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Doctors, health care groups push back on FDA attempts to justify illegal approval of chemical abortion drugs

ADF attorneys represent four health care orgs, four doctors in lawsuit challenging FDA’s unlawful authorization of mifepristone, misoprostol
Woman sitting on a couch in a hospital gown

AMARILLO, Texas – Four national medical associations and four doctors experienced in caring for pregnant and post-abortive women filed a brief Friday in federal court that pushes back on the Food and Drug Administration’s arguments against withdrawing or suspending its approval of chemical abortion drugs that harm women and girls.

In November, Alliance Defending Freedom attorneys filed suit against the agency on behalf of 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.

“By illegally approving dangerous chemical abortion drugs, FDA officials put women and girls in harm’s way, and now it’s high time they were held accountable for their reckless actions,” said ADF Senior Counsel Erik Baptist. “Science was the FDA’s first victim. Women and girls were soon to follow. We urge the court to listen to the doctors we represent who are seeking to protect women from the documented dangers of chemical abortion drugs.”

The only way the FDA was able to approve the legalization of the chemical abortion drugs in 2000 was by characterizing pregnancy as an “illness” and arguing that these drugs provide a “meaningful therapeutic benefit.”

As the medical groups and doctors who filed suit explain, the FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women when it approved chemical abortion drugs. 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 the dangerous drug regimen.

ADF attorneys filed their reply brief with the U.S. District Court for the Northern District of Texas, Amarillo Division, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. In it, they note that “after stonewalling [the medical groups and doctors] for nearly two decades, the FDA admitted what [the medical groups and doctors] have been saying all along: the agency has never required or relied on a single study that evaluated the safety and effectiveness of these drugs under real-world conditions. Without these vital studies, the harms that these drugs inflict on women are a heartbreaking, yet unsurprising, reality.”

In 2016, the FDA extended the permissible gestational age of the baby for which a girl or woman may take chemical abortion drugs—from seven weeks’ gestation to 10 weeks’ gestation—increasing the mother’s risk of adverse complications. The FDA also changed the dosage and route of administration for the drugs, reduced the number of required in-person doctor visits from three to one, expanded who could prescribe and administer chemical abortion drugs beyond medical doctors, and eliminated the requirement for abortionists to report non-fatal complications from chemical abortion drugs.

Further, in 2021, the FDA announced that it would allow abortionists to send chemical abortion drugs through the mail—in direct violation of longstanding federal law. As the lawsuit points out, this decision puts girls and women at additional risk from chemical abortion drugs since mail-order, at-home abortions skip necessary medical examinations to ensure that girls and women do not have conditions that could lead to fatal outcomes.

Jester is a board-certified OB-GYN and medical director of Moore County Obstetrics & Gynecology in Dumas, Texas; Frost-Clark is a board-certified OB-GYN in St. Clair Shores, Michigan; Johnson is a board-certified emergency department physician in Leo, Indiana; and Delgado is a board-certified physician and serves as the medical director of Abortion Pill Reversal and Culture of Life Family Health Care in Escondido, California.

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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