[Congressional Record Volume 141, Number 109 (Friday, June 30, 1995)]
[House]
[Pages H6683-H6684]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                AMERICANS WANT FASTER FDA DRUG APPROVALS

  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, 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, A.L.S., Lou Gehrig's disease, epilepsy, or 
AIDS, who speak of the difficulties in obtaining these life-saving, 
life-extending drugs. They need them 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.
  Is it not ironic that most of the life-saving drugs that are produced 
in the 

[[Page H6684]]
world are produced here in the United Stats, but our patients and our 
constituents are the last to receive them because of over-regulation 
and delays in the system which can be cleared up.
  Do not 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. What we need to have is a speeded 
up process to approve or disapprove drugs so that the investments made 
by biotech and pharmaceutical companies can result in having saved 
lives and the quality of those lives extended for many years to come.
  In addition, the FDA regulates businesses that produce 25 percent of 
America's gross national product, so the agency's actions also impact 
on our country's economic well-being. The United States is far and away 
the world leader in pharmaceutical and biotech discovery, but many 
firms are moving clinical trials overseas because of needless trends 
that do not bode well for the economic future of the United States.
  This can all be changed by legislation; by making sure that we speed 
up the process of FDA approval so that our constituents will have the 
benefit of these life-extending and live-saving drugs.
  In my 13th Congressional District of Pennsylvania alone, we have 10 
facilities of 4 major pharmaceutical companies that employ 11,000 
people. Here they are at work very hard every day to make sure that we 
save lives and improve those lives. I would not want to see any of 
those companies or constituents lost their jobs because FDA regulation 
is so overburdened and so over-regulated that we delay, in fact, the 
service and the medical care for our constituents.
  Americans want safe medicines. They want a strong FDA that will keep 
unsafe products off the market. But they also want to see more emphasis 
on quicker access to medicines, faster clinical trials, and the 
delivery of those services and devices to them. That is why I am 
introducing, working with colleagues on both sides of the aisle, to 
have the Life Extending and Life Saving Drug Act passed here in this 
104th Congress. We need to take the action as soon as possible for the 
great benefit of our Nation's patients and our constituents. I look 
forward to working with my colleagues and the chairmen of the important 
committees, like Commerce's Thomas Bliley, to make sure we act 
critically, quickly, and in an efficient manner so that our 
constituents will be served and, in fact, an industry that is so vital 
to the country moves forward with economic stability.


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