Judicial Watch Files Brief in Support of Legal Challenge to Safety of Abortion Drug
(Washington, DC) – Judicial Watch announced today that it filed an amicus curiae (friend of the court) brief in support of Texas-based Alliance for Hippocratic Medicine (AHM) in its lawsuit against the Food and Drug Administration over the FDA’s approval of the controversial abortion drug Mifeprex(Mifepristone, formerly known as RU-486). In its brief, Judicial Watch describes the FDA’s approval process as “arbitrary, capricious, an abuse of discretion and not in accordance with the law.”
Judicial Watch filed the brief in the U.S. District Court for the Northern District of Texas Amarillo Division in the case of Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (No. 2:22-cv-00223-z).
Judicial Watch points out the Clinton administration’s use of political pressure to force the drug through the approval process:
The evidence uncovered of [the FDA’s] true motivation for their decision to approve Mifeprex is eye-opening and shows the [Clinton] administration and FDA applying political pressure on not only international corporations, but on international governments – all for a drug to kill prenatal human beings. The evidence also shows the intricate political and corporate machinations spent in the service of promoting a drug that has nothing to do with women’s health. [The FDA] pressured both Roussel, a French company, and Hoechst AG, the German pharmaceutical company and majority shareholder of Roussel, to bring the abortion pill to the U.S.
In a November 15, 1993 letter from Donna Shalala, HHS Secretary to the White House, she states that “Dr.Kessler [FDA Commissioner] and I have taken steps to persuade Roussel Uclef and Hoechst to change their position.”
The [Clinton administration] and the FDA were willing to place political pressure on two foreign governments [France and Germany] to accomplish the task of approving an abortion pill. This was not a life-saving medication or a drug that cured cancer. This was a drug which was being sought for one purpose and one purpose alone: the intentional death of prenatal humans. And for what reason? The ability to satisfy a financially and politically powerful group of abortion advocates.
Judicial Watch explains that the FDA improperly weakened safety restrictions regarding Mifeprex over the years:
In a congressional hearing after the 2000 approval of Mifeprex, the FDA asserted that it chose to approve mifepristone [and] to maintain more stringent safety restrictions on the drug…. This included the requirement that the drug be administered “by or under the supervision of a physician” who met several qualifications.
[H]istory shows that in the first decade of post-approval use, the FDA increased Mifeprex safety requirements. [Emphasis in original] … Yet, despite these very public safety concerns, the [Obama] FDA significantly revised the Mifeprex labeling and REMS in 2016 and reducedthe safety requirements. [Emphasis in original] These changes included significantly altered dosage, removal of the follow-up medical visit, removal of the requirement to take the drug in a doctor’s office, and expansion of the use through 70 days gestation. Also of significance and concern, the FDA modified the REMS [Risk Evaluation and Mitigation Strategy] to require reporting of only deaths attributable to the drug. No longer would hospitalizations, transfusions, or other serious adverse events need to be reported.
In 2021, using the COVID-19 pandemic as a tool, abortion proponents, led by the American College of Obstetricians and Gynecologists “(ACOG”), sued the FDA to dispense with the REMS in-person medical visit as a prerequisite for obtaining Mifeprex and permit the drug to be mailed…. With the pandemic declared over by President Biden on September 18, 2022, the foundation of concern for in-person medical visits should have ended. Instead, the FDA maintained its temporary suspension and continued permitting Mifeprex to be mailed. Then on December 16, 2022, the [Biden] FDA permanently removed the [Risk Evaluation and Mitigation Strategy] requirement for any in-person medical visits.
Judicial Watch’s brief alleges that the FDA, in approving Mifeprex, did not demonstrate as required under law, (1) pregnancy was a “serious or life-threatening illness” or a “disease,” and (2) that the drug “provided a meaningful therapeutic benefit to patients over existing treatments.”
“The chemical abortion drug would never have been approved but for pro-abortion politics. Pregnant mothers and their unborn children will continue to be harmed and maimed unless the courts require the FDA to follow the law,” said Judicial Watch President Tom Fitton.
In an effort to appease pro-abortion activists, the Clinton FDA hastily approved the abortion pill on September 28, 2000. Judicial Watch immediately filed a Freedom of Information Act (FOIA) request and then battled the government in court to force the release of documents pertaining to the decision to approve the drug. Judicial Watch successfully obtained over 9,000 pages of records and then fought the agency over withheld records.
In May 2006, Judicial Watch released a special report containing documents that shed light on the Clinton administration’s push to get the abortion drug to market in the United States.
In 2007, Judicial Watch received 175 pages of documents pertaining to the abortion pill RU-486 that had previously been withheld by the FDA. According to the records, the China-based Hua Lian Pharmaceutical Company manufactured RU-486 at the time of approval. This seems to be the first official document confirming that the abortion drug had been manufactured in China. The records also indicated the extent to which the pro-abortion lobby was involved in the approval process. For example, one of the trials used by the FDA to justify its decision was conducted by Dr. Suzanne Poppema, president of the National Abortion Federation. Another trial was performed by Dr. Daniel Mishell, a senior scientist for RU-486’s then-patent holder, the Population Council.
In October 2022, Judicial Watch also sued HHS for records regarding drug stability test results, new drug applications and related materials of the abortion drug Mifeprex well as requests for reviews and assessments of the manufacturing facilities DANCO and GenBio where the abortion pills are produced.