American Academy of Dermatology Commends Senators for Addressing iPLEDGE Program Concerns

SCHAUMBURG, IL (Jun 23, 2006) — The American Academy of Dermatology and the American Academy of Dermatology Association (Academy) commend U.S. Senators Judd Gregg (R-NH) and Dick Durbin (D-IL), along with senators from both political parties, for contacting the U.S. Food and Drug Administration (FDA) regarding concerns with the iPLEDGE program.

"The American Academy of Dermatology's primary concern is the health, safety and welfare of our patients, especially in relation to the iPLEDGE program," said dermatologist Stephen P. Stone, M.D., president of the Academy. "The Academy appreciates the actions of Senators Gregg, Durbin and others to bring awareness of this issue to the forefront of the FDA in order to ensure patient safety."

The iPLEDGE program is a regulatory program for isotretinoin, a medication used in the treatment of severe cystic acne, 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 using the drug during pregnancy in order to prevent birth defects associated with this medication.

Several very serious concerns regarding the implementation of iPLEDGE have emerged since the FDA approved the program. These concerns include mandatory 7-day timeframes for picking up a prescription, a subsequent 23-day lockout period in which dosage cannot be adjusted nor additional medication be obtained in case of loss or other unforeseen events, and a 30-day period between office visits that has led to gaps in therapy during which patients have no medication. Other concerns include the discontinuation of a free isotretinoin program for indigent patients, and the inclusion of male patients and female patients not of childbearing potential in a program designed to prevent fetal exposure to isotretinoin. Addressing these pressing issues would lessen the burden by making iPLEDGE more workable for patients and their prescribers. Although the Academy has repeatedly pointed out the importance of addressing these concerns, many of these issues have not yet been addressed and are affecting patients' ability to access this important medication. "We will continue to bring the program's flaws to the attention of the FDA and we hope to work together 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," stated Dr. Stone.

In their letter to the FDA, Senators Gregg and Durbin, along with others, urged Acting Commissioner of the FDA, Andrew Eschenbach, M.D., to address problems associated with the implementation of the iPLEDGE program. Gregg is the former chairman of the Senate Health, Education, Labor and Pensions Committee and Durbin serves on the Senate Appropriations Subcommittee on Health and Human Services. Both Senators support the risk-management goals of the program. Additional signatories to the letter include Senators Pat Roberts (R-KS), Ron Wyden (D-OR), Bob Bennett (R-UT), Russ Feingold (D-WI), Orrin Hatch (R-UT), and Chris Dodd (D-CT).