At an FDA meeting in September, a panel of medical experts indicated that while the reported psychiatric events do not appear to be of major concern, the ongoing pregnancies are of particular concern considering that the use of Accutane has tripled since its approval. The panel commended Roche for its ongoing efforts to educate physicians and patients, but then recommended that a mandatory registration program be created to ensure that patients use the drug as directed. Roche wants a voluntary registration program.
At present, Roche already is phasing in a Targeted Pregnancy Prevention Program directly aimed at those women who, for whatever reason, fail to comply with the mandatory pregnancy prevention provisions required under the prescription. Roche also has prepared a checklist for doctor and patients, which includes a 24-hour contraceptive counseling hotline. And the company has begun shipping pregnancy tests to physicians and now plans to send marketing representatives to about 97% of the prescribing doctors as well.
The FDA has yet to act on the panel's recommendations for Accutane. But the agency recently has taken a number of actions to ensure the proper use of other controversial drugs that, in one instance, eventually resulted in the drug's withdrawal.
The FDA recently attempted to restrict the distribution of Glaxo Wellcome's Lotronex (alosetron), a treatment for irritable bowel syndrome. Lotronex has been associated with 49 cases of a rare, but potentially serious side effect called ischemic colitis. But rather than accept the FDA's proposed restrictions, the British drug maker decided to withdraw the drug voluntarily, saying that the agency's proposed restrictions were equivalent to a withdrawal.
Experts caution that restricting Accutane to only a set of registered pharmacies and physicians could in effect lead to a similar result.
"As dermatologists, we strongly believe that limiting access to [Accutane] is a disservice to patients and erodes the patient-physician relationship," said Richard Scher, MD, president of the American Academy of Dermatology (AAD), following the FDA panel meeting in September. "Education, not regulation, is the key to safe use of this drug to protect women of childbearing age."