The Food and Drug Administration on Tuesday unveiled new restrictions for Accutane, a drug indicated for the treatment of a specific type of severe acne that is not responsive to other therapies.

The goal of the strengthened risk minimization action plan (RiskMAP) for Accutane and its generic equivalents is to reduce the risk of birth defects associated with fetal exposure to Accutane, the agency said in an FDA Talk Paper.

Under the new program, makers will obtain registration of not only prescribers, but also pharmacies that dispense and patients who use Accutane. The program also includes documentation of a negative pregnancy test before giving Accutane 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.

As stated in 2002, the goal of the agency was to eliminate fetal exposure to Accutane by ensuring that no woman start Accutane therapy if pregnant and no woman on Accutane therapy become pregnant. The agency and the sponsors believe this new program will go a long way to achieving this goal.

While the program development itself is complex, FDA has emphasized the need to make it as unintrusive as possible for healthcare providers and patients. At the same time that FDA has asked industry to be mindful of the need for simplicity and minimal burden on the health care community and patients.

The FDA will continue to monitor all adverse events reported with Accutane use, to include neuropsychiatric adverse events, in order to protect the public health by ensuring that the risks associated with Accutane use are minimized for those patients who need treatment with this drug.

(via U.S. Food and Drug Administration)