Doctors, health care groups sue FDA for approving dangerous chemical abortion drugs

ADF attorneys represent four health care organizations, four doctors in first lawsuit to challenge FDA’s authorization of chemical abortion drugs, removal of safeguards

AMARILLO, Texas – In the first lawsuit of its kind, four national medical associations and four doctors experienced in caring for pregnant and post-abortive women are suing federal government officials for illegally approving chemical abortion drugs that harm girls and women. ADF attorneys filed a federal lawsuit Friday 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.

The U.S. Food and Drug Administration chose politics over science when it pushed for the legalization of the chemical abortion drugs mifepristone and misoprostol in 2000. The only way the FDA was able to approve the drugs was by characterizing pregnancy as an “illness” and arguing that these drugs provide a “meaningful therapeutic benefit.” As the medical groups and doctors filing suit 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.

“Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit — they end a baby’s life and they pose serious and life-threatening complications to the mother,” said ADF Senior Counsel Julie Marie Blake. “The FDA never had the authority to approve these dangerous drugs for sale. We urge the court to listen to the doctors we represent who are seeking to protect girls and women from the documented dangers of chemical abortion drugs.”

“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 girls and women,” said ADF Senior Counsel Erik Baptist. “On behalf of the national health care organizations and physicians we represent, we ask the court to hold the FDA accountable for its reckless, unlawful behavior. We urge the court to reject the marketing and distribution of dangerous chemical abortion drugs so that the health, safety, and welfare of women are protected.”

The FDA also removed the few safeguards that were in place. In 2016, for example, 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.

ADF attorneys filed the lawsuit, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, in the U.S. District Court for the Northern District of Texas, Amarillo Division.