Judicial Watch Sues FDA on Behalf of Advancing American Freedom Foundation for Records on Abortion Pill Mifepristone

(Washington, DC) – Judicial Watch announced today it filed a Freedom of Information Act (FOIA) lawsuit on behalf of Advancing American Freedom Foundation against the U.S. Department of Health and Human Services (HHS) for FDA records concerning approval of the abortion drug Mifeprex (Mifepristone, formerly known as RU-486) and meetings between senior FDA officials, White House counsel, and foreign actors (Advancing American Freedom Foundation v. U.S. Department of Health and Human Services (No. 1:24-cv-02803)).

Advancing American Freedom Foundation develops innovative policy solutions, strategies, coalitions, and messaging that expand freedom for all Americans.

The lawsuit was filed after HHS and the Food & Drug Administration (FDA), which is a component of HHS, failed to respond to identical May 31, 2024, FOIA requests. Among the requested records are:

• Communications between the FDA and the House Committee on Commerce Subcommittee on Oversight and Investigations (“Subcommittee”) concerning letters from the Subcommittee dated June 27, 1996; July 1, 1996; and September 17, 1996.
• All records requested in the September 17, 1996, letter from Subcommittee Chairman Joe Barton to FDA Commissioner David A. Kessler.
• All records of communications: between any FDA personnel and the Office of White House Counsel between November 1, 1992, and January 31, 2001, regarding the approval of “mifepristone” (which includes, but is not limited to, such terms as Mifeprex, Mifegyne, Korlym, abortion pill, RU-486, RU-38486, ZK-98296, and/or the mifepristone … including communications with Associate White House Counsel Elena Kagan.
• All records of communications between any FDA personnel and any person or entity between November 1, 1992, and January 31, 2001, regarding FDA Commissioner David Kessler’s overseas trip or trips to meet with individuals from Roussel Uclaf on an unknown date, but on information or belief took place in April or May 1994…. including communications mentioning the Population Council (“PC”).
• Any other records which, though not specifically requested, would have a reasonable relationship to the subject matter of this request, including any record or document.

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.)

“The FDA has repeatedly refused to acknowledge its role in approving the dangerous abortion drug, mifepristone and has refused to disclose communications regarding its approval,” said AAF General Counsel J. Marc Wheat. “Advancing American Freedom Foundation has worked tirelessly to disclose the truth behind the FDA’s negligence and to bring justice for the women hurt or killed by this drug. The American people deserve to know the facts of how the FDA shirked protocols in order to expand abortions, even at the cost of the health of the women using the drug. We are grateful to Judicial Watch for picking up AAF’s case.”

“From the get-go, the abortion pill has been promoted by a corrupted and politicized FDA, contrary to health of both pregnant mothers and their unborn children,” said Judicial Watch President Tom Fitton. “That the Biden-Harris FDA is covering up key facts about the approval of the abortion pill while simultaneously promoting its wide usage is a scandal.”

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

In March of this year, 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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