Dermatology Association Urges FDA to Postpone Program for Isotretinoin Patients

Posted: February 14, 2006

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“Since its FDA approval nearly 25 years ago, members of the Academy have had considerable experience with isotretinoin. Our members and their patients experience firsthand the significant - and in most cases, life changing - benefits that isotretinoin provides for individuals with severe acne and some rarer dermatologic conditions, as well. At the same time, the Academy recognizes the seriousness and importance of careful prescribing and patient education to ensure that women of childbearing age who are taking the medication do not become pregnant.

“We believe that the iPLEDGE program should not become effective on March 1, 2008, or at any time in the future unless the Academy's concerns are fully resolved. Forcing this program onto the public would not promote the health, safety, and welfare of isotretinoin patients and would be detrimental to the practice of dermatology in this country.”