[Congressional Record Volume 142, Number 117 (Friday, August 2, 1996)]
[Senate]
[Page S9550]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]
FDA PERFORMANCE ACCOUNTABILITY ACT
Mr. GRASSLEY. Mr. President, we have accomplished many things this
Congress. Just this week we passed a comprehensive welfare reform
proposal which will end welfare as we know it. We passed a meaningful
small business tax relief bill. And, we will pass a momentous health
insurance reform bill that will improve the availability and
portability of health insurance coverage.
I would like to point out another opportunity Congress has to pass a
significant reform proposal and that is the Food and Drug
Administration Performance and Accountability Act. I hope we can
consider this bill when we return in September.
The Senate Labor Committee has spent a considerable amount of time on
this comprehensive piece of legislation. And, let me point out, this
reform proposal passed out of committee on an 11 to 4 vote.
The commonsense proposals in this bill are designed to strengthen the
agency's ability to ensure that safe and effective new medicines are
made available to patients without delay by eliminating redtape and
streamlining operations.
The FDA is designed to achieve the goal of ensuring a safe and
efficient approval process. And, the FDA has been concerned to protect
the public from unsafe drugs.
But, it is time to ensure that the agency becomes equally concerned
about promoting public health by making safe and effective new
therapies available to patients as soon as possible. Patients can be
harmed by delay in approving safe and effective new medicines just as
they can by the approval of unsafe new medicines.
I urge the majority leader to consider this legislation in a timely
enough matter so that we can send it to the President and I ask
unanimous consent to have printed in the Record an editorial by
Senators Kassebaum and Mikulski in support of this piece of
legislation.
There being no objection, the editorial was ordered to be printed in
the Record, as follows:
[From the Washington Post, July 26, 1996]
The FDA Can Work Better
(ByBarbara Mikulski and Nancy Kassebaum)
The Post's July 17 editorial ``Reform Isn't Risk-Free''
continues the drumbeat of negative commentary on our efforts
and the efforts of a bipartisan group of our colleagues on
the Senate Labor and Human Resources Committee to achieve
meaningful reform of the Food and Drug Administration.
At the outset, we would make the point that a failure to
make needed reforms is by no means a risk-free proposition.
Inaction and delay victimize just as surely as the wrong
action. We hear constantly about the deformities prevented in
the early 1960s by the agency's not approving thalidomide.
Rarely, however, is a word spoken about the cases of spina
bifida that could have been averted had the FDA not delayed
for years in permitting health claims to be made about the
benefits of folic acid in preventing such neural tube
disorders.
As the 1989 ``Edwards Commission'' report put it: ``The
agency should be guided by the principle that expeditious
approval of useful and safe new products enhances the health
of the American people. Approving such products can be as
important as preventing the marketing of harmful or
ineffective products.'' The Edwards Commission was but one of
a series of distinguished panels convened during the past two
decades that have urged FDA reform.
During the year-long process in which our legislation was
developed, we drew heavily from the work on these expert
panels. Contrary to The Post's suggestion that we are rushing
a poorly though-out piece of legislation to the Senate floor,
we believe that this bill embodies the best thinking on this
topic produced over years and years of study.
Moreover, we have drawn as well from the successful
experience of the FDA in expediting approval of AIDS drugs
without jeopardizing safety and effectiveness. In response to
sustained pressure from the AIDS community, the agency
demonstrated that it could, in fact, change its culture and
its procedures to implement reforms it had resisted for
years.
Unfortunately, this experience has not been regarded as a
foundation upon which to build further improvements but,
rather, has been seized upon as ``proof'' that further
changes are unnecessary. Scientific methods and technology
have changed dramatically since the thalidomide incident,
while regulatory structures have barely bulged. Applications
for the approval of new drugs typically run to hundreds of
thousands of pages.
An incentive is growing for U.S. companies to move
research, development and production abroad, threatening our
nation's continued world leadership in new product
development, costing American jobs and further delaying
the public's access to important new products.
It is disconcerting to us that our efforts are being
regarded as a ``hostile takeover'' of the agency, as opposed
to the sincere effort it is to enhance the professionalism,
stature and effectiveness of the agency. The bill maintains
the FDA firmly in the driver's seat; it does not turn over
all the regulatory power to the private sector, as critics
have charged inaccurately. It encourages cooperation from the
very beginning of the process so that costly delays can be
avoided at the end of the road.
It is perhaps even more disconcerting to hear critics of
our efforts suggest that we are willing to put people's lives
at risk in order to collect large campaign contributions from
the drug industry.
The strong bipartisan vote in the Senate Labor and Human
Resources Committee reflects the desire of Republicans and
Democrats alike to make the FDA work better for all
Americans. We have reached out to the administration, and we
are more than willing to make constructive changes in the
legislation as reported by the committee. We are not,
however, willing to tolerate endless rationalizations as to
why the status quo should be maintained. Our goal is to
maintain these core principles: streamline and clarify the
regulatory process while maintaining safety and efficacy.
Our determination to move forward is fueled by the plight
of countless individuals who have contacted us over the years
to request assistance in speeding the FDA's evaluation of new
therapies that hold promise for treating serious illnesses,
such as amyotrophic lateral sclerosis (ALS), multiple
sclerosis and cancer. For these individuals, the real risk is
not that we will act in haste, but rather that we will fail
to act at all.
Barbara Mikulski is a Democratic senator from Maryland.
Nancy Kassebaum is a Republican senator from Kansas.
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