[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11228-11262]
[From the U.S. Government Publishing Office, www.gpo.gov]




             PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

  The ACTING PRESIDENT pro tempore. Under the previous order, the 
Senate will resume consideration of S. 1082, which the clerk will 
report.
  The bill clerk read as follows:

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

  Pending:

       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.
       Cochran amendment No. 1010 (to amendment No. 990), to 
     protect the health and safety of the public.
       Stabenow amendment No. 1011, to insert provisions related 
     to citizens petitions.
       Brown (for Brownback/Brown) amendment No. 985, to establish 
     a priority drug review process to encourage treatments of 
     tropical diseases.
       Vitter amendment No. 983, to require counterfeit-resistant 
     technologies for prescription drugs.
       Inhofe amendment No. 988, to protect children and their 
     parents from being coerced into administering a controlled 
     substance in order to attend school.
       Gregg/Coleman amendment No. 993, to provide for the 
     regulation of Internet pharmacies.
  The ACTING PRESIDENT pro tempore. Under the previous order, there 
will be an hour for debate prior to a vote on the motion to invoke 
cloture on amendment No. 990, with the time equally divided between the 
Senator from North Dakota, Mr. Dorgan, and the Republican leader or 
their designees.
  Who yields time?
  The Senator from Massachusetts.
  Mr. KENNEDY. Would the Senator from Wyoming yield me 3 minutes.
  Mr. ENZI. Certainly.

[[Page 11229]]


  Mr. KENNEDY. Mr. President, we now have an agreement that we are 
going to vote on cloture on the Dorgan amendment. The Senator from 
North Dakota will be here to speak on that. He has a half hour. To 
bring our colleagues up to date, we have made very good progress during 
the evening, clearing matters with the Members. There are still a 
number of items that we will want to accept. We will indicate to the 
Members the topical areas so they will be familiar with the areas that 
we are moving ahead on. But we have narrowed the areas of controversy 
to probably four or five important areas where we may very well have 
votes during the day. The rest we will announce the agreements that 
have been made with the particular Senators on these issues.
  We want to thank all of our colleagues. This has been very 
constructive. A number of these suggestions and ideas are extremely 
valuable. We will tell our colleagues the areas and the content of 
these agreements as we move on through the day.
  We are in touch with a couple of Senators so we will be able to make 
a judgment decision at the conclusion of this vote on the cloture. We 
will be ready to go so we will not miss any opportunity to make 
progress on the bill.
  I thank the Senator. The Senate will now debate the underlying 
cloture motion.
  The ACTING PRESIDENT pro tempore. The Senator from Iowa.
  Mr. GRASSLEY. Mr. President, I have not had an opportunity to speak 
with the Senator from North Dakota. I hope I am not abusing my 
privilege of working with him and having some time this morning. I 
yield myself 7 minutes.
  The Dorgan amendment is the moment American consumers have been 
waiting for. I am here to urge my colleagues to vote for cloture so we 
can finally legalize drug importation.
  As I said yesterday, the Dorgan amendment is the result of a 
collaborative effort by myself, with Senators Dorgan, Snowe, and 
Kennedy, to finally make drug importation legal. This is a golden 
opportunity that we have been waiting for years to accomplish. The bill 
before us is the vehicle this year to get it done.
  The bill we are debating is a must-pass Food and Drug Administration 
bill. The Senate should send a strong message that we are committed to 
finally getting it done this year. This is what we have been working to 
accomplish today.
  Making it legal for Americans to import their prescription drugs is a 
top priority at the grassroots of America. It needs to be a top 
priority here in Washington.
  It is something that shows up in almost every one of my town meetings 
throughout Iowa. I have long advocated allowing American consumers 
access to safe drugs from other countries. I have always considered 
this more a free trade issue than I have a health or prescription drug 
issue.
  Imports create competition and keep domestic industry more responsive 
to consumers. In the United States--so that I explain why I consider 
this a free trade issue more than a health issue--we import everything. 
We allow everything that consumers might want to buy; based upon the 
quality they choose and the price they choose, we have allowed it to 
come into the country if Americans want to buy from overseas. 
Hopefully, they want to buy American-made products. But we have 
considered free trade something that has given consumers the best deal 
they can get. So why not do it for pharmaceuticals as well as any other 
product people want to buy?
  Consumers in the United States now pay far more for prescription 
drugs than consumers in other countries. If Americans could legally and 
safely access prescription drugs from outside the United States under a 
regulation that we established to guarantee safety, drug companies will 
be forced to reevaluate the price strategies that they have for 
American consumers. They would no longer be able to gouge American 
consumers by making them pay more than their fair share for the high 
cost of research and development. I sort out research and development 
because I think Canadians are getting a better deal from American 
pharmaceuticals. Germans are getting a better deal from American 
pharmaceuticals. They get such a low price. They don't pay the fair 
share. The American consumer of pharmaceutical products pays for most 
of the research and development that benefits the entire world. It is 
not fair to the American consumer.
  It is true that pharmaceutical companies do not like the idea of 
opening American consumption of drugs to the global marketplace. They 
want to keep the United States closed to other markets in order to 
charge higher prices here. They would argue: We have to charge higher 
prices here. The Government directs what we pay the consumers or charge 
the consumers of Germany. Well, that is not fair to the American to pay 
for that sort of research.
  However, with the Dorgan amendment--and this is what we are talking 
about on this important vote coming up--prescription drug companies 
will be forced to compete, forced to establish a fair price here in 
America.
  Some don't want this to happen. I want to reiterate that there is an 
attempt to kill drug importation, as has been done many times before in 
this Chamber. I am referring to an amendment to make sure there is 
certification of health and safety. That amendment is designed to kill 
drug importation once again. It is a clever amendment, but it is a 
poison pill. Our effort develops an effective and safe system. This 
amendment requires all imported drugs to be approved by the Food and 
Drug Administration. That is the right thing to do. The amendment sets 
a stringent set of safety requirements that must be met before 
Americans can import drugs into this country, and there are stiff 
penalties for violation. Don't be fooled by this poison pill amendment. 
Voting for that amendment is a vote to kill drug importation. That 
amendment surely will be up if we get beyond the cloture vote, the next 
vote. It is important that people vote for cloture.
  With the Dorgan amendment, we are getting the job of safety done. 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. We must make sure they have access to 
affordable prescription drugs.
  I urge my colleagues to vote for cloture.
  One additional editorial comment that is legitimate to maybe 
criticize Grassley for voting for this amendment but a criticism that I 
think I would now explain; that is, that comes from a very good fellow 
Member and friend of mine in the Senate who came up to me yesterday and 
said: Then wouldn't I be for having all restrictions against ethanol 
coming into this country done away with because I represent a State 
that is very high in ethanol.
  I said the answer to that is twofold: No. 1, all restrictions ought 
to go off when ethanol is no longer an infant industry, and it is still 
an infant industry. Secondly, and more importantly, there is already a 
free importation of ethanol in this country of up to 7 percent of our 
production, and we have not even reached that 7 percent importation of 
ethanol. I will debate that issue when the leeway within present law 
allows.
  So I do not think there is an inconsistency on my part in what I said 
about the free entry from the mature industry of pharmaceuticals--maybe 
not mature in biotechnology but surely mature in pharmaceuticals.
  I yield the floor.
  The ACTING PRESIDENT pro tempore. Who yields time?
  Mr. DORGAN. Mr. President, 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. DORGAN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  Mr. DORGAN. Mr. President, I suggest the absence of a quorum and ask

[[Page 11230]]

unanimous consent that the time in the quorum call be charged to both 
sides equally.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. DORGAN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  Mr. DORGAN. Mr. President, let me yield myself 5 minutes from the 
time allotted.
  Mr. President, the vote that will occur at 10:30 or thereabouts is a 
vote that will determine whether we can proceed to have a vote on my 
amendment. It is called a cloture vote--to shut off debate so we can 
move to the amendment I have offered. I wish to remind my colleagues 
again of what this amendment is.
  This amendment is a bipartisan amendment sponsored by 33 Senators, 
Republicans and Democrats--Senator Grassley, who just spoke, myself, 
Senator Snowe, Senator McCain, Senator Kennedy, Senator Stabenow; a 
wide range of Senators, Republicans and Democrats--who believe U.S. 
citizens ought to be able to purchase FDA-approved prescription drugs, 
the identical FDA-approved drugs that are sold in other countries for a 
fraction of the cost of what they are sold for in this country. We 
believe the American people ought to be able to make the global economy 
work for them and ought to be able to access those same prescription 
drugs as long as they are in a chain of custody that makes them safe 
and as long as they are FDA approved.
  I described them yesterday, and let me, again, ask unanimous consent 
to describe to my colleagues these two bottles.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  Mr. DORGAN. In these bottles is the medication called Lipitor. 
Lipitor is made in Ireland. It is a common cholesterol-lowering drug 
taken by a good many Americans. As you can see, when made in the plant 
in Ireland, it is put in these bottles--identical bottles--with a label 
that is blue in this case, red in this case, otherwise identical. The 
difference in this situation is that this blue bottle is sent to Canada 
from Ireland, this red bottle is sent to the United States. It is the 
same pill, same bottle, made in the same manufacturing plant, FDA 
approved.
  The difference? Well, the American consumer is told: You get to pay 
twice as much for the identical drug. You get to pay twice as much.
  It describes a serious problem of what I believe is the overpricing 
of prescription drugs in this country. We pay the highest prices in the 
world for prescription drugs. I do not know of anyone in this Chamber 
who stands up and says: Let me sign up for that. Let me tell you, I 
think it is right, I think it is fair, and I think it is important that 
the American consumers pay the highest prices in the world for 
prescription drugs.
  I do not think anybody stands up here and claims that. What they 
claim is, if they do not get that kind of money, they will shut down 
research and development, and they are forced to charge lower prices 
overseas because those governments overseas won't allow them to make 
money.
  Let me show you what happened a while ago. This Chamber--without my 
support because it was a foolish thing to do--said: Do you know what. 
We want to say to the biggest economic interests in our country, the 
biggest companies that have moved American jobs overseas and make 
investments overseas, we want to say to them that if you make profits 
overseas, we will allow you to repatriate those profits into this 
country, back here, and you get to pay a special tax rate.
  Normally, when a company repatriates its profits made elsewhere, it 
pays normal income tax rates. But this Congress said to them: Do you 
know what. We will give you a special deal, a big fat tax break. If you 
repatriate your foreign profits, you get to pay a 5.25-percent income 
tax rate. Nobody gets to pay a 5.25-percent income tax rate. I would 
love to pay that. Everybody else would, as well. But the biggest 
companies in our country got to repatriate a massive amount of money 
and save, I estimate, about $100 billion in taxes that should have been 
paid because they got a 5.25-percent sweetheart deal.
  So let me just turn to one drug company--Pfizer, a good company, one 
of the world's biggest drugmakers. This is from the New York Times of 
June 24, 2005. It said it would return ``$8.6 billion in overseas 
profits.'' So the combined repatriation of $36.9 billion--it had 
already announced $28.3 billion--so that makes it $36 billion they are 
repatriating in profits they have made overseas. The New York Times 
says that is four times what Pfizer spent on research and development 
last year.
  But isn't it interesting that they charge lower prices for 
prescription drugs in other countries, they say they do not make money 
in other countries, yet when they get a big fat sweetheart deal to pay 
a 5.25-percent income tax rate, they repatriate $36 billion. That is on 
the profit they made in other countries. It looks to me as if it is 
profitable selling these drugs at lower prices in foreign countries. So 
much for that argument.
  The price discrepancy I have indicated previously. I used Canada as 
an example, but I could use France, Italy, Germany, Spain--it would not 
matter. Lipitor, 96 percent higher prices for Americans; Prevacid, 97 
percent higher prices for Americans; Nexium, 55 percent higher prices; 
Zocor--the fact is, we are paying the highest prices for brand-name 
prescription drugs in the world, and it is unfair. We are trying to 
change that.
  What we are saying is: Let's let the global economy work for 
everybody, not just the large pharmaceutical industry. How about 
allowing it to work for regular folks, to buy a safe FDA-approved 
prescription drug, for example, from a Canadian pharmacy.
  Can anybody give me one reason why a U.S.-licensed pharmacist should 
not be able to go to a licensed pharmacist in Winnipeg, Canada--both 
licensed, both with an identical chain of custody--why a U.S.-licensed 
pharmacist should not be able to go to a licensed pharmacist in Canada 
and acquire an FDA-approved drug, such as Tamoxifen, at one-fourth or 
one-fifth of the price charged in the United States and pass the 
savings along to the consumer? I am not asking for five reasons. I am 
asking: Can anyone give me one reason why that should be prohibited? I 
think the answer is that there is not a good reason why we should 
prohibit that sort of thing.
  So we will have a vote on this amendment. My hope is we will be able 
to invoke cloture so we will be able to proceed to the amendment. There 
will be a Cochran amendment to my amendment, a second degree, and then 
a vote on my amendment. My hope is we will be able to do that today.
  Mr. President, I yield the floor.
  The ACTING PRESIDENT pro tempore. Who yields time?
  The Senator from Wyoming.
  Mr. ENZI. Mr. President, I yield 10 minutes to the Senator from 
Mississippi.
  The ACTING PRESIDENT pro tempore. The Senator from Mississippi.
  Mr. COCHRAN. Mr. President, I am on the floor to urge the Senate not 
to invoke cloture. This is a very serious amendment the Senator from 
North Dakota has proffered and is being considered by the Senate, and 
it should attract the attention and careful review of all Senators.
  I noticed in the Washington Post, in an article on Thursday, May 3, 
the editorial writer says--of the amendment the Senator from North 
Dakota has offered, which ``would allow the importation of prescription 
drugs from other countries,'' which he claims and other supporters 
claim ``would let cut-rate pharmaceuticals flow into the United 
States'' allegedly ``saving ailing Americans untold amounts of money.'' 
But here is the catch, and I quote from the editorial:

       This is a mirage; importation will not solve the problem of 
     drug pricing. U.S. drug firms sell prescription medications 
     to countries such as Canada at low prices, a situation that 
     would quickly change if Canadian

[[Page 11231]]

     distributors started to recycle large quantities of drugs 
     back to the United States.

  Another fact in this debate that should not be overlooked is that 
President Bush has threatened to veto the bill if it contains this 
language.
  So to achieve our goal of helping to ensure safe and unadulterated 
prescription drugs marketed in the United States are safe, we need to 
have the Federal agencies that have the responsibility of assuring that 
safety to be in charge of certifying that.
  So I have offered an amendment to the Dorgan amendment--if cloture is 
invoked, it will be subject to consideration--that says unless the Food 
and Drug Administration or the Department of Health and Human Services 
can certify and vouch for the safety and efficacy of imported drugs, 
this amendment would not be operative. And we have been told by 
administration officials they cannot make that certification. They do 
try. We all try to help by working together to ensure that what the 
consumers are buying is what the labels on the drugs say they are. But 
we have seen in recent years a growing threat from counterfeit drugs 
that are made in other countries--not Canada necessarily but other 
countries--which could be transshipped through Canada or could be 
mailed directly to purchasers in the United States that aren't what 
they say they are. Some are even dangerous. Some contain nothing at 
all--nothing that is effective to do what the drug is supposed to do.
  So we are already confronted with a serious problem. This is going to 
make it much worse and exceedingly difficult for those who are charged 
with certifying the efficacies of drugs, protecting our citizens from 
dangerous drugs, counterfeit drugs, to do their job. This is going to 
make it much more difficult.
  This is not the first time the Senate has been asked to make a 
decision on this amendment or amendments similar to it. On three 
different occasions the Senate has, without objection, or on a vote--
one vote was 99 to nothing--rejected this amendment. There have been 
votes that have been closer. Recently, I think Senators have gotten the 
message this is not an amendment that is going to achieve the goals 
that the proponents who are offering it say it will. There will be some 
cheaper drugs coming into the country--but maybe temporarily--for the 
reasons that have been pointed out by others and in the Washington Post 
editorial this morning.
  So I am hopeful Senators will carefully look at the situation we 
face. The intent, of course, is certainly laudable, but we have an 
overriding responsibility to make sure medications purchased by 
American citizens in the United States are safe and that those are 
decisions made by the regulators and the inspectors in the United 
States who have the responsibility of making those decisions. So I am 
hopeful the Senate will not vote to invoke cloture. If it does, we will 
talk a little more about the situation. But up until that point, I hope 
Senators will review the history of the Senate on this subject and vote 
against the motion to invoke cloture.
  The PRESIDING OFFICER (Mr. Obama). The Senator from Wyoming is 
recognized.
  Mr. ENZI. Mr. President, I yield 5 minutes to the Senator from New 
Jersey.
  Mr. LAUTENBERG. Mr. President, we have an interesting challenge in 
front of us today. All of us support drug availability at affordable 
prices. The challenge that brings us to the floor today is how to 
ensure that prescription drugs used by Americans are both affordable 
and safe. That is the goal for all of us, I believe, in the Senate.
  We trust the drugs we get at our local pharmacies, our neighborhood 
pharmacies, are safe because they go through a rigorous FDA approval 
process, and a series of tests and inspections are done before they 
reach our medicine chests. Those drugs improve, extend, and save lives.
  I am proud so many of these drugs originate in my home State. In 
fact, more than half the medicines approved by the FDA in 2001 were 
developed by 70,000 hard-working people employed in the pharmaceutical 
companies of New Jersey. These companies have received more than 11,000 
patents for their products since 1985 for their innovative work. Many 
of these products are life-extending and limit often painful and 
debilitating conditions.
  When we look at the prospects these companies are offering, we want 
to encourage the research. I heard this morning about an inoculation 
that could be sufficient, given one time to women, that could prevent 
osteoporosis. What a wonderful thing. Recently, we have had a product 
come to the market called Gardasil. It says that young women who 
receive an injection of Gardasil can be protected against cervical 
cancer for their lives. What a wonderful thing that is. Lipitor has 
been known for some time to reduce plaque gathering in the valves and 
the veins that lead to the heart. We want to encourage that kind of 
development, and our goal is to make sure these workers continue 
developing lifesaving medications and at the same time lower costs and 
increase access to these drugs.
  I support the efforts to lower prescription drug prices, and I 
understand the appeal of reimportation, as long as we are absolutely 
assured of the safety and efficacy of these products. So if we are 
going to trust drugs imported from other countries, we need to be sure 
they are as effective and completely safe. We cannot put our citizens 
in the position of buying medicine they think will lower their 
cholesterol or prevent heart disease only to find out years later the 
drug was a fake.
  According to the World Health Organization, up to 10 percent of all 
drugs sold across the globe are counterfeit. We heard debate about the 
countries that some of these drugs come from. If we want to give 
consumers the chance to buy drugs imported from other countries, we 
have to insist these drugs are authentic, reliable, and safe.
  That is why the Senate has, on three prior occasions, required the 
Department of Health and Human Services to certify that importation be 
without additional risk to the public health while it reduces costs. 
That is why I intend to support the Cochran second-degree amendment, 
and I encourage my colleagues to do the same thing. Let's make sure 
what we are telling the public to buy is absolutely safe, harmless, and 
can improve life's qualities.
  The PRESIDING OFFICER. The Senator's time has expired.
  Mr. LAUTENBERG. Mr. President, I ask unanimous consent for 30 seconds 
more.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. LAUTENBERG. Mr. President, the Cochran amendment would require 
the same certification this body has approved three times before--to 
guarantee prescription drugs and provide consumers peace of mind, 
knowing that the drugs they are taking are safe and effective no matter 
where they originated.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Mississippi is recognized.
  Mr. COCHRAN. Mr. President, I ask unanimous consent that the article 
I referred to from the washingtonpost.com be printed in the Record, and 
I thank the distinguished Senator from New Jersey for his excellent 
statement. We urge the Senate to reject this motion to invoke cloture.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

               [From the Washingtonpost.com, May 3, 2007]

                          Almost the Right Rx

       Legislation to give the FDA important new powers can do 
     without one provision
       While most attention this week has been focused on the Iraq 
     supplemental appropriations bill, the Senate also has been 
     debating far-reaching legislation to give the Food and Drug 
     Administration a long-needed increase in its regulatory 
     powers. A very unneeded amendment, however, is threatening 
     the bill.
       The bill would reauthorize the system of user fees that the 
     FDA charges pharmaceutical companies and manufacturers of 
     medical devices. Congress approved this arrangement in 1992 
     to speed FDA decision making and get needed drugs onto the 
     market more efficiently. User fees account for a large 
     portion of the FDA budget, but the agency's authority to 
     collect them expires in

[[Page 11232]]

     September. There is broad support not only for maintaining 
     the system but for increasing the amount of fees that the FDA 
     can collect.
       Attached to the must-pass user fees measure are a number of 
     important enhancements to the FDA's regulatory authority and 
     responsibilities. Under the legislation, the agency would be 
     required to collect massive amounts of data on prescription 
     drug use from public and private sources after drugs have 
     been approved, to detect harmful side effects and other 
     dangers that testing before approval might have missed. The 
     FDA would also be able to require drug companies to alter 
     warnings and other information on labels. And, critically, 
     the agency would have the power to order drug trials after a 
     drug's approval in certain cases.
       All of these reforms would lead to better-informed 
     regulators, patients and doctors. Everyone has an interest in 
     enhancing the data available to the government and, 
     ultimately, the public on prescription drugs after they enter 
     the market. Compiling more evidence more quickly would help 
     detect problems with new prescription medications faster and 
     with greater accuracy and assist consumers in making reasoned 
     choices about the drugs they take.
       Complicating the bill's prospects for passage, however, is 
     an amendment from Sens. Byron L. Dorgan (D-N.D.) and Olympia 
     J. Snowe (R-Maine) that would allow the importation of 
     prescription drugs from other countries, a proposal that 
     supporters claim would let cut-rate pharmaceuticals flow into 
     the United States, saving ailing Americans untold amounts of 
     money. This is mirage; importation will not solve the problem 
     of drug pricing. U.S. drug firms sell prescription 
     medications to countries such as Canada at low prices, a 
     situation that would quickly change if Canadian distributors 
     started to recycle large quantities of drugs back to the 
     United States. Further, President Bush has threatened to veto 
     the bill if it contains such language. For the sake of common 
     sense, and to enhance the chances of urgently needed 
     legislation, the Senate should reject the importation 
     amendment before passing the bill.

  The PRESIDING OFFICER. The Senator from North Carolina is recognized.
  Mr. BURR. Mr. President, if I could ask the ranking member for a few 
minutes to speak about reimportation.
  Mr. ENZI. I yield 4 minutes to the Senator from North Carolina.
  Mr. BURR. Mr. President, I thank the ranking member.
  I find it somewhat ironic that we are on the floor to discuss an 
amendment to a drug safety bill which would allow drugs to be imported 
freely from any country around the world. Maybe I am the only one who 
finds some irony in that. We are constructing a mechanism in this 
country to set up a system of surveillance, to recognize red flags that 
may suggest to us we need to look deeper into the unintended 
consequences of drugs that have already been proven safe and effective; 
and we go even further than that and codify into law a very regimented 
process for the Food and Drug Administration to go through if, in fact, 
it is triggered that there might be a problem. Then, in the same bill, 
because of the outrage over the concerns we have for prescription 
drugs, now we are going to say to the Chinese: continue to manufacture, 
continue to ship in, and these products may not even have an active 
ingredient.
  We adopted Senator Durbin's amendment that related to pet food safety 
standards. Well, what this suggests to me is that for us to consider 
the importation or reimportation of drugs is to say we put pet food 
above the drug chain for the American people, that we are willing to 
put more standards on pet food today than we are on the importation of 
these drugs.
  Passage of the Medicare prescription Part D plan, which was a year 
ago, lowered significantly the pressure that was felt to obtain drugs 
over the Internet or drugs from other countries. Why? Because in the 
first year, we have seen a 33-percent reduction in the price of those 
pharmaceuticals for our Medicare-eligible population. It is not that 
all the pressure is off, but I am not sure the remaining pressure is 
going to be alleviated by providing a drug supply that has no active 
ingredient or that denies consumers the security of knowing they are 
going home and they are taking their drugs but then they suffer the 
consequences of ending up in an emergency room because they didn't get 
the active ingredient they needed.
  Last year, 1.7 million tablets of counterfeit Viagra were uncovered; 
1 million tablets of Lipitor that were, in fact, counterfeit; and a 
half a million tablets of Norvasc were seized in China.
  What is unfortunate is China is not the only country in the world 
where we have created a cottage industry of producing drugs that look 
just like the ones we sell in a pharmacy but that we regulate at a gold 
standard that many on this floor have tried to protect every time we 
debate legislation that is about the Food and Drug Administration. We 
are here today to assure the American people that we are raising the 
gold standard--that it is not just the bar of where we determine safety 
and efficacy but we are raising the standard when the population at 
large is exposed to that medication to make sure that, in fact, 
unintended consequences are fully investigated. To accept the 
importation of foreign drugs is to open the door for a cottage industry 
today to become a mega industry tomorrow by supplying counterfeit drugs 
with no active ingredient, with the potential that there are 
ingredients in it that are adulterated, that will not only not solve 
the health problems but, as has been proven in the pet food supply, 
could kill. Now, when people die, we put the standards higher than we 
do the standards of reimportation or importation of drugs. I urge my 
colleagues to at least accept the Cochran amendment which puts a safety 
standard in, but do not pass this importation legislation.
  The PRESIDING OFFICER. The Senator's time has expired.
  The Senator from North Dakota is recognized.
  Mr. DORGAN. Mr. President, my colleague is apparently going to win a 
debate we are not having: that this is a bill that will allow the 
import of prescription drugs from any country around the world. I don't 
know of that piece of legislation, but if it exists, I will be happy to 
vote against it. That is not what this amendment is. This amendment 
doesn't allow imported drugs from anywhere around the world at all. So 
I am not interested in losing a debate I am not involved in. This 
debate is about a piece of legislation, carefully constructed, in which 
we allow imported drugs from countries which have been judged to have a 
safe supply of drugs.
  Let me give an example of testimony from David Kessler. I would say 
if you could find an expert better on these subjects than David 
Kessler, I would like to hear the name. He ran the FDA for 8 years and 
has been identified by everybody as an outstanding FDA Commissioner. 
Here is what he says. 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 the 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 these standards and are not 
     counterfeit.

  All of this discussion about counterfeit that is happening today, 
under today's rules, without importation. That is a specious issue. Dr. 
David Kessler says it provides a sound framework for assuring that 
imported drugs are safe and effective.
  Let me show you a chart from Dr. Rost. I mentioned earlier that they 
have been doing this for 20 years in Europe. Dr. Peter Rost, former 
vice president of marketing at Pfizer, said:

       During my time responsible for a region in northern Europe, 
     I never once--not once--heard the drug industry, regulatory 
     agency, the government, or anyone else saying that this 
     practice was unsafe--

  He was talking about importation of prescription drugs. If you are in 
Germany and you want to bring a drug in from France, you can do it 
through what is called parallel trading. If you are in Spain and want 
to bring a drug in from Italy, you can do that. So he said not once has 
anybody raised the issue that this practice was unsafe.
  He also said:

       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.

  That is the fact. One other thing: the Congressional Budget Office 
says this

[[Page 11233]]

amendment will save $50 billion in 10 years. The leading expert says 
there is no safety issue. We have a regime in this bill that provides 
for safety. So the question isn't on all of these ancillary issues--by 
the way, the Washington Post doesn't take on this issue with respect to 
safety. It says there is, in fact, a problem with drug pricing. I will 
read it. They don't want this passed, but the reason is they are 
worried it will undercut the underlying bill because the President will 
veto it.
  Here is what the President said when he was running in 2000. He was 
asked:

       What about importing drugs?

  The President said:

       Well, if it is safe, then it makes sense.
       Obviously, he was telling those at that debate that he 
     thinks it makes sense if it is safe. How about consulting Dr. 
     David Kessler, who says it is safe and effective, as we have 
     described it in this legislation. So what the Washington Post 
     says--because the President threatened to veto the bill--they 
     are talking about ``importation will not solve the problem of 
     drug pricing.''

  Apparently, the Washington Post thinks there is a problem in drug 
pricing. What is that problem? To respond to my colleague's comments, 
in the first quarter of 2007 we had the largest price increase in 
prescription drugs in this country in 6 years. The American Association 
of Retired Persons, AARP, said in 2006 the price of prescription drugs 
rose four times the rate of inflation. There is no problem? I think 
there is a problem. The Washington Post says there is. The numbers show 
there is a problem.
  The question is, Are we going to solve the problem, or are we going 
to punt it down the road one more time?
  Mr. President, I yield 5 minutes to my colleague from Vermont.
  The PRESIDING OFFICER. The Senator from Vermont is recognized.
  Mr. SANDERS. Mr. President, I congratulate my colleague from North 
Dakota for the extraordinary and comprehensive outline of this issue 
that he has made not only today but in the past.
  Mr. President, every single day in this Congress, and throughout 
America, people sit down and eat their lettuce and tomato and their 
salads. Their tomatoes come from Mexico, Latin America, and their 
lettuce comes from Latin America. Other foods they eat come from as far 
away as China. Billions of dollars of food imports come into this 
country, but I don't hear anybody in this body standing up and saying, 
oh, we have a problem about food safety or food coming from other 
countries. They come in.
  There is a problem--and I don't hear it too often here, but somehow 
the U.S. Government, with the FDA, cannot regulate a small number of 
drug companies so that we can safely bring in prescription drugs from 
Canada and other industrialized countries so that, as a result, we can 
substantially lower the cost of medicine for millions and millions of 
Americans. This is absurd. Of course, we can safely regulate the flow 
of medicine coming into this country.
  The real issue is not the safety of medicine. The real issue is the 
power of the pharmaceutical industry, the most powerful industry in 
terms of lobbying impact in the United States of America. If you think 
the oil companies are powerful, take a look at the drug companies. If 
you think the banks are powerful, take a look at the drug companies. 
Today, we are living under a Medicare Part D prescription drug program 
that was written by the drug companies, for the drug companies. Today, 
billions of dollars of taxpayer money goes into research and 
development for new medicines that go to benefit the drug companies, 
while the American people do not get reasonable prices for the products 
they help to produce.
  Mr. President, since 1998, the pharmaceutical industry has spent over 
$900 million on lobbying activity--$900 million. That is more than any 
other industry. Today, there are over 1,200 prescription drug lobbyists 
right here on Capitol Hill and throughout this country. Do you know 
what their job is? Their job is to make sure in the United States of 
America we continue to pay, by far, the highest prices in the world for 
the medicine we use.
  If you have a chronic illness, there is a strong likelihood you will 
be paying two times as much for the same medicine as our friends in 
Canada or Europe pay. Why is it that the same medicine, manufactured in 
the same factory, costs us, in some cases two times, and in some cases 
three times, as much money as it costs our Canadian and European 
friends?
  The answer is pretty simple. It has everything to do with the power 
of the pharmaceutical industry and the enormous amounts of money they 
spend on lobbying, on campaign contributions, on advertising, and the 
pressure they put on Members of the United States Congress.
  Mr. President, I have been involved in this issue for a number of 
years. I have been involved in it in an emotional way because I was the 
first Member of Congress to take constituents over the Canadian border 
to purchase, in that case Tamoxifen, which is a widely prescribed 
breast cancer drug that ended up costing Vermont women one-tenth the 
price they had to pay in the United States.
  In our country today, there are people struggling very hard with 
terrible illnesses who have no health insurance and who need their 
prescription drugs. Some of them simply cannot purchase their 
prescription drugs. Some are taking money out of their food budget to 
buy their prescription drugs. We are a great nation in many respects. 
But the time is long overdue for Members of the Senate, for Members of 
the House, to reclaim this institution from the powerful special 
interests.
  Today is a day of reckoning. This is very important legislation. This 
can drive the price of prescription drugs down by 25 to 50 percent. 
Let's stand together and, for those Members who are wavering on the 
issue, who think they cannot vote for it, I hope at least they will 
support cloture to allow us to continue this debate and to finally 
lower the cost of prescription drugs for the American people.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Mr. President, what is the time situation?
  The PRESIDING OFFICER. The Senator from Wyoming has 10 minutes. The 
Senator from North Dakota has 3\1/2\ minutes.
  Mr. ENZI. Mr. President, I rise to oppose cloture on the amendment. I 
find it ironic that in the midst of the work on the biggest drug safety 
reform in the last decade, perhaps longer than that, we are even 
considering the issue of drug importation.
  Our drug safety bill is an acknowledgment that we don't have things 
quite right in our domestic drug safety system. I am baffled that we 
want to take on all the hard work and effort to fix our drug safety 
problems and throw it away by opening our borders to foreign drugs.
  When I was Chairman of the HELP Committee, we held three hearings on 
drug importation. The witnesses at the hearings raised a number of 
problems and questions about importation in general, and this bill in 
particular. In fact, one of those hearings was entirely about this 
bill. At that time, I asked my colleague from North Dakota if he would 
work with me to develop a State-based pilot program for drug 
importation. He turned me down. He was convinced then, as he is now, 
that this bill is the way to go. I would like to take these kinds of 
proposals in small chunks, if we are going to have to take them, to 
ensure we don't create a large-scale disaster. I hope we are not going 
to create a disaster here by accepting this amendment without further 
consideration.
  I respectfully suggest that this bill is not the way to go, and even 
if it were, this isn't the time for it to go there. We have heard a lot 
of comments about the Washington Post editorial, and I refer people to 
that editorial. They cover a number of factors, but they do emphasize 
that the main bill, the safety bill--the FDA safety reform bill that we 
are working on--is a very important bill. They do recognize this 
amendment would add some very strong complications to it. The Senator 
from North Dakota suggests we read the bill. You know, that is a good

[[Page 11234]]

suggestion for anything we cover around here. I make an effort to read 
all of the bills we do, and I have read this one. I hope everybody 
takes a look at this one.
  I think you will vote against cloture if you read the bill. It is a 
roadmap to loopholes. Yes, every time somebody brings up a potential 
safety issue, they stick another clause in there that might cover that 
gap. But it shows where the gaps are most likely. They keep adding 
paragraphs to try to patch up these loopholes. We have an amendment 
that would have been a second degree, but it was too late for it to be 
submitted as a second degree, so it is a first-degree amendment that 
would deal with anti-counterfeiting.
  That is another area that has to be looked at carefully. The Senator 
from Vermont talks about taking people into Canada to buy drugs. Well, 
you know they are going to the exact pharmacy at that point. They are 
not going through the Internet or through the telephone. These drugs 
can be intercepted--there are false sites that are set up out there, 
and people may think they are getting drugs from Canada, but are 
actually getting them from Saudi Arabia and other places around the 
world. It is so easy to get information and believe it is coming from a 
particular location--they may even imply it is a particular location to 
get the consumer's confidence. There are so many ways they can mislead 
consumers and it may not be that location. To try to solve some of 
that, Senator Gregg has an amendment that would perhaps tighten up the 
Internet problems. But look at that, too, and you will see there are 
problems if you are not getting it directly from the pharmacy.
  I am a strong supporter of people getting drugs from their local 
pharmacist, the one who will help you interpret all of the sheets of 
paper that come with the prescription. They are going to know what 
other drugs you are taking and if there are possible interactions. 
Local pharmacists are the most valuable asset we have in the entire 
pharmaceutical chain. But bills like this work against them and may 
have consequently put them out of business. That is going to be a 
tragedy for America.
  I have read the amendment. I encourage people to read it and look at 
the complexity of the amendment and look at the loopholes they are 
suggesting they have fixed. See if you think this patchwork fixed them. 
But I also ask that you look at what the Washington Post said, and I am 
not one of those who normally advocates that you listen to what they 
say. But it is definitely food for thought on this bill. It will take 
away a major reform that we could have by throwing something else in 
that we need to discuss more.
  I ask my colleagues to oppose cloture for the sake of the safety of 
our drug supply. Let's get it fixed at home before we try to open it up 
to the world.
  Mr. President, how much of my time remains?
  The PRESIDING OFFICER. The Senator has 5 minutes.
  Mr. ENZI. Mr. President, in order to allow the Senator from North 
Dakota to have the final word, since it is his amendment, I ask people 
to vote against cloture.
  I yield back the remainder of my time.
  The PRESIDING OFFICER. The Senator from North Dakota.
  Mr. DORGAN. Mr. President, I thank my colleague from Wyoming. I 
regret he cannot be a supporter of cloture and the amendment. I respect 
and understand his position. We disagree, and I do so respectfully.
  I do wish to mention one thing with respect to a pilot program. 
Following that hearing, I did put together a pilot project and went to 
Tommy Thompson. I went down to his office and made a presentation of a 
northern plains pilot project on prescription drugs. He felt like he 
couldn't move forward with it.
  I do want to say what he said to me after he left Health and Human 
Services. I met him in the elevator outside the Senate Chamber one day 
after he left being Secretary. I badgered him a lot about the issue of 
reimportation. As I got off the elevator and he was getting on, we 
greeted each other. I liked him. I thought he was a good Health and 
Human Services Secretary. He said: By the way, Byron, you keep working 
on the imported drug issue. You are right about that. That was after he 
left Health and Human Services.
  Let me again respond with respect to David Kessler. All this talk 
about safety. First of all, this is where this amendment belongs, on 
this bill. This improves the bill. It doesn't detract from safety 
issues at all. It does address something not addressed in this bill, 
and that is a serious pricing problem with prescription drugs in our 
country.
  There is no answer to this that I have heard in all the discussion. 
David Kessler, head of FDA for 8 years--I think he is the expert on 
these issues--said: The Dorgan-Snowe bill ``provides a sound framework 
for assuring that imported drugs are safe and effective.''
  He says they will be safe and effective. Why would someone go to some 
fraudulent Web site, as was discussed, or maybe go to a bad Web site, 
why would somebody go to a bad Web site in order to import prescription 
drugs if a Web site by the FDA exists that would describe where they 
can access these prescription drugs safely? Those are specious 
arguments.
  The Congressional Budget Office says this amendment will save $50 
billion over 10 years. Why would they say that? Precisely because the 
Washington Post acknowledges there is a pricing problem with 
prescription drugs in our country. There will be a $50 billion savings 
over 10 years.
  I mentioned that in the first quarter of this year the price of 
prescription drugs had the largest increase in 6 years in this country. 
Last year, 2006, according to AARP, it rose four times the rate of 
inflation.
  There is a pricing problem with prescription drugs. The identical 
drug FDA approved, same pill, put in the same bottle, made by the same 
company, is sent virtually every other place in the world at a lower 
price, and the American consumer is told: You know what, we have a 
special deal for you. You get to pay the highest price in the world.
  The question is whether this Congress will decide that special deal 
of the highest price in the world ought to stop. I hope this Congress 
will decide we are going to stand with the consumers. Yes, we are going 
to insist on safety, but we are going to stand with consumers. There is 
a pricing problem. This amendment is one way to fix that problem in a 
manner that is safe and effective.
  Finally, Mr. Rost says that for 20 years, they did this in Europe. He 
said:

       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.

  Of course, we can do this. Of course, we can allow someone to go to 
Canada and buy from a Canadian drugstore that has as safe a chain of 
custody as we do and buy prescription drugs, in this case Lipitor, for 
half the price that is being charged 5 miles south across the border.
  Why on Earth should the global economy not be able to work for 
average folks? The pharmaceutical industry imports all of these drugs. 
Why should the average person in this country not be able to put 
downward pressure on prescription drug prices by being able to access 
FDA-approved drugs from other countries, such as Canada and other 
countries, that have a supply of safe drugs. That is what our amendment 
does. It is the right thing to do.
  Mr. President, how much time remains?
  The PRESIDING OFFICER. The Senator's time has expired.
  Mr. DORGAN. Then I yield the floor, Mr. President.


                             Cloture Motion

  The PRESIDING OFFICER. Under the previous order, pursuant to rule 
XXII, the Chair lays before the Senate the pending cloture motion, 
which the clerk will report.
  The assistant legislative clerk read as follows:

                             Cloture Motion

  We, the undersigned Senators, in accordance with the provisions of 
rule

[[Page 11235]]

 XXII of the Standing Rules of the Senate, hereby move to bring to a 
close debate on the Dorgan amendment No. 990 to S. 1082, the FDA 
Revitalization bill.
         Byron L. Dorgan, Dick Durbin, Claire McCaskill, John 
           Kerry, Ted Kennedy, Amy Klobuchar, Sherrod Brown, Ken 
           Salazar, Mark Pryor, Daniel K. Inouye, Chuck Schumer, 
           Harry Reid, Ron Wyden, Dianne Feinstein, Carl Levin, 
           Blanche L. Lincoln.
  The PRESIDING OFFICER. By unanimous consent, the mandatory quorum 
call has been waived.
  The question is, Is it the sense of the Senate that debate on 
amendment No. 990, offered by the Senator from North Dakota, to provide 
for the importation of prescription drugs shall be brought to a close?
  The yeas and nays are mandatory under the rule. 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 New Mexico (Mr. Bingaman), 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), the Senator from Utah (Mr. Hatch), the Senator from Arizona 
(Mr. McCain), and the Senator from Virginia (Mr. Warner).
  Further, if present and voting, the Senator from Utah (Mr. Hatch) and 
the Senator from South Carolina (Mr. Graham) would have voted ``nay.''
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The yeas and nays resulted--yeas 63, nays 28, as follows:

                      [Rollcall Vote No. 150 Leg.]

                                YEAS--63

     Akaka
     Baucus
     Bayh
     Boxer
     Brown
     Byrd
     Cantwell
     Cardin
     Carper
     Casey
     Clinton
     Coburn
     Coleman
     Collins
     Conrad
     Corker
     Craig
     DeMint
     Dorgan
     Durbin
     Feingold
     Feinstein
     Grassley
     Harkin
     Inouye
     Kennedy
     Kerry
     Klobuchar
     Kohl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Lott
     Martinez
     McCaskill
     Menendez
     Mikulski
     Murray
     Nelson (FL)
     Nelson (NE)
     Obama
     Pryor
     Reed
     Reid
     Rockefeller
     Salazar
     Sanders
     Schumer
     Sessions
     Shelby
     Smith
     Snowe
     Specter
     Stabenow
     Tester
     Thune
     Vitter
     Webb
     Whitehouse
     Wyden

                                NAYS--28

     Alexander
     Allard
     Bennett
     Bond
     Bunning
     Burr
     Chambliss
     Cochran
     Cornyn
     Crapo
     Dole
     Domenici
     Ensign
     Enzi
     Gregg
     Hagel
     Hutchison
     Inhofe
     Isakson
     Kyl
     Lugar
     McConnell
     Murkowski
     Roberts
     Stevens
     Sununu
     Thomas
     Voinovich

                             NOT VOTING--9

     Biden
     Bingaman
     Brownback
     Dodd
     Graham
     Hatch
     Johnson
     McCain
     Warner
  The PRESIDING OFFICER (Mr. Brown.) On this vote, the yeas are 63, the 
nays are 28. Three-fifths of the Senators duly chosen and sworn having 
voted in the affirmative, the motion is agreed to.


                           Amendment No. 1010

  Mr. COCHRAN. Mr. President, I have an amendment at the desk. It is to 
S. 1082. I propose this amendment in my behalf and in behalf of 
Senators Carper, Nelson of Nebraska, Hatch, Bennett, Enzi, Burr, and 
Menendez. I ask the amendment be stated or reported.
  The PRESIDING OFFICER. The amendment of the Senator is already 
pending. The Senator may proceed.
  Mr. COCHRAN. Mr. President, the purpose of this amendment is to 
require, before importation can be undertaken, a certification by the 
Secretary of Health and Human Services or the Food and Drug 
Administration that the importation of the drugs will indeed have an 
economic benefit to the consumers who buy those drugs and that they are 
safe and not harmful for human consumption.
  We have had discussions over the last several years, really, with 
administration officials who have been very concerned that the 
importation of drugs that would be permitted by the Dorgan amendment 
needs to be balanced by the interest we have in protecting the 
integrity of the marketplace so no counterfeit drugs are imported, 
creating the impression that they are something that they are not.
  This is a very real problem. I recall having meetings here in the 
Senate with members of the committees with jurisdiction, learning about 
the growing problem and the continuing increase in instances where 
postal inspectors and others who are charged with the responsibility of 
enforcing our laws and protecting American consumers are finding that 
drugs which are manufactured in other countries--not Canada necessarily 
but in India, in Asia, in South America--are counterfeit. They look 
like the real thing. The labels look like the legitimate and ordinary 
labels you see on the drugs being purchased, but they are not what they 
say they are.
  This is a very difficult issue to deal with. What we are asking in 
this amendment is that the Senate insist that if drugs are going to be 
imported, then there has to be a certification by the FDA or the 
Department of Health and Human Services that they are safe for human 
consumption, that they have not been tampered with, and that they are 
not counterfeit.
  I hope the Senate will approve this amendment to the Dorgan 
amendment. I don't know of anything else to say. I submitted, in 
earlier comments, a washingtonpost.com article, which is printed in the 
Record now, which supports this effort and talks about the importance 
of certification to the consuming public. We have a lot of information. 
We will be happy to discuss the details with any Senator who is 
undecided about approving this amendment, but I hope the Senate can 
adopt this amendment.
  The PRESIDING OFFICER. The Senator from Wisconsin is recognized.


                           Amendment No. 991

  Mr. KOHL. Mr. President, I ask unanimous consent to set aside the 
pending amendment so I may call up my amendment, amendment No. 991, and 
I ask for its immediate consideration.
  The PRESIDING OFFICER. Is there objection?
  Mr. ENZI. I object.
  The PRESIDING OFFICER. Objection is heard.
  Mr. ENZI. There is still a lot of work being done on this amendment. 
Senator Kyl and others are involved in it and would not want the debate 
until we had more chance to work on it.
  Mr. KOHL. I will offer the amendment after that.
  Mr. President, I rise to speak to amendment No. 991, which is 
supported by Senators Grassley and Leahy. I thank my colleagues for 
their support. Our amendment is in almost all respects identical to S. 
316, the Preserve Access to Affordable Generics Act, which passed the 
Judiciary Committee unanimously earlier this year.
  Our amendment will prevent one of the most egregious tactics used to 
keep generic competitors off the market, leaving consumers with 
unnecessarily high drug prices. The way it is done is simple--a drug 
company that holds a patent on a brandname drug pays a generic 
drugmaker to not put a competing product on the market. The brandname 
company profits so much by delaying competition that it can easily 
afford to pay off the generic company. And the generic company can also 
make much more money by simply accepting this pay-off settlement. The 
losers are the American people, who would continue to pay unnecessarily 
high drug prices for years to come.
  Our amendment is basically very simple--it will make these 
anticompetitive, anticonsumer patent payoffs illegal. We will thereby 
end a practice seriously impeding generic drug competition, competition 
that could save consumers literally billions of dollars in health care 
costs.
  Despite the FTC's opposition, recent court decisions have permitted 
these backroom payoffs. And the effect of

[[Page 11236]]

these court decisions has been stark. In the year after these two 
decisions, the FTC has found, half of all patent settlements--14 of 
28--involved payments from the brandname to the generic manufacturer in 
return for an agreement by the generic to keep its drug off the market. 
In the year before these two court decisions, not a single patent 
settlement reported to the FTC contained such an agreement.
  When brandname drugs lose their patent monopoly, this opens the door 
for consumers, employers, third-party payers, and other purchasers to 
save billions--63 percent on average--by using generic versions of 
these drugs. A recent study released earlier this year by 
Pharmaceutical Care Management Association, showed that health plans 
and consumers could save $26.4 billion over the next 5 years by using 
the generic versions of 14 popular drugs that are scheduled to lose 
their patent protections before 2010.
  We have heard from some in the generic drug industry that on occasion 
these patent settlements may not harm competition. That is why our 
amendment includes a new provision not contained in S. 316. This new 
provision would permit the Federal Trade Commission--the guardians of 
competition in this industry--to exempt from this amendment's ban 
certain agreements if the FTC determines such agreements would benefit 
consumers. This provision will ensure that our amendment does not 
prevent any agreements which will truly benefit consumers.
  It is also important to note that--contrary to the arguments made by 
some--our amendment will not ban all patent settlements. In fact, our 
amendment will not ban any settlement which does not involve an 
exchange of money. Our amendment will do nothing to prevent parties 
from settling patent litigation with an agreement that a generic will 
delay entry for some period of time in return for ending its challenge 
to the validity of the patent. Only the egregious pay-off settlements 
in which the brandname company also pays the generic company a sum of 
money to do so will be banned.
  We understand that several of our colleagues would prefer alternative 
versions of this proposal. As I have said all along, we continue to be 
willing to consider modifications to this measure as long as this 
legislation will be effective to ensure these anticonsumer payoff 
settlements stop. I am happy to work with my colleagues to find an 
effective manner to do this. I have directed my staff to work with the 
staff of other interested Senators in this regard, and I am willing to 
continue to engage in this process. Short of such an effective 
alternative being presented to me, we will ask for a vote on adoption 
of this amendment.
  In closing, we cannot profess to care about the high cost of 
prescription drugs while turning a blind eye to anticompetitive 
backroom deals between brand and generic drug companies. It is time to 
stop these drug company pay-offs that only serve the companies involved 
and deny consumers to affordable generic drugs. I urge my colleagues to 
join me in this effort by supporting this amendment. I yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KENNEDY. Mr. President, the Kohl amendment seeks to end abuse of 
the system for bringing generic drugs to the market. Under Hatch-
Waxman, there is a sensible and balanced system for rewarding generic 
drug makers who enter the market first, but some companies have 
subverted this balanced system.
  Instead of allowing market forces to bring medicines to consumers at 
lower prices, companies collude to deny consumers the benefit of the 
lower cost drugs through ``reverse payments.'' Essentially, there is a 
payoff from the brand drug companies to the generic companies to split 
the benefits of the incentives provided under Hatch-Waxman.
  Everyone benefits under these arrangements, except consumers. Brand 
drug companies get further protection from competition, generics get 
payoffs and a guaranteed market. Only consumers get left behind, stuck 
with high prices and lesser competition.
  The Judiciary Committee reported legislation on this important issue. 
I commend Senator Kohl for his leadership. I know Senator Specter and 
Senator Hatch have important recommendations. I am sure we can work 
these matters out in a proposal to include the best ideas.
  We understand there are members of the Judiciary Committee who may 
want to speak to this amendment. I would hope the Senator would 
withhold further comments until we can see if there are members of the 
Judiciary Committee who want to address this amendment. I hope we will 
be able to include it and adopt it.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Mississippi is recognized.
  Mr. COCHRAN. Mr. President, I ask unanimous consent the Senator from 
New Mexico, Mr. Domenici, be added as a cosponsor to my amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  The PRESIDING OFFICER. The Senator from Michigan.
  Ms. STABENOW. I ask unanimous consent that the order for the quorum 
call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Ms. STABENOW. Mr. President, I send to the desk a modified version of 
amendment No. 1001 to the desk. We are adding Senator Kohl, Senator 
Hatch, and Senator Coburn as cosponsors of the amendment.
  Mr. ENZI. I object.
  The PRESIDING OFFICER. The objection is heard.
  The Senator from North Dakota is recognized.
  Mr. DORGAN. Mr. President, as was indicated earlier, the Cochran 
amendment, with cosponsors, is currently pending, I believe, or has 
been appropriately offered and is pending. I would like to make a 
couple of comments about the vote we will have at some point in the 
future on the Cochran amendment. And what I would like to do is go 
through so that all of our colleagues understand what is in the 
underlying bill.
  I indicated earlier that one of my colleagues stood up and said the 
legislation we had offered would allow drug importation from any 
country in the world, and that is not true. There is no such debate on 
a bill that doesn't exist.
  Mr. President, I have a piece of information distributed by Pfizer 
Corporation that is opposed to my amendment. It describes various 
problems with the drugs that are purchased online and counterfeit 
drugs, and so on. Interestingly enough, all of these problems would be 
solved by the legislation I have introduced with all of the safety 
issues involved. You know these are specious issues because the 
underlying legislation would address all of those issues.
  Now, let me go through a list--this is the list; you won't be able to 
read it, but I will go through them--of the safety provisions in this 
legislation. First of all, with imported drugs, drugs imported from 
other countries, which, as I have indicated, Europe has done for 20 
years with no safety issues at all, so we are as competent as the 
Europeans are in being able to do this.
  Our bill would require that all imported drugs be approved by the 
Food and Drug Administration. So we are not talking about any renegade 
drugs, all FDA-approved drugs, all of them imported be approved by the 
FDA.
  It creates a process to approve medications sold outside the United 
States which are identical to FDA-approved products. It sets a process 
by which the FDA may approve medications which differ from the domestic 
version of the drug; provides that no imported drug may be misbranded 
or adulterated, and requires compliance with GMP. It requires the FDA 
to enter into agreements to monitor drug recalls and approval status 
changes; establishes a set of standards which countries must meet to be 
a ``permitted'' country. With respect to pharmacies and wholesalers on 
this list, we say it provides

[[Page 11237]]

for registration and regulation of exporting pharmacies and importing 
wholesalers, only by licensed operators in both cases; requires 
registrants to pay an application fee, submit to evaluation, and post a 
substantial bond; requires pharmacists and wholesalers to be fully 
compliant with applicable local, State, provincial, and national laws; 
requires the FDA to perform inspections of operations, including 
facilities and records, at least 12 times per year; requires exporting 
pharmacies to verify prescriptions, to review medications for 
interactions, to ensure privacy; requires pharmacies to maintain 
records for 2 years for FDA review.
  Exporting pharmacies must preserve samples of each lot of a drug for 
the FDA to utilize for testing. It gives authority to FDA to monitor 
and inspect the full chain of custody of a drug; sets penalties for 
violation, including suspension, lifetime revocation, and criminal 
penalties. It requires every imported drug to have a full record of the 
chain of custody, which is a pedigree. That is very important. Every 
imported drug will have to have a pedigree, full record of the chain of 
custody.
  It requires every package to have an FDA-approved label affixed, and 
every product must clearly be identified as ``imported.'' Drug labeling 
would also include the name of the registrant who handled the 
medication and the product lot number as a part of that pedigree. Any 
differences in the imported drug, even in an inert ingredient, must be 
noted on the label.
  It requires packaging to include anticounterfeiting or track-and-
trace technologies. Exporters must provide the FDA with prior notice of 
shipments of prescription drugs to the U.S. importing wholesalers.
  It provides, for the first sale of a drug, it may not be shipped 
outside of the permitted countries. It requires the FDA to provide 
information to consumers to identify the safe and legal directed 
sources of approved imports. It gives Customs Service the authority to 
seize and destroy any unauthorized shipments; blocking elicit 
electronic payments to unauthorized foreign pharmacies by Customs; full 
funding for FDA to facilitate the drug import regulatory operations 
through a 2\1/2\-percent user fee.
  It provides implementation of drug pedigrees for domestic medications 
by 2010, which do not exist now, by the way; requires the packaging of 
all prescription drugs to incorporate a standardized numerical 
identifier unique to each package of a drug and counterfeit resistant 
technologies.
  When one reads through these safety features and then alleges that 
this is unsafe, I mean it just--it baffles me how one can reach that 
conclusion.
  Tommy Thompson, Secretary of Health and Human Services, said: In 
order to import drugs from any country, and especially Canada, I have 
to certify that all of those drugs are safe. That is an impossible 
thing. If Congress wants to import drugs, they should take out that 
provision.
  Well, let me ask this question: Would it be possible for the Health 
and Human Services Secretary to certify that all drugs sold in this 
country, FDA-approved drugs, are safe? Does one think the HHS Secretary 
could certify that? The answer is, no, of course not.
  I can give you examples of metal traces and things in pharmaceuticals 
that were sold in this country, FDA-approved, by major manufacturers. 
Could a Health and Human Services Secretary certify that the existing 
drug supply is ``safe,'' possess no ``risk''? They can't do that for 
pet food. They could not do that for lettuce. They could not do it for 
carrots. They could not do it for celery. They could not do it for 
imported vegetables. They can't do it for imported meats. They can't do 
it for domestic production to say, there is no risk.
  The issue of requiring certification is an attempt to kill the 
legislation. It is perfectly appropriate for some to say: The current 
system works fine, don't change it. I don't quarrel with that. I don't 
agree with it, but I respect those who hold that view. But I do believe 
it is hard for anyone to, with great merit, make the case that with 
what we have done in this legislation, on a bipartisan basis, it still 
renders this to be an unsafe process.
  The experience in Europe, of course, undermines that argument. They 
have done it for 20 years. It has been perfectly safe. Also, let me go 
back to David Kessler's statement. I don't know of an FDA Commissioner 
who comes to his belt buckle, let alone his shoulders in terms of 
capability.
  I thought David Kessler had been an extraordinary FDA Commissioner 
back for 8 years. I worked with him when he was there. He said this: 
The Dorgan-Snowe bill ``provides a sound framework for assuring that 
imported drugs are safe and effective.''
  Now, we can talk all day about these drugs being unsafe, but, 
obviously, that does not change the facts. It does not change Dr. 
Kessler's opinion. It does not change the circumstances of the safety 
provisions we put in the bill. They are there. They are there for a 
very specific reason. We took the interests and concerns of Secretary 
Shalala and Secretary Thompson. We wrote them into this bill dealing 
with safety provisions.
  The fact is, this bill will make our domestic supply of prescription 
drugs safer. That is the plain fact. Then we will have a pedigree for 
all prescription drugs, imported or domestic. That is just a fact.
  Now, the second part of the amendment says it has to be assured that 
it will save money and pose no risk. Well, ``save money,'' that is 
easy. The Congressional Budget Office has said it is going to save $50 
billion in 10 years. And $6.1 billion--I thought it was 5--$6.1 billion 
of that is savings to the Federal Government.
  We just have a new estimate by the Congressional Budget Office that 
if the Cochran amendment is passed, that savings goes to zero. Why? It 
undermines the bill. It means this will not have impact. Importing 
won't happen. Not because anyone wants to import an unsafe drug 
because, in fact, the safety provisions we have included will make this 
supply, the drug supply, domestic supply included, as well as imported 
drugs, safer. That is the point.
  This issue is not horribly complicated. The question is, should the 
American people have the ability in this global economy to access a 
drug that has been produced, in many cases by an American company, with 
research in many cases paid for by American taxpayers, produced in many 
cases in a plant here in the United States, and then sent to another 
country at a much lower price? Should the American consumers be able to 
access that FDA-approved drug that is sold for a lower price elsewhere? 
Stated another way, should American consumers continue to accept the 
notion that they should pay the highest prices in the world?
  Some say: There is not a problem here. They cite the Washington Post 
editorial today. That editorial says there is a problem with respect to 
drug pricing. The first 3 months of this year saw the highest price 
increases on prescription drugs in the last 6 years. In 2006, it was 
six times the rate of inflation, the price increase in prescription 
drugs. In addition, we pay the highest prices of all the other 
countries. Does that make sense? It doesn't to me.
  I want to have somebody stand up on the other side of this issue and 
say: I disagree; I think the American people should pay the higher 
prices; I think that is fair.
  That is the alternative, it seems, because that is the reality. I am 
not interested in debating some fiction. The reality is this: We pay 
prices that I believe are wrong. I said yesterday, I don't come here 
with any disrespect for the pharmaceutical industry. I have met many of 
these people. I know the head of PhRMA, former Congressman Billy 
Tauzin. I used to serve with him. I like him. I don't come here 
disrespecting the industry. They do important work. I have a profound 
disagreement with their pricing policies because they are unfair to 
consumers in this country. That is my difference and my beef. Their 
pricing policies are wrong.
  Why should an 80-year-old woman have to go to Canada every 3 months 
as she is fighting breast cancer in order to

[[Page 11238]]

buy Tamoxifen at a price she can afford? Why should you be able to 
cross an imaginary line into Canada and discover that you could pay 
one-fifth the price you have to pay for Tamoxifen in this country? The 
pricing policy is wrong, and we ought to fix it. This is an approach 
that will fix it.
  We will have other debate. I do not disrespect the pharmaceutical 
industry. I have great respect for what they do. I have a profound 
disagreement about their pricing policy. I don't disrespect those who 
have a profound disagreement with my amendment. I respectfully think 
they are wrong.
  In the end, the question for the Congress is, do you think what is 
happening with respect to drug pricing is appropriate? My answer is no. 
The American people are being disserved by a pricing policy that the 
pharmaceutical industry can make stick. They have the capability to 
control prices. They do it behind a law that says the only interest 
that is able to import prescription drugs is the manufacturer of that 
drug. Europe doesn't require that. Europe hasn't required that for a 
long while. They allow parallel trading so the consumer can take 
advantage of price shopping among the countries of Europe. Only this 
country has decided, no, the consumer doesn't have this right. The 
manufacturer has the right but not the consumer.
  I say let's let the consumer, let's let the American people have 
access to the benefits of the global economy as well. Yes, let's make 
it safe. We have done that. This legislation with the safety 
precautions I have described in some detail, if passed, this amendment, 
if passed, would significantly improve the safety of the domestic drug 
supply and significantly improve safety of the reimportation that now 
occurs on an occasional basis by people driving back and forth across 
the border, those who are fortunate enough to live near a border.
  We have just gotten a Congressional Budget Office score on the 
amendment I have offered. It says the amendment, if passed, will save 
the Federal Government $10.6 billion in a 10-year period. I believe it 
is a $50 billion savings in total for consumers. I will put in the 
Congressional Record the specifics. But I do know the Congressional 
Budget Office has just scored this amendment. It will save consumers 
tens of billions of dollars. The specific savings to the Federal 
Government itself, as a result of savings through our programs and 
expenditures, will be $10.6 billion.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Menendez). The Senator from Mississippi.
  Mr. COCHRAN. Mr. President, for the information of Senators, I will 
seek to define in more specific terms exactly what the Dorgan-Snowe 
prescription drug amendment does.
  Before proceeding to that, I ask unanimous consent that the Senator 
from Pennsylvania, Mr. Specter, be added as a cosponsor to amendment 
No. 1010.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. COCHRAN. Mr. President, the Dorgan-Snowe bill, pending before the 
Senate as an amendment, eliminates language from the Food, Drug, and 
Cosmetic Act that allows importation to take effect only if the 
Secretary of Health and Human Services can demonstrate to Congress that 
it will pose no additional risk to the public health and result in a 
significant reduction in the cost of covered products to the American 
consumer.
  The amendment I have offered to the Dorgan-Snowe bill would restore 
this language. The Senate has overwhelmingly voted on three occasions 
to include a safety and savings certification provision in prescription 
drug importation legislation for the purpose of protecting the public 
health. Following passage of the safety and savings certification 
requirement, no Secretary of HHS, Democrat or Republican, has been able 
to demonstrate that importation is safe or will lead to cost savings. 
Both Secretary Shalala in the Clinton administration and Secretary 
Thompson in the Bush administration could not demonstrate that 
importation poses no additional risk to public health or would lead to 
significant cost savings.
  Back in 2000, Secretary Shalala concluded it was ``impossible . . . 
to demonstrate that it [importation] is safe and cost effective.''
  Secretary Thompson reached a similar conclusion in the next year, 
2001, by saying he could not ``sacrifice public safety for uncertain 
and speculative cost savings.''
  The Dorgan-Snowe bill contains numerous provisions that would expose 
Americans to harmful or adulterated imported drugs--could expose. In 
particular, the bill permits the importation of drugs that originate in 
such countries as Latvia, Estonia, Slovakia, Greece, Hungary, and the 
Czech Republic. These are outside the control of the manufacturers and 
outside of the jurisdiction of the Food and Drug Administration.
  The bill also permits the importation of drugs that are not FDA 
approved and are not equivalent to FDA-approved products. Some of the 
drugs that could be imported under this provision would violate Food, 
Drug, and Cosmetic Act requirements against adulteration and 
misbranding.
  Canadian law has been discussed here. It permits the transshipment of 
unapproved prescription drugs from any country in the world through its 
borders to the United States. These shipments move across borders, free 
from examination from Canadian regulators who have said their 
Government will not ensure the safety and effectiveness of exported 
drugs. The FDA and Customs officials have seized counterfeit drugs 
entering the United States from alleged Canadian pharmacies that are 
established for the purpose of permitting transshipments from other 
countries outside of Canada into the United States. These places where 
the drugs have originated include countries such as India, Pakistan, 
China, and Thailand.
  If my amendment is not adopted, the underlying bill, as amended by 
the amendment of the Senator from North Dakota, would permit 
transshipment and severely restrict the ability of border officials to 
stop suspected drug shipments entering the United States. My amendment 
would not allow importation to begin unless these safety concerns are 
resolved and the Government can assure the American public that 
imported drugs will not endanger their health.
  There is no guarantee that American consumers will experience 
reductions in their prescription drug costs if the Dorgan bill takes 
effect, because middlemen have shown they may keep the savings. The 
amendment I have offered ensures that consumers would benefit from 
importation before weakening consumer protections against potentially 
unsafe drugs.
  In conclusion, the Dorgan bill requires the FDA to allow importation 
from Canada within 90 days of enactment, whether the FDA has had time 
to set up an appropriate regulatory framework or not.
  In addition, the bill places an arbitrary cap on user fees collected 
to oversee the importation system. My amendment would ensure that an 
importation program would take effect only after a regulatory system 
has been put in place to protect American consumers.
  I hope the Senate will approve my amendment.
  The PRESIDING OFFICER. The Senator from North Dakota.
  Mr. DORGAN. I won't speak at length. I do want to make one point. The 
Senator from Mississippi indicated the amendment I have offered would 
allow for the reimportation of drugs that are not FDA approved. I don't 
know where that information comes from, but it is demonstrably untrue. 
I don't want there to be a mistaken impression on that. I ask my 
colleague from Mississippi if we could at least resolve that issue. The 
intent of this, the written version of this, is very clear. No drug 
will be imported into this country unless it is FDA approved. My 
colleague indicated this amendment would allow drugs to come in that 
are not approved. I don't know where that information comes from. If he 
and I could at least exchange information so that we resolve that, I 
would appreciate that.

[[Page 11239]]


  Mr. COCHRAN. Mr. President, if the Senator will yield, I am advised 
that the FDA has said it could not put a regulatory framework in effect 
to guarantee what my amendment insists it should guarantee; that is, 
the effectiveness of the drug, the fact that there will likely be 
savings that will result for American consumers if the Dorgan amendment 
is adopted.
  Mr. DORGAN. Mr. President, that is a different issue. The amendment 
itself, whether there is a regulatory framework or not, will not allow 
a drug to be imported that is not FDA approved. That is the written 
provision in the amendment itself.
  Second, with respect to cost, we may have a disagreement on that, but 
I again observe that the Congressional Budget Office this morning has 
given us another score, and the score from the Congressional Budget 
Office says this will save the Federal Government $10.6 billion in a 
10-year period. I believe the global savings--the rest would be for 
consumers--is slightly over $50 billion in 10 years. So it seems to me 
it is self-evident. If the Congressional Budget Office is putting out 
information to the Senate this morning that describes the amount of 
savings, in this case averaging about $5 billion a year, it is quite 
clear, someone is going to save something somewhere. I think we also 
can resolve the cost issue at some point down the road.
  Let me say, I respect the Senator from Mississippi. He is a very 
worthy legislator, cares passionately about the things he works on. I 
do the same. I think the way to resolve this is to talk through what 
are the safety provisions in the bill. If they are inadequate, 
demonstrably inaccurate, I will accept that we would make some changes. 
But I do not believe that is the case. I do not believe it has been 
demonstrated.
  As I have indicated previously, Dr. David Kessler, who ran FDA for 8 
years, says this bill provides a sound framework for assuring that 
imported drugs are safe and effective. I understand the pharmaceutical 
industry does not say that. I understand some others do not believe 
that. I understand and respect that. But I also believe, very strongly, 
that the evidence is overwhelming. We have added the safety provisions 
that were raised by Secretary Shalala. We have added the provisions 
raised by Secretary Thompson.
  I believe--and 33 of my colleagues in this Chamber, Republicans and 
Democrats, believe--we have done a very good job in resolving those 
issues. This issue almost has a gray beard. It has been around a long 
time. We have been trying a long time. It is hard to win on this issue. 
I accept that, and I understand it. But I am hoping that perhaps this 
is the year in which we might give the American consumer an opportunity 
to be able to participate in the global marketplace in a safe and 
effective way, just as the Europeans do, and be able to access a lower 
price of FDA-approved drugs.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senator from North Carolina.
  Mr. BURR. Mr. President, I agree with my colleague that this issue 
has been around for a long time. One of the reasons we continue to 
debate it is because we continue to have real-life examples of a 
product that comes in that is adulterated. I am not sure we have done 
anything to eliminate the ability to counterfeit, other than to confuse 
it even more, because, in fact, today we basically say it is almost 
impossible, unless you are an individual crossing the border, to bring 
in drugs from another country.
  We are challenged at Customs today with immigration. Oh, we are just 
as challenged at Customs today on the shipment of pharmaceutical 
products that come into this country from abroad. It is not held to a 
single country.
  I do not believe the reason we embrace this bill is because the 
Europeans do it. There are a lot of things the Europeans do today that 
I would not necessarily suggest are right for America. As a matter of 
fact, we have some international treaties that suggest we should 
harmonize our drug standards with the European Union. What we found 
was, for the European Union, with 22 members, they accept whichever 
country the application was applied for. If that country approves it, 
then it is good for the EU. If you look at some of the standards 
throughout the 22 countries, it would be dismantling the gold standard 
of the FDA.
  So for those who suggest what we would do in this amendment maintains 
our gold standard, it would not happen. The reality is, as you accept 
what they do--which does not come close to the gold standard of the FDA 
for safety and efficacy--over time it would bring further deterioration 
to the confidence of our drug supply. When every American goes to their 
local pharmacy and they have their prescription that is written by a 
doctor, they go in with 100 percent confidence of knowing there is an 
active ingredient in it, that it is not adulterated, that their health 
is not going to be affected adversely when they take it.
  We are on the floor today. This is part of the drug safety bill. Why? 
Because in some cases when products are approved and given to a much 
larger population, that larger population experiences different side 
effects because every person is genetically different. There are no two 
alike, unless we change the cloning laws in this country. The reality 
is, I do not think we are going to do that, so we do not have it to 
worry about. But we are here trying to strengthen the safety of the 
product. We currently can maintain the chain of custody because it is 
manufactured, it is distributed, and every product has a case lot 
number.
  What have we experienced with counterfeit drugs? They have been able 
to make a pill look identical to the pills we go to the pharmacy and 
buy--identical in not just the pill but the packaging. As we shift 
packaging, so do those who are trying to game the system. The reality 
is, the person who is on the receiving end--and I sympathize with 
exactly what the Senator from North Dakota has claimed; that in many 
cases, pharmaceuticals are not affordable for some people. That is why 
we created Part D Medicare. That is why over 30 million Americans who 
are Medicare eligible now have coverage--coverage that has brought down 
the price of pharmaceuticals 33 percent in the first year.
  For any other area for which we would propose legislation, if we saw 
a trend like this, we would be embracing the fix we put in. But no, we 
are going to delude it even further and confuse seniors across the 
country and say: Now just go on the Internet and buy it because we have 
said it can only come in if it is an FDA-approved product. Well, FDA-
approved products are the only things we write prescriptions for in the 
country. The reality is, the only counterfeit product that 
counterfeiters are making are FDA look-alikes.
  There is nothing in the Dorgan bill that says somebody cannot 
counterfeit anymore. There is nothing in the bill that says if we do 
not catch it at Dulles Airport when it flies in and test it immediately 
to find there is no active ingredient, we have not put somebody's life 
in danger. There is no assurance in this bill that if there is an 
adulteration of some kind that affects somebody's health--in the host 
of millions of pills that come in, if we do not catch it, there is 
somebody on the receiving end who is going to be adversely affected 
health-wise.
  So I appreciate the fact that everybody wants cheaper drugs. We all 
do. But there is a reality about the United States of America: We 
protect intellectual property; therefore, we attract companies. And it 
is not just limited to pharmaceuticals. I guess the next thing we are 
going to do is claim Microsoft software is too expensive, so we are now 
going to allow that to come in from somewhere else. Well, we protect 
handbags. We protect clothing. We protect the copyrights, the 
intellectual property. There is even more of a reason to do it in 
pharmaceuticals. It is because there is a safety component.
  I think when many people think they might be buying a counterfeit 
handbag--if they buy it on the streets of this town or some other 
town--they probably think: Well, if I get a year's use out of it, based 
on the price, that is OK. I do not think you can apply the

[[Page 11240]]

same standard to pharmaceuticals. If it does not have the active 
ingredient, somebody might die. In fact, we beefed up, in the drug 
safety bill, dog food higher than what this importation provides for 
our pharmaceutical supply in this country.
  We are going to have plenty of time to talk about it. And just as the 
Senator from North Dakota brings a lot of facts and figures to the 
floor, there are a lot of facts and figures from the 8 years--maybe 
more--we have debated this issue. It has not been Congress that has 
turned it down, it has been the American people. At the end of the day, 
they send us here to make decisions that are positive in relation to 
their health and their future. I do not think Americans want to take a 
pig in a poke on pharmaceuticals. But that is what this amendment will 
allow to happen.
  This will probably change America being the innovator of drugs and 
medical devices because we will ignore patents and copyrights. We are 
advantaged by that. There are many countries in the world where you do 
not have access to the drugs and biologics and devices we have in this 
country. Yes, they are expensive because they are expensive to develop, 
but we put more value on quality of life, the ability for us in this 
country to treat what others are not able to treat because we believe 
that, in the overall scheme of our system, we save more money in health 
care if, in fact, we give somebody a pill. If that was not the case, we 
would not have programs for HIV/AIDS. But every time we supply that 
therapeutic for an HIV/AIDS patient, we know they are not going to have 
one case a year with some type of retinal infection. We know they are 
not going to be admitted to the hospital for a week because of 
pneumonia. We know the savings over that incident is probably going to 
be $15,000 or $20,000, and that is before we put any cost on the 
quality of life of the patient who is affected by the disease.
  Well, I would imagine we will see counterfeit HIV products because 
they are expensive. It is one of those diseases that does not stay in 
the same place. It is smart. It changes itself within somebody's body, 
and it means that over a period of time, you can take a drug that is 
very effective or a combination of drugs that is very effective, and 
after 2 or 2\1/2\ or 3 years, the disease has now changed, and if you 
do not change with new therapies, the reality is there is going to be a 
deterioration of that person's quality of life and a further advance of 
the disease.
  Right now, we have companies that are excited about working on the 
next product that will continue to take a disease we cannot cure today 
but for which we can stop the progression right in its tracks. What we 
are going to say to those companies that spend hundreds of millions of 
dollars, if not billions of dollars, is: Well, the United States does 
not put any value on that anymore. Say that to the population that is 
affected by the disease. Say that to the population of any group of 
Americans that is affected by a disease, that we are not going to have 
the policies in place that advance the development of drugs, biologics, 
and devices. When we do this, that is what we are saying.
  Again, I appreciate the authors' attempts to try to assure us that 
safety is at the forefront. But that is only there if we are smart 
enough to catch it. If we were that smart, we would not have an illegal 
immigration problem in this country. If we were that smart, we would 
know that we caught 100 percent of what was coming in the country. But 
I do not think there is anybody who is going to take this floor and 
suggest to the American people that we catch 100 percent of the 
adulterated or counterfeit drugs. There is certainly nobody who can 
come to the floor, even with our food safety standards where they are--
where the FDA is in charge and USDA is in charge and DHS now has some 
responsibility for it--and suggest to the American people that we catch 
100 percent of the contaminated food before it finds its way to the 
shelf or to a plate in our house.
  The reality is, we have had 12 examples just in the last year where 
we are just not that good. We are not perfect. I would suggest to you, 
to try the system, by setting up a program that cannot be policed--and 
I think that is what my colleague from Mississippi was saying. Time and 
time again, we have had the debate. We have pulled in the experts. They 
have said this is just something which is undoable for us. We cannot do 
it.
  My hope is that as this debate goes on, more and more Members will 
realize it sounds good, but it is not a risk we should take in this 
country. It is a risk that affects people's lives.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Tester). The Senator from North Dakota.
  Mr. DORGAN. Mr. President, one of the observations I made when I was 
privileged to come to the Senate is that virtually everyone here is a 
pretty effective communicator. I am reminded of that every day. I hear 
debate by people who really are effective, and I always appreciate it, 
and it is always interesting to me.
  I do think--certainly everybody is entitled to their opinions; I 
respect their opinions--not everybody is entitled to their own set of 
facts. We have to deal with a common set of facts.
  My colleague just made a statement, a philosophical statement, about 
what he believes. I respect that. But the statement included thoughts 
like that this piece of legislation would probably abrogate or not 
respect copyrights. Nothing could be further from the truth. There is 
nothing in here that would abrogate copyright protection, and so on. In 
fact, this amendment provides the requirement of serial numbers on lots 
and samples by those who are engaged in this sort of thing that has 
been prevented from occurring inside this country. It requires it for 
importation, and it requires it for domestic medicines. This will 
dramatically change the safety of the drug supply here and with respect 
to that which would be imported.
  With respect to the American people, the American people are not 
undecided on this issue. Mr. President, 70 or 80 percent of them 
believe there ought to be allowed the importation of prescription 
drugs. This is not something the American people are undecided about. 
It is only in this Congress that it has not been decided. So I think 
that is something we should understand. Why would the American people 
believe they should be able to import FDA-approved drugs? Because they 
believe it is fair for them to be able to do it.
  Let me describe where the prescription drugs come from by the 
manufacturers of the drugs. If you are taking Lipitor, that is not made 
here; that is made in Ireland. If you are taking Toprol XL, that is 
made in Sweden. Nexium is made in France. Altace is made in Malta. 
Vytorin is made in Singapore and Italy. These drugs are already 
imported. Regrettably, by the way, I might say they are imported 
without the protections that would exist in our amendment. It would 
require the manufacturer--the manufacturer of the drug--to have serial 
numbers on the lots, to have samples of every lot reserved, to have a 
pedigree for every medicine that is moved. That is for domestic 
consumption. I am not talking about the imported drugs under my bill; I 
am talking about the drugs that are made in these countries and other 
countries that ship them into this country, and every drug that is 
produced in this country will require the same.
  The fact is we have tried to get that same requirement on domestic 
drugs and have been blocked for a long time. This legislation will make 
the drug supply in this country far more safe than it currently is.
  We all know the amendment that is being offered about risk. Were that 
amendment to be offered with respect to new prescription drugs that 
come from research to say, you can't put a drug out there if there is 
risk, do you think you would have a new drug on the market anytime 
soon? Do you think a Health and Human Services Secretary or an FDA 
administrator can say: By the way, I am approving this drug and there 
is no risk. Of course, they can't. Of course, they would not. We know 
that. Drugs have risks. In

[[Page 11241]]

fact, some drugs are put on the marketplace, and we discover later they 
should not have been there--a substantial risk. Vioxx. An official at 
the FDA says he believes 50,000 to 70,000 American people died of heart 
attacks as a result of Vioxx being put on the market. Further, he 
says--this isn't me, this is an official at the FDA--that Vioxx was 
widely advertised and widely promoted as some wonderful new drug, when 
in fact it was not a new class of drugs that had any significant 
benefit over existing drugs. The point is this: If one were to ascribe 
this risk category to new drugs, there would be no new drugs.
  I know all this talk about counterfeiting--and man, have we talked a 
lot about counterfeiting in this Chamber in the last couple of days--
all this talk about counterfeiting ignores the point that it is 
occurring under today's laws. The way to fix that and the way to stop 
counterfeiters is to do what we do in this amendment: You require on 
every prescription drug that is sold, that it have a pedigree. You 
require in every circumstance there be serial numbers on lots and 
samples. It is incontrovertible, in my judgment, that this will 
dramatically improve the safety of domestic prescription drugs as well 
as imported prescription drugs.
  One final point with respect to the issue of research. My colleague 
said: Well, if we pass this amendment, what the Senate has said is 
there is no value to research on prescription drugs. I don't have the 
foggiest idea where that concept comes from. We spend a lot of money on 
research. I was one of a group of Senators who said: Let's double the 
amount of money at the National Institutes of Health, and we did, in 5 
years, to dramatically improve and increase the amount of research at 
the National Institutes of Health. I am a big supporter of research. We 
do a lot of wonderful research, some in the public sector, some in the 
private sector. At the NIH, by the way, we do the research and often 
much of that research is used by the pharmaceutical industry to produce 
lifesaving drugs. But lifesaving drugs save no lives if you can't 
afford to get them, if you can't afford to have them, and if you can't 
afford to take them.
  It is true none of us have a problem, in this Chamber, dealing with 
the price of drugs; we have health care policies and those kinds of 
things. But there are a lot of folks all over the country who are 
taking a lot of different prescription drugs. I think prescription 
drugs are wonderful. They keep people out of an acute care hospital 
bed, the most expensive kind of health care. Interestingly enough, in 
many cases they are taking 10 or 12 different kinds of prescription 
drugs to manage various diseases. As a result of that, we passed Part 
D; my colleague is correct about that. Part D provides drug benefits to 
those who have reached the age of Medicare. Regrettably, of course, 
there was nothing in Part D that would put downward pressure on 
prescription drug prices. I would say look at the increase in 
prescription drug prices in the first quarter in this country. Look at 
the increase in prescription drug prices in 2006, and then ask yourself 
whether all of this is working to put some downward pressure on 
pricing. It is not. It is just not.
  So as I said earlier this morning, I hate to lose a debate I am not 
having. I would love to have a debate in which we are both debating the 
same bill, but a suggestion somehow that this bill allows drugs to come 
into this country that are not FDA-approved means that you are off 
debating some other bill someplace. Well, fine. Win that debate if you 
want. It is not the bill that is on the floor of the Senate. It isn't. 
The same is true with a number of statements that have been made about 
respecting copyrights, and so on. In fact, what we have required is a 
regulatory burden that the industry doesn't like--I understand that--
but it will, in fact, protect them and protect their copyright because 
it will make it much harder for anyone to counterfeit. That is a fact.
  One of the interesting aspects of this country is that we are seeing 
some unbelievably good news. The good news is people are living longer 
and better lives. In a century, in 100 years, we have increased the 
lifespan by somewhere around 30 years, from 46 years old to about 76 
years old. That is good news. People are living longer and better 
lives. A significant part of that, I think, is being able to, at an 
advanced age, manage diseases. A significant part of that is 
prescription drugs. There are some who don't have that. I have an uncle 
I have described before who is now 86 years old. He and his wife take 
no prescription drugs at age 86. The fact is, as I have also described 
to my colleagues, he is a runner. He runs in the Senior Olympics at age 
86. He used to run in his seventies and early eighties the 400 meter 
and the 800 meter. Now he tells me he is a specialist in the 100-meter 
dash, at age 86. He has a good life. He is healthy. He likes life. He 
is very active. He is not riding his motorcycle so much anymore, but he 
has one of the biggest motorcycles you can get sitting in his garage. 
He doesn't need to take prescription drugs. Good for him.
  We have a lot of folks who reach their eighties and nineties. We know 
about that because in our part of the country, my State of North Dakota 
ranks No. 1 in the Nation in the number of people 86 years of age or 
older as a percent of the population. We rank No. 5 in the country in 
the number of people 65 years of age or older as a percent of the 
population. So a lot of people are living a lot longer. That is good 
news. It puts some drain on Social Security and Medicare.
  A quick way to fix Social Security and Medicare is to go back to the 
old life expectancy, go back to age 46. We wouldn't have any trouble. I 
am digressing a bit, but when Social Security was created, on average, 
people lived to be 63. So we created a system that says: When you 
retire, you get benefits at 65. Well, I went to a small school, but I 
understood enough in math to think that works out real well. You pay 
taxes and, on average, you are going to live to age 63, and when you 
retire at 65, you get some benefits. That is not a system that is going 
to have financing trouble at all. But then the problem is people began 
living much longer. That is not a problem. That is a success. So good 
for them.
  At any rate, prescription drugs about 40 years ago became a much 
larger part of the discussion in modern life, to keep people out of the 
acute care hospital beds and to manage their diseases. So that is a 
wonderful thing. I have said before, and I will say it again: The 
pharmaceutical industry is a fine industry; I have serious problems 
with their pricing strategy. I think it is wrong. I want them to 
succeed. I want them to research. I want them to do the research on 
prescription drugs. I would like them to stop advertising early in the 
morning when I am shaving and brushing my teeth and getting ready for 
work, telling me what I ought to go talk to my doctor about. They have 
all these pills they want me to ask the doctor if they are right for 
me. I get confused. I am not sure I need them. But there is a lot of 
advertising going on and a lot of promotion.
  I want them to find new medicines to unlock the mysteries of dread 
diseases. I want the Federal Government, through the NIH, to 
substantially invest in new research and development. I want all of 
those things. But I also want, even as I compliment the pharmaceutical 
industry and I compliment the NIH and all those who are spending their 
days--today, Thursday--trying to figure out how do you unlock the 
mysteries of ALS or diabetes or cancer or heart disease, even as I do 
that, I say to the pharmaceutical industry: I think your pricing 
strategy is wrong and it is unfair to the American people. We ought not 
be paying the highest prices in the world for prescription drugs. That 
is unfair.
  The amendment I have offered with 33 of my colleagues, Republicans 
and Democrats, would change that. No, it wouldn't shut down research, 
not at all. No, it wouldn't exacerbate counterfeiting, not at all. The 
fact is this will be fair to the American people, if we pass this 
legislation. It will continue, I think, to see substantial research. It 
will also, in my judgment, contribute to shutting down the 
counterfeiting of

[[Page 11242]]

prescription drugs, but most importantly, it will finally say to the 
American people that we are on your side on this issue. We believe in 
fair pricing and we finally are going to insist on it.
  I yield the floor, and I make a point of order that a quorum is not 
present.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. SANDERS. 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. SANDERS. Mr. President, I rise in strong opposition to the 
Cochran amendment. We should be very clear. For anybody who is 
interested in prescription drug reimportation, for anybody who is 
interested in lowering the cost of prescription drugs in this country 
from 25 to 50 percent, for anybody who is interested in standing up for 
the working families of this country who are getting ripped off every 
day by outrageously high prescription drug costs, the Cochran amendment 
is a poison pill. To vote for the Cochran amendment is to vote against 
prescription drug reimportation; it is to kill the Dorgan amendment.
  The idea of asking permission from the Secretary of Health and Human 
Services, from the Bush administration, who have already gone on record 
rather firmly and decisively in opposition to reimportation, is to 
simply mask your vote. The Bush administration represents the 
pharmaceutical industry. They will kill prescription drug 
reimportation. To ask their permission to go forward is simply to kill 
prescription drug reimportation. So anyone who is serious about 
lowering the cost of prescription drugs will not be supporting the 
Cochran amendment.
  The unfortunate reality is, in the United States of America we 
continue to pay, by far--it is not even close--the highest prices in 
the world for prescription drugs. Because of the escalating cost of 
medicines, many of our fellow Americans, many working people, many 
people with chronic health problems, simply do not get their 
prescriptions filled. I am sure in Montana the experience is the same 
as it is in Vermont. People tell me they walk into the drugstore and 
cannot believe the prices they are being charged. They can't afford 
those prices. I have talked to pharmacists, as I suspect the Chair has 
as well, who have been embarrassed. They have seen tears coming out of 
people's eyes when they have told them the cost of their medicine.
  Meanwhile, as a result of the power of the pharmaceutical industry, 
we have the highest prices in the world, and those prices are rising 
every single day. In fact, tomorrow, if an American walks into a 
pharmacy and the pharmacist says to that person: I am sorry to have to 
tell you this, but the cost of your medicine went up 50 percent, or 75 
percent, we can do nothing about it. Unlike the rest of the 
industrialized world--Canada, Europe--where they understand 
prescription drugs are an integral part of a whole strategy regarding 
health care, we let the drug companies do anything they want to do.
  As the first Member of Congress to take constituents across the 
Canadian border to enable them to pay substantially lower prices than 
they were paying in the United States, I have seen firsthand what it 
means to people's lives when they get the drugs they need at a price 
they can afford. I will never forget--never forget--when in 1999 I 
brought a busload of Vermonters over the Canadian border. Many of the 
women there were struggling with breast cancer, fighting for their 
lives, and they didn't have a whole lot of money. They went to Montreal 
and purchased Tamoxifen, a widely prescribed breast cancer drug, which 
at that time--at that time--was one-tenth the price they were paying in 
the United States. Imagine that. Fighting for your life, not having a 
lot of money, and needing a drug. Suddenly, they looked at the price 
they were paying and they literally could not believe it.
  Mr. President, I ask unanimous consent that a chart which compares 
prices in the year 2005--so the prices may be different today, but as 
of April 2005, a price comparison between United States prices and 
Canadian prices, and United States prices and German prices.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                 SOME PRICE COMPARISONS AS OF 4/06/2005
------------------------------------------------------------------------
                                                                Canadian
        Drug  (in US $)          Illness/condition   US price    price
------------------------------------------------------------------------
Actos (15mg, 90)...............  diabetes.........     296.89     257.97
Cardizem CD (240mg, 90)........  heart............     215.89      88.03
Celexa (20mg, 30)..............  depression.......      81.99      52.05
Clarinex (5mg, 30).............  allergies........      74.99      37.31
Fosamax (10mg, 100)............  osteoporosis.....     242.89     178.62
Imitrex (50mg, 27).............  migraines........     503.89     365.08
Nexium (20mg, 30)..............  heartburn........     144.99      87.77
Norvasc (5mg, 90)..............  blood pressure...     127.59     135.32
Prevacid (15mg, 30)............  ulcers...........     129.99      74.40
Prilosec (20mg, 30)............  ulcer............     128.99      74.50
Procardia XL (30mg, 30)........  heart............      53.99      33.84
Relafen (500mg, 200)...........  arthritis........     340.19     183.86
Tamoxifen (20mg, 30)*..........  breast cancer....      68.59      40.21
Ticlid (250mg, 60).............  stroke...........     171.99     101.36
Vasotec (10mg, 60).............  heart............      70.99      63.30
Zocor (20mg, 30)...............  cholesterol......     131.99      74.65
Zoloft (50mg, 100).............  depression.......     227.49     182.04
Zyrtec (10mg, 30)..............  allergies........      69.99      41.87
------------------------------------------------------------------------
Drug                             Illness/condition   US Price    German
(in US $)                                                        price
------------------------------------------------------------------------
Actos (15mg, 30)...............  diabetes.........     116.64      50.62
Celexa (20mg, 30)..............  depression.......      85.46      35.72
Clarinex (5mg, 30).............  allergies........      77.06      38.64
Imitrex (50mg, 9)..............  migraines........     166.40     102.67
Nexium (20mg, 30)..............  heartburn........     145.33      60.25
Norvasc (5mg, 30)..............  blood pressure...      54.83      35.72
Prevacid (15mg, 30)............  ulcers...........     146.47      35.22
Zocor (50mg, 30)...............  cholesterol......      85.39      23.83
Zoloft (50mg, 30)..............  depression.......      89.44      54.98
Zyrtec (10mg, 30)..............  allergies........      73.02      34.33
------------------------------------------------------------------------
All prices found via www.walgreens.com and www.canadadrugs.com.
*Price found at www.cvs.com.

  Mr. SANDERS. Mr. President, let me talk about a few of the drugs.
  Actos is a drug for diabetes. As of 2005, in the United States, the 
price of that drug was $116. For the same number of pills and the same 
milligrams, it was $50.62 in Germany. Twice the price--same product, 
same company, same factory, but less than half the price in Germany.
  For Celexa, a drug for depression, it was $85 in the United States 
and $35 in Germany. Same company, same product. Clarinex was $77 in the 
United States and $38 in Germany. On and on

[[Page 11243]]

it goes--sometimes more, sometimes less but often half the price in 
Germany, and different prices in Canada but often the same end result.
  The very simple question the Members of the Senate have to ask 
themselves is: Why is it that in the United States we have to pay the 
highest prices in the world for our medicine? Why is it that at a 
moment in history when we are eating food products from farms in Mexico 
and in Latin America, produced in China, and they are coming to our 
kitchen tables today, why is it that anybody here can say with a 
straight face it is OK for products all over the world to come into 
this country from tens of thousands of farms, but in terms of a handful 
of major drug companies, somehow we cannot regulate the flow of those 
medicines from Canada, for goodness' sake, into the United States?
  Give me a break. That argument is so totally absurd as to be almost 
beyond the laugh test. This debate has nothing to do with drug safety. 
All of us are concerned about drug safety, and the Dorgan amendment has 
page after page after page of regulations making sure the FDA-approved 
medicines that come into our country will be safe.
  What saddens me very much is that in many ways the American people 
have given up on this issue in terms of the ability of their own 
government to act, and they have taken matters into their own hands. I 
don't know what goes on in Montana, but in the State of Vermont 
thousands of people in our State go over the Canadian border. They go 
to the Canadian drugstores and buy the products they need. It is not a 
big deal, and they save substantial sums of money.
  There was an estimate a few years ago, and I don't know what those 
numbers are today, but there was an estimate several years ago that 
about 2 million Americans were buying their medicine in Canada. What 
the Dorgan amendment is about is simply saying that it is a little bit 
absurd for Americans to have to get in their cars and drive to Canada 
to get the drugs they need; that it might make more sense for our 
pharmacists to be able to purchase that medicine, our prescription drug 
distributors to be able to purchase that medicine so, in fact, 
Americans could take advantage of the lower prices at their own local 
drugstore.
  That is what we want to do. We don't want all of America to have to 
go to Canada or Germany to buy reasonably priced medicine. We want 
those products sold in this country at an affordable price.
  I think many Americans are wondering: Well, how does it happen that a 
product made by an American drug company--at a time when the taxpayers 
of this country, by the way, spend billions of dollars in research and 
development for drugs that go to the drug companies--that in the midst 
of all this, how does it happen that we pay two or three times as much 
as our neighbors in Canada or our friends in Germany or throughout 
Europe? How does that happen?
  Well, the answer is pretty simple. The answer is pretty simple. The 
answer has everything to do with the way we do politics in this country 
and the enormous power of large multinational corporations and the 
enormous power of lobbyists who represent those corporations. Let me 
quote from a Washington Post article of Friday, January 12, 2007. It is 
a front page article. This is what it says. This is January 12, 2007:

       This month alone [i.e. January] the Pharmaceutical Research 
     and Manufacturers of America [PhRMA] spent more than $1 
     million on full-page newspaper ads touting the success of the 
     existing Medicare drug system.
       Drug companies spent more on lobbying than any other 
     industry between 1998 and 2005--$900 million, according to 
     the nonpartisan Center for Responsive Politics. They donated 
     a total of $89.9 million in the same period to Federal 
     candidates and party committees, nearly three-quarters of it 
     to Republicans.
       ``You can hardly swing a cat by the tail in Washington 
     without hitting a pharmaceutical lobbyist,'' said Senator 
     Charles E. Grassley, Republican of Iowa, a key sponsor of the 
     2003 legislation that created the current program.

  That is what we are dealing with today, and we should not kid 
ourselves. The pharmaceutical industry, year after year, turns out to 
be one of the more financially successful industries in our country. 
According to Fortune magazine, the top 19 pharmaceutical companies in 
2005 made $42.1 billion in profit; in 2004 the profit margin was almost 
16 percent, three times higher than the average Fortune 500 company.
  That is what you have. We have a situation where millions of 
Americans are struggling to pay their prescription drug costs. We have 
a situation where many Americans simply cannot afford the medicine they 
desperately need. We have a pharmaceutical industry which, year after 
year, enjoys some of the highest profits of any industry in this 
country. We have an industry which pays its CEOs very exorbitant 
salaries. We have an industry which has an estimated 1,200 paid 
lobbyists in this country, many of them former leaders of the 
Republican and Democratic Parties. We have an industry that makes huge 
amounts of campaign contributions. We end up with a situation in which 
we pay by far the highest prices in the world for prescription drugs.
  Senator Dorgan quoted a study from the CBO, I believe it was, that 
suggests we could save some $50 billion over a 5-year period if we move 
to prescription drug reimportation. In this body we have people who get 
up every day and tell us how wonderful they perceive unfettered free 
trade to be. It is not a problem when American workers are thrown out 
on the street because factories are moved to China where people are 
paid 30 cents an hour; hey, that is part of the global economy. No 
problem there. There is no problem when food comes into this country 
from China and our farmers lose money. No problem. That is part of the 
global economy.
  But somehow, amazingly enough, when an aspect of free trade works for 
the average American and not for a large multinational corporation, 
suddenly we do not like unfettered free trade. Suddenly we cannot 
reimport prescription drugs from Canada--from Canada, which neighbors 
us, obviously--from a handful of drug companies. We cannot do that. I 
think that argument is very absurd.
  Let me conclude. A vote for the Cochran amendment is a vote to kill 
prescription drug reimportation, pure and simple. The Bush 
administration has said they will not go forward with reimportation. 
Let us defeat the Cochran amendment. Let us pass the Dorgan amendment. 
Let us lower prescription drug costs in this country by 25 percent to 
50 percent. Perhaps even more important, let us show the American 
people that the Congress has the courage to stand up to the most 
wealthy and powerful lobby on Capitol Hill.
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER (Mrs. McCaskill). The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Ms. MIKULSKI. I ask unanimous consent that the order for the quorum 
call be rescinded.
  The PRESIDING OFFICER (Mr. Salazar). Without objection, it is so 
ordered.
  Ms. MIKULSKI. As a member of the HELP Committee and someone who was 
an active participant in shaping this legislation, I rise to let 
everyone know it is very important that we pass this bill. This 
legislation is perhaps one of the most important bills in more than a 
decade to improve drug safety. I am very distressed that for a variety 
of ideological reasons, this bill is being impeded. Yet drug safety 
should not be impeded. Drug safety is one of the most important issues 
we face. The recent testimony of two former FDA commissioners--one 
appointed by a Republican, Dr. Mark McClellan, and the other appointed 
by a Democrat, Dr. David Kessler--discussed the need for this 
legislation as one of the most important items to come before the 
Senate.
  Congress has a unique opportunity to change the way we monitor the 
safety of drugs. We can't afford to miss this chance. We owe it to 
consumers, physicians, and patients, who rely on FDA to be the gold 
standard, to pass this

[[Page 11244]]

legislation. This is about protecting the American people. There are 
countries all over the world that can't afford an FDA so they look to 
us to see what drugs are approved.
  I have long been a supporter of the Food and Drug Administration. It 
is in my State, and I am very proud of it. I have fought hard for the 
employees at the FDA; for the resources to maintain the mission of the 
FDA. Through the years we have done a variety of things to improve FDA 
but nothing as important as this bill.
  When we began to work on this legislation, I wanted to know what 
impact I could make. I was concerned about the fact that FDA seemed to 
have lost its way. It seemed not to have the right leadership, and it 
certainly didn't have the right monitoring for drug safety--
particularly post-market surveillance. So we ended up with the Vioxx 
situation. We ended up with drugs to treat young adolescents triggering 
suicidal thoughts and worse. The issue of drug safety is paramount in 
America. When I looked at this legislation before the HELP Committee, I 
wanted to find a way to strengthen the FDA but not create a whole set 
of regulations that were bureaucratic and technocratic but without 
efficacy. So where did I turn? I turned to the Institute of Medicine. 
The Institute of Medicine is the premier agency that often gives advice 
and direction to the larger community.
  They published a report called ``The Future of Drug Safety.'' It had 
been commissioned by the FDA itself. As I read this report, I was 
struck by its commonsense provisions. I was also struck by the fact 
that we have endless reports. We have lots of commissions that Congress 
asks to be created, but we never act upon them. Just yesterday, the 
Journal of the American Medical Association ran an editorial about how 
the Institute of Medicine developed the right prescription for FDA, but 
no one is going to act on it.
  Well, I acted on it. I took the prescription to help the ailing FDA. 
While our leadership, through Senators Kennedy and Enzi, was working a 
comprehensive bill, I brought to their attention these recommendations. 
By working in a civilized, collegial way, my amendments were adopted. 
It is not about my amendments. It is about the Institute of Medicine 
recommendations. Isn't it great when we can take the best thinking, 
work on a bipartisan basis, and put it into action to protect the 
American people. To me, that is what it is all about.
  Today when I look at this bill, I am so proud of the provisions we 
included. It strengthens science. It increases transparency. It 
improves drug safety. Yet it doesn't shackle the FDA.
  Let me share the recommendations of the Institute of Medicine. In 
terms of strengthening science, they were very clear and said that 
science must be strong to protect the public and to keep the best and 
brightest scientists at FDA. What did we do? No. 1, we created the 
Office of Chief Scientist at the FDA. A single scientist will now 
oversee all of the offices to be sure they have strong scientific 
guidance from the very top of the agency. This Chief Scientist will 
work with a strengthened Scientific Advisory Board who will make sure 
the Commissioner and the Center Directors are getting the best 
scientific advice. Imagine, the FDA didn't have a chief scientist. We 
have a chief scientist at the National Space Agency. We should 
certainly have a chief scientist at the Nation's drug safety agency.
  Then we made sure that all new drugs would be reviewed by an Advisory 
Committee. That means all new drugs will receive a comprehensive 
review. You might ask: Don't they now? No. Most got an advisory 
committee review, but under this legislation, there will be an advisory 
committee review of ALL new drugs to help assure that as a drug moves 
into clinical practice, it will be as safe as it can be. Remember, the 
FDA has a job to make sure drugs do two things: are safe and effective. 
These Advisory Committees will help make sure the drugs do no harm but 
also make sure they do good.
  We also reinforced the ability of scientists at the FDA to publish 
their scientific papers. One might ask: Can't they now? No. If you work 
at the FDA, you often can't publish articles unless your boss says it 
is OK. Imagine that. We are talking about allowing scientists to 
publish in peer-reviewed scientific journals. This might sound kind of 
wonky, but it is important to morale. Its important for Scientists who 
now work at the FDA and important for recruiting new scientists that 
the FDA desperately needs.
  The other actions we took were to improve transparency. Transparency 
at the FDA is critical, especially throughout the drug approval process 
where all scientific views, even dissenting ones, should be made 
public. I added provisions to make sure this will happen. Through 
language I had incorporated in the bill, we will make summaries of the 
drug approval process available to the public on the Internet. A 
summary will be available 48 hours after the drug is approved and the 
whole drug review package will be publically available within 30 days. 
If there are dissenting scientific views, they will also be made 
available as well. If you are a scientist, a researcher, even if you 
are a consumer, you will be able to know the history of a particular 
drug and review its approval process. You can learn if there were there 
flashing lights raised during the approval process about which you can 
talk to your doctor.
  This is big. I know the distinguished presiding Senator was the 
attorney general for the great State of Colorado. I know he would also 
be very concerned about protecting proprietary information. This is not 
going to be about that. It is about safety issues, and they will be 
made public. We are also going to make sure patients and consumers help 
to make sure the FDA is communicating well with the public by creating 
an Advisory Committee on Risk Communication. This is modeled after two 
committees at the NIH and will facilitate getting FDA's message out to 
the public.
  We also made additional changes that will directly improve drug 
safety. Throughout the approval process, it is important to include 
scientists who know how to follow drugs after they are approved. This 
takes me to one of my most important considerations. This legislation 
will strengthen the Office of Surveillance and Epidemiology to make 
sure it is part of the drug process from the beginning and all the way 
through.
  This legislation will also generate additional money for drug safety. 
Provisions in this bill would add $29 million in PDUFA fees and up to 
an additional $65 million specifically for monitoring drug safety.
  In sum, there are about 15 IOM drug safety recommendations we added 
to this bill. By working together, we have improved safety, we have 
improved transparency, we have improved morale, and we have improved 
resources. This is a good bill.
  I say to my colleagues on the other side of the aisle: I don't know 
what you are cranky about. I don't know why you are holding up this 
bill. I will tell you what I am cranky about. I am real cranky when a 
drug goes out into clinical practice, and all of a sudden kids have 
problems. Kids have problems because they are trying to be like other 
kids. They are taking medication and it triggers something biomedical 
in their brain and gives them very dark thoughts. We don't want them to 
do dark things to each other. I am cranky when we have a doctor working 
in a rural part of my State, who doesn't have the time to read every 
medical journal but is relying on the fact that the drug he is 
prescribing to a patient for a heart condition has been approved by the 
FDA. He relies on the FDA to make sure that drug is as safe and as 
reliable as that doctor is in his own clinical practice.
  I get cranky, real cranky, when we cannot improve drug safety. If we 
want to talk about that, we have to get back to mission and to purpose. 
It is the mission of the FDA to stand sentry over our food and drug 
supply to ensure safety and efficacy. It is incumbent upon us to give 
them the right policy framework and the right resources. I think we 
ought to get into action and pass this bill. Let's work together to

[[Page 11245]]

make sure that when we talk about defending America, we defend 
Americans by passing this bill.
  I yield the floor and 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. Mr. President, I wanted to speak briefly, partially in 
response to statements made on the other side of the aisle, 
specifically by the Senator from Vermont whom I had the good fortune to 
listen to and whom I always enjoy listening to--the junior Senator from 
Vermont. Although I always enjoy listening to him, the junior Senator, 
I enjoy listening to the senior Senator, too, but in this case it was 
the junior Senator, a very eloquent individual and a neighbor.
  I did want to make a couple of points. He said, or implied--in fact, 
he said--that the Cochran amendment was essentially a poison pill to 
the efforts of Senator Dorgan to generate reimportation language which 
would be effective in allowing Americans to purchase drugs from Canada, 
or over the Internet for that matter. Then he said this was a result of 
the fact that the Bush administration was basically a tool--those are 
my words, but I think that is a characterization that is fairly 
accurate--a tool of the pharmaceutical industry, and the Cochran 
language was a reflection of that sort of attitude.
  I think it is important to understand what the genesis of the Cochran 
language is. The Cochran language did not come from the Bush 
administration. The Cochran language actually came from the Clinton 
administration. I was here when it was originally proposed, and it was 
supported by President Clinton and by his Secretary of Health and Human 
Services--I believe it was Donna Shalala--because they felt very 
strongly, as does the Bush administration, that the FDA should not have 
two standards of safety. It should not have a standard of safety that 
says the products that are sold in the United States have to be subject 
to FDA review to make sure they are safe, but for products which 
somebody goes out of the country and buys and brings back to the United 
States, the FDA will be forced to turn a blind eye and will not review 
that product's safety.
  The language is simple. It says if the Secretary of Health and Human 
Services cannot assure, through the FDA, a product coming into the 
country is safe and effective, then the product cannot be brought into 
the country. That is pretty reasonable language. That is what we asked 
the FDA to do. That is why the FDA was created, to protect American 
citizens who are purchasing pharmaceutical products or medicines. What 
this language which Senator Cochran is proposing would do is simply 
extend that language, should the Dorgan amendment pass, to products 
which are purchased outside of the United States and brought into the 
United States the same way, the exact same way, the FDA is required to 
review the safety and efficacy of a product which is purchased in the 
United States. That is all the language does.
  Yes, it will have a significant impact on the Dorgan language 
because, yes, both under the Clinton administration and under the Bush 
administration the Secretaries of Health and Human Services have said 
it is going to be extremely difficult, with the resources they have, 
with the authorities they presently have, to assure the safety and 
efficacy of drugs that are being reimported into this country.
  But it is truly an inaccurate representation to say this is a Bush 
initiative, the purposes of which are to protect the pharmaceutical 
industry. It is just the opposite, in fact. This was an initiative 
created by President Clinton and his administration to protect the 
American consumer from purchasing drugs which the FDA doesn't have the 
wherewithal to determine whether or not they are adulterated.
  Now, the response to this, of course, the substantive response versus 
the pejorative response, which is that it is just a pharmaceutical 
stalking horse--the substantive response to this from the Senator from 
North Dakota is, we are not suggesting anything that gets purchased 
isn't FDA approved. It has to be an FDA-approved drug. That is what the 
language in his amendment says. Yes, that is true; that is what the 
language of his amendment says. But the practical way it works is the 
FDA can't assure you, the American customer, my constituents, they 
can't assure that customer who goes to Canada the product they purchase 
in Canada is FDA approved, is the FDA-approved drug it says it is 
because the FDA has no ability to monitor that drug in Canada.
  In the United States, it can absolutely guarantee if you buy--the 
Senator from North Dakota has been using the example of Lipitor--if you 
buy a bottle of Lipitor, that it is going to be Lipitor. But if you buy 
that bottle and you cross the border and bring it back into the United 
States, the FDA has no way of knowing or being able to manage the 
question of whether that is the drug that is supposed to be in that 
bottle. That bottle can be bottled in a way that puts a drug that has 
been adulterated into the bottle and then claim to be FDA approved. 
That is not a projection. In fact, that is exactly what is happening 
today.
  Yesterday, for example, the FDA put out a press release citing the 
fact that there are 24 pharmacies that are online today people use in 
America that are not American pharmacies, that are international, and 
they now have absolutely firm evidence those pharmacies, or the group 
of pharmacies, the group that manages those pharmacies, is selling 
drugs representing that they are one type of drug but actually what is 
being delivered is something entirely different. In some cases it was 
just starch. It wasn't a drug at all. Even though it was claimed to be 
an FDA-approved drug, with the certification on it, with the batch 
number on it, with the expiration number on the package, it turned out 
it was starch.
  In another instance it turned out it was an entirely different 
component than the drug which was allegedly being sold, which could do 
significant harm to you if you took it. In fact, we have innumerable 
anecdotal examples of people being harmed by purchasing drugs both over 
the Internet and by crossing the border because those drugs turned out 
to be fabrications. They turned out to be counterfeit. They turned out 
to be basically fraud on that consumer. So the purpose of the FDA is to 
ensure that doesn't happen.
  What this language says very simply is, the FDA will assure that 
doesn't happen by giving the authority to the Secretary to make the 
decision--the same authority asked for by President Clinton and his 
Secretary of Health and Human Services--to make the determination as to 
whether a drug coming into this country through reimportation is safe 
and effective. That is what we charge the FDA to do. To claim it is 
some sort of an attempt to undermine the purpose of keeping consumers 
safe is just the exact opposite of what it is.
  The purpose of this amendment is to make sure American consumers, 
when they buy a pharmaceutical, whether they buy it in the United 
States or whether they go over the border and buy it and bring it back 
into the United States, can be confident that pharmaceutical is safe 
and effective as determined by the FDA. So it is extremely reasonable 
language. It is not language that was proposed, as was represented by 
the Senator from Vermont, by the Bush administration as a stalking 
horse for the drug industry. It is, in fact, language which was 
proposed by President Clinton, President Clinton's Secretary of Health 
and Human Services, supported by them. They asked for the authority, 
and it is now the same position which has been taken by this 
administration, the Bush administration.
  Mr. President, the Senator from Georgia has been very courteous in 
allowing me to go forward and taking this time before he and the 
Senator from Arkansas were to speak. So at this time I will reserve my 
comments and yield the floor so the Senator from Georgia can take his 
time.

[[Page 11246]]

  The PRESIDING OFFICER. The Senator from Georgia is recognized.
  Mr. CHAMBLISS. Mr. President, I thank my good friend from New 
Hampshire for yielding. I certainly agree with everything he has just 
been speaking about relative to the bill that is on the Senate floor 
now.
  (The remarks of Mr. Chambliss pertaining to the introduction of S. 
1283 are located in today's Record under ``Statements on Introduced 
bills and Joint Resolutions.'')
  Mr. SANDERS. 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. SANDERS. Mr. President, the debate we are now having is an 
extraordinarily important debate; in fact, it will be one of the most 
important votes we will be casting this year.
  This vote is about whether we stand with the American people, 
millions of whom are having a very difficult time paying their 
prescription drug bills or whether we stand with the most powerful and 
greedy lobby on Capitol Hill, and that is the pharmaceutical industry 
which has spent extraordinary sums of money to make sure the American 
people pay outrageously high prices for the medicine they desperately 
need.
  I wish to briefly examine a chart which talks about the very high 
profit margin of the pharmaceutical industry. One of the reasons why 
the pharmaceutical industry can spend so much money on lobbying, on 
campaign contributions, on advertising is because of the profits they 
make year after year.
  In 2004, drug companies ranked as the third most profitable industry 
in the United States with a 15.8-percent profit margin, which is about 
three times higher than the profitability of a median Fortune 500 
company, which is at about 5.3 percent. This is in 2004. This comes 
from the Kaiser Foundation.
  What we can also see, and what this chart tells us, is the 
extraordinary profits the drug companies are making from particular 
drugs. Epogen is the drug. Amgen is the company with profits of $2.5 
billion. Taxol is the drug; the firm is Bristol-Myers Squibb, $2.1 
billion for one drug, and on it goes. They are profitable year after 
year. The pharmaceutical industry continues to be one of the most 
profitable industries in this country.
  I have another chart. One of the issues I look forward to discussing 
with Members of the Senate is the fact that as taxpayers in our 
country, we contribute billions and billions of dollars to the National 
Institutes of Health, the universities, the foundations for the very 
noble and important purpose all of us support: to create drugs that 
will address the major illnesses facing us, whether it is cancer, 
diabetes, AIDS, whatever it may be. We have spent billions and billions 
of taxpayers' dollars in a sense subsidizing the drug companies and, in 
fact, taxpayers do not get any reasonable price returns from them. We 
just give them the money.
  Here is an example. Taxol is a very important and widely used 
medicine. According to a 2003 GAO report, the NIH spent $484 million on 
research for Taxol, Bristol-Myers Squibb spent $1 billion and 
subsequently earned $9 billion in profits.
  In other words, American taxpayers are paying twice: once in the form 
of underwriting pharmaceutical research and the second time in the form 
of monopoly prices.
  When we talk about the drug companies, we should also deal with the 
issue they often bring up. PhRMA is a very powerful lobbying group, the 
most powerful trade group on Capitol Hill. What they tell us is they 
need these very high prices, they need all of the taxpayers' money 
because they are putting all of that into research and development. 
Don't we all want new drugs for diabetes, cancer, AIDS, and a dozen 
other terrible illnesses? This chart tells us something a little bit 
different.
  This chart tells us the pharmaceutical industry spends far more for 
marketing--and goodness knows we have seen their ads on television over 
and over again, and guess who is paying for those ads. We are, in terms 
of high prices for the drugs, far more for marketing than for research 
and development.
  Let me get back to the thrust of what this debate is all about, and 
let me be very clear. As I mentioned a little while ago, the Cochran 
amendment is a poison pill. If anyone is serious about prescription 
drug reimportation, if people are serious about lowering the cost of 
prescription drugs from 25 to 50 percent, if people are serious about 
standing up for consumers in this country, they will vote against the 
Cochran amendment.
  So that no Senator has any doubt about what is going on, Mr. 
President, I ask unanimous consent to have printed in the Record a 
Statement of Administration Policy, dated May 1, 2007, from the 
President's office, and I will quote from the bottom of page 2, where 
there it is in black and white. This is a two-page letter. It says:

       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 advisers would recommend 
     that he veto the bill.

  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 
     two thousand 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

[[Page 11247]]

     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. SANDERS If you are voting for the Cochran amendment, which says, 
well, we want the Secretary to certify we can go forward, what you are 
voting for is to kill reimportation. The White House was honest enough 
to make that very clear. So it would seem to me that for those people 
who want reimportation, you have to vote ``no.'' If you don't want 
reimportation, then you can vote for it. But that is the simple 
reality.
  There is another issue which I understand was raised a little while 
ago--I was not on the floor at that moment--and that dealing with the 
Clinton administration's attitude toward reimportation. I must say when 
I was a Member of the House, I was very involved in this issue. I was 
one of the leaders in the House in fighting for prescription drug 
reimportation. Back in the year 2000, we worked very closely with the 
Clinton administration and with then Secretary of Health and Human 
Services Donna Shalala to craft and pass reimportation legislation. 
During that process, the Clinton administration came to support 
reimportation over a period of time.
  Unfortunately, as many in this Chamber remember, it was during that 
debate on reimportation that the Senator from Mississippi first offered 
the certification language he is putting forward today. So he has been 
doing this for quite a while. It is true Secretary Shalala refused to 
implement the reimportation legislation passed in 2000 as a result of 
this certification. I know opponents of reimportation like to 
characterize Secretary Shalala's refusal to implement reimportation 
because she believed reimportation was impossible to make safe. That is 
the argument we hear over and over again: Hey, it is not us. Even the 
Clinton administration said reimportation could not be made safe. But 
what I must say, as straightforwardly as I can, is that argument is not 
accurate. It is not right.
  In her December 26, 2000, letter to President Clinton dealing with 
this issue, Secretary Shalala outlined several ``flaws and loopholes'' 
that would prevent the legislation from being effective. As someone who 
was active in the debate of 2000, let me also say it is a fact that 
these ``flaws and loopholes'' were identified prior to the passage of 
that legislation, but opponents of reimportation refused to address 
them because they knew those flaws and loopholes would be fatal.
  The legislation being offered today by Senator Dorgan addresses each 
and every one of those flaws and loopholes identified by Secretary 
Shalala. So let me say this again. If anyone comes to the floor of the 
Senate and says the Clinton administration thought reimportation should 
not go forward because there were flaws in it that could not be dealt 
with, that is simply inaccurate. What Secretary Shalala said is, there 
are concerns I have, and these concerns have got to be addressed. Well, 
guess what. Senator Dorgan's legislation does just that.
  Let us take a look at her letter. Mr. President, I ask unanimous 
consent that the letter I am referring to be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                December 26, 2000.
     Hon. William J. Clinton,
     The White House
     Washington, DC.
       Dear Mr. President: The annual appropriations bill for the 
     Food and Drug Administration (FDA) (P.L. 106-387), signed 
     into law earlier this year, included a provision to allow 
     prescription drugs to be reimported from certain countries 
     for sale in the United States. The law requires that, prior 
     to implementation, the Secretary of Health and Human Services 
     demonstrate that this reimportation poses no additional risk 
     to the public's health and safety and that it will result in 
     a significant reduction in the cost of covered products to 
     the American consumer.
       I am writing to advise you that I cannot make the 
     demonstration called for in the statute because of serious 
     flaws and loopholes in the design of the new drug 
     reimportation system. As such, I will not request the $23 
     million that was conditionally appropriated for FDA 
     implementation costs for the drug reimportation system 
     included in the FY 2001 appropriations bill.
       As you know, Administration officials worked for months 
     with members of Congress and staff to help them design safe 
     and workable drug reimportation legislation. Unfortunately, 
     our most significant concerns about this proposal were not 
     addressed. These flaws, outlined below, undermine the 
     potential for cost savings associated with prescription drug 
     reimportation and could pose unnecessary public health risks.
       First, the provision allows drug manufacturers to deny U.S. 
     importers legal access to the FDA approved labeling that is 
     required for reimportation. In fact, the provision explicitly 
     states that any labeling information provided by 
     manufacturers may be used only for testing product 
     authenticity. This is a major loophole that Administration 
     officials discussed with congressional staff but was not 
     closed in the final legislation.
       Second, the drug reimportation provision fails to prevent 
     drug manufacturers from discriminating against foreign 
     distributors that import drugs to the U.S. While the law 
     prevents contracts or agreements that explicitly prohibit 
     drug importation, it does not prohibit drug manufacturers 
     from requiring distributors to charge higher prices! limit 
     supply, or otherwise treat U.S. importers less favorably than 
     foreign purchasers.
       Third, the reimportation system has both authorization and 
     funding limitations. The law requires that the system end 
     five years after it goes into effect. This ``sunset'' 
     provision will likely have a chilling effect on private-
     sector investment in the required testing and distribution 
     systems because of the uncertainty of long-term financial 
     returns. In addition, the public benefits of the new system 
     are diminished since the significant investment of taxpayer 
     funds to establish the new safety monitoring and enforcement 
     functions will not be offset by long-term savings to 
     consumers from lower priced drugs. Finally, Congress 
     appropriated the $23 million necessary for first year 
     implementation costs of the program but did so without 
     funding core and priority activities in FDA, such as 
     enforcement of standards for internet drug purchase and post-
     market surveillance activities.
       In addition, while FDA's responsibilities last five years, 
     its funding authorization is only for one year. Without a 
     stable funding base, FDA will not be able implement the

[[Page 11248]]

     new program in a way that protects the public health.
       As you and I have discussed, we in the Administration and 
     the Congress have a strong obligation to communicate clearly 
     to the American people the shortcomings in policies that 
     purport to offer relief from the high cost of prescription 
     drugs. For this reason, I feel compelled to inform you that 
     the flaws and loopholes contained in the reimportation 
     provision make it impossible for me to demonstrate that it is 
     safe and cost effective. As such, I cannot sanction the 
     allocation of taxpayer dollars to implement such a system.
       Mr. President, the changes to the reimportation legislation 
     that we have proposed can and should be enacted by the 
     Congress next year. At the same time, I know you share my 
     view that an importation provision--no matter how well 
     crafted--cannot be a substitute for a voluntary prescription 
     drug benefit provided through the Medicare program. Nor is 
     the solution a low-income, state-based prescription drug 
     program that would exclude millions of beneficiaries and 
     takes years to implement in all states. What is needed is a 
     real Medicare prescription drug option that is affordable and 
     accessible to all beneficiaries regardless of where they 
     live. It is my strong hope that, when Congress and the next 
     Administration evaluate the policy options before them, they 
     will come together on this approach and, at long last, make 
     prescription drug coverage an integral part of Medicare.
           Sincerely.
                                                 Donna E. Shalala.

  Mr. SANDERS. Mr. President, the first flaw Secretary Shalala 
identified was the lack of any requirement that the drug manufacturers 
give importers permission to use the FDA-approved labeling for imported 
medicines.
  The Dorgan amendment addresses that concern.
  The second flaw identified by Secretary Shalala was the lack of any 
ban on drug companies discriminating against foreign companies that 
export medicines to the United States.
  The Dorgan amendment addresses that concern.
  The third flaw identified by Secretary Shalala was the 5-year sunset 
in that version of the bill. That sunset would limit the public benefit 
from the investment the public would be making to put a safe 
reimportation system in place. In other words, she was saying, why 
should we go through all this effort if we are to only have a 5-year 
process.
  The Dorgan amendment addresses that concern.
  Finally, the Secretary noted the absence of a long-term income stream 
to fund enforcement of the reimportation system.
  The Dorgan amendment addresses that concern.
  In short, to characterize Secretary Shalala's letter as one that says 
reimportation is unsafe is to mischaracterize the essence of that 
letter. What Secretary Shalala was critical of was poison pills, what 
she called ``flaws and loopholes'' that were put in, or allowed to 
remain in the bill at the bidding of the pharmaceutical industry so 
they could defeat reimportation.
  I have been involved in this issue for a long time, and that is what 
the drug companies do. Every day there is another reason why we can't 
go forward to lower the cost of prescription drugs. Every day there is 
another reason why we have to pay the highest prices in the world for 
prescription drugs. We have 1,200 lobbyists, no doubt many of them 
running around right now knocking on doors, to make sure our people 
continue to pay the highest prices in the world.
  Secretary Shalala wrote in her letter that she, in fact, hoped 
Congress would fix the flaws and close the loopholes in that 2000 
legislation of 7 years ago, and this is what she wrote to President 
Clinton:

       Mr. President, the changes to the reimportation legislation 
     that we have proposed can and should be enacted by the 
     Congress next year.

  In other words, in 2001. Let me repeat that. Secretary Shalala wrote 
to President Clinton:

       Mr. President, the changes to the reimportation legislation 
     that we have proposed can and should be enacted by the 
     Congress next year.

  Unfortunately, it has taken 7 years of work to bring us to where we 
are today. This should have been done years ago. Under the Republican 
leadership, there was no question we could not get to first base on 
reimportation. I hope things have changed now.
  Let me conclude by saying that anyone who comes up here and says they 
are for reimportation but they are voting for the Cochran amendment is 
in fact not for reimportation. Anybody who comes up here and says, 
well, even the Clinton administration said we could not do that, I am 
afraid also that is not accurate and I think they are quoting Secretary 
Shalala, who was then Secretary of Health and Human Services, out of 
context.
  As I have mentioned before, I have been through these battles with 
the drug companies before. There is nothing the pharmaceutical industry 
will not do--nothing--in order to make sure they remain one of the most 
profitable industries in America. They will say anything, do anything, 
and put any kind of pressure they can on Members of the Senate or 
Members of the House.
  Today, we have an opportunity to do something important. For many 
years there was growing concern in this country about a do-nothing 
Congress, about a Congress that was worried far more about the wealthy 
and the powerful than the needs of ordinary Americans. The elections in 
November have changed that. We have new leadership here. I hope very 
much that under this new leadership we will all summon up the courage 
to stand up to the drug companies, the most powerful, the most greedy 
lobby and industry right here on Capitol Hill, and that we will go 
forward and we will pass this legislation to lower the cost of 
prescription drugs for all Americans.
  Mr. President, I yield the floor, and I suggest the absence of a 
quorum.
  The PRESIDING OFFICER (Mr. Nelson of Nebraska). The clerk will call 
the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. BURR. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER (Mr. Cardin). Without objection, it is so 
ordered.
  Mr. BURR. Mr. President, we are at a lull in the movement of the drug 
safety bill, a bill to assure American consumers, American patients, 
that there is more than just the acknowledgment by the Food and Drug 
Administration that a drug is safe and effective; that there is a 
mechanism post-approval as Americans across the country begin to take 
those medications; that we are watching for potentially any adverse 
reactions to a drug that a new population, an increased number of 
Americans that may be taking the drug. It is in an effort to make sure 
that if we see the signals of that unintended consequence, that we look 
more thoroughly at the benefits of that drug being on the market.
  When I left the floor earlier today, the sponsor of the importation 
amendment suggested that Vioxx was not beneficial to anybody. The fact 
is, I do not think it is the role of Members of the Senate--unless you 
are Dr. Coburn--to suggest that you practice medicine. There are 
physicians who found the advantages of Vioxx, while it was on the 
market, they found it was advantageous to thousands, if not hundreds of 
thousands, of patients.
  I am sure those patients are back on ibuprofen, Naprosyn, or other 
products that might cause significant gastro challenges for them, and 
that is why their doctors switched them originally. They needed relief 
from pain.
  Well, a lot of things have been said, and the Senator from North 
Dakota said we should stay focused on the facts. I have come to the 
floor for a few minutes just to talk about some of the facts.
  Many of us have suggested that, two years ago, when we created 
Medicare Part D--which is a prescription drug benefit for individuals 
in this country who are Medicare eligible--we lessened the problem that 
many seniors had expressed; and that is, their inability to buy 
pharmaceutical products.
  Just recently, an analysis published by AARP, the American 
Association of Retired Persons, showed the new Medicare drug benefit 
saves seniors more money than buying pharmaceuticals from Canada. Now 
there is a new one. For those who are on border States, the AARP--the 
authority because they certainly had a loud voice before Part D

[[Page 11249]]

was created--said drugs from Canada are actually more expensive than 
what Part D has been able to negotiate.
  Let me say in every State we have multiple choices. Seniors make 
their choice. They participate in a plan. It is a private sector plan. 
But there are basically four large benefit managers, and they negotiate 
prices. What they have done is, they have been able to negotiate a 
price that has even exceeded what Canada could sell drugs for at 
retail.
  This AARP bulletin found that many who choose the least expensive 
plan that meets their prescription drug needs--this is under Part D--
will still pay less for those drugs than they would purchasing them 
from Canada. So it is not the ``Cadillac'' plan that seniors would have 
to choose to get less expensive drugs in the United States than from 
Canada. In fact, with the least expensive plan, AARP evaluated they 
would get a cheaper price on their pharmaceuticals by having Part D, 
accessing it at a U.S. pharmacy where they can feel fairly confident, 
if not totally confident, the product is, in fact, what they thought it 
was.
  Just recently, in Detroit, MI, an indictment charging 19 individuals 
with operating a global racketeering conspiracy, was unsealed. The 
Federal court announced--the U.S. attorney for the Eastern District of 
Michigan--the indictment alleges that portions of the profits made from 
illegal enterprises were, in fact, funding Hezbollah. This is a foreign 
terrorist organization, by the way. Nine of the individuals were 
arrested. The indictment charged that between 1996 and 2004, this group 
worked together in a criminal enterprise to traffic in contraband 
cigarettes, counterfeit Zig-Zag rolling papers, and counterfeit Viagra.
  So as to the claims we have made on the Senate floor--I believe the 
Senator from North Dakota when he says: We have done everything we can 
in this bill to assure the public of the safety and integrity of the 
product--though there is nothing in the bill that forbids anybody who 
wants to circumvent the law, in other words, make counterfeit drugs, 
make drugs that have no active ingredient, make drugs that look just 
like those drugs that are approved by the FDA, whether they are Viagra 
or Zocor, and to find a way for those to come to the marketplace.
  It is not something the FDA today, or any FDA prior, has said they 
can police. For those Members who have been intricately involved since 
September 11, 2001, at understanding what our ability is to have a full 
knowledge of what comes into this country, some of us have actually 
gone to Washington Dulles Airport. We have seen the Customs officials 
go through the bags and bags of pharmaceutical products that come into 
this country. It is impossible, without a chemical test, to determine 
whether one tablet is authentic or the next one is counterfeit, whether 
one has an active ingredient or whether one is minus all active 
ingredients.
  There have been several operations conducted in this country that 
deal with the cyber-trafficking of pharmaceutical products.
  Fictitious pharmacies: These are companies that prey on individuals 
who are solely looking for low-priced pharmaceuticals. They think they 
are dealing with reputable pharmacies around the world. Yet there is no 
pharmacy. At the other end of the Internet are crooks. They prey on 
people who look for pricing. In fact, as some of those groups have been 
rolled up by our law enforcement, what we find is the products that 
were coming in had substantial deficiencies in things such as active 
ingredients.
  What happens when a patient takes a product where the active 
ingredient does not exist? The illness they have is not affected. For 
an individual who might have high cholesterol who has been put on a 
drug that will lower that cholesterol because they are susceptible to 
heart problems, to have no active ingredient means they have a 
cholesterol buildup in their veins, and without intervention the 
likelihood is they might have a heart attack. They might die. 
Unfortunately, when they take a drug they think is real, but it has no 
active ingredient, unfortunately, they do not know until they have a 
medical incident.
  So let me make this point to all my colleagues: If the purpose is to 
lower the cost of health care, then we are taking a mighty big risk 
because, in fact, what we may be doing is we may be raising the cost of 
health care in America, and with a disregard for the lives of the 
individuals who might be affected.
  When I came to the floor earlier today, I mentioned that last year 
alone 1.7 million tablets of counterfeit Viagra were uncovered, 1 
million tablets of Lipitor. This is according to the Wall Street 
Journal. I think that is surpassed, though, by the fact that last 
year--as we were in the heat of this new potential pandemic flu, H5N1, 
the bird flu; and we aggressively in this country then and still today 
are trying to come up with a vaccine and with other countermeasures 
that might be able to defeat or minimize the impact of the bird flu--
companies around the world started to look for Tamiflu as a successful 
countermeasure.

       Individuals in this country searched outside of the country 
     because the supply was so limited. Well, Customs agents have 
     intercepted more than 50 shipments of counterfeit Tamiflu. It 
     is an antiviral drug that is specifically designed to be 
     stockpiled for the pandemic flu.

  You see, my point is this: Counterfeiting, the trafficking of 
pharmaceuticals exists today. Anything that loosens the regulations on 
access to these pharmaceuticals invites more people to participate in 
gaming the U.S. consumer and, for that matter, the global patient. This 
is not something that is limited to the United States.

       Clearly, the adulterated product is usually a product that 
     is manufactured somewhere outside of this country. Not only 
     can they make a handbag look like a designer bag, they can 
     make a ``Viagra'' pill look like Viagra. Now, unfortunately, 
     you will know real quick whether there is an active 
     ingredient in that. But you will not know if it is, in fact, 
     a cholesterol-lowering drug or one of the things that really 
     does affect the long-term health of the American people.

  A study published in the medical journal Science found when a 
cholesterol-lowering drug manufactured in the United States was 
compared just to generic copies bought over the Internet from Mexico, 
Thailand, India, and Brazil, there were differences in the blend, the 
uniformity of the blend--an error that could dilute their effect on 
patients. The authors concluded that clinically this would have 
significance for a patient who was prescribed a half a tablet per day, 
which is not an uncommon practice.
  So for that senior at home, who has suggested an increase in the 
amount of milligrams of active ingredients so they can cut their 
pills--take half one day and half the next day because there are ways 
to maximize--what this report found, published in the medical journal 
Science, was that an adulterated product that does not reach the 
correct consistency throughout the pill might on one side provide the 
active ingredient and might on the other side not provide any active 
ingredient whatsoever. It could affect the dissolving rate, which could 
affect the onset of effect, or bioavailability.
  These are stories that come right out of medical journals. This is 
not about pharmaceutical companies and how powerful they are in 
Washington. This is about whether the focus of the Senate is on the 
safety and the well-being of the American people. This is about 
whether, in fact, we are going to maintain the gold standard of the 
Food and Drug Administration or whether we are going to accept the 
standards of other countries in the world where their bar is not quite 
as high, where they are willing to accept less in innovation, just to 
receive less in price.
  I am not sure that is a good tradeoff for the country. Clearly, the 
Senator from North Dakota has the votes potentially to win this. I do 
not find that too comforting, myself. I spent 2 years of my life 
actively involved in the 1997 modernization of the Food and Drug 
Administration. I worked with people on the right, the left, and the 
middle. I worked with people who wanted to do things at the FDA that 
today we still have not done, thank goodness, but there are still 
people who want to do it.

[[Page 11250]]

But we all came together to uphold one thing in that process--not to 
lower the bar, not to lower the standard that we asked companies to 
reach with their products for us to put that FDA stamp of approval, 
``safe and effective,'' on it.
  There are products sold outside the United States that could never 
pass the application process in this country. I know the Senator from 
North Dakota does not, in his bill, allow those products to come in. He 
limits it to FDA-approved products. So my focus is solely on the 
product that is FDA-approved in this country, but that has been 
manufactured in a way that either provides little active ingredient or 
no active ingredient, and with potentially harmful components found in 
that pill, or whatever the dosage might be.
  It is my hope we will continue to talk about this issue. But when I 
left the floor I thought it was important to go look at some of the 
articles to see if this is still a real problem. It is a problem today. 
It will be a problem tomorrow, and if we pass this, I think it will be 
a bigger problem in the future. It is a problem that is involved in 
funding terrorism around the world. It is a problem that will not go 
away, but at least today, we are able to control it. We are able to 
control it in a way that has a smaller effect on the quality of life of 
the people in this country. I think that is why they have us here. But 
we will continue the debate and we will see where we end. I think it is 
important enough that we spend days, if it takes days, to debate this 
legislation and to make sure everybody in this country understands what 
is at stake.
  I yield the floor.
  The PRESIDING OFFICER (Mrs. McCaskill). The Senator from North Dakota 
is recognized.
  Mr. DORGAN. Madam President, I would like to offer a few comments 
about this subject. My colleague has spoken on it several times. As I 
have indicated, we all want to deal from the same set of facts. This is 
not--let me emphasize again--it is not importing the standards of other 
countries with respect to the safety of prescription drugs. It does not 
do that. I want to make sure everybody understands what the facts are. 
Everyone is entitled to their own opinion; everyone is not entitled to 
their own set of facts. This does not import the standards of some 
other country into this country with respect to the safety of 
prescription drugs. This is simply the question of whether we want to 
continue to have FDA-approved drugs made in FDA-approved plants; that 
is, a plant inspected by our Food and Drug Administration, producing 
medicine and put into a bottle that is approved by our Food and Drug 
Administration and sold in this country and the same medicine, in the 
same bottles, sold in France, sold in Italy, sold in Germany, sold in 
Canada, sold in England, to have the U.S. consumer pay the highest 
prices of all of those countries. Is that fair to the U.S. consumer? 
The answer is no.
  We have a lot of issues that are being raised on the issue of safety. 
All the things I have heard discussed on the floor of the Senate apply 
to today--now--when we don't have importation. We are not able to 
import safely. I should say we are not able to import, rather, 
prescription drugs because there is a prohibition against it. The only 
entity that can import a prescription drug is the manufacturer. 
Lipitor. I held up two bottles of Lipitor on the floor today. Lipitor 
is made in Ireland. They send it all around the world. They send it to 
Canada and they send it to the United States. The bottle looks the 
same, the pill looks the same because it is the same, and it is sold 
under the same chain of custody--Canada and the United States. There is 
only one difference. The U.S. consumer is treated to double the price 
when they purchase their Lipitor. Is that fair? Should we pay twice the 
price for an FDA-approved drug? I don't think so.
  My colleagues have said there are counterfeiting issues. Well, all of 
the stories that have been recounted about counterfeiting issues are 
occurring under today's schematic of prescription drug sales in 
America. This has nothing to do with importing. In fact, the 
legislation I have offered is legislation that would make the supply of 
prescription drugs in this country and the supply that would come into 
this country under reimportation much safer. They would be safer 
because we have put in place safety procedures that have previously 
been blocked in the Congress, establishing serial numbers on the supply 
of prescription drugs, samples of the supply of prescription drugs to 
be held back by those who are manufacturing and moving the prescription 
drugs, establishing a pedigree for all of these drugs and the bottles 
in which they travel. It is much safer. It will be much safer for the 
domestic supply in addition to the supply of imported prescription 
drugs. That is the point we make.
  I suppose people will be tired of hearing me say that I respect those 
who have a different opinion, but I would prefer if they would stand up 
and say: You know something. Here is my situation. I think the American 
people ought to pay twice the cost for Lipitor because I believe that. 
That is a pricing strategy that works for my constituents.
  I don't hear anybody saying that, of course. They stand up and say 
there will be big safety issues, or my colleague who in an earlier 
speech this morning said this amendment would allow drugs to be 
imported into this country from all over the world. I am sorry. That is 
not right. That is not debating the bill that exists. We are not 
letting drugs in from all over the world; only from countries that 
would qualify, that meet the safety standards. These would only be FDA-
approved drugs, and they would only be drugs that are retained under a 
chain of custody, with a pedigree attached to the drug. There are no 
safety issues, unless one thinks it is unsafe for the pharmaceutical 
industry not to make the profits they currently make. They perhaps 
would see some smaller amount of profit if they passed part of the 
lower cost along to the consumers.
  Maybe perhaps the industry could do a little less advertising, just a 
little less advertising. When you turn on the television at night and 
you sit down at the end of a long day and you see somebody driving in a 
convertible with beautiful people and they park under a tree someplace 
and the Sun is setting, it is a beautiful appearance, and they say: 
These people are feeling good because of medicine they are taking. You 
should be asking your doctor whether you might want to take some of 
that. Get some of this pill. Get some of this medicine. The Sun shines, 
you get to ride in convertibles, feel better, hang around beautiful 
people. That is the way advertising works, I guess. I have talked about 
the purple pill. They say: Ask your doctor, is the purple pill right 
for you? I don't know what the purple pill is, but I almost feel like 
asking the doctor, is the purple pill right for me? All of this 
promotion and advertising, maybe they could back off a little bit of 
that and reduce the prices to the American consumer. But that is not 
the strategy.
  The strategy in pricing prescription drugs is that almost every 
country has some kind of limitation on what can be priced with respect 
to prescription drugs, except the United States of America, and here it 
is Katie bar the door. Whatever they want. We do have price controls in 
America. Not imposed by the Government; price controls by the 
pharmaceutical industry.
  Now, this is a fine industry. They have men and women working, trying 
to unlock the mystery of diseases, trying to find ways to produce 
medicines that will manage diseases. I admire all of that. I say 
congratulations to them. But I have a serious disagreement with them on 
pricing strategy. They are wrong to believe they have to charge the 
highest prices to American consumers. That is a fact. They are wrong 
about that. They say: Well, it is the only way we can do research and 
development. That is not true at all. That is not true. A substantial 
portion of research and development is done by the taxpayer through the 
National Institutes of Health and others, and the product of that is 
turned over to the pharmaceutical manufacturers in terms of 
intellectual property that is developed and they manufacture drugs. 
Good for them. I know they also do

[[Page 11251]]

substantial research on their own and I appreciate that. I don't 
appreciate the pricing strategy because I think it is unfair to the 
American consumer.
  I don't know how many people I have talked to over the years who have 
come up to me and told me of their problems: I am 80 years old. I have 
heart disease. I have diabetes. I take all kinds of medicines, they 
say, but I can't afford them. The doctor says in Dickinson, ND, one 
night: I have this welfare woman, and this patient has a pretty 
aggressive form of breast cancer. He says: You have to be taking this 
medicine to prevent a reoccurrence when you have surgery. You have to 
take this medicine to prevent a reoccurrence of breast cancer. She 
says: What does it cost? He tells her. She says: I can't possibly do 
that. I can't possibly take that. I don't have the money to do that. I 
can't buy that medicine. Does this matter? It sure matters to the 
person whose life is at stake. So price is an issue. It is a big issue.
  We have all these anecdotal stories. We know the data. The amendment 
I have offered will save $50 billion over the next 10 years--$50 
billion--most of it to consumers, through lower drug prices. That is a 
fact. It is not going to, in any way, injure the safety of our 
prescription drug supply. It will, in fact, enhance it dramatically by 
establishing pedigrees with respect to the movement of prescription 
drugs in this country and into this country. That is a fact as well.
  I said this morning I hate to lose debates I am not having, and it 
happens all the time on the floor of the Senate because someone is 
debating a bill I didn't introduce. They are welcome to do that. If it 
is attractive, maybe I will introduce it someday, but I am not 
interested in having a debate with somebody who wants to reformulate 
the legislation I have introduced. This addresses safety, all of the 
issues that Donna Shalala, the former Secretary of Health and Human 
Services raised, so we have incorporated into the bill, Senator Snowe 
and I and others have incorporated that right into the legislation. So 
you can't, it seems to me, make a strong case that there are valid 
safety issues. Again, I don't have problems with those who come to the 
floor saying let's continue the current system, but I think the current 
system is wrong. They have a right to advocate for the current system, 
but the current system is unfair to the American consumer, in my 
judgment.
  I want us to have the opportunity to have good health care and 
opportunities to be able to access miracle drugs, the opportunity to 
use those miracle drugs to manage diseases so you can stay out of an 
acute care bed, which is the most costly health care in our country. 
But I think it becomes almost a health care rationing in our country 
when we say we will ignore the situation that exists in this global 
economy in which the American consumer pays one price and consumers in 
virtually every other country pay a lower price for their prescription 
drugs. That, I think, is a horrible disadvantage to consumers in our 
country.
  Some will say: Well, you know now we have a Part D in Medicare which 
offers prescription drug benefits to senior citizens. Yes, that is 
true. It does. It has what has been defined around here only in the 
lexicon of politics as a doughnut hole. Only in the political system 
could we use those kinds of descriptions, but it has a kind of a 
circumstance where you reach a certain level and then there is no drug 
coverage on up from that level. Obviously, the prescription drug Part D 
for Medicare is helpful to senior citizens; there is no question about 
that. But it certainly isn't perfect because there is a substantial 
portion of it in which prescription drugs are not covered. At that 
point, senior citizens who are reaching the declining years of their 
lives are finding it very difficult to purchase their prescription 
drugs.
  There is much to say about this issue. I know there are some who 
worry that offering this amendment on prescription drug pricing to this 
underlying bill, the FDA Reauthorization Act, injures the underlying 
bill. I support the underlying bill. I think my colleagues, Senator 
Kennedy and Senator Enzi, have done some good work. I support that 
work. Let me say--and I know they know this--it is perfectly 
appropriate to offer this amendment on this bill because this is where 
it belongs. This is exactly where you would offer an amendment of this 
type. No one should express surprise about that.
  So we offer the amendment and then we file cloture so we can actually 
get to a vote on it, and all of a sudden it is like the circus left 
town. They pull up the tent stakes, fold up the tent, everybody is 
gone. All of a sudden we can't vote anymore. Why? I guess they are 
upset that my amendment is now in order to be voted on, and they say: 
You know, I don't know. We can't do that.
  As I have indicated before, I would be willing to offer this 
amendment in a different form--the same amendment but in a circumstance 
where I had an agreement to be able to bring it up. Four hours of 
debate, for example, a couple of amendments that would be offered by 
the other side, I would have the right to offer second-degree 
amendments, we would go to a vote and decide whether the Senate will 
pass a proposition that would give us an opportunity to reimport FDA-
approved drugs from other countries that are identical to the other 
drugs we now purchase, except at a lower price. I would be happy to 
agree with others who would give us that time and that circumstance so 
that we could have this vote. I don't need to have the vote today or 
Monday or Tuesday, if I have an agreement that we will be able to get 
the vote at some moment.
  This vote has been stalled a long while. Senator Frist, when he was 
the majority leader, standing right back here at the end of this aisle 
at about 1 o'clock in the morning, in exchange for my releasing a hold 
on the nomination of Dr. McClellan, indicated to me and then put into 
the Congressional Record, in the Senate Record, that we were going to 
have action on this kind of legislation. It turns out it never 
happened. Senator Frist, of course, is now gone. For whatever reason, 
it never happened. I spoke at great length to him about these issues, 
but it didn't happen.
  So this is an opportunity for us to advance this legislation, and it 
is the right place at the right time. This has 33 cosponsors. John 
McCain is a cosponsor, Ted Kennedy is a cosponsor, Chuck Grassley is a 
cosponsor, Debbie Stabenow is a cosponsor, and Olympia Snowe is the 
major cosponsor with me. It is the Dorgan-Snowe bill.
  Thirty-three Republicans and Democrats are cosponsors of this 
legislation. This is exactly where it should have been offered, and it 
was. Now, all of a sudden, apparently there is some kind of gastric 
distress because we had a cloture vote and we prevailed in the vote 
that we say, all right, let's have votes on this amendment. So my hope 
is that, first, while we might form opinions on this amendment, we 
could coalesce on a central set of facts that represents what the 
amendment does and says; and, second, that we can begin, on behalf of 
the American people, to make some movement here and to begin to have 
votes.
  I also hope that, as I listen to further debate on the floor, we can 
stick to what the amendment is. It is not to reimport lower priced FDA-
approved prescription drugs from everywhere. It limits it to those 
areas where we have safe and effective supplies of prescription drugs.
  I hope we can get all of the facts straight. This amendment has a lot 
of support. I believe the American people, by 75 to 80 percent, support 
this. I have seen poll after poll where the American people believe it 
is wrong and unfair for them to be charged the highest prices in the 
world for prescription drugs. Why on Earth should they drive 10 miles 
between two drugstores--one on the Canadian side and one on the 
American side of the border--only to find that the same medicine, put 
in the same bottle, made by the same company, FDA approved, has only 
one difference--the American consumer gets a chance to pay double. How 
do you justify that? You don't. We ought to change it.
  I yield the floor and suggest the absence of a quorum.

[[Page 11252]]

  The PRESIDING OFFICER (Ms. Klobuchar). The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. BYRD. Madam President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                          U.S. Policy in Iraq

  Mr. BYRD. Madam President, President Bush marked the fourth 
anniversary of his announcement that major combat operations in Iraq 
have ended by vetoing war funding legislation because he claimed it 
limited his ability to prosecute a war unconditionally and 
indefinitely. Our Armed Forces are now well into their fifth year of 
combat operations--longer than the U.S. was involved in World War II--
and the time is overdue to examine and update U.S. policy in Iraq.
  The legislation, which President Bush vetoed, would have set a 
responsible, new course for the war that was a balanced and fair 
proposal that I was pleased to support. Sadly, the President continues 
to believe peace and stability can be forced on the Iraqi people at the 
point of a gun. He was wrong in 2002 when he sought authorization to go 
to war, and he is wrong today.
  However, now that the President has insisted on continuing down this 
failed path, it is our responsibility to discuss alternatives that can 
become law. The Congress is not an ATM, spitting out billions whenever 
the President requests it. It is a policy arm of the Government, as 
well as its banker. The Constitution says the Congress shall have power 
to provide for the common defense. It is the Congress--yes, it is the 
Congress--that is given the sole power to declare war. The Congress is 
sworn to raise and support armies. The Congress and the people of the 
United States have a right to expect clarity in our mission and a 
foreseeable end to this conflict.
  The situation in Iraq, in 2007, is very different from what it was in 
2002, when the Congress authorized the use of military force in Iraq. 
The President himself said this:

       This is not the war we entered in Iraq, but it is the war 
     we are in.

  It is time to rethink, reset our goals, and consider a new 
authorization which outlines the mission as the President now sees it. 
The October 11, 2002, authorization for the President to use force in 
Iraq was very specific. After expressing support for diplomatic efforts 
to resolve the causes of conflict with Iraq, the authorization allowed 
the use of force for two purposes. The first was to defend the national 
security of the United States against the continuing threat posed by 
Iraq. The second reason was to enforce all relevant United Nations 
Security Council resolutions against Iraq.
  In 2002, and early 2003, President Bush made his case to Congress and 
to the American people for the invasion of Iraq. His stated goals 
included the elimination of the weapons of mass destruction programs 
that Iraq was thought to possess, and the overthrow of Saddam Hussein's 
regime. By that yardstick, the U.S. military has achieved brilliant 
success. No weapons of mass destruction were found in Iraq--not just 
weapons that could threaten the national security of the United States 
but also no weapons of mass destruction of any description. Saddam 
Hussein and his Government are gone. The Iraqi people have elected a 
new government. The U.S. military has achieved success in Iraq, and 
that success has come at a high price, both in dollars and in lives. 
Thus far, over 3,350 American men and women have been killed, and many 
more have been wounded. Including the funding in the emergency 
supplemental vetoed by the President, over $450 billion has been 
provided by Congress to execute this war.
  The October 11, 2002, authorization to use force has run its course. 
It is time--past time--to decommission this authorization and retire it 
to the archives. If the President has more that he wants to do in Iraq, 
then he needs to make that case to Congress and to the American public. 
Our continuing presence in Iraq is not supported by the people or the 
Congress. The President must redefine the goals and submit his plan to 
achieve them to a thorough and open debate in the Congress and 
throughout the country. That is the American way. Success will elude us 
without the support of the people whose sons and daughters are being 
asked to die daily in the sands--yes, the sands--of Iraq.
  I propose October 11, 2007, as the expiration date for the 2002 
authorization and that the President seek a new authorization from the 
elected representatives of the people in Congress. The President must 
be clear about what he now hopes to accomplish in Iraq and how he 
intends to achieve it. President Bush must build support for his plan. 
Without the support of the public and the Congress, we should no longer 
be in this fight. It is now an Iraqi fight for national reconciliation, 
not a war to ensure U.S. national security. If the President sees a 
further role for U.S. troops, he should articulate it and seek 
consensus for a changed mission. I hope my colleagues on both sides of 
this important debate and on both sides of the aisle can agree that the 
2002 authorization has run its course. It is no longer viable, and it 
should be set aside.
  What I propose does not mandate redeployment on any date certain. It 
simply calls on the President to make the case for the new situation in 
which we find ourselves. My proposal does not set limits on troop 
levels, nor prevent them from doing what is necessary to protect 
themselves and U.S. personnel. It also does not prevent us from 
pursuing terrorists who may have set their sights on the United States. 
What it does is stop our troops from fighting endlessly in an Iraqi 
civil war after October 11, 2007, unless the President--our President--
receives a mandate from the American public and the U.S. Congress.
  Let us try to give the President a chance to refocus his vision on 
the changed circumstances in Iraq, free from the shackles of a 
shamelessly outdated grant of authority. I deplore the political 
gamesmanship which has polarized our Nation. I regret the harsh 
partisanship which rages while our brave troops fight and die.
  A fresh start could help to change the dynamic in this country. A 
concerted effort by the White House to reassess its goals and 
opportunities in Iraq could point a path to progress. A new debate in 
Congress could resolve confusion and contention about continuing a 
strategy for Iraq that no longer addresses the exigencies of today. We 
need a new mission which makes clear the changed role of our troops. We 
need a diplomatic component to the plan which might encourage the 
national reconciliation so badly needed to quell the violence in Iraq. 
We need a plan to reach out to other countries in the area which share 
our interest in seeking stability in Iraq. But first we need to clear 
the cobwebs and the confusion caused by a grant of authority that no 
longer has any relevance to the present conditions of Iraq.
  I ask other Senators to consider my proposal, whether this proposal 
is considered on the supplemental, on the Defense authorization bill, 
or on the Defense appropriations bill. I ask cooler heads to see the 
possibilities of beginning a new assessment of where we are and where 
we are going. I ask for a cease-fire in the political war in Washington 
for the sake of our troops and for the sake of our country.
  Madam President, I yield the floor, and 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.
  Mrs. CLINTON. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mrs. CLINTON. Madam President, I rise to join my colleague and 
friend, Senator Byrd, to announce our intention to introduce 
legislation which proposes October 11, 2007--the 5-year anniversary of 
the original resolution authorizing the use of force in Iraq--as the 
expiration date for that resolution.
  As Senator Byrd pointed out, the October 11, 2002, authorization to 
use

[[Page 11253]]

force has run its course, and it is time to reverse the failed policies 
of President Bush and to end this war as soon as possible.
  Earlier this week, President Bush vetoed legislation reflecting the 
will of the Congress and the American people that would have provided 
needed funding for our troops while also changing course in Iraq and 
beginning to bring our troops home.
  I believe this fall is the time to review the Iraq war authorization 
and to have a full national debate so people can be heard. I supported 
the Byrd amendment on October 10, 2002, which would have limited the 
original authorization to 1 year, and I believe a full reconsideration 
of the terms and conditions of that authorization is overdue. This bill 
would require the President to do just that.
  The American people have called for change, the facts on the ground 
demand change, and the Congress has passed legislation to require 
change. It is time to sunset the authorization for the war in Iraq. If 
the President will not bring himself to accept reality, it is time for 
Congress to bring reality to him.
  I urge my colleagues to join Senator Byrd and me in supporting this 
effort to require a new authorization resolution or to refuse to do so 
for these new times and these new conditions that we and our troops are 
facing every single day.
  Madam President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Madam President, what we are actually on, of course, is the 
30 hours of debate postcloture on the drug importation amendment, and I 
do want to make some comments on that. I perhaps should have done more 
extensive debate before, rather than agreeing for a time specific for a 
vote on it, but that option has passed at the moment. I congratulate 
Senator Dorgan for his tremendous victory.
  I am hoping there will be some changes yet. Perhaps there will not 
be. We took a 300-page bill that dealt with drug safety in the United 
States and we then added a 140-page bill that deals with bringing in 
drugs from other countries. It is a limited number of countries, to 
start with, but it is bringing in drugs from other countries. I suggest 
if they are as safe as what we have been told, parts of this bill would 
not exist.
  For instance, page 48, on bioequivalence. It was my understanding 
what would be brought into the United States would be drugs from 
companies from the United States that went to Canada, or went to some 
other place, and could be brought back into this country. These would 
be FDA-approved drugs. These would be the ones we rely on the FDA for. 
If they are exactly the same drugs, by exactly the same company, why 
would there be a section on bioequivalence?
  It says:

      . . . if the Secretary determines that the qualifying drug 
     is not bioequivalent . . . the Secretary shall . . . include 
     in the labeling provided under paragraph (3) prominent 
     advisory that the qualifying drug is safe and effective.

  Well, let me see. We didn't ask them to review it, we didn't ask that 
it go through the same procedure, but we want the Secretary to provide 
labeling that says it is safe and effective. I don't know why we would 
expect the FDA to say anything that is bioequivalent should have their 
endorsement of being safe and effective. If we do, it expands their job 
dramatically and there ought to be resources that go with it to be sure 
that what we are promising will be done gets done.
  There are a lot of pages here, a lot of different things. I am 
definitely not going to hit on all of them, but I am going to mention a 
few that people probably ought to be a little concerned about.
  Here again, on page 56, I thought it was going to be U.S. drugs, or 
at least drugs from U.S. companies that are already FDA approved that 
we were going to make sure there was an absolute chain of making sure 
they got back into the United States so that you could trust what came 
from U.S. companies. Yet on page 56 we see:

       Notice; drug difference not requiring approval.

  What?

     . . . supplemental application would not be required for the 
     difference to be made to the U.S. label drug, or that states 
     that there is no difference.

  And then a whole bunch of requirements again for the Secretary, which 
goes down the line to the FDA. So I think we can conclude we are not 
just going to bring in U.S. drugs. If there is anything you would like 
to have, you can.
  Then there is a section called ``Importation by Individual.'' This 
covers the portion where each person can get on the Internet or 
telephone or whatever way and order drugs. There are requirements in 
this bill for exporters, which are the people who are sending drugs to 
other countries; there are requirements in here for importers, which 
are companies receiving drugs--and those could be pharmacies, probably 
would be pharmacies, although there could be some wholesale--but there 
is also this section about importation by the individual.
  I hope everybody takes a little look at that, because in the United 
States I have been working a lot on financial literacy, trying to get 
people to understand finances and how they can stay financially sound 
and hopefully financially secure, and it is a huge job. With regard to 
the No Child Left Behind Act and in Education, we keep talking about 
plain old literacy; just being able to have people read, and read at 
grade level, and hopefully read well enough to have a good job and to 
protect themselves. They better be literate, because look on page 62 
and read what the importing individual is responsible for. Because if 
they are not responsible for this, they could easily be getting 
something that is not an approved drug or that is not from the source 
they think it is. It could be a counterfeit drug, and particularly as 
this opens up on the front end. How many people doing counterfeit drugs 
now are going to want to jump into the breach and catch people before 
they understand any of this? I suspect there will be a huge escalation 
of companies getting into the counterfeit business. There are a few 
dollars in it--quite a few dollars.
  I would encourage people to look on page 62. There are things 
scattered throughout the bill an individual would have to know to be 
sure what they were getting was safe, if they ordered individually. But 
that is kind of the point of the bill, because most of them probably 
will be ordered individually.
  On page 64, Request for Copy of Special Labeling and Ingredient List. 
I think that probably would be handy.
  Then, on page 65, it goes into the question of adulteration, where it 
says a qualifying drug that is imported or offered for import shall be 
considered to be in compliance if the drug is in compliance with all 
these other sections.
  There is also a section titled Standards for Refusing Admission. 
There are quite a few ways it can be denied, but in order for these 
adulterated drugs to be denied, to be refused admission, somebody has 
to find them. So what kind of force are we going to add to the FDA to 
make sure these things can be found?
  I am particularly fascinated with item (F), which gives the Secretary 
some extra capability if the drug is counterfeit or if the drug may 
have been prepared, packed, or held under insanitary conditions. Now, 
the fact that they mention it has to make you believe there is a 
possibility--maybe a probability, the way it is put in here--that they 
will be prepared, packed, or held under insanitary conditions.
  The United States has a little different level of sanitation than a 
lot of the countries around the world. Of course, all of these aren't 
going to come from all around the world to begin with, or will they?
  Let's see. They do not have to be bioequivalent. There are a whole 
bunch of things the individual has to watch out for themselves. It 
doesn't have to be the same drug that was manufactured in the United 
States or from a United States company, and if it gets into the EU, it 
can come to us. That is EU now; EU later. The EU is expanding. We ought 
to take a look at some of the

[[Page 11254]]

countries that are being brought into consideration, particularly if 
you might be worried about them being packed, held, or prepared under 
insanitary conditions.
  Then we get to page 71. Again, there are a lot of things I would like 
to mention in between, but this is all boring detail stuff, anyway, so 
I will highlight a few of these things and let people think about them 
a little bit.
  On page 71, we give the Secretary some more responsibilities. They 
have to:

     . . . enter into an agreement with the government of the 
     country to receive information about recalls and withdrawals 
     of qualifying drugs in the country; to monitor recalls and 
     withdrawals of qualifying drugs in the country using any 
     information that is available to the public in any media.

  There are requirements for notice and changes in the labeling, 
packaging, and that sort of thing.
  That is all additional. We are asking them to do some more things in 
the United States to make what we have here and are relatively certain 
about even safer. That is the purpose of the bill. Now we are adding 
these additional sections, 140 pages, which bring the problem from 
other countries to our country. I grant it, a lot of those are made in 
the United States or by companies from the United States.
  Page 72, again, has a whole bunch of requirements for what kinds of 
things ought to be included with the drug. You need to know those 
because if they are not, you maybe ought to suspect there may be a 
problem. You have to be able to check the packaging and note whether it 
has the proper seals and whether there could have been any damage to 
them. It is your problem--unless, of course, the consumer consents to 
waive the requirements after being informed the packaging does not 
comply. There is fascinating stuff in here.
  Here is one of the parts that really ought to interest us. When we 
get to page 76, page 76 says you have to play the game: You can't win, 
you can't lose, and you can't get out. Here is how that works.
  Canada has price fixing. There is no doubt about it. That is how they 
get some of the lower prices on some of the drugs. You can't buy all of 
the drugs in Canada at lower prices. In fact, I have a friend in Afton, 
WY, who is a pharmacist. He had a fellow come in who was from Canada 
but he could not get back to Canada and his prescription had run out, 
so he relied on an American pharmacy to get his prescription refilled. 
All the time they were filling the thing, he is complaining about how 
this darned prescription is going to cost him an arm and a leg because 
it is in the United States and the cheap drugs are in Canada. The 
pharmacist gave it to him, told him what the price was, and he said: 
But that is cheaper than I get it in Canada.
  That is a little bit of financial literacy. Just because you heard 
everything is cheaper in Canada doesn't mean it is.
  You should particularly pay attention if there are generics because 
U.S. generics do not translate to Canada nearly as quickly, if at all. 
The companies had to go through this bidding process. The bid doesn't 
take into consideration the change, and that is part of the deal, that 
you get a little bit of exclusivity with your pill.
  I was interested in Zocor. It is a big drug in the United States and 
a big drug in Canada, although Canada has one-tenth the population of 
the United States. The Health Minister called me and said: You cannot 
be considering this import thing. We do not have the capability to 
supply the United States with their drugs. We will be inundated with 
prescriptions, and we do not have that big of a supply because we have 
a tenth of the people the United States has.
  Getting back to my Zocor story, that has gone generic. In Canada, you 
still have to get Zocor, and it is $33.64 for 30 pills. That is a 1-
month supply of 10-milligram pills. That would not, of course, include 
the cost of shipping and handling.
  In the United States, there is a generic Zocor, simvastatin. The 
statins are all designed so that part of the label talks about doing 
similar things. But the generic Zocor in the United States costs $29.99 
for 30. So that is $3.50 less. It is not a lot, depending on what you 
consider a lot to be, but it is less. But if you are willing to use 
provostatin or lovastatin, we are talking about $4 a month--$4 a month 
as opposed to $33.64 a month.
  People need to be aware that just because we say Canada is cheaper, 
it is not always cheaper. But for those drugs which are cheaper, page 
75 has a little provision.
  I need to explain how Canada gets this price fix. It is called 
negotiated price. How do you negotiate a price if there is a sole 
supplier? You really do not have much luck negotiating if it is a sole 
supplier, so you have to take similars. I use the example that if there 
are five heart medicines, you make those five bid against each other. 
That is your leverage. If you make them bid against each other, you 
have to drop somebody to get the price down, and probably several to 
get the price down, so maybe you have one or two heart drugs instead of 
five. But you tell your doctors--who in Canada work for the state--that 
is their choice, and they make it.
  But in the United States, we are used to having our doctor make the 
decision. And because of television advertising, we are able to make 
some of our own decisions on what we think would be the best one and 
tell our doctor what he better do for us. Sometimes that is another 
little problem.
  At any rate, that is how Canada gets lower prices. We can probably do 
that in the United States, too, but people in the United States really 
expect to be able to get the drug their doctor says they ought to have. 
I think we would have a large-scale revolution if we started suggesting 
that the Government could figure out which drugs they could have so we 
could get lower prices.
  Page 75, section (b), that is where they say if a company has a drug 
that is in Canada, it has to be sold in the United States at the same 
price. So you really do not have to go through Canada. That will just 
move Canada's price fixing down to the United States.
  I have to mention a little thing on pricing when the Government gets 
into that business. Back in 1975, I got married, and my wife and I 
started a shoe store in Gillette, WY. You will recall at that time that 
the Government decided they would put some prices in there. This really 
shows that it was 1975. We always made sure there were several styles 
of men's shoes that were under $10. I don't know if you can get the 
laces for $10--yes, you can. But you cannot buy $10 leather shoes, 
leather lined, particularly not made in America. That has disappeared, 
too.
  But they decided, for a whole range of products in the United States, 
that the Government would set the price to keep down inflation. The 
companies, as soon as they heard about that, said: This will really 
affect our profitability, and we are not going to be allowed to raise 
them except at set particular times and for set amounts. So what they 
did was raise their prices right away. A $10 shoe became a $15 shoe 
overnight. Then the price setting went into effect and they were 
allowed to raise it again, and they raised it again to the maximum 
there. And every time they were allowed to raise it, they raised it. It 
made a huge difference in the price of shoes, as it did with everything 
that was being attempted to be controlled. People wound up paying a lot 
more than if there had been no Government pricing.
  How will that work here, if you are a pharmaceutical company and they 
say that you are not going to be able:

     . . . to discriminate by denying, restricting or delaying 
     supplies of a prescription drug to a registered exporter or 
     other person in a &fnlpermitted country that exports a 
     qualifying drug to the United States under this section. . . 
     .

  And you can't:

     discriminate by publicly, privately, or otherwise refusing to 
     do business with a registered exporter or other person in a 
     permitted country that exports a qualifying drug to the 
     United States under this section . . .

  And so on. I am reading from the bill here. What it says is that if 
you are selling it to them now, you can't change at all.
  If I am the company that is about to find out that the price I have 
in this

[[Page 11255]]

deal with Canada, which is just a small part of the deal, and I am 
doing it--I am the only accountant in the Senate. For accounting 
purposes, sometimes these companies will sell to another entity a ways 
away--in this case, another country--for a lower price because they 
cover the costs and make a profit on what they are doing. But by 
picking up peripheral sales, there is less cost involved in them, so 
there is still the same amount of profit. Granted, that is kind of an 
accounting technique, but it is the way a lot of businesses have to 
pick it up. That is why they keep going for additional sales and 
looking for ways to get additional sales. They have gotten additional 
sales in Canada by going through this bidding process which fixes the 
price.
  But what we are saying on page 75 of this bill is that if you sell to 
Canada, you have to keep selling, you have to keep selling at the same 
price, and you cannot get out of the game unless--and here is the 
``unless'' that I bet you kicks in--unless you are not selling to them. 
So unless there is some kind of ironclad contract that requires them to 
continue to do that, Canada is just about to lose its drug supply 
because they are not going to continue to sell up there at a rate that 
is below cost--if you are doing it at U.S. costs--if you can jerk that 
drug.
  That is why Canada is a little bit concerned about what we are doing 
here. First of all, they don't have enough drugs in the pharmacy and 
enough pharmacies to supply 10 times their population, for the people 
in the United States, and second, they are worried because their supply 
will be cut off before this bill goes into effect, so it really doesn't 
go into effect. That would be the effect of it, that this would be 140 
pages of wasted trees.
  You have to believe, unless there is an ironclad contract, that is 
what a business would do. It is a terrible thing to have happen to 
Canada or the other countries. But that is what happens when you fix 
prices.
  I would mention that on page 115, it begins a section on Internet 
sales of prescription drugs. I will give them credit for giving it a 
try. I will not give them credit for having a very complete or safe job 
on it, but it is a try. It is important for them to try because most of 
the people in the United States will be ordering their drugs, probably, 
through the Internet--perhaps over the telephone but not in person.
  The examples we have heard of everything working fine have been of 
people going across the border in a car and buying at a pharmacy. That 
makes sure the trail of concern and safety is more likely to be there. 
But the Internet is a little bit more universal. Things can go around 
the world in a matter of minutes. They can go from one server to 
another server to another server--you are now covering three 
countries--and it looks as if it came out of the last country, perhaps, 
if you want it to look like that. There are a lot of things that can be 
done. I know the kids would probably understand that more than I would 
because they are able to do a lot more things on the Internet than I am 
able to do on it.
  I know there are some difficulties with the Internet because the FDA 
has already intercepted problems and been able to confiscate some drugs 
that were tremendous problems. They are pretty sure some got into the 
country and didn't wind up in a situation of death, but they did find 
out they wound up in a situation where the person was not getting what 
they thought they were getting and it wouldn't digest and problems such 
as that. But they have also confiscated a huge amount of drugs which 
have been sold over the Internet which came into this country and which 
have a lot of problems.
  I had a display up here on the desk. The Senator from North Dakota 
likes to hold up two pill bottles and say: What is the difference 
between these two pill bottles? One is the United States and one is 
Canada. What is the difference in price? And he goes through the 
pricing difference. But one of the things he ought to go through at the 
same time is: Can you tell which was made in the United States and 
which was not? Can you be sure the one you say was made in Canada was 
made in Canada? I will tell you, there are some absolutely marvelous 
counterfeits out there.
  The box I have here has a couple of examples of confiscated drugs 
from the FDA. You cannot tell by the box, you cannot tell by the 
packaging, you cannot tell by the pill. I am even told that if you 
grind it up, you will wind up with the same components; they are just 
not put together right, so they don't work. But as long as it is not a 
lifesaving drug for you, you can get along with it, anyway, you just 
will not be getting the benefits from the drug. Something to think 
about.
  There is a possibility of improving that section, because one of the 
amendments that has already been filed is by the Senator from New 
Hampshire, Mr. Gregg, who has been working this Internet problem for a 
long time. He has an amendment that is a vast improvement over this 
section and might be able to greatly enhance and perhaps correct some 
of the problems that can happen there.
  I would mention one more. Page 131, a restricted transaction. See if 
you have the pharmaceutical literacy to know exactly what is happening 
here. A restricted transaction means a transaction or transmittal on 
behalf of an individual who places an unlawful drug importation request 
to any person engaged in the operation of a registered foreign 
pharmacy.
  Now we have got to know who the registered and unregistered ones are 
and whether it is lawful or unlawful drugs. Again, there is so much 
literacy that has to go into this, as opposed to what you get in the 
United States, that you know it was from the United States.
  We probably do pay a premium for our safety. Most people want to be 
sure they are safe. There is also a little bit of a problem with the 
bill the way it is written and being able to tell about the wholesale 
licensure and the pedigrees that go with that licensure. There will be 
another amendment that will be submitted that hopefully can clear up 
some of those problems. I hope people will work with us.
  As you can see, one of the things we are trying to do is to make a 
problem better. I think it would have been a lot better if we could 
have gone ahead and had the drug safety taken care of today, which we 
were on a track to do, because Senator Kennedy and I had already worked 
through all of the amendments that had been turned in, with the 
exception of the importation one. We had been able to resolve or have 
them withdrawn for almost everything and could have wrapped it up with 
a few more votes. But it will take us a little longer now. We are 
hoping there are opportunities to improve the bill. I know under the 
procedure of the Senate there are ways to keep people from being able 
to have votes.
  I mentioned a number of times the success Senator Kennedy and I have 
had with the Health, Education, Labor, and Pension Committee, a big 
bite of the apple, the success we have had in the previous 2 years. 
Some was because we did not follow an exact procedure of going to a 
markup and arguing until things were polarized. We took what we could 
and worked with people through the process, and they trusted us enough 
to work through the process, so by the time it came to the floor, we 
had a managers' amendment that covered a lot of the difficulties people 
had with the bill.
  When you put in an amendment, technically the amendment is one way or 
the other. Oh, yes, there are ways to do second-degree amendments, but 
you will not see many of those around here, because that is putting in 
another very concise set of words that is accepted or rejected. They 
can change the original bill a little, or perhaps a lot. Some of them 
can be complete substitutes. But they are polarizing, and they do not 
take care of the technicalities. The advantage of running the bill 
through this sized body, then through the other end of the building 
with 435 people, is to get 535 opinions of what ought to be done. Out 
of 535 opinions, we can usually come up with a pretty good bill. But 
when an amendment is put in and there is no way to do any correcting, 
or the only way you can do correcting is another take-it-or-leave-it 
bill correction to it, it is a very difficult way to get any 
legislation done.

[[Page 11256]]

  Our success over the last 2 years of getting legislation done was 
because we worked this process of continually working until we got to a 
final product, which meant cleared through conference committee.
  But evidently we are not going to do that this year with this piece. 
It was a significant victory for someone who has worked very hard on 
it. Senator Dorgan has worked hard on it for a long time. He did an 
outstanding job of presenting it. Now I am hoping he will work to see 
that it gets perfected a little bit more. It cannot be perfected in the 
way we normally perfect it, but a little bit more as we go through the 
process, and perhaps by about next Thursday we can finish with the 
bill. It is an extra week of work, but I think this could have been 
brought up in a separate bill, handled individually, and had some of 
the same mechanisms for improving it we would normally have in a bill. 
But that is behind us now. So we continue to work on the bill, and we 
hope by a week from today we can have this concluded.
  Mr. President, I yield the floor, and suggest the absence of a 
quorum.
  The PRESIDING OFFICER (Mr. Whitehouse). The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KENNEDY. 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. KENNEDY. Mr. President, to review where we are in this debate and 
discussion, we will be meeting again on Monday next, making critical 
choices and decisions about the way we are going to proceed. We have 
made good progress over the course of this week. Some of us were 
hopeful that we would be able to move toward the completion of this 
legislation. But this legislation is enormously complex and enormously 
important.
  We have made, as I say, good progress. We have a number of different 
areas we have worked through over the period of these past days. We 
will propose a managers' package and we will make the final judgments 
about the determination of this legislation on Monday next.
  Again, we thank all of our colleagues who have worked with us on the 
legislation. Very quickly, to say again why this legislation is 
important, and that is because, as we know, the FDA effectively 
protects the prescription drug supply and our pharmaceutical supplies, 
medical devices, vaccines, food supply and cosmetics; about 25, almost 
30 percent of all of the consumer products. So, it is enormously 
important that we have the FDA be the gold standard to protect American 
families, particularly with regard to prescription drugs and with 
regard to food and other items as well.
  So very quickly, and finally, to review exactly what this legislation 
does and why it is so important, why it is so urgent, why it is so 
necessary--and this legislation falls in that category--that is why we 
are urging that we reach conclusion on Monday next.
  One of the notorious recent examples of fear that took place in many 
households this past year, over the period of the last year, was the 
Vioxx scare, the whole issue and question about those whose lives may 
very well have been shortened because of Vioxx.
  The best way to illustrate what we are talking about in terms of 
patient safety is how this legislation would deal with a future kind of 
a Vioxx that might endanger the health of our fellow citizens.
  First, can the FDA quickly detect a safety problem with a drug? With 
the Vioxx situation, the answer was no. Now we have a completely new 
system, a sort of an information technology system with regard to post-
marketing surveillance. We draw on all of the public as well as private 
systems--the Mayo system, the veterans system, the myriad different 
systems that will be collecting information. It will be collected in 
one central place--the FDA--so the Food and Drug Administration can 
demonstrate that there is a safety problem. There will be notice for 
the Agency.
  Can the FDA require the label changes to warn of safety problems? 
Under the existing circumstances, there was a negotiation for some 14 
months before they were able to resolve that issue. Finally, the drug 
was withdrawn by the company. If the company doesn't deal with the 
Agency, the Food and Drug Administration has the authority and power to 
withdraw the approval and effectively repeal the drug. But that has 
very important safety considerations because there may be certain 
populations where this particular drug may be suitable. That is 
probably true with Vioxx. It is not suitable for the general population 
but suitable for a particular population. What this does is give the 
FDA the kind of opportunity for labeling changes to warn of safety 
problems. It has other alternatives which I will refer to lower in the 
chart.
  Are companies stopped from hiding safety problems? It is extremely 
difficult because we include the publication of clinical trials so they 
will be available to the public. This transparency included in this 
legislation is enormously important. The value of clinical trials is 
not only important from a safety point of view but also for individuals 
who are affected by disease and illness. They may make a judgment that 
they want to enroll in a particular clinical trial and try to remedy 
their particular health challenge. There will be the registry and the 
opportunity for them to do that. That has not existed in the way we 
have done this. That opens up enormous kinds of opportunities for many 
people who have many of the illnesses and sicknesses we know affect so 
many of our families. So, we have the safety provision and also the 
opportunity for people who have those illnesses and diseases to take 
advantage of this program.
  Does the FDA have flexible tools to enforce safety decisions? The 
answer is yes. This was described well by my friend from Wyoming, 
Senator Enzi. He talked about the toolbox available to the FDA. It can 
be included in labeling. It can be included in terms of training of 
various personnel to administer the drug. It can be included in terms 
of specialized targeting, particularly groups in the medical profession 
who have the skills to dispense those drugs. There are a variety of 
different tools that are in there that do not exist today.
  Finally, is the FDA the gold standard for protecting the public 
health and assuring access? We believe the answer is yes. These are 
practical examples of how we protect families.
  We have another chart which makes this point as well. We had an 
excellent study done by the Institute of Medicine, an extraordinary 
group of individuals who reviewed the powers of the FDA and made 
recommendations. This chart shows we have incorporated in this 
legislation, by and large, the recommendations made by the Institute of 
Medicine, with respect to drug safety. We built in the epidemiology and 
the informatics capacity to improve post- marketing assessment, using 
information technology; to make public the results of the post-clinical 
trial; to regularly analyze post-market study results; to give FDA 
clear authority to require post-marketing risk assessment and 
management. If there are additional kinds of requirements in terms of 
the drug itself, the FDA will have that authority and give better 
enforcement tools. We also include some civil penalties to make sure 
this is going to be enforced--that is important--and conduct regular 
evaluation of a new drug's safety profile. We will continue with post-
marketing surveillance. This will be a continuing process to protect 
the American consumer. It is an enormously important concept to 
implement this. We will also increase drug safety resources available 
to the FDA. We have done all of these in this legislation.
  We have enhanced the Office of Science, and we have improved 
significantly the conflict of interest and other provisions.
  This gives you some idea. We have an excellent statement from groups 
who represent 30 million patients: This legislation gives the FDA the 
ability to

[[Page 11257]]

continue to study the safety of drugs after approval, flexible 
enforcement tools necessary to ensure compliance with these new safety 
protections, and additional funding to support these new activities. 
Allowing the Agency to act on clear safety signals could actually allow 
the FDA to approve drugs more quickly, knowing it will have the ability 
to respond on behalf of patients if safety concerns appear post-market.
  That is important. With breakthroughs in the life sciences and 
different opportunities that are now available, the Agency will feel 
more comfortable in approving drugs which they may have a speck of 
doubt about, but they will know that with the kind of review processes 
we have insisted on in this legislation, they can get on the market 
quicker and that it can improve the quality of health and safe lives. 
This is very important: ``knowing it will have the ability to respond 
on behalf of patients if safety concerns appear post-market.''
  This is from the Alliance for Drug Safety that represents 30 million 
patients, a very solid endorsement of what this legislation is all 
about.
  We have done a similar protocol with regard to food safety as well, 
of the importance of surveillance. As we would with some bioterrorist 
threat, it is enormously important that we understand what is happening 
in a number of these countries around the world, early survey labs, and 
the follow-on provisions that we have included.
  A final point, we have had a debate with regard to the differential 
that has taken place in the different countries. The presentation has 
been made. There has now been the pending Dorgan amendment which 
recognizes this disparity to make some adjustments on this issue in 
terms of the medicines.
  We will move ahead on this. We have other items which have been 
proposed by our colleagues and on which we are prepared to make some 
recommendations. We have worked very closely during the evening, early 
morning with Senator Enzi and our colleagues. We are hopeful we will be 
able to see a conclusion of this legislation, which is so vitally 
important to the American people during the early part of next week.
  Again, we are enormously thankful to all and extremely grateful to my 
friend and colleague, Senator Enzi. We look forward to a good 
discussion and debate and continued progress on this very important 
bill at the beginning of the week.
  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. DURBIN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                             Peace in Sudan

  Mr. DURBIN. Mr. President, I rise today to once again address the 
ongoing violence in Darfur, Sudan.
  Hundreds of thousands of people have been killed in that terrible 
genocide, and millions have been driven from their homes.
  This week, the International Criminal Court has issued its first 
arrest warrants for these murderous crimes. The ICC issued warrants for 
the arrest of Sudan's so-called Humanitarian Affairs Minister Ahmed 
Haroun and against a jingaweit militia leader known as Ali Kushayb. 
Sudan says there is no need for such a trial and that its own courts 
are capable of prosecution. This is the very same Government that has 
helped orchestrate this campaign of violence, a government wheree 
courts are more likely to prosecute rape victims than the men who 
attack them. That is why we need international action in response to 
these crimes against humanity.
  Mr. Haroun, who today serves as Sudan's Minister for Humanitarian 
Affairs, was in charge of Darfur in 2003 and 2004, at the height of the 
killing.
  The jingaweit commander, who is the second man named in the warrant, 
commanded thousands of militia members and is accused of promoting rape 
and torture as part of his war strategy. The Sudanese Government claims 
he is in custody, but witnesses have told reporters that in reality he 
has been traveling in Darfur under police protection.
  These arrest warrants are a significant, if small, step toward 
justice, but there is so much more the world must do to bring peace, 
justice, and security to the people of Darfur.
  Recently, President Bush delivered a speech at the Holocaust Museum, 
promising that unless Sudan agreed to a full-scale peacekeeping mission 
and took other steps, then the United States would expand unilateral 
sanctions against the Sudanese--in the President's words--``within a 
short period of time.'' The President also stated he would press for 
multilateral sanctions through the United Nations. Both are important 
steps. I wish they had been taken far earlier, but they are still 
welcome steps.
  Deputy Secretary of State John Negroponte recently returned from 
Sudan. The report on his trip was not encouraging. He told us that 
Sudan's President Bashir continues to stand in the way of a full-scale 
U.N. mission. He also said Bashir is not taking steps to disarm the 
militia that have terrorized villages in Darfur, with the Khartoum 
Government's tacit, if not open, support.
  I know President Bush had planned to announce new sanctions at his 
speech at the Holocaust Museum. He agreed to delay implementing further 
measures in response to a strong personal request from the Secretary 
General of the United Nations.
  We cannot solve Darfur alone. It will take many nations. I understand 
why President Bush felt compelled to give the United Nations an 
opportunity. But the world cannot wait long, and the people in Darfur 
certainly cannot be asked to wait any longer. The violence there is 
entering its fifth year.
  A new report by the International Crisis Group, a nongovernmental 
organization working to prevent conflict across the world, spells out 
the urgency. This report states that combat in Darfur is rising, and 
the Sudanese Government continues to rely on aerial bombardment and 
raids by the jingaweit militia as its tactics of choice against its own 
people.
  The Crisis Group report also spells out the complexity of what is 
happening there. The report states:

       Darfur is the epicenter of three overlapping circles of 
     conflict.
       First and foremost, there is the four-year-old war between 
     the Darfur rebel movements and the government, which is part 
     of the breakdown between Sudan's centre--the National 
     Congress Party in Khartoum, which controls wealth and 
     political power--and the marginalized peripheries.
       Secondly, the Darfur conflict has triggered a proxy war 
     that Chad and Sudan are fighting by hosting and supporting 
     the other's rebel groups.
       Finally, there are localized conflicts, primarily centered 
     on land tensions between sedentary and nomadic tribes.
       The regime has manipulated these to win Arab support for 
     its war against the mostly non-Arab rebels.
       International interests, not least the priority the U.S. 
     has placed on regime assistance in its ``war on terrorism'' 
     and China's investment in Sudan's oil sector, have added to 
     the difficulty in resolving the conflict.

  This report calls for implementation of a full-scale peacekeeping 
mission and the need to revitalize the peace process itself. 
Peacekeeping troops can help keep civilians protected. International 
mediators from the African Union and the United Nations must also help 
the rebel groups and the Sudanese Government reach a more broad-based 
peace agreement. The first requirement, however, is getting 
peacekeepers into Darfur. Conflict is rising. The humanitarian space is 
shrinking. It is becoming harder and harder for many relief groups to 
reach those in need.
  In testimony before the Senate Foreign Relations Committee on April 
11, Special Envoy to Sudan Andrew Natsios stated that Secretary General 
Ban Ki-moon had requested a 2- to 4-week window in order to pursue 
diplomatic negotiations with Khartoum before any additional measures 
were taken. May 11, just a few days away, will mark a full month since 
Mr. Natsios's testimony. On that date, if Khartoum has not acted to 
take the necessary steps toward peace, I hope President Bush will 
launch expanded,

[[Page 11258]]

hard-hitting U.S. sanctions and seek to pass a United Nations Security 
Council resolution with meaningful multilateral sanctions.
  We need to strike out economically where it will hurt--against 
Sudan's oil industry. And I hope that China, which sits as a permanent 
member of the Security Council and represents Sudan's biggest oil 
customer, will join in our efforts. China buys 70 percent of Sudan's 
oil, and reportedly the Khartoum Government spends 60 to 80 percent of 
its oil revenue on its military. The Sudanese Government uses that 
military against its own people, especially in Darfur.
  As a rising power, as the host of the next Olympics, and as a member 
of the Security Council, it really is China's responsibility to use its 
influence to convince Sudan to accept the full-scale peacekeeping 
mission that is really needed. China has helped convince Sudan to say 
it will accept 3,000 U.N. peacekeepers, but far more than that is 
needed, and Beijing can play a pivotal role in bringing peace to 
Darfur. The statement made by the Chinese Government a few days ago was 
encouraging, but it was a very modest statement when you consider the 
magnitude of this genocide.
  Today, there are fewer than 7,000 underequipped African Union 
peacekeepers spread across Darfur--an area the size of Texas but Texas 
without roads or infrastructure.
  The cause of Darfur has captured the hearts of millions of Americans. 
This past weekend, in Chicago and in cities across the Nation and 
around the world, thousands of people gathered in support of the people 
of Darfur and in support of efforts to divest from companies that 
invest in Sudan.
  I should also mention that this same weekend, at Soldier Field in 
Chicago, thousands of young people gathered in support of the 
``Invisible Children'' of Uganda. These children have also been 
victimized by years of war, and indeed the conflicts in Northen Uganda 
and Sudan are intertwined.
  For years, the Sudanese Government has supported and assisted the 
Lord's Resistance Army, which has terrorized northern Uganda.
  One of the focal points of the Sudan rally last weekend was to 
support legislation introduced by my friend, State Senator Jackie 
Collins of Chicago. She is a wonderful leader on this issue. She has 
shown such persistence and courage, pushing for divestment so that 
Illinois, my home State, can have maximum impact to end this genocide. 
Her bill would divest State pension funds and other investments that 
add to the coffers of the Sudan Government.
  At the rally, participants also supported efforts here in Congress, 
which Senator John Cornyn and I have introduced, to express Federal 
support for States, universities, and others that choose to divest.
  This movement is expanding, not just here at home but abroad as well. 
Rolls-Royce has announced it is withdrawing from Sudan. According to 
media accounts, including the Associated Press, the Ford Motor Company, 
which produces Land Rovers, will no longer sell Land Rovers in Sudan. 
According to these press accounts, Ford made this decision after the 
Securities and Exchange Commission sent the company an inquiry asking 
about reports that some Land Rovers may have been used by military or 
paramilitary organizations.
  This Saturday, Berkshire Hathaway, one of the largest and most 
respected investment firms in the country, will convene a shareholder 
meeting. Warren Buffett, who runs Berkshire Hathaway, has agreed to put 
the divestment question on the agenda.
  The divestment movement was launched on college campuses. It is now 
reaching the boardrooms of major corporations and the agenda of 
shareholder meetings. Divestment is one tool among many, along with 
U.S. and U.N. sanctions, increased penalties for violations of U.S. 
law, stepped up engagement by China, and a commitment to reengage the 
peace process itself.
  I have made these points before, but we must not let the Sudanese 
Government think that the often limited American attention span will 
wander away from Darfur. We will not blind ourselves to genocide, and 
we will not grow fatigued by more news stories of suffering in this 
distant place. We must do, in every way possible, what we can do as 
individuals, as Members of Congress, and as Americans who care, 
Americans who have said when it comes to a genocide: Never again.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Ohio is recognized.
  Mr. BROWN. Mr. President, I appreciate very much Senator Durbin's 
words on Darfur and how he continues to keep that issue in front of the 
American public, and how important it is that the assistant majority 
leader do that.
  I rise to speak on behalf of the Dorgan amendment, the reimportation 
amendment, which will mean major cost savings to Americans when they 
buy prescription drugs. Several times over the last decade as a Member 
of the House of Representatives from a district in northeast Ohio, 
including Lorraine, Akron, and Medina, I took busloads of senior 
citizens to Windsor, Ontario to buy prescription drugs--a rather 
peculiar thing perhaps for a Federal official to do, to take people to 
another country to buy a consumer good. But what all of us know in this 
Chamber and most of the American people who have paid attention to this 
and understand, is that the same drug, the same dosage, the same 
manufacturer, often the same packaging--that those prescription drugs 
cost one-half, one-third, and sometimes as little as one-fourth in 
Canada what they cost in the United States. So we would take busloads 
of mostly seniors across I90 on the turnpike, up through Toledo, into 
Windsor, Ontario to buy prescription drugs and save seniors several 
hundred dollars, sometimes several thousand dollars a trip for each of 
them.
  The opponents of the Dorgan amendment, the opponents of 
reimportation, for years--and when I was in the House they used these 
same arguments--have continued to use the issue of safety, as if the 
drugs you buy at Hunter's Pharmacy in Windsor, Ontario are any less 
safe than the drugs you buy 3 miles away across the bridge in Detroit, 
MI, or 50 miles down the road or 60 miles down the road in Toledo, OH. 
The fact is that issue is a smokescreen. We know that drugs sold in 
Canada often are drugs that are made in the United States. Lipitor is a 
drug made in Ireland. It is sent to Canada or it is sent to 
Steubenville, OH. It is the same drug, the same packaging, the same 
dosage, the same manufacturer, and it is every bit as safe in 
Steubenville, OH, as it is in Windsor, Canada, or just as safe in 
Windsor as it is in Steubenville.
  Let me talk for a moment about the whole issue of the safety of these 
drugs. Importation, I believe, as Senator Dorgan does and as do so many 
in this Chamber, as do I believe 62 Senators who voted for cloture, 
importation is safe for drugs and for other sensitive commodities. In 
the year 2000, for example, the Pentagon imported Anthrax vaccine from 
Canada for U.S. troops. There was no question as to whether it was 
safe. Of course it was safe, and it mattered, and it protected our 
troops. The U.S. imports guns and explosive chemicals, uranium, food, 
pacemakers, heart valves, and other medical devices safely. Again, we 
are able to make sure these drugs are safe.
  If the Federal Government can put a man on the Moon, they can 
certainly ensure the safety of imported prescription drugs. The Federal 
Government that says it can build a nationwide missile shield with 
thousands of precisely coordinated weapons and sensors can ensure the 
safety of imported prescription drugs. The Federal Government that says 
it can develop hydrogen-powered cars within 15 years can surely ensure 
the safety of imported prescription drugs. A Federal Government that 
says it can safely ship and store thousands of tons of nuclear waste 
can surely ensure the safety of imported prescription drugs.
  What is the real safety issue? The real safety issue is not whether a 
consumer from Ohio, from Ashtabula, driving up to Canada, driving 
through Erie, PA, into Buffalo and across the river into Ontario, can't 
buy the same safe drug with the same safe drug regimen in Ontario as 
that consumer does in

[[Page 11259]]

Ashtabula. The issue about drug safety is that, frankly, unaffordable 
drug prices are what compromise the safety of these drugs.
  Let me give a couple of examples. The drug companies' pricing 
policies compromise the health and safety of U.S. patients in this way: 
A study completed last year found that seniors who can't pay what the 
drug companies demand fill fewer of their prescriptions. That means the 
doctor is telling the patient that the patient should take this drug 
the doctor prescribed and the patient is not fully filling the 
prescription, so the patient is compromising his or her safety. Another 
study found that thousands of seniors with serious health problems 
reported they skipped doses to make prescriptions last longer. My wife 
last year was in a Shaker Heights drugstore--a generally affluent 
suburb west of Cleveland--and standing in line behind a patient who was 
trying to negotiate the price with the pharmacist. The patient asked if 
there was any way she could get the drug less expensively. The 
pharmacist said: This is the only price I am able to charge. The 
elderly woman said: How about if I just skip today and take the drug 
every other day, and the pharmacist said: You can't do that. It would 
compromise your health. The lady said: How about if I cut the pill in 
half and take a half a pill every day, and the pharmacist cautioned 
against that. When she walked away, my wife said: Does that happen 
often? The pharmacist said that happens every day, all day.
  A 2001 study determined that patients were choosing less effective 
alternative medicines instead--pill-splitting, for instance. Patients 
will sometimes buy doses larger than appropriate for their condition in 
order to save money, and then divide the pills with a knife. That kind 
of pill-splitting is on the rise. Some health insurers actually require 
their enrollees to do it. The VA encourages it. Florida's Medicaid 
Program requires its beneficiaries to split their antidepressant 
medication that way. This controversial practice raises important 
safety concerns, all because of cost. It is why Medicaid, why the VA, 
and why health insurers require their enrollees to do it. The American 
Medical Association, the American Pharmaceutical Association, the 
American Society of Consultant Pharmacists, all oppose this pill-
splitting.
  The Miami Herald last year reported that a recent study of 11 
commonly split tablets found that 8 of them, after splitting, no longer 
met industry guidelines.
  A spokesman for the drugmaker Pfizer told the Washington Post:

       We don't recommend it for patients. Splitting can lead 
     patients to receive too much or too little medicine.

  All of this happens because of the pricing of prescription drugs.
  So when the opponents of the Dorgan amendment say we can't guarantee 
the safety of these prescriptions we get from Canada, that Drug Mart or 
CVS might buy wholesale from Canada, that these can't be guaranteed 
safe--they can be guaranteed safe just as well as CVS or Drug Mart 
going to an American wholesaler the FDA has approved. The real safety 
issues are when patients cannot afford the high cost of these drugs and 
either don't fill the prescription or take the drug every other day or 
cut the pill in half so their prescription lasts twice as long for the 
same costs. Those are the real problems.
  Only the Dorgan amendment will save money. When you think about what 
has happened with drug costs in this country, the Alliance for Retired 
Americans issued a comparison this year of United States and Canadian 
retail prices for 20 popular medicines. Compared to Canadian citizens, 
United States customers pay 20 percent more, for instance, for their 
high blood pressure medicine Norvasc, 60 percent more for their 
cholesterol medicine Pravachol, 100 percent more, twice as much, for 
the heartburn drug Prilosec, 200 percent more, 3 times as much, for the 
heart medicine Toprol XL, and 750 percent more for the breast cancer 
medicine Tamoxifen--750 percent more.
  Many of these drugs were developed by U.S. taxpayers through National 
Institutes of Health grants. Yet the drug companies thank American 
taxpayers for doing all this research by charging Americans 750 percent 
more for Tamoxifen that will save the lives of women who have breast 
cancer, and by charging 3 times more for heart medicine, and by 
charging 3 times more for another drug or 60 percent more for 
cholesterol medicine. The fact is, again, that safety is compromised 
because of the high price of these drugs.
  In 2001, U.S. consumers filled 24 million prescriptions for the 
arthritis medicine Celebrex and another 23 million prescriptions for 
the arthritis medicine Vioxx. Using the ARA price differential of about 
$41 for Celebrex and $46 for Vioxx, U.S. consumers spent almost $1 
billion more for Celebrex in 2001 than Canadian consumers, and over $1 
billion more for Vioxx than did Canadian consumers.
  No wonder so much is at stake in the Dorgan amendment. It saves 
consumers billions--$50 billion is I think the number he used on the 
floor yesterday--$50 billion. This saves American consumers billions of 
dollars. That means individual seniors out of pocket, it means 
insurance companies, it means taxpayers, it means the VA, it means all 
of us would save significant amounts of money. But we know what is at 
stake because the drug companies are going to make that much more money 
as a result.
  That is what this is all about. It is all about drug companies 
protecting their profits, increasing their profits. We all know the 
drug industry--and this amendment is not against the drug industry. It 
is for consumers. It is for taxpayers. It is for small businesses. It 
is for insurers. It is for the payers, people who are paying for these 
expensive drugs. But we know that in this institution, in the Senate 
and down the hall in the House of Representatives, it is all about drug 
company lobbyists, hundreds and hundreds and hundreds of drug company 
lobbyists fighting to keep their profits, to expand their profits. It 
is an industry that over the last 20 years has been the most profitable 
industry in America, year in and year out, exceeded only a couple of 
years by the oil industry. But typically, in a normal year, the drug 
industry's return on investment, return on equity, return on sales is 
far and away the most profitable industry in this country.
  The U.S. market accounted for 60 cents of every dollar in revenue for 
the 10 biggest drugmakers. The 10 biggest drugmakers in 2001, for 
instance, their revenue was $217 billion more than the gross domestic 
product of Austria. They had profits of $37 billion--more than the 
Government spent on VA health care, more than the entire budget that 
year for the U.S. Department of Housing and Urban Development; profit 
margins of over 18 percent, 3 times the average of other Fortune 500 
companies. These companies charge too much. They get much of their 
research done by the U.S. Government, and then they are charging these 
kinds of prices, which compromises the safety of seniors who struggle 
to pay for these prescriptions that their doctors have ordered.
  In addition, when you think about what these skyrocketing drug prices 
mean--health care overall, and especially skyrocketing drug prices--
just for American families, not just for seniors but for taxpayers and 
for small businesses--prescription drug costs increased almost 19 
percent in 2002. Medicaid prescription drug costs increased a similar 
amount in 2001. Private health insurance premiums grew 15 percent and 
are projected to grow another 14 percent this year. Small employers saw 
HMO premiums increase 25 percent. This is consistently, 25 percent, 15 
percent, 10 percent, year to year to year. What that means is because 
of the high cost of drugs, it is not just compromising the safety of 
our seniors, it is also hurting our small businesses. It also means 
that in too many cases, American companies simply have difficulty 
internationally competing with other countries, because they want to 
take care of their own employees and provide prescription drug coverage 
for them.
  The Dorgan amendment makes sense for small business. It makes sense 
for taxpayers. It makes sense especially for seniors who are taking 
these prescription drugs. Pure and simple, it

[[Page 11260]]

makes sense for our country. If we care about the safety of seniors and 
the safety of drugs, don't buy the argument that these drugs are 
contaminated or adulterated or not safe. The fact is we know the drugs 
that are sold in pharmacies in Canada or Great Britain or by 
pharmacists in those countries or pharmacies in Japan or Israel and 
Germany are safe. They have a regimen like FDA to protect the safety of 
their drugs. The issue here is whose side are you on? Are you on the 
side of seniors, on the side of taxpayers, on the side of small 
business, or are you going to side with the drug companies? It is 
pretty clear where people line up in this institution.
  I ask my colleagues in the Senate to support the Dorgan amendment 
when it comes to a vote next week.
  Mr. President, I yield the floor, and 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. NELSON of Florida. Mr. President, I ask unanimous consent that 
the order for the quorum call be rescinded.
  The PRESIDING OFFICER (Mr. Brown). Without objection, it is so 
ordered.
  Mr. NELSON of Florida. Mr. President, I rise to support the Dorgan 
amendment of which I am a cosponsor. Senior citizens in Florida in the 
year 2007 should not be in a position, as some are, of having to make a 
choice between buying groceries or buying their medicine. 
Unfortunately, there are some seniors who have to make that choice. 
Ultimately, once we get the Medicare prescription drug law changed that 
will ultimately bring down the cost of those prescriptions, that will 
solve the problem.
  I might say that the private marketplace is starting to have an 
effect. It was some several months ago that Wal-Mart announced it was 
going to start selling, for $4 per prescription for a 30-day supply, 
generic drugs from a compendium of over some 200 drugs. That program 
has been successful. And, of course, others, such as Target, have 
picked up and started that program as well. So we are seeing that the 
marketplace is starting to have some say in this.
  But with regard to the delivery of these drugs, senior citizens are 
having difficulty, even under what is supplied by Medicare right now. 
Until we have, eventually, the ability of Medicare to use its bulk 
purchasing power in order to negotiate prices of drugs--something the 
Veterans' Administration has been doing for years--until that occurs, 
along with the effects of the marketplace, along with the entry of 
generic drugs--until all of that happens, we are not going to see the 
cost of these drugs brought down to where in America today we do not 
have a senior citizen making a choice between buying groceries or 
buying their prescription medicines. In the meantime, there is 
something we can do about it; that is, we can allow senior citizens to 
purchase drugs from Canada, where often the price is one-half of what 
they get those drugs retail here.
  This Senator has been involved in this because, naturally, my State 
has the highest percentage of the population that is 65 and older. 
Naturally, when their shipments of drugs coming from Canada are 
interdicted, as they have been by Customs over the last several years, 
guess who they are going to call. I get involved in this, and then I 
have to get ahold of the Customs Department to find out why they are 
doing this. I have to get ahold of the FDA, and I get conflicting 
messages.
  A couple years ago, I spoke to the acting head of the FDA. He said 
that, as a policy, we do not have any objection to a limited supply--
and he named that as 90 days or less--for personal use. Naturally, the 
FDA has to be concerned about the safety of large quantities of 
counterfeit drugs. That is what we want to protect. That is what we 
want Customs to be going after.
  He pointed out that all of the counterfeits we have to go after--it 
is not the individual senior citizen wanting a limited supply, 90 days 
or less, for personal use coming from a Canadian pharmacy; that is not 
a threat to the health of our people.
  Last year on the floor, Senator Vitter of Louisiana and I coauthored 
and offered an amendment, and it passed. It would have allowed what I 
just described. That bill went to the House in a conference committee 
and, because of the power of the pharmaceutical industry, they watered 
it down so that instead of the senior citizen being able to order by 
mail, by Internet, or by telephone, what became law was that they could 
bring it personally across the border. Well, that may do somebody good 
in Michigan or in North Dakota, but it is obviously not going to do 
senior citizens in other parts of the country, including Florida, any 
good.
  Thus, until we can get this equilibrium of the marketplace by bulk 
purchases, by additional generics--all the time--and there is an 
interest, I agree, of the pharmaceutical industry, protecting them with 
those patents so they can recoup research and development costs but not 
to keep extending that patent after the life of the patent so that the 
generic can never get to the marketplace--until we can get all of those 
things straightened out, we simply have to bring some relief to our 
people. Albeit this is just one small way of doing it, it is an 
important step to allow the purchase from Canadian pharmacies. It is 
the same drug, made in the same pharmaceutical facility, that we get 
here. Indeed, it is even the same packaging, except it is sold through 
a Canadian pharmacy at half the price.
  I am as reasonable as any Senator in trying to work out an 
accommodation with certain interests that want to protect their turf, 
but this has simply gone too far. As the Senator from Ohio has just 
given a number of examples his wife was observing at the counter of the 
pharmacy, so too have I witnessed this among seniors.
  A lot of the seniors today came out of the ``greatest generation.'' 
We have an obligation to them, and no senior citizen should not be 
able, either through a Government program such as Medicare or a 
Government-subsidized program, through Medicaid--if they don't get 
their pharmaceuticals from one of those, they simply should not be in a 
position where they have to cut those pills in half or take them every 
other day or not be able to take those pills at all.
  When Medicare was set up back in the mid sixties, we didn't have the 
miracles of modern-day drugs; there wasn't a Medicare prescription drug 
benefit back then. Now, thanks to--kudos ought to go to the 
pharmaceutical industry, and the money we vote here for the research 
that goes through a lot of our scientific and medical institutions, 
federally funded money that goes to that research, the commendations 
ought to be all the way around the block, including the pharmaceutical 
companies. But we have to take the view that we cannot keep looking out 
for our own selfish interests all the time. We have to look to the 
greater good. When there is a part of America that is hurting, we have 
to address it.
  It is for those reasons that I am a cosponsor of this amendment. I 
was quite heartened when, earlier today, we got the necessary 60 votes 
in order to break the filibuster and proceed with the amendment. I hope 
that once we pass it here in this Chamber, it will not be stripped off 
when it gets to the other Chamber.
  Mr. President, I yield the floor and 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. REID. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER (Mr. Nelson of Florida). Without objection, it 
is so ordered.


                             Cloture Motion

  Mr. REID. Mr. President, I send a cloture motion to the desk.
  The PRESIDING OFFICER. The cloture motion having been presented under 
rule XXII, the Chair directs the clerk to read the motion.
  Mr. REID. Mr. President, this is regarding the substitute amendment 
to S. 1082.

[[Page 11261]]

  The legislative clerk read as follows:

                             Cloture Motion

       We, the undersigned Senators, in accordance with the 
     provisions of rule XXII of the Standing Rules of the Senate, 
     hereby move to bring to a close debate on the committee 
     substitute amendment, as modified, to S. 1082, the FDA 
     Revitalization bill.
         Ted Kennedy, Dick Durbin, Byron L. Dorgan, B.A. Mikulski, 
           Patty Murray, Claire McCaskill, Amy Klobuchar, Sherrod 
           Brown, Jack Reed, Herb Kohl, Charles Schumer, 
           Christopher Dodd, Barbara Boxer, Bill Nelson, Jeff 
           Bingaman, Debbie Stabenow.


                             Cloture Motion

  Mr. REID. Mr. President, I send a cloture motion to the desk.
  The PRESIDING OFFICER. The cloture motion having been presented under 
rule XXII, the Chair directs the clerk to read the motion.
  Mr. REID. Mr. President, this is calendar No. 120, S. 1082.
  The legislative clerk read as follows:

                             Cloture Motion

       We, the undersigned Senators, in accordance with the 
     provisions of rule XXII of the Standing Rules of the Senate, 
     do hereby move to bring to a close debate on Calendar No. 
     120, S. 1082, the FDA Revitalization Act.
         Harry Reid, Jeff Bingaman, Patrick Leahy, Russell D. 
           Feingold, H.R. Clinton, Patty Murray, Bernard Sanders, 
           Frank R. Lautenberg, Christopher Dodd, Dianne 
           Feinstein, Ted Kennedy, Benjamin L. Cardin, Benjamin 
           Nelson, Bryon L. Dorgan, Kent Conrad, Dick Durbin, Jack 
           Reed.

  Mr. DURBIN. Mr. President, I rise today to discuss two amendments 
that I have filed to this bill, Nos. 1027 and 1023. I do not intend to 
offer them at this time, but they raise important issues that I would 
like to highlight.
  I want to begin by thanking the chairman, Senator Kennedy, and 
ranking member, Senator Enzi, for their hard work on this bill. 
Together, we made significant progress yesterday by adopting an 
ambitious amendment to improve our food safety system for both humans 
and pets.
  I also want to thank Senators Kennedy and Enzi for agreeing to work 
on a comprehensive food safety package. That commitment is not taken 
lightly, and I look forward to working with them on this comprehensive 
package.
  Although we took great strides yesterday with respect to food safety, 
there are two important areas where the FDA is limited in its ability 
to protect our food supply. These weaknesses have been exposed in 
recent recalls: the E. coli spinach contamination; the peanut butter 
recall; and, most recently, the expanding pet food recall that has 
entered, or at least come very close to entering, the human food 
supply.
  The first weakness is that the FDA lacks the authority to issue a 
recall or pull defective products from shelves to protect consumers.
  This is surprising to many people, but here is a quote from the FDA 
website, summarizing its recall authorities:

       The manufacturers or distributors of the product carry out 
     most recalls of products regulated by FDA voluntarily. In 
     some instances, a company discovers that one of its products 
     is defective and recalls it entirely on its own. In others, 
     FDA informs a company of findings that one of its products is 
     defective and suggests or requests a recall. Usually, the 
     company will comply.

  This is true. Most often, companies comply, and there are penalties 
for failing to recall.
  However, sometimes companies recognize that they have a problem but 
choose not to recall a product because they are afraid of upsetting 
consumer confidence or losing market share. The FDA has reported 
multiple instances of firms failing to recall or recall in a timely 
fashion.
  In the pet food recall, companies have time and time again expanded 
their recalls, and the process has lasted more than 6 weeks. Just 
yesterday Menu Foods, the first company to recall on March 16, 2007, 
expanded its recall yet again. This recall was for products made during 
the same period of time as the other recalled products announced on 
March 16. Menu Foods has also announced an expanding date range of 
contaminated product.
  This same weakness was on display in 2002 in the ConAgra beef recall.
  Unfortunately, without the power of mandatory recall, the FDA is in a 
weaker position to force companies to announce recalls quickly or to 
thoroughly study the extent of a recall. The result is slow, uneven, 
voluntary recalls that leave consumers at risk.
  The Consumer Protection Safety Commission, the EPA, and even the FDA 
with respect to infant formula have recall authority. Why, then, does 
the FDA not have that authority for the other foods it regulates?
  This authority would expedite the speed and thoroughness of voluntary 
recalls, protect consumers, and protect industries against bad actions 
that threaten consumer confidence.
  A revision of recall authority is very much overdue, and my amendment 
would provide that. I hope that this issue will be seriously considered 
in the broader package of food safety reform.
  The second area I would like to raise is the lack of resources for 
the FDA's food safety efforts.
  One of the most significant aspects of the pet food recall and other 
food contaminations we have observed in recent years is that the FDA is 
struggling with its increasing responsibilities and its current level 
of resources.
  If we look at the increasing volume of food that the United States 
imports each year, it is clear why this is a problem. In 2003, the 
United States imported $45.6 billion of agricultural products. Today, 
that number is $64 billion. Agricultural imports from China alone have 
nearly doubled from $1.2 billion to $2.1 billion.
  Much of the responsibility for overseeing and inspecting the safety 
of these imports rests with the FDA. However, due to fairly flat 
budgets, the overall number of inspectors looking at these shipments 
and at domestic food processors actually has decreased from 2003 to the 
present from a level of more than 3,000 inspectors to about 2,700 
inspectors today.
  Less than 1.5 percent of these imports are inspected by the FDA, and 
the FDA lacks the resources and authorities to certify the standards of 
our trading partners.
  This situation presents an economic, public health, and bioterrorism 
risk to the United States. The CDC estimates that 76 million Americans 
become sick from food borne illnesses each year. More than 300,000 are 
hospitalized and 5,000 die each year.
  We clearly need to review the FDA's funding to ensure it has the 
resources necessary to safeguard the 80 percent of our food supply that 
it is responsible for regulating.
  The FDA office that is responsible for food imports, the Center for 
Food Safety and Nutrition, is also responsible for regulating $417 
billion of domestic food and $59 billion of cosmetics. This includes 
points of entry into the United States, approximately 300,000 food 
establishments, and 3,500 cosmetic firms. President Bush has requested 
only $467 million for fiscal year 2008 for this department to regulate 
all of this activity, and only $312 million of that amount would be for 
inspectors.
  Therefore, I am pursuing two tracks in this area. Last week, I sent a 
letter to Chairman Kohl and Senator Bennett of the Agriculture 
Appropriations Subcommittee, which funds the FDA, asking for a 
significant increase in the level of funding for the FDA Foods Program. 
I hope my colleagues will join me in this effort.
  Secondly, the amendment I have filed to this bill would direct the 
Secretary of Health and Human Services to study the feasibility of a 
user fee program for foods that would incorporate lessons learned from 
the prescription drug user fee program. This study would present 
various options on creating a user fee program for foods that could 
increase the resources and capabilities of the FDA in this area. 
Specifically, it calls for legislative recommendations that analyze the 
expected revenues for the FDA, as well as the costs to industry by 
sector.
  For the sake of improving food safety, I think it is vital that we 
explore the various options for providing the FDA with adequate 
resources.
  Again, I will not offer this amendment at this time, but I hope my 
colleagues will join me in supporting such a study in the future as 
Congress deals with broad food safety reform.
  Mr. HATCH. Mr. President, a number of questions have been raised 
about how the Durbin amendment on food

[[Page 11262]]

safety, adopted yesterday by a unanimous vote, would affect regulation 
of dietary supplements.
  I wanted to take this opportunity to clarify the record.
  First, let me indicate my support for the efforts of the Senator from 
Illinois, Mr. Durbin. The recent misfortunes with peanut butter, 
spinach, and pet food show me that our Nation's food safety policies 
are pitifully lacking. Therefore, I am supportive of Senator Durbin's 
work and also the considerable work of Senator Enzi and his staff to 
resolve problems that were found with the draft amendment.
  For the edification of my colleagues, section 201ff of the Federal 
Food, Drug and Cosmetic Act, FFDCA, contains the definition of dietary 
supplements. That definition includes a proviso that supplements are to 
be considered foods, except in the instance when a product makes a drug 
claim. In other words, by Federal law, dietary supplements are 
generally considered to be foods.
  It is for this reason that the language of the original Durbin 
amendment establishing a new adulterated food registry could have been 
read to apply to dietary supplements.
  This raised problems for me, and indeed for our colleague Senator 
Harkin, since we had spent more than 2 years working with Senators 
Durbin, Kennedy, and Enzi to draft, pass and enact the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act, Public Law 
109-462. That law authorizes a new program so that reports of serious 
adverse events related to the use of a dietary supplement or over-the-
counter drug would be reported to the Food and Drug Administration, 
FDA, on a priority basis.
  As I said, the Durbin amendment contemplates a new adulterated food 
registry. Under the provisions establishing that registry, reports of 
adulterated foods would be made by many, if not all, of the same 
parties who are required to file reports of serious adverse events 
associated with the use of dietary supplements under Public Law 109-
462. And so passage of the Durbin amendment could be seen to supersede 
the law we enacted last year for supplements, which I am relieved to 
hear was not the intent of our colleague, Senator Durbin.
  Consequently, the amendment we adopted yesterday contains language 
that Senator Harkin and I suggested to make certain that dietary 
supplements would not be covered by the new food safety language and 
thus last year's law would not be superseded. To reassure those who are 
interested in the Dietary Supplement Health and Education Act, DSHEA, I 
wanted to take a moment to outline those changes.
  First, there is new language in the section establishing the 
adulterated food registry to express the sense of the Senate that: (1) 
DSHEA has established the legal framework to ensure that dietary 
supplements are safe and properly labeled foods; (2) the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act has 
established a mandatory reporting system of serious adverse events for 
nonprescription drugs and dietary supplements sold and consumed in the 
United States; and (3) the adverse events reporting system under that 
act will serve as the early warning system for any potential public 
health issues associated with the use of these food products.
  In addition, language contained in the Durbin amendment modifies the 
definition of supplement contained in 201ff of the FFDCA so that 
supplements will not be considered foods for the purpose of the new 
adulterated foods registry. This in no way would alter the time-honored 
conclusion of the Congress that supplements are to be considered foods. 
On the contrary, all it would do is exempt supplements from the 
registry.
  These changes, all contained in the amendment which was approved 
yesterday, make clear that there are no new dietary supplement 
requirements in the Food and Drug Administration Revitalization Act. It 
is my hope this will reassure the many who have expressed concern that 
Congress was inadvertently repealing Public Law 109-462.
  Mr. KOHL. Mr. President, I rise to make a correction to the record. 
Earlier today, I erroneously named Senator Leahy as a cosponsor of my 
amendment No. 991. Senator Leahy is not a cosponsor of this amendment.
  I thank the chair.

                          ____________________