A federal appeals court panel has ruled that the abortion pill mifepristone should remain legal in the United States but with significant restrictions on patient access. The decision comes as part of a closely watched lawsuit seeking to remove abortion pills from the market. The ruling prohibits the pill from being sent through the mail or prescribed through telemedicine. However, the ruling will not have an immediate effect as the Supreme Court had previously stated that mifepristone must remain available under the current rules until the appeals process is complete.
Anti-abortion groups filed the lawsuit last year following the Supreme Court’s decision to overturn the constitutional right to abortion. The Justice Department has stated that it will ask the Supreme Court to hear the case.
The Supreme Court will now have to decide whether to deny review, leaving the appeals court’s ruling in place with limited access to the pill, or to hear the appeal, which could open up controversial territory. The court’s decision will be made in the context of its previous ruling overturning Roe v. Wade, which led to a backlash and questions about the court’s legitimacy.
The appeals court’s decision upholds part of a ruling by a federal judge in Texas that effectively invalidated the FDA’s approval of mifepristone. However, the appeals court ruling also keeps the FDA’s approval in place, as well as the approval of the generic version of the drug.
If upheld by the Supreme Court, the ruling would reverse recent changes made by the FDA that increased access to the pill. These changes included allowing some healthcare providers who are not doctors to prescribe mifepristone and allowing patients to obtain the pill without an in-person visit. The ability to use telemedicine and receive prescribed pills through the mail has significantly expanded the use of medication abortion.
The lawsuit against the FDA was filed by anti-abortion doctors and a consortium of anti-abortion medical groups. The appeals court majority stated that the statute of limitations prevented a challenge to the FDA’s initial approval of mifepristone in 2000. They also argued that the approval of the generic version of the drug in 2019 should remain in effect as the plaintiffs did not demonstrate adverse effects from that approval.
The ruling by the appeals court panel comes after the FDA made changes in 2016 and 2021 to increase access to mifepristone. These changes allowed nurse midwives and other providers to prescribe the drug, reduced the required number of in-person visits, and extended the time frame for its use. In 2021, the FDA lifted the in-person dispensing requirement altogether, allowing telemedicine and mail delivery of abortion pills.
Mifepristone has been used by over five million women in the United States and is considered highly safe and effective. It has undergone extensive regulation and study. The medication abortion protocol involves taking mifepristone followed by another drug, misoprostol, to induce contractions.
If access to mifepristone is limited, providers may have to rely solely on misoprostol, which is less effective and more prone to side effects. One dissenting judge argued for invalidating the approval of mifepristone in 2000, criticizing the FDA for potential mistakes.