Guidance formats risk/benefit measure

The FDA last week issued its first guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), which the regulator can require in cases where it wants to make sure that a drug's benefits outweigh its risks. The guide represents a blueprint for how drugmakers should develop safety strategies.

A recent example in which REMS played a role in a drug's approval is Sabril, a medication to treat epilepsy in pediatric patients, made by Lundbeck. The drug carries with it a significant risk of vision damage, including the potential for vision loss. Sabril, approved in August, is available with a REMS that attempts to manage the risk of permanent vision loss. Restricted distribution, required vision testing, a patient registry, and mandatory benefit-risk assessments are all part of that strategy. The REMS was critical in gaining FDA approval, according to Medical News Today

REMS components, according to an FDA announcement, 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The draft guidance, Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications, provides FDA's current thinking on the format and content that drug sponsors should follow for REMS submissions. The document includes a sample REMS.

- here's the announcement
- here's the draft guidance
- see the Sabril article

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