FDA modifies iPLEDGE 'lockout'

November 1, 2006

Washington - A recent change to the federal iPLEDGE program that eliminates one controversial lockout period is a welcome one, says Stephen P. Stone, M.D., president of the American Academy of Dermatology (AAD).

But the AAD urges that patient restrictions be eased even further.

The Food and Drug Administration (FDA) announced last month that its mandatory isotretinoin registry will no longer require a 23-day lockout for males and females of non-childbearing potential who fail to fill their prescriptions within seven days.

"This (recent) improvement will definitely ease the hurdles for prescribing isotretinoin by making the program more flexible - and therefore more workable and less burdensome - for more than half of the isotretinoin patient population in the U.S.," he tells Dermatology Times.

That recommendation is one of several still under consideration.

"At this time, Covance reports that female patients of childbearing potential may not have this same benefit until 2007. The Academy urges the FDA, Covance and the Isotretinoin Product Manufacturers Group (IPMG) to accelerate this schedule so that all isotretinoin patients benefit from this important improvement."

Covance, based in Princeton, N.J., manages iPLEDGE. The IPMG comprises the four manufacturers that designed and sponsor iPLEDGE: Roche Laboratories (Accutane), Mylan Pharmaceuticals (Amnesteem), Bar Laboratories (Claravis) and Ranbaxy Laboratories (Sotret). All are involved with the FDA in decisions on program changes.

AAD recommendations

iPLEDGE was created to minimize incidents of birth defects, long known to be a risk to pregnant women who take isotretinoin.

The program went into effect March 1, 2006, despite protests by the AAD and other organizations decrying the program's restrictive requirements and the potential impact on physicians' ability to deliver top quality care.

The lockout provision was designed to prevent potential exposure to the drug during pregnancy. The AAD strongly urged elimination of the provision as one of its top two recommendations for improving the program; its first recommendation was to eliminate the rule requiring that 30 days pass between patients' office visits.

A recent survey of AAD members prompted other recommendations for improving iPLEDGE, including:

"These sought-after improvements are included in a larger package of changes that Covance and the IPMG submitted to the FDA (last) summer," Dr. Stone says. "They are now under agency review, making the likelihood of approval and implementation stronger."

Dr. Stone says he and other AAD staff members are in constant communication with the FDA, Congress, Covance and the IPMG on matters relating to iPLEDGE.

"Our conversations focus on the experiences of dermatologists and their patients with iPLEDGE, and recommendations for improving it," he says. "We will continue to advocate strongly for all of these changes and others, and I think it's likely that more changes to iPLEDGE are forthcoming."

However, clearly there are some dermatologists who believe iPLEDGE will continue to pose problems despite any forthcoming changes.

"I think iPLEDGE represents a barrier to care for many patients, and has created an unreasonable amount of work for dermatologists," says Boston-based dermatologist Ranella Hirsch, M.D., vice president of the American Society of Cosmetic Dermatology & Aesthetic Surgery. "I'm in favor it being dropped."

William Philip Werschler, M.D., says the program should be replaced.

"What they're doing is tweaking a bad program to make it better, but iPLEDGE is fatally flawed and should be replaced by a program that puts more of the onus of responsibility on the patient, rather than on physicians and pharmacists," says Dr. Werschler, assistant clinical professor of medicine and dermatology at the University of Washington School of Medicine.

"By the time you make all the changes that need to be made to iPLEDGE, it's not the same program - so what's the point?"