[Congressional Record Volume 142, Number 138 (Monday, September 30, 1996)]
[Senate]
[Pages S12020-S12021]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




           REFORM OF THE FEDERAL FOOD AND DRUG ADMINISTRATION

  Mr. GREGG. Mr. President, I would like to take one last opportunity 
in this Congress to discuss on the floor of the Senate a matter that is 
of high priority to me: reform of the Federal Food and Drug 
Administration. As I have stated many times, FDA reform is critical if 
the United States is going to continue to be the world leader in the 
field of medical technology, and I, for one, plan to pick up the mantle 
that was dropped in relation to this legislation this year.
  And I believe the amendments that I offered that were adopted during 
consideration of Senator Kassebaum's bill by the Labor Committee 
represent some important principles on which we will need to build a 
new reform bill in the 105th Congress. One of these amendments dealt 
with the dissemination of new information relating to health 
discoveries uncovered by other authoritative Government agencies, such 
as the National Institutes of Health or the National Academy of 
Sciences. I believe the American public has the right to be as informed 
as possible about the nutritional value--or even the scientific 
potential value--of the food they eat.
  Another amendment adopted would allow a system of national uniformity 
for the regulation, labeling, and marketing of nonprescription drugs. 
This is an important, pro-consumer provision. It would put an end to 
the confusing requirements that various States and localities choose to 
impose on these common products, ensure more efficient interstate 
commerce of these products, and will not force manufacturers to bear 
the cost of such mandates which are generally passed on to purchasers. 
This amendment also contributes to a higher standard of safety by 
exempting compelling State or local requirements, and creating a 
mechanism to make truly worthy requirements national.
  Mr. President, I was especially pleased to see report language 
included by the committee acknowledging that other FDA-regulated 
products, ``may also lend themselves to such a comprehensive system.'' 
I would hope that the starting point of this provision next year will 
include cosmetics, prescription drugs, and biologics along with 
nonprescription products. The value of governing these products by a 
single, nationwide system is potentially vast. And, Mr. President, I 
think that discussion of such a comprehensive system for the regulation 
of food and food additives should be part of the debate.
  This provision also dovetails nicely with another amendment that was 
accepted by the Labor Committee. For example, there is a global trend 
of international harmonization for products such as cosmetics: The 
countries in the European Union, Latin American, and various Asian 
countries are working toward regulatory cooperation. The Labor 
Committee, recognizing the significance of mutual recognition 
agreements [MRA] and the on-going negotiations the U.S. Commerce 
Department and others are involved in, accepted my amendment urging the 
continuation and completion of such MRA's.
  I am concerned by reports that many times, when the folks negotiating 
these agreements are very close, it is the FDA that throws a wrench 
into the works. I hope that the agency will take

[[Page S12021]]

the instruction passed as part of the Labor Committee bill seriously in 
regard to these international agreements. We need to see them 
demonstrate a greater willingness to recognize the standards used in 
other countries. As I have stated many times, the Food and Drug 
Administration in this country does not have a corner on the ability to 
regulate well.
  These are the sort of FDA reforms that I believe will promote a more 
efficient, higher quality regulatory process at the Food and Drug 
Administration. I look forward to revisiting these issues, and all of 
the other aspects of FDA reform, early in the 105th Congress. 

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