Appeals court rules on restrictions to mifepristone abortion pill availability

Key takeaways:

• The court ruling rolls back mifepristone regulations to those in effect before 2016, preventing availability via telehealth or mail.
• The restrictions are paused until the Supreme Court makes its ruling.

The 5th U.S. Circuit Court of Appeals ruled on restrictions on the abortion drug mifepristone, but this ruling will not go into effect unless it is upheld by the U.S. Supreme Court.

Based on arguments presented in May, the 5th U.S. Circuit Court of Appeals ruled on Wednesday that FDA decisions made in 2016 to make mifepristone more easily accessible to women in the U.S. did not account for safety concerns. However, this ruling will not go into immediate effect until the Supreme Court makes its final ruling.

If the Supreme Court upholds the 5th U.S. Circuit Court of Appeals ruling, then women will no longer be able to obtain mifepristone via telehealth appointments or by mail. Instead, they will need a prescription for mifepristone from a physician and three in-person follow-up appointments.

In addition, these restrictions on mifepristone will shorten the period in which women can take the drug from 70 days into their pregnancy to 49 days.

This ruling by the appeals court will keep the FDA approval of mifepristone from 2000 and its 2019 authorization of a generic form of mifepristone.

“Medication abortion using mifepristone is safe and effective. This is a fact, based on hundreds of medical studies, vast amounts of data amassed over the course of two decades and millions of uses of mifepristone for medication abortion,” Molly Meegan, JD, chief legal officer and general counsel for ACOG, told Healio. “Arbitrary restrictions, like forcing patients to pick up the medication at a doctor’s office, would place undue burden on patients and would not improve this already safe and effective medicine. The Fifth Circuit’s decision is not supported by the evidence and should be rejected by the Supreme Court.”

Currently, mifepristone in combination with misoprostol is the most common method to terminate pregnancies in the U.S. The Alliance for Hippocratic Medicine; American Association of Pro-Life Obstetricians & Gynecologists; American College of Pediatricians; Christian Medical & Dental Associations v. U.S. Food & Drug Administration v. Danco Laboratories LLC case ended up appealed in the 5th Circuit following a ruling in April 2023 by U.S. Judge Matthew J. Kacsmaryk that suspended FDA approval of mifepristone.

As Healio previously reported, the panel heard oral arguments in May from the Alliance for Hippocratic Medicine, the FDA and the distributor of mifepristone (Danco Laboratories). Arguments focused on whether plaintiffs were harmed by mifepristone availability and have the legal right to challenge its approval.

“The decision from the Fifth Circuit Court of Appeals is another example of judicial activism that reflects ideology, not science. Mifepristone is demonstrably safe and effective for its FDA-approved use up to 10 weeks of gestation, it is demonstrably safe and effective when used as directed by telemedicine, and it is demonstrably safe and effective when prescribed by qualified advanced practice clinicians. The FDA made these changes to mifepristone’s regulation for medication abortion and miscarriage management based on robust scientific data and with the support of the medical community, including ACOG,” Christopher M. Zahn, MD, FACOG, interim CEO of ACOG, told Healio. “We are relieved that because of the Supreme Court’s prior action, mifepristone will remain available under its current regulatory oversight, as it should. We look forward to sharing with the Supreme Court the overwhelming evidence and consensus of the medical community in support of mifepristone for medication abortion and miscarriage management.”