American Academy Of Dermatology Says FDA Not Likely To Postpone Start Date For Accutane Registry

The American Academy of Dermatology on Tuesday said that, despite its concerns about a program that seeks to reduce the number of pregnant women who use the acne medication isotretinoin, sold under the brand name Accutane, FDA has said the program will begin as planned, the AP/San Jose Mercury News reports (Schmid, AP/San Jose Mercury News, 2/21). FDA on Dec. 30, 2005, began to register physicians, prescription drug wholesalers, pharmacists and women into the program, known as iPledge, after an FDA advisory committee in March 2004 recommended the program. Under the program, women must submit two negative pregnancy tests before they can receive an initial prescription for isotretinoin and must undergo a monthly pregnancy test before each refill. In addition, women must agree to use two forms of birth control at the same time or to abstain from intercourse for one month prior to treatment with isotretinoin, during treatment and for one month after treatment has ended, according to FDA. Women also must sign a document to acknowledge that isotretinoin can increase risk for birth defects, depression and suicidal thoughts. The program also requires physicians who prescribe isotretinoin and wholesalers and pharmacists who distribute the medication to register with the database. About 88% of the nation's 55,000 pharmacies and 56% of the estimated 36,000 doctors who prescribe Accutane have registered with system, and 17,881 patients had registered with the program as of the week of Feb. 13. FDA officials earlier this month said they were considering postponing the mandatory start date of March 1 after glitches in the program delayed registration (Kaiser Daily Women's Health Policy Report, 2/13). AAD President Clay Cockerell said in a statement that with the decision not to delay the iPledge start date, "it is now the duty of the FDA to guarantee that the flaws, inconsistencies and confusion" in the program are fixed. According to the AP/San Jose Mercury News, FDA has not confirmed that it will not postpone the start date (AP/San Jose Mercury News, 2/21).


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