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February 19, 2019

Mitigating Health Risks of Prescription Drugs: Lessons From FDA Oversight of Opioid Products

Author Affiliations
  • 1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 2Deputy Editor, JAMA
JAMA. 2019;321(7):651-653. doi:10.1001/jama.2019.0236

In this issue of JAMA, Rollman et al report concerning findings regarding US Food and Drug Administration (FDA) stewardship of the Risk Evaluation and Mitigation Strategies (REMS) system,1 raising further uncertainty as to its utility in ensuring the safe use of prescription drugs. Created under the 2007 FDA Amendments Act, this system was intended to address the FDA’s limited powers over approved drugs, authorizing the agency to require manufacturers to develop and implement REMS for drugs or drug classes posing special safety risks. Components of REMS may include a lay medication guide for patients, a communication plan for physicians, and—for drugs posing the greatest risks—elements to assure safe use (ETASU), such as volume restrictions on dispensing, mandatory physician training and certification, and patient enrollment in a registry.

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