As the first week of 2023 rolled on, the U.S. Food and Drug Administration (FDA) quietly released new rules for the dispersal of the abortion medication mifepristone. The decision has the potential to expand nationwide access to medical abortions through a patient’s local pharmacies — should the businesses agree.
A new regulatory change to what is known as the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program allows pharmacies, from local businesses to major retailers, to fill valid prescriptions for mifepristone from a certified health care provider without requiring in-person administration at a clinic or physician’s office. The adjusted language was added to the federal agency’s information page for mifepristone (also known as Mifeprex) on Tuesday, Jan. 3, the New York Times reported, and the agency also updated its online FAQ on the drug and its uses.
The pill is one part of a two-pill medical procedure that is both medically safe and extremely common. As Planned Parenthood explains on its website, mifepristone blocks an individual’s production of progesterone, which halts the growth of a pregnancy. Misoprostol then causes cramping and bleeding to clear out the uterus. Until 2021, both medications had to be given to patients by a nurse or doctor at a qualified health center, with guidelines on use and care that varied depending on the location one received the pills. The new FDA rules advance a shift away from that procedural requirement, allowing pregnant people to get their prescriptions straight from a pharmacy.
“Mifepristone may only be dispensed by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription issued by a certified prescriber,” the new rules read. “Certified pharmacies must ensure mifepristone is dispensed to the patient in a timely manner.”
Health care providers must be certified to oversee the use of the medication under the Mifepristone REMS Program, and — this is where many will keep a watchful eye — the pharmacy must choose to become certified to dispense the pill through a separate FDA process. As of Tuesday, major retail pharmacy chains, including Walgreens and CVS, had only committed to reviewing the updated requirements. A CVS spokesperson said it is “evaluating requirements to dispense the drug in states that don’t restrict the availability of abortion pills,” Axios reported.
In 2019, the FDA simultaneously approved a generic version of Mifeprex and the REMS joint drug safety program to administer the two forms of mifepristone. Two years later, based on a review of the program’s effectiveness and health safety by the FDA, the agency removed an in-person physician appointment requirement (prioritizing the need for expanded telehealth access) and permanently approved by-mail prescriptions for the pills.
These decisions spawn from the need to address public health and safety concerns affecting individuals across the United States — most of whom, should they need to have an abortion, will use the pill-based medical procedure. Currently, the FDA does not encourage individuals to purchase mifepristone from online sources, according to its website.
But global reproductive justice networks have long found that’s the only avenue for receiving at-home medication-based abortion care, especially in countries where abortion is illegal. In 2022, as the threat of state abortion bans and a federal axing of the right to abortion loomed over the heads of Americans, many individuals began outsourcing these needs across borders, as well as connecting with local abortion funds and reproductive justice advocates who could provide assistance should the need arise in a post-Roe America. Sites and organizations like Plan C became frequented sources for how people in the U.S. were receiving at-home care.
With the new flexibility afforded by the FDA’s procedural change, there’s hope that this necessity could be erased for individuals with access to both a certified physician and a complying pharmacy. But the decision’s real reach still has gatekeepers.