Accutane is known to cause birth defects, and as a result, a panel of medical experts recently suggested the adoption of a mandatory registry, which would limit the drug's distribution to only registered pharmacies and physicians. Roche and dermatologists want a voluntary system.
Medical experts and Roche oppose this mandatory registry because they say it would undermine the physician/patient relationship and make the drug unavailable to thousands of patients. Education, not regulation, is the key to the safe use of this drug, says the American Academy of Dermatology.
That doesn't mean a registry will not be established. Speaking before the committee, Jonca Bull, MD, deputy director of the FDA office responsible for Accutane indicated to the lawmakers that the agency is in negotiations with the drugmaker to establish a registry by mid-2001.
Also speaking at the hearing were family members of teens believed to have committed suicide or attempted suicide as a result of Accutane. Despite their experiences, however, these family members did not call for the drug's withdrawal.
"I am not angry with the drug company that makes [Accutane] because I believe that for many [teens], it is a godsend," said Michael Baumann, of Mundelein, Ill., who lost his son Daniel in December 1999. "But I think its distribution should be handled differently and additional research conducted by an independent source as to the potential hazards."
The hearing follows another well-publicized claim by Rep. Bart Stupak (D-Mich.) that Accutane was also responsible for his son's suicide. At a recent press conference, Stupak called upon Roche to conduct further studies into the drug's mood-altering effects and for the FDA to enhance its surveillance over the drug's distribution.
In a prepared statement submitted for the record, Roche said it now plans to fund an educational program for health care professionals regarding the drug's psychiatric concerns. "It is our expectation that this program will have broad benefits beyond the Accutane population by increasing the likelihood that health care professionals will take advantage of an important opportunity to identify patients potentially at risk of psychiatric disease," reads the statement.