“Several members of Congress” have been informed that the US Food and Drug Administration (FDA) is expected to wrap up its safety review of the abortion medication mifepristone by September.
A lawmaker, who wished to remain unnamed, mentioned this development as conservatives and pro-life advocates push for the FDA to reverse a regulation from the Biden administration that permits abortion pills to be sent by mail without requiring an in-person appointment.
The FDA originally categorized pregnancy as a “disease” in 2000 when it first approved mifepristone. At that time, the drug was subject to strict guidelines, known as Risk Evaluation and Mitigation Strategies (REMS), that mandated only licensed physicians could prescribe it, necessitated three in-person visits, and required patients to report any serious adverse events before receiving a prescription.
Since then, many of these safety measures have been eased. In 2016, the FDA announced that medical personnel would only need to report fatalities associated with the drug.
In a significant move in 2021, the Biden administration suspended the in-person requirement, making this change permanent in 2023—an act seen by many as a response to the Supreme Court’s overturning of Roe v. Wade. The FDA’s mail-order policy allows abortion providers in states with more lenient laws to send abortion medication to states where restrictions are in place, aided by shield laws that protect these providers from legal ramifications in more conservative states.
Since then, numerous instances have emerged where individuals have obtained abortion pills online and coerced women into using them.
In a recent report, pro-life legislators on the House Appropriations Committee discussed a provision in a funding bill that could overturn the Biden-era rule on mailing abortion pills. However, they’ve chosen to hold off until the FDA publishes its safety review.
The report indicates that if the FDA concludes, based on its review, that abortion pills are unsafe, it may revise the Risk Assessment and Mitigation Strategy for high-risk drugs, reinstating the in-person prescribing requirement for mifepristone.
Pro-life organizations and conservative lawmakers had previously urged the FDA to carry out this safety review after a report last April highlighted that around 11% of women experienced symptoms related to mifepristone—far exceeding the less than 0.5% reported in clinical trials.
In Louisiana, a woman named Rosalie Markesic is suing the FDA over the regulations concerning mail-order pills, after her boyfriend allegedly coerced her into taking pills he ordered online.
In May, the Supreme Court allowed mail-order abortion procedures to persist despite ongoing litigation in lower courts. Conservative Justices Alito and Thomas dissented, with Thomas stating that the two pharmaceutical companies, Danko Laboratories and GenBioPro, should not have standing to sue over “lost profits from a criminal enterprise.”
During the Trump administration, the FDA largely refrained from making definitive stands on the issue, merely requesting the courts permit the continuation of the mail-order process while the review was ongoing. The pro-life community has expressed frustration over this situation. Pharmaceutical firms intervened as defendants, arguing that halting mail-order abortions would cause economic harm. They later appealed to the Supreme Court after the Fifth Circuit imposed restrictions on mail-order abortions.
The Department of Health and Human Services was contacted for comment but did not respond. The White House press secretary remarked that the administration is adhering to rigorous standards in their review of mifepristone due to broad safety concerns.
According to the Guttmacher Institute in 2023, medication abortions constituted 63% of all abortions in the formal healthcare system in the US, a rise from 53% in 2020 and 39% in 2017. The numbers exclude cases involving pills obtained outside the recognized medical framework.
Pro-abortion advocates estimate roughly 91,000 telemedicine abortions were conducted in 2025 in states with protective laws for abortion seekers from more restrictive areas.
Mifepristone works by blocking the action of progesterone, a hormone essential for sustaining pregnancy. By preventing progesterone’s action, the mother’s endometrial lining breaks down, depriving the fetus of necessary nutrients, which ultimately leads to the demise of the developing baby before physical expulsion occurs through another medication, misoprostol.
