Judicial Watch Sues HHS Regarding Stability and Manufacturing of Abortion Drug Mifeprex

(Washington, DC) – Judicial Watch announced today that it filed a Freedom of Information Act (FOIA) lawsuit against the U.S. Department of Health and Human Services (HHS) for records regarding drug stability test results, new drug applications and related materials of the abortion drug Mifeprex (Mifepristone, formerly known as RU-486), as well as requests for reviews and assessments of the manufacturing facilities DANCO and GenBio where the abortion pills are produced (Judicial Watch, Inc. v. U.S. Department of Health and Human Services (No. 1:22-cv-03152)).

The lawsuit was filed after the Food and Drug Administration (a component of HHS) failed to respond to three February 2022 Freedom of Information Act (FOIA) requests from Judicial Watch.

The first request asks for correspondence with the manufacturers of Mifeprex regarding the drug’s stability and for all FDA reports from assessments of DANCO and GenBio manufacturing facilities.

The second request asks for investigational and new drug applications related to Mifeprex (Mifepristone).

The third request asks for stability test results for the drug Mifeprex (Mifepristone), including records reflecting long-term stability, as well as accelerated and forced degradation results.

In response to pressure from pro-abortion activists, the Clinton Food and Drug Administration accelerated approved the abortion pill in September 2000.

The Biden administration is pushing to prevent states from restricting access to the controversial abortion drug.

“Our experience is that this chemical abortion pill did not and will not receive appropriate review from the politicized FDA,” said Judicial Watch President Tom Fitton. “It is outrageous that Judicial Watch has had to sue in federal court for basic safety information about the abortion pill, which is being pushed on women by a desperate pro-abortion movement.”

In May 2006, Judicial Watch released a Special Report, containing records that shed light on the Clinton administration’s aggressive drive to push RU-486 to market in the United States. Judicial Watch obtained the documents from the National Archives at the Clinton Presidential Library in Little Rock, Arkansas, in February 2006, shortly after the archives allowed public access to Bill Clinton’s presidential papers.

In October 2007, through a FOIA lawsuit, Judicial Watch forced the FDA to release records about to the abortion drug. Included in the records is a letter written in October 2000 from then-Oklahoma Congressman Tom A. Coburn, M.D. to then-executive vice president of the American College of Obstetricians and Gynecologists (ACOG), Ralph W. Hale, M.D:

It was a sad day when the FDA approved RU-486 – the first drug ever approved for the specific purpose of ending a human life. But that was made even worse by the fact that the FDA succumbed to the political pressure brought by ACOG and other elements of the abortion lobby by dropping most of the proposed patient protections, and thereby recklessly exposing women to avoidable risk.

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