US FDA issues Draft Guidance on Risk Evaluation and Mitigation Strategies

The US Food and Drug Administration has announced the long-awaited availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies, or REMS, which are required for certain drugs or biologics.

The document holds few surprises, and follows from the agency's announcement early last year that it had identified 25 drugs and biologic products that will be required to submit REMS, in a notice published in the Federal Register on March 27, 2008.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the FDA the authority to require the submission and implementation of a REMS if the agency determines a REMS is necessary to ensure that a drug's benefits outweigh its risks.
REMS components include medication guides; patient package inserts; a communication plan for health care providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for REMS submission.
The draft guidance for industry titled Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications:

* provides the FDA's current thinking on the format and content that industry should use for submissions of proposed REMS;
* includes preliminary information on the content of assessments and proposed modifications of approved REMS;
* describes REMS policies for certain regulatory situations;
* informs industry about who to contact within FDA about a REMS;
* indicates FDA Web sites where documents about approved REMS will be posted; and
* provides an example of what an approved REMS might look like for a fictitious product.

'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.