AMCP Hosts Webinar on FDA REMS Initiatives
Academy members gained insights and offered suggestions at a recent AMCP-sponsored webinar on the Food and Drug Administration’s (FDA’s) initiatives around Risk Evaluation Mitigation Strategies (REMS) for pharmaceuticals. The June 30 event featured presentations from Gaurang Gandhi, PharmD, of Curascript Inc. and Annette Stemhagen, DrPH, of United BioSource Corp. AMCP scheduled the event in anticipation of an FDA public meeting later in July on proposals to standardize REMS to improve transparency and communications, and to ensure that the public is aware of the risks of certain medications.
Because AMCP members are involved in some REMS programs, the Academy will provide public testimony during the FDA meeting on July 25-26. AMCP’s comments will focus on the regulatory and legislative burden of REMS; the effects of standardization; and an encouragement that FDA utilize managed care organizations through subsidized research to disseminate information related to the impact of REMS on outcomes.
Approximately 60 AMCP members participated in the June webinar. For more information on the FDA’s July 25-26 REMS meeting, click here, or contact Mary Jo Carden, AMCP Director of Regulatory Affairs, at firstname.lastname@example.org.