Federal Appeals Court Halts Loosened Restrictions On Mifepristone

In a resounding victory for the sanctity of life and safety, a conservative advocacy group has won a lawsuit against the U.S. Food and Drug Administration as the federal appeals court issued an order that puts a hold on two of the agency’s actions which had relaxed restrictions surrounding the use of mifepristone, the first pill in a two-drug chemical abortion regimen.

The U.S. Court of Appeals for the Fifth Circuit, in a ruling by a three-judge panel, declared that the FDA’s decisions in 2016 and 2021 to permit mifepristone to be taken later in pregnancy and to be mailed directly to patients were not only unlawful but also posed a threat to the well-being of women.

Judge Jennifer Walker Elrod, the author of the panel’s opinion, wrote that the FDA’s actions had failed to adequately address important concerns about the safety of mifepristone for women who use it. 

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” the opinion read, in part.

The court further expressed concerns about the cumulative effect of removing critical safeguards, the potential alteration of the risk profile, and the lack of evidence supporting the safe use of mifepristone without in-person prescription and dispensing.

The lawsuit, led by the Alliance Defending Freedom, represents a milestone in advocating for science-based regulations. 

Filed on behalf of medical associations and doctors, the lawsuit recorded as Alliance for Hippocratic Medicine v. FDA and Danco Laboratories, No. 23-10362, pinpointed multiple instances where the FDA overstepped its authority with federal laws, including extending the permissible gestational age and permitting mail-order distribution of the abortion drugs.

ADF CEO and President, Kristen Waggoner, applauded the court’s decision, emphasizing that this ruling is a victory for women’s health and safety. She called on the FDA to reinstate crucial safeguards and put an end to illegal mail-order abortions.

Despite the ruling by the appellate court, the decision will not take effect immediately as the true curtailing of accessibility of the drug ultimately lies in the hands of the Supreme Court which is expected to revisit the case in 2024 or 2025.