WASHINGTON, Feb. 21 /PRNewswire/ -- The following is a statement from Clay J. Cockerell, M.D., President of the American Academy of Dermatology Association:
The 15,000 physician members of the American Academy of Dermatology Association (Academy) express serious disappointment in the failure of the U.S. Food and Drug Administration (FDA) to postpone the mandatory March 1, 2006, start date of the iPLEDGE program. Members of the Academy believe that flaws and inefficiencies in the program have not been sufficiently addressed prior to its launch, and remain very concerned that the program will not work as intended, likely impeding patient access to this important medication.
Numerous concerns regarding the implementation of iPLEDGE have emerged since the FDA approved the program in August 2005. Although the Academy has repeatedly pointed out the importance of addressing these concerns before the program takes effect -- including testimony by Academy member and practicing dermatologist Diane Thiboutot, M.D., before the FDA’s Drug Safety and Risk Management Advisory Committee on February 10, 2006 -- the FDA is moving forward with the program’s March 1, 2006, start date.
It is now the duty of the FDA to guarantee that the flaws, inconsistencies, and confusion in the iPLEDGE program are resolved on the March 1 start date.
Under the direction of the FDA, the Isotretinoin Product Manufacturers Group (IPMG) and its chosen vendor, Covance, designed iPLEDGE -- a mandatory, risk management system that tracks registered prescribers and all registered patients to ensure that women of childbearing potential do not become pregnant while taking isotretinoin.
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. 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.
While the Academy and its membership do not agree with the FDA’s decision, patient safety remains our number one priority. We will continue to bring the program’s flaws to the attention of the FDA, and we hope to work together with the FDA, the IPMG, and Covance to effectively and efficiently correct the program’s shortcomings -- ultimately ensuring that isotretinoin patients receive safe, high-quality care and careful monitoring of their treatment regimen.
American Academy of Dermatology Association
CONTACT: Jennifer Allyn, +1-847-240-1730, jallyn@aad.org, Lisa Doty,+1-847-240-1746, ldoty@aad.org, or Aisha Hasan, +1-847-240-1735,ahasan@aad.org, all of the American Academy of Dermatology Association
Web site: http://www.aad.org/
