Judicial Watch Sues FDA for Commissioner’s Communications Involving the Abortion Drug Mifepristone

(Washington, DC) – Judicial Watch announced today that it filed a Freedom of Information Act (FOIA) lawsuit for records of communications and meetings of the Federal Drug Administration (FDA) commissioner involving the abortion drug Mifepristone (Judicial Watch Inc. v. U.S. Department of Health and Human Services (1:26-cv-01546)).

Judicial Watch sued in the U.S. District Court for the District of Columbia after the FDA failed to respond to a February 25, 2026 FOIA request for:

1. All communications sent to, received by, or copied to the Commissioner of Food and Drugs, or to the Commissioner’s immediate office, that concern, refer to, or discuss mifepristone, RU-486, or any generic or branded form of mifepristone approved, regulated, or reviewed by the Food and Drug Administration.

2. All documents related to any meeting with the Commissioner of Food Drugs where mifepristone, RU-486,or any generic or branded form of mifepristone approved, regulated, or reviewed by the Food and Drug Administration was discussed, including, but not limited to calendar events, calendar invitations, talking points, PowerPoint presentations, written or audio recordings, and post-meeting summaries

The request asked that records be provided for the period April 1, 2025, to the present.

In response to pressure from pro-abortion activists, the Clinton Food and Drug Administration accelerated approval of the abortion pill in September 2000. Similarly, the Obama and Biden administrations took steps to make the controversial abortion pill more widely available in a way that undermined its “safe” use.

FDA Commissioner Marty Makary resigned earlier this month amid friction with the administration.

Pro-life advocates had called for his ouster. Makary reportedly slow-walked a safety review of the pill, which can be mailed to states that have limited abortion. Makary’s successor will inherit that review and the tricky politics associated with abortion.

“For decades, Judicial Watch has investigated and exposed the dangers of the abortion pill pushed on pregnant mothers by the Clinton/Obama/Biden operations,,” Judicial Watch President Tom Fitton said. “The new FDA leadership needs to get its act together quickly, stop providing special treatment for the abortion pill, and ensure transparency to preserve the rule of law and the public health.”

Judicial Watch has been instrumental in bringing the controversies surrounding the abortion drug to the public’s attention.

In March 2024 Judicial Watch filed an amicus curiae (friend of the court) brief in the U.S. Supreme Court in which it argued “the FDA violated its own unambiguous regulation and relied on pretext…. The FDA’s actions in 2016 and 2021 were arbitrary and capricious and violated the Administrative Procedures Act (“APA”).” And, in 2021, using the Covid-19 pandemic as a tool, abortion proponents “sued the FDA to dispense with the REMS [risk evaluation and mitigation strategy] in-person medical visits as a prerequisite for obtaining Mifeprex and permit the drug to be mailed.”

Through a FOIA lawsuit Judicial Watch in 2023 uncovered at least six Mifeprex-related deaths between 2000 to 2002 that were detailed in Health and Human Services records.

Records produced to Judicial Watch in September 2023 included an “Annual Report for Mifepristone,” covering the period September 28, 2000, to September 27, 2001, produced by the Population Council/Danco Laboratories, LLC. The summary indicated that during the testing period 32 “adverse events were reported to Danco and reported by Danco to FDA in periodic reports.” (The existence of adverse event reports does not necessarily establish causation.) 

Of the 32 reported adverse events, two were 15-day reports (the others were not serious and/or not unexpected). One of the 15-day reports was reported as “hemorrhage due to a ruptured ectopic pregnancy and death.” [Emphasis added] The other was reported as “post-abortal parametritis/endometritis, adult respiratory distress syndrome and bilateral pneumonia.” This latter 15-day report and one case where fever was reported represent the total reports on the marketed drug suggesting infection. In addition, one infection was reported in the Population Council’s 200 mifepristone study and one death [Emphasis added] due to clostridium sordelli infection was reported in the Canadian study.

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