Restrictions on pharmacist dispensing of mifepristone remain a hard pill to swallow

Abstract

This analysis explores the basis for the US Food and Drug Administration (FDA) requiring a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone for the termination of intrauterine pregnancy. Controversies surround mifepristone and its REMS. The safety and efficacy of mifepristone are briefly reviewed with respect to FDA's actions. It is difficult to justify the continued requirement for a REMS for mifepristone by applying the regulatory framework and considering mifepristone's safety record. Drugs with higher risks are on the US market without an FDA-mandated REMS. Canada removed all restrictions on the use of mifepristone for abortion, which has not resulted in patient safety concerns. All pharmacists should be permitted to dispense mifepristone. The continued requirement for a mifepristone REMS in the US appears to be based more on politics rather than evidence.