FDA removes in-person dispensing requirement for abortion medication

Regulatory NewsRegulatory News | 17 December 2021 |  By 

The US Food and Drug Administration (FDA) is modifying the shared Risk Evaluation and Mitigation Strategy (REMS) for mifepristone products to allow women to continue to access the abortion medication through the mail via a certified prescriber.
The move, highlighted on FDA’s mifepristone information webpage and in updates to an associated question-and-answer (Q&A) page on 16 December, makes permanent the eased restrictions permitted during the COVID-19 pandemic. At press time, FDA had not responded to a request for comment.
The agency removed the in-person dispensing requirement that had mandated that mifepristone be dispensed only in certain health care settings, such as medical offices, clinics, and hospitals. FDA also added a requirement that pharmacies that dispense the drug must be certified. This means that women can receive mifepristone by mail through certified prescribers or pharmacies, in additional to in person dispensing options.
“After conducting a review of the single, shared system Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, known as the Mifepristone REMS Program, FDA determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks,” agency officials wrote in a Q&A on the FDA website.
In addition to the requirement that dispensing pharmacies be certified, the adjusted mifepristone REMS requires prescription by, or under the supervision of, a healthcare provider who, among other quaifications, must sign a Prescriber Agreement Form. Patients must sign a parallel Agreement Form.
The issue of telemedicine access to medication abortion recently came up during the US Senate confirmation hearing for FDA commissioner nominee Robert Califf, when Republican lawmakers pressed him to weigh in on the whether the mifepristone REMS should be “weakened.” Califf declined to give a specific answer other than to say that the agency would follow the evidence. (RELATED: Califf skates through nomination hearing, Regulatory Focus 14 December 2021)
Mifepristone, in combination with misoprostol, is prescribed to end early pregnancy through 70 days gestation. Mifeprex (mifepristone) was first approved by the FDA in 2000 and a generic version was given the nod in 2019. The FDA approved a revised dosing regimen, with lower dose Mifeprex, in 2016. (RELATED: FDA Approves New Label for Lower Dose of Abortion Drug, Regulatory Focus 30 March 2016)
The agency initially imposed certain distribution restrictions on Mifeprex with the original approval of the drug in 2000 and converted these restrictions to a REMS program in 2011. Those restrictions were applied to the generic version of mifepristone and the REMS became a single, shared system for both Mifeprex and generic mifepristone in 2019.
The Mifepristone REMS Program had previously required that certified prescribers dispense mifepristone directly to the patient in a clinic, medical office, or hospital. Enforcement of this in-person dispensing requirement was halted as part of a lawsuit from 13 July 2020 until 12 January 2021. Starting in April, the FDA said it would exercise enforcement discretion on the in-person dispensing requirement during the COVID-19 public health emergency, which is ongoing. The enforcement discretion applies to dispensing of Mifeprex and the approved generic mifepristone through the mail or a mail-order pharmacy, under the supervision of a certified prescriber.
The FDA’s April decision to exercise enforcement discretion on the in-person dispensing requirement was based on a literature search that included four publications with relevant clinical outcome data during the COVID-19 pandemic, and postmarketing adverse event reports throughout 2020. The medical literature did not appear to show increases in serious safety concerns such as hemorrhage, ectopic pregnancy, or surgical interventions as a result of modifying the in-person dispensing requirement, the FDA wrote in an April 2021 letter to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. Similarly, the agency noted that the “small number of adverse events reported” during the COVID-19 public health emergency did not indicate that modifying the in-person requirement contributed to reported adverse events.
FDA Q&A on mifepristone


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