Copyright 1999 Federal News Service, Inc.
Federal News Service
AUGUST 4, 1999, WEDNESDAY
SECTION: IN THE NEWS
LENGTH:
1057 words
HEADLINE: PREPARED STATEMENT OF
SENATOR
PATRICK LEAHY,
RANKING MEMBER, SENATE JUDICIARY COMMITTEE
BEFORE THE SENATE JUDICIARY COMMITTEE
SUBJECT - HEARING
ON S.1172 (PATENT EXTENSIONS)
BODY:
Today
we are here to receive testimony on S. 1172, a bill introduced by Senator
Torricelli to extend the patents on seven drugs, each of which was in the
"pipeline" in 1984, when the Senate last passed comprehensive drug patent
legislation. This bill proposes to make significant changes to the Drug Price
Competition and Patent Term Restoration Act of 1984, also known as the
Hatch-Waxman Act.
I have a number of concerns about this
bill and am interested in the insights that will be offered by our witnesses
today. Thank you for taking the time to be with us.
A basic problem with
this legislation is this: Congress should not be in the business of extending
individual patents for drugs, nor should we be authorizing special extensions
without overwhelming justification. The legislation which our distinguished
Chairman - working with my good friend Congressman Henry Waxman -- so deftly
crafted in 1984 has served the nation well and continues to do so. Sure there
are individual complaints that have arisen from Hatch- Waxman.
However, we all know that crafting bipartisan legislation is going to leave
somebody unhappy. But anyone who sees a bill that has Hatch and
Waxman as the sponsors must know that one of them has either had a
lapse in judgment or it is a dam good piece of legislation.
Schering-Plough
Corporation, one of the pharmaceutical companies that would be affected by this
legislation, has enjoyed patent protection for its most popular product, the
allergy medication Claritin, for many years. In fact, since the original patent
was awarded in 1981, Claritin already has received two patent extensions -- even
before we consider S. 1172.
When we passed the Hatch-Waxman
Act, Claritin was granted a two-year patent extension because it was under
development -- or, in the "pipeline" -- when the new law was enacted. In 1994,
Claritin received a second 22-month patent extension under the terms of the
General Agreement on Tariffs and Trade (GATT). With these two additional patent
extensions, the patent on Claritin will expire in June, 2002, after
approximately 21 years of protection. I need a lot of convincing before I can
support a third extension.
Setting aside for a moment the policy problems of
reopening bipartisan legislation that balancedmany competing interests, there is
an important aspect to this legislation that goes beyond whatever policy this or
any other committee sets on patent extensions for drugs: the cost to consumers
and taxpayers.
Stephen Schondelmeyer, of the Pharmaceutical Research in
Management and Economics (PRIME) Institute, conducted a recent study on the
costs of proposed extensions for the drugs in S. 1172. This study examined a
variety of economic scenarios. In one scenario, the study evaluated the cost to
consumers from a three-year delay in generic competition. If we grant Claritin a
three-year extension, it will cost consumers $5.31 billion from 2002 to 2007.
Excuse the pun, but that's nothing to sneeze at. Over this same time period, the
legislation would cost the taxpayers approximately $2.5 billion. Medicaid bears
the brunt of the costs at $1.34 billion. A Medicare prescription medication
benefit would cost about $5 billion. These are the real costs that we are
talking about.
I continue to hear from one Vermonter after another about the
prohibitive costs of their medications. Americans need better access to
affordable prescription drugs. This bill goes in precisely the wrong direction,
and for no compelling reasons.
Schering-Plough has repeatedly tried to seek
patent extension provisions over the past few years, and Congress has declined
that invitation, for good reasons. The Hatch-Waxman Act was
intended to stop the practice of Congress legislating patent extensions, one
drug at a time. It was a balanced and fair act that has worked well.
If we
are going to reform any piece of the Hatch-Waxman Act, it must
be done in a comprehensive manner with the same consensus that the 1984
legislation has enjoyed. Any effort for reform must preserve the balance that
was so carefully fostered in the original 1984 legislation. I do not believe
that piecemeal changes to the Act will work. Each change we make now will have
some effect on another provision of the original bill. If there is a belief that
Hatch-Waxman should be thoroughly reexamined, then we should
discuss that. However, I do not believe that this bill, and the practice of
legislating extensions, are the appropriate manner in which to reform the
Hatch- Waxman Act.
My final concern with S. 1172 is that it
would create an unbalanced review process that appears to undercut the current
responsibility of the FDA. This bill proposes to create a new step in the patent
review process by allowing the Patent Trade Office to question and potentially
undercut the scientific judgments made by the FDA and its advisory committees.
Why should we set up an entirely new step in the review process in order to
allow one entity, the Patent Trade Office, to second-guess the conclusions of a
regulatory agency with scientific background such as the FDA?
Schering-Plough has expressed concerns that the patent approval process for
its most popular product, the allergy drug Claritin, was delayed at the FDA.
Because the patent review process at FDA is confidential, up to this point it
has been difficult to determine the validity of this claim. I asked, along with
Congressman Waxman, the General Accounting Office (GAO) to review theFDA process
surrounding the Claritin patent to determine the cause of the delays.
It
would be premature for the Committee to act on any piece of legislation that
would alter the review process determined by the Hatch-Waxman
Act based on disputed claims. It would be foolish not to at least wait to hear
the results of the GAO report, due out this fall, before any such action.
I
do not believe that Congress should be in the business of approving individual
patents for drugs. The huge costs to consumers and taxpayers of enacting this
bill, in particular, should give us pause, especially at a time when Congress,
the President and the American people are looking for ways to improve access to
prescription medicines and to help consumers afford them.
Again, I want to
thank the members for our panel for joining us today.
END
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LOAD-DATE: August 5, 1999 
