A sloppy report on mifepristone is being used to undermine the FDA -- and the biotech industry

"For decades, the Food and Drug Administration has partnered with clinicians and industry to deliver evidence-based medical innovations using a gold-standard framework for drug development and oversight. The agency has the authority to review any approved drug, and such reviews are a vital part of ensuring public health. That process has long been grounded in transparent and methodologically sound science.

Now that approach is under threat. In April, the Ethics and Public Policy Center (EPPC), a conservative think tank, released a deeply flawed, politically driven report with the inflammatory title “The Abortion Pill Harms Women.” It’s being used to challenge the FDA’s long-standing approval of mifepristone, one of the FDA’s most studied medications. It’s been safely used by millions for more than two decades, with over 25 years of data confirming its safety and efficacy.

The report has already begun to shape policy, political strategy, and public discourse. The day the report was released, Sen. Josh Hawley cited it in a letter urging the FDA commissioner to tighten restrictions on mifepristone and said he plans to introduce legislation to that effect. HHS Secretary Robert F. Kennedy Jr. used the report to justify a formal FDA review of its approval. And anti-abortion groups like Americans United for Life launched a coordinated campaign called “Rolling Thunder” focused on the report’s so-called findings to pressure the FDA, sue shield-law protected providers, and push Congress to act.

Alongside more than 50 biotech leaders and investors representing dozens of companies, I’ve urged the FDA to disregard this methodologically flawed policy paper. As Ushma D. Upadhyay, professor at the University of California, San Francisco, wrote in her comment to the FDA, the EPPC report fundamentally misrepresents what constitutes a medical complication. It conflates emergency room visits with serious adverse events — contrary to FDA guidance — and counts routine follow-up procedures as complications, even though 3-5% of patients typically need such care."


https://www.statnews.com/2025/07/19/epcc-report-mifepristone-abortion-pill-republican-politicians-fda-undermining-biotech/