Accutane Safety and Risk Management Act

H.R. 2956, the Accutane Safety and Risk Management Act, would implement strict federal controls over the distribution and use of isotretinoin, a powerful acne medication commonly known by the brand name Accutane. The bill would temporarily withdraw the drug from the market and only allow it to be sold again under a rigorous "restricted distribution" system designed to prevent birth defects and monitor mental health side effects.

For citizens, this legislation would mean that isotretinoin could only be obtained through certified treatment centers and registered pharmacists, with prescriptions limited to a 30-day supply and no refills. Patients would be required to sign informed consent forms, undergo regular medical testing, and complete monthly questionnaires to monitor for adverse effects such as depression or suicidal thoughts. Additionally, the bill mandates increased federal research into the drug's impact on the central nervous system and behavior.