Few Retail Pharmacies Dispense Mifepristone Despite FDA Rule Change: USC Study

A study from the University of Southern California (USC) published in JAMA indicates that only a small fraction of mifepristone prescriptions have been filled at brick-and-mortar retail pharmacies, despite a regulatory shift intended to expand access to the medication.

The findings follow a January 2023 decision by the U.S. Food and Drug Administration (FDA) to permanently remove rules that previously required patients to obtain mifepristone in person at a clinic or hospital. Mifepristone is the first of two medications used in a medication abortion regimen.

By lifting these longstanding dispensing limits, the FDA enabled in-store and mail-order pharmacies to provide the drug when prescribed by a certified provider. This policy change was expected to broaden nationwide access by removing the necessity of visiting a specialized medical facility for the initial dose.

Regulatory Framework and Dispensing Changes

The FDA originally approved Mifeprex (mifepristone), used in combination with misoprostol, in 2000 to end intrauterine pregnancies through seven weeks of gestation. For years, the drug was subject to specific restrictions designed for patient safety.

Many of these restrictions were managed under a risk evaluation and mitigation strategy (REMS) program. REMS are safety programs the FDA utilizes for medications with serious safety concerns to monitor and manage specific risks and reinforce safe medication use behaviors.

The shift in January 2023 moved the dispensing process away from a clinic-only model. This transition allowed retail pharmacies to act as a point of distribution, theoretically reducing barriers for patients who might lack transportation or access to specialized clinics.

Legal and Political Challenges

The availability of mifepristone has been the subject of significant legal volatility. In November 2022, the case of Alliance for Hippocratic Medicine (AHM) v. FDA was filed, challenging the FDA’s decision to approve the drug and include misoprostol in the regimen. Plaintiffs in that case argued the FDA exceeded its authority and cited the Comstock Act, an 1873 law, to argue that mailing abortion medications is prohibited.

On June 13, 2024, the Supreme Court of the United States ruled that the AHM did not have standing to sue the FDA for injury. However, legal challenges have continued, with some state Attorneys General intervening in district court.

a coalition of states led by Idaho has argued in legal filings that the FDA should reinstate the requirement for in-person dispensing and remove the ability for retail pharmacies to dispense the medication.

Impact on Pharmacy Participation

Despite the federal removal of dispensing limits, the USC study highlights a gap between regulatory permission and actual pharmacy practice. The fact that few retail pharmacies are filling these prescriptions suggests that the expected increase in access via brick-and-mortar locations has not fully materialized.

The medication abortion regimen typically consists of mifepristone followed by misoprostol, though misoprostol can be used alone. Other medications, such as methotrexate, are used in different contexts, such as ending ectopic pregnancies.

The disparity between the FDA’s January 2023 rule change and the actual dispensing rates at retail pharmacies underscores the complex environment in which these medications are distributed, involving a combination of federal guidelines, judicial rulings, and individual pharmacy policies.