[Congressional Record Volume 142, Number 15 (Monday, February 5, 1996)]
[Extensions of Remarks]
[Page E173]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                     IN SUPPORT OF FDA LEGISLATION

                                 ______


                        HON. CHARLES W. STENHOLM

                                of texas

                    in the house of representatives

                       Thursday, February 1, 1996

  Mr. STENHOLM. Mr. Speaker, I am pleased to be an original cosponsor 
of the Food and Drug Administration [FDA] legislation introduced today 
by Congressman Burr, which would provide some regulatory relief for 
health professionals. The legislation would allow the holder of an 
approved new drug application to provide health professionals a reprint 
of a medical journal article which includes information about the drug 
that is not in the FDA-approved package insert.
  While I certainly support the basic health and safety mission of the 
FDA, I have heard numerous concerns from my constituents about the FDA 
approved process and the frustrations they have in dealing with the 
Federal bureaucracy in general. As a representative of a rural 
district, I am very aware of the feeling of isolation that rural 
providers experience. Many times, rural providers find themselves with 
limited access to information they are unable to find someone to cover 
their practices so that they can attend conferences or meetings at 
which new medical technology is discussed. I believe Representative 
Burr's legislation is a good first step in addressing some of my 
constituents' frustrations.
  Current law allows doctors to prescribe drugs for the users they feel 
most appropriately meet their patients' needs. For instance, if a 
doctor reads a journal article showing the effectiveness of a 
particular drug treating an illness for which it was not originally 
approved, the doctor is not prohibited from prescribing the drug for 
that use.
  However, current FDA regulations prohibit drug manufacturers from 
providing doctors with information about any use of the drug that has 
not been previously approved by the FDA. Therefore, while studies might 
have shown the safety and effectiveness of the drug for additional 
uses, manufacturers are not allowed to share this information with 
doctors. Representative Burr's legislation attempts to address this 
issue in a fair way that will maintain the FDA's mission of protecting 
consumers from unsafe, ineffective drugs.
  I believe it is important for the committees of jurisdiction to 
consider this legislation and all of its ramifications, particularly 
with regard to consumer safety. I feel very confident that liability 
responsibilities shouldered by physicians more than adequately ensure 
that they will not carelessly prescribe inadequately proven drugs.
  Many agree that the FDA approval process, while attempting to ensure 
consumers have safe and efficient drugs, may actually delay the 
availability of some breakthrough drugs. This bill may not contain all 
of the answers, but it is a productive first step and it should receive 
a hearing in the regular committee process, so that interests on all 
sides of the issue can be heard and considered. It is important that we 
reform the FDA with an awareness of the agency's responsibility, which 
is to see that the medicines we use are safe and effective.

                          ____________________