FDA urged to adopt flexible distribution for acne drug

August 20, 2007

The advisers recommended that the agency approve proposed changes to iPLEDGE, a computer-based distribution program and pregnancy registry that provides a closed-loop system for prescribing, dispensing, and distributing isotretinoin, a drug that can cause birth defects, miscarriages, and premature births, according to the FDA.

An FDA advisory committee has urged the agency to modify the distribution requirements of a popular acne drug. The advisers recommended that the agency approve proposed changes to iPLEDGE, a computer-based distribution program and pregnancy registry that provides a closed-loop system for prescribing, dispensing, and distributing isotretinoin, a drug that can cause birth defects, miscarriages, and premature births, according to the FDA. The $110 million distribution program and pregnancy registry is run by the five makers of isotretinoin—Barr, Genpharm, Hoffmann-La Roche, Mylan, and Ranbaxy—and is designed to prevent pregnant women from using the drug. The committee wants iPLEDGE to drop the 23-day waiting period required for women of childbearing age who miss the initial seven-day window for filling their isotretinoin prescription. iPLEDGE requires women of childbearing age to have two negative pregnancy tests before starting isotretinoin therapy, a negative test every month during treatment, and a negative test one month after stopping therapy. Advisers also encouraged the FDA to accept the drugmakers' proposal to extend to 30 days the period that men and women of non-childbearing age have to fill their Rxs. More than 135,000 men and 133,000 women are enrolled in iPLEDGE.

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