FDA Seeks Public Comment on REMS Program

The FDA is seeking public comments on a proposed plan to release information on how drugmakers are doing in their implementation of Risk Evaluation and Mitigation Strategy (REMS) programs.

Under a REMS program, the agency requires manufacturers to implement specific postmarket safety measures and to send periodic assessments to the agency for review. Currently, the FDA’s reviews may only be publicly accessed through a Freedom of Information Act request.

The agency is considering changing its policy to make its internal reviews and manufacturer assessments public. The comments are due to the FDA by Jan. 4.