[Congressional Record Volume 143, Number 2 (Thursday, January 9, 1997)]
[Extensions of Remarks]
[Pages E83-E84]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                     THE NEED FOR FDA MODERNIZATION

                                 ______
                                 

                            HON. JOE BARTON

                                of texas

                    in the house of representatives

                       Thursday, January 9, 1997

  Mr. BARTON of Texas. Mr. Speaker, in this last election cycle, many 
of us campaigned on the need for the Federal Government to use a common 
sense approach in dealing with private industry. The regulatory yoke 
placed upon the medical device industry in the United States by the 
Food and Drug Administration is a prime example of how a bureaucratic 
agency can destroy small business, as well as the entrepreneurial 
spirit.

[[Page E84]]

  My goal, which I believe is shared with many of my colleagues on both 
sides of the aisle, is to modernize the Food and Drug Administration. 
This is to be distinguished from terminating or eliminating the FDA, 
which I have also been accused of, and I want to make it clear that I 
believe there is a legitimate need for the FDA. However, it is 
imperative that this Congress lead the charge to bring the FDA into the 
21st century. The current FDA approval process is slow and 
unpredictable, while at the same time costing the United States jobs, 
technology, and most importantly--lives.
  We held numerous hearings in the 104th Congress in my subcommittee 
and others detailing the need to change the manner in which our 
domestic device industry is regulated. In the 104th Congress I 
introduced H.R. 3201 to reform the medical device industry. With the 
help of many of my Democrat colleagues, especially Bill Richardson and 
Anna Eshoo, we were able to get 162 cosponsors on H.R. 3201, both 
Republican and Democrat. This strongly indicates that there is support 
for FDA reform. I intend to continue refining H.R. 3201 in hopes of 
obtaining more support. Under the leadership of Jim Greenwood, and with 
the great deal of help from Richard Burr and Scott Klug, our FDA reform 
team was able to make amazing strides and I fully intend to maintain 
this momentum.
  I will be introducing the Medical Device Modernization Act of 1997 
shortly, which will insure the safety and effectiveness of medical 
devices, assure a predictable approval process for our companies and 
insure that U.S. patients are receiving the best available medical 
technology in the world. I will be asking for your cosponsorship and 
support of this bill.
  Again it is imperative that we pass reform for the medical device 
industry. Small business is the nerve center of this county's current 
economic growth. Sixty-five percent of the companies in the medical 
device industry have less than 20 employees and 98 percent of medical 
device firms have less than 500 employees. These are the companies 
involved in high technology which is fueling economic expansion, these 
are the companies hiring your constituents, these are the companies 
doing the research and development that can lead to saving your 
constituent's lives. These small companies have been more vocal on FDA 
modernization in the last 2 years and I applaud them in their efforts.
  We spent a great deal of time laying the groundwork for reform in the 
104th Congress for FDA reform by educating Members, conducting 
oversight hearings, and working with various segments of the industry. 
It is now time for the 105th Congress to implement the solution. I look 
forward to working with House Commerce Committee Chairman Bliley, 
subcommittee Chairman Bilirakis, Congressman Dingell, and Senate 
Majority Leader Lott in arriving at an acceptable solution to all.

                          ____________________