Court halts FDA's unlawful approval of chemical abortion drugs

AMARILLO, Texas – A federal district court ruled Friday to protect the health and safety of women and girls by halting the Food and Drug Administration’s approval of chemical abortion drugs. The court’s order in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration will go into effect in seven days, allowing time for the Biden administration to seek review from appellate courts.

Alliance Defending Freedom attorneys argued for this result on behalf of four medical groups and four doctors experienced in caring for pregnant and post-abortive women: 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 lawsuit, filed in November of last year, is the first to challenge federal government officials for their illegal approval of chemical abortion drugs that harm women and girls.

“By illegally approving dangerous chemical abortion drugs, the FDA put women and girls in harm’s way, and it’s high time the agency is held accountable for its reckless actions,” said ADF Senior Counsel Erik Baptist, who argued before the court on March 15. “Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they can pose serious and life-threatening complications to the mother, in addition to ending a baby’s life. The FDA never had the authority to approve these hazardous drugs or to remove important safeguards. This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women and girls.”

“Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within ‘180 days of receipt of the petition…,’” the U.S. District Court for the Northern District of Texas, Amarillo Division, wrote in its decision. “Plaintiffs have credibly alleged past and future harm resulting from the removal of restrictions for chemical abortion drugs.”

According to Baptist, the FDA chose politics over science when it pushed for the legalization of the chemical abortion drugs mifepristone and misoprostol in 2000. For example, the FDA was able to approve the drugs only by characterizing pregnancy as an “illness” and arguing that they 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 lawsuit notes that 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, and disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions.

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 office 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.

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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