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American Academy of Dermatology Association disappointed by iPLEDGE REMS Program transition


Statement from AADA President Kenneth J. Tomecki, MD, FAAD

ROSEMONT, Ill. (Dec. 14, 2021) — The American Academy of Dermatology Association (AADA) has been working closely with the U.S. Food and Drug Administration (FDA), the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program administrator, and the program sponsors to ensure a seamless transition to the new platform that launched on Dec.13, 2021.

In advance of this transition, the AADA engaged the FDA and the iPLEDGE administrator about the numerous workflow concerns raised by dermatologists and how the impending changes would threaten patient access to necessary medication. Those concerns have become a reality across the country and we’re working to ensure patients can maintain safe and appropriate access to the treatment they need.

For years, the AADA has worked with the FDA to make the iPLEDGE program less burdensome for patients. The challenges facing dermatologists and their patients is unacceptable and we’re calling on the FDA, the iPLEDGE administrator, and the program sponsors to support physicians and their patients.

The AADA supports any efforts to streamline the iPLEDGE program while preserving patient safety and incorporating physician input. Our focus remains on working with the FDA, the iPLEDGE administrator, and the program sponsors to increase access to medications that will strengthen patient outcomes.

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About the AAD Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 20,000 physicians worldwide, the AAD is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the AAD at 1-888-462-DERM (3376) or aad.org. Follow the AAD on Facebook (American Academy of Dermatology), Twitter (@AADskin) or YouTube(AcademyofDermatology).