The U.S. Food and Drug Administration (FDA) has made a move that will permanently expand access to medication abortions, colloquially called abortion pills. On Thursday, December 16, the FDA announced that they are removing the in-person dispensing requirement for mifepristone, the first of two pills in a medication abortion regimen. “Removing the in person dispensing requirement will allow, for example, dispensing of mifepristone by mail via certified prescribers or pharmacies,” according to the FDA—at least, in states that don’t have laws banning medication abortions via telemedicine. Previously, the drug had to be picked up in person at a doctor’s office, clinic, or hospital.
The decision follows an FDA review of its own regulations under the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, which was prompted by civil rights lawsuits led by the American Civil Liberties Union, as well as pressure from medical and reproductive rights organizations, as NPR reports. Based on this review, the agency “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,” according to the FDA. Those changes include “removing the requirement that mifepristone be dispensed only in certain healthcare settings, specifically clinics, medical offices, and hospitals,” which will allow, for instance, prescriptions written during telemedicine appointments to be filled via certified mail-order or retail pharmacies.
This is the the latest chapter in a long battle to increase access to medication abortions in the U.S. For years, major medical organizations, reproductive health experts, and reproductive rights groups have campaigned for the FDA to do away with the in person requirement for abortion pills, arguing that this (and other) barriers to access are medically unnecessary and onerous restrictions for a drug shown to be low-risk, effective, and easy-to-use, as SELF has explained.
During the pandemic, some restrictions, including the in person appointment rule, were temporarily suspended, opening the door to medical abortions via telemedicine and mifepristone prescriptions being filled via mail-order pharmacies, as SELF reported. The in person requirement was halted by a federal judge in July 2020 before being reinstated by the Supreme Court in January 2021 and then halted again by the FDA itself in June following a review of the scientific literature, as SELF has reported.
Medication abortions accounted for 39% of all abortions in the U.S. in 2017, according to the Guttmacher Institute—a proportion that has certainly grown with loosened restrictions during the pandemic. Mifepristone, which is FDA-approved to terminate early pregnancies (up to 10 weeks), works by blocking progesterone receptors to stop the pregnancy, as SELF has explained. Currently, 19 states require the provider to be physically present when the patient takes the pill, according to the Guttmacher Institute, preventing medication abortions via telemedicine. (Unfortunately, the FDA’s choice to remove restrictions will not override these kinds of state or local laws restricting medication abortion, common in red states, including a new law in Texas banning the procedure after seven weeks.) Six to 48 hours after the mifepristone (taken at home or at a doctor’s office), the patient takes a a second pill (misoprostol), which causes contractions that expel the pregnancy tissue. (Misoprostol has not been subject to the same in person requirement by the FDA.)
The FDA Is Permanently Lifting This Restriction on Abortion Pills
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