[Congressional Record Volume 142, Number 44 (Wednesday, March 27, 1996)]
[House]
[Page H2931]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                               FDA REFORM

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Pennsylvania [Mr. Fox] is recognized for 5 minutes.
  Mr. FOX of Pennsylvania. Mr. Speaker, I appreciate the opportunity to 
address my colleagues tonight on a very important topic. Today it was 
announced that legislation will be introduced this week on FDA reform. 
This is long overdue here in the Congress, to make sure we help protect 
the health and safety of our constituents.

                              {time}  2045

  Today Congressman Greenwood, the task force chairman under 
Congressman Bliley started out with a discussion of our mission and was 
followed with remarks from Chairman Bilirakis, Chairman Barton, 
Congressman Klug, Congressman Buyer, Congressman Pallone, and 
Congressman Richardson.
  It is a bipartisan effort, Mr. Speaker, for the purpose of making 
sure that we stop the insidious problem we have had in the country with 
the FDA treatment delayed become FDA treatment denied. We need to save 
lives, extend the years, and improve quality of life for all of our 
constituents. An idea whose time has arrived is FDA reform, not just 
for food, but for medical devices and pharmaceuticals as well.
  It may well be the most extensive and important piece of legislation 
we will deal with in the second session of the 104th Congress, that 
being FDA reform. If we can hasten the approval process for drugs and 
medical devices while patients await a cure or a vaccine, we will 
certainly have accomplished much as Congressman and Senators.
  Mr. Speaker, lest anyone believe otherwise, we are certainly not 
going to reduce in any way the safety of drugs, the efficacy of those 
drugs, but we want to speed up the process of the approval. It can be 
done through streamlining the clinical research, through third-party 
review and through working with international harmonization, by 
accepting certified results of tests by other countries.
  I am hopeful the many people who came to Washington today who had 
illnesses such as cancer, ALS, epilepsy, AIDS, and a myriad of other 
conditions they have come to us saying, look, we need to make sure we 
can live longer, please, do not stop us from getting the experimental 
drugs, the miracle drugs we need in order to live a little longer and 
hope for a cure.
  I believe today, ladies and gentleman, that we have heard from the 
American people, that we can work together in a bipartisan fashion, 
House and Senate together, working with the White House and working 
with the FDA. Dr. Kessler has a very important organization that he 
heads. We need to work with him to make sure the reforms we need are 
ones that can be embraced by all, because what we are talking about is 
the health care and the life of all of our constituents across this 
United States, in the country where 85 percent of the new drugs to 
extend life and to sustain life are being created. We want to make sure 
those discoveries stay here and the jobs of the people who are, 
thankfully, making those discoveries every day.
  I thank you for the opportunity to address my colleagues, and I hope 
that we will fast-track this important legislation and it does in fact 
become passed before the end of the session.

                          ____________________