[Congressional Record Volume 143, Number 111 (Thursday, July 31, 1997)]
[Senate]
[Page S8482]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                               FDA REFORM

  Mr. KENNEDY. Mr. President, I regret that we have been unable to 
reach final agreement so far on FDA reform. In fact, the negotiations 
this month have made significant progress on almost all of the issues 
surrounding the bill. Reasonable compromises were reached on 26 
separate proposals that had raised serious health and safety concerns 
and were opposed by the FDA and the administration.
  Two issues remained today. It is critical that FDA be able to get all 
the data they need to ensure that devices that have different 
technological characteristics from a predecessor device are safe and 
effective. Provisions of the committee-reported bill might unduly tie 
the FDA's hands in this important area.
  The second issue involves the proposal for sweeping Federal pre-
emption of the current authority of States to regulate over-the-counter 
drugs and cosmetics. In cosmetics, for example, there is virtually no 
significant Federal regulation at the present time, and States should 
have the right to act to protect their citizens against dangerous 
products. Too often, there have been abuses such as lipsticks 
containing substances that could cause birth defects, skin creams made 
with known carcinogens, excessive lead in hair dye, and suntan products 
that produce severe chemical burns.
  In my view, acceptable compromises can be reached on both of these 
issues, and I hope that good faith negotiations will continue.
  Unfortunately, in the wake of the current impasses on these two 
issues, several additional matters that had previously been settled 
have now been reopened. A fair overall compromise is still possible 
that adequately protects the public, and I am optimistic that we can 
achieve it by September.

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