Sixteen Years of Overregulation: Time to Unburden Mifeprex

New England Journal of Medicine; 2017 Feb 23; 376(8): 790-794; doi:10.1056/NEJMsb1612526

Researchers criticize the FDA regulation mechanism known as a “REMS” (Risk Evaluation and Mitigation Strategy). The REMS restrictions, implemented when mifepristone was first introduced in the U.S. in 2000, are inconsistent with how most drugs are regulated. Stringent REMS restrictions are only used for a small number of drugs, typically those with either a limited safety record or serious risk of complication or abuse. The REMS place medically unnecessary burdens on patients and providers, and keep mifepristone from being prescribed by clinicians or sold in pharmacies alongside hundreds of other prescription medications. Overregulation means that fewer providers offer mifepristone and fewer women have access to this safe and effective option for ending a pregnancy. Removal of the REMS would also foster opportunities for innovation in service delivery and important opportunities to increase access to safe abortion. Medical abortion has potential to fill in gaps in abortion access: it doesn’t require the infrastructure or facilities that other abortion procedures require and could be better integrated into the U.S. health system by expanding who provides it, how, and when. Removing the REMS would also help make medical abortion through telemedicine possible for some women in underserved areas.