The FDA will allow mifepristone (Mifeprex), one of the drugs used for medical abortions, to be dispensed at pharmacies or by mail, that required patients to pick up the drug in person, though certain states are already making moves to block access.
Previously, providers were only allowed to give patients mifepristone at a medical office, clinic, or hospital -- a requirement mandated under the Risk Evaluation and Mitigation Strategy (REMS) program. But removal of the in-person dispensing rule will expand access to the medication, as patients who can't travel long distances to see a provider, or those who would prefer to manage their care in the privacy of their own home, can do so without having to physically interact with the healthcare system.
Additionally, the FDA's removal of in-person dispensing rules have cleared the way for telemedicine abortion, which gained traction during the COVID-19 pandemic.
The FDA decided to remove the REMS restriction following a year-long review of the evidence. The agency stated that "the data support modification of the REMS to reduce burden on patient access and the health care delivery system."
The permanent repeal follows the FDA's decision not to enforce mifepristone's REMS protocol during the pandemic. Last April, the agency stated that it would "exercise enforcement discretion" on the in-person dispensing requirements for the remainder of the public health emergency, citing research that showed the abortion pill was safe and effective when administered remotely.
Mifepristone is the first of a two-drug regimen used to terminate pregnancies at up to 10 weeks' gestation. Patients who undergo a medical abortion first take mifepristone to block progesterone, the hormone needed to continue a pregnancy. Then 2 days later, patients take misoprostol to induce contractions of the uterus that will expel its contents.
The provision of mifepristone has become more prevalent as more patients turn to medical abortion instead of surgical methods. In 2019, 42% of all abortions occurred with medication before 10 weeks' gestation, according to a .
Although mifepristone has a favorable safety and efficacy profile, the drug has been heavily regulated in the U.S. since it was approved in 2000. While the in-person dispensing requirements have been removed, REMS still requires patients to sign consent forms upon receiving the medication, which can only be administered by a provider with special certifications.
Medical groups such as the have repeatedly urged the federal government to remove in-person dispensing requirements. Joined by other reproductive rights groups, ACOG sued the FDA and the Department of Health and Human Services in May 2020 to challenge the in-person dispensing restrictions on mifepristone during the public health emergency, stating that they put patients who need abortion care at risk of exposure to COVID-19.
The restrictions were suspended, but the Trump administration fought that decision up to the Supreme Court, which allowed the requirements to be reinstated in January. The FDA then decided not to enforce in-person dispensing requirements in the spring.
The latest decision to permanently modify REMS has received praise from reproductive rights groups. Maureen Phipps, MD, MPH, the CEO of ACOG, said that the organization applauds the lifting of the "burdensome" in-person dispensing requirement.
"Today's decision from the Food and Drug Administration is a step in the right direction when it comes to regulation of mifepristone for medication abortion and will make a meaningful difference in the lives and well-being of many of our patients," Phipps said. However, she added that the remaining REMS requirements, including both prescriber certification and patient consent forms, "are not medically necessary," noting that the organization will continue to advocate for regulations that reflect the data.
Although the FDA has relaxed federal restrictions on mifepristone, that does not stop state legislatures from imposing their own restraints. Texas, for example, recently to provide the abortion pill after 7 weeks of pregnancy -- 3 weeks earlier than what the FDA currently advises.
According to the Guttmacher Institute, still require the clinician who provides medication abortion to be physically present when distributing the drug -- which prohibits people living in these states from using telemedicine to obtain abortion care.