The U.S. Food and Drug Administration announced (30 Sept 2009) the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), which are required for certain drugs or biologics.

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 FDA determines that a REMS is necessary to ensure that a drug’s benefit outweighs its risks.

An approved REMS that is voluntarily submitted is subject to the same requirements and enforcement as a REMS that was originally submitted as a required proposed REMS.  If an applicant voluntarily submits a proposed REMS, it will not be approved as a REMS until the FDA determines that it is required to ensure that the benefits of the drug outweigh the risks and that it meets the FDAAA criteria.  Proposed REMS that are not approved are not subject to the requirements and enforcement of an approved REMS.  FDA will notify applicants who voluntarily submit a proposed REMS whether the REMS will be required.  If the FDA determines that a REMS is not required, an applicant may undertake voluntary risk management measures that would be performed outside of a REMS.

Differentiation between a REMS and the earlier (i.e., prior to FDAAA) risk minimization action plans (RiskMAPs) is addressed.

Source: FDA Draft Guidance