[Congressional Record (Bound Edition), Volume 150 (2004), Part 13]
[Extensions of Remarks]
[Page 17363]
[From the U.S. Government Publishing Office, www.gpo.gov]




                   BILL CALLS FOR REGULATING ACCUTANE

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                       HON. CHRISTOPHER H. SMITH

                             of new jersey

                    in the house of representatives

                        Thursday, July 22, 2004

  Mr. SMITH of New Jersey. Mr. Speaker, I rise in support of H.R. 4598: 
the Accutane Safety and Risk Management Act.
  In an effort to improve the health and safety of patients using a 
pharmaceutical product that has been linked to several major side 
effects, I recently joined with my friend and colleague Congressman 
Bart Stupak of Michigan to introduce this legislation that will 
establish a comprehensive patient registry for users of the drug 
Accutane and its generic forms.
  Accutane was approved for use in treating severe acne in the early 
1980s. Today, more than 1 million prescriptions are approved each year, 
and not always for the serious cases of acne for which the drug is 
intended. The Food & Drug Administration states that, ``Accutane may 
cause depression, psychosis, and rarely, suicidal ideation, suicide 
attempts, and suicide.'' Additionally, the makers of the drug state 
that ``there is an extremely high risk that a deformed infant can 
result if pregnancy occurs while taking Accutane in any amount, even 
for short periods of time.''
  Four years ago, Congressman Stupak had to endure the tragic suicide 
of his teenage son, who was using Accutane at the time of his death.
  Despite the fact that the significant and serious side effects linked 
to Accutane are well known, the Food and Drug Administration has yet to 
mandate a program to better monitor the use of this drug and to 
document its effects in patients. Such a registry has been recommended 
by FDA advisory panels on two separate occasions.
  Mr. Speaker, our bill is common sense legislation that will build 
upon a safety plan first proposed by the makers of this drug 
themselves. It will still permit doctors to prescribe Accutane, but 
will also institute several additional patient safety and protection 
measures and ensure patients and their families know the full risks 
before beginning treatment.
  H.R. 4598 will permit physicians to prescribe Accutane only for 
``severe, recalcitrant nodular acne'' that has been unresponsive to 
other forms of treatment. Severe acne is the condition for which 
Accutane was originally approved by the FDA to treat.
  For patients with severe acne, Accutane may be the only medication 
that can successfully treat their affliction. But in far too many 
cases, Accutane is prescribed in an overly cavalier manner, and 
patients are being placed at risk to the drug's potential side effects 
for no medically valid reason. Many teenagers suffer from acne, and 
doctors and patients need to be cautious and not treat this drug 
lightly.
  The legislation will also register all physicians and pharmacists who 
prescribe and dispense the drug, and institute an education campaign to 
ensure these providers are well-informed about the potential risks 
associated with Accutane. All patients will also be educated and be 
required to receive similar information before starting treatment with 
Accutane and throughout the treatment regimen.
  Prescriptions will only be written for 30 days and will not be 
permitted via the telephone, Internet, or mail. Female patients will 
also have to undergo a monthly pregnancy test before receiving a 
renewal on their prescription, and all patients will be required to 
take a monthly blood test.
  The makers of the drug and all practitioners who dispense Accutane 
will also be required to file prompt reports with the Department of 
Health and Human Services anytime they learn of a negative reaction, 
including a death, that occurs in a patient while using Accutane.

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