[Congressional Record Volume 142, Number 38 (Tuesday, March 19, 1996)]
[House]
[Pages H2464-H2465]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




             THE NEED TO SPEED UP THE PROCESS OF FDA REFORM

  The SPEAKER pro tempore (Mr. Taylor of North Carolina). Under the 
Speaker's announced policy of May 12, 1995, the gentleman from 
Pennsylvania [Mr. Fox] is recognized for 30 minutes as the designee of 
the majority leader.
  Mr. FOX of Pennsylvania. Mr. Speaker, I appreciate the opportunity to 
discuss with my colleagues some very important issues that will be 
facing the 104th Congress in this second session. Mr. Speaker, I speak 
of FDA reform, Food and Drug Administration reform.
  We know that many Americans are waiting for the approval of drugs or 
medical devices, because FDA has been so far mired down in 
overregulation and delay. I believe that it is a bipartisan effort that 
we are undertaking here in the House to make sure we speed up the 
approval of medical devices and pharmaceuticals. The legislation which 
I have introduced, H.R. 1995 and H.R. 2290, will in fact address for 
the biotech and the pharmaceutical fields speeding

[[Page H2465]]

up those processes of FDA reform, which we think is legislation whose 
time has arrived.
  Mr. Speaker, I am pleased to note that the gentleman from Virginia 
[Mr. Bliley], chairman of the Committee on Commerce, has appointed a 
fellow Pennsylvanian, Mr. Greenwood, to head up the FDA reform effort. 
With him working on this effort will in fact be the gentleman from 
Texas [Mr. Barton], the gentleman from Wisconsin [Mr. Klug], and the 
gentleman from North Carolina [Mr. Burr], in fact working not only on 
medical devices, but pharmaceuticals and foods as well.
  Mr. Speaker, I can tell the Members from testimony in my town and my 
county seat in Norristown, PA, that we had just in June 1995 many 
witnesses, patients, doctors, hospitals, discussing the need for 
speeding up the approval process for FDA in drugs and medical devices. 
We had patients with ALS, with AIDS, with cancer, with epilepsy, to 
name a few.
  In each of these cases, the patients have said that while they are 
waiting for a cure or they are waiting for a vaccine to help extend 
their lives, to improve the quality of those lives, to extend the years 
of those lives, they need to have the Congress, working with the White 
House, make sure we do what we can, working with the FDA, to make sure 
that we speed up the process.
  Mr. Speaker, we all know that the main job of the Food and Drug 
Administration is to protect us, to look out to make sure that drugs 
are not only safe but they are efficacious, that they are effective, 
for what they were intended. I know in my travels in Montgomery County 
and in parts of Delaware Valley, PA, and in other parts of the country, 
we need to make sure that we work together in a teamwork fashion to 
make the kinds of innovations in FDA, working with the agency, to make 
sure that we can speed up the process, whether it is from a personnel 
point of view, allowing us to use outside companies for the testing, or 
working with international harmonization, whereby we allow some of the 
clinical trials and testings from other countries whose results we can 
verify as being accurate, we can apply that understanding and that 
research to speed up the process for the approval.
  Mr. Speaker, we are a long way in this process already by the fact 
that many bills have been filed, and I was pleased to work with my 
colleagues to introduce the bills that I have thus far in Congress.
  But beyond the health care benefits of living longer and living 
better, Mr. Speaker, I wish to bring to the attention of my colleagues 
that there are many jobs now in the pharmaceutical, biotech, and FDA 
field for which we need to make sure we keep the process moving and to 
speed up the FDA reform, because, Mr. Speaker, if we do not speed up 
the process and we do not make the accurate and appropriate reforms, 
not only will the discoveries go overseas about medical devices and 
drugs, but the jobs will go overseas as well. America has worked too 
hard, done too much right, and been too creative and been too smart in 
their approach to the discoveries of these important drugs and medical 
devices to let it slip through our fingers now.
  By working together, the Congress and the White House, the private 
and the public sector, patients and hospitals, we can, in fact, have 
FDA reform achieved in this Congress, in this session, which will 
improve the quality of life for our constituents, and make sure we keep 
the jobs here as well, to improve America and to improve our 
communities.

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