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REMS, Risk and Reward

By Alan Minsk and Lanchi Nguyen

REMS, while not to be confused with R.E.M., the Athens, GA-based rock band, is becoming almost as ubiquitous and as influential on its respective audience. REMS, or Risk Evaluation and Mitigation Strategy, is a new tool that Congress provided the Food and Drug Administration to ensure the safe use of certain types of prescription drug products. REMS is an extension of Congress and the FDA's renewed emphasis on drug safety and proactive risk management. The FDA may require a drug manufacturer to include a REMS in its new drug application when the agency concludes this is necessary to ensure that the benefits of the drug outweigh its risks.

On first review, one might conclude drugs that require a REMS present an increased liability risk for drug manufacturers because of safety-related concerns. Perhaps, it will in a particular case. However, REMS, while potentially negatively affecting product sales, might actually help minimize liability risk, if the company follows the conditions described in the program.

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