November 9, 2002 WASHINGTON (AP) -- Sufferers of serious acne will soon be able to buy the first generic version of the drug Accutane — if they follow strict rules designed to keep the birth defect-causing drug out of pregnant women's hands.
Health officials have worked for years to associate the name Accutane with birth defects so women know not to use it if there's a chance they can get pregnant. Generic drugs are sold under a medication's chemical name — in this case isotretinoin — so the question now is whether doctors and women will make that crucial connection.
"One of our biggest concerns was that because they'll have different names, that may lead to confusion," said Dr. Sandra Kweder of the Food and Drug Administration, which approved sale of the generic version late Friday.
The FDA has stressed to generic manufacturer GenPharm Inc. that "one of their biggest missions is to ensure the practitioners and patients recognize this is the same stuff."
Accutane is not for routine pimples, but for treating the most serious form of acne. Among its side effects are serious birth defects and fetal death. There is also a possible but unproven link to depression and suicide.
Despite intense efforts to keep the drug away from pregnant women, the FDA has had over 2,000 reports in the last decade of women becoming pregnant while taking Accutane. The vast majority chose abortion, but there also were birth defects, miscarriages and some healthy births.
Last spring, the FDA and Accutane maker Roche Laboratories began a program making it far tougher for women to get the prescription drug. Among other things, the program requires a doctor's certification that each patient has had a negative pregnancy test, a patient commitment to use birth control, a ban on pharmacies filling Accutane prescriptions without the required certification and release of a month's supply at a time, with patients getting a new pregnancy test before each renewal.
GenPharm's generic version of Accutane will have to follow those same safety steps, the FDA said Friday.
Toronto-based GenPharm didn't return a call seeking comment on how much its generic version will cost or when sales will begin. Generics typically cost half the price of their name-brand counterparts. Accutane typically sells for $4 a pill.
Copyright 2002 The Associated Press. All rights reserved.
