Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee

Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee
Meeting on December 1, 2011, from 8 a.m. to 5 p.m.

Agenda: The Food and Drug Administration Amendments Act of 2007 (Public Law 110–85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1, 2011, the DSaRM and the Dermatologic and Ophthalmic Drugs Advisory Committees will meet in joint session to discuss REMS-related topics. During the morning session, the committees will discuss the REMS program for isotretinoin, also known as iPLEDGE, as an example of a REMS that has ETASU. During the afternoon session, the committees will discuss general issues related to the impact of REMS with ETASU on the health care system and patient access, such as how programs with ETASU can be better integratedinto existing health systems.