it that we have a good, strong 
bill. The result is a program which has gone far beyond what we 
anticipated might happen.
  The slight adjustment we have made after analyzing this bill after 10 
years is little to ask. If one of the largest beneficiaries of the 
program is satisfied, and if the organizations who support this program 
believe it is all right, why are we adding a $50 million pricetag and 
asking consumers to pay more?
  I urge my colleagues to reject the Allard amendment when the vote 
occurs. I thank Senator Kennedy and others who have worked so hard to 
make this possible. This is a very important piece of legislation, and 
one that can do an awful lot of good. The amendment offered by my 
colleague from Colorado puts that at risk. Our children in this country 
deserve better than what he is offering, which is to try to break up 
the delicate balance I have tried to put together for a decade.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Utah is recognized.
  Mr. HATCH. Mr. President, I thank my dear colleague from Tennessee 
for allowing me to go first, and also my two colleagues on the 
Democratic side, Senators Carper and Stabenow.
  I ask unanimous consent that Senator Alexander be permitted to go 
next and then Senator Carper and then Senator Stabenow.
  The PRESIDING OFFICER. Is there objection?
  Mr. KENNEDY. Reserving the right to object, I think it would be 
useful if we rotate it back and forth.
  Mr. HATCH. I think we have an agreement among the four of us.
  Mr. KENNEDY. If the Senator from Delaware is satisfied, that is fine 
with me.
  Mr. ENZI. One of the things we are trying to do is keep the debate on 
the children's amendment so we can get a conclusion to the children's 
amendment before time deadlines come up. So if those who wanted to 
speak on other issues can reserve their time until later, that would be 
very helpful.
  Mr. HATCH. I would add to that request the Senator from Oklahoma 
after Senator Stabenow.
  Mr. KENNEDY. We still have the Pastore rules in effect, which means 
the debate on the first 2 hours is supposed to be on matters which are 
subject to it. I mean it is not generally enforced, but Senator Enzi 
and I are trying to move forward.

[[Page 10921]]

  The PRESIDING OFFICER. Is there objection to the unanimous consent 
request from the Senator from Utah?
  Without objection, it is so ordered. The Senator from Utah is 
recognized.
  Mr. HATCH. Mr. President, I thank my colleagues, including the two 
managers of the bill on both the Democratic and the Republican side.
  I rise in support of the Allard amendment. I want to take a few 
minutes to talk about pediatric testing and research provisions 
included in this bill. I have strongly supported both the Best 
Pharmaceuticals for Children Act and the Pediatric Research Improvement 
Act.
  As my colleagues know, current law provides 6 months of exclusivity 
for drugs that do research and development in the area of pediatric 
use. I am very interested in keeping it that way. That has proven very 
efficacious in the Hatch-Waxman bill. It keeps companies involved in 
developing great drugs for children in this area. So it is a very 
important part of this.
  I was deeply involved in those negotiations in 1997 with my former 
colleague, our former colleague, Senator Mike DeWine. I have supported 
these efforts from Ohio Senator Mike DeWine that brought additional 
pediatric testing of prescription drugs to our attention during 
consideration of the FDA Modernization Act of 1997. He fought long and 
hard to encourage drug companies to conduct clinical trials on 
pediatric uses of their drugs.
  His efforts paid off and this program has been extremely successful. 
As a result, pediatric drugs are safer and more effective for children. 
The bill before us today reduces the 6-month exclusivity period for 
blockbuster drugs to 3 months.
  I emphasize again this market exclusivity has provided the incentive 
needed to increase research and development for pediatric drugs. We 
used the same type of an approach on the orphan drug bill many years 
ago. At that time there were only a few orphan drugs. Today there are 
over 300 being developed. It is the same principle here.
  The Allard amendment restores current law and provides 6 months of 
exclusivity for all drugs. As I mentioned last night, my good friend 
and colleague from Connecticut, Senator Chris Dodd, has also shown 
great leadership on this issue when FDAMA was being considered in 1997. 
He held a hearing on this issue earlier this year with his ranking 
Republican member, Senator Lamar Alexander, who has served long and 
well on this committee.
  That hearing was very insightful, and I believe many of us are trying 
to do the right thing as we reauthorize both programs. I urge my 
colleagues not to lose sight of the purpose of these two programs as we 
make decisions on this part of the bill. We want good solid information 
about the safest way to prescribe drugs for children.
  By giving companies market exclusivity to conduct clinical trials, we 
will know the safest dosage levels for children. So let's not lose 
sight of the original purpose of these programs: to help children have 
the safest dosages for prescriptions.
  Now, it is no secret I support the Allard amendment. I would just 
like to add a few more facts. Nearly two-thirds of the drugs prescribed 
for children have not been studied and labeled for pediatric use. I 
know the importance of accurate clinical information about a drug's use 
in the pediatric population. This smaller body mass and higher 
metabolic rates of children mean they often respond differently to drug 
dosing than adults do.
  A drug that is safe and effective in adults may not always be safe 
for children. The question is not whether we should study the safety of 
drugs for children but how we make that research happen.
  In 1997, Congress considered this issue and created an incentives 
program for companies to study the use of their drugs in pediatric 
populations. The program offers an additional 6-month patent protection 
or exclusivity to drug manufacturers to help recoup the cost of 
investing in these critical pediatric studies. It is a win-win 
situation. Drug companies have the incentive to invest time and extra 
resources for a small share of the market, and, more importantly, 
children get the research they need.
  The evidence is that the incentives for exclusivity should be 
maintained, not lowered. Despite the fact that the bill providing the 
incentive for pediatric studies was enacted a decade ago, nearly two-
thirds of the drugs prescribed for children have not been studied and 
labeled for pediatric use.
  We have had a great deal of study about the need for this incentive 
and how it should work.
  The fact remains that there is a persistent public health need for 
accurate clinical information about how adult drugs will work in 
children.
  Children are not adults, for reasons that the Senator from Oklahoma, 
Dr. Coburn, has well explained to this body.
  Much of what our colleague from Connecticut, Senator Dodd, has just 
said underscores the need for a continued, strong, exclusivity 
provision.
  The statistics he cited about the success of this program are truly 
remarkable and a significant milestone in the history of public health.
  The only place where there seems to be disagreement on Best 
Pharmaceuticals for Children Act is the exclusivity period for what 
some define as ``blockbuster drugs.'' I know the Senator may call the 6 
months period ``gouging'' but that ``gouging'' may very well be the 
incentive that has led to the FDA receiving more than 400 proposed 
pediatric-study requests and receiving 144 completed studies.
  Those who support the Senator's amendment--and I know it is well-
intentioned--suggest that without the 6 months' incentive, the 
pediatric testing will still continue and will be robust. Who knows if 
this is true?
  I wonder if we want to call their bluff and take away this powerful 
incentive? I don't think we can take that chance.
  The PRESIDING OFFICER. The Senator from Tennessee is recognized.
  Mr. ALEXANDER. Mr. President, first I would like to congratulate 
Senator Dodd and others who over the past 10 years have developed this 
piece of legislation. It has been remarkably effective. I think it is 
important as we talk about this that we remind ourselves what we are 
saying. What we are saying is, we live in this country with all of 
these wonderful pharmaceutical drugs for adults, but in many cases, 
before this legislation had been enacted, doctors were flying blind. 
They were guessing about the effect of these drugs on children.
  That sometimes had very unfortunate results. I know that in my home 
State of Tennessee a drug for whooping cough was given to a number of 
children. There had been a clinical trial for the effect it would have 
on adults but not on children. And the children were so seriously 
harmed by the drug that the Centers for Disease Control later found 
that the drug was the reason they needed stomach surgery.
  So it is remarkable that 10 years ago Senator Dodd and others--
Senator DeWine, Senator Hatch, and many others who have been 
mentioned--came up with the idea that if we strike this balance that 
Senator Dodd has referred to several times and give the companies that 
make the drugs a little more time, 6 months with their patent, that 
they in return would then conduct trials on these drugs on how they 
affect children.
  No one knew at that time exactly what would happen. They were 
guessing. This is long before I came to the Senate. But they guessed 
well. As a result, as has been said, about one-third of the drugs that 
are given to children now have had testing and trials for use in 
children. Now doctors, when we bring our babies and grandbabies in, 
have a better idea of what they are doing. They are guessing less. It 
is better for the children.
  In my family we have two new grandchildren under the age of 2. 
Senator Dodd, being younger than I am, has two children who are young 
like that. Maybe he has heard what I have heard. My mother used to say 
to me when I would go to the babies and they were happy, she would say: 
``Son, don't try to make a happy baby happier.''

[[Page 10922]]

  In effect, what she was saying is, leave it alone if it is happy. 
Well, this is a happy piece of legislation for which Senator Dodd and 
others should have a lot of credit. My suggestion would be let's not 
try to make a happy piece of legislation happier. It is happy because 
one-third of medicines are being studied, and doctors know more about 
what they are giving to their patients who are children.
  What the Allard amendment would do is keep the law the way it is. It 
is the bill that is on the Senate floor that would change things.
  I understand this is an estimate, but I listened to the testimony. 
The Senator from Connecticut suggested we are all racing here at the 
last minute and changing it. Wait a minute. We had a hearing on this 
some time ago. It was a terrific hearing. I was there. We heard various 
points of view, a lot of celebration about the effect of this act over 
the last 10 years. The only reason I was not a cosponsor of this 
legislation was because I wanted to hear the testimony about what the 
effect would be of changing this law that is a happy law that has 
worked so well for so long. As a result, it created the situation where 
a third of the children have drugs that doctors know more about.
  After listening to all the testimony, if I were going to change the 
law, I would make the incentive 7 months or 8 months or 9 months. Why 
would I do that? The reason is, at the hearing it was said that while a 
third of the drugs that are administered to children have had been 
tested for use in children, probably we need two-thirds of the drugs 
that are ready for adults to have that sort of testing. In other words, 
we are about halfway where we want to go if we want to have drugs that 
are tested to see what their effect will be on children.
  So my question was, if giving 6 months' incentive has gotten us 
halfway where we want to go, then maybe to get all the way where we 
want to go, we should go to a 7 months' or 8 months' incentive. But my 
feeling at the end of the hearing was, well, the existing law has 
worked well by providing an incentive of 6 months. Let's leave it like 
it is. The end result of the legislation that is on the floor is not to 
leave it like it is but to change it, to reduce it from 6 months to 3 
months, which is exactly backwards.
  What the effect of this reduction will be is to reduce the 
opportunities for tests of drugs for children, which would fail to move 
us along toward the goal of having two-thirds of drugs studied for use 
in children.
  I applaud Senator Dodd. I give him great credit for this. When he 
retires from the Senate in another 30 years, this will be one great 
feather in his cap, as well as for Senator Clinton and others who have 
worked on this. But I would go back to what my mother said: ``Don't try 
to make a happy baby happy.'' Let's not try to make a happy piece of 
legislation happy. Let's leave it the way it is. It has worked for 10 
years. Let's let it work for another 5 years the way it is. Adopting 
the Allard amendment would keep it the way it is.
  I have one suggestion for Senators Kennedy and Enzi, if I may. Maybe 
they would want to consider it as part of the managers' amendment. We 
heard testimony at our hearing that perhaps our goal should be someday 
to get two-thirds or three-fourths of the drugs that are for adults 
studied for use in children. Today it is one-third. I think it would be 
useful for us at a future time to know exactly what our goal ought to 
be. Maybe it ought to be 90 percent. Maybe it ought to be 50 percent. 
But I wanted to suggest to the Senator from Massachusetts and the 
Senator from Connecticut that we might want to include in this 
legislation asking the FDA or the appropriate agency to study what 
percent of drugs approved for adults should also be tested for 
children, what is that proper goal, so that the next time this issue 
comes up we have some informed judgment about it. A quick review of the 
medical literature shows there hasn't been any such study. I could be 
corrected if there has been. If there hasn't been, I suggest we make 
that a part of the legislation. I make that simply by suggestion, not 
amendment. I intend to vote for the Allard amendment, and I have stated 
the reasons why. If we have a happy piece of legislation, let's keep it 
happy. That will do it.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Delaware.


                           Amendment No. 990

  Mr. CARPER. Mr. President, I wish to change the subject for a moment, 
if I may. The overall subject is the same; that is, the legislation 
that is before us. I salute Senators Kennedy and Enzi and their staffs 
for providing an excellent piece of legislation. It was not an easy 
thing to do on a difficult subject. I thank them for their efforts and 
for getting us to this point.
  Yesterday evening, our colleagues and friends, Senators Dorgan and 
Snowe, filed an amendment to S. 1082 that would allow for reimportation 
of prescription drugs from Canada and from certain other countries. In 
previous years, a number of us, including me, supported reimportation 
legislation, so long as the Secretary of Health and Human Services 
certifies that the reimportation of prescription drugs can be done both 
safely and cost-effectively.
  Earlier this morning Senator Cochran filed a second-degree amendment 
to the Dorgan-Snowe legislation that seeks to require that 
certification in the context of this legislation that is before us 
today. Senator Cochran's amendment would require the Secretary of 
Health and Human Services to certify that the provisions within the 
Dorgan-Snowe reimportation program would pose no additional risk to the 
public's health and safety.
  In addition, the Cochran amendment would require the Secretary of 
Health and Human Services to certify that this reimportation program 
would result in a significant reduction in the cost of prescription 
drugs to the American consumer. So there are two goals. These few lines 
that Senator Cochran just introduced were passed by unanimous consent 4 
years ago in 2003. In 2002, this language passed the Senate by a vote 
of 99 to nothing. It is clear, at least to me, from these past votes 
that this is not the first time the Senate has taken up this issue and, 
again, with some consensus.
  Since the last time reimportation was before this body, Senators 
Dorgan and Snowe have worked hard to address many of the safety 
concerns folks had raised in previous iterations. I commend both of 
them and their staffs for working diligently to try to address a number 
of these concerns. I believe they have made significant progress. For 
instance, concerns were voiced earlier that the FDA would not have 
enough funds to operate a reimportation program. To provide the FDA 
with additional resources, the revised Dorgan-Snowe proposal would 
increase user fees paid by those drug wholesalers and pharmacies 
participating in the program from 1 percent to 2.5 percent of the total 
price of the drugs that are reimported. This moves us closer to 
ensuring that FDA will have the resources they need to operate this 
program effectively.
  Senators Dorgan and Snowe's new legislation would also allow the FDA 
more time to phase in the number of drug exporters and importers that 
want to participate in the program. A slower phase-in would give the 
FDA more time to ensure that the importers and exporters are aboveboard 
and should help alleviate concerns that we would unknowingly allow 
unscrupulous vendors into this reimportation program.
  Although Senators Dorgan and Snowe address a number of the drug 
safety concerns, I believe a couple of possible shortfalls remain, 
especially when it comes to stopping the proliferation of counterfeit, 
adulterated drugs. Specifically, this legislation relies on what are 
called paper pedigrees to show a drug's chain of custody, but there is 
no guarantee that these paper pedigrees could not be forged to hide 
possible counterfeiting, possibly leaving American consumers with a 
less safe drug supply. Moreover, this bill relies on what some believe 
are unproven and untested anticounterfeiting technologies to guarantee 
drug safety. While I give credit to my friends for

[[Page 10923]]

trying hard to build safety into the proposal, it is not yet clear that 
anticounterfeit technologies, which the proposal relies so heavily 
upon, is yet at the point of being both widely available and, more 
importantly, cost effective.
  In addition, it is unclear to me if this reimportation program would 
give the FDA the authority to conduct inspections of foreign 
manufacturing plants. It is unclear to me whether the countries 
permitted under this bill to export drugs into the United States have 
the same kind of safety and quality control standards that we enjoy at 
home.
  In the end, drug reimportation will only work if we are able to 
ensure that the drugs we import are as safe as those manufactured and 
sold in the United States. If the Secretary of Health and Human 
Services, the person who directly overseas the FDA to ensure the 
public's health and safety, is not prepared to certify that the 
importation is safe, then that gives me pause, and I believe it should 
give us pause. We don't have a reimportation program operating right 
now, but the incidence of drug counterfeiting and adulterated drugs 
still exists. In the last few years, prescription drugs that contained 
bogus or dangerous ingredients as well as actual drugs that were 
deceptively labeled to hide their origin have made their way into the 
United States. For example, 4 years ago, counterfeits of the 
cholesterol drug Lipitor were found in the United States and made their 
way to a number of American consumers. Recently, FDA warned consumers 
about counterfeit drugs from multiple Internet sellers.
  Many would argue that the FDA already has its hands full. If that is 
true, how do we in good faith add another layer of complexity such as 
reimportation to an already overburdened and underresourced system 
without also demanding that the Secretary of Health and Human Services 
certify that reimported drugs are safe for American consumption.
  Similar to most of my colleagues, I am not opposed to reimportation, 
but I do firmly believe that despite the very real progress that has 
been made with respect to the earlier Dorgan-Snowe proposal, some 
uncertainties remain in the revised legislation they offered yesterday. 
Because of those remaining concerns, I support the Cochran amendment 
and ask my colleagues to do the same.
  Similar to some of my colleagues, I have held in my hands medicines 
that appear to be the same as the prescription medicines manufactured 
in this country. They were the same size, same shape, same color. They 
have the same markings. The wrapping and the materials they come in are 
the same. They appear to be, for all intents and purposes, the same 
legitimate prescription medicines. They were not. In some cases, they 
contained materials that were unsafe, and in other cases they contained 
materials that were not helpful to the person suffering from a 
particular malady. I would like to say that those concerns for that 
kind of behavior have gone away. They haven't. The profit motives for 
those who would like to sell bogus drugs, counterfeit drugs, the 
economic attraction of doing that is enormous. As a result, I think we 
need to proceed with caution.
  I again commend Senators Dorgan and Snowe. They are trying hard. 
Their staffs are trying hard to get us to the point where the Secretary 
of Health and Human Services can actually certify that we can reimport 
these drugs in a way that is safe and cost effective. We will be voting 
later today to determine whether we have gotten that far. The Cochran 
amendment made sense before, and I think it still makes sense.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Casey). The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, for the benefit of the Members and the 
greatest convenience, we will vote on the Allard amendment at 12:25. 
What I would like to do is propose a consent agreement that we vote at 
that time. I know the Senator from Oklahoma and the Senator from 
Michigan want to talk. We have 35 or 40 minutes. Probably Senator 
Allard and Senator Dodd would want to make a comment before we get to 
the vote.
  I ask unanimous consent that at 12:25 the Senate vote in relation to 
the Allard amendment 982 and that the time until then be for debate 
with respect to the amendment, with the 40 minutes divided as 20 
minutes being divided equally between Senator Allard and Senator Dodd 
and 20 minutes between the Senator from Michigan and the Senator from 
Oklahoma; furthermore, that no amendments be in order to the amendment 
prior to the vote.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The Senator from Michigan.


                           Amendment No. 1011

  Ms. STABENOW. Mr. President, first, I ask unanimous consent that the 
pending amendment be temporarily set aside and call up amendment No. 
1011 for the purposes of offering the amendment.
  The PRESIDING OFFICER. Without objection, the pending amendment is 
set aside. The clerk will report the amendment.
  The legislative clerk read as follows:

       The Senator from Michigan [Ms. Stabenow], for herself, Mr. 
     Thune, Mr. Lott, Mr. Brown, and Mr. Kohl, proposes an 
     amendment numbered 1011.

  Ms. STABENOW. Mr. President, I ask unanimous consent that reading of 
the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

     (Purpose: To insert provisions related to citizens petitions)

       At the appropriate place, insert the following:

     SEC. __. 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:
       ``(r) 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.--The receipt of a 
     petition is not just cause to delay consideration of an 
     application submitted under subsection (b)(2) or (j) and 
     consideration of a petition described in clause (i) shall be 
     separate and apart from the review of an application 
     submitted under either such subsection.
       ``(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 30 days after the 
     submission of the petition, that a delay is necessary to 
     protect the public health.
       ``(B) Determination of delay.--With respect to a 
     determination by the Secretary under subparagraph (A)(iii) 
     that a delay is necessary to protect the public health the 
     following shall apply:
       ``(i) Not later than 5 days after making such 
     determination, the Secretary shall publish on the Internet 
     website of the Food and Drug Administration a detailed 
     statement providing the reasons underlying the determination. 
     The detailed statement shall include a summary of the 
     petition and comments and supplements, the specific 
     substantive issues that the petition raises which need to be 
     considered prior to approving a pending application submitted 
     under subsection (b)(2) or (j), and any clarifications and 
     additional data that is needed by the Secretary to promptly 
     review the petition.
       ``(ii) Not later than 10 days after making such 
     determination, the Secretary shall provide notice to the 
     sponsor of the pending application submitted under subsection 
     (b)(2) or (j) and provide an opportunity for a meeting with 
     appropriate staff as determined by the Commissioner to 
     discuss the determination.
       ``(2) Timing of final agency action on petitions.--
       ``(A) In general.--Notwithstanding a determination made by 
     the Secretary under paragraph (1)(A)(iii), the Secretary 
     shall take final agency action with respect to a petition not 
     later than 180 days of submission of that petition unless the 
     Secretary determines, prior to the date that is 180 days 
     after the date of submission of the petition, that a delay is 
     necessary to protect the public health.
       ``(B) Determination of delay.--With respect to a 
     determination by the Secretary

[[Page 10924]]

     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; and (b) this petition 
     includes representative data and/or information known to the 
     petitioner which are unfavorable to the petition. I further 
     certify that the 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. I further certify that 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 to the Secretary, 
     without regard to whether the request is characterized as a 
     petition.''.

  Ms. STABENOW. First, Mr. President, I thank Senator Kennedy for his 
incredible leadership and work on this very important legislation, and 
Senator Enzi, as well, for his leadership and work and partnership with 
Senator Kennedy on this legislation. I also thank Senator Dodd for his 
years of advocacy for children. I join with him in opposing the Allard 
amendment, and believe Senator Dodd has given us the first step as to 
where we need to go in terms of more medicines being available for 
children. I thank him for all of his leadership.
  Mr. President, I today am offering an amendment--a bipartisan 
amendment, with Senator Thune, as well as Senator Lott and Senator 
Brown; we also have Senator Kohl joining us--to close a loophole that 
the brandname pharmaceutical companies are using to prevent competition 
by delaying the entry of generic drugs.
  Our amendment is based on the citizen petition provision that is 
included in a bill Senator Lott and I introduced last session and again 
this session, but it has been greatly improved by contributions from 
Senator Brown. I particularly thank him for his hard work and 
contributions to this amendment.
  The citizen petition process is intended to allow citizens to raise 
legitimate issues regarding drug products, and it is very important we 
have that. However, the brandname pharmaceutical companies have 
increasingly used citizen petitions to delay access to safe, effective, 
and affordable generic drugs.
  Simply put, citizen petitions have become PhRMA petitions to block 
consumers from having access to affordable medicines, unfortunately. 
The cost to employers, consumers, health insurance plans, and 
Government health plans, as a result of delayed entry of generics, 
amounts to hundreds of millions of dollars--and in some cases billions 
of dollars.
  For that reason, our amendment has the support of a very broad range 
of consumer groups, business groups, labor, pharmacy, and other 
organizations, including the AARP, the chain drugstores, General 
Motors, Ford, DaimlerChrysler, the AFL-CIO, the Alliance for Retired 
Americans, CalPERS, the National Committee to Preserve Social Security 
and Medicare, Families USA, the Pharmaceutical Care Management 
Association, the UAW, and the Coalition for a Competitive 
Pharmaceutical Market, which is a broad coalition of our employers and 
insurers across the country.
  What would our amendment do? Our amendment would, first, preserve the 
right to file citizen petitions and raise legitimate safety issues. 
This is very important. We do nothing to take away the citizen 
petition. It would reduce the filings, though, of frivolous citizen 
petitions, and it would stop frivolous petitions from delaying generic 
entry--and thus costing businesses, consumers, and taxpayers--by 
allowing needed competition to bring down prices in the pharmaceutical 
market.
  It would do so by, first, requiring the generic approval process to 
move forward while a petition is considered, unless the petition has 
raised legitimate public health concerns about the drug.
  Second, it would require that final action on a petition be taken 
within 6 months of the petition being received.
  Third, it would require petitions to be signed and include a 
verification that the petitioner has taken reasonable steps to ensure 
all relevant information is included in the petition and whether any 
payments have been made in exchange for filing the petition. This is 
very important.
  And, fourth, it would ensure transparency surrounding FDA's decisions 
on whether to delay generic drugs on the basis of a citizen petition.
  Our amendment improves upon the language in the Stabenow-Lott bill in 
that it sets timelines for FDA to evaluate petitions and absolutely 
ensures that if it is a legitimate public safety issue, then medicines 
will not be approved unless and until the safety issues are resolved.
  Why do we need this amendment? Any person or organization can file a 
citizen petition with the FDA raising concern. We certainly want people 
to be able to do that. However, the process right now is being used in 
ways that are unintended.
  The Medicare Modernization Act closed a lot of loopholes that the 
brandname companies were using to delay generics from going into the 
marketplace. So, unfortunately, they have looked to another tool. They 
are now using these frivolous citizen petitions.

[[Page 10925]]

  Between passage of the Medicare Modernization Act and April 30, 2006, 
brandname companies filed 45 citizen petitions requesting that the FDA 
delay approval of a competing generic drug. Of the 45 petitions, the 
FDA has ruled on 25 of them. Of the 25 petitions, 92 percent of them 
were denied.
  The brandname companies often file these petitions right on the eve 
of the generic drug being approved, making it very clear that delay is 
the goal. These are ``11th hour'' petitions, as they have been called, 
and 12 of those ``11th hour'' petitions--12 of them--were denied in 
whole and 1 in part by the FDA.
  What do the petitions ask for? Do they raise new and important 
issues? Unfortunately, the answer is no. Although the petitions are 
filed before or after a generic drug has received tentative approval 
from the FDA, they commonly simply request additional studies or 
additional data, based on mere speculation by the brand companies.
  The FDA typically will not approve a generic drug until all the 
underlying issues of a citizen petition have been addressed. As a 
result, although the FDA regulators provide that citizen petitions 
should be addressed within 6 months--and that is what our amendment 
says--the average review time is 10 months. And 10 months means lots of 
lost dollars. It leaves consumers paying more, businesses paying more, 
and insurers paying more.
  The fact is the vast majority of petitions filed by brand companies 
have nothing to do with science and everything to do with delaying 
generic drugs, stopping the competition. Consumers lose as a result of 
that.
  In December 2005, Merrill Lynch released a report analyzing brand 
company use of the FDA citizen petition processes. The analysis 
involved a review of citizen petitions filed by brand companies since 
2001. They said there was a ``sharp uptick'' in the number of citizen 
petitions filed by brand companies in 2004 and 2005 and,

       In many instances, the filing of [these citizen petitions] 
     by branded companies coincided with the expiration of a 
     product's patent (or other marketing exclusivity) effectively 
     delaying generic competition for months and sometimes years.

  Why is this important? Well, I want to give you a few examples.
  Flonase is a drug that is used to treat nasal symptoms and allergies. 
It is a very commonly used drug. In this case, the brand company filed 
multiple citizen petitions in an effort to delay the generic 
competition, a lower priced drug, from going on the market. All three 
citizen petitions were denied.
  According to the FDA:

       [The brand company] has not articulated sound public policy 
     grounds for supporting a stay. In addition, [the brand name 
     company] has not demonstrated that the delay resulting from 
     the stay is not outweighed by public health and other public 
     interests.

  In other words, no sound public policy, but, unfortunately, the delay 
took months to resolve.
  The following quote from Gary Buehler, Director of the Office of 
Generic Drugs at FDA, was reported in the New York Times on February 
23, 2006:

       The agency was required to consider the petitions and to 
     write responses. That took time and delayed the approval 
     [process].

  So what happened? Even though all of these petitions were denied by 
the FDA, it took so much time, and generic entry was delayed by 656 
days, and the brand company was able to get $1.65 billion more in 
sales.
  We see with all of these drugs shown on this chart delays that have, 
in fact, allowed the brandname company to be able to continue sales. 
Unfortunately, these higher costs are paid by our seniors, consumers, 
and businesses that offer medication, as well as by insurers 
themselves.
  We have not only large delays, but even in the case of 5 days, $17 
million more in sales. So there is great incentive to use delaying 
tactics in order to be able to continue this process.
  Mr. President, I see my time is up. Let me say this amendment was 
carefully constructed to allow citizen petitions to continue. The 
overwhelming evidence from the Federal Trade Commission, the Office of 
Inspector General, as well as the FDA, and others--the overwhelming 
evidence is we are seeing this as a new loophole that is being used to 
delay effective competition and lower cost medicine from going into the 
marketplace. We can fix that and keep the citizen petition for 
legitimate issues. We certainly want that. We certainly are concerned 
about safety, as is the FDA. But it is time to close this loophole.
  I thank my colleagues who are cosponsoring this amendment and urge 
support for the amendment.
  The PRESIDING OFFICER. The Senator from Oklahoma.


                           Amendment No. 982

  Mr. COBURN. Mr. President, I rise to speak for a minute in support of 
Senator Allard's amendment. I also want to recognize Senator Dodd's 
work, and I believe he truly cares about us getting pharmaceuticals to 
children. But I think the bill as written today has some very great 
risks for our children.
  I practice medicine. I can remember 25 years ago, for so many of the 
drugs, we did not know what we were doing as they related to children. 
We had sometimes great outcomes and sometimes poor outcomes as to the 
availability and knowledge of pharmaceuticals for children.
  We have a system that started 10 years ago that has been highly 
successful. Mr. President, 144 drugs have now been studied in kids. We 
know what we are doing with 144 drugs. With 25 of those drugs, we now 
know not to use them for children.
  How did we get there? We created an incentive that said: We will give 
you a 6-month patent extension if you will study pediatric indications 
and do a study on pediatric patients for this drug. It worked. As a 
matter of fact, it worked great.
  Now, I am having trouble understanding, as a physician, the therapy 
Senator Dodd wants to put on this. He is back to practicing medicine 
the way we did pediatrics 25 years ago with his amendment. I certainly 
hope he is right if he wins because there are going to be a lot of 
children in trouble if he is not.
  What his amendment actually says is, if you made $1 billion off a 
drug, you only get a 3-month extension. I can see how we could look and 
say they are making too much money. But only 1 out of every 10 drugs we 
studied in pediatrics was a blockbuster drug. So what is happening with 
these high-profile drugs they are making a lot of money off of is they 
are the things that are funding the other 130 studies of drugs that are 
not blockbusters, that are not profitable.
  So what Senator Dodd has put in this bill--and I know it is well-
meaning--is to limit that profitability, hoping drugs will become more 
reasonable, and gambling--a very risky gamble--that the research on 
pediatric drugs will continue with that 3-month extension.
  He may be right. But as someone who cares for kids in my own 
practice, I am not willing to take that gamble. I am not willing to 
say: What if he is wrong? What if the studies go from 144 to 15?
  Now that we are seeing all these new drugs coming out, we are not 
going to have a study for kids? We are going to take away opportunities 
for young children to have the benefits of a new drug because they are 
not studied? Or we are going to use the drugs anyhow, even though they 
are not indicated and we do not know what we are doing, in a hope--not 
in a knowledgeable, scientific way but in a hope we are doing some 
good?
  We have a system that has worked very well. Senator Dodd was 
supportive of that system. I do not know that he is right. He could be 
right. But the question will be: What if he is wrong? What if the next 
100 drugs that come out for maladies that could have an application for 
children--especially some very small used drugs, specialty drugs for 
chemotherapy, and have a very low incidence of usage in kids--what if 
they are not available? What if they are not made available? How many 
children are not going to get that drug? Now the system is paying for 
90 percent of the studies on drugs that aren't the blockbusters, and we 
are going to cut the incentive in half. It may work. I don't know where 
the knowledge is, the scientific inquiry, or the study that says that 
going from 6

[[Page 10926]]

months to 3 months is the right amount. What about 2 months? What about 
1 month? What about 5 months? We don't know. So what are we going to 
do? We are now going to go back and practice on pediatric drug studies 
the way we used to practice on children. We are going to guess.
  What the Allard amendment says is: We are not real happy there is 
this amount of tremendous profit, but we do understand that the profit 
off the blockbuster drugs is actually paying for 90 percent of the 
studies on nonblockbuster drugs for kids, that we are going to take 
away that incentive. It is really comforting as a physician to know now 
what I didn't know before in terms of giving a kid a medicine and 
knowing how it is going to be metabolized, knowing its half-life, 
knowing it is different in a child and being able to dose it correctly, 
and confidently saying to a parent: I have given you something that is 
going to fix your child, that is going to cure this illness, and I know 
you are not going to have a side effect from it.
  What we have done has worked. Why would we mess with it unless we 
know? I have listened to this debate. I don't see anybody telling me 
how we know we are not going to disincentivize further drug studies. If 
somebody can show me that, then I will be happy to vote against the 
Allard amendment. But there is not anybody who can show me 
scientifically that we are going to have another 144 drugs studied if 
we cut this in half. Maybe we will, maybe we won't. I can't see into 
the future, but I am cautious enough to know I love the progress we 
have made.
  If we change this, if we change it--and it sounds as if, from the 
debate here, the Allard amendment isn't going to be approved--we better 
darn sure know what we are doing, and we better darn sure say that 
taking money away from drug companies in terms of extending patents is 
not going to have a negative impact in terms of positive benefits.
  I am not the greatest defender of the drug companies. I authored the 
first bill that was signed by President Clinton which allowed 
reimportation of drugs into this country. Why did I do it? I think we 
need to have a worldwide market on pharmaceuticals. We don't. We have a 
controlled market everywhere except in this country. The American 
taxpayers end up subsidizing the research and subsidizing the profits. 
But I also recognize that some of these drugs' profits are the very 
things that allow me to now give comfort to a mother and a father when 
they have a very sick child.
  I hope Senator Dodd has the wisdom to know that he has done it just 
right and that there is not going to be one cancer chemotherapeutic 
agent that wasn't studied in children because it is not a blockbuster 
drug, and now that we are going to cut it to 3 months, that there will 
still be an incentive to make sure that the next child with a sarcoma 
or the next child with an aplastic anemia or the next child with a 
leukemia that is resistant to bone marrow transplant or anything else 
is going to be able to have the medicine.
  We are going to go back to the way we practiced medicine 10 or 12 
years ago. We are not going to know, and we are going to shoot from the 
hip and pray and hope. What we have today is we don't have to pray and 
hope anymore. We now have the studies.
  I don't know the answer to it, and I am not saying Senator Dodd is 
wrong, but I think a legitimate question to ask is, What if he is 
wrong? What if he is wrong? How many children aren't going to have 
drugs? How many children are going to have a drug complication? How 
many children are going to have a drug interaction? How many children's 
lives aren't going to be saved because we decided the drug companies 
are making too much money and we are going to tell them how much they 
should make?
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. Who yields time?
  Mr. DODD. Mr. President, if I may, I would like to divide my 10 
minutes, and I would like to spend a few minutes on another part of the 
bill, the Pediatric Medical Device Safety and Improvement Act.
  I thank Senator Kennedy and Senator Enzi for including this bill 
which I authored in the underlying legislation.
  The pediatric medical devices provision of the underlying bill is not 
subject to an amendment, but I want my colleagues to know what we have 
done with this provision, which is a complementary piece of legislation 
dealing with a similar set of issues as under the Best Pharmaceuticals 
for Children Act. That is, ensuring that medical devices used in 
children are safe and designed specifically for children. One of the 
fundamental hurdles with respect to children is that the market for 
products designed for them is relatively small. However, I believe the 
proposals in the underlying bill will make a huge difference in the 
lives of children.
  This initiative provides a very comprehensive approach to ensuring 
that children are not left behind as cutting-edge research and 
revolutionary technologies for medical devices advance.
  Like drugs, where for too long children were treated like small 
adults and were just given reduced dosages, many essential medical 
devices used by pediatricians are not designed or sized for children, 
and that has been the case for many years. Pediatric providers have had 
to resort to jury-rigging or fashioning makeshift device solutions for 
pediatric use. When that is not an option, providers may be forced to 
use more invasive treatments or less effective therapies. This 
legislation addresses the need to promote pediatric device development 
by providing incentives to manufacturers while at the same time 
equipping the Food and Drug Administration with appropriate authority 
to monitor and ensure the postmarket safety of medical devices used 
significantly in children.
  One such example which highlights the need for this legislation is a 
device known as the Vertical Expandable Prosthetic Titanium Rib, a 
device invented, developed, and brought to market by Dr. Robert 
Campbell, Professor of Orthopaedics at the University of Texas Health 
Science Center. Dr. Campbell appeared before the Health, Education, 
Labor and Pensions Committee in late March and testified about the 
arduous 14 years it took to bring the titanium rib to market. Dr. 
Robert Campbell made remarkable breakthroughs with this technology but 
the hurdles he faced were, at times, seemingly insurmountable.
  I want to put up a photograph of a boy named Devin Alvarez, of 
Hialeah Gardens, Florida, which shows the remarkable difference this 
device has made for him. Devin was born with six ribs missing and a 
very small left lung and kidney. At birth, the doctors did not believe 
he was going to survive his first night. In May 2002, Devin underwent 
titanium rib implant surgery and the curve of his spine was reduced to 
45 degrees. Devin stood straight for the first time in his life and, at 
present, Devin is a very typical 9-year-old boy who enjoys playing 
sports such as golf and baseball.
  Again, remarkable ideas for pediatric medical devices happen 
regularly, but the incentives to transform ideas into new FDA-approved 
devices simply don't exist. So the motivation for the Best 
Pharmaceuticals for Children Act legislation 10 years ago dealing with 
pharmaceutical products for children is the same motivation behind this 
legislation--to encourage the medical device industry to develop and to 
engage in the kind of research to allow these technologies to emerge.
  In describing the pediatric medical devices bill which is now 
included in this legislation, Dr. Campbell, who has been so 
instrumental in all of this, said:

       This bill represents an historic step forward for 
     children's medical and surgical devices similar to those 
     steps taken on drugs. It will help future medical inventors 
     of pediatric devices to avoid my mistakes and my frustrations 
     so that they can get their devices ``off the napkin,'' if you 
     will, and into the pediatric patients who need them, in a 
     safe and timely fashion.

  I thank my colleagues from Massachusetts and Wyoming for working hard 
to make sure this will be a part of the underlying bill. I am grateful 
to them. It is my understanding that concerns have been raised by some 
in the

[[Page 10927]]

medical device industry regarding a particular provision of the bill 
related to equipping the Food and Drug Administration with authority to 
ensure the safety of medical devices in children once they are already 
on the market.
  The provisions in the bill mirror the recommendations made by the 
Institute of Medicine in its 2005 report on pediatric medical device 
safety. The Institute of Medicine found serious flaws in the current 
postmarket safety surveillance of these devices and the provisions in 
my bill correct those serious flaws. I am disheartened by those who 
would attempt to deprive children and physicians with information that 
pertains to device safety.
  I think we have made some tremendous advances for children and their 
families in this legislation.
  Mr. President, I ask unanimous consent that relevant material 
relating to the medical device provision of this legislation be printed 
in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                        Elizabeth Glaser Pediatric


                                              AIDS Foundation,

                                    Washington, DC, March 5, 2007.
     Hon. Christopher Dodd,
     Russell Senate Office Building,
     Washington, DC.
       Dear Senator Dodd: On behalf of the Elizabeth Glaser 
     Pediatric AIDS Foundation, I would 1ike to thank you for your 
     leadership in introducing the Pediatric Medical Device Safety 
     and Improvement Act of 2007 and offer our strong support for 
     this legislation, which will improve the health and we11-
     being of children across the country.
       This legislation will ensure that children enjoy the same 
     protections as adults do when using necessary medical 
     devices. Over the last few decades, countless innovative 
     medical device products have been developed as a result of 
     cutting-edge research and new technologies. As you know, 
     children are being left out of the equation. Many challenges 
     limit children's access to safe and effective medical 
     devices, including differences in size, weight, metabolism 
     rates, etc. With very few devices available for pediatric 
     use, pediatric providers must resort to fashioning make-shift 
     devices for their patients. Left with no alternative options, 
     providers may be forced to use older or less optimal 
     interventions, which can be less effective and could pose 
     greater risk.
       The Pediatric Medical Device Safety and Improvement Act of 
     2007 recognizes the urgency for greater development of 
     medical devices created with children's special needs in 
     mind. It provides a comprehensive approach to improving 
     children's access to medical devices and includes provisions 
     to assist innovators with technical and financial resources, 
     streamline the regulatory processes, elevate pediatric device 
     issues at the FDA and NIH, and improve incentives for devices 
     for small pediatric populations--while still preserving the 
     ability to ensure the safety of new products.
       Thank you for your leadership and commitment to this issue. 
     We look forward to working closely with you to ensure that 
     children across the U.S. benefit from this important piece of 
     legislation.
           Sincerely,
                                                 Pamela W. Barnes,
     President and Chief Executive Officer.
                                  ____

                                    The Society for Cardiovascular


                                Angiography and Interventions,

                                   Washington, DC, March 15, 2007.
     Hon. Christopher J. Dodd,
     Chair, Subcommittee on Education and Early Childhood 
         Development, Senate Committee on Health, Education, Labor 
         and Pensions, Washington, DC.
       Dear Chairman Dodd: I am writing to express our support for 
     passage of your Pediatric Medical Device Safety Act of 2007. 
     We greatly appreciate your efforts to expand pediatric 
     patients' access to safe medical devices. Your proposal will 
     be an important step forward.
       The Society for Cardiovascular Angiography and 
     Interventions is a professional association representing over 
     3,700 invasive and interventional cardiologists. SCAI 
     promotes excellence in cardiac catheterization, angiography, 
     and interventional cardiology through physician education and 
     representation, and quality initiatives to enhance patient 
     care.
       Fortunately, cardiovascular disease is far less common in 
     the pediatric population than it is in the adult population. 
     This good fortune does however frequently lead to unique 
     challenges for the pediatric interventional cardiologist who 
     treats these patients. Some of the challenges are clinical 
     and we are more frequently solving those problems, saving 
     children's lives and avoiding the trauma of surgery. Other 
     challenges, and perhaps the most frustrating ones are related 
     to obtaining the safe medical devices necessary to treat 
     these patients. Devices that are available to our colleagues 
     in Europe are not available in America. We support the FDA's 
     efforts to ensure that only safe and effective medical 
     devices are used on patients in our country, but when the 
     entry barriers into the American markets are so high that 
     manufacturers refuse to enter--some patients suffer and die 
     needlessly. Required is an appropriate balance between the 
     sometimes mutually exclusive goals of safety and 
     availability.
       We are especially pleased that your legislation will 
     require the FDA to issue guidance to institutional review 
     committees (IRCs) on how to appropriately consider the use of 
     the humanitarian device exemption (HDE) at their institution. 
     When HDE devices are not part of an ongoing trial, IRCs 
     (which focus on reviewing the care of patients in trials) are 
     sometimes confused.
       We believe that giving the FDA explicit statutory authority 
     to extrapolate from adult to pediatric patients in 
     appropriate situations could help FDA officials expedite 
     their review of some pediatric medical devices.
       We applaud the provision that allows companies to make a 
     profit on HDE devices designed for children. This change will 
     encourage the development of more devices by providing an 
     opportunity for profit and also by reducing concerns about 
     audits, specifically those using different assumptions which 
     could determine a profit was made when a manufacturer 
     calculated their financial situation differently. We note 
     that the 4,000 cap is arbitrary and far below the 200,000 
     patient limit that is placed on orphan drugs. We believe that 
     more devices could be made available to pediatric patients 
     and those with congenital heart disease if that cap is 
     raised. We encourage you to consider such an increase either 
     as a part of this legislation or broader FDA reform 
     legislation.
       We also understand that there are some concerns on the part 
     of industry about the section 522 provisions of this 
     proposal. As clinicians, we are not in a position to evaluate 
     the precise impact of those provisions but we certainly hope 
     those concerns can be resolved.
       We look forward to working with you and your staff to 
     support passage of this legislation and thank you once again 
     for your efforts. Our Senior Director for Advocacy and 
     Guidelines, Wayne Powell will be coordinating this effort for 
     the Society and he may be reached at (202) 375-6341 or 
     [email protected].
           Sincerely,
                                   Gregory J. Dehmer, M.D., FSCAI,
     President.
                                  ____

                                                February 28, 2007.
     Hon. Christopher J. Dodd,
     U.S. Senate,
     Washington, DC.
       Dear Senator Dodd: On behalf of the 60,000 primary care 
     pediatricians, pediatric medical subspecialists, and surgical 
     specialists of the American Academy of Pediatrics who are 
     committed to the attainment of optimal physical, mental and 
     social health and well-being for all infants, children, 
     adolescents, and young adults, we write today to express our 
     gratitude and support for the ``Pediatric Medical Devices'' 
     legislation. This legislation is an important step towards 
     improving the process for the development of needed pediatric 
     medical devices.
       Children and adults often suffer from many of the same 
     diseases and conditions, however their medical device needs 
     vary considerably. Children are not just small adults and 
     medical device technologies manufactured for adults often do 
     not fit the needs of children. This problem forces 
     pediatricians to ``jury-rig'' adult medical devices that are 
     often too large, in order to make them fit smaller bodies. 
     This practice, however, is not always effective and leaves 
     children without optimal treatment. Additionally, children's 
     device needs vary considerably due, not only to size, but 
     also to different rates of growth, anatomy, physiological 
     differences and physical activity levels.
       This legislation offers incentives to device manufactures 
     to create needed medical devices specifically designed to 
     meet the needs of pediatric patients and it gives the FDA the 
     authority to require post-market studies to ensure continued 
     efficacy and safety of these devices. The need for pediatric 
     medical devices to treat or diagnose diseases and conditions 
     affecting children is clear; it is essential that medical 
     devices be manufactured with children's needs in mind.
       Thank you for your continued commitment to improving the 
     health and well-being of children. We look forward to working 
     with you as this important legislation moves through 
     Congress.
           Sincerely,
       American Academy of Pediatrics.
       American Pediatric Society.
       Association of Medical School Pediatric Department Chairs.
       Society for Pediatric Research.
                                  ____



                                          Stryker Corporation,

                                    Washington, DC, March 6, 2007.
     Senator Christopher J. Dodd,
     Russell Senate Office Building,
     Washington, DC.
       Dear Senator Dodd: On behalf of Stryker Corporation 
     (``Stryker''), I am pleased to announce our support for your 
     legislation to

[[Page 10928]]

     improve the availability and safety of pediatric medical 
     devices--the Pediatric Medical Device Safety and Improvement 
     Act of 2007. Like you and your colleagues, we want our 
     children to have access to the fullest and best range of 
     possible medical treatments, even if that means doing or 
     inventing something new just for them.
       We view this as our responsibility both as the leading 
     manufacturer of orthopaedic oncology prostheses in the United 
     States and as a global medical technology company with a 
     significant presence in other medical specialties, including 
     craniofacial deformities such as cleft lip and palate. We 
     take pride in partnering with and sponsoring a range of 
     medical organizations, including one which last year was able 
     to provide free cleft lip surgeries to 8,531 children in 23 
     countries. The surgery took only about 45 minutes and cost 
     $750 per child, but the corrective surgery changed, in a 
     positive way, forevermore the lives of each and every child 
     and the lives of their families, too.
       We sincerely appreciate your leadership role on children's 
     issues. We take very seriously not only our commitment to 
     children with cancer and craniofacial deformities but also 
     our responsibility to ensure that our devices are safe and 
     effective for use in pediatric patients.
       As you may know, there has been significant progress over 
     the past two decades in the management of patients with 
     musculoskeletal cancers that has improved both the survival 
     rates and quality of life of afflicted individuals. Twenty 
     years ago, the standard treatment for any primary malignant 
     bone and soft tissue sarcomas of the extremity was amputation 
     of the affected arm or leg. Since that time, Stryker is proud 
     to have partnered with leading pediatric oncology surgeons to 
     develop limb-sparing, surgical solutions, including the 
     implantation of a growing prosthesis that can be elongated to 
     account for children's growth.
       As with cancer, the treatment of craniofacial deformities 
     is an area in which Stryker has also significantly improved 
     and broadened its range of available medical products and 
     solutions. With continued innovation of new and improved 
     craniomaxillofacial technologies, Stryker hopes to continue 
     to transform the lives of children with craniofacial 
     deformities, such as craniosynostis and cleft lip and palate.
       It is our hope that your legislation will further spur the 
     evolution of novel health care solutions for children. The 
     bill's efforts to streamline approvals for devices with 
     pediatric indications, improve incentives for the development 
     of devices for small pediatric populations, and encourage the 
     establishment of non-profit consortia for pediatric device 
     development should be commended.
       Stryker stands ready to assist you in your drive to 
     stimulate the further development of child-centered medical 
     technologies while closely monitoring the safety of such 
     products after they have entered the market. Thank you again 
     for your leadership on this important issue, and we look 
     forward to working with you to advance your bill as medical 
     device reauthorization legislation moves forward in the 110th 
     Congress.
           Sincerely,

                                                  Ed Rozynski,

                                                   Vice President,
     Global Government Affairs.
                                  ____

                                                  Advanced Medical


                                       Technology Association,

                                    Washington, DC, March 6, 2007.
     Hon. Christopher J. Dodd,
     Chair, Subcommittee on Education and Early Childhood 
         Development, Senate Committee on Health, Education, 
         Labor, & Pensions, Washington, DC.
       Dear Chairman Dodd: On behalf of the Advanced Medical 
     Technology Association (AdvaMed), I am writing in support of 
     the Pediatric Medical Device Safety Act of 2007. We 
     particularly appreciate your willingness to work together 
     with all stakeholders in the development of this legislation. 
     Your bill is an important step in ensuring expanded access to 
     medical devices for children.
       As you may know, AdvaMed represents over 1,300 of the 
     world's leading medical technology innovators and 
     manufacturers of medical devices, diagnostic products and 
     medical information systems. Its member companies are devoted 
     to helping patients lead longer, healthier, and more 
     productive lives through the development of new lifesaving 
     and life-enhancing technologies.
       AdvaMed fully supports the development of medical devices 
     for pediatric patients. Your bill goes a long way to 
     encourage the development of pediatric devices. As your 
     legislation is considered, AdvaMed would like to continue to 
     work with you to strengthen your legislation to enhance 
     development of and access to pediatric devices. For example, 
     we have a number of proposals to highlight existing FDA 
     regulatory tools that could improve the number of devices 
     cleared and approved for pediatric use. We also have 
     recommendations to improve the proposed pediatric 
     Humanitarian Device Exemption (HDE) and propose a 
     compassionate use provision for extremely small pediatric 
     populations to enhance your legislation.
       Sec. 522 of the Federal Food, Drug, and Cosmetic Act 
     (FFDCA) provides the FDA with broad authority to require 
     postmarket surveillance for any product for which FDA has 
     concerns. We believe that the FDA's authority under Sec. 522 
     is sufficient to cover pediatric patients. In fact, we are 
     concerned that the language in your bill may unintentionally 
     reduce access to medical devices for pediatric patients.
       Finally, although we recognize and appreciate your efforts 
     to restrict the types of studies in your postmarket database 
     to only ``scientific'' studies, we believe the language in 
     your bill duplicates both the database that FDA is currently 
     working to establish and the clinical trial registry 
     legislation and legislation currently being contemplated by 
     the HELP Committee.
       In closing, thank you once again for your work on ensuring 
     access to medical devices for children. We look forward to 
     working with you on these and other improvements to your 
     legislation as the bill moves through the Committee and the 
     Senate.
           Sincerely,
     Stephen J. Ubl.
                                  ____



                                            Respironics, Inc.,

                                 Murrysville, PA, August 16, 2006.
     Hon. Mike DeWine,
     Russell Senate Office Building,
     Washington, DC.
       Dear Senator DeWine: Respironics, Inc. is a global medical 
     device company based in Pittsburgh, Pennsylvania. We are the 
     worldwide leader at anticipating needs and providing valued 
     solutions to the sleep and respiratory markets. We employ 
     approximately 4,700 employees and have annual sales in excess 
     of one billion dollars.
       In our business, we often are called upon to work with 
     pediatric patients. Based on this work, it is clear that 
     changes are needed to facilitate an improvement in the 
     availability of diagnostic and therapeutic medical devices 
     for children.
       Currently, a draft of a bill entitled ``To improve the 
     process for the development of needed pediatric medical 
     devices'' is being circulated among some Senators for 
     discussion. After reviewing this bill, Respironics believes 
     that the changes contemplated by this bill could help improve 
     the availability of medical devices for children. Therefore, 
     Respironics supports enactment of the bill.
       We hope that you will join Respironics in supporting this 
     important legislation.
           Sincerely,
                                             David P. White, M.D.,
     Chief Medical Officer.
                                  ____



                                             Breas Medical AB,

                               Molnlycke, Sweden, August 17, 2006.
     Hon. Christopher J. Dodd,
     Hon. Mike DeWine,
     Russell Senate Office Building,
     Washington, DC.
       Dear Senators Dodd and DeWine: On behalf of Breas Medical, 
     I would like to thank you for your efforts to expand the 
     availability of medical devices for children. We appreciate 
     your long-standing leadership on behalf of children and 
     welcome your interest in ensuring that they are not left 
     behind when it comes to critical medical advances. Our 
     devices were developed in Europe and are available for home 
     use in the pediatric population there. We have partnered with 
     companies in the United States, including Sleep Services of 
     America, and now have FDA approval for device use in adults. 
     We are seeking approval for the use of our devices in 
     children where there is a great need.
       While children and adults suffer from many of the same 
     diseases and conditions, their device needs can vary 
     considerably. Cutting-edge research and revolutionary 
     technologies have led to the development of many innovative 
     medical products, however, very few are designed specifically 
     for children. We support your efforts to address the barriers 
     to pediatric device development through legislation, 
     particularly in the following areas:
       1. Improving the ability of the Food and Drug 
     Administration (FDA) to track how many and what types of 
     devices are approved for children each year;
       2. Streamlining pediatric device approvals by allowing the 
     extrapolation of adult data to support pediatric indications, 
     as appropriate;
       3. Encouraging device manufacturers to create products for 
     conditions that affect small numbers of children by removing 
     existing restrictions on profit;
       4. Improving federal support for pediatric device 
     development by creating a coordinated research agenda and 
     establishing a contact point at the National Institutes of 
     Health to help innovators access existing funding;
       5. Improving pediatric device availability by establishing 
     demonstration grants to promote pediatric device development, 
     including connecting inventors and manufacturers, product 
     identification, prototype development, and testing; and
       6. Improving post-market safety of pediatric devices by 
     allowing FDA to call for postmarket pediatric studies, 
     establishing a publicly accessible database of postmarket 
     studies, and giving FDA the ability to require studies longer 
     than 3 years if needed to answer longer-term pediatric 
     questions.

[[Page 10929]]

       Thank you for your leadership and commitment to this issue. 
     We look forward to working closely with you toward passage of 
     legislation to improve children's access to medical devices.
           Sincerely,
                                                      Ulf Jonsson,
     President.
                                  ____



                                                 Seleon, Inc.,

                                Baltimore, MD, September 23, 2006.
     Hon. Mike DeWine,
     Russell Senate Office Building,
     Washington, DC.
       Dear Senator DeWine: On behalf of Seleon Inc., I want to 
     encourage you to continue your efforts to improve access to 
     medical therapies for children by introducing the bill, ``to 
     improve the process for the development of needed pediatric 
     medical devices'' this fall.
       Seleon Inc., a medical device manufacturing company, 
     strongly supports this bill. Thank you for your ongoing 
     support of children's health and this important issue.
           Sincerely,
                                              Michael Lauk, Ph.D.,
     President.
                                  ____

                                        Elizabeth Glaser Pediatric


                                             AIDS, Foundation,

                                   Washington, DC, April 17, 2007.
     Hon. Edward Kennedy,
     U.S. Senate,
     Washington, DC.
     Hon. Christopher J. Dodd,
     U.S. Senate,
     Washington, DC.
     Hon. Michael B. Enzi,
     U.S. Senate,
     Washington, DC.
     Hon. Hillary Rodham Clinton,
     U.S. Senate,
     Washington, DC.
       Dear Senators Kennedy, Enzi, Dodd and Clinton: As 
     organizations working to ensure better health care for the 
     nation's children, we write to thank you for your long-
     standing commitment to children's health and to express our 
     support for legislation to reauthorize the Best 
     Pharmaceuticals for Children Act (BPCA) and the Pediatric 
     Research Equity Act (PREA) and to improve children's access 
     to safe medical devices. We are very pleased that BPCA and 
     PREA reauthorization language and S. 830, the Pediatric 
     Medical Device Safety and Improvement Act, have been included 
     in the Chairman's mark of S. 1082, the ``Food and Drug 
     Administration Revitalization Act,'' for consideration by the 
     Senate Health, Education, Labor and Pensions Committee 
     tomorrow.
       Over the past decade, Congress has enacted bipartisan 
     legislation that has dramatically increased the number of 
     drugs tested and labeled for children. The results from BPCA 
     are extraordinary--over 336 requests have been generated for 
     over 780 pediatric studies, resulting in over 115 new drug 
     labels for children. Senator Dodd's BPCA reauthorization 
     language strengthens this very successful existing program in 
     several important ways, including ensuring prompt label 
     changes, requiring that all study protocols and results be 
     made public, improving adverse events reporting for children, 
     and identifying and addressing important gaps in treatments 
     for children's diseases. In addition, the BPCA language 
     includes a reasoned approach to address the small percentage 
     of drugs for which the exclusivity provision has far exceeded 
     the incentive it was intended to provide pharmaceutical 
     companies.
       S. 993, the Pediatric Research Improvement Act (PRIA), 
     introduced by Senator Clinton and included in the Chairman's 
     mark, reauthorizes the Pediatric Research Equity Act of 2003 
     (PREA), which requires drug manufacturers to test their 
     products for use in children. This law ensures that children 
     are not a therapeutic afterthought and has generated 
     impressive and invaluable safety and dosing information for 
     children. Since the 2003 passage of PREA, 55 drugs have new 
     or improved pediatric labeling. These drugs range from 
     treatment of ear infections to the prevention of rejection of 
     organ transplants. S. 993 places children on equal 
     therapeutic footing with adults by creating the presumption 
     that medicines coming onto the market for illnesses and 
     conditions that occur in children will be labeled for 
     pediatric use and be available in formulations (e.g., 
     liquids, chewable tablets) that children can take.
       The Pediatric Medical Device Safety and Improvement Act of 
     2007 provides a comprehensive approach to ensuring that 
     children are not left behind as cutting-edge research and 
     revolutionary technologies for medical devices advance. Like 
     drugs, where for too long children were treated like small 
     adults, many essential medical devices used extensively by 
     pediatricians are not designed or sized for children. 
     According to pediatricians, the development of new medical 
     devices suitable for children's smaller and growing bodies 
     can lag 5-10 years behind those for adults. S. 830 improves 
     incentives for devices for small markets--while still 
     preserving the ability to ensure the safety of new products 
     once on the market. It provides assistance to innovators, 
     streamlines regulatory processes and elevates pediatric 
     device issues at the Food and Drug Administration (FDA) and 
     the National Institutes of Health.
       Despite our support for the Chairman's mark, we are 
     disappointed that a key provision to make PRIA permanent has 
     been omitted. As this legislation moves to the floor of the 
     Senate, we urge you to restore the permanent authority of the 
     FDA to ensure that children have properly studied medications 
     as a matter of fact, not chance.
       We are grateful for your long-standing leadership and 
     commitment to improving the health of our nation's children 
     and look forward to working with you toward swift Committee 
     action and passage of these pediatric therapeutic bills by 
     the full Senate.
           Sincerely,
       American Academy of Pediatrics.
       Elizabeth Glaser Pediatric AIDS Foundation.
       AIDS Alliance for Children, Youth & Families.
       American Academy of Child and Adolescent Psychiatry.
       American Brain Coalition.
       American Pediatric Society.
       American Psychiatric Association.
       American Thoracic Society.
       Arthritis Foundation.
       Association of Medical School Pediatric Department Chairs.
       Children's Cause for Cancer Advocacy.
       National Association of Children's Hospitals (N.A.C.H.).
       National Organization for Rare Disorders.
       National Research Center for Women and Families.
       Society for Pediatric Research.

  Mr. DODD. Mr. President, let me go back, if I can, to my proposal on 
the Best Pharmaceuticals for Children Act and the objections raised by 
my colleague from Colorado to it. Just for the record and so we 
understand what we are talking about, according to a study recently 
published in the Journal of the American Medical Association that 
looked at the costs and benefits of these pediatric trials. It showed 
that the overwhelming majority of drugs studied under this incentive 
program are not blockbusters.
  In fact, the study found that less than 20 percent were. That leaves 
80 percent of drugs completely unaffected by the underlying bill which 
the Allard amendment seeks to amend. To be clear, the proposal in the 
underlying bill that would adjust exclusivity from 6 months to 3 months 
affects less than about 20 percent of drugs studied under this program. 
Using data from this recent study, 80 percent of drugs studied under 
BPCA--those which do not fall into the blockbuster category--the 6 
months' exclusivity would remain unchanged. It doesn't change that at 
all; only in cases where there has been over $1 billion in prior year 
drug sales will the underlying bill change the exclusivity to 3 months.
  This is to strike a balance. Obviously, I feel very strongly, having 
authored this legislation, about ensuring that appropriate clinical 
trials occur to protect children's health. Our notion was, when we 
wrote the legislation 10 years ago, that the 6 months of exclusivity 
would be the carrot that would incentivize the industry to go forward. 
There were some concerns expressed at the time that 6 months wasn't 
going to be anywhere near enough and that we would need more 
exclusivity. Some in the industry suggested a year or even 3 years of 
exclusivity. We settled on 6 months as the appropriate balance at the 
time.
  What happened, of course, is we had this wonderful explosion of work 
that occurred. It resulted in nearly 800 clinical trials involving more 
than 45,000 children, with new pediatric labeling information on more 
than 119 drugs where previously there was none. I recall the debate on 
this program ten years ago very well, the industry said: Six months is 
never going to be enough; none of us will step up to the plate on this. 
And they really argued very strenuously for something longer than the 6 
months. In fact, the 6 months has worked well, and almost all requests 
issued to drug companies to conduct pediatric trials under this program 
have been accepted.
  What I have had growing concern about is the 20 percent of drugs 
receiving exclusivity where the profit realized as far exceeded the 
carrot intended to provide to drug companies. So to strike that balance 
between the cost to taxpayers and the benefits to children, we are 
saying that where sales of a drug being studied under this program 
exceed $1 billion in prior years, the company can get 3 months' 
exclusivity.
  I don't know what the right answer will be on this issue. Neither me 
nor

[[Page 10930]]

my colleague from Oklahoma can say with absolute certainty. But I 
recall the debate 10 years ago when many said 6 months will never be 
enough. Six months has done very well by the industry, as it turned 
out.
  So by striking this balance and having the sunset provision which I 
strongly support in this legislation--and I have from the beginning--it 
will allow us to review periodically how we are doing with all of this.
  There is an increase in Federal spending of $50 million over 10 years 
as a result of the Allard amendment. I can't invoke a point of order 
because the impact on federal spending is outside our current budget 
window, but the Allard amendment comes with a $50 million pricetag to 
taxpayers.
  I believe this program is working well. We think by adjusting the 
length of exclusivity from 6 months to 3 months for a limited number of 
drugs, we are striking the right balance. The 5-year sunset will give 
us a chance to assess the program again and make a judgment: How are we 
doing here? Are we getting more or less of what we thought we would in 
the process? At that time, we will make a judgment again as to how we 
ought to go forward.
  It is not easy to strike these balances. I know my colleagues who 
have engaged in these debates, try to come up with answers that will 
satisfy the various elements and concerns various Members have. That is 
what Mike DeWine and I did 10 years ago and why I had such a good 
partner in this where we struck that balance. Mike was under a lot of 
pressure to have a lot more than 6 months of exclusivity. I was under 
pressure in saying: Why do we give them any exclusivity? So we 
compromised on 6 months to see what happened. We got great results.
  I would love to predict with absolute certainty that what we craft 
here will produce those same results. I can't say that absolutely. But 
based on the analyses of others who have looked at this, their 
conclusion is this is a pretty healthy balance between consumer 
interests, taxpayer interests, and the needs of children. We will see 
what happens over the next 4 or 5 years as to whether this is 
continuing to produce the desired results. I believe it will. I think 
we will get that.
  Here again, based on recent data, under my proposal, 80 percent of 
drugs studied under this program will see no change in the exclusivity 
award of 6 months. Again, for the 20 percent of drugs in the 
blockbuster category, they can receive 3 months of exclusivity. I still 
believe many will go forward, given that incentive.
  So respectfully I say to my friend from Colorado--we serve on two 
committees together and we work well together on a lot of issues here. 
I respect him immensely. I do not question at all his motivations in 
offering this amendment. This disagreement is over the impact of his 
language versus the language I have crafted in this legislation as part 
of the committee print.
  So I urge my colleagues to reject the Allard amendment and to stick 
what with what we put together in the underlying bill. It is a good 
balance between taxpayer interests, consumer interests, and the 
interests of children and their families.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Colorado is recognized.
  Mr. ALLARD. I understand I have 10 minutes allocated to me. I would 
like to take 4 minutes and allocate those to the Senator from North 
Carolina.
  The PRESIDING OFFICER. The Senator from North Carolina is recognized.
  Mr. BURR. Mr. President, let me say, as Senator Dodd finishes, that 
nobody has worked more tirelessly than he on behalf of children's 
health and specifically as it relates to prescription drugs. He did 
list a long list of people, including taxpayers and so forth.
  This is about children, plain and simple. It is one group. It is our 
children, this country's kids. In 1997, I authored what became the Food 
and Drug Cosmetic Modernization Act. Prior to that, there weren't any 
clinical studies done for pediatric purposes. It was on the heels of 
that that Senator Dodd and others created the exclusivity--exclusivity 
that Senator Allard is not changing. What we are changing is in the 
base bill and going from 6 to 3 months.
  The reality is that, prior to the enactment, we didn't have companies 
that were studying the right dosages, what side effects there were, and 
whether it was effective in children. Sure, we had it for adults but 
not for kids. We have made tremendous progress. Under this pediatric 
exclusivity, though, we would cap it at 3 months. Companies that 
exceeded a dollar value--we pulled this out of the sky. Why $1 billion 
and not $2 billion? If it was $2 billion, why not $4 billion? Why not 
$100,000? The reality is that none of us knows. There is no expert who 
can tell us what is the right amount of incentive needed for a company 
to go through the types of trials to get these indications for kids. 
Why? Because every drug is different, and, more importantly, every 
child is different. So if we are going to err, I suggest that we err on 
the side of what has worked. Eighty-seven percent of all pediatric 
drugs have pediatric indications. It has been the carrot of 6 months.
  Members will come to the floor and vote for or against the Allard 
amendment. I believe it is crucial that if we err, we err on the side 
of what already has worked and what continues to work. If Senator Dodd 
prevails, I hope he is right. I hope he is right because we won't know, 
until this bill sunsets, whether in fact the incentive wasn't great 
enough for companies to go through this process to find out the 
indications for children.
  The people who will suffer because of our willingness to arbitrarily 
change will be the kids. That is the same group I started with--the 
ones we should be solely focused on. It was the kids when this was 
created 10 years ago; it should be the kids today. If we are going to 
err, let's err on the side of the kids and not use this as a way to 
potentially alter the profitability of an industry or a given company. 
Let's make sure that the true beneficiary of the work of this body is 
in fact the children of this country.
  I thank the Senator from Colorado for yielding me the time.
  I yield the floor.
  Mr. ALLARD. Mr. President, I join my colleagues in recognizing the 
fine work that Senator Dodd has done in the area of children and 
children's health. He recognized one decade ago how important it was to 
have incentives in place for drug companies to properly label drugs so 
they are available and a physician has some guidance when they are 
putting therapy out.
  I particularly thank Dr. Coburn for bringing a message to the floor 
that reflects his practical experience, in a period of time when there 
weren't a lot of drugs specifically labeled for children, to help him 
establish the proper dosage and to be aware of the side effects that 
may happen to various age groups. Also, I thank the Senator from North 
Carolina for his comments.
  I think I bring a certain degree of practical experience to this 
debate as a veterinarian. We are frequently put in a position where we 
have to recommend drugs for therapy without having had research done. 
You have to extrapolate what you think might happen. The drug companies 
will do research on those products on which they can make a profit. I 
am talking about veterinary prescription drugs right now. There is a 
plethora of medications available in the human market. Many times, in 
treating eye conditions or some exotic problem in a species where there 
isn't much of a market, we have to take the scientific literature that 
we know, and perhaps we know what the reaction may be in humans or 
maybe in some other species, where the drug company has done the 
research to reflect what the adequate dosage is, and we extrapolate 
that and predict as best we can what the reaction and how effective 
that drug may be at a certain dosage.
  I think our children's health is too valuable to put a physician in a 
position where they have to make those sorts of subjective evaluations. 
I happen to believe the incentives we put in place a decade ago are 
working. That belief is substantiated by people who

[[Page 10931]]

have looked at the program--the Best Pharmaceuticals for Children Act--
and what happened as a result of that. I am not the only one who 
believes that. We had a study by the GAO, whose responsibility it is to 
look at programs to see whether they are working. They give this 
program a strong A. It is working. I don't think we ought to be messing 
with a program that has worked. Three months may be adequate, but there 
are a lot of other drugs that we have to still get on the market.
  Several years back, during the Reagan administration--and it might 
have been President Reagan who said it--there was a general belief in 
Washington that if it is making a profit, let's tax it; if it is 
working, let's regulate it to death. Here is a program that is working 
because we have backed off on the rules and regulations. I don't think 
we ought to be making a decision, in light of the work that has yet to 
be done in moving pediatric medications to the market, to mess with 
this. Maybe 10 years from now it might be even more appropriate; I 
don't know. This is, to a certain degree, subjectivity. I think we have 
a huge need in making sure we have adequate medications available to 
treat children.
  I agree with many of my colleagues that we should not be messing with 
a program that works, and we need to support this. I also wish to point 
out that this doesn't have an impact. There is not a budget point of 
order on this particular amendment. It doesn't add to the deficit of 
this country. So it is a program we can move forward on, without 
increasing the cost to the Federal Government.
  I hope my colleagues will join me in supporting this most important 
amendment because it is very important, it is important to the 
practitioner who is trying to provide the best care that scientists 
will allow him to provide to patients--in this case, children. If we 
don't keep these choices available for the practitioner, then what 
happens is he doesn't have the options he should have to give the best 
care to our children?
  So for our children's health in the future, I think we need to pass 
this amendment and go back to current law, which has been working so 
very well for us today.
  Mr. KENNEDY. Mr. President, I ask unanimous consent that we be able 
to proceed for 2 minutes. I yield myself 1 minute and 1 minute to the 
Senator from Wyoming.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. Mr. President, for the benefit of the membership, we are 
having a good, substantive debate this morning. We are going to vote on 
this amendment in a few minutes.
  Because of the meetings of the leadership at the White House, we will 
not be able to have votes until 4 o'clock this afternoon. That doesn't 
mean that Senator Enzi and I are not prepared to move ahead in lining 
up some other amendments. We have that intention.
  After this vote, the next vote will be at 4 o'clock. If there are 
those who have additional amendments, we ask them to come over. We are 
moving along. We have several items that are almost complete, which we 
will include. If there are any final amendments, we hope Senators will 
be in touch.
  I thank my friend and colleague from Wyoming for his good cooperation 
and for making progress on a very important bill for the health and 
safety of American families.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Mr. President, I, too, encourage people to get their 
amendments to us, so we can talk about the amendments. The amendment 
process is a difficult thing around here because it doesn't allow for 
some of the tweaks noticed by people who have expertise in that area. 
If we get to talk about them first, sometimes there can be 
modifications to them before they are put in. We want to move this 
along and have some things to vote on at 4 o'clock today. I hope 
everybody will cooperate on it.
  I thank Senator Kennedy and his staff and my staff who have been 
working together with anybody who has an amendment. They were working 
at 3 and 4 o'clock this morning on different things, trying to get them 
ironed out so that it would be possible to move the bill forward.
  Mr. President, what's wrong with limiting exclusivity for blockbuster 
drugs? It is the exact opposite of what we should do. The whole point 
of the law is to leverage the large adult market for the benefit of the 
smaller kids' market. The effect of the cap will be to discourage 
companies from studying the effects of the most-widely used drugs on 
kids. Seventy-five percent of the drugs are not being studied under the 
current incentive. We need more studied, not less.
  Are not companies only studying blockbuster drugs that make the most 
money, not the drugs needed most in kids? No. According to a Tufts 
University study, only about 10 percent of drugs with pediatric 
exclusivity are blockbusters. GAO says most products obtaining 
exclusivity have annual sales of less than $200 million.
  Do companies get to choose the drugs they study? What is to stop 
companies from ``cherry picking'' to make money, not help kids? No drug 
is eligible for pediatric exclusivity unless FDA requests, in writing, 
a pediatric study of the drug. FDA's decision is based on whether more 
information about safety and efficacy for children is necessary.
  Doesn't the Duke/JAMA study demonstrate that 6 months of additional 
exclusivity is a windfall? It's been said that a cynic is someone who 
knows the cost of everything, and the value of nothing. That applies 
here. The Duke/JAMA study concluded that the financial benefit of 
exclusivity for blockbuster drugs often exceeded the cost of the 
pediatric study. This completely misses the point. This law is not 
about micromanaging drug company profits. It's about helping kids. In 
fact, the very last sentence of the study reads: ``Clearly, however, 
the greatest return of the exclusivity program is the benefit derived 
in obtaining new information relevant and applicable to the care of 
children, and this benefit should not be compromised.''
  Companies can spend only a few million dollars on a study and get 
many millions in return. Shouldn't the reward be equal to the amount 
spent on studies? The incentive is designed to raise the priority of 
pediatric studies among all the competing research priorities for drug 
development within companies. Just covering the cost of the studies 
will not do it--the drug company knows it can put those same dollars 
into the development of a drug for adults that will earn much higher 
profits. Incentives work by making pediatric study more attractive than 
other studies for drug companies.
  Aren't windfall profits unfair? No. The benefits to kids, and to 
society in general, from pediatric studies far outweighs the cost.
  What are workability issues with the exclusivity cap? FDA says the 
cap has ``serious workability issues.'' It is unclear how FDA will 
obtain the right type of sale data or how the data's accuracy can be 
verified. FDA would spend lots of time litigating the validity of 
exclusivity decisions, and less time making drugs safe for kids.
  Why shouldn't we restrict excessive drug company profit? The problem 
is not excessive profits. The problem is that most drugs aren't tested 
for kids. It is wrong to play the politics of drug pricing at the 
expense of kids.
  Mr. ALLARD. Mr. President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second? There is a 
sufficient second.
  The question is on agreeing to the amendment.
  The clerk will call the roll.
  The assistant legislative clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Delaware (Mr. Biden), 
the Senator from South Dakota (Mr. Johnson), and the Senator from 
Washington (Mrs. Murray) are necessarily absent.
  Mr. LOTT. The following Senators are necessarily absent: the Senator 
from Kansas (Mr. Brownback), the Senator from New Mexico (Mr. 
Domenici), and the Senator from Arizona (Mr. McCain).

[[Page 10932]]

  The PRESIDING OFFICER (Mr. Menendez). Are there any other Senators in 
the Chamber desiring to vote?
  The result was announced--yeas 41, nays 53, as follows:

                      [Rollcall Vote No. 148 Leg.]

                                YEAS--41

     Alexander
     Allard
     Bennett
     Bond
     Bunning
     Burr
     Chambliss
     Coburn
     Cochran
     Coleman
     Corker
     Cornyn
     Craig
     Crapo
     DeMint
     Dole
     Ensign
     Enzi
     Graham
     Grassley
     Gregg
     Hagel
     Hatch
     Hutchison
     Inhofe
     Isakson
     Kyl
     Lugar
     Martinez
     McConnell
     Murkowski
     Roberts
     Sessions
     Shelby
     Smith
     Specter
     Stevens
     Sununu
     Thomas
     Voinovich
     Warner

                                NAYS--53

     Akaka
     Baucus
     Bayh
     Bingaman
     Boxer
     Brown
     Byrd
     Cantwell
     Cardin
     Carper
     Casey
     Clinton
     Collins
     Conrad
     Dodd
     Dorgan
     Durbin
     Feingold
     Feinstein
     Harkin
     Inouye
     Kennedy
     Kerry
     Klobuchar
     Kohl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Lott
     McCaskill
     Menendez
     Mikulski
     Nelson (FL)
     Nelson (NE)
     Obama
     Pryor
     Reed
     Reid
     Rockefeller
     Salazar
     Sanders
     Schumer
     Snowe
     Stabenow
     Tester
     Thune
     Vitter
     Webb
     Whitehouse
     Wyden

                             NOT VOTING--6

     Biden
     Brownback
     Domenici
     Johnson
     McCain
     Murray
  The amendment (No. 982) was rejected.
  Mr. DODD. Mr. President, I move to reconsider the vote.
  Mr. KENNEDY. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.


                           Amendment No. 990

  The PRESIDING OFFICER. The Senator from North Dakota.
  Mr. DORGAN. Mr. President, I offered an amendment yesterday that a 
number of my colleagues have spoken on, both in favor and against. When 
I laid down the amendment yesterday, I did not speak on it, so I wish 
to take some time to describe what the amendment is, why it is 
important, and why those who have spoken against it are wrong.
  Let me describe, first of all, what the amendment is about, and let 
me do it, if I might, by asking unanimous consent that I be allowed to 
show on the floor of the Senate two bottles of medicine.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DORGAN. Mr. President, these two bottles of medicine contain 
Lipitor. Most people know about Lipitor. It is a cholesterol-lowering 
drug. This particular prescription drug is produced in Ireland, and it 
is sent from that production point, in a plant, by the way, that is 
approved by our Food and Drug Administration. We inspect that plant, as 
we do others. So they produce an FDA-approved drug--this drug has been 
approved--in a plant in Ireland that has been inspected by the FDA. 
These two bottles of medicine containing Lipitor, 20 milligrams, 
identical bottles with a difference in color, are sent to two different 
places in this case but sent to many places around the world. This one 
is sent to the United States to be sold to consumers in the United 
States that want to lower their cholesterol. This one is sent to 
consumers in Canada for those Canadians who wish to take Lipitor to 
lower their cholesterol.
  There is a difference. Oh, not in the medicine, not in the bottle, 
and not in the instruction. What is the difference? The American 
consumer is told: You have to pay twice as much. Let me say that again. 
The difference is the price. The Canadian consumer is told: You pay 
half the price. The American consumer is told: You pay double the 
price.
  Now, I use the Lipitor as an example only to describe a very 
significant problem. We have price controls on prescription drugs in 
this country. Those price controls are not established by the 
Government. They are not established by the Congress. These price 
controls are imposed by the pharmaceutical industry.
  I have a problem with the pharmaceutical industry saying to the 
American consumer: We have a deal for you; we want you to pay the 
highest prices in the world for prescription drugs. We are going to 
sell them all over the world: Italy, Japan, Germany, France, China. We 
are going to sell our prescription drugs, and in almost every 
circumstance, in other countries, we are going to give them a lower 
price. But to you consumers in the United States, we say: You pay the 
highest prices.
  Let me give you a couple of examples, and I will use Canada, but I 
could be using any number of countries around the world. Lipitor. We 
pay 96 percent more. Plavix, 46 percent more. Prevacid, 97 percent more 
than if you were to buy it in Canada. Zoloft, 52 percent more. It goes 
on and on.
  I said yesterday that I actually sat on a bale of straw on a farm 
talking to a bunch of folks, and there was a fellow in his 80s sitting 
on a straw bale talking about life and things, and he said: You know, 
Mr. Senator, my wife has been fighting breast cancer for 3 years. Every 
3 months, we have driven to Canada to buy Tamoxifen because we save 80 
percent by buying Tamoxifen to help my wife fight her breast cancer--we 
save 80 percent by buying it in Canada. So every 3 months, for 3 years, 
we have been driving back and forth to Canada because it is the only 
way we can afford that drug. He said: How do you justify that? How do 
you explain the difference in price? I said: I can't. It doesn't make 
any sense to me.
  I don't come here to be critical of the pharmaceutical industry, I 
come here to be critical of their pricing policy. Their pricing 
policies are unfair to the American consumer. Yes, the pharmaceutical 
industry produces miracle drugs; a fair amount of them are produced 
with research we pay for through the American taxpayer at the National 
Institutes of Health. Others are produced with the research and 
development done by the drug industry themselves. But I would say that 
miracle drugs offer no miracles to those who can't afford to buy them, 
and that is the point.
  What is fair pricing for pharmaceutical drugs, and why is it so 
unfair at this point to the American people? I introduced a piece of 
legislation with many of my colleagues, and let me read a list of the 
bipartisan cosponsors, Republicans and Democrats, who sponsored the 
legislation that we introduced in this Congress, the very legislation I 
have now offered as an amendment to this bill. Let me go through a list 
of some of the names. Myself, Senator Snowe, Senator Kennedy, Senators 
Stabenow, Bingaman, Feinstein, Nelson, Kohl, Schumer, Inouye, Brown, 
Sanders, Senators Grassley, McCain, Specter, Collins, Durbin, Pryor, 
Levin, Leahy, Tester, Conrad, McCaskill, Johnson, Casey, Boxer, 
Salazar, Clinton, Lincoln, Feingold. Thirty-three sponsors for this 
legislation that I have offered as an amendment here today.
  Let me now begin to describe a few of the opponents' arguments and 
then respond to them. My colleague, Senator Cochran, came out and 
offered an amendment that says in order for this to be effective, the 
Secretary would have to certify that it poses no additional risk to the 
public health and safety. Well, that is an amendment that is designed 
to kill the bill because the Health and Human Services Secretary will 
not certify to anything.
  Does anyone think the Health and Human Services Secretary or the FDA 
or anybody is going to certify that the chicken feed served to 3 
million chickens with contaminated material from China, which now goes 
into our food source that humans are eating in this country today, that 
poses a risk? Or how about we say that we want them to certify that the 
vegetables imported into this country from Mexico pose no additional 
risk? Does anyone think anybody is going to certify to that? Do you, 
really?
  I could go on at great length. Does anybody know of any circumstance 
in which any part of our food supply is certified by anybody saying 
that the import of this poses no additional risk? No. So this is an 
amendment designed to make this inoperative.

[[Page 10933]]

  What my amendment does is actually make our drug supply safer with 
respect to the importation. Because the fact is people are now going 
back and forth across the border, those who can get there by car. Most 
Americans can't, but most are bringing prescription drugs back across 
the border for a 3-month supply. This makes that even safer.
  I am going to go through a number of the safety areas here, but first 
let me say this. I understand that the pharmaceutical industry wants to 
continue its pricing policies. I understand that. It is perfectly 
understandable. I have some differences with them.
  In the morning, perhaps while you are brushing your teeth or shaving, 
getting ready for work, you might turn on the television and what do 
you hear them saying on television? They say, well, you need to go talk 
to your doctor. You are brushing your teeth and thinking, why on Earth 
should I go talk to my doctor? Because the television advertisement 
says that you need to see if the little purple pill is right for you. 
You need to ask your doctor whether you ought to take the purple pill. 
I don't know what the purple pill is, but you get this urge that you 
think, maybe I should go ask somebody. If everybody is taking the 
purple pill, maybe I should find out if the purple pill is right for 
me. Maybe it is right for my colleague from Wyoming or West Virginia. 
Maybe we all ought to be taking the purple pill. I don't know.
  If they ever describe what the purple pill does, they also have to 
then describe what the potential risks might be of the pill. But in 
most cases, the TV just says, go talk to your doctor to see if it is 
right for you. So we have a lot of advertising going on, and we 
dramatically increase the use of prescription drugs. Go talk to any 
doctor and ask them if patients are coming to them and telling them 
what kind of prescription medication they want to take because they 
heard it on television. Go ask a doctor, and I tell you what the doctor 
will say. Absolutely.
  Of course, these are medicines that you can only get because a doctor 
has said you need them and, therefore, I prescribe them. Television 
advertising is creating a demand. I am not here with an amendment on 
television advertising, but I am observing that every morning they ask 
whether the purple pill, or whatever other medicine they are talking 
about, is right for you and that you ought to be visiting with your 
doctor about it.
  In addition to the issue of demand, there is the issue of pricing. I 
don't know. Somebody doesn't have to give me five reasons or three 
reasons or even two reasons. I want somebody to give me one reason, 
just one, that says we think it is perfectly defensible that the 
American people ought to be charged the highest prices for prescription 
drugs. Or in the specific case I mentioned, we think it is perfectly 
defensible that the American consumer taking Lipitor ought to be 
charged twice as much as the Canadian consumer. Give me one reason. I 
am not asking for five, just one reason. I can't believe there is one 
person on the floor of this Senate that has the ability to construct 
one thoughtful reason in support of that policy.
  Let me put in the Record a letter the AARP has written yesterday. Let 
me read a little bit of it:

       On behalf of the AARP's more than 38 million members, we 
     urge you to support the Dorgan-Snowe importation amendment. 
     This amendment provides for the safe, legal importation of 
     lower price prescription drugs from abroad.
       In the quest for lower-priced prescription drugs, many 
     Americans are already importing prescription drugs from 
     abroad. [The Dorgan-Snowe] amendment would create a framework 
     for the safe, legal importation of prescription drugs that 
     will better protect the health and pocketbooks of those 
     desperate for lower-priced prescription drugs. We are also 
     very pleased to see that the [Dorgan-Snowe] amendment 
     includes a number of safety requirements including 
     inspections and measures to prevent the counterfeiting of 
     imported drugs.

  I ask unanimous consent that the entire letter be printed in the 
Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                         AARP,

                                                   April 30, 2007.
     Hon. Byron Dorgan,
     U.S. Senate,
     Washington, DC.
       Dear Senator Dorgan: AARP is pleased to endorse your 
     importation amendment to S. 1028, the Prescription Drug User 
     Fee Amendments of 2007. Your amendment will provide for the 
     safe, legal importation of lower-priced prescription drugs 
     from abroad. We applaud your continued leadership on this 
     important measure to help reduce prescription drug costs.
       Brand name prescription drug prices continue to rise at 
     unsustainable rates. AARP's latest Rx Watchdog report 
     released in March 2007 found that manufacturers' prices for 
     nearly 200 of the brand-name medications most commonly used 
     by older Americans rose 6.2 percent in 2006--nearly twice the 
     3.2 percent rate of general inflation. These prescription 
     drug price increases particularly burden the tens of millions 
     of Americans who lack access to affordable prescription drug 
     coverage.
       In the quest for lower-priced prescription drugs, many 
     Americans are already importing prescription drugs from 
     abroad. Your amendment would create a framework for the safe, 
     legal importation of prescription drugs that will better 
     protect the health and pocketbooks of those desperate for 
     lower priced prescription drugs. We are also very pleased to 
     see that your amendment includes a number of safety 
     requirements including inspections and measures to prevent 
     the counterfeiting of imported drugs.
       We believe the phase-in set forth in your amendment will 
     enable better management of those important new activities. 
     It is important that any importation system begin with 
     Canada. However, ultimately in order to be sustainable, any 
     importation system would have to go beyond Canada. Finally, 
     no importation system could function if entities 
     (particularly pharmaceutical manufacturers) were allowed to 
     shut off or manipulate supply of their product. Your 
     amendment grants the Federal Trade Commission the authority 
     to prevent such abuse.
       We understand that there may be attempts to limit 
     consumers' ability to import prescription drugs by attaching 
     a certification requirement to your amendment. AARP believes 
     that your amendment strikes the right balance between 
     providing a workable system of importation while at the same 
     time ensuring the safety of imported pharmaceuticals. Thus, 
     we believe that any amendment that would require 
     Administrative certification in any form would be nothing 
     more than an attempt to prohibit the implementation of an 
     importation system. We oppose such a change to your 
     amendment.
       As you know, our members widely support legislation that 
     would allow for the safe, legal importation of prescription 
     drugs. They have expressed strong interest in knowing how 
     their elected officials vote on key issues that affect older 
     Americans. As part of our ongoing effort to let our members 
     know of action taken on key issues, we will be informing them 
     how their Senators vote on your amendment when it comes to 
     the Senate floor.
       We look forward to working with you and your colleagues on 
     both sides of the aisle to enact this needed legislation. If 
     you have any further questions, please feel free to contact 
     me, or have your staff contact Anna Schwamlein Howard of our 
     Federal Affairs staff at 202-434-3770.
           Sincerely,
     William D. Novelli,
       Chief Executive Officer.

  Mr. DORGAN. It is interesting to me that those who have spoken 
against this come to the floor of the Senate with the specter of 
counterfeiting. Counterfeiting exists at this point. My amendment will 
make it less likely. This puts in place the very safety features and 
the very capability to try to shut that down. But if they are talking 
about counterfeiting that is existing now, it is existing without these 
kind of safety precautions on importation.
  Let me describe a man, a very courageous man named Dr. Peter Rost. He 
came to testify at a hearing we held on the subject of reimportation. 
Peter Rost was responsible for a region in northern Europe where they 
did this routinely. They had an approach in Europe called parallel 
trading. If you are in Germany and want to buy a prescription drug in 
France, that is not a problem. If you are in Italy and want to buy a 
prescription drug in Spain, that is not a problem. They have done this 
for a couple of decades. Dr. Peter Rost was in charge of a region in 
northern Europe. He said:

       I never once--not once--heard the drug industry, regulatory 
     agencies, the government or anyone else saying that this 
     practice was unsafe. And personally, I think it is outright 
     derogatory to claim that Americans would not be able to 
     handle reimportation of drugs, when the rest of the educated 
     world can do this.


[[Page 10934]]


  This from Dr. Rost. He actually paid a price for speaking out and 
speaking the truth. He actually was working for Pfizer Pharmaceuticals 
at the time. He has had a little problem with his employer, but that is 
another story perhaps for another day. But Dr. Rost said it right, in 
my judgment.
  Let me, if I might, show this quote from Tommy Thompson, former 
Health and Human Services Secretary. He says:

       The law is this: In order to import drugs from any country, 
     and especially Canada, I have to certify that all those drugs 
     are safe. That's an impossible thing. If Congress wants to 
     import drugs, they should take that provision out, because 
     the Secretary of Health and Human Services cannot certify 
     that all drugs coming into America are safe.

  Let me tell you something about Tommy Thompson. I like Tommy 
Thompson. He was a Governor from Wisconsin. That's a guy with spirit. I 
kind of like him. In fact, I think he is thinking about running for 
President. I probably will not vote for him because I am going to vote 
for a Democrat in this coming election, but I like Tommy Thompson. Do 
you know what he said to me at the elevator, right outside this Senate 
door after he left Health and Human Services? He was getting off the 
elevator as I was coming on the elevator, and I had been down to see 
him about this issue of reimportation of prescription drugs. I said: 
Secretary Thompson, why don't you work with us to get this done?
  He said: I can't.
  He explained there are lots of things going on, including the White 
House makes the call on this policy, et cetera. At any rate, after he 
left as Secretary of HHS, he was coming off an elevator out here and I 
was getting on the elevator. We said hello. I like him. I think he was 
a good Secretary.
  He turned around and said to me: Byron, he said, keep going on that 
imported drug issue. You are right about that. You are right about 
that.
  That is after he left office. He comes from Wisconsin. He knows. That 
is a State that borders Canada. He knows his constituents are able to 
just go miles up into Canada and seek prescription drugs for a fraction 
of the price.
  Let me respond for a moment to this issue of safety because my 
colleague from Mississippi and others have spoken about it. David 
Kessler, he served for 8 years as FDA Commissioner. He is a terrific 
public servant. In my judgment, there has been none better than Dr. 
Kessler over at the FDA. Here is what he said:

       [The Dorgan-Snowe bill] provides a sound framework for 
     assuring that imported drugs are safe and effective. Most 
     notably, it provides additional resources to the agency to 
     run such a program, oversight by the FDA of the chain of 
     custody of imported drugs back to FDA-inspected plants, a 
     mechanism to review imported drugs to ensure that they meet 
     FDA's approval standards, and the registration and oversight 
     of importers and exporters to assure that imported drugs meet 
     those standards and are not counterfeit.

  Let me make one with respect to this. A couple of my colleagues stood 
on the floor and said: Well, you would create a giant bureaucracy in 
order to do this. That is interesting. The Congressional Budget Office 
actually scored this bill we have introduced. Do you know what the 
score was? This will save $50 billion in a 10-year period.
  Mr. BYRD. With a ``b''?
  Mr. DORGAN. With a ``b,'' $50 billion; just over $5 billion of that 
savings is to the Federal Government; just about $45 billion of that 
savings is to the American consumer. Is that an illusion? No, that is 
the score we have.
  We come to the floor of the Senate and the question is asked: Whom do 
you stand for? Whom do you stand with? Some will say: You know what, we 
believe--they will not say that. I do not believe they will stand and 
say: We believe the current surprising strategy is right, by which 
Americans are charged the highest price. I don't think they will say 
that. I think what they will see is we think there are serious safety 
issues with this.
  Let me again refer back to the expert who would perhaps know more 
about this than any other American. I have heard things read on the 
floor of the Senate by the assistant this or the assistant that. The 
last assistant we had come over to a hearing I held had not even read 
the bill. That is some assistant. At any rate, we don't have to worry 
about assistants. Let's worry about Dr. David Kessler, who I think is 
the preeminent authority. He said we can do this; we can do this, and 
it will make the drug supply in this country safer.
  I wish to talk about the issue of safety. It is not as if 
prescription drugs are not coming into this country from other 
countries. They, of course, are. Our pharmaceutical industry, and 
others, manufacture all over the world and then they ship these drugs 
into our country to be sold here. But there is a law that prohibits 
anyone other than the manufacturer to ship them in. Lipitor is made in 
Dublin, Ireland; Nexium is made in France; Tricor is made in France; 
Actos is made in Japan; Vytorin is made in Singapore and Italy and the 
United Kingdom. Those are pills made elsewhere, the medicines are made 
there and they are shipped here. Are they safe? Sure. I believe they 
are safe. I believe we have an enormously safe drug supply, despite the 
fright that is discussed on the floor of the Senate about 
counterfeiting.
  Is counterfeiting an issue? Sure, it is. It has nothing to do with 
this subject. Counterfeiting exists now and we have to take action and 
steps to fight it and we should fight it aggressively. But the fact is, 
this legislation that we introduce has a range of safety features that 
will guarantee the safety of FDA-approved prescription drugs that are 
imported into this country.
  First of all, we provide that only FDA-approved medicines with a 
``chain of custody'' will be sent into this country. Dr. Mark 
McClellan, who used to head the FDA, and I was very critical of him 
because he continued to speak as if he represented the pharmaceutical 
industry instead of regulating it as head of the FDA, he and I had 
substantial differences, but even he said the chain of custody in 
Canada is safe, almost identical to the chain of custody for 
prescription drugs in the United States.
  If that is the case, and he said it, then tell me with respect to 
this risk, I go to a little one-room drug store in Emerson, Canada, 
with a woman named ``Sylvia'' and a number of other senior citizens. We 
take a little bus up to a one-room drugstore in Emerson, Canada, and 
they bring their prescriptions.
  That drug store has a licensed pharmacist, as the drug store a few 
miles south of the border has, a licensed pharmacist and a chain of 
custody from the drug manufacturer to the wholesaler to the retailer to 
the drug store. We go to that drug store and Sylvia and her friends buy 
prescription drugs at a fraction of the price they would have bought it 
in Fargo, ND, that morning. Tell me, is there a risk in that 
transaction? The answer is no. Don't represent there is because there 
is not.
  The chain of custody is nearly identical. I am speaking now of 
Canada. Tell me there is a risk and you are wrong, there is not.
  All the protestation on the floor of the Senate on this issue is 
protestation in support of the pharmaceutical industry. I like the 
industry. I have been helpful to them. I support research and 
development tax credits to find new prescription drugs. I have done a 
number of things to say I want us to be able to have a successful 
pharmaceutical industry in this country. But I am not willing to go so 
far as to say it is OK to me, I will be quiet if you decide the pricing 
strategy is we are going to price our prescription drugs at the highest 
prices for the American consumer. I will not sit in this chair and say 
it is fine with me. It is not, and that ought not be fine for any 
Member of the Senate. It should not.
  Mr. BYRD. No. No.
  Mr. DORGAN. Let me make some comments on safety. One-quarter of the 
prescription drugs taken in this country are produced outside this 
country in foreign manufacturing plants. In the last 5 years, the FDA 
has inspected more than 850 foreign drug factories in 41 different 
countries. The drug industry wants to take advantage of the global 
economy to manufacture

[[Page 10935]]

their drugs in lower cost countries, but they do not want a licensed 
U.S. pharmacist and drug wholesalers to be able to take advantage of 
the global economy to get the best price for the American consumer.
  Let me say that again. The pharmaceutical industry wants to take 
advantage of the global economy for the purpose of their manufacture 
and profitability, but they do not want a licensed U.S. pharmacist or 
licensed wholesaler to be able to access those same drugs from a 
licensed wholesaler or pharmacist in another country in order to pass 
along lower prices to the American consumer. I do not think that is 
right.
  We have addressed all the issues that have been raised by two former 
Secretaries of Health and Human Services, saying in order for me to 
certify, we need to have this and that. We have addressed those safety 
issues in this legislation. Yet if you listen to the opponents who 
stand on the floor of the Senate with the talking points, there are 
safety and security issues and all these issues--I mean I have gotten 
the talking points, too, from the pharmaceutical industry. Heck, if I 
were in their position, I would want to keep this situation as long as 
possible. You have a good deal, don't give it up.
  But one of my colleagues yesterday, speaking on the floor, said: The 
people who are offering this amendment--and again this amendment goes 
from Senator Kennedy to Senator McCain to Senator Grassley to Senator 
Stabenow back and forth, Republicans and Democrats. One Senator, one of 
my colleagues, stood up and said there are political motives.
  I said I hope you don't mean that, and I hope you will withdraw that. 
This is a thoughtful serious debate. There are plenty of people who 
feel strongly in opposition to my amendment. Fine. But then you should 
stand and debate the proposition that you support. We support the 
current situation. We support the circumstance in which a pricing 
policy that prices the prescription drugs higher for the U.S. consumer 
is already with us. That ought to be the proposition you stand and 
support.
  You ought not stand and say there are significant safety issues here 
because that is not the case. It is not.
  There is much to say, and a number of my colleagues will continue to 
debate this issue. My own view is this is a hard issue to get passed on 
the floor of the Senate. I say that having had some experience with it.
  I must say I admire the pharmaceutical industry. They have been tough 
opponents. They feel strongly about their profitability. They say a 
couple of things. No. 1, this is unsafe. It is not. No. 2, it would 
somehow exacerbate counterfeiting. It will not. Counterfeiting now 
exists. We need to address that, but this would in many ways make the 
supply of drugs safer. They say a number of other things they believe--
that this would cause the American people to change their buying habits 
in ways that would be unhelpful to them. They believe you do not have a 
chain of custody that you can control or see that is transparent. That 
is not true.
  You know, I mentioned earlier about this issue of the industry 
itself. I want the pharmaceutical industry to succeed. They succeeded. 
This has been a very successful industry. They have made a great deal 
of money. But on this issue of research and development, I want them to 
engage in research and development. We are doing it here in the public 
sector of the NIH. We turn that material over to the pharmaceutical 
industry. They do research and development. Good for them. They spend a 
massive amount of money on promotion and development. I think that is 
of some concern for a number of people, but I am not here saying I do 
not want the pharmaceutical industry to succeed. There are those who 
also say, in addition to safety and other issues, they will say, all 
right, if you do not allow a pricing policy that prices prescription 
drugs at the highest level for the American consumer, it will mean less 
research and development by the pharmaceutical industry.
  The fact is, more research and development has gone on in other 
countries in which they charged lower prices for the same prescription 
drugs. So how does that hold water? It does not. My hope is, at long 
last, perhaps, this Senate will stand up for the interests of the 
American consumer. At long last, we can put to bed these specious 
arguments about safety because they are not applicable. Read the bill. 
These arguments about safety are not accurate. Let's put to bed this 
connection between counterfeiting. It is not accurate. Let's also stop 
talking about how this would shut off research and development. That is 
not accurate.
  Let's talk about what this bill would do, what this piece of 
legislation, this amendment we have now offered is. It would save about 
$50 billion over 10 years, $5 billion a year. It would probably require 
the drug industry to reprice for sure because, the fact is, if they are 
pricing at the highest levels to the American people, and they say that 
is the only way they can recover their costs, perhaps others ought to 
be paying more to recover costs. I don't know. I am saying that the 
industry, I believe the top seven U.S. pharmaceutical companies, a 
couple of years ago made $34 billion together. The industry has done 
very well. But there are a whole lot of folks in this country who 
haven't.
  It was about 9:30 one night in a tiny town north of Highway 2 in 
North Dakota. I had a town meeting. At the end of the town meeting, an 
older woman came up to me, and she was probably in her early eighties. 
She said: Mr. Senator, may I speak to you? I said: Sure. She grabbed my 
elbow with her hand. She began to speak. Her eyes welled up with tears 
and her chin began to quiver. She said: I am in my eighties. I don't 
have much money. She said: I have got heart disease and diabetes. My 
doctor prescribes medicines for me that are too expensive. I cannot 
afford them. Is there any way you can help me, Mr. Senator? Is there a 
way you can help me?
  This woman, with tears in her eyes, was asking: Is there someone who 
can help me manage this disease of mine because I cannot afford these 
medicines?
  We have taken steps to try to be helpful. I might say that some in 
the drug industry have taken steps by offering programs to low-income 
people. It is not enough. But I commend those who have and recognize 
it. But we should not have to do that in this country. We should not 
have the highest prices for prescription drugs. We should not have an 
80-year-old woman driving to Canada to pay four-fifths less in cost for 
Tamoxifen to treat her breast cancer. That should not happen.
  So let's do this. Let's create a regime of safety--which we have 
done. Wonder about it? Go talk to Dr. David Kessler. You find a better 
expert, you tell me his name. We have created a regime of safety here 
that will work. Then let us decide to proceed, as Europe has done, as 
others have done, to allow the global marketplace to work for real 
people, to work for ordinary folks, not only the big interests. The big 
interests always do well. At the end of the day, when all of the dust 
settles, and all of the shouting is over, guess who almost always wins. 
Yes: Them that's got is them that gets and I ain't got nothing lately. 
I think that was Ray Charles.
  Isn't that always the case? When the dust settles, the big interests 
always win. Let's hope when the dust settles here tomorrow morning, and 
we have a vote on something that is important, is something that will 
help a lot of American people, millions, tens of millions, hundreds of 
millions, let's hope when the dust settles here, ordinary Americans 
will say, you know what. We won today in the Senate. Hallelujah, we won 
a vote in the Senate. Let's hope that is the case tomorrow morning.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Vermont is recognized.
  Mr. SANDERS. Mr. President, there is not much I can add to the 
brilliant remarks made by Senator Dorgan. I think he, in a very 
comprehensive manner, made clear why the Senate and this country should 
move to prescription drug reimportation. I think he very ably answered 
the objections that we know are sure to come and made the case as well 
as could be made.

[[Page 10936]]

  I want to touch on some personal reflections on this issue. Some 
years ago, as the Congressman then from the State of Vermont--and I 
live an hour and a half away from the Canadian border. My State borders 
Canada. Some years ago, I put together what, in fact, turns out to be 
the very first bus trip to take constituents over the Canadian border 
to buy low-cost prescription drugs.
  All of us have days which are transformative where something happens 
we will never forget, and that is the day I will never forget. On that 
day we took a busload of Vermonters, mostly women, many of the women 
struggling with breast cancer. We went from St. Albans, VT, to 
Montreal, Canada. I will never forget the look on the faces of those 
women who were struggling for their lives when they bought breast 
cancer medicine at 10 percent of the cost they were paying in the State 
of Vermont. The drug was Tamoxifen, a widely prescribed drug for those 
people who are struggling with breast cancer.
  These women walked in fighting for their lives, many of whom did not 
have a lot of money. They walked in there and they could not believe, 
literally could not believe, the cost of that medicine which they 
needed to keep them alive. At that moment some years ago--it may well 
have changed since then--the cost was one-tenth what it was in the 
United States of America.
  The question is a very simple question: How do you have a drug 
manufactured by a company, manufactured in the same factory, put in the 
same bottles, sold in Canada, in some cases for one-tenth the price 
that same medicine is sold in the United States of America? How 
possibly can that happen?
  Now, as it occurs, I am not a great fan of unfettered free trade. I 
have very serious concerns about what our trade policy is doing in 
terms of throwing American workers out on the street, moving plants to 
China and other low-wage countries. But I am always amazed that on the 
floor of Congress, when it comes to representing the interests of 
multinational corporations, people are always speaking about how great 
unfettered free trade is; it is not a problem; American workers going 
down the street; workers in China paid 30 cents an hour. That is okay. 
That is part of globalization.
  Well, why isn't it part of globalization that prescription drug 
distributors and pharmacists can pick up FDA safety-approved medicine 
at a fraction of the price they are currently forced to pay, and lower 
the cost of prescription drugs in this country very substantially? Why 
is that not a process of globalization that every Member of the Senate 
should be supporting?
  We should not kid ourselves as to what this debate is about. I think 
most Americans understand that large multinational corporations have 
enormous power over the Congress. You have big oil running up 
recordbreaking profits, receiving tax breaks and corporate welfare. You 
have credit card companies with tremendous power over what goes on in 
Congress, able to charge Americans 25, 28 percent usurious interest 
rates. You have insurance companies blocking national health care 
efforts so all of our American people can have health care as a right 
of citizenship. But at the top of the list of powerful, greedy special 
interests, at the top of that list, that very impressive list, stands 
the pharmaceutical industry. They are at the top.
  So when you talk about powerful interests, look at the pharmaceutical 
industry and the impact and the power they have in terms of what goes 
on here in Congress. Since 1998, the pharmaceutical industry has spent 
over $900 million on lobbying activities; $900 million since 1998. That 
is more than any other industry in the United States of America.
  It is hard to believe, but there are now over 1,200 prescription drug 
lobbyists right here in America, many of them right here on Capitol 
Hill. That amounts to more than two lobbyists for every Member of the 
House and the Senate. They have us well covered. These people are paid 
top dollar as lobbyists. These are former leaders of the Republican 
Party, former leaders of the Democratic Party.
  Let me tell you, they are hard at work today. They will be hard at 
work tomorrow. What they have done successfully, year after year after 
year, is when an effort comes up in the House and an effort comes up in 
the Senate, they descend like locusts into the offices of Members of 
Congress and say: Don't vote for change. Keep the status quo alive. 
Make sure the American people continue to pay the highest prices for 
medicine in the entire world.
  Since 2000--I don't know if you are supposed to talk about these 
things on the floor of the Senate. I will. Since the year 2000, the 
pharmaceutical companies have contributed almost $250 million in 
campaign contributions. Let me repeat that. Since the year 2000, the 
pharmaceutical companies have contributed almost $250 million in 
campaign contributions.
  What this debate is about is not just whether we are going to lower 
the cost of medicine in this country and save billions and billions of 
dollars for the consumers of our country, for people with acute and 
chronic illnesses, for our seniors; it is also about whether the 
Congress of the United States is, in fact, prepared to stand up to the 
most powerful, the greediest special interest in the United States of 
America.
  In my view, the time is long overdue for us to begin to make some 
fundamental changes in our prescription drug policies in this country. 
The time is long overdue for us to lower the price of medicine for our 
people, which not only will help people, of course, pay for their 
prescription drugs, it will lower the entire cost of health care in the 
United States.
  We spend far more money per capita on health care than does any other 
country on Earth. If we lower the cost of prescription drugs, we will 
have an impact on that.
  Tomorrow I will be speaking at greater length on this issue, but I 
think the arguments are so clear that prescription drug reimportation 
makes sense. The idea, as Senator Dorgan has mentioned, that somehow we 
can import tomatoes and lettuce from farms in Mexico and in Latin 
America, that is okay, but we cannot reimport prescription drugs from 
Canada with FDA regulations, that is impossible, makes sense to nobody 
at all. Food coming in from China, no problem; FDA-regulated 
prescription drugs coming from Canada, oh, my word, it can't be done. 
Give me a break. Of course, it can be done.
  What this issue is about is not drug safety. What this issue is about 
is the profits of the pharmaceutical industry and the enormous power 
they have over Congress. Now is the time for us to say to the drug 
companies: You have dominated what goes on year after year after year. 
You, in the drug industry, wrote the prescription drug Medicare bill. 
You have resisted year after year every effort to reform how we price 
medicine in the United States.
  Maybe the year 2007 might be the moment in which Members of Congress 
have the courage to stand up and say enough is enough. Let's support 
the men and women and children, the seniors of our country. Let's lower 
the cost of prescription drugs. Let's pass prescription drug 
reimportation.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from West Virginia.
  Mr. BYRD. Mr. President, thank God for Bernie Sanders, the Senator 
from Vermont. Thank God. Sail on, brother.
  I thank the Chair.
  Mr. SANDERS. I thank the Senator.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Mr. President, I will have a lot more comments on this bill 
at a later time. In light of the comments by the Senator from North 
Dakota about the importance of reading the bill, I wasn't sure that I 
had read the most recent copy of it. I think I have the most recent 
copy of it now. It is a fascinating 140 pages that is being attached to 
our 300-page drug safety bill. The reason I am checking it is because 
in the past we have noticed some strong implications for safety 
problems with drug importation, and I want to make sure we are not 
opening the door for even more safety problems. I had hoped that the 
bill on safety wouldn't have to get into the safety of imported

[[Page 10937]]

drugs, but I can see that is not the direction we are going. I am more 
than happy to address it.
  I am fascinated by the discussion today because the people who 
normally are talking about free trade are now talking about some 
restrictions. That would be my side of the aisle. Those who normally 
rail at any kind of opening of the market to anyplace outside of the 
United States are the ones who are supporting this bill. It is kind of 
a reversal of situations.
  I have heard the Senator from North Dakota talk about the way the 
Canadian Government is subsidizing the grain in that country and how 
that gives them an unfair advantage in the United States market and how 
we have to be sure that doesn't happen. Yes, the Canadian Government 
subsidizes. Yes, the Canadian Government gives an unfair advantage to 
their citizens. On drugs, the Canadians do some interesting things, 
too. They are a very small, limited market compared to the United 
States.
  Sometimes in business when you are trying to price things, you say: I 
could pick up a little bit more in the market if I changed my price a 
little bit. But I am only willing to go after the fringe in order to do 
that. That is kind of what has happened in Canada. Canada has made it a 
little more difficult for the drug companies because they say: We are 
going to negotiate the price. I love that word ``negotiate.'' Normally 
that means there is a little give and take on both sides and some 
advantages that are picked up on both sides in order for the outcome 
that is derived.
  In terms of pharmaceuticals, usually ``negotiation'' is the code word 
for ``price fixing.'' That is what they have done in Canada. They have 
fixed the price. If you want to be able to sell your drug up there, 
they will tell you what bid you better come in at and they are willing 
to have various pharmaceuticals bid against each other for the right to 
enter that fringe market, a small portion of what is in the United 
States but a potential customer. If you can cover your costs and pick 
up a few more sales, perhaps you can increase profits. It is a little 
accounting trick, but it happens. But they negotiate the price.
  There are five drugs for heart that do similar things. They make the 
five drugs for heart bid against each other. That means one or two of 
them will win the bid. If your doctor prescribed one of the other three 
in Canada, you are out of luck. The decision by the doctor is taken 
away because you will get a good price on the pharmaceutical that may 
not be quite right for you, but it will be cheaper than what you could 
have gotten. That is not the way we work it in the United States. We 
try to have competition between all of the different products and hope 
that brings the price down.
  There is some positive indication that it does bring the price down. 
We have the Medicare plan D. When they did the calculations on how much 
that was going to cost, it was considerably higher than what it 
actually came in at when there was competition among the providers, who 
in some cases represent more people than Medicare or Medicaid or the 
veterans and negotiate prices, but they negotiate realizing that we are 
forcing them to provide all of the pharmaceuticals, not just one or two 
out of five. If they are providing a plan, they have to provide for the 
prescription drugs.
  When I was doing hearings across Wyoming, I had a little surprise 
almost at every meeting that I had to explain Medicare Part D. That was 
somebody saying: I can't get the prescriptions I really want. I was 
doing all of this promotion before Part D even went into effect. So I 
knew something was wrong with that kind of a response. It occurred to 
me that maybe those were veterans. We negotiate the price on drugs for 
veterans. That means when the Government is doing it, they have to say: 
You know, I don't think your price is low enough so we are just not 
going to make that available to our people.
  Did you know that a whole bunch of veterans are taking prescriptions 
under plan D because they can't get what they want under veterans? It 
is an interesting situation. When you negotiate these things, you 
change some of the dynamics and you do not make everything available. I 
don't think we in the United States are going to settle for just having 
some, although if we can tap the cheap one in Canada where they fix the 
price, that will lend an advantage to people in the United States. I am 
ready to admit that. I am ready to admit if we didn't have restrictions 
on ethanol and subsidies in this country, we would bring in a whole 
bunch of ethanol from Brazil. But we are going to protect the ethanol. 
Again, it is a different group of people who are talking about that 
than are talking about drug importation.
  Let me get back to drug importation because that is important. The 
Senator from North Dakota several times--in fact, all the time--used to 
say ``where are all the dead Canadians'' when he was talking about 
safety. That is what my colleague from North Dakota used to come down 
to the Senate floor and say when he was talking about importation. He 
always asked that question. It may have escaped the notice of those of 
us in this body that he didn't ask that question anywhere in 
yesterday's debate or today's debate. Why not? Because two summers ago, 
five people in Hamilton, Ontario, died from taking counterfeit Norvasc. 
Norvasc is a blood pressure drug taken by millions upon millions of 
people who rely on it for their health and well-being. Since so many 
people take it, it is a target for counterfeiters looking to make a 
quick buck. I know he did say that counterfeiting is going to happen 
anyway. Probably. It happens in virtually every industry, and there are 
some countries that actually specialize in it. But imagine opening an 
opportunity for counterfeiters, an opportunity for them.
  In the portions of the bill I have gotten through already, I know 
there are some pretty tight restrictions on who can be an exporter and 
who can be an importer and how packages will be labeled and all of 
those sorts of things. It is a marvelous effort to try to tighten it up 
so that what you buy is what you think you are getting. But how many of 
us, when the program was to first start, would know what to look for or 
even who to order from in order to be sure the drugs we are getting are 
safe? How do you do that? It is a tremendous opportunity for 
counterfeiters. We already have a problem with counterfeiters. There is 
no way you can write off the counterfeit argument.
  I ask unanimous consent that I be able to show some three-dimensional 
objects on the Senate floor, the same as the Senator from North Dakota.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. ENZI. I will leave this on the desk so people can take a look at 
it. This is the Norvasc product with which the Canadians had a problem. 
It killed people. I want Members to take a look at the packaging. I 
have the external packaging. I have the internal packaging. I have the 
pills themselves. I challenge anybody to see the difference. We are 
going to put some special labels on anything that gets shipped into the 
country. I am sure nobody would ever be able to counterfeit any labels 
that were coming into the country. It just couldn't happen. There are 
now dead Canadians, and it saddens me to say that I believe there will 
be even more. These unfortunate individuals got their fake pills from a 
brick-and-mortar pharmacy. If that is what is happening when you buy 
drugs in person in Canada, who knows what you might get when ordering 
from a Web site that says it is in Canada but could really be based 
anywhere in the world.
  In fact, some of the drugs that have been intercepted by the FDA have 
come through Canada but actually were from Saudi Arabia. Communication 
worldwide is transparent these days. Whom you think you are ordering 
from is not always whom you are ordering from. Right now that practice 
is referred to as hiding the maple leaf.
  I would like to invite my colleagues to visit with me when I am 
finished my remarks. I have these pills I would like them to take a 
look at. There are other examples, too.
  So anybody who holds up two bottles and says, this one is this and 
this one

[[Page 10938]]

is this, they can't be sure if the one that is being imported is really 
from the country they are talking about. It has to be a concern. That 
has to be tightened up. There have to be some ways people can really 
tell.
  There is also a difference between whether you are importing for an 
individual or you are importing for a pharmacy. If you are importing 
for a pharmacy and they get a counterfeit load, it is not just one 
person who dies. It is the whole community, everybody who is taking 
that medication. So there needs to be some concern with these things.
  As I said earlier, we all want to have affordable drugs. We would 
like to bring down the cost of medicine every way that we possibly can. 
But a counterfeit or tainted drug is unsafe at any price.
  I want to add another thing on the counterfeit drugs. You can take 
the pills and you can grind them up and do a chemical analysis of one 
pill against the other, and they will come out identical. Now, part of 
the problem is the way you put these together to make them dissolve 
properly so what you need in your bloodstream gets into your 
bloodstream.
  A number of the imported drugs that have been confiscated are shown 
they will not even dissolve. If you take a pill, and it goes completely 
through your whole system, you could die. It is a serious problem. It 
looks good, it even checks out good, but there are processes for 
putting these things together.
  From my brief reading of the bill, I am also worried about some of 
the biologic information that may be in there that could be imported as 
well.
  The Food and Drug Administration Revitalization Act is about 
restoring the trust of the American people in the FDA. That is where it 
belongs. We should have a lot of concern.
  There is an amendment that is going to come up everybody is working 
on right now to make sure it would work, and it talks about some 
increased safety with food. Now, food, some of it, such as tomato 
packaging, is pretty well there. It is not put in another container. It 
is hard to fake. But there can be problems. We had problems with 
spinach in this country. We have a big problem with pet food right now, 
and it is because of China.
  China--how much do you trust them with your drugs? We have been 
trusting them with our pet food, and they are killing our pets. It took 
a little thing called melamine that increases the protein count in the 
food. It does not increase the protein, it just increases the protein 
count. It makes it look like a much richer food than it is. 
Unfortunately, it kills. Unfortunately, they have not just been using 
it in pet food; they have it in their regular food chain, and 
children--young children--got it, and the children died. When they 
checked on it, they found out they died of starvation, even though they 
had what should have been a good protein diet. There was a little 
melamine in it, and it was starvation rather than poisoning.
  But if they do that to food products, how much would we worry about 
drug products that come in from there? I know there are some 
limitations on where they can come from, but if they get into the 
European Union, there does not appear to be any constraint on it then, 
and it could be transferred on over to the United States. So throwing 
our borders open to drug importation would, instead, falsely place 
trust in criminals trafficking in illegal pharmaceuticals.
  I think the American people deserve better. I hope we do not make 
this move at this point in time, and that we constrain the bill to 
those things we know will add safety to our pharmaceuticals and medical 
devices and things for children in this country.
  I yield the floor.
  The ACTING PRESIDENT pro tempore. The Senator from New Hampshire.
  Mr. GREGG. Mr. President, I join with the ranking member of the HELP 
Committee--the Health, Education, Labor, and Pensions Committee--in 
raising the concerns and agreeing with the concerns he has raised about 
the reimportation proposal which has come forward from the Senator from 
North Dakota, which has been debated on this floor a number of times.
  The issue, of course, is the safety and efficacy of products which 
Americans buy. The FDA has been given the responsibility and has 
executed that responsibility extraordinarily well to make sure when an 
American citizen buys a pharmaceutical product or a medication, it is 
what it says it is and it does what the doctor prescribes.
  If you start buying medications internationally, you are in the 
position where you have no capacity for the FDA to monitor that 
purchase. So the drug may be represented to be an FDA-approved drug, 
but it could easily not be. In fact, case after case has been 
discovered of adulterated and changed medication coming into this 
country under the representation the medication which is being 
purchased is medication which has been approved by the FDA. So you are 
basically opening up a massive loophole in the area of safety for the 
American citizenry.
  Now, the demand for this comes from the cost of the drugs. People 
want to be able to go across the border to Canada, which is obviously a 
very sophisticated nation, and buy a pharmaceutical product there, 
which costs significantly less than the same pharmaceutical product may 
cost in the United States. That is a natural instinct of the market 
economy and of people. But critical to this exercise, of course, is the 
ability to get a safe drug.
  If you go across the border, and you buy a pharmaceutical product 
which is alleged to be one thing, and it turns out to be another thing, 
the damage it causes you is going to be economically much more 
significant than the savings which you may have accomplished by 
purchasing that drug across the border.
  Also, it should be noted that with the Part D pharmaceutical program 
which we now have relative to Medicare, the pressure--because 
pharmaceutical products are now insured and people receive them under 
the insurance plan as created under the Part D program, which has been 
an extraordinary success to supplying pharmaceuticals, though its cost 
remains extraordinarily expensive for the next generation of 
Americans--but pharmaceutical products are now available under an 
insurance program to most American seniors, and, as a result, if you 
are a senior, one of the people most likely to use a large number of 
drugs, and most often are on a fixed income and have problems 
purchasing drugs as a result of the fixed income situation--those 
issues were addressed by Part D to a large degree relative to the 
senior purchasing drugs; and it did create the ancillary problem of 
creating a huge cost which has to be borne by the next generation--but 
relative to the supplying of drugs, the pressure which was forcing 
people to take the chance of purchasing a drug internationally has been 
relieved to some degree, significantly in the area of senior citizens.
  I proposed language which would create a safe pharmaceutical 
approach, where you would create an Internet pharmacy approach, where 
you would create a regime under the FDA where people could go on the 
Internet and buy pharmaceutical products knowing they have been 
approved by the FDA.
  Today, unfortunately, that is not the case. If you go on the 
Internet, and you purchase something through a pharmaceutical firm off 
the Internet, you do not know whether that product--even though it may 
be represented to be FDA-approved--is FDA-approved because there is no 
way to certify the site you are purchasing from is an FDA-approved 
supplier.
  So this reimportation bill is essentially going to create an 
atmosphere where those Internet pharmacies are going to become 
basically the ``wild west'' of supplying drugs in this country, and you 
are going to see people going on to these Internet pharmacy sites and 
purchasing drugs they think are being represented as an American-
approved drug that has been reimported--and is at a lower price--but 
may actually be a totally adulterated drug which will do significant 
harm to you.
  We have seen instances of that already--dramatic instances. Case 
after

[[Page 10939]]

case has been reported of people being significantly harmed and in some 
instances dying as a result of buying pharmaceuticals off the Internet 
that turned out not to be what they were represented to be from 
international sites.
  So at a minimum, this reimportation proposal, which has received 
significant support in the past because it has a motherhood name on 
it--even though it might be actually creating significant problems for 
children and for other people in this country as a result of the risk 
it puts people at--at a minimum, this proposal should be subject to 
creating some sort of a regime where FDA has the ability to monitor and 
to approve and to make available to the public the knowledge that 
Internet pharmaceutical sites have been approved by the FDA. That is 
what my amendment does. It tries to address that.
  So we should not move forward precipitously in the way that is 
proposed by the Senator from North Dakota. We should not be supporting 
this simply because it has a nice name on it and because he can hold up 
two bottles which are the same drug but costs differently in a managed 
economy in Canada and a market economy here in the United States. We 
should, rather, set up a structure where FDA can be sure that when you 
buy that pharmaceutical product through an Internet site that is 
international or from a Canadian pharmacy, that you are getting what 
they claim you are getting, so when you take that drug, you benefit 
from it and are not harmed by it.
  This all, however, gets to a bigger issue. Probably, there is not 
time right now to go into it in depth. But the bigger issue is, where 
do pharmaceutical products come from? Where do all these amazing 
products, the biologic products that are saving lives in this country 
and are creating such a much better lifestyle come from? Remember, they 
do not come from trees, and they are not grown in North Dakota in the 
sugar beet fields. They are developed through processes which involve 
years--years of investigation and research.
  The average pharmaceutical product in this country takes 12 years and 
$800 million to bring to the market. Think about that: 12 years and 
$800 million before you can produce a product Americans can take. That 
is a pharmaceutical product. If you are getting in the biologics area, 
which is a much more complicated area, it takes even longer. It is even 
more complex, and in many instances it is even more expensive.
  It is these products that are changing the life expectancy of people 
and making the quality of life of people so much better. We have 
basically gone from a medical regime in this Nation where invasive 
action was always the first call, was always the first event, where you 
basically went under the surgical knife, to a regime where you are 
given pharmaceuticals or biologics to try to address a very serious 
illness. It is a huge step, an exponential step in the direction of 
better health care and a better lifestyle for Americans and for the 
world.
  Where are these products developed? Well, they are developed here in 
the United States. Why are they developed here in the United States? 
Why are almost all the major pharmaceutical breakthroughs and all the 
biologic breakthroughs coming in the United States? Because we have a 
market system which allows people to take the risks to develop those 
products.
  We do not fix prices, as they do in Canada or in England, at a rate 
that is so low that nobody would be willing to invest in developing 
that product because the return on that investment is too low. We allow 
people who make the investment, who take the risk, who put the 12 years 
in, who invest $800 million, to get a reasonable return on their 
investment and on their effort. As a result, we have the explosion in 
advances in technology, in medical technology, in biologics, and in 
pharmaceuticals.
  It is a result of the fact that people who want to take that risk, 
and who have the ability to pursue that type of opportunity to make 
life better for people by creating these pharmaceutical products and 
these biologic products, have the capacity to get resources to do it. 
It is called capital markets.
  Now, capital does not flow for goodwill. People do not invest in 
things because it makes them feel good, in most instances. People 
invest where they are going to get the best return on the dollars they 
invest, or a reasonable return on the dollars they invest. So we have 
to maintain an atmosphere in this country where people are willing to 
put money--cash, capital resources--into the investment and research 
and development of pharmaceutical and biological and device products.
  But if you listen to the other side of the aisle, almost every 
proposal they come forward with seems to be of the view that these 
products are grown in some wheatfield in North Dakota, that they do not 
take any effort, that they do not require any capital, they do not 
require any expertise, research, or time. All they require is to be 
price fixed, to be limited in their ability to be distributed relative 
to the price that is charged.
  Time and again, the other side of the aisle has come forward with 
proposals which basically undermine the incentive for capital to flow 
into these research areas. Believe me, if capital is disincentivized 
from going into these areas because they do not get a reasonable 
return, they will go somewhere else--they will go into developing 
software, into gaming, into whatever it is that happens to give them a 
reasonable return, into investing in some other country's activities in 
some area.
  Capital does not flow out of goodwill into pharmaceutical production, 
into biologic production, into device production. It flows into those 
accounts because they expect a reasonable return.
  Now, sure, the countries of Canada, England, and the European common 
market, to some degree, are living off of the fact that we give people 
a reasonable return on our pharmaceuticals and biologics in this 
country. That is absolutely true, and it is reasonably disgraceful. In 
fact, in Canada, they threaten to take people's patents away if they 
don't--they basically capture American patents if they don't sell these 
drugs at a price which nobody would have invested in them in the first 
place to produce them were the price fixed at that level. But that is 
their policy.
  Now, we could subscribe to that policy, which is what the other side 
of the aisle wants us to do. They proposed it in Medicare negotiations, 
they proposed it now and passed it here in the child drug review. They 
proposed it in this reimportation, and they proposed it in the 
negotiated language relative to Medicare, and in biologic generics. In 
all of these areas they are basically saying: Well, drugs must appear 
in the marketplace. We don't have to be concerned with the fact of 
getting capital into the investment exercise. We don't have to be 
concerned with the fact that it takes years and years to research these 
products and hundreds of millions of dollars to bring them to the 
market, they just appear. We can basically, for lack of a better term, 
kill the goose that is laying the drug or the biologic or the 
pharmaceutical or the device that is saving people and not worry about 
it.
  Well, that is not true. If you were to follow all of the proposals 
from the other side of the aisle, or even a significant amount of them, 
we would see investment in this area start to dry up. We would see a 
contraction of the production of pharmaceuticals that save lives, of 
biologics that save lives, of devices that save lives. We would see 
fewer and fewer of those coming to the American people and to the world 
because people wouldn't invest in that activity any longer, or the 
investments would be significantly curtailed because money would flow 
in other directions.
  This concept of the marketplace totally escapes the other side of the 
aisle. This concept that drugs have to actually have some flow of 
capital behind them to be produced because it takes so long to get them 
to the market, and it takes so much money to actually research them--
and that is especially true in biologics and equally true in devices. 
It totally escapes the other side

[[Page 10940]]

of the aisle. Their idea is, we have a good line, we have a motherhood 
statement, let's let people go buy the drugs somewhere else at a price 
that is fixed at which nobody would have ever produced the drug in the 
first place if that was the price. Let's negotiate so we have a regime 
of price setting at the Federal level, which basically eliminates the 
capacity for that drug to be competitive.
  Let's create a biologic generic which basically wipes out the 
capacity of the true biologic to actually come to the market and be 
successful. Let's create an atmosphere where testing on children of the 
drugs will basically not have a fiscal return which will make it 
worthwhile to test them on children. Let's do all of those things in 
the name of the motherhood language of getting a better price for drugs 
for Americans, ignoring the fact that what you are actually going to 
end up doing is dramatically limiting the number of drugs coming to the 
market for Americans, and therefore significantly impacting the quality 
of life of Americans and our ability to advance the dramatic and 
revolutionary activity that we are seeing in bringing biologics to the 
marketplace, which are basically curing and have the potential to cure 
diseases which have been extraordinarily threatening to the American 
population for so long.
  It makes no sense, if you look at the substance of the issue, what 
they are proposing. It is totally inconsistent. They are saying they 
are doing this to help people. What they are actually ending up doing 
is harming not only the people of today who won't be able to get the 
drugs because they won't be produced but people in the future because 
the drugs won't be brought to the market. There is a blindness to the 
fact that market forces are at work. I guess it is just a function of 
the fact that you want to get out a good press release, so you are 
going to send it out. Of course, anybody who takes the position I just 
outlined is immediately demagogued, and the pejorative tool of the drug 
industry is thrown out there.
  Well, I am hardly that, since I was one of the few people in this 
Chamber who actually aggressively opposed and tried to stop the 
Medicare Part D Program, which was the biggest windfall the drug 
industry ever got and which was voted for by many of my colleagues on 
the other side of the aisle and which ended up putting an $8 trillion 
bill which is unpaid for onto our children's future.
  More importantly, the reason I take the position I take is because I 
believe very strongly that America should not give up its lead in one 
of the industries where it is at the cutting edge and where it is 
producing jobs and where it is producing the intellectual capital that 
is going to keep us a vibrant, strong economy. In addition, we should 
not give up an industry or undermine an industry and geniuses and 
creative individuals who are producing products which are saving lives 
and are giving people a better livelihood. So I am not going to sign on 
to these various jingoistic proposals which are brought to the floor 
for the purposes of putting out good press releases about how I did 
this or that for motherhood at the expense of undermining the quality 
of care for future generations by basically limiting dramatically the 
ability of people to get capital who want to be creative, who want to 
invest, and who want to do research in the area of producing biologic 
products, pharmaceutical products, and medical devices.
  That is why I take the position I take, to say nothing of the fact 
that if you start haphazardly importing products from the Internet and 
from countries such as Canada, as strong as Canada is, without any FDA 
oversight or approval of those products, you are going to harm a lot of 
people at the end of the day. A lot of people are going to be hurt, and 
some people are going to die as a result of buying products which have 
not gone through FDA approval and which are not subject to FDA 
oversight because they are bought from a pharmacy or a provider in 
Canada, and that product may have come out of India or it may have come 
out of Afghanistan. It may have come out of Pakistan. It may be 
adulterated, and it may kill. The same can be said by a factor of 10 
relative to purchasing on Internet pharmacies.
  So there are some big issues at play. There are big issues at play 
relative to the future of the health of Americans on the issue of 
importation, on the issue of negotiation and Medicare, on the issue of 
biologic generics, and on the issue of making sure that children are 
adequately tested relative to the application of drugs which are 
brought to the market. There are big issues relative to safety and big 
issues relative to whether this country remains on the cutting edge of 
producing products that help people and give them a better lifestyle 
with a biological, pharmaceutical, or medical device. We shouldn't just 
pass these proposals willy-nilly for the sake of putting out a nice 
press release.
  Mr. President, I yield the floor.
  The ACTING PRESIDENT pro tempore. The Senator from South Carolina is 
recognized.
  Mr. DeMint. Mr. President, I ask unanimous consent that the pending 
amendment be set aside.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.


                           Amendment No. 1018

  Mr. DeMINT. Mr. President, I have an amendment at the desk and ask 
for its immediate consideration.
  The ACTING PRESIDENT pro tempore. The clerk will report the 
amendment.
  The legislative clerk read as follows:

       The Senator from South Carolina [Mr. DeMint] proposes an 
     amendment numbered 1018.

  Mr. DeMINT. Mr. President, I ask unanimous consent that the reading 
of the amendment be dispensed with.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  The amendment is as follows:

  (Purpose: To amend the notification provision with respect to drugs 
       deemed to have risk evaluation and mitigation strategies)

       In section 214(b)(3)(B) of the bill, insert ``, except with 
     respect to the drug Mifeprex (mifepristone), such assessment 
     shall be submitted 6 months after the applicant is so 
     notified'' before the period at the end.

  Mr. DeMINT. Mr. President, my amendment calls for the Food and Drug 
Administration to conduct an assessment of the risk evaluation and 
mitigation strategy, which we refer to as REMS, for Mifeprex, commonly 
known as RU-486, within 7 months of the effective date of this 
legislation.
  According to the legislation before us, any drug that is currently on 
the market with restrictions on its distribution or use, which includes 
RU-486, would be required to have a risk evaluation and mitigation 
strategy. This means that RU-486 would be subject to periodic 
assessment of how well the risk management plan, including its 
restrictions, is working. Unfortunately, the bill does not establish a 
deadline for the risk evaluation for RU-486.
  The current RU-486 abortion regimen was approved by the Food and Drug 
Administration in September of 2000. Since that time, the regimen has 
been linked to the deaths of seven women, including three Americans. 
The public has learned since November of 2004, through the release of 
documents by the FDA through a Freedom of Information Act request, that 
over 1,000 additional women have experienced adverse effects from the 
RU-486 regimen, including 9 life-threatening incidences, 232 
hospitalizations, 116 blood transfusions, and 88 cases of infection. It 
should be noted this dangerous drug is attacking young, healthy women.
  I also want to point out the approval process for RU-486 was highly 
irregular in the first place. The drug regimen was approved under FDA 
subpart H, which is a regulation that applies to certain new drugs used 
for treating serious or life-threatening illnesses. While certain 
conditions may arise during pregnancy that are dangerous, pregnancy 
itself is hardly a serious or life-threatening illness.
  The RU-486 regimen actually requires the use of two drugs: RU-486, 
which kills the child, and misoprostol, which causes the uterus to 
expel the dead baby. G.D. Searle, the manufacturer of misoprostol, 
never sought to have its drug approved by the FDA for

[[Page 10941]]

abortions. Nevertheless, the FDA, in what appears to be an 
unprecedented decision, mandated that misoprostol be used for 
unapproved ``off-label'' use in an abortion regimen along with RU-486.
  Finally, the FDA approved the RU-486 regimen based on data submitted 
from clinical trials in which there was no control group comparison. 
This directly violates Federal law and appears to be unprecedented as 
well.
  In my opinion, the FDA has not done enough to curb the use of this 
deadly drug, and for far too long the FDA has put politics ahead of 
science and ahead of women's health. When the Clinton administration 
expedited the approval process for RU-486 in the final days of its 
tenure, many medical professionals expressed serious concerns about the 
FDA's rush to bring RU-486 to market. Since then, the statistics have 
proven these concerns to be well-founded.
  The legislation we are considering today has everything to do with 
drug safety. Yet we have a drug on the market that has killed several 
women and injured many others. My amendment simply sets a 7-month 
deadline for the FDA to assess the risk evaluation and mitigation 
strategy for RU-486. Given all the adverse events associated with this 
drug, this is the least we can do.
  This is not an abortion issue, it is a women's health issue. Even 
those who support abortion agree there are serious problems with this 
drug. Let me read several quotes from abortion supporters which were 
part of a New York Times story that ran last year: ``None of these 
women should be dying; it's shocking,'' said Dr. Peter Bours, an 
abortion provider in Portland, OR, who is rethinking whether to offer 
pill-based or medical abortions.
  Dr. Warren Hern, an abortion provider in Denver, said the latest 
reports demonstrated that abortions by RU-486, or Mifeprex, were far 
riskier than the surgical ones. ``I think surgery should be the 
procedure of choice,'' Dr. Hern said. ``Pills,'' he said, ``are a lousy 
way to perform an abortion.''
  I quote again from another source: ``The complications associated 
with RU-486 far exceed the complications of surgical abortion,'' said 
Dr. Damon Stutes. He is an abortion provider in Reno, NV. He refuses to 
offer pill-based abortions.
  Dr. Stutes, whose clinic has been bombed, said he was uneasy about 
agreeing with abortion proponents on anything. But the truth is the 
truth, he said.
  Another quote:

       One needs to tell patients that the medical procedure, even 
     though it seems more natural, may be more likely to result in 
     death.

  That is Dr. Phillip G. Stubblefield, a professor of obstetrics and 
gynecology at Boston University.
  It is clear that even the supporters of abortion believe this drug is 
dangerous. It also appears that even the leader of the abortion 
industry--Planned Parenthood--supports actions by the FDA to further 
examine the safety of the drug. Dr. Vanessa Cullins, vice president for 
Medical Affairs at Planned Parenthood, told the San Francisco 
Chronicle:

       We are glad there will be continuing investigations by the 
     FDA. We will work with the CDC, the FDA, and academicians to 
     figure this out.

  The FDA needs to quickly complete its risk evaluation on RU-486. That 
is what my amendment guarantees. I urge my colleagues to support it. I 
understand that Senator Kennedy will accept a voice vote on this. I 
look forward to supporting it, along with all of my colleagues.
  I yield the floor.
  The ACTING PRESIDENT pro tempore. The Senator from North Dakota is 
recognized.


                           Amendment No. 990

  Mr. DORGAN. Mr. President, I have listened to some of the debate on 
the floor of the Senate in opposition to the amendment I have offered 
with many colleagues dealing with the reimportation of prescription 
drugs. Especially entertaining was to hear the Senator from New 
Hampshire, Mr. Gregg, describe North Dakota wheatfields. The Senate is 
a place of fascinating and interesting debate. I expect we will have 
more of that in the coming hours, leading up to a vote tomorrow on a 
cloture motion on this amendment.
  The continued and insistent reference to this amendment posing safety 
risks, or risks of unsafe prescription drugs, is at odds with 
everything we know to be the case. I described Dr. David Kessler, and I 
suggested if anybody knows a more important, better informed expert 
than Dr. David Kessler, who was head of the FDA for nearly 8 years, 
tell me his or her name. I described the statement that Dr. David 
Kessler made that says this will make the prescription drug supply 
safer. In fact, the regime of safety we have put into this amendment is 
appropriate, important, and will mean that we will be able to allow 
reimportation without a safety risk.
  Despite the evidence, we continue to hear this issue. I was thinking, 
as I was listening to this a while ago, about the Lincoln-Douglas 
debates, when Lincoln became enormously exasperated at one point and he 
said to Douglas: Tell me, how many legs does a horse have?
  Douglas said: Well, four, of course.
  Lincoln said: Now, if you were to call the tail of a horse a leg, 
then how many legs would a horse have?
  Douglas said: Well, five.
  Lincoln said: You see, that is where you are wrong. Just because you 
call the tail a leg doesn't make it a leg at all.
  The same principle holds true now on the floor of the Senate. You can 
say what you want, but that doesn't make it true. Safety issues? That 
doesn't exist in the amendment we are talking about. This will make the 
drug supply safer. While I am speaking of Lincoln and Douglas, let me 
say something else that Lincoln said, which has always been interesting 
to me. He was describing his opponent's arguments. He said: Your 
argument is as thin as the homeopathic soup made from boiling the 
shadow of a pigeon that has been starved to death.
  Wasn't Abraham Lincoln wonderful? That description can still exist 
for some of the arguments we are hearing these days on some of these 
issues.
  I hope my colleague was not serious a few moments ago when he said 
this is an amendment that is not worthy and is put out by a bunch of 
people who want to put out press releases and aren't concerned about 
the safety of the drug supply. My colleague surely doesn't mean to say 
that Senators Grassley, McCain, Snowe, and Collins on his side and 
Senators Kennedy, Stabenow, Brown, and so many on our side--the 33 
Senators who have come to a serious issue with a thoughtful proposal--
did so because they want a press release. My colleague knows better 
than that. He perhaps ought to tell the Senate he knows better than 
that.
  I respect those who disagree with this amendment. I hope they will 
respect as well our determination to correct something we see as a 
serious problem. When my colleague says we don't want to give up our 
lead, describing our lead in pharmaceuticals and the development of 
prescription drugs, I don't want to give that up. Let me tell you 
another lead we don't want to give up; that is, the lead in providing 
the highest prices in the world to the American consumer who needs 
prescription drugs. That is a lead we ought to relinquish right now. I 
wonder if my colleague would agree with that.
  Mr. President, this is an interesting debate, a useful debate. It 
will conclude tomorrow with the vote. My colleague from Michigan, 
Senator Stabenow, has gone across the bridge that connects our two 
countries, taken busloads of senior citizens and has been involved in 
this issue for many years, believing that we ought to insist on fair 
pricing for prescription drugs for the American people. I am pleased 
that she was one of the people who helped put together the bill 
introduced by 33 Senators, and I am pleased that she is a strong 
advocate for the amendment that we have added to this piece of 
underlying legislation.
  I yield the floor.
  The ACTING PRESIDENT pro tempore. The Senator from Michigan is 
recognized.
  Ms. STABENOW. Mr. President, I rise to support the amendment we have 
put together, led by the Senator from North Dakota. I thank him for his 
passionate leadership and advocacy and

[[Page 10942]]

the way he is able to speak in very commonsense terms about what this 
is all about. What we are talking about is common sense. We are talking 
about whether we have the most competition that will allow the best 
price for people related to their medicine. I also am looking around 
for Senator Brown, who is also here to speak. I thank him publicly for 
his help on another amendment that relates to competition and closing 
patent loopholes relating to generic drugs. I thank him again. Senator 
Brown has been a wonderful advocate on these issues.
  I find it so interesting whenever we hear that we cannot lower the 
price of prescription drugs without losing research. Let me comment on 
that first. Here is what is happening today as it relates to the 
development of new medicine. We all want that. We all want that, those 
of us who supported overwhelmingly, the 63 Members of the Senate who 
voted for stem cell research to provide new lifesaving research and 
tools for our researchers. We came together and said, yes, we want new 
lifesaving research.
  That is not what this debate is about. The debate is about whether 
there is going to be a closed market to folks who get to set the price 
without competition or whether there will be competition so people can 
afford to buy medicine. The reality is that our structure is such right 
now, as it relates to the way we bring drugs to market, that you start 
with basic research, of which last year $29 billion was paid for by the 
American taxpayer--$29 billion. Now, the industry then added another 
$39 billion, according to the PhARMA Web site. They are allowed to 
write off their research as a business expense, or take an additional 
amount--the R&D tax credit on top of that to write off their research. 
So the taxpayers are paying, it is fair to say, the majority of what it 
costs in basic research right now for new lifesaving medicine.
  Personally, I am willing to do that because I think it is incredibly 
important. It is in our public interest. Having all of us together as 
taxpayers invest in the National Institutes of Health and other 
lifesaving research makes sense to me. After we do that, we allow the 
companies to take that information and research and begin to develop 
medicine. That is fine, too. We then allow up to a 20-year patent, so 
that the company that does this development can recoup their costs 
without the same kind of competition from a generic company, another 
kind of company. So we give them a privileged status. We cover their 
costs, after we as taxpayers have helped them or may have fully funded 
the research done in the beginning. So we go through all this, and all 
that I ask on behalf of the people of Michigan and all I think we are 
asking for is, when they get done with the patent, people be able to 
afford to buy the medicine and that we have the kind of competition 
that allows that to happen.
  One piece is to make sure patents are not extended beyond 20 years 
unfairly by manipulation. I will have an amendment that deals with 
closing some loopholes. The other is to make sure we open our borders 
to allow our pharmacies, our hospitals, our medical schools, all those 
who are providing prescription drugs to consumers, to be able to 
purchase those and get the best price.
  In Michigan, it may be from Michigan or it may be from Ohio or 
Wisconsin, but it may be 5 minutes across the bridge in Canada. In 
fact, Mr. President, that is what we find 5 minutes across the bridge. 
I have had a lot of opportunities to put seniors on buses to go to a 
pharmacy in Canada to see the fact that you are looking at 30-, 
40-, 50-percent cheaper prices. I think of my sister-in-law when I say 
this. She was diagnosed with breast cancer, and thank God is doing well 
and has recovered. But when I look at the drug Tamoxifen that many 
breast cancer patients are required to take, or are asked to take, in 
Michigan, the last time I looked, it was about $360 a month for that 
medicine. Five minutes across the bridge, it is $60. That is a huge 
difference. That is a huge difference in somebody's ability to get the 
treatment they need for breast cancer. That can be replayed over and 
over again as it relates to medicine.
  Now, what is also interesting is that prescription drugs are being 
brought across the border every day legally by the companies 
themselves. Lipitor, which was developed in Michigan--and I am proud of 
that--is manufactured in Ireland. They bring it back. There is no 
argument about safety when they are bringing it back. We have, right 
now, around the world, from Slovakia to China to India, medications 
that are being brought into this country by the companies themselves, 
under safe conditions.
  Our legislation puts into place safety requirements that will allow 
the same thing to happen if it is a wholesaler, a pharmacy doing 
business with another pharmacy. There is no rocket science here. The 
very same safety provisions can be put into place. We also know that, 
in doing that, it is important to put that language directly into this 
bill. It is important. We have put in there a chain-of-custody 
requirement to ensure that drugs are handled not only by authorized 
persons but shipments must use anticounterfeiting technology to assure 
the products' integrity.
  We do a number of things that relate to registering with the FDA and 
agreeing to strict requirements to ensure safety. But those 
requirements are not all in the bill. Why is that? Because we know that 
in the past we have seen--we see again now--a second-degree amendment 
to say that citizens cannot get the best price, and pharmacies cannot 
do business with pharmacies across the border, unless the Secretary 
certifies safety. And we know that for whatever political reasons, that 
has not happened over the years. That is actually current law.
  To get beyond the politics of this, we have worked on a bipartisan 
basis, with wonderful bipartisan support, to actually put the safety 
provisions that are required into the bill so the certification by the 
Secretary is not necessary.
  We have had legislation passed by the Senate with wonderful 
bipartisan support in the last few years on related issues that involve 
reimportation. Last July, 68 Senators voted for an amendment to 
prohibit U.S. Customs and Border Protection from stopping individuals 
from importing FDA-approved drugs--individual reimportation.
  I thank Senator Vitter for his leadership. I have been pleased to 
work with him on this issue of individuals being able to import 
medicines for themselves. Senator Vitter and I also worked together to 
make sure trade agreements cannot be used as a backdoor way to stop 
reimportation of cheaper prescription drugs into this country.
  We are already on record as supporting this effort to lower 
prescription drug prices and create competition. It is my hope that, 
once again, in this bill we will reaffirm that we support the FDA 
creating safety regimens--we know they exist--to be able to bring 
medicine safely into the United States from other countries, and we 
will no longer allow a group--it is the only group I know that is able 
to stop trade at the border. Everyone talks about free and open trade, 
and yet in Michigan you can bring auto supplies back and forth every 
day, you can bring all kinds of agricultural products, you can bring 
anything back and forth across the border except medicine, except 
prescription drugs, unless you are a drug company. Drug companies can, 
but if you are somebody trying to make sure you get the lowest possible 
prices to consumers through a pharmacy, a hospital, medical school, or 
other businesses, you are not allowed to do it. It doesn't make any 
sense.
  I believe we need to take off this protectionism which has been in 
place for years which has put consumers and businesspeople, frankly, 
into a situation where they are paying higher prices for medicine than 
they should.
  This is not about research. I conclude by saying that according to 
SEC filings, 2\1/2\ times more is spent on marketing and advertising 
brand-name prescription drugs in the United States than is spent on 
research. This is not about research. We as taxpayers are

[[Page 10943]]

leading the way on funding research, and we all support doing that. 
This is about competition versus protectionism and whether consumers 
will get the very best price for lifesaving medicine.
  I urge the adoption of our amendment.
  The ACTING PRESIDENT pro tempore. The Senator from Ohio.


                           Amendment No. 1018

  Mr. BROWN. Mr. President, I understand there is no further debate 
with respect to the pending amendment No. 1018, so I ask that the 
amendment be agreed to and the motion to reconsider be laid upon the 
table.
  The ACTING PRESIDENT pro tempore. Is there objection?
  Mr. COBURN. Reserving the right to object.
  Mr. BROWN. Mr. President, amendment No. 1018 is the DeMint amendment.
  Mr. COBURN. I have no objection.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  The amendment (No. 1018) was agreed to.
  The ACTING PRESIDENT pro tempore. The Senator from Iowa.
  Mr. LEAHY. Mr. President, will the Senator from Iowa yield to me for 
1 minute?
  Mr. GRASSLEY. Yes.
  The ACTING PRESIDENT pro tempore. The Senator from Vermont.
  (The remarks of Mr. Leahy are printed in today's Record under 
``Morning Business.'')
  Mr. LEAHY. Mr. President, I thank my dear friend from Iowa.
  The ACTING PRESIDENT pro tempore. The Senator from Iowa is 
recognized.


                           Amendment No. 990

  Mr. GRASSLEY. Mr. President, I am a cosponsor of Senator Dorgan's 
amendment called the Pharmaceutical Market Access and Drug Safety Act. 
We want to add the provisions on the importation of drugs to this 
measure. Obviously, I support that effort. That legislation is the 
result of a collaborative effort by this Senator, Senator Dorgan, 
Senator Snowe, and Senator Kennedy to finally make drug importation 
legal in this country. This is one effort which I hope the new 
Democratic Congress can finally get passed because last time, my own 
party did not want to see this passed, even though I worked hard to get 
that done.
  Now is the time for us to make this happen. This is a golden 
opportunity this year to get it done. I think we are well on the way to 
getting it done.
  I have been a longtime proponent of drug importation. In the years 
2000, 2002, and 2003, I supported amendments permitting importation of 
prescription drugs from one country--Canada.
  In 2004, Senator Kennedy and I worked together on a bill that would 
authorize drug importation, but it did not survive the partisan 
politics of that year.
  I then introduced my own drug importation bill in 2004 with the 
number S. 2307. After introducing my bill, I began working in 
conjunction with the efforts of Senator Dorgan, Senator Snowe, and 
Senator Kennedy. So in this provision before us, we combined our 
efforts so that we could all get behind the same bill and have a better 
chance of getting it passed. Of course, that is where we are, working 
together this very minute.
  Making it legal for Americans to import their prescription drugs is a 
top priority at the grassroots level, as it shows up in my 99 town 
meetings I have every year in each of our 99 counties, and I have been 
doing that for 26 years. So I think I have a feel for what the 
grassroots of my State wants Congress to hear.
  This is one issue about which I constantly hear, although I am 
probably hearing it a little bit less now that we have the Part D 
provisions of the Medicare bill because for people who couldn't afford 
drugs, who maybe relied on imports or at least drugs from other 
countries, they are able to get them a little better through the 
subsidization under the Part D Program. But I still hear about this 
issue, and that is why I am still working to get it passed. So this 
needs to be a top priority in Washington as it is at the grassroots of 
America.
  I have long advocated allowing American consumers access to safe 
drugs from other countries, but I have not looked at this solely or 
even most importantly as a health issue. I have looked at it more often 
as a free-trade issue. Imports of any kind coming into our country 
create competition and keep domestic industry of all segments of our 
economy more responsive to the consumer, giving the consumer what they 
want at a price they are willing to pay and a quality they care about.
  In the United States, we seem to import anything that the consumer 
wants to buy in America, but we don't do it for pharmaceuticals. So why 
not, with this legislation, do for pharmaceuticals what we do for 
everything else American consumers want to buy? That is what breaking 
down the barriers to trade is all about. That is where our country has 
been for 50 years, breaking down barriers to trade around the world. 
Yet we keep this barrier up. Consumers in the United States then pay 
far more for prescription drugs than those in other countries.
  If Americans could legally and safely access prescription drugs 
outside the United States, then drug companies would be forced to 
reevaluate pricing strategies. More competition would have an impact. 
They would no longer be able to gouge the American consumer by making 
them pay more than a fair share of the higher costs of research and 
development, which is a resource we need for research and development, 
but why should just the American consumers pay for that?
  It is true that pharmaceutical companies do not like the idea of 
opening up America to the global marketplace. They want to keep the 
United States closed to other markets in order to charge higher prices 
here. However, with this amendment, prescription drug companies will be 
forced to be competitive and establish fair prices in America.
  The drug companies will try to find, of course, loopholes to protect 
their bottom line, but I think our amendment is comprehensive enough to 
keep that action illegal. It would not allow, for instance, 
manufacturers to discriminate against registered exporters or 
importers. It would prohibit drug companies from engaging in any 
activities to restrict, to prohibit, or to delay the importation of a 
qualifying drug. The amendment would give the Federal Trade Commission 
the authority to prevent this kind of possible abuse of the system.
  I also understand that there will be an attempt to kill this 
amendment, as it has been, I believe, in the years 2000, 2002, and 
2003, by an amendment that would require a certification about health 
and safety. That amendment is designed to kill the underlying Dorgan 
amendment. It is a clever amendment and for sure can legitimately be 
determined to be a poison pill.
  Our efforts develop an effective and safe system that gives Americans 
access to lower prices. This amendment requires that all imported drugs 
be approved by the Food and Drug Administration. The amendment sets a 
stringent set of safety requirements that must be met before Americans 
can import drugs from that country.
  The amendment requires all exporting pharmacies and importing 
wholesalers to be registered with the Food and Drug Administration, as 
well as being inspected. It gives the authority for the FDA to inspect 
entire distribution chains of imported drugs, and it sets very 
stringent penalties for violation of the safety requirements in this 
bill, including criminal penalties and up to 10 years in prison.
  Don't be fooled by the poison pill amendment to which I just 
referred. Voting for that amendment is a vote to kill drug importation.
  With the Dorgan amendment, we are going to get this job done because 
we need to make sure Americans have even greater, more affordable 
access to wonder drugs by further opening the doors to competition in 
the global pharmaceutical industry.
  I think Americans have been waiting for this for a long period of 
time. When a country such as ours allows every other product to come 
into this country that the consumer wants for the

[[Page 10944]]

best price and the best quality, there is no reason we should make an 
exception for pharmaceuticals. We must make sure they have access to 
these affordable prescription drugs. So I urge my colleagues to support 
the Dorgan amendment.
  Mr. COBURN. Mr. President, I want to chime in for a minute on this 
amendment, and I want to set a little background. Why do we want to 
import prescription drugs? What is the reason behind it? The reason is 
that there is not a true international market in pharmaceuticals. 
Senator Stabenow quoted a figure of $29 billion worth of Government 
research. That is not quite accurate. There is $29 billion that goes to 
NIH, but that is not all related to drug development. Probably half of 
that is. So we do have a great investment in drugs. There is no 
question that the American consumer subsidizes the pharmaceuticals of 
almost every other nation in this world. So the purpose behind this 
amendment is a good one.
  I would draw attention to the fact that Senator Brown and I passed a 
drug reimportation bill in the late 1990s that became law, and 
President Clinton signed it. Donna Shalala, however, under the same 
guidelines, refused to carry out that mandate--that bill is still on 
the books, by the way--claiming there was nothing they could do that 
would make them safe and that they could assure they were safe.
  I am going to vote for this amendment, and I think it is right that 
we should develop a worldwide market on pharmaceuticals, but I am not 
sure we are going to accomplish this. Having authored the first bill on 
drug reimportation when I was a Member in the House, what I have seen 
is that the problem is much bigger than what we are attacking. I find 
it kind of peculiar and strange that we haven't gone a little further. 
What really needs to happen is we need to tell all our friends around 
the world that tell the pharmaceutical companies what price they will 
pay for drugs, we need to tell them what price we will pay for their 
products. As soon as we did that, guess what. There would be a 
worldwide market on pharmaceuticals. We may get there through 
reimportation, but I don't think so. I think it is going to get 
squeezed down. I think greed conquers technological difficulty almost 
every time.
  So I think this is a good step, but if we really want to solve this 
problem, let us put an amendment on the floor which says that any 
country that essentially fixes the price on pharmaceuticals, their 
products coming into our country will have their prices fixed. Can you 
imagine if we were to tell BMW what they are going to get for a BMW 
531, or Volkswagen what they are going to get for one of their 
vehicles, or Toyota what they are going to sell a car for? That is 
essentially what they are doing to the pharmaceutical industry in this 
country.
  I believe this is a good amendment, and I am supportive of 
reimportation, but I don't believe it solves the problem. I don't want 
the American people to think that if we pass this, all of a sudden the 
price of drugs is going to come down. It will not. It is great that we 
are doing it, but we are not going far enough. We need to ask the 
administration to carry out the strength of their ability through 
Executive orders to create true competition throughout the country and 
throughout the world on pharmaceutical prices.
  Regardless of all the precautions and the well-thought-out plans of 
Senator Dorgan--and I know Senator Brown has worked on this for years, 
as has Senator Stabenow and Senator Vitter and several others--I 
believe they will get around it. I believe they will sign contracts for 
fixed quantities of drugs, and then the countries that have the 
potential to take a drug that was produced here or produced by a 
manufacturer that is based out of this country, they will limit the 
amount of drugs that are available to them based on the contract they 
sign for the number of drugs. So we will have made everybody feel 
better, but we will not really have created a worldwide market for 
pharmaceuticals. That is what I think we have to do.
  I would like to put out to the author of this amendment, as well as 
the sponsors, that we ought to think bigger on how to handle this 
because what we really have is one industry where there is not true 
free trading. We are not ever going to get the benefits, we are not 
ever going to relieve the burden of the American consumer, who is 
paying to subsidize drugs in Germany, in England, in France, and in 
Japan, we are not ever going to take that burden off until we really 
create a true worldwide market in pharmaceuticals. I am just hesitant 
to believe this is going to accomplish it.
  Like I said, I am going to vote for it. I believe it is a step in the 
right direction, but I think we need to be more bold. If we really 
believe in the benefits of international free trade, then we should do 
whatever is in our power to insist it become an international market 
for pharmaceuticals. That way, the pharmaceutical companies won't have 
to use the only market there is in our country to subsidize the 
variable costs and the research that they contribute to a lot of the 
drugs that come today.
  So I am supportive, I think it will pass, but I would reach out to 
the other Members who are interested and say: Let's do something 
bigger. Let's do something that will really fix it and do it fairly 
quickly. We will have a thriving pharmaceutical industry that way. It 
truly will be based on competition. Intellectual properties that are 
truly researched and supported by the country--we as Americans, if we 
have done that, we will get the better benefit from it if we have a 
true international market. I think the drug companies would like to see 
that as well.
  I understand they are trying to get return on invested assets. I 
believe it is important that everyone has a fair price for a 
pharmaceutical and that people make money when they sell a 
pharmaceutical. But we have to have an international market, and we 
have to solve it that way.
  I thank Senator Brown for allowing me the time, and I yield the 
floor.


                           Amendment No. 985

  Mr. BROWN. Mr. President, I thank Senator Coburn for his always 
innovative approach and his support of this and for all he does in 
working on health care issues generally and especially on prescription 
drugs.
  Mr. President, I ask unanimous consent that the pending amendment be 
set aside, and on behalf of Senator Brownback and myself, I call up 
amendment No. 985.
  The ACTING PRESIDENT pro tempore. Is there objection?
  Hearing no objection, it is so ordered.
  The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Ohio [Mr. Brown], for himself and Mr. 
     Brownback, proposes an amendment numbered 985.

  Mr. BROWN. Mr. President, I ask unanimous consent that the reading of 
the amendment be dispensed with.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  The amendment is as follows:

  (Purpose: To establish a priority drug review process to encourage 
                    treatments of tropical diseases)

       At the appropriate place, insert the following:

     SEC. __. 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.

[[Page 10945]]

       ``(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.''.

  Mr. BROWN. Mr. President, I rise today to offer the Brownback-Brown 
amendment, No. 985, which provides incentives for pharmaceutical 
companies to develop and manufacture treatments for neglected tropical 
diseases. According to the World Health Organization, more than 1 
billion people--that is one of every six people worldwide--are affected 
by at least one neglected tropical disease. In addition, neglected 
tropical diseases claim roughly 500,000 lives every year. However, less 
than 1 percent of the roughly 1,400 drugs registered between 1975 and 
1999 treated such diseases.
  This disparity is obviously due to the lack of financial incentives 
for pharmaceutical companies to bring neglected tropical disease 
treatments to market because these diseases disproportionately affect 
low-income countries, mainly in Africa. Creating incentives for 
companies to invest in treatments for these diseases is not only in our 
country's national interest, but it is consistent with the longstanding 
tradition of this country of caring for those less fortunate around the 
world.
  This amendment would award a priority review voucher to any company 
that brings a neglected tropical disease treatment to market. Priority 
review is an existing FDA process by which drugs are reviewed in 6 
months as opposed to the average time of 18 months. This priority 
review voucher would be transferable and could be applied to any drug 
in a company's pipeline.
  This voucher, which would be worth hundreds of millions of dollars 
for a company with a new blockbuster drug, would also benefit 
consumers. That is because it would give consumers earlier access to a 
new prescription drug. Most importantly, creating incentives for 
pharmaceutical companies to develop and manufacture neglected tropical 
disease treatments will obviously save lives.
  I commend Senator Brownback for his hard work on behalf of 
impoverished populations who desperately need our attention. He is 
offering Members of this body the opportunity to simultaneously save 
lives in developing nations, get U.S. consumers access to new medicines 
more quickly, and engage the drug industry in a win-win proposition. It 
is a rare opportunity, and I urge Members on both sides of the aisle to 
support the Brownback-Brown amendment.


                           Amendment No. 1011

  Mr. President, I would like to make a few comments on two other 
amendments, the first being the Stabenow amendment, which I have also 
cosponsored, along with Senators Lott and Thune. That amendment will 
save U.S. taxpayers hundreds of millions of dollars while restoring the 
integrity of the citizen petition process. That is important because 
the citizen petition process is fundamental to our Nation's democratic 
system.
  Under U.S. law, individuals and organizations have the right and 
should have the right to petition the Federal Government, which is 
another way of saying they have a right to communicate their views and 
have their views heard. The Federal Government is, after all, an 
employee of the American people. Americans absolutely should have the 
right to weigh in on Government policies and actions.
  Unfortunately, some brand-name pharmaceutical companies have 
regularly exploited the citizen petition process, filing frivolous 
petitions solely for the purpose of delaying the approval of generic 
drugs. They have been quite successful at it. Since 2003, brand drug 
companies have filed dozens and dozens of citizen petitions trying to 
stop or delay FDA approval of competing generic products. Ninety-five 
percent--roughly 19 in 20--of these petitions have been denied 
outright. What about the other 5 percent? FDA either hasn't acted on 
them or has approved them in whole or in part because they had no other 
choice--the brand companies had simply reiterated a factual issue that 
had already been addressed by FDA. In other words, even the approved 
petitions, the approved 5 percent, were frivolous.
  While drugmakers waste FDA's time and taxpayers' money, American 
patients are forced to continue paying top dollar--the name-brand 
price--for the medicines they need. Frivolous citizen petitions have 
created delays that often range from 11 to 15 months, preventing price 
competition for drugs that generate millions of dollars in revenue each 
day. American consumers--American taxpayers, who help finance Medicare, 
Medicaid, and VA health care--can't afford it. These costs are borne 
not just by consumers and taxpayers but also employers.
  I have worked closely with Senator Stabenow to make sure this 
amendment doesn't interfere with the right of individuals or companies 
to petition FDA and that the amendment ensures these individuals that 
the concerns raised in their petitions will still be taken seriously by 
FDA. What this amendment does do is fight back against the 
unjustifiable and costly delays caused by frivolous petitions submitted 
for the express purpose of blocking price competition in the 
marketplace.
  No one, not the drug industry or any other industry, should be 
allowed to make a mockery of one of our democratic rights--the right to 
petition our Government--particularly at the expense of patients and 
taxpayers. Ms. Stabenow's amendment, cosponsored by Senator Thune and 
Senator Lott, will put a stop to a tactic which is as costly as it is 
unethical. I urge every Member of this body to support it.


                           Amendment No. 990

  Mr. President, I also would briefly speak out on the Dorgan 
reimportation amendment, joining Senators Grassley and Stabenow and so 
many others in both parties in supporting the reimportation amendment.

[[Page 10946]]

  Some time ago, about 10 years ago, from my northeast Ohio 
congressional district when I served in the House of Representatives, 
along with the Presiding Officer, I used to sponsor bus trips to Canada 
where we would take mostly senior citizens to a Canadian drugstore 
right across the river from Detroit--Windsor--which was about a 3- or 
4-hour bus drive from Lorain County, where I lived. We would take a 
busload of 40 seniors and others--mostly seniors, as I said. We would 
buy prescription drugs in Canada--same dosage, same package, same drug 
manufacturer, for half or even sometimes a third the cost because the 
Canadian Government directly negotiated on behalf of 30 million 
Canadians, negotiated directly with the drug company for specifically 
less expensive drugs. It was clear to me then that reimportation was 
legislation we needed so seniors did not have to go to Canada; instead, 
that wholesalers, the Drug Marts and the CVS's of the world and the 
mom-and-pop drugstores can negotiate, could get those prices wholesale 
from Canadian drugmakers or companies and bring those prices 
significantly down for American consumers.
  As Senator Coburn said, when we were House Members we passed 
legislation 8 or 9 years ago. That legislation was never implemented 
the way it should have been. The Dorgan amendment will save money for 
America's seniors, for America's drug consumers, for prescription drug 
users. It is an important amendment, and I ask for support for the 
Stabenow amendment, the Dorgan amendment, and the Brownback-Brown 
amendment.
  I suggest the absence of a quorum.
  The ACTING PRESIDENT pro tempore. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. CASEY. Mr. President, I ask unanimous consent the order for the 
quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  The Senator from Pennsylvania is recognized.
  Mr. CASEY. Mr. President, I stand today in support of an amendment to 
S. 1082 offered by Senator Dorgan and several of our colleagues. This 
amendment is identical to a bill sponsored by the Senator from North 
Dakota, a bill I am proud to cosponsor.
  We have a serious problem today with drug prices all across our land. 
The American people have asked us to do something constructive about 
this crisis. Why is it Americans pay the world's highest prices for 
prescription drugs? This is simply not fair, and I have to believe we 
can do better in America. While the issues contributing to prescription 
drug prices are many and complex, this amendment, the Pharmaceutical 
Market Access and Drug Safety Act, offers a genuine and workable piece 
of the solution.
  It is no secret to anyone that Americans already import many 
prescription drugs, and I have heard from constituents in my home State 
of Pennsylvania about buying drugs outside of this country. A recent 
study shows that would cost from 35 to 55 percent less than 
constituents of mine are paying. They can pay a much lower price if 
they are able to get prescriptions from another country. Seniors who 
are living on limited incomes are especially vulnerable and need to cut 
costs wherever they can.
  We all know the high cost of health care across all of our States is 
prohibitive for so many vulnerable citizens--children, working 
families, and older citizens. The reality is when the monthly budget 
has been spent on necessities such as food or childcare, doctors' 
visits, housing, transportation--when all those costs are incurred, 
many families do not have money left over for medicine. These 
individuals may have no choice but to forgo needed medicine and hope 
for the best.
  Another recent study found 43 percent of uninsured Americans ages 19 
to 64, and even 18 percent of insured adults, did not fill a 
prescription because of cost. This is in the richest country in the 
world. We can do a lot better than that, and we must do better than 
that.
  I support this legislation because it gives us the opportunity to 
help families in America, and to do so safely. There are a number of 
safety features that are intended to guarantee that only safe and 
effective--let me say that again, only safe and effective--FDA-approved 
drugs are imported across our borders. These safety features are 
comprehensive. For purposes of time, I want to highlight a few.
  First, this act allows only the importation of FDA-approved medicines 
with a chain of custody, to ensure that drugs are handled only by 
authorized persons. In most cases, the medicines that are imported 
under this act are identical to the medications sold in the United 
States--literally the same medications made by the same manufacturers.
  Exporters would be required to maintain detailed records and a sample 
of each lot sent to the U.S., so that the FDA can conduct testing on 
any lot at any time. The FDA would have broad authorities, including 
the power to cease importation of a drug or to suspend a registered 
exporter without notice. The FDA also has the authority to inspect all 
facilities in the chain of custody of a drug.
  The bottom line is this bill gives the FDA broad authority and the 
resources to ensure that imported drugs are in fact safe. It is 
unacceptable that working parents have to make a choice between 
medicine they cannot afford for their child and making the rent payment 
on time. It is unacceptable that older citizens have to choose between 
paying for needed medication and paying for food.
  This Chamber can do something about this challenge, can do something 
about this Hobson's choice so many families face every day in America. 
The Dorgan amendment provides an effective regulatory framework to 
ensure that imported drugs are safe for our families. I urge all my 
colleagues to support this amendment which will provide an invaluable 
piece of the solution to making FDA-approved prescription drugs 
affordable for everyone.
  The PRESIDING OFFICER. The Senator from Oklahoma is recognized.
  Mr. INHOFE. Mr. President, I ask unanimous consent that I be 
permitted to speak as in morning business for up to 10 minutes.
  The PRESIDING OFFICER (Mr. Brown). Without objection, it is so 
ordered.
  (The remarks of Mr. Inhofe are printed in today's Record under 
``Morning Business.'')
  Mr. INHOFE. Mr. President, I yield the floor, and suggest the absence 
of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  The PRESIDING OFFICER (Mr. Whitehouse.) The senior Senator from Maine 
is recognized.
  Ms. SNOWE. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Ms. SNOWE. Mr. President, I rise in support of the amendment that has 
been introduced by Senator Dorgan with whom I have joined as a 
cosponsor regarding drug importation.
  First of all, I commend Senator Dorgan for his longstanding 
leadership and advocacy on this issue which has been for the better 
part of a decade. Regretfully, we are still at a point where we have 
been unable to pass legislation that would create a drug safety regime 
for drug importation.
  That is the purpose of our amendment, Members of the Senate, as we 
today consider legislation to address an essential new function in how 
the FDA will finance the cost of reviewing new drugs; that is, the 
critical process of bringing new medications to market to Americans.
  At the same time, this bill has directly raised a number of issues in 
how we assure that drugs are as safe as they should be, how we can 
bring new low-cost generic biologics to market. Key to this debate on 
this legislation that is pending before the Senate is the adage, which 
we have heard time and time again, that is: A drug which is not 
affordable is neither safe nor effective.

[[Page 10947]]

  The simple fact is, even with the new Part D prescription drug 
benefit as part of the Medicare Program that has been in place for more 
than 2 years now, we still have at least 60 million Americans overall 
that today pay the full price of medications, have no help whatsoever 
because many have no health insurance or their insurance does not 
provide coverage for prescription drugs.
  At the same time, the price that Americans are paying is the highest 
price in the world. For those of us who are fortunate to have 
prescription drug coverage, the estimated cost of medications is part 
of the major exorbitant increase in the cost of health care.
  Many of my colleagues have recognized that our system lacks 
competition that would assure our constituents more affordable access 
to lifesaving medications. That is why I am very pleased to join with 
the Senator from North Dakota, and we have the support of a bipartisan 
group of colleagues in the Senate, along with Senators Grassley and 
Kennedy and Senators McCain and Stabenow who are unified with us in 
supporting this bipartisan approach.
  Today, our voices echo those of 8 out of 10 Americans who are calling 
for safe importation. After nearly 3 years of awaiting Senate 
consideration of our legislation in 11 related hearings on this subject 
in the Senate, we simply must move forward. The reason is abundantly 
clear. We know the cost of health care is rapidly rising in America.
  Prescription drug prices have contributed to that exorbitant 
increase. Compared to 1990, nearly twice as much of our health care 
dollar goes to medications. As the GAO has readily told us, the cost of 
prescription drugs commonly used by seniors has consistently increased 
at two to three times the rate of inflation, as indicated by this 
chart, when you are comparing brand drugs, generics, and the CPI.
  That is why we can no longer afford to postpone any action. We have 
acted before. We acted on legislation back in 2000. Then we also took 
action with respect to the Medicare Modernization Act in 2003 which 
created a Part D prescription drug program. We have found the 
requirements for the Secretary of Health and Human Services to certify 
the safety and savings of drug importation have blocked any action; it 
has become a roadblock to safe importation.
  While FDA was unable to point to a single individual harmed by 
Canadian drugs--and in Europe, where they have had a track record of 
more than 30 years of parallel trading--it has proven that this trade 
can be conducted safely.
  Time and time again, they have demonstrated that their process of 
parallel trading has worked without any harm to their consumers. 
Without a doubt, Americans would not be turning to imports if there was 
not substantial savings. Indeed, the CBO has told us that countries 
from which we would import under this bill would pay 35 to 55 percent 
less for a brand prescription drug. Let me repeat that--35 to 55 
percent less than we pay today.
  In other words, American consumers are paying 35 to 55 percent more 
than foreign consumers when it comes to medications. That is 
remarkable. We have seen so many objections to this legislation for the 
better part of a decade. That is why we have taken it upon ourselves to 
develop a regime that has been incorporated in this amendment and in 
our legislation that would address every facet, every issue that is 
associated with safety in order to allow drug importation to occur.
  As I said earlier, the European Union has already engaged in parallel 
trading for three decades without incident. As seen here on this chart, 
where we have incorporated 31 different key safety provisions in our 
legislation, and compare that to the Medicare Modernization Act that 
passed in 2003 that created the Part D prescription drug benefit to the 
Medicare Program, only 6 provisions that related to safety were 
incorporated in that landmark initiative.
  We include 31 different initiatives to address every single safety-
related issue that has emerged in this debate. Whether it has been on 
the floor of the Senate, whether it has been in the course of hearings 
or elsewhere, we have addressed every safety-related issue to create a 
regime that should create the assurance that this can be done safely 
and without harm to Americans so they can benefit from lower priced 
medications.
  Americans deserve to have the lower priced medications. The FDA can 
conduct this program. They can conduct this regime. They should work 
proactively to assure these drugs are safe. We give them the means and 
the wherewithal and the resources in order to accomplish this. We 
comprehensively address the various concerns that have been raised 
months and years about drug importation so we can get something done.
  People say: Well, let's just certify safety. Well, as I have said 
earlier, it is a roadblock. It is an impediment to get anything done. 
It essentially becomes the poison pill. We have tried certification. We 
have given the Secretary of Health and Human Services under two 
administrations--this administration and the previous administration--
the ability to do that, to certify it. They are unwilling to do so 
because they have said they do not have the resources, they do not have 
the means.
  Well, we are giving them the means and the resources. But to pass 
another amendment that simply calls for the Secretary of Health and 
Human Services to certify drug importation is a roadblock. It is a road 
to nowhere with respect to this initiative. That is why Senator Dorgan 
and I took a different route.
  We address all the safety questions. We do not certify to ensure 
safety, we take action with these provisions. What we do is employ the 
measures to actually make drug importation safe.
  Opponents claim importation will cause harm. But they fail to note 
that the greatest threat to the safety of Americans is the inability to 
take a drug as it is prescribed. That exacts a toll on thousands, if 
not millions, of Americans each and every year, not to mention lives 
lost.
  Some say Americans would receive drugs from illegitimate sources, but 
under our legislation, Americans will receive imported drugs from 32 
countries with high standards. In most cases Americans will purchase an 
imported prescription drug from their local pharmacies just as they do 
today. The pharmacies will receive these drugs from the U.S. 
wholesalers which import them. These wholesalers will have been 
registered. They will be inspected. They will be monitored by the FDA. 
This higher level of safety is also a first step in establishing a 
higher standard for handling of prescription drugs right here in the 
United States where we have had the preponderance of problems.
  Our legislation allows individuals to directly order medications 
using an FDA-registered and approved Canadian pharmacy. Again, just as 
with wholesalers handling prescription drugs, the FDA will examine, 
register, and inspect these facilities on a frequent basis. The FDA 
will assure the highest standards for such functions as making sure the 
medical history is recorded of the individual, verifying prescriptions, 
and tracking the shipments.
  Some say consumers will get medications they should not be getting. 
Regardless of whether one purchases imported drugs from the local 
pharmacist or uses a Canadian pharmacy, we assure that a legitimate 
prescription and a qualified pharmacist will be vital ingredients to 
ensuring safety. In fact, we have many standards incorporated in this 
legislation in which it would occur.
  We adopted language that had been introduced by the Senator from 
California, Mrs. Feinstein, with respect to Web sites and domestic 
Internet pharmacies so that we assure that properly licensed pharmacies 
and pharmacists are behind Web sites that are offering these 
medications.
  Some say importation will allow unapproved drugs to enter the United 
States. Again, on that point, our legislation is abundantly clear. 
Every drug received will always be FDA-approved. If any difference 
exists in a foreign drug, even the most minute, our legislation assures 
FDA will evaluate the

[[Page 10948]]

product and determine its acceptability. If the drug is not 
bioequivalent to a U.S. drug, the Secretary may reject approval of that 
medication.
  Some say we will import counterfeits. The truth is, today the FDA 
does not know even the level of domestic counterfeiting where, as I 
said earlier, the preponderance of the problem exists. It is simply not 
employing the very anticounterfeiting technologies which our 
legislation demands in order to ensure that we protect against the 
threat of counterfeits. The fact is, we employ technologies today like 
the ones we use now for twenty-dollar bills. We can use the same for 
prescription drugs.
  Moreover, this bill supports development of future anticounterfeiting 
and track-and-trace technologies, very effective methods which we hope 
will be used to protect all drugs. For those who say consumers would 
not know who has handled the imported prescription drug, again, our 
bill requires a chain of custody, a pedigree to be maintained and 
inspected to help ensure the integrity of imported medications. A 
pedigree for prescription drugs was mandated, believe it or not, by law 
in 1988 and still has not been implemented by the FDA. Under our 
legislation, at last we will require pedigrees to be implemented for 
all medications.
  Some opponents will even attempt to alarm Americans about the 
countries from which we import drugs, citing Latvia, Estonia, Slovakia, 
and members of the European Union. But consider that another member is 
Ireland where Lipitor is made. Again, I call your attention to this 
chart which indicates the European Union and other countries from which 
we import drugs designated in blue. They either meet our standards or 
have even higher ones, ones as you can see in this chart, all of the 
blue countries from which we would import. They have our standards or 
they exceed our standards.
  In contrast, this chart denotes the countries in red from which, 
again, our manufacturers import medications. That is interesting. The 
FDA inspects pharmaceutical manufacturing plants in these countries 
denoted in red. These are countries from which manufacturers will 
import products. It includes China, India, Bulgaria, Jordan, and other 
countries. In fact, they have lower standards. So what I have 
indicated, based on what this map shows, is that we have the blue 
countries from which we would allow importation of drugs that would be 
FDA-approved, facilities inspected, documented. We would have pedigrees 
and technologies to track the shipments. These are countries that meet 
or exceed our standards. Today we already have FDA pharmaceutical 
manufacturing plants in these countries in red that, in fact, have 
lower standards. So we already, amazingly enough, allow medications to 
come in from countries that have lower standards. Why do we? Because 
they are inspected by FDA. So the same process can't work for countries 
that meet or exceed our standards already, that already have a track 
record in parallel trading in and amongst their own countries, and we 
can't do it today for those countries when FDA already does it for 
other countries that have lower standards? Because that is where many 
of our medications are manufactured. That is where our manufacturers 
import and FDA inspects those facilities before those medications enter 
the United States. So this is already done. It is done with countries 
that have lower standards, and we find that acceptable. Yet we say we 
are not finding it acceptable from countries that already have a track 
record of parallel trading amongst their own country without injury to 
any of their consumers over the last 30 years that meet or exceed our 
standards. It simply doesn't make sense.
  We are setting a model for improving safety because we are saying we 
are going to create 36 different measures for establishing safety for 
the American consumer to assure all those concerned that we have the 
measures in place and the resources with which to do it. So to those 
who say importation is unsafe, we show them how it shall be safe under 
our legislation. It sets a model and a standard.
  Some say consumers will not see significant savings. But drugs 
imported under this program will be labeled as imports so consumers 
will have the opportunity to do some comparative shopping. They will be 
able to take those prices and do a side-by-side comparison between the 
imports and those medications they buy in the United States. Consumers 
have become well aware of foreign pricing and the competition that 
exists between imported and wholesalers. We know they will achieve 
consumer savings; there is no question. That is why so many Americans, 
including many of my constituents from the State of Maine who have been 
able to access medications from Canada, have had to take bus trip after 
bus trip. They have been compelled to do that in order to achieve 
savings because of our unwillingness to address this issue in the 
Senate and the overall Congress. This legislation should have been 
accomplished a long time ago.
  In terms of savings, it should be interesting to note the independent 
analysis of the Congressional Budget Office which has confirmed that 
the savings, indeed, should be substantial--not surprising. It would be 
very substantial, indeed. They estimate a 10-year direct savings alone 
of $50 billion to the American consumer--$50 billion. That is probably 
on the conservative side. The Federal Government stands to save $6.1 
billion in the Medicare and Medicaid Programs alone. This is only the 
savings that CBO projected from purchases of imports. With increased 
competition in our markets, we could indeed save more, having 
competition, having the pharmaceutical industry have some competition 
in their pricing. Understand, individuals can't import medications. 
Pharmacists can't import medications. Only manufacturers can. So we are 
saying: Let's set a standard. Let's allow imports that benefit the 
individual consumer with safety-related provisions put in place.
  In fact, in a recent Commerce Committee subcommittee hearing, we had 
the opportunity to hear from a number of experts. We heard from a 
pharmaceutical economist who estimated that importation could result in 
a 12- to 20-percent reduction in domestic drug costs. That is an annual 
savings, not over 10 years, of up to $40 billion per year, as 
competition is created for consumer savings. So as a direct result of 
the competition that would develop as a result of importation, 
consumers alone could save up to $40 billion a year.
  So at a time when health care spending is reaching 16 percent of GDP 
and is climbing, this competition is an imperative. It is central. It 
is central to the consumer who is facing double-digit increases in 
prescription drugs. Prescription drugs are not getting cheaper in 
America. They are getting more expensive. As I said, the American 
consumer is spending 35 to 55 percent more than the foreign consumer. 
Health care spending is 16 percent of the GDP. Much of the increase in 
health care spending is attributed to the rising cost in prescription 
drugs.
  So that is why this becomes all the more important to the American 
consumer and, indeed, to the Federal Government that will save $50 
billion over 10 years and 6 billion alone in Medicare and Medicaid 
spending. That is important to our own interests and to our budgetary 
concerns about the growth in these respective programs.
  Some have argued that we haven't provided the resources necessary to 
run an importation program. But we have established a means of 
financing, a small fee based on the value of imported drugs which will 
now be set at a cap of 2.5 percent. We have always agreed that the FDA 
should have adequate resources. In fact, we heard from previous 
Secretaries of Health and Human Services, we don't have the resources 
to certify safety. So now we are providing a certification for that by 
including this cap of 2.5 percent for a fee on the total import of 
medications. This is what CBO has indicated to us would be necessary in 
order to accomplish and implement these safety-related measures. We 
think it is important the FDA have the resources that are essential for 
regulation, for monitoring inspections of both domestic

[[Page 10949]]

wholesalers, who would import the prescription drugs, as well as the 
Canadian pharmacies from which American consumers could order.
  Some say our bill is intended to adopt Canadian prices. Again, quite 
the contrary. We open importation to 32 countries which meet our safety 
standards. We are not simply adopting the price of another country. 
Rather, we are purchasing in a world market. That is a critical point. 
We are allowing American consumers to benefit from worldwide prices 
because of the competition that would be allowed. Obviously, something 
is happening in other countries where we want to import these 
medications because they are paying 35 to 55 percent less than American 
consumers. Why should that be the case? These are countries, by the 
way, that meet or exceed our standards when it comes to drug safety. 
Yet American consumers are paying 35 to 55 percent more for the same 
medications.
  Some say we compel manufacturers to sell the product. But our bill is 
very clear on that specific point. We never compel any manufacturer to 
sell any particular product. But when a manufacturer chooses to sell 
product, the bipartisan bill prohibits discriminatory acts against 
pharmacists and wholesalers who sell these medications. Those actions 
have reduced supplies of essential drugs for some Americans, at peril 
to their health.
  We are saying they cannot take action that discriminates against a 
pharmacy because they have sold those drugs to an American consumer. 
They are not penalized because their supplies are cut off by the 
manufacturer as a means of punishment and discrimination.
  Now, some say importation will threaten research and development. But 
the fact is, manufacturers will invest just as other industries do, in 
order to develop innovative products and remain competitive. The 
taxpayer is a partner in that investment. The American taxpayer is a 
partner. The taxpayer makes investments in research and development. In 
fact, we fund nearly $30 billion a year to do basic and applied 
research at the National Institutes of Health alone--$30 billion.
  So as you can see on this chart, as to R&D spending from all the 
companies, we--the United States consumer and taxpayer--fund and 
underwrite much of their research and development.
  As I said earlier, other industrialized countries pay 35 to 55 
percent less for their drugs. But because of the higher prices 
Americans pay for their medications, the American consumer ends up 
paying $99 billion more for their prescription drugs each year than 
otherwise would be the case. Let me repeat that. Because we pay 35 to 
55 percent more than foreign consumers, American consumers end up 
paying $99 billion more for their medications.
  With all that additional profit, the industry spends about $9 billion 
more on research and development than they do in Europe. That is 10 
cents return on the dollar for all that added profit margin. So while 
the American consumers spend $99 billion more for their prescription 
drugs than foreign consumers, in Europe, for example, American 
pharmaceuticals spend only $9 billion more--from that $99 billion--on 
research and development than they do in Europe. We spend only $9 
billion more here than they do in Europe on research and development. 
That means American pharmaceuticals are netting $90 billion more, that 
they are only investing $9 billion more in research and development.
  So it is not undercutting their ability for research and development, 
not to also mention, by the way, the American taxpayer invests more 
than $30 billion at the National Institutes of Health alone for basic 
research as well.
  In fact, if you look at the R&D spending of the largest 
pharmaceutical firms--as indicated again by this chart--it is not 
markedly different from many other firms. If you look at other firms, 
such as Intel, Microsoft, Lucent, and others with high research and 
development costs and relatively low production costs, their research 
and development spending averages about 14.3 percent of gross 
revenues--not much different--yet their products are highly 
competitive, very competitive. You have seen the software, cell phones, 
computers, laptops, whatever. You have seen the very competitive 
pricing today, yet they make an investment of 14.3 percent for research 
and development as a percentage of their gross revenues.
  Yet, paying the world's highest prices for drugs does not ensure 
additional research, but it certainly does decrease access to drugs. So 
while they do not invest in considerably more research and 
development--since we pay $99 billion more in prices for prescription 
medications, and they only spend $9 billion more on research and 
development, and the taxpayer spends $30 billion at NIH alone, as I 
indicated; but even, comparatively speaking, it is 14.4 percent of 
their gross revenues that are invested in research and development--if 
you compare that to, as I said, Intel, Microsoft, Lucent, and other 
companies, which is 14.3 percent, you find more competitive products in 
the technology arena. Their prices are coming down. The American 
consumer is not benefiting from the investments that are being made by 
the pharmaceuticals, yet it is a highly profitable industry. So we are 
not seeing the same benefits that would yield lower prices for the 
American consumer.
  Now, in conclusion, let me say, I hope this Senate will adopt this 
amendment that creates the kind of safety regime that would ensure drug 
importation will become a reality. Simply certifying safety on the part 
of the Secretary of Health and Human Services has been tried and yet 
has never accomplished that goal. It has been an impediment to drug 
importation. It has occurred twice in the last 10 years, and for 
whatever reasons the Secretaries in the previous administration and 
this administration have concluded they will not certify the safety 
regime because there has been no safety regime. It could be done, but 
it has not been done through the agencies. FDA could do it. It has not 
accomplished it. It has not implemented it. It has not had the impetus 
to pursue it. That is why we have taken it a step further. This 
legislation has been examined, reexamined, based on the concerns that 
have been expressed by those who have been opposed to it in the past 
saying they have concern about safety.
  We understand that. So we have gone a step further and incorporated 
every safety-related measure possible that is achievable, measurable, 
and provide the FDA with the resources to accomplish it.
  The Senate has voiced its view to provide market access on this issue 
on many occasions, even by virtue of passing the certification 
standard. Obviously, I think there has been an indication on the part 
of the Senate to support some type of initiative that allows for drug 
importation. But we want to mitigate the concerns that have been 
expressed repeatedly about the issues of safety by incorporating all of 
those measures in this amendment that is pending before the Senate.
  In fact, 68 Members of this body voted to adopt the amendment that 
was offered by the Senator from Louisiana, Mr. Vitter, to the Homeland 
Security appropriations bill. But we need more than to simply allow 
importation. We must provide an effective framework that will address 
the concerns that will ultimately ensure the safety of our consumers.
  Sixty-eight Members of this body supported blocking the Customs 
agency from banning drug importation, so it is obvious Members of this 
Senate truly want to pass a measure that will allow for drug 
importation. That is why I think this legislation logically affords us 
the ability to provide the safety and, at the same time, allow 
consumers in America to benefit from competition, from lower prices, 
based on the track record and the experience of other countries that 
have been adopting this approach for many decades.
  Competition is what is missing in this process. It will work for the 
consumer. To date, the process has not worked for the consumer where 
they have benefited from lower prices for

[[Page 10950]]

medications because there has been no competition. Competition has been 
virtually absent. I note the comment of the former Pfizer CEO, Hank 
McKinnell, who wrote:

       Competition is good medicine for economies. . . . Name an 
     industry in which competition is allowed to flourish--
     computers, telecommunications, small package shipping, 
     retailing, entertainment--and I'll show you lower prices, 
     higher quality, more innovation, and better customer service. 
     There's nary an exception. Okay, there's one. So far the 
     healthcare industry seems immune to the discipline of 
     competition.

  Those are the words of the former Pfizer CEO, Hank McKinnell.
  It is indeed time to make competition work to benefit consumers and 
taxpayers. Americans deserve and will seek out affordable life-
sustaining medications. We must assure that access is safe. That is 
what we accomplish in this amendment that is pending before the Senate.
  Again, I thank my colleague from North Dakota, Senator Dorgan, for 
his leadership on this question and for all those who are supporting 
this initiative.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senate majority whip.


                           Amendment No. 1022

         (Purpose: To ensure the safety of human and pet food.)

  Mr. DURBIN. Mr. President, in a brief period of time I will be 
offering an amendment which I hope to bring to a vote very shortly, 
perhaps in the next 15 or 20 minutes, depending on the wishes of the 
chairman of the committee and the ranking member, Senator Enzi.
  This amendment relates to the issue of food safety. This has been one 
of my concerns for a long time as a Member of the House and the Senate. 
I know everyone across America trusts that the food they buy for their 
families and everyone in their house is safe, that they can eat it and 
not get sick.
  We all know what has happened over the last several months. Whether 
we are talking about contaminated E. coli in spinach, salmonella in 
peanut butter, or the latest pet food contamination, people are asking 
questions of Members of Congress and this Government: Are we doing our 
job? What is happening here? Why are so many dangerous food products 
showing up so frequently? How can we protect ourselves?
  For many years I have thought the real answer is to tackle the whole 
issue. I have said it before on the floor, 12 to 15 different Federal 
agencies inspect our food--imagine that--and they all have different 
standards. Some inspect food every single day. Go to a meatpacking 
plant, poultry processing plant; the food is inspected every single 
day, every minute of every day, as it passes along those lines by the 
U.S. Department of Agriculture.
  Fish is another story. Fish is inspected by the Food and Drug 
Administration. How do they inspect it? By what they call the ``sniff 
test.'' They lean over and smell the fish, and if they have what they 
call a ``head snap,'' they know they have a bad load of fish. Sounds 
kind of comical, but it is what we get down to, by and large, in terms 
of inspecting fish.
  So when you go throughout our Government and look at different 
products and how they are inspected, it makes no sense why different 
agencies are doing different parts of the food chain. From a consumer's 
point of view, I do not want to know there are 12 or 15 different 
agencies at work, with their lights on, in Washington, with a lot of 
different employees. I want to know there is one good agency, 
scientifically driven, that is making the right call as to whether 
there should be an inspection every day, every month, every year--
whenever.
  They do not have that today, and the system breaks down. What we have 
seen happen over the last several months is a clear indication that our 
food safety system--as good as it may be--needs to be a lot better. So 
I am offering this amendment on food safety.
  I thank the Senator from Wyoming who has been very cooperative and 
helpful in making certain this is a bipartisan amendment. There is 
nothing partisan about food safety. We should all agree that the goal 
is one both parties share, all Americans share. Senator Kennedy has 
given me the time to offer this amendment on this important bill early 
on, and I certainly appreciate it. Senator Allard from Colorado, a 
veterinarian, has been involved in this negotiation, as has Senator 
Harkin, the chairman of the Agriculture Committee. Many people have 
come together to take a look at this and make sure it is moving in the 
right direction.
  There was an early warning. The early warning came a few weeks ago 
when we had a pet food crisis. People who own dogs and cats know what I 
am talking about. All of a sudden there was a suspicion that the food 
you were giving your dog--that animal you love, an animal that is part 
of your family--could be poisoning that animal. Well, for 90 million 
Americans that is a big deal, and they were concerned about it. So we 
started looking into why this pet food was contaminated.
  That crisis was an early warning signal to America. It was a warning 
signal that we came to learn had a lot to do with the imports coming 
into America. More and more imports of food products are coming in from 
overseas. If you believe we have inspectors sitting in China and France 
and Germany and Brazil taking a look at these things as they come off 
the assembly line, taking a little test sample and running it to the 
lab, you are wrong. It does not happen. In fact, once the shipment is 
on the boat, or on the plane, coming to America, the odds are 99 to 1 
no inspector will ever look at it before it is put into a food 
product--99 to 1. Only 1 to 1.5 percent of food products sent to 
America is actually inspected by our Government.
  Now, we look at what came over from the Chinese and find out they 
were adding a chemical to wheat gluten, a protein product called 
melamine. Melamine is a chemical derived from coal, which is used in 
the manufacturing of plastic. It has no business in anything that is 
edible. It was put into the shipment of protein, this wheat gluten, in 
order to enhance its value because when they tested this wheat gluten 
on its arrival, this melamine chemical indicated the presence of 
nitrogen, therefore, more protein, and, therefore, it was worth more. 
They would sprinkle in the melamine and make more money off the 
shipment. If this were the end of the story, you would say: Well, that 
was a pretty nice move; they just made a bigger profit off the 
shipment. It wasn't the end of the story. It turns out that wheat 
gluten, when used for pet foods, is toxic. Over 4,000 animals died 
across America because of melamine and possibly other contaminants. We 
are still investigating.
  So we went to find out how it got into the shipment, and the Chinese 
did not cooperate. They have started to. I am glad they have. They have 
agreed to visas for our inspectors. But this pet food crisis was a 
warning sign, a signal to us in America that this dramatic increase in 
imports of food products leaves us vulnerable. Today, it was your cat 
or your dog. Tomorrow, it could be someone in your family whom you 
love. So we address part of this in this bill.
  Secondly, it is an indication that the Food and Drug Administration 
doesn't have the authority or the resources to do their job as well as 
they should. This is a great agency. They have an awesome 
responsibility. We heap more and more responsibility on them each year, 
we provide them very little by way of additional resources, and they 
are being stretched to the absolute limit. Of course, this pet food 
crisis is an early warning that the whole food safety system has to be 
investigated and honestly looked at. So this is a start. It is an 
effort to try to make a difference.
  I wish to thank Senator Kohl from Wisconsin and Senator Bennett from 
Utah. When the pet food crisis came out, they called a timely hearing 
after our Easter recess, and we started working on this amendment just 
at that moment, and thanks to them for realizing the importance of this 
issue.
  I also thank those who helped us draft this legislation--the Center 
for Science and the Public Interest, the Humane Society, which has been 
terrific from start to finish, the American

[[Page 10951]]

Veterinary Medical Association, and the Coalition for a Stronger FDA.
  Special thanks, while I am giving out bouquets here, to my staffer 
David Lazarus. This young staffer has really put his heart and soul 
into this effort. It is his first major legislative undertaking, and I 
commend him for the very fine job he has done.
  Let me say very briefly what this amendment will do. First, it deals 
with pet food because we have just come off of a pet food crisis, but 
it doesn't stop there because this contamination doesn't stop with pet 
food. Sure, we found it in the cans of dog food and cat food, but guess 
what. It ended up in livestock feed. It ended up moving into the 
feedlots for hogs, turning into pork products we buy in the store. It 
ended up in poultry plants, being fed to chickens. We are naive to 
believe that any problem in the pet food industry can't possibly make 
it to the human food side of the equation. It can. God forbid that it 
ever does. We hope we have stopped it in this instance, but it is pure 
luck if we were able to save ourselves from that calamity this time. We 
don't want it to happen again.
  There are provisions in this amendment which go directly to the pet 
food issue, provisions which require the FDA to update their labeling 
standards for pet food, including nutritional and ingredient 
information, working closely with the American Association of Feed 
Control so that the representations on the labels of these cans of pet 
food are honest representations about what is good for your animal and 
what is safe. Also, it requires that the Secretary of Health and Human 
Services establish an enhanced system capable of detecting food 
contamination and outbreaks of pet illness and death.
  This amendment also requires the FDA to develop an efficient, 
effective communication plan to coordinate with veterinarians and 
consumers, owners across America, so that we can find out if we are 
dealing with a need for a recall. Recall data would be consolidated and 
presented in a searchable format. They were recalling pet food so 
quickly that if you went to the FDA Web site, you had to plow through 
all of the corporate press releases to figure out just exactly what was 
a dangerous product. When I mentioned this to the FDA, they changed 
their Web site, and we put it into law, to make sure they are consumer 
friendly and have up-to-date information consumers can understand.
  We work with the Secretary as well and the States on activities and 
programs to improve the safety of raw agricultural commodities. We go 
beyond just pet food into all edible products, agricultural products. 
What we attempt to do is to have the Secretary share resources with the 
States to improve State food programs and help States establish 
standards for inspection. Fifty States, 50 standards, is unacceptable. 
There should be one scientific matrix we follow so we know that whether 
the product comes from Oregon or Illinois or New Hampshire, that it is 
safe.
  We also establish something that I think is historic. It applies to 
pet and human food as well. It is an adulterated food register, to 
collect information on cases of food adulteration and suspected 
adulteration that are potentially dangerous and improve the speed by 
which consumers learn about them. We want an early-warning system, and 
in this age of computers and the Internet, we can achieve it.
  I believe this is critically important. In this case, there was a 
Canadian company called Menu which made dog food. Menu discovered in 
the middle of February that the cats and dogs were turning up their 
noses at their product, and then they found those that were eating 
their products started to show signs of illness, and then some of the 
animals died. Do you know how long it took them to report this to the 
Food and Drug Administration? Three weeks. Three weeks, while their 
products spread across Canada and North America, on the shelves of 
stores, and unsuspecting customers were buying them, they weren't 
reporting them. Our law now requires reporting within 2 days, and if 
they fail to report, they face civil penalties, which I hope will be 
imposed on a timely basis so that we let all companies know this kind 
of delay is intolerable.
  We also do something here that is important. If we find evidence of 
adulterated food, we report it as well to Homeland Security. Why? Well, 
Governor Tommy Thompson told us why. When he left as Secretary of 
Health and Human Services under this administration, he said: I find it 
unimaginable that someone hasn't tried to use our food supply--the 
terrorists haven't turned to our food supply to cause injury and death. 
He understood, as I do, and everyone should at this moment, it is a 
vulnerability for America we need to avoid. So this food registry will 
move us into a notification phase so the Department of Homeland 
Security can at least have notice if there is a problem.
  We also require better access to business records for the 
investigation to get to the bottom of it. Where did it come from? How 
is it used? How can we contain the need?
  We talk about a sense of the Senate in this amendment that points in 
another direction, maybe going beyond this current crisis into looking 
at an overhaul of our whole food safety system, and we require the 
Secretary of Health and Human Services to report annually to Congress 
with information about their inspections and enforcement.
  I am going to yield the floor at this point, and I again thank 
Senators Kennedy and Enzi for their help on this important legislation.
  I wish to tell my colleagues that there were things I wanted to add 
in with this amendment, but in the interest of avoiding political 
conflict and in the interest of not slowing down this important 
legislation and in the interest of making certain we did achieve 
something today, I am saving those arguments for another day.
  One of them is the issue of mandatory recall, which I think our 
Government should have the power to do and currently does not. Our 
Government and its agencies do not have the power to recall 
contaminated food from the shelves. I believe that law needs to be 
changed. It is not included in this amendment. We will save that debate 
for another day.
  Again, my thanks to my colleagues.
  Madam President, I ask unanimous consent that the pending amendment 
be set aside, and I send an amendment to the desk and ask for its 
immediate consideration.
  The PRESIDING OFFICER (Mrs. McCaskill). Without objection, it is so 
ordered.
  The clerk will report the amendment.
  The legislative clerk read as follows:

       The Senator from Illinois [Mr. Durbin], for himself and Mr. 
     Enzi, Mr. Kennedy, Mr. Allard, and Mr. Nelson of Florida, 
     proposes an amendment numbered 1022.

  Mr. DURBIN. I ask unanimous consent that the reading of the amendment 
be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The amendment is printed in today's Record under ``Text of 
Amendments.'')
  Mr. DURBIN. Madam President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second? There appears to 
be a sufficient second.
  The yeas and nays are ordered.
  Mr. DURBIN. Madam President, before yielding the floor, of course I 
will leave it to Senator Enzi and Senator Kennedy for the timing of 
this rollcall, but I am ready at any time for it to be called after 
they have had a chance to make a statement.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Madam President, I thank the Senator from Illinois, Mr. 
Durbin, for his tremendous work and creativity and willingness to make 
revisions to his amendment so that we can clear up outstanding concerns 
or clarify outstanding concerns people might have had with it. I think 
we are at the point where that is the case. I would like to make a few 
comments on it myself.
  Food safety is an issue that affects us all. It is not a partisan 
issue. We all want the safest food supply possible. It is, instead, our 
shared goal, a goal that requires cooperation and teamwork through a 
complicated process, and we have had that.

[[Page 10952]]

  For many of us, the safety and reliability of our food system is 
something we all too often take for granted. Day by day, we consume our 
favorite beverages, enjoy a quick snack, or sit down to a meal at a 
local restaurant. We rely on a system of checks and balances that takes 
place behind the scenes that we are often unaware of until something 
goes wrong. Then and only then do we realize how dependent we are on 
the food safety system that is supported by the activities carried out 
by the Federal, State, and local government agencies, as well as by the 
food industry itself. Together, they inspect, test, research, and 
monitor our food supply from the farm or ranch where it is produced to 
the family dinner table where it is consumed. The type and amount of 
oversight they exercise depends on the food product, and the degree of 
regulatory scrutiny they demand is commensurate with the degree of 
risk.
  In addition to these longstanding authorities and the activities of 
food safety, the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 required the Food and Drug Administration to 
register food processors, inspect their records, and detain adulterated 
food. It also requires the Food and Drug Administration to issue 
regulations to ensure the safety of imported foods.
  Food safety has been making news lately. From E. coli in fresh 
spinach to salmonella in peanut butter to melamine-contaminated pet 
food, we hear a constant drumbeat of food safety problems.
  The United States has one of the best food safety systems in the 
world, but even in the best of systems, there is room for improvement. 
Those improvements can take many forms. For example, we can address how 
food becomes contaminated in the first place, and we can make advances 
in the processing and handling of food. Our surveillance, testing, and 
reporting systems represent areas we should evaluate, as well as 
internal and external communications. Interagency cooperation and 
coordination between Federal and State officials is critical in 
identifying, tracking, and responding to outbreaks of foodborne 
illness.
  The amendment offered by my colleague, Senator Durbin, contains 
several important elements in that response, but it is the beginning, 
not the end, of the process of food safety. This amendment does a 
number of important things. It establishes standards for pet food and 
sets up early-warning systems for any problems with pet food. The 
amendment improves communications systems about all food recalls, and 
it coordinates State and Federal activities on fresh and processed 
produce. Finally, the amendment creates a database of instances of 
adulterated food so that the FDA can better track patterns of problems 
and target its limited resources where they are most needed.
  I am pleased we are able to work across party lines to develop an 
amendment today that we can all support, and I ask unanimous consent to 
be a cosponsor, along with Senator Allard.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. ENZI. However, there is much more work to be done. This amendment 
is a good first step on the road to a comprehensive response to food 
safety.
  In March 2005, Senator Kennedy and I announced that we were working 
to develop a comprehensive response on another FDA issue, which is drug 
safety. The bill on the floor this week is a direct result of that 
announcement and that pledge to work together. So when I pledge today 
to work to develop a comprehensive response on food safety, you can 
have some sense that I do mean that. I want my colleagues to work 
quickly and diligently to get this amendment to the point where we can 
accept it. I know we have it scheduled for a vote at the moment, too.
  Madam President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KENNEDY. Madam President, I wish to join with Senator Enzi and 
thank our friend and colleague, Senator Durbin, for his strong 
leadership on this issue. This is an issue of enormous importance to 
families across the country.
  As Senator Enzi just mentioned, over a year ago we made a strong 
commitment to the Senate that we were going to work on this drug safety 
issue, and we have come here in a bipartisan way to put forward a very 
strong bill that will ensure greater safety for American families in 
the area of prescription drugs. I think we are here to say that we will 
join with our friend and colleague from Illinois to build on what is an 
enormously important amendment and commitment to ensuring that we are 
going to have food safety as well as pet food safety in this country.
  I think this amendment, as has been outlined by Senator Durbin and 
Senator Enzi, reaches the heart of the challenges we face. One is on 
the issue of surveillance. We understand that is an essential aspect, 
whether it is food safety or prescription drugs, or whether it is in 
the area of avian flu, bioterrorism--whatever the challenge that is out 
there, surveillance is the first thing that needs to be done. We know 
that today the system is grossly inadequate.
  Second, we know the information about food and food safety is 
scattered through a number of agencies and through a number of 
different kinds of delivery systems, and that the coordination between 
the Federal and State is loose. In all of these areas, this amendment 
addresses these issues and questions in a very effective way, to bring 
common sense to and put real teeth into the safety provisions.
  The pet food standards that are in this legislation are strong and 
effective and would be very much appreciated by all Americans who are 
concerned about this issue. The standards are variable at the present 
time. The reporting is not good today, and this particular amendment is 
particularly responsive to that kind of challenge.
  Finally, this addresses the central concern all of us have read about 
and are concerned about, which the Senator has spoken to, and that is 
the issue of importation. When you add up all of those kinds of 
elements, we find this is a very solid and meaningful amendment. I 
think it strengthens the legislation immensely. We have every purpose, 
as we move forward, to find ways we can provide even a greater kind of 
protection and safety to the food supply for American families.
  I commend the Senator from Illinois. I think we will be ready to have 
a vote on this at the earliest time.
  The PRESIDING OFFICER. The Senator from Illinois.
  Mr. DURBIN. Madam President, I ask unanimous consent that Senators 
Kohl, Cantwell, Schumer, and Biden be added as cosponsors of this 
amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DURBIN. Madam President, I ask unanimous consent that the Senate 
proceed to vote in relation to the Durbin amendment No. 1022; that no 
other amendments be in order prior to the vote; that the time until 
then be equally divided and controlled between Senators Kennedy and 
Enzi; and that the vote be scheduled for 4:30 p.m.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  Mr. DURBIN. Madam President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KENNEDY. Madam President, we expect the vote at 4:30, for our 
colleagues. After that, we are going to have a conversation with those 
who have been primarily interested and concerned about the whole issue 
of biologics. So I give the assurance we are going to address that 
issue in a timely way. That will ultimately be part of this 
legislation.
  We also will be able to report on progress we have made on several 
other amendments. There are a few items that are going to necessitate 
our attention through the evening. We had a very good debate earlier 
today on the children's provisions; we had an important vote and 
discussion on that.
  This addition this afternoon is enormously important, and I think the 
time that has been taken to work through this legislation has made it

[[Page 10953]]

even stronger and better than I think it otherwise might have been. I 
am grateful to all of our colleagues who are working with us on both 
sides of the aisle, and particularly the staffs. We are moving forward. 
We are going to be busy this evening trying to work through some of the 
items, and we will have the cloture vote tomorrow and the follow-on 
Cochran amendment.
  There is a glimmer in sight about reaching a conclusion to this 
legislation. Again, we are very appreciative of all who have helped us 
up to this point.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. DURBIN. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                   Modification to Amendment No. 1022

  Mr. DURBIN. Madam President, we found a typo on page 5 in the 
amendment that we want to clear up before the amendment is considered.
  I ask unanimous consent to modify the amendment as submitted to the 
Senate. I send the modification to the desk.
  The PRESIDING OFFICER. Without objection, the amendment is so 
modified.
  The modification is as follows:

       (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. _04. 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;

  Mr. DURBIN. Madam President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. KOHL. Madam President, I rise today and would like to briefly 
speak about Senator Durbin's amendment regarding food safety. I was 
happy to cosponsor this amendment, and I agree with all of the 
sentiments expressed by the Senator earlier today.
  This amendment deals with many of the underlying problems that allow 
food safety issues, such as the ones we have dealt with in recent 
months that have affected not only humans, but their pets as well.
  It requires the FDA to set standards for pet food and to update them 
as necessary, and it directs the Secretary of Health and Human Services 
to establish a system capable of detecting pet food contamination and 
outbreaks of pet illnesses and death--this will prevent the type of 
confusion that continues to surround the recent melamine outbreak, and 
will help detect these problems much earlier. It requires FDA to 
develop effective communication plans to coordinate with stakeholders 
during outbreaks of both pet and human foods, so people know what is 
going on--quickly--and know what to do. It directs the Secretary to 
work with States to collaborate on activities and programs that assist 
in improving the safety of raw agricultural products such as spinach, 
which was the cause of a major food safety recall last fall. 
Importantly, it requires FDA to establish a registry to collect 
information on cases of potentially dangerous food adulteration to help 
get any dangerous food off of the shelves more quickly and to allow FDA 
to target inspection resources where most needed.
  This amendment does many important things--and takes many important 
first steps. I know that Senator Durbin would have liked this amendment 
to go a little further, and I agree with his sentiments, but it is 
important to at least take the first step.
  In March of this year, I held a hearing in Madison, WI, on food 
safety issues at the FDA. The Commissioner of FDA attended, as well as 
the Director of the FDA's Center for Food Safety. At that time, I 
pointed out that outbreaks of foodborne illness caused by produce have 
doubled since 1998. During this same time, the FDA's food budget has 
suffered. The number of people getting sick is going up, but the number 
of inspections and food safety tests being conducted is dwindling. So 
too are the number of food inspectors and overall staff at the FDA's 
Center for Food Safety. Imports have risen dramatically over the years, 
but the FDA is only able to inspect less than 1 percent of them.
  Events after that hearing seemed to exacerbate what I pointed out. 
The recent pet food scare, and the ongoing melamine investigation, 
serve as constant reminders that we have been taking this issue for 
granted, assuming that the FDA has the authority and funding necessary 
to do its job, when that is clearly not the case.
  Senator Durbin's amendment begins to take care of some of the 
problems with FDA authority and actions.
  As the chairman of the Agriculture Appropriations Subcommittee, which 
has jurisdiction over the FDA's budget, it is my job to make certain 
that the FDA has the money to carry out its vital role of protecting 
our food. The Food Center at FDA doesn't have user fees from industry 
to boost its funding--it all comes from the Congress, and has been 
stagnant for far too long.
  I have been working diligently to make sure that when the fiscal year 
2008 Agriculture Appropriations bill is written, food safety will be 
one of its highlights. I do not believe the administration has ever 
requested enough funding for food safety at the FDA, this year 
notwithstanding. I plan to correct that. It may not happen all in the 
first year being fiscally responsible can be tough--but it will happen. 
We will provide a significant increase to the FDA this year, so they 
can implement some of what Senator Durbin's amendment proposes, and 
quite simply, so they can hire inspectors where they are needed, to do 
the necessary research to prevent outbreaks from occurring wherever 
possible, and so we don't continue to see large recall notices in our 
newspapers every day. It is not a problem that can be fixed 
immediately, but I fully intend to meet my end of the obligation in 
making sure that FDA has the money that it needs, and can use 
responsibly, to tackle this problem head on.
  Mr. DURBIN. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DURBIN. Madam President, pursuant to the unanimous consent 
request, I ask that the roll be called on amendment No. 1022.
  The PRESIDING OFFICER. Under the previous order, the question is on 
agreeing to amendment No. 1022, as modified, offered by the Senator 
from Illinois.
  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 Delaware (Mr. Biden), 
the Senator from Connecticut (Mr. Dodd) and the Senator from South 
Dakota (Mr. Johnson) are necessarily absent.
  I further announce that, if present and voting, the Senator from 
Delaware (Mr. Biden) would vote ``yea.''
  Mr. LOTT. The following Senators are necessarily absent: the Senator 
from Kansas (Mr. Brownback), the Senator from South Carolina (Mr. 
Graham), and the Senator from Arizona (Mr. McCain).
  The result was announced--yeas 94, nays 0, as follows:

[[Page 10954]]



                      [Rollcall Vote No. 149 Leg.]

                                YEAS--94

     Akaka
     Alexander
     Allard
     Baucus
     Bayh
     Bennett
     Bingaman
     Bond
     Boxer
     Brown
     Bunning
     Burr
     Byrd
     Cantwell
     Cardin
     Carper
     Casey
     Chambliss
     Clinton
     Coburn
     Cochran
     Coleman
     Collins
     Conrad
     Corker
     Cornyn
     Craig
     Crapo
     DeMint
     Dole
     Domenici
     Dorgan
     Durbin
     Ensign
     Enzi
     Feingold
     Feinstein
     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
     Roberts
     Rockefeller
     Salazar
     Sanders
     Schumer
     Sessions
     Shelby
     Smith
     Snowe
     Specter
     Stabenow
     Stevens
     Sununu
     Tester
     Thomas
     Thune
     Vitter
     Voinovich
     Warner
     Webb
     Whitehouse
     Wyden

                             NOT VOTING--6

     Biden
     Brownback
     Dodd
     Graham
     Johnson
     McCain
  The amendment (No. 1022), as modified, was agreed to.
  Mr. DURBIN. Madam 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.
  Mr. VITTER. Madam President, I ask unanimous consent that the pending 
amendment be set aside and that I may call up amendment No. 983.
  The PRESIDING OFFICER. Is there objection to setting aside the 
pending amendment?
  Mr. KENNEDY. Reserving the right to object, I suggest the absence of 
a quorum.
  The PRESIDING OFFICER. The Senator from Louisiana has the floor.
  Mr. KENNEDY. I object to the unanimous consent request.
  The PRESIDING OFFICER. Objection is heard.
  Mr. KENNEDY. Madam President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. KENNEDY. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 983

  Mr. VITTER. Madam President, I renew my unanimous consent request 
that any pending amendment be set aside and that amendment No. 983 be 
called up.
  The PRESIDING OFFICER. Is there objection?
  Without objection, the amendment is set aside, and the clerk will 
report.
  The assistant legislative clerk read as follows:

       The Senator from Louisiana [Mr. Vitter] proposes amendment 
     numbered 983.

  Mr. VITTER. Madam President, I ask unanimous consent that the reading 
of the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

      (Purpose: To require counterfeit-resistant technologies for 
                          prescription drugs)

       At the end of subtitle E of title II, insert the following:

     SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES FOR PRESCRIPTION 
                   DRUGS.

       (a) Required Technologies.--The Secretary of Health and 
     Human Services shall require that the packaging of any 
     prescription drug incorporate--
       (1) radio frequency identification (RFID) tagging 
     technology, or similar trace and track technologies that have 
     an equivalent function;
       (2) tamper-indicating technologies; and
       (3) blister security packaging when possible.
       (b) Use of Technologies.--
       (1) Authorized uses.--The Secretary shall require that 
     technologies described in subsection (a)(1) be used 
     exclusively to authenticate the pedigree of prescription 
     drugs, including by--
       (A) implementing inventory control;
       (B) tracking and tracing prescription drugs;
       (C) verifying shipment or receipt of prescription drugs;
       (D) authenticating finished prescription drugs; and
       (E) electronically authenticating the pedigree of 
     prescription drugs.
       (2) Privacy protection.--The Secretary shall prohibit 
     technologies required by subsection (a)(1) from containing or 
     transmitting any information that may be used to identify a 
     health care practitioner or the prescription drug consumer.
       (3) Prohibition against advertising.--The Secretary shall 
     prohibit technologies required by subsection (a)(1) from 
     containing or transmitting any advertisement or information 
     about prescription drug indications or off-label prescription 
     drug uses.
       (c) Recommended Technologies.--The Secretary shall 
     encourage the manufacturers and distributors of prescription 
     drugs to incorporate into the packaging of such drugs, in 
     addition to the technologies required under subsection (a), 
     overt optically variable counterfeit-resistant technologies 
     that--
       (1) are visible to the naked eye, providing for visual 
     identification of prescription drug authenticity without the 
     need for readers, microscopes, lighting devices, or scanners;
       (2) are similar to technologies used by the Bureau of 
     Engraving and Printing to secure United States currency;
       (3) are manufactured and distributed in a highly secure, 
     tightly controlled environment; and
       (4) incorporate additional layers of non-visible covert 
     security features up to and including forensic capability.
       (d) Standards for Packaging.--
       (1) Multiple elements.--For the purpose of making it more 
     difficult to counterfeit the packaging of prescription drugs, 
     the Secretary shall require manufacturers of prescription 
     drugs to incorporate the technologies described in paragraphs 
     (1), (2), and (3) of subsection (a), and shall encourage 
     manufacturers and distributors of prescription drugs to 
     incorporate the technologies described in subsection (c), 
     into multiple elements of the physical packaging of the 
     drugs, including--
       (A) blister packs, shrink wrap, package labels, package 
     seals, bottles, and boxes; and
       (B) at the item level.
       (2) Labeling of shipping container.--Shipments of 
     prescription drugs shall include a label on the shipping 
     container that incorporates the technologies described in 
     subsection (a)(1), so that members of the supply chain 
     inspecting the packages will be able to determine the 
     authenticity of the shipment. Chain of custody procedures 
     shall apply to such labels and shall include procedures 
     applicable to contractual agreements for the use and 
     distribution of the labels, methods to audit the use of the 
     labels, and database access for the relevant governmental 
     agencies for audit or verification of the use and 
     distribution of the labels.
       (e) Penalty.--A prescription drug is deemed to be 
     misbranded for purposes of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.) if the packaging or 
     labeling of the drug is in violation of a requirement or 
     prohibition applicable to the drug under subsection (a), (b), 
     or (d).
       (f) Transitional Provisions; Effective Dates.--
       (1) National specified list of susceptible prescription 
     drugs.--
       (A) Initial publication.--Not later than 180 days after the 
     date of the enactment of this Act, the Secretary shall 
     publish in the Federal Register a list, to be known as the 
     National Specified List of Susceptible Prescription Drugs, 
     consisting of not less than 30 of the prescription drugs that 
     are most frequently subject to counterfeiting in the United 
     States (as determined by the Secretary).
       (B) Revision.--Not less than annually through the end of 
     calendar year 2010, the Secretary shall review and, as 
     appropriate, revise the National Specified List of 
     Susceptible Prescription Drugs. The Secretary may not revise 
     the List to include fewer than 30 prescription drugs.
       (2) Effective dates.--The Secretary shall implement the 
     requirements and prohibitions of subsections (a), (b), and 
     (d)--
       (A) with respect to prescription drugs on the National 
     Specified List of Susceptible Prescription Drugs, beginning 
     not later than the earlier of--
       (i) 1 year after the initial publication of such List; or
       (ii) December 31, 2008; and
       (B) with respect to all prescription drugs, beginning not 
     later than December 31, 2011.
       (3) Authorized uses during transitional period.--In lieu of 
     the requirements specified in subsection (b)(1), for the 
     period beginning on the effective date applicable under 
     paragraph (2)(A) and ending on the commencement of the 
     effective date applicable under paragraph (2)(B), the 
     Secretary shall require that technologies described in 
     subsection (a)(1) be used exclusively to verify the 
     authenticity of prescription drugs.
       (g) Definitions.--In this Act:
       (1) The term ``pedigree''--
       (A) means the history of each prior sale, purchase, or 
     trade of the prescription drug involved to a distributor or 
     retailer of the drug (including the date of the transaction 
     and the names and addresses of all parties to the 
     transaction); and
       (B) excludes information about the sale, purchase, or trade 
     of the drug to the drug consumer.

[[Page 10955]]

       (2) The term ``prescription drug'' means a drug subject to 
     section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 353(b)(1)).
       (3) The term ``Secretary'' means the Secretary of Health 
     and Human Services.

  Mr. VITTER. Madam President, first, in terms of laying the groundwork 
for this amendment, let me speak very briefly about the broader 
reimportation debate. I commend my colleagues who have brought this 
issue to the floor, and I certainly join them in pushing strongly for 
reimportation language in this bill. I have worked with many Members of 
this body, Republican and Democrat, on this issue since I was elected, 
including the primary authors of the reimportation amendment that we 
will be voting on later under this bill. I certainly want to join many 
voices, again, on both sides of the aisle, in terms of the need for 
this sort of important legislation that helps stabilize and bring down 
the price of prescription drugs.
  My amendment, No. 983, to which I will now turn, is very directly 
related to that. It is not a reimportation amendment per se, but it 
goes directly to one of the primary issues that opponents of 
reimportation regularly bring up, which is safety. My amendment, No. 
983, is about tamper-resistent technology--packaging technology--which 
can go a long way in meeting all of those safety concerns. I think 
there are many legitimate ways we can meet them, but this is a very 
effective and a very economical way to help meet any of those concerns.
  This amendment, No. 983, would require the incorporation of 
counterfeit resistent technologies into the packaging of prescription 
drugs. Not just reimported prescription drugs, but all prescription 
drugs because counterfeit prescription drugs is an issue not simply 
with regard to reimportation. Specifically, wholesale prescription 
drugs would contain RFID radio-tagging technology, tamper-resistent 
packaging, and blister security packaging, when possible.
  This is language directly from my legislation of the last Congress, 
the Reducing Fraudulent and Imitation Drugs Act. Of course, the purpose 
of that bill and this amendment is to address that safety concern, 
which comes up in a number of contexts, but certainly including 
reimportation. By ensuring that prescription drugs are authentic, this 
amendment would ensure the drug supply within the United States, as 
well as prescriptions reimported from Canada and other industrialized 
nations, are indeed safe.
  Again, the amendment would require that such technologies be used 
exclusively to authenticate the pedigree of prescription drugs. It 
would actually prohibit such technologies from containing or 
transmitting any identifying information of a health care practitioner 
or consumer or any advertisement or information about indications or 
off-label uses. So it is specifically for authentication. This is what 
you are getting. It cannot be used for any other purpose that might 
bring up privacy or other concerns.
  It would also require prescription drug shipments to include a label 
on the shipper container that incorporates similar packaging 
technologies.
  Finally, the amendment would require the Secretary to publish a 
national specified list of susceptible prescription drugs consisting of 
not less than 30 of the most frequently counterfeited prescription 
drugs in the United States. This would provide significant assistance 
to efforts by U.S. law enforcement and the FDA to deal with this issue.
  I hope all of us can join together around this very promising new 
technology that can help meet any legitimate safety concerns out there. 
Much more broadly speaking, of course, I certainly hope we come 
together to pass broad-based reimportation language in this bill, which 
I have supported well before coming to the Senate and, being in the 
Senate, certainly support in this context.
  Mr. NELSON of Florida. Will the Senator yield?
  Mr. VITTER. Certainly I yield.
  Mr. NELSON of Florida. Certainly the Senator remembers when he and 
this Senator from Florida introduced an amendment a year ago to allow 
the importation of drugs from Canada for a limited supply, stated as 90 
days or less, for personal use, and how we passed that here in the 
Senate. It was watered down once it got into conference in the House. 
It only allowed Americans going to and from Canada to carry drugs in 
that capacity--personal use, limited supply.
  Now we are going to be approaching this, and I ask the Senator, he is 
joining on the Dorgan amendment on the reimportation as one of the 
cosponsors of this amendment, is that correct?
  Mr. VITTER. I honestly do not know if I am technically a cosponsor. I 
am certainly supporting it. I supported our common efforts for several 
years. Many of the elements of my separate bill have been incorporated 
into the Dorgan-Snowe language, going back to last year. So we are 
certainly all working in concert.
  I again recognize and thank the Senator from Florida for our common 
work on the amendment last year, which he referenced.
  Mr. NELSON of Florida. If the Senator will further yield, does he 
remember in the debate we had when we agreed to that amendment, that 
Customs had even gotten into the act and was seizing thousands and 
thousands of these pharmaceutical packages for individual use and 
limited supply? Of course, in my State of Florida that happened with 
great frequency since a number of our senior citizens, in fact, do 
that. Finally we got Customs to come out and say they were no longer 
going to do that, they were going to defer it to the Food and Drug 
Administration. The Acting Administrator of the FDA had actually said 
no, they didn't have an objection to a limited supply for personal use, 
whether it was ordered by phone or Internet or by the mail, or someone 
walking across the border.
  Isn't it interesting that after all of that--and we finally agreed to 
the amendment--we still come to the year 2007 and we are having to 
address this issue again?
  Mr. VITTER. I agree with the Senator, absolutely. We should have 
taken care of this a long time ago. But we are where we are, and I 
certainly urge my colleagues on both sides of the aisle to address this 
in a full and comprehensive way.
  Mr. NELSON of Florida. The Congressional Budget Office is estimating 
that this legislation is going to save consumers in this country $50 
billion over the next 10 years because so often the price they get it 
for at the retail outlet here is twice what they can get it for from a 
Canadian pharmacy.
  It has been a pleasure for me to work with the Senator. I look 
forward to working with Senator Dorgan on his amendment.
  Mr. VITTER. I thank the Senator from Florida. I certainly have 
similar beliefs.
  I urge adoption of this amendment I presented and certainly urge my 
colleagues to also support the broader reimportation language, as will 
I.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Obama). The Senator from Wyoming.
  Mr. ENZI. I thank the Senator from Louisiana for his patience on this 
amendment, and also his understanding that he would work with my staff 
and the staff of Senator Kennedy to see what can be done to make our 
drug supply safer. I appreciate that.
  I also thank him for all the efforts he has made on behalf of the 
Louisiana turtle farmers, which was a new industry to me--although they 
have been exporting turtles all over the world for years--for the work 
he did drafting and putting together a mechanism for eliminating 
salmonella in turtles so they can be, once again, pets in the United 
States.
  The PRESIDING OFFICER. The Senator from New York.
  Mr. SCHUMER. Mr. President, I rise to engage in a colloquy with my 
colleagues from Utah, New York, Massachusetts, and Wyoming on 
biologics. I thank every one of them for their cooperation and help as 
we move forward.
  Mr. President, I rise today with my colleagues to speak about 
biologic drugs, a large and growing sector of the drug market. Biologic 
drugs can cost

[[Page 10956]]

tens of thousands of dollars a year for a single patient, and treat 
devastating diseases such as cancer and its complications. There is 
currently no clear pathway for lower cost competitors to biologic drugs 
to enter the market, as there is for generic versions of traditional 
chemical drugs. I have introduced a bill to create such a pathway. I am 
glad to see my friends Senator Kennedy, Senator Enzi, and Senator Hatch 
on the floor to discuss this issue with us. I yield to my colleague 
from Utah.
  Mr. HATCH. I am happy to discuss this issue with my colleagues. As 
they are aware, this has been my high priority for a number of years, 
given that I am the author with Representative Henry Waxman of the Drug 
Price Competition and Patent Term Restoration Act--or ``Hatch-Waxman''. 
The Schumer-Clinton bill, which I know has been introduced by 
Representative Waxman in the House, is an important contribution to 
this dialogue. I want to work to reach an acceptable compromise on an 
expedited basis, and it is clear to me it must be a bipartisan effort.
  Mrs. CLINTON. I thank the Senator for his leadership on generic drugs 
and for his presence here today. In 1984 when the Hatch-Waxman generic 
drug law was written, very few biologic drugs existed and there was no 
need to empower the FDA to approve lower cost versions of existing 
biologic drugs. This is no longer the case and it is time to enact 
legislation that will allow the FDA to approve safe and effective 
follow-on versions of biotech drugs.
  Mr. KENNEDY. I thank my colleagues and I agree that creating a 
pathway for follow-on biologics is an important issue worthy of our 
consideration.
  Mr. SCHUMER. I say to Chairman Kennedy, the junior Senator from New 
York and I stand ready to offer a bipartisan amendment to this bill 
that would establish a pathway for follow-on biologic drugs. We would 
prefer to work with you, and with the distinguished Senators from 
Wyoming and Utah. To that end, we would like to work together to 
discuss a pathway that protects patient safety, enables consumer access 
to more affordable biologic drugs, and provides appropriate incentives 
for continued innovation of lifesaving drugs.
  Mrs. CLINTON. I agree with my friend Senator Schumer, and note with 
gratitude that the HELP Committee began bipartisan discussions on how 
to accomplish this goal. And while I was disappointed that follow-on 
biologic legislation was not included during committee consideration of 
S. 1082, it was in good faith that I did not offer an amendment with 
the understanding that our bipartisan efforts would continue.
  As my colleagues and I move forward on this important effort, I think 
it is important to identify the key principles that must be contained 
in the legislation: We must provide the FDA with the authority and 
flexibility to approve biopharmaceuticals subject to a workable, 
abbreviated approval pathway that is efficient, effective and 
scientifically grounded. We must also include measures to ensure timely 
resolution of patent disputes, as well as adequate incentives for 
continued innovation.
  Mr. KENNEDY. I assure the Senators from New York that the conference 
report on the FDA Revitalization Act will include a pathway to follow-
on biologics that has been reported out of the HELP Committee and that 
is acceptable to the Senators from New York. I plan to hold a markup on 
this issue on June 13.
  Mr. ENZI. The heart of the debate is how to construct a regulatory 
framework so that biologic drugs can be safely available under an 
accelerated pathway. It is more difficult to approve biosimilars than 
to approve generic versions of typical drugs. The balance we are trying 
to find is a compromise that promotes access with innovation, while 
also maintaining the high standards of safety at the Food and Drug 
Administration.
  Biologics are complex molecules modeled after key processes occurring 
daily within the human body. One analogy is that if a typical drug was 
a 3 bedroom, 2 bath starter home, a biologic would be a skyscraper. The 
size, scope and complexity are completely different. The nomenclature 
is, too. As key scientists stated at our HELP Committee hearing on this 
topic, these are not generic biologics but biosimilars.
  With many drugs, we can describe their structure with a high degree 
of precision--but not with follow-on biologics. You can't make an exact 
``copy'' of a biologic, like you can for most typical generic drugs. 
For example, if I was to try to build the skyscraper of a biologic 
without the blueprints, as any generic company would need to do to 
create a follow-on biologic, I would have to ensure that every copy was 
identical or there could be fatal results.
  Because of this, science must be an essential part of any safety 
standard. One piece out of place would cause the entire structure to 
fall.
  But to be clear, a safe pathway for an accelerated approval process 
for biologics, that also preserves innovation, is possible. It is not 
just me who believes it--the FDA, generic and pharmaceutical industries 
have all said so as well. I have been working across party lines with 
Senators Hatch, Kennedy and Clinton to develop legislation that does 
just that. Our staffs have been working tirelessly on this topic: 
individually meeting with experts and stakeholders; and as a group, 
talking with experts from the United States and global leaders. After 
all, we want the same end result--legislation that ensures medicines 
are safe and affordable, and that medical innovation continues to 
flourish.
  I have a track record of working across party lines to build 
consensus and find common ground on tricky legislative issues. I know 
that with a little more time, and through regular order, we will 
develop a bipartisan package that accomplishes our common goals.
  I concur with the chairman and am committed to moving a bipartisan 
bill through the HELP Committee in the near future with the goal that 
it can be joined with the conference on the FDA Revitalization Act.
  Mr. HATCH. I look forward to working with my colleagues to include 
bipartisan follow-on biologics legislation in the conference agreement 
on the FDA Revitalization Act. It is clear that consumers would benefit 
tremendously from an abbreviated pathway for consideration of 
biosimilar products. Any effort, though, must be based on a sound 
understanding of the science involved and it must contain incentives 
for development of the innovator products which will be copied.
  Mr. SCHUMER. I thank my colleagues for these commitments. I look 
forward to working together with Chairman Kennedy, Senator Enzi, 
Senator Clinton, and Senator Hatch to develop workable legislative 
language that can be scheduled for a June 13 markup in the HELP 
Committee and included in the FDA Revitalization Act conference report.


                           Amendment No. 1025

  With that, I ask unanimous consent to set aside the pending amendment 
and send my amendment, a sense of the Senate, to the desk.
  The PRESIDING OFFICER. Without objection, it is so ordered. The 
pending amendment is set aside. The clerk will report the amendment.
  The bill clerk read as follows.

       The Senator from New York [Mr. Schumer], for himself, Mrs. 
     Clinton, Mr. Enzi, Mr. Hatch, and Mr. Kennedy, proposes an 
     amendment numbered 1025.

  Mr. SCHUMER. I ask unanimous consent the reading of the amendment be 
dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

(Purpose: To express the sense of the Senate with respect to follow-on 
                               biologies)

       At the end of the bill, add the following:

     SEC. __. 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.

[[Page 10957]]

       (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--
       (1) legislation should be enacted to--
       (A) provide the Food and Drug Administration with the 
     authority and flexibility to approve biopharmaceuticals 
     subject to an abbreviated approval pathway;
       (B) ensure that patient safety remains paramount in the 
     system;
       (C) establish a regulatory pathway that is efficient, 
     effective, and scientifically-grounded and that also includes 
     measures to ensure timely resolution of patent disputes; and
       (D) provide appropriate incentives to facilitate the 
     research and development of innovative biopharmaceuticals.

  Mr. SCHUMER. Mr. President, I ask that the amendment be adopted.
  The PRESIDING OFFICER. Is there further debate on the amendment?
  If not, the question is agreeing to the amendment of the Senator from 
New York.
  The amendment (No. 1025) was agreed to.
  Mr. KENNEDY. Mr. President, I move to reconsider the vote by which 
the amendment was agreed to.
  Mr. ENZI. Mr. President, I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KENNEDY. Mr. President, I thank all of our colleagues for their 
cooperation and their help on this particular subject matter. It is a 
matter of enormous importance, incredible consequence, and enormous 
complexity. We thank them for all of their help and assistance in 
bringing us to where we are so that the Members understand better where 
we are. We are absolutely committed to having that hearing and having 
the results of that go into our conference.
  I am enormously appreciative of the patience and the cooperation we 
have received. I am grateful again to all of those here, colleagues on 
both sides, for their cooperation in helping us move this forward.
  I thank the Senator from Utah. I want to congratulate him. He is 
receiving an honorary degree tomorrow from a great university in his 
State. We were talking about biologics. We think of the Hatch-Waxman 
proposal and acknowledge his work, attention, and help in the 
fashioning of that important piece of legislation, particularly when we 
are thinking about his involvement in the biologics, a clear indication 
we are going to have some good bipartisan support and we are going to 
have a team that has a breadth of knowledge and understanding of these 
kinds of subject matters. We wish him well on his trip to Utah and 
congratulate him on his degree tomorrow.
  Mr. HATCH. Will the Senator yield?
  Mr. KENNEDY. I will yield.
  Mr. HATCH. Mr. President, I thank my dear friend and colleague. It is 
so nice of him to say that. I take tremendous interest in this bill, as 
I do every piece of legislation, but this bill in particular.
  I congratulate the chairman and the ranking member for the way they 
have conducted not only the committee through this process but this 
bill itself. I hope this bill will pass and that we can correct 
whatever needs to be corrected, and that we will be able to do this 
follow-on biological work together. If we can do that, this will be a 
major breakthrough bill, and will do a great deal of good for the FDA. 
If that happens, then I think the chairman and the ranking member 
deserve a great deal of credit. I am very grateful my friend from 
Massachusetts has been so kind to me today.
  The PRESIDING OFFICER. The Senator from New York is recognized.
  Mr. SCHUMER. I add my thanks to the chairman and ranking member of 
the HELP Committee for all of their help and constructive resolution of 
this. It allows us to pass a very important FDA bill and at the same 
time move on the biologics.
  I join my colleague from Massachusetts in congratulating my friend 
from Utah on his honorary degree. He will get a doctorate, I imagine, 
and perhaps after he will not only get an honorary degree and be a 
doctor but maybe he can even create a few biologics after we pass the 
law.
  The PRESIDING OFFICER. The Senator from Utah is recognized.
  Mr. HATCH. Mr. President, to say the distinguished Senator from New 
York knows how to stick it to a person on the floor is all I can say.
  I am grateful for this friendship and grateful for his and Senator 
Clinton's work on this as well, and willingness to work together in a 
bipartisan way. This is big-time stuff. If we get it right, it will 
surely do a lot of good, as Hatch-Waxman has done over the last 23 
years.
  The PRESIDING OFFICER. The Senator from New Mexico is recognized.
  Mr. DOMENICI. Mr. President, I ask unanimous consent that I be 
permitted to speak for up to 10 minutes as in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                         Honoring Jack Valenti

  Mr. DOMENICI. Mr. President, I was present yesterday at the funeral 
mass at St. Matthew's for Jack Joseph Valenti. I did not know he had a 
middle name, Joseph, but I am learning more and more about him now 
after his passing. I was a friend of his. I thought I knew much about 
him. But the more I read, the more I find out what a spectacular man 
and a marvelous life he lived.
  I thought I would share with the Senate, since somebody said at the 
mass, as they were permitted to speak--they were one of the few who 
were selected--I would bet that everybody in this church would like to 
come up here and be given 10 minutes to say something about their 
friend Jack Valenti.
  That person who said that was absolutely right. That is exactly how I 
felt sitting there: Wouldn't it be nice if I could walk up there and 
tell all of these people and whoever else was listening, share what I 
knew about him. Of course, that was not to be.
  But today I am going to do that in the Senate for a few minutes, and 
tell the Senate about how this man, who was known to try to help 
everybody in very different circumstances, how he came to know me and 
how I came to know him.
  I was elected in 1972, and of course right now it sort of goes by 
easy; my last name is Italian. You know it was pretty well understood 
when I was elected that I was Italian--Domenici from out in the West, 
when all of the Italians who are in politics are from out here in the 
East, from New York, New Jersey. People wondered: Where did that guy 
come from?
  Well, the truth is, Jack Valenti also wondered. He called me on the 
telephone and said: Are you Pete Domenici, the new Senator?
  I said: Yes, sir. He told me who he was. He said: You know, I don't 
know you, you don't know me, but you probably could easily find out who 
I am. All I want to tell you is: I would like to help you.
  Now, we are thousands of miles away. I have never seen him. I was 
elected. He is telling me on the phone: I would sure like to help you 
if I can.
  Of course, I said: Give me your phone number and let me get ahold of 
you. By the time I asked a few people, they said: You are lucky. He is 
one of the people in Washington who knows more about what is going on 
here, than the man who called you.
  I quickly arranged a meeting at the Willard Hotel. It was prior to 
its remodeling so it wasn't as nice as it is today. But I didn't know 
better. I made arrangements there. Then I invited him to come and 
visit. Here comes Mr. Valenti to come and meet me there at the Willard 
Hotel. I mean, it was a joyous occasion. You would have thought I was a 
long-lost relative. It was all because he was glad to see a young 
Italian boy get elected to the Senate. He came from an immigrant 
Italian family himself.
  So we talked. He said: Well, let me try to help you. I would like to 
tell you what his first offer was. Let's go meet some people and see 
what we can do about talking about the committee assignments you might 
get.
  I told him: Here is the one I want. I want the Joint Committee on 
Atomic Energy, because that has a lot to do with my State. So we talked 
and we

[[Page 10958]]

worked. Sure enough, we were making a little headway and we read that 
the House had had a meeting of leadership and they had decided there 
would no longer be a Joint Committee on Atomic Energy so they abolished 
it. So all of my work and all of his work was for naught, because we 
decided we were not going do business in a joint manner on atomic 
energy.
  But what a joy it was, the first meeting--not successful in terms of 
our mission but greatly successful in terms of establishing our 
friendship.
  I will mention two things in my life and then yield to the Senator.
  Years later, one of my sons was working here in Washington. Some 
people know him. His name is David. He had established and built a 
charter school here, a school in town that ended up being called Maya 
Angelou School, a school named after the great poet laureate. And, of 
course, as you would guess from the name of the school, it was sort of 
a special school. It was a charter school my son started with the help 
of another man, and it was for the purpose of taking the troubled young 
teenagers, who were either going to jail, because they had already done 
enough bad things, criminal things, they were going to jail, or the 
judge would assign them to this school.
  This son of mine built this charter school. It got to be a pretty 
good size. At a point in time he was opening a new building, and he 
called me and talked to me and said: You know, maybe I could get some 
help from somebody for some computers for these students.
  This is my second meeting with my friend. I called him up and said: I 
would like you to meet my son David. I told him why. He said: Of 
course. They met, talked on the telephone. Within a very short period 
of time, the charter school I am describing to you, which was a very 
difficult thing for my son and his friend to run--had a great success. 
He opened two of them; two of them exist in Washington now. But, lo and 
behold, shortly after this meeting and our discussion with Mr. Valenti, 
the computers that were needed for the school to totally fill out all 
of the computer needs arrived as a special donation from somebody.
  Well, of course, we know the somebody. We found out later our friend 
Mr. Valenti worked to get in touch with those who could help donate to 
these students' needs.
  He is gone now, but we do not know how many thousands of things like 
this he did during his life, along with the other things that are more 
notorious that he did in his job, which was a very open and public job 
for many years of his life, and a hard one when he worked for the 
motion picture industry. So we do not know how many people he helped. 
But I thought maybe I would borrow this few minutes of the Senate's 
time to put down my thoughts for his wife, who I obviously did not know 
as well as I knew him. But I did get to know her. I saw her at the 
funeral. Of course, she is having a difficult time. I do not know their 
children. I did have a chance to talk to his wife and say I hope that 
everything went well. I think it will. With this, I say maybe no one 
else in the Senate will do this, but as part of my day, I salute Mr. 
Jack Valenti for all he did, and I am very grateful I had the chance to 
say a few words about him.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KENNEDY. Mr. President, I thank my friend from New Mexico. I had 
the good opportunity to attend that service as well. I will include my 
comments about Jack Valenti. He was a dear and valued friend of the 
Kennedys. We went back a long time with Jack, to the 1960 campaign. It 
was a long friendship, that endured a lot of very glorious times and 
difficult and challenging ones as well. He was a person of great 
purpose, with a love for his country, devotion to his industry, which 
he represented so effectively, and a wonderful friend to many of us. I 
thank the Senator for his comments.
  Mr. President, for the benefit of our Members here, we are going to 
recess shortly and go over to 9:30 tomorrow morning. The hour before 
the cloture vote will run from 9:30 to 10:30, and we will yield a half 
hour on our side to the proponent of the amendment, Senator Dorgan. 
Then at 10:30 or just about 10:30 we expect we will have a roll call 
vote on the Dorgan amendment, or the motion to invoke cloture on the 
Dorgan amendment. Then, depending on how that comes out, we will move 
ahead to hopefully conclude work on some of the items we have had good 
discussions about today--the Stabenow amendment. I am grateful to 
Senator Stabenow. We spoke about this earlier in the day. We have 
worked with her and made some very important progress and are grateful 
to her for her cooperation.
  We indicated now to the membership how we are going to proceed on the 
extremely important item of biologics. We now have the drug safety. We 
have enhanced this bill with food safety. We are going to address in 
our conference the issue of biologics. This is going to be an extremely 
important pathway. We have been working with Senator Roberts and 
Senator Harkin on the direct consumer advertising issue. There are some 
very important constitutional issues. I am grateful to Senator Roberts 
for his cooperation and help. Senator Kohl has an amendment on reverse 
payments. There is Senator Vitter's amendment and potentially one or 
two others that Members have indicated they are giving thought to 
offering, but haven't decided whether they would.
  We are getting close to the end of this, but we still have important 
matters to do. We are going to try to work with our colleagues. We have 
made great strides in the evenings. I am very grateful to Senator Enzi 
and particularly to our staffs who have, each evening, including 
through the weekend, worked tirelessly to try and ease the differences 
on many of these amendments and have done a brilliant job. This 
legislation is extraordinarily important. We have had several 
amendments, important amendments, but we have also worked out some 
others that have strengthened the legislation.
  In a few moments, we will go into adjournment until tomorrow. But 
Senators should look forward to the debate at 9:30 and vote at 10:30 on 
the cloture petition relative to the Dorgan amendment.
  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. KENNEDY. I ask unanimous consent that the order for the quorum 
call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. Mr. President, for the information of the Members, there 
will be no further votes this evening.
  The PRESIDING OFFICER. The Senator from Oklahoma.
  Mr. INHOFE. Mr. President, I ask unanimous consent that the pending 
amendment be set aside for the consideration of amendment 988.
  Mr. KENNEDY. If the Senator would withhold, we have a pending 
amendment. I will have to object until we clarify exactly where we are. 
Would the Senator give us 30 seconds?
  Mr. INHOFE. That would be fine. My intention was to set aside the 
pending amendment so I could consider this. Then set this aside and go 
back to the pending amendment.
  Mr. KENNEDY. I have no objection to that.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 988

  Mr. INHOFE. I thank the Senator from Massachusetts for his tolerance.
  Mr. President, I introduced last year a bill I called the Child 
Medication Safety Act. We are offering it as an amendment to this 
underlying bill. It is my anticipation that we will get a vote on it 
ultimately. This is to protect children and their parents from being 
coerced into administering a controlled substance or psychotropic drug 
in order to attend school. The House passed their version of H.R. 1790 
by 407 to 12 under suspension of the rules in November of 2005.
  Parents today face many challenges when raising their children, one 
of which is ensuring that their children receive the best education 
possible. My

[[Page 10959]]

views on education come from a somewhat unique perspective in that my 
wife Kay was a teacher at Edison High School. My daughters are both 
teachers. I can assure my colleagues that I am one of the strongest 
supporters of quality education. However, it has come to my attention 
that schools have been acting as physicians or psychologists by 
strongly suggesting that children with behavioral problems be put 
immediately on some form of psychotropic drugs. Schools and teachers 
are not equipped to make these diagnoses and should make it mandatory 
for the student to continue attending the school. This is clearly 
beyond their area of expertise. Therefore, I am introducing this 
legislation to ensure that parents are not required by school personnel 
to medicate their children.
  The Child Medication Safety Act requires, as a condition of receiving 
funds from the Department of Education, that States develop and 
implement policies and procedures prohibiting school personnel from 
requiring a child to obtain a prescription as a condition of attending 
school. It should be noted that this bill does not prevent teachers or 
other school personnel from sharing with parents or guardians 
classroom-based observations regarding a student's academic performance 
or regarding the need for evaluation of for special education.
  Additionally, this bill calls for a study by the Comptroller General 
of the United States reviewing: No. 1, the variation among States in 
the definition of psychotropic medication as used in public education; 
No. 2, the prescription rates of medication used in public schools to 
treat children with attention deficit disorders and other such 
disorders; No. 3, which medications listed under the Controlled 
Substances Act are being prescribed to such children; and, No. 4, which 
medications not listed under the Controlled Substances Act are being 
used to treat these children and their properties and effects. This GAO 
report is due no later than 1 year after enactment of this act.
  I believe it is an extremely important amendment. It protects the 
rights of our children against improper intrusion regarding health 
issues by those not qualified. If a parent or guardian believes their 
child is in need of medication, then they ought to have the right to 
make that decision and consult with a licensed medical practitioner who 
is qualified to prescribe an appropriate drug. I am hoping others will 
join me in support of the amendment. It is a parental rights amendment 
that should be supported by all.
  With that, it is my intention that we will be putting this in line to 
get a vote. I ask unanimous consent now to return to the previous 
pending amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. I thank the Senator for his cooperation. 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. GREGG. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GREGG. I understand the Senator from Oklahoma wants to go into 
morning business to make a statement. I ask unanimous consent that 
after he has completed his statement, that I be recognized for purposes 
of offering my Internet pharmacy protection and safety bill to the 
underlying bill.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. INHOFE. Mr. President, may I ask a point of inquiry of the 
Senator from Massachusetts. Apparently the desk is not in agreement 
with what we did. We set aside the pending amendment for consideration 
of my amendment which I brought up and presented. Then we returned to 
that amendment. I would like to ask the Chair if that is accurate.
  The PRESIDING OFFICER. The Senator did not offer his amendment. The 
Senator may offer his amendment, but it was not offered.
  Mr. KENNEDY. I ask unanimous consent that his amendment be at the 
desk and be subject to being called up.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       The Senator from Oklahoma [Mr. Inhofe] proposes an 
     amendment numbered 988.

  Mr. INHOFE. I ask unanimous consent that reading of the amendment be 
dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

(Purpose: To protect children and their parents from being coerced into 
administering a controlled substance in order to attend school, and for 
                            other purposes)

     SEC.   . CHILD MEDICATION SAFETY.

       (a) Required Policies and Procedures.--
       (1) In general.--As a condition of receiving funds under 
     any program or activity administered by the Secretary of 
     Education, not later than 1 year after the date of enactment 
     of this section, each State shall develop and implement 
     policies and procedures prohibiting school personnel from 
     requiring a child to obtain a prescription for substances 
     covered by section 202(c) of the Controlled Substances Act 
     (21 U.S.C. 812(c)) or a psychotropic drug as a condition of 
     attending school or receiving services.
       (2) Rule of construction.--Nothing in paragraph (1) shall 
     be construed to create a Federal prohibition against teachers 
     and other school personnel consulting or sharing classroom-
     based observations with parents or guardians regarding a 
     student's academic performance or behavior in the classroom 
     or school, or regarding the need for evaluation for special 
     education or related services under section 612(a)(3) of the 
     Individuals with Disabilities Education Act (20 U.S.C. 
     1412(a)(3)).
       (3) Prohibition of payment of funds.--No Federal education 
     funds may be paid to any local educational agency or other 
     instrument of government that uses the refusal of a parent or 
     legal guardian to provide a substance covered by section 
     202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) or 
     a psychotropic drug for such individual's child as the basis 
     of a charge of child abuse, child neglect, education neglect, 
     or medical neglect until the agency or instrument 
     demonstrates that it is no longer using such refusal as a 
     basis of a child abuse, child neglect, education neglect, or 
     medical neglect charge.
       (b) Definitions.--In this section:
       (1) Child.--The term ``child'' means any person within the 
     age limits for which the State provides free public 
     education.
       (2) Psychotropic drug.--The term ``psychotropic drug'' 
     means a drug subject to section 505 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355) that is not a 
     substance covered by section 202(c) of the Controlled 
     Substances Act (21 U.S.C. 812(c)) but is--
       (A) used in the diagnosis, treatment, or prevention of a 
     disease; and
       (B) intended to have an altering effect on perception, 
     emotion, or behavior.
       (3) State.--The term ``State'' means each of the 50 States, 
     the District of Columbia, and the Commonwealth of Puerto 
     Rico.
       (c) GAO Study and Review.--
       (1) Review.--The Comptroller General of the United States 
     shall conduct a review of--
       (A) the variation among States in definitions of 
     psychotropic medications as used in regard to State 
     jurisdiction over public education;
       (B) the prescription rates of medications used in public 
     schools to treat children diagnosed with attention deficit 
     disorder, attention deficit hyperactivity disorder, and other 
     disorders or illnesses;
       (C) which medications used to treat such children in public 
     schools are listed under the Controlled Substances Act; and
       (D) which medications used to treat such children in public 
     schools are not listed under the Controlled Substances Act, 
     including the properties and effects of any such medications, 
     including the incidence of hallucinations, psychosis, 
     violence, suicide, heart problems, significant weight gain, 
     or diabetes that students may experience while on these 
     medications.
       (2) Report.--Not later than 1 year after the date of 
     enactment of this section, the Comptroller General of the 
     United States shall prepare and submit a report that contains 
     the results of the review under paragraph (1).

  Mr. INHOFE. I do apologize to the managers of the bill as well as to 
the Chair. It was my understanding that I actually had that done 
previously. With that, if it is proper form now to get into the mix, I 
ask unanimous consent that I be permitted to speak as in morning 
business for up to 12 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The remarks of Mr. Inhofe pertaining to the introduction of S. 1269 
are located in today's Record under ``Statements on Introduced Bills 
and Joint Resolutions.'')

[[Page 10960]]


  Mr. INHOFE. I thank the managers of this bill for giving me this time 
to make this presentation.
  I yield the floor.
  The PRESIDING OFFICER (Ms. Cantwell). The Senator from New Hampshire.
  Mr. GREGG. Madam President, I understand that I may go forward. I 
appreciate the courtesy of the Senator from Massachusetts.


                           Amendment No. 993

       (Purpose: To provide for the regulation of Internet 
     pharmacies)
  Madam President, today we have been discussing, at some depth, and 
appropriately so, how to protect American citizens who purchase drugs 
overseas--from overseas pharmacies or from Canadian pharmacies--or 
purchase drugs on the Internet. This is a very significant issue for 
Americans, especially as more and more Americans use the Internet for 
the purposes of buying all sorts of items, including pharmaceuticals.
  So we need to be sure this extraordinary regime we have set up in 
this country stays intact that allows a person, when he or she goes 
into an American drugstore or goes into an American supermarket, to be 
fairly confident the product they buy is not adulterated and the 
product they buy is what it says it is and that in the instance of a 
pharmaceutical or a medication, it is going to be what the doctor told 
them to take. That has been one of the great successes of American 
Government. It is because the Food and Drug Administration is 
overseeing this effort to protect the food supply and the 
pharmaceutical supply.
  Whether the Food and Drug Administration has the wherewithal, the 
legal ability, and the technical and physical ability to protect an 
American who buys an overseas product, a medicine, and imports it into 
the United States is very much an issue. The FDA is very concerned 
about their capacity to police effectively drugs coming into this 
country, especially over the Internet.
  So I have an amendment to this bill which basically is the Safe 
Internet Pharmaceutical Act, the purpose of which is to give the FDA 
the authority necessary to protect people who are buying pharmaceutical 
products over the Internet. This is, in my opinion, very important.
  The importance of this has only been further stressed and exemplified 
by a warning that came out today, fortuitously, from the FDA on the 
issue of Internet pharmacies. I want to read extensively from this 
warning because it goes to the essence of the debate we have heard on 
the floor, especially from Senators supporting the proposal from the 
Senator from North Dakota relative to reimportation and safety and 
their representation that it is safe to buy over the Internet and that 
their amendment will make it legal to buy drugs from outside the United 
States over the Internet through their reimportation language.
  This warning from the FDA states as follows: ``FDA Warns Consumers 
about Counterfeit Drugs from Multiple Internet Sellers.'' I am going to 
read quite a bit of the text because I think, first, it is so on point 
and it is so important:

       The Food and Drug Administration (FDA) is cautioning U.S. 
     consumers about dangers associated with buying prescription 
     drugs over the internet. This alert is being issued based on 
     information the agency received showing that 24 apparently 
     related Web sites may be involved in the distribution of 
     counterfeit prescription drugs.
       On three occasions during recent months, FDA received 
     information that counterfeit versions of--

  I may not get all these medical terms correct, but I hope I do.

       On three occasions during recent months, FDA received 
     information that counterfeit versions of Xenical 120 mg 
     capsules, a drug manufactured by Hoffmann-LaRoche Inc. 
     (Roche), were obtained by three consumers from two different 
     Web sites. Xenical is an FDA-approved drug used to help obese 
     individuals who meet certain weight and height requirements 
     lose weight and maintain weight loss.
       None of the capsules ordered off the Web sites contained 
     orlistat, the active ingredient in authentic Xenical. In 
     fact, laboratory analysis conducted by Roche and submitted to 
     the FDA confirmed that one capsule contained sibutramine, 
     which is the active ingredient in Meridia, an FDA-approved 
     prescription drug manufactured by Abbott Laboratories.
       While this product is also used to help people lose weight 
     and maintain that loss, it should not be used in certain 
     patient populations and therefore is not a substitute for 
     other weight loss products. In addition the drug interactions 
     profile is different between Xenical and sibutramine, as is 
     the dosing frequency; sibutramine is administered once daily 
     while Xenical is dosed three times a day.
       Other samples of drug product obtained from two of the 
     Internet orders were composed of only talc and starch. 
     According to Roche, these two samples displayed a valid Roche 
     lot number of B2306 and were labeled with an expiration date 
     of April 2007. The correct expiration date for this lot 
     number is actually March 2005.

  Pictures of the counterfeit Xenical capsules can be seen on the Web 
site at FDA. I would note they look exactly like the Xenical that is 
legitimate. We had a Senator here earlier holding up two prescription 
bottles of, I think it was Lipitor, saying: These two bottles are 
exactly the same, and one could be bought in Canada for about a third 
of what it costs in the United States. Well, you can buy this Xenical 
over the Internet for probably about a third of what it costs in the 
United States. The only problem is it might kill you. I am going to 
read further:
       Roche identified the two Web sites involved in this 
     incident as brandpills.com and pillspharm.com. Further 
     investigation by FDA disclosed that these Web sites are two 
     of 24 Web sites that appear on the pharmacycall365.com home 
     page under the ``Our Websites'' heading. Four of these Web 
     sites previously have been identified by FDA's Office of 
     Criminal Investigations as being associated with the 
     distribution of counterfeit Tamiflu and counterfeit Cialis.
       At this point, it appears that these Web sites are operated 
     from outside of the United States. Consumers should be wary, 
     if there is no way to contact the Web site pharmacy by phone, 
     if prices are dramatically lower than the competition, or if 
     no prescription from your doctor is required. As a result, 
     FDA strongly cautions consumers about purchasing drugs from 
     any of these Web sites which may be involved in the 
     distribution of counterfeit drugs and reiterates previous 
     public warnings about buying prescription drugs online.

  Then it lists the 24 Web sites, and some of them have very seductive 
names: ``Pharmacea.org,'' ``MensHealthDrugs.net,'' ``MediClub.md''--
very seductive names, in order to draw people into purchasing drugs on 
these sites.
  Madam President, I ask unanimous consent that this press release from 
the FDA be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                    [From the FDA News, May 1, 2007]

  FDA Warns Consumers About Counterfeit Drugs from Multiple Internet 
                                Sellers

       The Food and Drug Administration (FDA) is cautioning U.S. 
     consumers about dangers associated with buying prescription 
     drugs over the Internet. This alert is being issued based on 
     information the agency received showing that 24 apparently 
     related Web sites may be involved in the distribution of 
     counterfeit prescription drugs.
       On three occasions during recent months, FDA received 
     information that counterfeit versions of Xenical 120 mg 
     capsules, a drug manufactured by Hoffmann-La Roche Inc. 
     (Roche), were obtained by three consumers from two different 
     Web sites. Xenical is an FDA-approved drug used to help obese 
     individuals who meet certain weight and height requirements 
     lose weight and maintain weight loss.
       None of the capsules ordered off the Web sites contained 
     orlistat, the active ingredient in authentic Xenical. In 
     fact, laboratory analysis conducted by Roche and submitted to 
     the FDA confirmed that one capsule contained sibutramine, 
     which is the active ingredient in Meridia, an FDA-approved 
     prescription drug manufactured by Abbott Laboratories.
       While this product is also used to help people lose weight 
     and maintain that loss, it should not be used in certain 
     patient populations and therefore is not a substitute for 
     other weight loss products. In addition the drug interactions 
     profile is different between Xenical and sibutramine, as is 
     the dosing frequency; sibutramine is administered once daily 
     while Xenical is dosed three times a day.
       Other samples of drug product obtained from two of the 
     Internet orders were composed of only talc and starch. 
     According to Roche, these two samples displayed a valid Roche 
     lot number of B2306 and were labeled with an expiration date 
     of April 2007. The correct expiration date for this lot 
     number is actually March 2005. (Pictures of the counterfeit 
     Xenical capsules provided by Roche can be viewed at http://
www.fda.gov/bbs/topics/news/photos/xenical.html.)

[[Page 10961]]

       Roche identified the two Web sites involved in this 
     incident as brandpills.com and pillspharm.com. Further 
     investigation by FDA disclosed that these Web sites are two 
     of 24 Web sites that appear on the pharmacycall365.com home 
     page under the ``Our Websites'' heading. Four of these Web 
     sites previously have been identified by FDA's Office of 
     Criminal Investigations as being associated with the 
     distribution of counterfeit Tamiflu and counterfeit Cialis.
       At this point, it appears that these Web sites are operated 
     from outside of the United States. Consumers should be wary, 
     if there is no way to contact the Web site pharmacy by phone, 
     if prices are dramatically lower than the competition, or if 
     no prescription from your doctor is required. As a result, 
     FDA strongly cautions consumers about purchasing drugs from 
     any of these Web sites which may be involved in the 
     distribution of counterfeit drugs and reiterates previous 
     public warnings about buying prescription drugs online. 
     [Consumers are urged to review the FDA Web page at 
     www.fda.gov/buyonline/ for additional information prior to 
     making purchases of prescription drugs over the Internet.]
       The 24 Web sites appear on pharmacycall365.com: 
     AllPills.net, Pharmacy-4U.net, DirectMedsMall.com, 
     Brandpills.com, Emediline.com, RX-ed.com, RXePharm.com, 
     Pharmacea.org, PillsPharm.com, MensHealthDrugs.net, 
     BigXplus.net, MediClub.md, InterTab.de, Pillenpharm.com, 
     Bigger-X.com, PillsLand.com, EZMEDZ.com, UnitedMedicals.com, 
     Best-Medz.com, USAPillsrx.net, USAMedz.com, BluePills-Rx.com, 
     Genericpharmacy.us and I-Kusui.jp.

  Mr. GREGG. It is, of course, ironic that in the middle of this debate 
over how you make safe drugs that Americans are purchasing, and assure 
that the FDA has the proper oversight, that the FDA would be issuing 
this warning. It is a coincidence. The FDA did not do it because we are 
in the middle of this debate. They did it because they had received the 
necessary information to fairly well substantiate that at least in 
three incidents the medication that was purchased was not the 
medication that was approved by the FDA, even though it was represented 
as that medication, even though it came in a bottle that looked exactly 
like that medication, even though it had a tamperproof seal, and it had 
a label and a date as to when that medication would expire and a lot 
number. So it certainly looked legitimate. So this just confirms the 
concern which many of us have that we have to set up a regime where the 
FDA can properly review what is happening relative to drugs that are 
being purchased over the Internet, especially. It is not impossible to 
do that. In fact, it is very doable. That is why I will offer this 
amendment.
  The amendment I will offer basically sets up a system whereby the FDA 
will require that pharmaceutical products sold over the Internet be 
subject to the jurisdiction of the United States and that they get an 
FDA seal of approval which is tamper-proof. So if a citizen wants to 
use a pharmaceutical site, he or she can go on line and call up a 
pharmaceutical site, such as drugs.com or whatever--that may actually 
be a site, so I probably shouldn't use that term--but a site where you 
think you can purchase drugs at a better price than what you are going 
to have to pay for them somewhere else, they will see on that Web site 
a seal like the Good Housekeeping Seal of Approval, only it will be a 
tamper-proof seal which will reflect the fact that the FDA monitors 
that site, monitors that pharmacy.
  Also, the pharmacy has subjected itself to American jurisdiction, so 
that if there is an illegal act, they can be prosecuted, or if there 
are issues of liability, they can be sued; also, that there is contact 
information which is based in America relative to that and that there 
is a searchable database where you can go in and find out what that 
pharmacy has done in the past relative to its prescription-filling 
activity.
  This would all be supported by a fee system which gives the FDA the 
resources to accomplish this type of monitoring. It really seems like 
the most logical thing to do.
  There is no way you can stop the imagination and desire of the 
American people to get the best price. That is part of the essence of 
our character. So it is reasonable that Americans are going to use 
online pharmacies, but we have to make sure we have a system where we 
do not have one approval process for legitimate purchasing of drugs 
through pharmaceutical activity at your local pharmacy and then another 
process for purchasing drugs which has absolutely no oversight from the 
FDA if you purchase on the Internet. We have to make sure that if you 
are using an Internet site, the site has been subject to the same 
review as the local pharmacy down at the corner is subject to, relative 
to the quality and management of that pharmaceutical product they are 
selling. That is what this amendment does.
  I hope no one will object to it, but I know other people will. But 
they shouldn't because this is really something whose time has come. So 
I am going to offer this amendment tonight. It is timely, of course, in 
light of this FDA warning which says there are potentially 24 Web sites 
they have identified, at least 3 of which are selling adulterated 
drugs, that they know of, which could seriously harm and possibly, if 
taken in the wrong dosage, since they aren't the proper drug, actually 
do more than just harm you, they could permanently injure you.
  In light of that warning which came out today, it is totally 
reasonable and appropriate that the Congress should certainly, if it is 
going to do a drug safety bill relative to the FDA, include in it an 
Internet pharmacy safety regime which will give the American people 
some confidence that when they go on line to purchase a drug on line, 
the site, the portal they are purchasing it through, is subject to FDA 
review and the drug they are purchasing is an FDA-approved drug, which 
is made clear by having this tamper-proof seal of approval. It would 
also reflect the fact that the FDA actually has physical oversight over 
that pharmacy, that online pharmacy, and gives the FDA the resources to 
do that oversight. You can't just say: Go and do it, if they don't have 
the money to do it; you have to give them the resources to do it.
  In addition, it sets up a one-stop shopping site at the FDA where 
people can go on line to the FDA site, check out that Internet 
pharmacy, if they wish, and make sure the Internet pharmacy does 
qualify and does carry FDA-approved drugs.
  I think it is a very proper approach. It is something, as I 
mentioned, which is clearly timely in light of this FDA warning.
  Madam President, at this time, I ask unanimous consent that the 
pending amendment be set aside and that I may call up amendment No. 993 
and ask for its immediate consideration.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will report the amendment.
  The legislative clerk read as follows:

       The Senator from New Hampshire [Mr. Gregg], for himself and 
     Mr. Coleman, proposes an amendment numbered 993.

  Mr. GREGG. I ask unanimous consent that the reading of the amendment 
be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The amendment is printed in the Record of Tuesday, May 1, 2007, 
under ``Text of Amendments.'')
  Mr. GREGG. I thank my colleagues for allowing me to go forward at 
this time.
  Madam President, I yield the floor and make a point of order that a 
quorum is not present.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. MENENDEZ. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 1010

  Mr. MENENDEZ. Madam President, I rise today to talk about an issue of 
great importance but also of great concern: the importation of 
prescription drugs.
  In their search for more affordable prescription drugs, many 
Americans have turned to pharmacies in other countries, either via the 
Internet or trips across the border. While I certainly understand their 
need for affordable drugs, I do have concerns about this particular 
solution. We must find

[[Page 10962]]

a way to ensure that the drugs Americans are buying are safe.
  I believe the Cochran amendment will do just that. Senator Cochran's 
amendment allows importation to take effect only if the Health and 
Human Services Secretary can ensure that it will pose no additional 
risk to the public health and result in a significant reduction in the 
cost of prescription drugs. So with this amendment, we get safe drugs 
at a reduced price, and our ultimate objective is achieved.
  Looking closely at the issue of safety, I am also concerned about the 
importation of counterfeit drugs. Americans deserve to know the label 
on the bottle--we have seen colleagues put bottles up and show 
differences. Well, Americans deserve to know the label on the bottle 
matches the pills inside they are taking. The only way to ensure that 
is to provide strong protections. We have all heard horror stories 
about innocent Americans, starved for cheaper prescription drugs, going 
online or getting in their cars to go to foreign pharmacies to buy 
their medications. They are coming back home with what they think is 
their usual medication, but the reality might be quite different.
  A recent New York Times article talked about the increasing number of 
counterfeit drugs. While in the past we may have noticed a misspelled 
label or off-color pill, today's counterfeit drugs are largely 
undetectable. The pills look correct, the cardboard boxes are the same, 
even the blister packaging and foil backing are all normal. But this is 
not your grandmother's forged medication. These are modern, scary, 
life-threatening tactics that place American lives in great danger.
  While the supporters of the underlying amendment believe their 
proposal addresses some of these concerns, there are a number of safety 
concerns that I believe must be addressed by the Secretary of Health 
and Human Services, and that is why the Cochran amendment is so 
important.
  The underlying proposal would undo current safety protections that 
ensure Americans are getting products that are essentially the same 
substance and quantity as what their doctor has prescribed.
  While the proposal requires an importer to retain samples of 
products, it does not require that those be tested to ensure the drugs 
are the same as what the doctor ordered.
  The proposal does not require that imported drugs be approved in 
their country of origin. It relies only on a paper trail to enforce 
chain-of-custody requirements, leaving consumers susceptible to 
unscrupulous dealers who can simply forge documents or copy 
anticounterfeit technology.
  While supporters of the proposal claim that they give FDA the 
authority to conduct inspections of foreign manufacturing plants, the 
reality is that the United States would actually have to get permission 
for those inspections from foreign countries, and that is assuming we 
can even trace the purchase of those products to their country of 
origin in the first place.
  Importers are not required to disclose the origin of the products 
they sell, so consumers would have no way to opt out if they wanted to 
ensure they were getting Food and Drug Administration-approved 
products.
  Finally, the underlying amendment allows importation from far more 
than just Canada. Written into the proposal is permission to import 
from Canada and other countries, including certain countries in the EU, 
even if the drugs leave the chain of custody of the manufacturer or 
fall outside of the Food and Drug Administration's jurisdiction. 
Because of the EU structure, we would actually be opening ourselves to 
drugs from countries such as Latvia, Estonia, and other recent 
additions to the EU. Some of these countries from the former Soviet 
Union have counterfeit rates up to 20 percent.
  The Cochran amendment would ensure these safety concerns are resolved 
and that the Government provides for the protection of the public's 
health and safety.
  Now, in my mind, as we have this debate, the real problem is 
affordability of prescription drugs, and the real solution to that 
problem is expanding access to affordable drugs in the United States. 
In that effort, I take a back seat to no one. But at the same time, I 
strongly believe we must also protect the health and safety of those we 
represent.
  These two goals are not mutually exclusive. We can and must do both. 
I believe this amendment--the Cochran amendment--accomplishes what we 
all want, which is expanding access to safe, affordable drugs. I 
encourage my colleagues to support the Cochran amendment.


                           amendment no. 1011

  Mr. KOHL. Madam President, I rise today to join Senators Stabenow, 
Lott, Brown, and Thune in offering amendment No. 1011. This amendment 
will help speed the introduction of cost-saving generic drugs by 
preventing abuses of the Food and Drug Administration citizen petition 
process.
  Consumers continue to suffer all across our country from the high--
and ever rising--cost of prescription drugs. A recent independent study 
found that prescription drug spending has more than quadrupled since 
1990, and now accounts for 11 percent of all health care spending. At 
the same time, the pharmaceutical industry is one of the most 
profitable industries in the world, returning more than 15 percent on 
their investments.
  One key method to bring prescription drug prices down is to promote 
the introduction of generic alternatives to expensive brand name drugs. 
Consumers realize substantial savings once generic drugs enter the 
market. Generic drugs cost on average of 63 percent less than their 
brandname equivalents. One study estimates that every 1 percent 
increase in the use of generic drugs could save as much as $4 billion 
in health care costs.
  This is why I have been so active in pursuing legislation designed to 
combat practices which impede the introduction of generic drugs. The 
amendment offered today, includes provisions based on legislation that 
I first introduced with Senator Leahy in the last Congress, and targets 
one particularly pernicious practice by brandname drug companies to 
impede or block the marketing of generic drugs--abuse of the FDA 
citizen petition process.
  FDA rules permit any person to file a so-called citizen petition to 
raise concerns about the safety or efficacy of a generic drug that a 
manufacturer is seeking FDA approval to bring to market. While this 
citizen petition process was put in place for a laudable purpose, 
unfortunately in recent years it has been abused by frivolous petitions 
submitted by brandname drug manufacturers, or individuals acting at 
their behest, whose only purpose is to delay the introduction of 
generic competition. The FDA has a policy of not granting any new 
generic manufacturer's drug application until after it has considered 
and evaluated any citizen petitions regarding that drug. The process of 
resolving a citizen petition, even if ultimately found to be 
groundless, can delay the approval by months or years. Indeed, 
brandname drug manufacturers often wait to file citizen petitions until 
just before the FDA is about to grant the application to market the new 
generic drug manufacturer's solely for the purpose of delaying the 
introduction of the generic competitor for the maximum amount of time 
possible. This gaming of the system should not be tolerated.
  In recent years, FDA officials have expressed serious concerns about 
the abuse of the citizen petition process. In 2005, FDA Chief Counsel 
Sheldon Bradshaw noted that ``[t]he citizen petition process is in some 
cases being abused. Sometimes, stakeholders try to use this mechanism 
to unnecessarily delay approval of a competitor's products.'' He added 
that he found it ``particularly troublesome'' that he had ``seen 
several examples of citizen petitions that appear designed not to raise 
timely concerns with respect to the legality or scientific soundness of 
approving a drug application, but rather to delay approval by 
compelling the agency to take the time to consider the arguments raised 
in the petition, regardless of their merits, and regardless of whether 
the petitioner could have made those very arguments months and months 
before.''

[[Page 10963]]

  And a simple look at the statistics gives credence to these concerns. 
Of the 21 citizen petitions for which the FDA has reached a decision 
since 2003, 20--or 95 percent of them--have been found to be without 
merit. Of these, 10 were identified as ``eleventh hour petitions''--
defined as those filed less than 6 months prior to the estimated entry 
date of the generic drug. None of these 10 ``eleventh hour petitions'' 
were found to have merit, but each caused unnecessary delays in the 
marketing of the generic drug by months or over a year, causing 
consumers to spend millions and millions of dollars for their 
prescription drugs than they would have spent without these abusive 
filings.
  Among other things, our amendment will, for the first time, require 
all those who file citizen petitions to affirm certain basic facts 
about the truthfulness and good faith of the petition, similar to what 
is required of every litigant who makes a filing in court. Our 
amendment also includes a provision from my bill that directs the HHS 
that all citizen petitions on generic drug applications be adjudicated 
within 6 months of filing, which will put an end to excessive delays in 
bringing needed generic drugs to market because of the filings of these 
petitions.
  While I strongly support this amendment and I am pleased that many of 
my provisions were included, I do wish the amendment could have gone 
even farther and include my provision to allow the Department of Health 
and Human Services--the FDA's parent agency--the power to sanction 
those who abuse the process. While this proposal would not have an 
effect on any person filing a truly meritorious citizen petition, this 
provision would serve as a strong deterrent to attempts by brand name 
drug manufacturers or any other party that seeks to abuse the citizen 
petition process to thwart competition. Having said that, I do believe 
our amendment today is an important step in the right direction to 
remove a significant obstacle exploited by brand name drug companies to 
prevent or delay the introduction of generic drugs. I urge my 
colleagues to support this amendment.


                           amendment no. 1016

  Mr. SPECTER. Madam President, the Food and Drug Administration 
Revitalization Act is an important step toward protecting American 
consumers and patients and ensuring the safety of prescription drugs. 
To increase the safety and efficacy of prescription drug approval, I 
will offer an amendment to establish the National Centers of 
Pharmaceutical Innovation. These Centers, in consultation with the Food 
and Drug Administration, FDA, Commissioner, will modernize medical 
product development and enhance product safety.
  I am very concerned about long delays and the safety of bringing new 
drugs to patients. The FDA has been faced with the withdrawal of 
prescription drugs from the market due to concerns about increased 
health risks. This situation illustrates the difficulty in achieving 
the right balance in investigating new drugs that, while intended to 
help patients, can also come with very serious risks. Furthermore, such 
incidents could lead to the erosion of public confidence in the safety 
of medicines developed by drug companies. Drug companies spend enormous 
sums of money to test potential new candidate medicines. Not only is 
the process of developing and testing a new drug costly, it is lengthy 
as well. As a result of delays in the clinical trials process, there 
are fewer drug discoveries each passing year, ultimately hindering our 
Nation's competitiveness in this field.
  According to Ernst R. Berndt, Ph.D., Adrian H. B. Gottschalk, S.M., 
Matthew W. Strobeck, Ph.D., Massachusetts Institute of Technology, MIT, 
Sloan School of Management, ``scientific advances and enhanced 
[research and development] efforts, the number of average annual new 
drug applications, NDAs, and new biologic license applications, BLAs, 
approved by the U.S. Food and Drug Administration has been smaller 
after 2000 than in the mid-1990s. Moreover, recent estimates suggest 
the average costs of bringing a new medicine to market have increased 
sharply to between $800 million and $1.7 billion, with the lower 
estimate being 2\1/2\ times higher than similar inflation-adjusted 
estimates published a dozen years earlier.'' Clearly, there is great 
need to improve the methods and science that are used to approve 
prescription drugs.
  I am further concerned that new technologies, including genomics, 
proteomics, and bioinformatics are not being fully incorporated into 
the drug approval process. Using these new technologies as part of the 
clinical drug approval process has the potential to substantially 
reduce costs and the time needed to develop and test new drugs. 
Additionally, we must improve the workforce available to pharmaceutical 
companies, which is not well trained in the modern tools needed for 
sophisticated drug development. The FDA does not have a structured 
research program to bridge this knowledge and workforce gap and has few 
extramural research activities in place to tap the expertise available 
in our Nation's university health programs.
  This amendment will establish the National Centers for Pharmaceutical 
Innovation to improve the development and testing of new drugs so that 
they make it to market more quickly and remain there. Up to five 
centers will be operated by universities in partnership with the FDA to 
develop methods to utilize new technology to improve the drug approval 
system. They will also expand the quality and number of professionals 
trained to work in this field. The centers will introduce new 
technologies to improve the manufacture of pharmaceutical and 
biotechnology products.
  I believe these centers can provide a significant part of the 
solution to this complex problem. These centers will be established 
from qualified universities that have graduate training programs with 
extensive experience in the development and evaluation of medicines; 
and proficiencies in pharmaceutical and biotechnology science and 
engineering. It is the expectation that the work completed by these 
centers and the FDA would lead to an increased number of drugs brought 
to market by industry, at a decreased cost. Another effect will be an 
enormous gain to the public's health, while decreasing the chance of 
unintentional harm and costs of medical care.
  The National Centers for Pharmaceutical Innovation hold a promising 
solution to the problems in drug discovery and safety facing our Nation 
today. I encourage my colleagues to support this important amendment.


                           Overturning DSHEA

  Mr. HATCH. My office has been inundated by calls from people 
throughout the country who believe that this legislation, specifically 
the provision establishing a Reagan-Udall Institute, will overturn the 
Dietary Supplement Health and Education Act of 1994. That has not been 
my reading of the bill, but I wonder if other Senators have heard 
similar concerns?
  Mr. HARKIN. Yes, I have received a good many calls as well. And, I 
have to say that I would be very concerned, as I know the Senator from 
Utah is, if anything in the bill we are considering, S. 1082, would 
overturn DSHEA, a law we fought side-by-side to see enacted.
  Mr. ENZI. It might be helpful if I explained the provision you are 
discussing, as my office has received many calls as well and I believe 
the callers are not informed about this matter. Subtitle B of title II 
of S. 1028 establishes the Reagan-Udall Foundation for the Food and 
Drug Administration. That simple purpose of that nonprofit Foundation 
is to lead collaborations among the FDA, academic research institutions 
and industry designed to bolster research and development productivity, 
provide new tools for improving safety in regulated product evaluation, 
and in the long term make the development of those products more 
predictable and manageable.
  Mr. KENNEDY. That is exactly the purpose of the Foundation, which was 
included in the drug safety legislation Senator Enzi and I introduced 
last year. The Foundation will be financially supported by industry and 
philanthropic donated funds. A chief scientist at FDA will promote 
intramural research and coordinate it with efforts at the Foundation.

[[Page 10964]]


  Mr. HATCH. That explanation is very helpful. What, specifically, 
would the role of the Foundation be with respect to dietary 
supplements?
  Mr. KENNEDY. Let me make absolutely clear that the Reagan-Udall 
Foundation will in no way override, overturn or conflict with the 
Dietary Supplement Health and Education Act. Nothing in this bill would 
have that effect.
  Mr. ENZI. Yes, we took great pains to make certain there would be no 
conflict with DSHEA. Regarding foods, and dietary supplements are 
generally regulated as foods, the general directive of the Foundation 
is to identify holes in the evaluation of food safety and identify ways 
to address those deficiencies through collaborative research with 
industry.
  Mr. HARKIN. So to make this absolutely clear, what you are saying is 
that the bill we are debating would in no way interfere with consumers' 
access to dietary supplements?
  Mr. HATCH. To add to that point, it seems that the language could, in 
fact, help dietary supplement consumers, because it would allow 
collaboration between government and industry to conduct research on 
issues that might be helpful to supplement consumers?
  Mr. KENNEDY. Yes, that is the case.
  Mr. ENZI. I agree with Chairman Kennedy's assessment.
  Mr. HATCH. I thank you for those assurances and that clarification.
  Mr. HARKIN. This has been a very helpful discussion, because Senator 
Hatch and I could never support legislation that would interfere with 
DSHEA and we are glad to receive the assurances of the chairman and the 
ranking Republican on the committee.

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