5th Circuit Judges Skeptical of Louisiana's Bid to Restrict Mifepristone Access

A U.S. appeals court panel on Wednesday expressed skepticism toward Louisiana's legal challenge seeking to restrict access to the abortion pill mifepristone. The case centers on a 2023 Food and Drug Administration (FDA) rule that permits the drug to be prescribed via telemedicine and delivered by mail.

Louisiana Challenges FDA Rule

During oral arguments before a three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals, Louisiana Solicitor General Ben Aguinaga argued that the FDA's 2023 decision undermines state-level abortion bans enacted after the Supreme Court's 2022 ruling that overturned the constitutional right to the procedure.

Aguinaga contended that the rule directly harms the state, claiming, "There’s no dispute that Louisiana is experiencing 1,000 abortions a month due to mifepristone mailed into the state." The state's lawsuit alleges the FDA ignored serious health risks when it removed the requirement for an in-person medical visit to obtain the drug.

Court Questions State's Standing

Two of the three judges on the panel repeatedly questioned whether Louisiana had the legal standing to bring the lawsuit. U.S. Circuit Judge Stephen Higginson pointed to previous Supreme Court actions that have preserved access to the drug, including a decision in May that lifted a prior 5th Circuit order that would have blocked the same telemedicine rule.

Ad

Higginson noted the difficulty in proving the FDA's rule was the direct cause of abortions in the state, stating, "There are too many independent actors to say that actually the government’s assessment of safety is what’s causing your 1,000 abortions a month." This line of questioning suggests a significant legal hurdle for the state, especially after the Supreme Court unanimously rejected a separate challenge to mifepristone access earlier this year.

Market and Regulatory Context

The legal battle over mifepristone is critical for the healthcare sector. Medication abortion, which uses mifepristone in a two-drug regimen, now accounts for more than 60% of all U.S. abortions, according to data from the Guttmacher Institute, an abortion rights advocacy group.

Lawyers for the drug's manufacturers, GenBioPro and Danco Laboratories, defended the FDA's decision-making process as "richly supported" and affirmed the medication's safety. A U.S. Department of Justice attorney confirmed that the FDA's safety review of the drug, first approved in 2000, remains ongoing. The case's outcome will directly impact pharmaceutical firms and the telehealth industry, which has expanded its services to include remote prescriptions for such medications.