FDA investigates mifepristone safety as anti-abortion pressure on Trump mounts

The Food and Drug Administration is conducting a safety investigation into mifepristone, the most widely used abortion pill in the US, in a move that could provide the Trump administration with a regulatory mechanism to restrict access to the drug, according to the Wall Street Journal.

The probe, expected to conclude by year-end, comes as anti-abortion groups intensify pressure on President Donald Trump to use executive authority to curtail mifepristone's availability. The pill was used in 63% of US abortions in 2023, according to the Guttmacher Institute, and has been on the market for more than 25 years.

The FDA said on its website that as of April it was conducting a safety study of the drug, with next steps to include "data exploration, evaluation of data integrity, and implementation of the analyses, validation, and peer-review." In a separate statement, the agency said it had been working on a "science-based safety review" for months, pushing back on reports suggesting the investigation was newly initiated.

The agency has previously drawn on its Adverse Event Reporting System database for similar reviews, including last year's examination of Covid mRNA vaccines.

The investigation follows a setback last month for anti-abortion advocates, when the Supreme Court blocked a federal appeals court ruling in Louisiana that would have barred mifepristone from being prescribed via telehealth and delivered by mail. That decision leaves telemedicine access to the pill intact while litigation continues in lower courts.

The ruling did little to quiet pro-life groups. Kristi Hamrick, a lobbyist for Students for Life of America, told Politico that "our patience has run out," adding that "the pro-life movement, like many other parts of the [Republican] coalition, made an investment in Donald Trump. We want a return on that investment."

Anti-abortion advocates have argued that mifepristone — used alongside misoprostol to terminate pregnancies up to 10 weeks — poses hemorrhage risks. Supporters of the drug dispute that framing. "The ban on mifepristone through telemedicine was never about safety. It was about controlling people's bodies and lives," said Angel Foster, co-founder of The Massachusetts Medication Abortion Access Project.

Mifepristone was developed in France and approved there in 1988. The FDA cleared it for use in the US in 2000. In 2021, pandemic-era rules that required in-person dispensing were lifted. A 2023 Fifth Circuit ruling sought to reimpose mail restrictions and shorten the permitted usage window from 10 weeks to seven, but that effort was ultimately stayed by the Supreme Court.

Nine former FDA commissioners warned in an amicus brief that the appeals court's approach would undermine the agency's science-based drug approval framework and "creates a roadmap for attacks on science-based drug regulatory decisions."