[Congressional Record Volume 142, Number 139 (Tuesday, October 1, 1996)]
[Senate]
[Pages S12053-S12054]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION REFORM LEGISLATION IN THE 104TH CONGRESS

  Mr. HATCH. Mr. President, as the 104th Congress winds to a close, I 
wanted to take this opportunity to comment on the demise of the Food 
and Drug Administration reform legislation.
  It has been extremely disappointing to me that efforts to prod the 
FDA into meaningful reform have not been fruitful. It is doubly 
disappointing because, our colleague, Senator Kassebaum, and her staff 
have spent countless hours crafting a solid reform bill, a bill that 
won overwhelming, bipartisan support from the Labor and Human Resources 
Committee.
  In remarks before this body earlier this year, I outlined my views on 
the need for FDA reform and the principles which should be embodied in 
any reform legislation. I continue to believe that reform of this tiny, 
but important, agency is sorely needed, reform that will both 
streamline its operations and preserve its commitment to ensuring the 
public health.
  I know that many who have worked on the FDA issues are discouraged, 
but we can be proud of three significant reforms to food and drug law 
this year: the first being the drug and device export amendments I 
authored with Representative Fred Upton; the Delaney clause reform 
embodied in the pesticide legislation the President recently signed; 
and the animal drug amendments so long championed by Senator Kassebaum. 
It seems, therefore, that the revolutionary course we charted for FDA 
reform at the beginning of the 104th Congress, evolved into a path 
evolutionary in nature, but still productive nonetheless.
  Much more remains to be done, and I will continue to work with my 
colleagues next year to advance the work we started this year. There 
are many priorities for further action, among them--speeding up generic 
drug approvals, clarifying how tissue should be regulated, expediting 
medical device approvals, deficiencies in the foreign inspections 
program, and rigorous oversight of the Dietary Supplement Health and 
Education Act's implementation.
  Another issue that I would like to see addressed next year is one 
that has been periodically on the FDA radar screen: the issue of 
national uniformity in regulation of products that fall within the 
FDA's purview.
  In 1987, FDA Commissioner Frank Young, in response to California's 
Proposition 65, was on the verge of issuing an FDA regulation that 
would have acted to preempt certain warning statements required by the 
State of California. In fact, in August of that year, Commissioner 
Young wrote the Governor of California to underscore his concerns about 
the potential negative effect of Proposition 65 on ``the interstate 
marketing of foods, drugs, cosmetics and other products regulated by 
the FDA.''

  Further, Commissioner Young pointed out that ``the agency has 
adequate procedures for determining their safety and taking necessary 
regulatory action if problems arise.''
  Although ultimately this regulation was not issued, the 1991 Advisory 
Committee on the Food and Drug Administration, chaired by former FDA 
Commissioner and Assistant Secretary for Health, Dr. Charles Edwards, 
examined this issue. The panel recommended that Congress enact 
legislation, ``that preempts additional and conflicting State 
requirements for all products subject to FDA regulation.''
  The issue of Federal preemption is extremely important for several 
industries, especially over-the-counter drugs, cosmetics, and foods. I 
was heartened when the Labor and Human Resources Committee approved 
Senator Gregg's amendment on national uniformity for over-the-counter 
drugs during consideration of the FDA reform legislation, S. 1477, but 
was disappointed that Senator Gregg did not extend the concept further 
in his amendment.
  Let us take the cosmetics industry as a case in point.
  In the United States, the cosmetics sector of the economy represents 
an estimated $21 billion in annual sales, a significant amount by 
almost any measure. It consists of over 10 billion individual packages 
that move through the stream of interstate commerce annually. These 
include soap, shampoo, mouthwash, and other products that Americans use 
daily. These hundreds and hundreds of product lines, and thousands and 
thousands of products are each subject to differing regulation in the 
various States--even though all must meet the rigorous safety, purity 
and labeling requirements of Federal law.
  Given this volume of economic activity, it is imperative that 
manufacturers be able to react quickly to trends in the marketplace; 
they must have the ability to move into new product lines and move in 
to and out of new geographic areas with a minimum--but adequate--level 
of regulation to ensure the products are not adulterated and are made 
according to good manufacturing practices.
  Today, cosmetics manufacturers are competing more and more in a 
global economy, and are making products consistent with the 
international harmonization of standards in such large marketing areas 
as the European Union. A single nationwide system for regulating the 
safety and labeling of cosmetic products would be a great step in 
helping that industry move toward the international trends in 
marketing. At the same time, it would be a more efficient system, since 
allowing individual States to impose varying labeling requirements 
inevitably leads to higher prices.
  In other words, the time has more than come for enactment of a 
national uniformity law for cosmetic regulation. It is my hope that 
this issue will be high on our congressional agenda next year.
  In closing, Mr. President, I want to offer my great respects to 
Chairman Kassebaum for the hours, weeks and months of time she has 
devoted to the

[[Page S12054]]

FDA reform issue. Although I have paid tribute to Senator Kassebaum in 
separate remarks here, I must reiterate again how much her reputation 
for equilibrium and fairness have lent to development of an FDA reform 
proposal which cleared the committee in such a bipartisan fashion.
  Finally, I must also pay tribute to the lead staffer on FDA issues, 
Jane Williams, who has worked virtually round-the-clock to try to 
fashion a good, fair, bipartisan reform bill. Jane more than exceeded 
that goal, and I think this body should give her some much-deserved 
recognition.
  I yield the floor.

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