[Congressional Record Volume 141, Number 99 (Friday, June 16, 1995)]
[Extensions of Remarks]
[Pages E1273-E1274]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                    FDA'S CAUTION IS KILLING PEOPLE

                                 ______


                        HON. JOHN J. DUNCAN, JR.

                              of tennessee

                    in the house of representatives

                        Thursday, June 15, 1995

  Mr. DUNCAN. Mr. Speaker, I would like to share with my colleagues an 
editorial from the June 4, 1995, Los Angeles Times written by James P. 
Driscoll.
  Mr. Driscoll, an AIDS activist, is currently vice president of Direct 
Action for Treatment in San Francisco. He has been working with my 
constituent, Alzheimer's activist George Rehnquist, to pressure the 
Food and Drug Administration [FDA] to approve tacrine, the first drug 
for treating Alzheimer's disease.
  One of the most wasteful, bureaucratic agencies in the Federal 
Government today is the FDA. They have delayed approval for medicines 
for sometimes up to years to the detriment of the health of American 
citizens.
  Mr. Driscoll's perspective on drug research, ``FDA's Caution is 
Killing People,'' brings awareness to the needless deaths caused by 
FDA's senseless delay of approval on vital medicines. I agree that 
Congress should no longer tolerate this practice.

               [From the Los Angeles Times, June 4, 1995]

                  FDA's ``Caution'' Is Killing People

                         (By James P. Driscoll)

       During the 1950s, drug approval in the United States was a 
     relatively quick and simple process. Then came thalidomide. 
     European regulators had approved this tranquilizer without 
     realizing that it could affect a fetus, and several hundred 
     birth defects resulted worldwide. Capitalizing on the 
     tragedy, liberals in Congress expanded the Food and Drug 
     Administration's powers and altered its priorities.
       After amendments in 1962, a peculiar system of drug 
     approval emerged. With each passing year, that system grew 
     more dilatory, more unbalanced and more costly to patients.
       FDA's top priority became--and remains--prevention of new 
     thalidomides.
       Much of our gross national product is spent on prevention: 
     national defense, vaccination, policing, flood control, 
     sanitation, auto safety, cholesterol tests, anti-terrorist 
     measures and burglar alarms.
       Our prevention needs are boundless, but resources are 
     limited and must be allocated wisely. Too much allocated to a 
     minor prevention need will leave major needs neglected. 
     Ideally, the greatest good for the greatest number should 
     determine priorities. In reality, narrow self-interest often 
     prevails. Thus, defense contractors build new weapons the 
     country doesn't need. Farmers get subsidies to grow surplus 
     crops. And FDA churns out burdensome regulations that 
     delay drug approval and actually harm patients.
       To better understand FDA's narrow priority, we need to see 
     it in light of the kinds of problems that beset drug 
     regulators. The least common problems are the thalidomides, 
     drugs approved before their safety hazards are known. Even 
     with the pre-1962 FDA, this kind of problem never was a 
     threat comparable to food poisoning or plane crashes. But 
     since Congress blamed FDA for mistaken approvals, the agency 
     made preventing new thalidomides its top priority. Through 
     scare tactics and deception, FDA sold the public on this 
     priority.
       Congress and the public are beginning to realize that they 
     have been unwitting parties to a deal made in hell. To 
     prevent a minor threat to public health, FDA created a major 
     health tragedy: needless deaths and suffering caused by 
     delaying useful medicines.
       Rational priorities would seek a balance that minimizes the 
     total deaths caused by both mistaken approvals and delays. 
     Rationality and balance are hard. Delay is easy and deals 
     made in hell are tempting.
       A recent FDA delay resulted in 3,500 deaths--those kidney 
     cancer patients who, by the FDA's own figures, would have 
     been saved if the drug Interleukin 2 had been approved here 
     as quickly as it was in Europe. These kidney cancer deaths 
     exceed the number of babies deformed by thalidomide. And 
     Interleukin 2 is only the tip of the iceberg. Delays in 
     approving heart drugs, cancer drugs, AIDS drugs and life-
     saving devices have contributed to tens of thousands of 
     deaths.
       Congress has tolerated FDA delay because its dangers are 
     difficult to prove. Individual patients usually don't know 
     about the unapproved drug or device that could save their 
     lives. Patients who suffer the worst loss from FDA delay 
     cannot protest from their graves. Fearing retaliation, drug 
     companies avoid blaming FDA for delays.
       Few people grasp the complexities of drug development. Few 
     politicians bother to 

[[Page E1274]]
     evaluate carefully either FDA's priorities or the human cost of 
     regulatory delays. Consequently, we've lacked effective 
     congressional oversight on FDA. Without oversight, rational 
     policy perishes, deceit flourishes and demagoguery can 
     triumph.
       Enter David A. Kessler, FDA's answer to J. Edgar Hoover. 
     Kessler's FDA boldly sets its own priorities. It does not 
     shrink from half-truths or scare tactics. It pursues 
     retaliation and selective enforcement without remorse. It has 
     made drug safety and efficacy testing a worse bargain than 
     the Pentagon's $600 toilet seats. Fortunately, recent House 
     and Senate hearings indicate that FDA abuses are finally 
     arousing congressional watchdogs.
       Congress should no longer tolerate the FDA's perversion of 
     its mission. To prevent a few mistaken approvals, FDA 
     sacrifices countless patients to approval delay, slows the 
     pace of medical progress and drives health-care costs through 
     the roof and jobs out of the country. It's time for Congress 
     to put patients above bureaucrats and hold the FDA strictly 
     accountable for the human cost of regulatory delays.

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