FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies

The FDA has announced the availability of the first draftguidance for industry on Risk Evaluation and Mitigation Strategies or REMS,which are required for certain drugs or biologics. The Food and Drug Administration Amendments Act of 2007 (FDAAA) grantedthe FDA the authority to require the submission and implementation of a REMSif the FDA determines a REMS is necessary to ensure that a drug’s benefitsoutweigh its risks. REMS components include medication guides; patient package inserts; acommunication plan for health care providers; elements to ensure safe useincluding requirements for those who prescribe, dispense, or use the drug; anda timetable for REMS submission. The draft guidance for industry titled “Format and Content of ProposedRisk Evaluation and Mitigation Strategies (REMS), REMS Assessments, andProposed REMS Modifications”: — provides FDA’s current thinking on the format and content thatindustry should use for submissions of proposed REMS — describes each potential element — includes preliminary information on the content of assessments andproposed 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 beposted — provides an example of what an approved REMS might look like for afictitious product. “With this new guidance, manufacturers will have a useful blueprint forhow to develop these important safety strategies,” said Janet Woodcock, M.D.,director of the FDA’s Center for Drug Evaluation and Research. The draft guidance is available athttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf