FDA panel backs patient registry for acne drug

A Food and Drug Administration advisory committee recommended in February that all patients who take isotretinoin as well as health professionals who prescribe and dispense it become part of a mandatory, manufacturer-proposed registry. Also, women would be unable to get the drug without a negative pregnancy test.

The registry is the latest idea for reducing the number of pregnant women exposed to the drug, which has long been linked to severe congenital anomalies. As part of this approach, both men and women would also receive extensive education about this risk.

A voluntary registry was launched in 2001, although it appears to have had little impact.

"We're trying to keep the drug available, but also to do whatever we can to reduce the risk relative to pregnancies," said Carolyn Glynn, spokeswoman for Roche Pharmaceuticals, manufacturer of the name-brand drug, Accutane.

Physicians praised the efforts attempting to keep this drug safely on the market but expressed concern that such action may increase the time necessary it takes them to prescribe the drug without addressing issues related to taking it while pregnant. The registry requirement may also decrease the number of doctors willing to prescribe it and increase the number of patients who buy it outside the United States or over the Internet.

"Some physicians may think it's not worth the bother," said Barbara R. Reed, MD, chair of the American Academy of Dermatology's ad hoc task force on the issue, who attended the hearing. "And it's too easy for many women to buy it from other countries or off the Internet. Then they have no supervision."

Experts expect that the registry will be similar to the thalidomide registry, although isotretinoin is prescribed more often and therefore potentially affects many more people.

Final details have not been approved by the FDA.The agency is not obligated to follow the committee's advice, although it usually does.