FDA must restore vital safeguards for chemical abortion drugs, 5th Circuit rules

Appeals court ends mail-order abortion regime, requires FDA to protect health, safety of women

NEW ORLEANS – In a victory for women’s health, a unanimous panel for the U.S. Court of Appeals for the 5th Circuit ruled Wednesday that the Food and Drug Administration must restore critical safeguards for chemical abortion drugs and disallow their shipment by mail. Alliance Defending Freedom attorneys representing four medical associations and four doctors experienced in caring for pregnant and post-abortive women asked the 5th Circuit to uphold a federal district court’s decision protecting the health and safety of women and girls against chemical abortion drugs.

“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” said ADF Senior Counsel Erin Hawley, vice president of the ADF Center for Life and Regulatory Practice, who argued before the court on behalf of the medical associations and doctors. “The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen. The FDA’s unprecedented and unlawful actions did not reflect scientific judgment but rather revealed politically driven decisions to push a dangerous drug regimen without regard to women’s health or the rule of law. This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women.”

The court’s ruling prohibits abortion providers from sending chemical abortion drugs through the mail, which the FDA had been allowing since 2021 in direct violation of longstanding federal law. Additionally, 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 to 10 weeks’ gestation—removed two of three required office visits, allowed non-doctors to prescribe the drug regimen, and eliminated the requirement that providers report non-fatal adverse events to the FDA Adverse Event Reporting System. The 5th Circuit held that the FDA’s 2016 action violated the Administrative Procedure Act and upheld the district court’s conclusion reinstating the original 2000 safeguards, including the seven weeks’ gestational limitation, necessary office visits, non-fatal adverse event reporting, and physician dispensation.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” the court wrote in its opinion in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. “It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”

With respect to the 2021 decision to allow mail-order abortion, the court criticized the FDA for giving dispositive weight to the adverse-event data in FAERS after eliminating the provider-reporting requirement, noting that “it’s unreasonable for an agency to eliminate the reporting requirement for a thing and then use the resulting absence of data to support its decision.”

The court further noted that the data the FDA cited in its 2000 approval of mifepristone shows “that thousands of women, and as many as hundreds of thousands, have experienced serious adverse effects as a result of taking the drug, and required surgery or emergency care to treat those effects.”

ADF attorneys filed the lawsuit against the FDA in November 2022 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. It is the first lawsuit to challenge federal government officials for their illegal approval of chemical abortion drugs that harm women and girls.

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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