American Academy of Dermatology Issues Statement in Response to FDA Approval of iPLEDGE Program for Isotretinoin

Schaumburg, Ill., (August 23, 2005) - The American Academy of Dermatology and the American Academy of Dermatology Association (Academy) today issued a statement in response to the U.S. Food and Drug Administration's (FDA) announcement of approval of the iPLEDGE program, a new regulatory program for isotretinoin developed by the four pharmaceutical companies marketing this medication in the U.S.

This program is designed to control dispensing of isotretinoin and requires prescribers, patients, pharmacies, wholesalers, and manufacturers to participate in a mandatory registry. The goal of this new program is to prevent female isotretinoin patients of childbearing age from becoming pregnant or using the drug during pregnancy in order to prevent birth defects associated with this medication.

While the Academy does not support the concept of a registry, the Academy is pleased that several of the improvements it insisted upon for making the new program more workable are included in iPledge. These improvements include:

  • Prescribing by phone, fax, or electronically;
  • Allowing registered dermatologists to delegate to staff designees the tasks of obtaining and entering patient information into the iPledge registry system;
  • Allowing the use of both urine and blood serum pregnancy tests; and
  • Correcting and/or clarifying inaccurate or confusing terminology in the program's educational materials.

"The American Academy of Dermatology's primary concern is the health, safety and welfare of our patients. The Academy members and staff will continue working with the FDA and the pharmaceutical companies sponsoring iPledge to ensure that the registry is a workable program that keeps this important medication available to the patients who need it and the people who prescribe it," said dermatologist Clay J. Cockerell, M.D., president of the American Academy of Dermatology and the American Academy of Dermatology Association.

The American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. A sister organization to the Academy, the American Academy of Dermatology Association is the resource for government affairs, health policy and practice information for dermatologists, and plays a major role in formulating socioeconomic policies that can enhance the quality of dermatologic care. With a membership of more than 14,000 physicians worldwide, the Academy 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. For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.