[Congressional Record (Bound Edition), Volume 150 (2004), Part 18]
[House]
[Page 24287]
[From the U.S. Government Publishing Office, www.gpo.gov]




                                ACCUTANE

  (Mr. STUPAK asked and was given permission to address the House for 1 
minute.)
  Mr. STUPAK. Mr. Speaker, Dr. Graham, medical review officer of the 
FDA, told the Senate that there are a number of drugs that should be 
pulled from the market. One of the drugs that should be pulled from the 
market is the drug Accutane. This devastating drug has crippled America 
for some time and its youth. Not only has Dr. Graham called for the 
pulling of Accutane, but Dr. Huene, one of the first medical review 
officers to look at Accutane when it first came on the market, found 
serious problems with Accutane and asked for help and was ignored by 
the FDA. Dr. O'Connell, who suggested severe restrictions of the use of 
the drug Accutane, again was ignored by the FDA management. Dr. Graham 
has now come out against this drug, again being ignored by FDA 
management.
  Not only are these three medical review officers in the FDA calling 
for severe restrictions or pulling the drug from the market, but also 
the CDC backed in 1990 because of birth defects said this drug should 
be pulled from the market. The March of Dimes has said this drug should 
be severely restricted when used because of birth defects. Two FDA 
panels have come out and told the FDA, their own advisery panels, to 
severely restrict the use and distribution of this drug. Again they 
were ignored.
  It is time we pulled this drug Accutane from the market.

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