The mifepristone REMS: A needless and unlawful barrier to care✰

Abstract

Mifepristone (brand name Mifeprex) is a prescription drug that has been safely used in the United States for twenty years to end early pregnancies and, more recently, to treat early miscarriages. Although the U.S. Food and Drug Administration (FDA) acknowledges that mifepristone's safety and efficacy are “well-established by both research and experience” [1], it imposes a Risk Evaluation and Mitigation Strategy (“REMS”) that severely restricts where, how, and from whom this medication can be obtained. Most notably, FDA requires that mifepristone be dispensed at a hospital, clinic, or medical office—not by mail or through a retail or mail-order pharmacy—even though patients can receive all evaluation and counseling via telemedicine and can self-administer the mifepristone tablet, unsupervised, at the location of their choice. Of more than 20,000 FDA-approved drugs [2], mifepristone is the only one FDA requires patients to pick up in a clinical setting even though they do not have to take it under clinical supervision [3].FDA's singular restrictions on mifepristone are not only clinically unjustified, but unlawful. On behalf of leading medical associations, individual physicians, and reproductive justice advocates, our organization, the American Civil Liberties Union, has taken FDA to court—twice—because the agency's restrictions on mifepristone do not satisfy the strict constraints Congress established for REMS programs and erect profound and unnecessary barriers to care in violation of the U.S. Constitution.