FDA set to launch acne drug registry program

Isotretinoin, marketed by Roche as Accutane, is approved to treat severe recalcitrant nodular acne. The drug is highly effective in the treatment of this form of acne, but has known serious side effects, particularly its ability to cause birth defects when pregnant women use the drug, and more recent concerns regarding its potential to be associated with severe depression.

The iPLEDGE program seeks to reduce the risk of inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin. It is a unique risk management program, unprecedented in size and scope.

To obtain the drug, in addition to registering with iPLEDGE, patients must comply with a number of key requirements that include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with necessary pregnancy testing.

The program has been developed through a cooperative effort of several manufacturers of isotretinoin. To date, a large number of prescribers, wholesalers, and pharmacies have registered in anticipation of the March 1, 2006 start date. In addition, more than 1200 patients per day have been registering for the program in recent weeks.

However, the scheme has its critics. For example, the 15,000 physician members of the American Academy of Dermatology Association (Academy) have expressed their disappointment in the FDA not postponing the program’s March start date. Members of the Academy believe flaws and inefficiencies in the program have not been sufficiently addressed prior to its launch, and say they are concerned that the program will not work as intended, which could impede patient access to the drug.