FDA Modifies REMS for Mifepristone

FDA has modified a Risk Evaluation and Mitigation Strategies (REMS) program for mifepristone, a drug used in early abortion and miscarriage care. While the agency did determine that the REMS continues to be necessary to ensure that the benefits of the drug outweigh its risks, it also concluded that it “must be modified to minimize the burden on the health care delivery system of complying with the REMS,” a 12/16 letter says. (XXINSERT LINKXX)

The modifications to the REMS comprises: (1) removing the requirement that mifepristone be dispensed only in certain healthcare settings, specifically clinics, medical offices, and hospitals (i.e., the “in-person dispensing requirement”); and (2) adding a requirement that pharmacies that dispense the drug be specially certified.

FDA says its review of the REMS was related to a citizen petition from the American Association of Pro-Life Obstetricians and Gynecologists and the American College of Pediatricians.