FDA Releases Draft Guidance for REMS

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009. The document describes the format and content of a proposed REMS, including supporting documentation, the content of assessments and proposed modifications of an approved REMS, which identifiers should be used on REMS documents, and how to communicate with FDA about a REMS. The guidance also provides an example of what an approved REMS might look like.

“With this new guidance, manufacturers will have a useful blueprint for how to develop these important safety strategies,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release.

According to the draft guidance, a proposed REMS submission to FDA should include a proposed REMS, which concisely describes the proposed goals and elements of the REMS, and a REMS supporting document that provides additional information such as a thorough explanation of the rationale for, and supporting information about, the content of the proposed REMS. All proposed materials that are included in the REMS (e.g., proposed communication and education materials, Medication Guide, elements to assure safe use, patient package insert, enrollment forms, and prescriber and patient agreements) should be appended to the proposed REMS. A template for the proposed REMS is available on FDA’s website.

The REMS supporting document should thoroughly explain the rationale for and supporting information about the content of the proposed REMS, according to the draft guidance. The REMS supporting document should describe how and when each REMS element will be implemented and specify the rationale for the timelines and milestones. If any REMS activity will not be implemented at the time of REMS approval, the REMS supporting document should describe the reason for the implementation schedule. “For example, the document should address the rationale for whether a communication plan would be implemented before, or concurrently with, other elements,” the draft guidance says. A template for the REMS supporting document can also be found on FDA’s website.

In addition, the draft guidance describes REMS policies for certain regulatory situations. The draft lists FDA websites where documents about approved REMS will be posted.

The FDA Amendments Act of 2007 granted FDA the authority to require the submission and implementation of a REMS if the agency determines that it is necessary to ensure that a drug’s benefits outweigh its risks. Future draft guidances will address additional REMS topics, according to an agency press release.