Gillings epidemiologists: Undermining FDA authority on mifepristone regulation puts drug safety at risk

June 6, 2023

A potential legal decision challenging the Food and Drug Administration’s (FDA) approval of mifepristone, one of two drugs used in medical abortions, could have far-reaching consequences for drug safety and regulation in the United States, according to pharmacoepidemiologists at the UNC Gillings School of Global Public Health.

Dr. Juan Hincapie-Castillo

Dr. Michele Jonsson-Funk

In a commentary published this week in Pharmacoepidemiology and Drug Safety, Assistant Professor Juan Hincapie-Castillo, PharmD, PhD, and Associate Professor Michele Jonsson-Funk, PhD, write that should current legal action regarding regulatory approval of mifepristone result in a ruling against the FDA, it could unravel the system that has ensured access to safe and effective medication in the U.S. for more than 60 years.

In the wake of the Supreme Court’s reversal on abortion rights in Dobbs v. Jackson, litigation now seeks to reduce access to mifepristone, specifically by challenging the FDA’s process for reviewing the safety and efficacy of the medication and its recent decision to expand access during the COVID-19 pandemic. The District Court for the Northern District of Texas recently issued a ruling in Alliance for Hippocratic Medicine v. FDA that would undo the approval and dispensing of mifepristone. That court decision was appealed to the U.S. Court of Appeals for the Fifth Circuit, where it was partially reversed, and a stay was granted by the Supreme Court to maintain access to the medication while the Fifth Circuit Court hears the appeal.

As the ruling hangs in limbo, pharmaceutical experts are concerned about the policy implications that may result if the court ultimately rules against the FDA’s medication safety regulatory process.

“To date, no court has ever overruled the FDA’s approval of a medication,” said Hincapie-Castillo. “This change in precedence could have adverse downstream effects beyond medications used for abortion as it opens the possibility for anyone to challenge the approval of any drug regardless of how long it has been on the market.”

Hincapie-Castillo and Jonsson-Funk’s commentary expresses particular concern about the impact on medication availability and deterioration of public trust that may result from undermining the scientific expertise and recommendations, which are based on empirical and rigorously tested data and are critical to the drug regulatory process.

“Undercutting the FDA’s authority to be the ultimate decision-making body for regulating pharmaceuticals also undermines the clinicians’ ability to practice evidence-based medicine that heavily relies on the approved prescribing information,” they write.

The Fifth Circuit Court recently heard arguments on the appeal, though it is uncertain when a ruling will be announced. That outcome is also likely to be appealed to the Supreme Court, which will make the ultimate decision on the ruling.

Read the full letter to the editor in Pharmacoepidemiology and Drug Safety. Hincapie-Castillo JM, Jonsson Funk M. Mifepristone and the courts: The thread that could unravel regulation of drugs in the United States [published online ahead of print, 2023 Jun 6]. Pharmacoepidemiol Drug Saf. 2023;10.1002/pds.5642. doi:10.1002/pds.5642 [PMID: 37278192]

Contact the UNC Gillings School of Global Public Health communications team at sphcomm@unc.edu.