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COPYRIGHT 2005 International Medical News Group
In a move that caught many in the medical community by surprise, the Food and Drug Administration last month announced a comprehensive--and mandatory--risk management program for the teratogenic acne drug isotretinoin and demands complete compliance by year's end.
The new program, called iPLEDGE, will require registration and ongoing compliance by all physicans and patients by Dec. 31, 2005. The iPLEDGE initiative replaces Roche's voluntary program for Accutane, called the System to Manage Accutane Related Teratogenicity (SMART), and similar programs for the four generic versions of isotretinoin.
The FDA informed physicians in November 2004 that SMART would be replaced (Stun & ALLERGY NEWS, January 2005, p. 1), hut the August announcement of iPLEDGE, uncertainty about the plan's details, and the impending deadlines for compliance left some dermatologists unsettled. At press time, officials with the American...
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