[Congressional Record Volume 142, Number 58 (Wednesday, May 1, 1996)]
[Extensions of Remarks]
[Page E676]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




    ON COSPONSORING H.R. 3199, H.R. 3200, AND H.R. 3201, FDA REFORM

                                 ______


                        HON. CHARLES W. STENHOLM

                                of texas

                    in the house of representatives

                        Tuesday, April 30, 1996

  Mr. STENHOLM. Mr. Speaker, today, I am pleased to add my name as a 
cosponsor of the three bills that make up the comprehensive Food and 
Drug Administration [FDA] reform being considered in the House. Most 
Americans believe that the FDA approval process for new drugs, medical 
devices, and foods should be streamlined to ensure that citizens have 
access to life-saving products. Many believe, however, that this 
streamlining effort also must preserve the public's confidence in the 
agency's mission of protecting the health and safety of consumers. I 
agree with both concerns and believe that both goals can be met through 
commonsense legislation.
  While I have some concerns about these FDA reform bills, I strongly 
agree with the underlying principle that there are constructive reforms 
of FDA that should be enacted. I am cosponsoring these bills because I 
believe they are a step in the right direction. At the same time, I 
believe it is critical that the hearing process function as it should, 
providing an opportunity for all interested parties to air their 
concerns and assisting Congress in making changes in the legislation as 
appropriate.
  Some of the people who have approached me about FDA reform have 
described it as a ``work in progress.'' Therefore, I look forward to 
seeing what progress can be made to address some of the concerns I have 
heard regarding safety. In particular, I know that breast implant 
recipients, understandably, have some concerns along these lines. I 
also have had expressed to me an uncertainty about moving too quickly 
to privatization, as well as concerns expressed from the State level 
about changes in the State and Federal relationship.
  I am convinced that a middle ground can be reached to reduce 
bureaucracy and delay, while also protecting the public health and 
safety. I believe that, while not perfect, these three bills set us off 
down that path toward appropriate FDA reform.

                          ____________________