Feedback Request: FDA Developing Guidance on REMS Assessments

On June 7, the FDA held a public workshop on risk evaluation and mitigation strategies (REMS) assessments. The purpose of the workshop was to initiate dialogue and information sharing among stakeholders about survey methodologies and instruments that can be used to evaluate patients’ and health care providers’ knowledge about the risks of drugs marketed with an approved REMS. FDA is gathering input as it develops guidance for industry describing the best practices for conducting an assessment of a REMS goal regarding patient and/or health care provider knowledge about a drug’s risk(s). As additional background, FDA has released an issue paper that discusses FDA’s experience with knowledge assessments for REMS and contains specific questions in which FDA is seeking input.

If you have experience implementing REMS programs and/or assessment processes related to challenges and successes with REMS programs, please provide your feedback to Marcie Bough, PharmD, APhA’s Senior Director of Government Affairs at or by phone at 202-429-7538. The comment deadline is July 7, 2012. Additional information about the meeting is available on the FDA’s meeting page and more on improving REMS programs can be found in the APhA 2011 REMS White Paper.

June 13, 2012