[Congressional Record Volume 142, Number 117 (Friday, August 2, 1996)]
[Senate]
[Page S9550]
From the Congressional Record Online through the Government Publishing 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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