US Appeals Court Panel Questions FDA Due Diligence on Abortion Pill

Pictured: Scales of justice/Kanizphoto, iStock

A three-judge panel in Louisiana’s 5th Circuit Court of Appeals proffered probing questions during oral arguments Wednesday about whether the FDA had done due diligence before it made changes in recent years that made the abortion pill, mifepristone, more accessible.

This comes after the U.S. Supreme Court granted the FDA’s application for a stay in April, effectively maintaining access to mifepristone as the case goes through the appeals process.

Anti-abortion groups sued the FDA in November 2022, arguing that its approval of mifepristone in 2000 was flawed and subsequent changes to its usage lacked solid scientific evidence.

The three-judge panel, consisting of Jennifer Walker Elrod, James C. Ho and Cory T. Wilson, raised questions about the FDA’s role in reviewing and approving medications during Wednesday’s hearing.

“I don’t understand this theme [that] ‘the FDA can do no wrong.’ That is basically the narrative you’re putting forth—nobody should ever question the FDA,” said Judge James Ho, according to a report by STAT News.

During Wednesday’s hearing, U.S. Deputy Assistant Attorney General Sarah Harrington criticized U.S. District Court Judge Matthew Kacsmaryk’s decision to overturn the approval of mifepristone, describing it as an “unjustified attack on FDA scientific expertise.”

Harrington argued that the physicians who brought the lawsuit failed to demonstrate an immediate risk of being compelled to perform a medical procedure against their conscience due to complications from mifepristone.

Jessica Ellsworth, the attorney representing Danco Laboratories, the manufacturer of the brand-name version of mifepristone called Mifeprex, questioned the claims made by anti-abortion physicians involved in the lawsuit, citing instances where patients took non-FDA-approved drugs or consumed mifepristone under certain medical conditions, which contradicted the anti-abortion groups’ arguments against its safety.

Harrington and Ellsworth provided different perspectives, with Harrington suggesting that doctors could ask specific questions to inform their prescribing decisions. At the same time, Ellsworth emphasized that the FDA does not regulate the practice of medicine but still has a stake in the outcomes of approved medications.

Meanwhile, Erin Morrow Hawley, senior counsel for Alliance Defending Freedom, the anti-abortion legal organization that filed the lawsuit, argued against the notion that mifepristone should remain on the market for miscarriage care, stating that not all doctors prescribe it for that purpose and that “off-label” use should not justify its approval.

However, major medical organizations, such as the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine and the American Society for Reproductive Medicine, urged the court to uphold the legality of mifepristone. They criticized the district court’s ruling, stating that it relied on pseudoscience and the assertions of a small group of individuals opposed to abortion, contradicting the overwhelming consensus of the medical community and the FDA.

There is no deadline for the three-judge panel to render a ruling after the oral arguments; the decision may likely be put on hold as the case hears further appeals. In the meantime, a temporary order from the Supreme Court allows continued access to mifepristone, one of the drugs used in medication abortions.

In a separate development, U.S. House Republicans introduced a funding bill that seeks to nullify the FDA’s January changes, which expanded access to medication abortion through mail-order pharmacies. The legislation aims to end dispensing chemical abortion drugs via mail order, an amendment proposed as part of the annual agriculture appropriations bill.

The 5th Circuit Court of Appeals case could affect abortion access throughout the U.S. However, any action the appeals court takes will likely be paused until the Supreme Court decides whether to hear the case again.

Should the Supreme Court take up the case and issue a ruling on mifepristone’s approval and usage, it would apply nationwide, including in states that have protected abortion access up to 10 weeks.

Lisa Munger is a senior editor at BioSpace. You can reach her at lisa.munger@biospace.com. Follow her on LinkedIn.