[Pharm-policy] Debate on Sanders Amendment

[James Love]

              [Page: H4291]  
 

 DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS ACT, 2001 
(House of Representatives - June 13, 2000)


AMENDMENT OFFERED BY MR. SANDERS

Mr. SANDERS. Mr. Chairman, I offer an amendment. 

The CHAIRMAN pro tempore. The Clerk will designate the amendment. 

The text of the amendment is as follows: 

Amendment offered by Mr. Sanders: 
Page 84, after line 21, insert the following section: 
Sec. 518. None of the funds made available in this Act for the
Department of Health and Human Services may be used to grant an
exclusive or partially exclusive license pursuant to chapter 18 of title
35, United States Code, except in accordance with section 209 of such
title (relating to the availability to the public of an invention and
its benefits on reasonable terms). 

The CHAIRMAN pro tempore. Pursuant to the order of the House of Monday,
June 12, 2000, the gentleman from Vermont (Mr. Sanders) and a Member
opposed each will control 5 minutes. 

The Chair recognizes the gentleman from Vermont (Mr. Sanders). 

Mr. SANDERS. Mr. Chairman, I yield myself such time as I may consume. 

This is a very simple bipartisan amendment that is cosponsored by the
gentleman from California (Mr. Rohrabacher), the gentleman from Oregon
(Mr. DeFazio), the gentleman from Minnesota (Mr. Gutknecht), the
gentleman from Wisconsin (Mr. Barrett), and the gentleman from Maine
(Mr. Baldacci). When I last introduced a version of this amendment in
1996, it received 180 votes. I hope we can win tonight with strong
bipartisan support. This amendment is supported by Families USA, the
National Council of Senior Citizens, and the Committee to Preserve
Social Security and Medicare. 

Mr. Chairman, over the years, the taxpayers of this country have
contributed billions of dollars to the National Institutes of Health for
research into new and important drugs, and that research money has paid
off. Between 1955 and 1992, 92 percent of drugs approved by the FDA to
treat cancer were researched and developed by the NIH. Today, many of
the most widely used drugs in this country dealing with a variety of
illnesses were developed through NIH research, and that is very good
news. 

The bad news is that, by and large, these drugs which were developed at
taxpayer expense were given over to the pharmaceutical industry with no
assurance that American consumers would not be charged outrageously high
prices. 

Mr. Chairman, the pharmaceutical companies constitute the most
profitable industry in this country. Yet while their profits soar,
millions of Americans cannot afford the prescription drugs they
desperately need because of the high prices they are forced to pay. In
fact, Americans pay by far the highest prices for prescription drugs
than the people of any other country on Earth, and many of these drugs
are manufactured right here in the United States and their research was
done through taxpayer dollars. 

While there are many reasons for the crisis in prescription drug costs
in this country today, in this amendment I want to focus on one small
part of that problem, and, that is, that it is totally unacceptable for
the taxpayers of this country to provide billions of dollars through the
NIH in research money for the pharmaceutical industry and get nothing in
return in terms of lower prices for the products that they help to
develop. 

Mr. Chairman, the reality is that taxpayers spend billions of dollars
for research and development of prescription drugs and they deserve to
get a return on that investment in terms of lower prices. 

Let me cite some examples. Tamoxifen, a widely prescribed drug for
breast cancer, received federally funded research, and NIH sponsored 140
clinical trials to test its efficacy. Yet today the pharmaceutical
industry charges women in this country 10 times more than they charge
women in Canada for a drug widely developed with U.S. taxpayer support.
Many, many other drugs were developed with NIH support: Zovirax; AZT,
the primary AIDS drug; Capoten; Platinol. And Prozac, the blockbuster
antidepresant, was made possible by the basic NIH-funded research that
discovered the brain chemical triggering depression. And on and on it
goes. 

The reality is, and The New York Times in a front page story made this
point, that much of the drug research in this country comes from
taxpayer support. 

Our amendment requires that the NIH abide by current law and ensure that
a company that receives federally owned research or a federally owned
drug provide that product to the American public on reasonable terms.
This is not a new issue. During the Bush administration, the NIH
insisted that cooperative research agreements contain, quote, a
reasonable pricing clause that would protect consumers from exorbitant
prices of products developed from federally funded research. The NIH
several years ago abandoned the clause under heavy pressure from the
pharmaceutical industry. 

While a reasonable pricing clause is not the only device that will
protect the investment that American taxpayers have made in numerous
profitable drugs, this amendment makes clear that Congress will not
stand by while NIH turns over valuable research without some evaluation
that the price charged to consumers will be reasonable as is required by
current law. 

                                       [Page: H4292] 

Mr. PORTER. Mr. Chairman, if the gentleman will yield, I need to know
what amendment he is offering because the amendment we have talks about
licensing, and he has just talked about reasonable pricing. I do not
know which one he is offering. 

Mr. SANDERS. This amendment, Mr. Chairman, is very, very clear. 

Mr. Chairman, am I on his time or my own? 

Mr. PORTER. The gentleman is still on his at the moment. 

Mr. SANDERS. Why does the gentleman not take his own time, if he would. 

Mr. Chairman, I reserve the balance of my time. 

The CHAIRMAN pro tempore. Does the gentleman from Illinois (Mr. Porter)
claim the time in opposition? 

Mr. PORTER. I do, Mr. Chairman. 

The CHAIRMAN pro tempore. The gentleman from Illinois is recognized for
5 minutes. 

Mr. PORTER. Mr. Chairman, I yield myself such time as I may consume. 

Let me first say a few things. First, this amendment has gone through
about four different iterations, and we are not quite sure which one the
gentleman is offering. I have the one in front of me dealing with
licensing. That is the correct one. 

Mr. SANDERS. Mr. Chairman, if the gentleman will yield, that is correct. 

Mr. PORTER. First, I understand the point the gentleman is trying to
make. I think the amendment misses the mark. First of all, let me say
that we have this wonderful synergy in our country where a great deal of
the basic research which provides the foundation for applied research is
done through NIH grants and we build this body of knowledge and then our
pharmaceutical industry and our biotech industry build on that knowledge
to develop products that they take to market. I think that that is a
wonderful system that does more to develop the kinds of drugs that help
eliminate disease or prevent it than any other place in the world. But
what the gentleman's amendment attempts to do, and if I can read it, I
would read it this way, it says, `None of the funds made available in
this Act for the National Institutes of Health may be used to grant an
exclusive or partially exclusive license pursuant to,' et cetera,
dealing with the licensing of drugs. 

The funds that NIH makes for grants are never involved in licensing
operations. The licensing is done by the institution subsequent to the
completion of the grant. So that while the gentleman, if this amendment
passed, might think he is accomplishing something, I believe that the
amendment as written would not hit the mark he is trying to hit. I think
under those circumstances, and I know how hard it is to fashion an
amendment that is in order on this subject under this bill, but this is
really an authorizing matter that the gentleman really ought to address
in an authorizing forum and not on an appropriations bill. 

                                             [TIME: 1900]

Mr. SANDERS. Mr. Chairman, will the gentleman yield? 

Mr. PORTER. I yield to the gentleman from Vermont. 

Mr. SANDERS. Mr. Chairman, I thank the gentleman from Illinois (Mr.
Porter) for his thoughts, but I respectfully disagree. And here is the
bottom line: the bottom line is that as a result of taxpayer-funded
support, very important and wonderful drugs are developed. But the
problem, Mr. Chairman, is that millions of Americans who paid for the
research to develop those drugs cannot afford the product. 

I think it is totally responsible for the United States Government to
say to the private companies we are giving you important research. But
in return, we have to make some guarantees to the public that we are
going to serve the public interests in terms of controlling the prices
that are charged. I think that that is something that the taxpayers of
this country deserve. 

Mr. PORTER. Mr. Chairman, reclaiming my time, I understand what the
gentleman is trying to do. My point is that this amendment does not do
that; that it deals with the grant funds for licensing, and grant funds
are not used for licensing. So the amendment will be ineffectual to
achieve the ends that the gentleman is seeking to attain, in my
judgment; and where this whole discussion belongs is not on an
appropriations bill but on an authorizing bill where that subject is in
order. 

Mr. SANDERS. Reclaiming my time, Mr. Chairman. 

Mr. PORTER. It is my time, but I yield to the gentleman. 

Mr. SANDERS. I am sorry. I did not mean to interrupt the gentleman. 

Mr. PORTER. I yield to the gentleman. 

Mr. Chairman, does the gentleman have additional time? 

The CHAIRMAN pro tempore (Mr. Pease). The gentleman from Vermont (Mr.
Sanders) has 30 seconds remaining, the gentleman from Illinois (Mr.
Porter) has the right to close and has 1 minute remaining. 

Mr. SANDERS. Mr. Chairman, I ask unanimous consent for an additional
minute and yield 1 minute to my friend, the gentleman from California
(Mr. Rohrabacher). 

The CHAIRMAN pro tempore. The Chair will entertain a request to grant 1
minute to each side. 

Is there objection? 

There was no objection. 

Mr. SANDERS. Mr. Chairman, I yield 1 minute to my friend, the gentleman
from California (Mr. Rohrabacher). 

Mr. ROHRABACHER. Mr. Chairman, I rise in strong support of this
amendment, and let me say that the gentleman from Vermont (Mr. Sanders)
has been trying to propose an amendment of this purpose for several
years now. But it seems that every time he proposes it, there is just
something wrong with it, that it just is not exactly right. 

I do not know about these details about the little loopholes of
intricacies of the writing of the bill, but I do know that the
fundamental principle he is trying to advocate here is right, and, that
is, if a pharmaceutical company takes money from the taxpayers to
develop a new drug, they have taken on the taxpayers as a partner; and
thus they cannot then turn around and exploit the taxpayers and soak
them for all money that they can get out of them because the taxpayer
has paid basically for their research and development. 

Research and development is the risk that a company takes, and if we are
going to pay for that risk, the taxpayers should get something back in
return. And fairer prices that are affordable prices is certainly a
reasonable assumption for companies that are taking that money. 

By the way, let me note, many pharmaceutical companies do not take
research and development money; and they should have every right to
charge what they want for their product. But in this case, the principle
is absolutely sound, whether you are conservative or a liberal or a
capitalist or a socialist. The fact is that the people have paid a
certain amount of money, they deserve some rights with that money and
protecting the consumer at the same time. 

Mr. SANDERS. Mr. Chairman, I yield myself such time as I may consume. 

Mr. Chairman, the gentleman from California (Mr. Rohrabacher) hit it
right on the head and, that is, at a time when millions of Americans
cannot afford the outrageously high costs of prescription drugs, they
need to know that when their tax dollars went to develop these drugs,
that the United States Government is saying to the private drug company
they cannot charge anything they want; that they are going to go through
the NIH, going to negotiate with you for reasonable prices. 

This is nothing more than asking for a fair return for the taxpayers of
this country on their investment. 

Mr. PORTER. Mr. Chairman, I yield myself such time as I may consume. 

Mr. Chairman, I would say to the gentleman from Vermont (Mr. Sanders),
again, I understand what he is talking about, but I think that it misses
the mark. If NIH is working on joint research with a pharmaceutical
company in developing a drug, then clearly the NIH shares in the
royalties or the profits from that drug. 

What the gentleman is talking about is when basic research is done and
then that body of knowledge, which is disseminated to everyone and
available to all sciences, then picked up by the pharmaceutical industry
from which they do research and develop a product that somehow we ought
to somehow measure what that contribution is; and the fact is that there
it is simply adding to a body of knowledge that is available to all
science everywhere. That is the role of NIH research. 

This amendment, even if the gentleman's premise was correct, this
amendment will not accomplish what he is seeking to do, and it is the
wrong place. It should be offered on the authorizing legislation dealing
with the subject matter. So I would oppose the amendment and hope
Members would not support it. 

Mr. Chairman, I yield back the balance of my time. 

The CHAIRMAN pro tempore. The question is on the amendment offered by
the gentleman from Vermont (Mr. Sanders). 

The question was taken; and the Chairman pro tempore announced that the
ayes appeared to have it. 

                                       [Page: H4293]  

Mr. PORTER. Mr. Chairman, I demand a recorded vote, and pending that, I
make the point of order that a quorum is not present. 

The CHAIRMAN pro tempore. Pursuant to House Resolution 518, further
proceedings on the amendment offered by the gentleman from Vermont (Mr.
Sanders) will be postponed. 

The point of no quorum is considered withdrawn. 

Mr. PORTER. Mr. Chairman, I move to strike the last word. 

Mr. Chairman, I yield 2 minutes to the gentleman from Michigan (Mr.
Smith). 

Mr. SMITH of Michigan. Mr. Chairman, I thank the gentleman from Illinois
for yielding to me. 

Mr. Chairman, I want to thank the gentleman from Illinois (Mr. Porter),
the gentleman from Wisconsin (Mr. Obey), the gentleman from Pennsylvania
(Mr. Goodling) for having some excellent provisions for giving education
a priority. 

I understand that an amendment that was going to take money out of Even
Start and put it into IDEA is now not going to be offered, and I just
want to emphasize how important I think that we move ahead with the
concept of Even Start. Even Start brings parents in to make sure that
parents are part of that encouraging effort. 

Just briefly, what happened in Michigan, I put in some appropriations
for what we call the HIPY program in Michigan, it is Home Improvement
for Preschool Youth, and that program helps teach parents how to react
to their kids to help their kids do a better job before they went in
school. 

What was exciting, it increased the reading comprehension for those
children by 80 percent; but even more significant, it increased the
reading comprehension for the parents by an equal amount. And 60 percent
of those parents went on to get their GED. 

As we move ahead with Even Start, as we move ahead with Head Start, it
is important that we continue to bring parents into the picture to be
part of that coordinated effort to encourage better education for their
kids. 

Mr. PORTER. Mr. Chairman, I yield back the balance of my time. 



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James Love, Director           | http://www.cptech.org
Consumer Project on Technology | mailto:love@cptech.org 
P.O. Box 19367                 | voice: 1.202.387.8030
Washington, DC 20036           | fax:   1.202.234.5176
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