Copyright 2001 eMediaMillWorks, Inc.
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Federal Document Clearing House
Congressional Testimony
June 13, 2001, Wednesday
SECTION: CAPITOL HILL HEARING TESTIMONY
LENGTH: 690 words
COMMITTEE:
HOUSE ENERGY AND COMMERCE
SUBCOMMITTEE: HEALTH
HEADLINE:
PHARMACEUTICAL DEMAND
TESTIMONY-BY: MICHAEL BILIRAKIS,
CONGRESSMAN
BODY: Prepared Statement of The
Honorable Michael Bilrakis
June 13, 2001
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This hearing will now come to order. Today the Subcommittee will
consider three matters within the jurisdiction of the Food and Drug
Administration which impact the demand for, and the price of, pharmaceuticals.
Congress is actively seeking to improve access to affordable
prescription drugs for all Americans, and particularly our seniors. As we debate
various proposals, we cannot ignore the impact of federal food and drug laws on
the availability and affordability of drugs. Today, we will focus on three
specific areas which have received a lot of attention recently: access to
generic drugs; the authority of the FDA to switch drugs from prescription to
over-the-counter status despite a manufacturer's objections; and
direct-to-consumer broadcast advertising.
At our recent Food and Drug
Administration Modernization Act hearing I mentioned my intent to examine issues
related to generic drugs. That is the purpose of today's hearing. Generic drugs
account for nearly half of all prescriptions filled, yet they amount to less
than 20% of pharmaceutical costs. Generics obviously save consumers billions of
dollars per year, and we should carefully consider their role as we work to
develop a
Medicare prescription drug benefit. I am particularly
interested in learning more about the science of generics. For instance, how
closely must a generic scientifically resemble the innovator drug for it to
receive FDA approval? I understand that the scientific standard for generic
approval is bioequivalence, but what exactly does that mean?
Also, do
consumers understand, and feel comfortable with, generic drugs and their role in
the modern marketplace? In addition, I am interested to learn why, on average,
it takes the FDA longer to approve generic drugs than it does for new drug
applications.
Of course, we cannot lose sight of the fact that without a
healthy, vibrant brand-name pharmaceutical industry, there would be no generic
drugs. I'd like to commend our colleague, Mr. Waxman, for his work as co-author
of the Hatch-Waxman Act, which increased consumer access to generic drugs, while
strengthening patent protections for new chemical entities. The Act has proven
quite successful for the past 17 years. Both the brand name pharmaceutical and
generic industries have thrived, and consumers have benefited greatly by access
to both new therapies and to cheaper copies of old therapies.
That being
said, concerns have been raised about provisions of the Hatch-Waxman Act which
may lead to anti-competitive behavior. The Federal Trade Commission is presently
conducting a year-long review to consider this matter. Our witnesses today will
shed light on the continued utility of the automatic 30-month stay on FDA
approval during patent challenges, as well as how the 180-day generic
exclusivity provision is working.
While I know that some of my
colleagues may wish to consider additional generic issues, we simply do not have
the time today to consider all of these matters. Thus, I hope we can focus on
the role of generic pharmaceuticals and not delve into other areas today.
The Subcommittee will also consider the authority of the FDA to force a
drug to be switched from prescription to over-the-counter status despite the
objection of drug's manufacturer. We are not looking at whether FDA should
switch specific drugs which have been in the news recently, but rather, whether
FDA can, under the law, make the switch. And if they can, what are the policy
impacts of such action?
Last, we'll hear from witnesses who will discuss
the impact of direct-to-consumer broadcast advertising on consumers. In 1997,
the FDA changed the guidelines for broadcast drug ads, and since then, this
advertising has increased dramatically. While the advertising has mostly focused
on the top selling drugs, it has also served to better inform consumers. Today,
this Subcommittee will consider the full impact of broadcast drug advertising on
consumers.
I will now yield to Mr. Brown for an opening statement.
LOAD-DATE: June 18, 2001