[Congressional Record (Bound Edition), Volume 150 (2004), Part 11]
[Extensions of Remarks]
[Pages 15642-15643]
[From the U.S. Government Publishing Office, www.gpo.gov]




              THE ACCUTANE SAFETY AND RISK MANAGEMENT ACT

                                 ______
                                 

                       HON. CHRISTOPHER H. SMITH

                             of new jersey

                    in the house of representatives

                         Tuesday, July 13, 2004

  Mr. SMITH of New Jersey. Mr. Speaker, I rise today to join with my 
colleague, Congressman Bart Stupak of Michigan, to introduce 
legislation that will help improve the safety and health of thousands 
of Americans who may be using the acne medication Accutane.
  Accutane has been documented as causing severe birth defects and 
miscarriages in pregnant women using the drug, and its side effects can 
result in the onset of depression, psychosis, and even suicide. Four 
years ago, my colleague and friend Mr. Stupak had to endure the tragic 
suicide of his teenage son, who was using Accutane at the time.
  Despite the fact that the significant and serious side effects 
associated with 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, despite the fact 
that such a registry has been recommended by FDA advisory panels on two 
separate occasions.

[[Page 15643]]

  The Accutane Safety and Risk Management Act 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.
  Mr. Speaker, the legislation we propose 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 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 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 doctors, 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.
  In closing, Mr. Speaker, let me just add that I commend my good 
friend Bart Stupak for having the courage and fortitude to turn a 
heartbreaking family tragedy into an effort to spare others from 
suffering a similar loss. I look forward to working with him to advance 
this important, common-sense health reform.

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