[Congressional Record Volume 141, Number 92 (Wednesday, June 7, 1995)]
[House]
[Page H5686]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                LIFE EXTENDING AND LIFE SAVING DRUG ACT

  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. Madam Speaker, as was aptly described by 
Carl B. Feldbaum, president of the BioTech Industry Organization, 
``Life-saving new drugs do take too long to reach the people who need 
them.''
  From my district in Montgomery County, PA, I have heard many a 
compelling story from constituents with cancer, Lou Gehrig's Disease, 
epilepsy, or AIDS who speak of the difficulties in accessing the 
medicines they need because the approval process in our country is so 
prolonged and, in effect, they have to turn to other countries where 
the products are available.
  Don't get me wrong. The Food and Drug Administration serves a 
valuable purpose in maintaining

 high safety and efficacy standards. However, it is important to note 
that the FDA's actions directly affect the lives of patients and the 
ability of physicians to provide state-of-the-art care for their 
patients.

  In addition, the FDA regulates businesses that produce 25 percent of 
America's gross national product, so the Agency's actions also impact 
our country's economic well-being. The pharmaceutical industry is an 
excellent example. The United States leads the world in discovering new 
drugs yet, all too often, these drugs are available overseas first. The 
United States is far and away the world leader in biotechnology, but 
many biotechnology firms are moving clinical trials overseas because of 
red tape imposed on them by the FDA. These are very troubling trends 
that do not bode well for the economic future of the United States, or 
for the economic future of Pennsylvania.
  In my 13th Congressional District of Pennsylvania alone, we have 10 
facilities of 4 major pharmaceutical companies. Together, these 
facilities employ more than 11,000 people. I would not want to see any 
of these constituents lose their jobs because FDA regulation is 
prompting companies to conduct some of their work overseas.
  Americans want safe medicines. They want a strong FDA that will keep 
unsafe products off the market but, I believe, they want to see more 
emphasis on the value of giving patients quicker access to safe and 
effective new medicines. That is why, today, I am introducing the Life 
Extending and Life Saving Drug Act. We need to take action as soon as 
possible for the great benefit of this Nation's patients, physicians, 
and our emerging industry. I look forward to working with my colleagues 
to act quickly on this critical piece of legislation.


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