Mifepristone Fills Spiked After In-Person Dispensing Rule Nixed

Mifepristone (Mifeprex) prescription fills, particularly mail-order fills, spiked after the in-person dispensing requirement was lifted, an analysis of individual prescription data found.

Historically, FDA required mifepristone used for medication abortion to be dispensed in-person at a clinic or hospital as part of a Risk Evaluation and Mitigation Strategy (REMS) safety protocol. But in January 2023, the agency removed this requirement, which allowed certified retail and mail-order pharmacies to dispense mifepristone.

The policy change was associated with a statistically significant increase in mifepristone users from 17.9 per month before the REMS policy change (January 2021 to December 2022) to 2,730.5 per month after implementation (April 2023 to August 2025) in data pooled from retail and mail-order pharmacies across the U.S.

That change was driven by a sudden jump in the first half of 2023, without a significant slope change thereafter, reported Dima Mazen Qato, PharmD, MPH, PhD, of the University of Southern California in Los Angeles, and colleagues in JAMA.

Most of the spike came from mail-order fills, which accounted for 97.8% of users in the post-policy period and 45.9% in the period before.

Nearly all (99.2%) of the mifepristone fills after the policy change were in states in which abortion was legal with telehealth allowed, which had an increase of 2,398.4 users per month (P<0.001). Only 1.8% of these fills were at retail pharmacies, with the rest being mail-order. But in the post-policy period in states where abortion is legal with telehealth restrictions, 39.4% of mifepristone users filled at mail-order pharmacies and 60.6% at retail pharmacies.

“While our findings suggest an increase in the use of mail-order to fill mifepristone in states where abortion is legal, restrictive state abortion policies undermine the impact of this policy change on mifepristone access in states that are most in need,” Qato told MedPage Today.

Daniel Grossman, MD, of the Advancing New Standards in Reproductive Health research group at the University of California San Francisco, who not involved in the research, told MedPage Today that the dataset studied appeared to represent only a sliver of the some 60,000 medication abortions (nearly half by telehealth) that occur in the U.S. each month based on estimates from the Guttmacher Institute and the Society of Family Planning’s WeCount reports.

“Some of it is that a large proportion of medication abortions during this period were provided by clinicians with medications dispensed in clinic or directly mailed from the clinic or telehealth service to the patient,” he said.

Qato’s team used IQVIA’s individual-level Longitudinal Prescription Data, which has been reported to cover more than 90% of retail pharmacies and 60% to 85% of mail-order pharmacies. However, Grossman noted the possibility that a few high-volume pharmacies might not have been included, adding to the gap in the database coverage of mifepristone use.

He also noted that Qato’s study doesn’t answer questions about the proportion of brick-and-mortar pharmacies that are dispensing and if dispensing varies by chain versus independent ownership.

Still, Grossman said the findings reinforce that “there has been tremendous growth in telehealth provision of medication abortion since the FDA removed the in-person dispensing requirement for mifepristone” and demonstrates “how any move by FDA or the courts to reimpose the in-person dispensing requirement for mifepristone would have a big impact on how services are being provided.”

Prior analyses have shown FDA’s cautious approach to regulating mifepristone. Despite what researchers called robust safety and efficacy data, the agency announced a safety review of mifepristone, and multiple pieces of legislation have been proposed to ban mifepristone or prosecute out-of-state doctors who have provided telemedicine abortion to patients in certain states. If a ban on telehealth provision of mifepristone were to occur, Grossman said, it’s unknown if telehealth providers would pivot to the misoprostol-only regimen for medication abortion.

Medication abortion use increased following the June 2022 Dobbs v. Jackson Women’s Health Organization that overturned federal abortion protections. Telehealth medication abortion jumped from 5% of all abortions in May 2022 to 28% in June 2025, according to WeCount.

“However, it is not known whether removing the in-person dispensing requirement on mifepristone affected access through pharmacies,” Qato’s group wrote.

To answer that question, they analyzed IQVIA’s data on monthly mifepristone users by pharmacy channel (retail or mail order), pharmacy type (chain or independent), prescriber specialty, and by the level of abortion restrictions in the individuals’ state of residence in July 2025.

Monthly mifepristone users peaked in June 2023. Prescriptions were primarily received from advanced practice providers and primary care physicians. In all, the database included 71,703 people age 15 to 49 who filled 80,388 mifepristone prescriptions during the study period. Mean age was 28.6.

The study was limited by not having information on mifepristone dispensed in-person at clinics or mailed by clinics to patients, authors noted. And for prescriptions filled at pharmacies, the data didn’t capture whether a visit was in-person or telehealth.

Qato said that next steps include evaluating “the role of state shield laws in facilitating access to mifepristone through mail-order or retail pharmacies for women in states with abortion bans.”