Report analyzes how FDA can use REMS most effectively

April 15, 2010

Following the FDA Amendments Act of 2007 that enabled the agency to mandate REMS for drugs and biologics that pose greater risks, a new document finds that REMS may be effective if FDA uses the proper approach and incorporates new technologies (e.g., genetic testing, electronic medical records).

Following the FDA Amendments Act of 2007 that enabled the agency to mandate REMS for drugs and biologics that pose greater risks, a new document finds that REMS may be effective if FDA uses the proper approach and incorporates new technologies (e.g., genetic testing, electronic medical records).

The document was born in a 2009 workshop entitled “Optimal Futures for Risk Evaluation and Mitigation Strategies” presented by the Institute for Alternative Futures. Its conclusion states that FDA can greatly enhance drug safety if its REMS requirements involve insights and input of everyone from patient advocates, prescribers, and pharmacists to academics, payers, and sponsors.

In the report, possible unexpected consequences that could make REMS difficult highlight the need to include processes that measure differences in patient groups when methods to alleviate risk are drawn up. Strategies are also needed to ensure that innovator and generic manufacturers follow the same standards regarding restricted distribution plans.

In analyzing the future of REMS, leaders created an “appreciative inquiry” approach. Appreciative inquiry entails applying positive outcomes with risk evaluation and mitigation to recognize how policy modifications can enhance REMS programs. The focus is on four areas: post-approval studies; restricted distribution programs; monitoring, testing, and special populations; and product quality safety studies.

To give high priority to the need to prescribe, dispense, and use medicines that pose high risks, the appreciative inquiry incorporates approaches derived from the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) in seeking ways to enhance the delivery of restricted distribution systems. S.T.E.P.S., spearheaded by Celgene Corp. and FDA, strictly monitors distribution of thalidomide for treatment of multiple myeloma as well as a complication of leprosy.

Appreciative inquiry also centers on the positive effects of generating post-approval studies and risk communications that consider biological differences between men and women, as well as the atypical needs of patients with rare disorders. The report details the importance of having all stakeholders participate in a systems approach to determine factors the agency might ordinarily overlook when developing targeted risk-management programs.

Appreciative inquiry also recognized the importance of personalized medicine for identifying patients to receive a specific drug at the appropriate dose. The report found new ways to use REMS to measure changes in risk and effectiveness in adolescents, older patients, those taking multiple drugs, and patients with variation in genes for drug metabolism. Discussion of electronic medical records as a way to personalize medicine use for better outcomes was also addressed.

The report was supported by the Society for Women’s Health Research.