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Groups, officials unite to hold FDA accountable for illegally approving chemical abortion drugs

Fifteen friend-of-the-court briefs filed with federal court in support of ADF lawsuit

Monday, Feb 13, 2023

AMARILLO, Texas – Pro-life organizations, 67 members of Congress, and 23 states are supporting four national medical associations and four doctors experienced in caring for pregnant and post-abortive women who are suing the federal government for illegally approving chemical abortion drugs that harm women and girls. The support came in 15 friend-of-the-court briefs filed with a federal court Friday in the case Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.

Alliance Defending Freedom attorneys representing the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations, and doctors Shaun Jester, Regina Frost-Clark, Tyler Johnson, and George Delgado filed suit in November in the U.S. District Court for the Northern District of Texas, Amarillo Division.

“The FDA’s approval of chemical abortion drugs has always stood on shaky legal and moral ground, and after years of evading responsibility, it’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls,” said ADF Senior Counsel Erik Baptist. “We and the many parties who are supporting the national medical associations and doctors hope the court will agree the FDA never had the authority to approve these dangerous drugs and reject the marketing and distribution of them.”

In 2000, the U.S. Food and Drug Administration approved the chemical abortion drugs mifepristone and misoprostol by characterizing pregnancy as an “illness” and arguing that these drugs provide a “meaningful therapeutic benefit.”

As the medical groups and doctors explain, by approving chemical abortion drugs, the FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women. The FDA never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen.

As the brief filed by 22 states explains, “Rather than respect the Constitution, the Supreme Court, and the democratic process, the Biden Administration has attacked and worked to undermine the considered judgments of the elected representatives of States like amici. The Administration’s actions on abortion drugs typify that effort…. The serious nature of the FDA’s unlawful actions, and the agency’s decision to invite lawbreaking by private parties and government actors across the country, favors broad relief. The FDA and the Administration as a whole have no intention to respect the Constitution, the Supreme Court, or the democratic process when it comes to abortion. This Court’s decisive action is warranted.”

“The FDA’s new regulations now allow women to self-manage their chemical abortions without ever seeing a doctor in person,” added the Charlotte Lozier Institute in its brief. “Yet the consequences of telemedicine chemical abortion are almost too numerous to count—lack of necessary ultrasounds to confirm gestational age and rule out ectopic pregnancy, inability to confirm that a woman is not being coerced to obtain an abortion, abandonment of women to deal with the medical and psychological repercussions of abortion by herself with no follow-up, and grave harm to physicians who are expected to clean up the mess (in the ER and elsewhere) of self-managed abortion.”

ADF attorneys filed a brief Friday that pushes back on the Food and Drug Administration’s arguments against withdrawing or suspending its approval of the chemical abortion drugs.

Alliance Defending Freedom is an alliance-building, non-profit legal organization committed to protecting religious freedom, free speech, parental rights, and the sanctity of life.

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Friend-of-the-court briefs filed with U.S. District Court for the Northern District of Texas