FDA Panel: Ease Accutane Rules

Aug. 1, 2007 – A program to prevent birth defects from the acne drug Accutane should be more flexible, an FDA advisory panel said today.

Accutane is a powerful drug that works against some of the hardest-to-treat forms of acne. But the drug also causes birth defects. Women who take the drug must take careful steps to avoid pregnancy.

FDA approval of Accutane requires all patients taking the drug to register with the so-called iPledge program. The program is designed to ensure that patients avoid pregnancy, and links prescriptions to pregnancy tests.

Even so, 122 women taking Accutane (or other versions of the drug generically known as isotretinoin) became pregnant during the first year of the program.

The FDA convened an expert panel to review the iPledge program and to make recommendations on how it might be improved.

The panel today voted to make the program more flexible, to take steps to reduce treatment interruptions, and to reduce unnecessary burdens for patients, an FDA spokesperson tells WebMD.

The panel recommended two major changes to the iPledge program:

• Currently, the program requires women to fill their isotretinoin prescriptions within seven days of the office visit at which they received the prescription. The panel recommended starting the seven-day clock at the time of a pregnancy test.
• If a patient fails to fill a prescription within the seven-day window, current rules require the patient to wait 23 days before the prescription can be filled. The panel recommended that a new seven-day window can begin on the date of a new pregnancy test.

FDA panel recommendations are not binding, although the agency almost always follows the advice of its panels.