Accutane Newsroom

FDA Announces Enhancement to Isotretinoin Risk Management Program

The Food and Drug Administration (FDA) today announced the strengthening of the risk minimization action plan (RiskMAP) for Accutane (isotretinoin) and its generic equivalents. Isotretinoin is a drug indicated for the treatment of a specific type of severe acne (severe recalcitrant nodular acne) that is not responsive to other therapies. The goal of the strengthened RiskMAP is to reduce the risk of birth defects associated with fetal exposure to isotretinoin.

The strengthened RiskMAP reflects agency and sponsor's consideration of the recommendations from the February 2004 joint Advisory Committee of the Drug Safety and Risk Management and the Dermatologic and Ophthalmic Drug Advisory Committees which examined the current isotretinoin risk management program known as the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.) program. SMART was implemented in 2002 in response to agency recommendations at that time to further decrease fetal exposures to isotretinoin.

The February 2004 joint Advisory Committee discussion focused on whether changes were necessary to SMART and its generic equivalents, based on FDA assessments of the program's performance and its ongoing surveillance of pregnancy exposures to isotretinoin.

The committees agreed that changes were called for, especially in light of the fact that the SMART program, operated by Roche Pharmaceuticals, was only one of several similar programs that had been created with the introduction of generic isotretinoin to the market. The multiple programs created confusion and the concern that patients would not receive appropriate counseling and testing to prevent the possibility of birth defects.

Today's changes reflect a joint response by the agency and the sponsors of isotretinoin drug products to the Advisory Committee's recommendations that the sponsors strengthen the isotretinoin RiskMAP. Under the new program, sponsors will obtain registration of not only prescribers, but also pharmacies that dispense and patients who use isotretinoin. The program also includes documentation of a negative pregnancy test before giving isotretinoin to women who are capable of becoming pregnant. Importantly, the registration system will be built to incorporate physician and patient identification codes that will also protect the privacy of patients. The innovator and generic sponsors of isotretinoin have jointly contracted with Covance, Inc., to design, build, implement, and operate a single strengthened isotretinoin riskMAP incorporating these elements.