5th Circuit ends FDA's illegal mail-order abortion regime

Appeals court rules to keep in place portion of district court’s order requiring the agency to restore previous safeguards for chemical abortion drugs

NEW ORLEANS – The U.S. Court of Appeals for the 5th Circuit ruled Wednesday to keep in place a portion of a federal district court’s order that protects the health and safety of women and girls by requiring the Food and Drug Administration to restore critical safeguards to chemical abortion drugs while the lawsuit proceeds.

In its decision, the 5th Circuit ruled that abortionists are no longer allowed to send 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 weeks’ gestation to 10 weeks’ gestation. The 5th Circuit’s order moved that back to seven weeks’ gestation, protecting the mother from adverse complications that increase with gestational age, reinstated necessary doctor visits, and brought back the requirement that abortionists must check women for complications after their chemical abortions. The 5th Circuit also agreed with Alliance Defending Freedom attorneys that the FDA’s approval of generic mifepristone was unlawful, and that the manufacturer must cease production by Friday.

“The FDA put politics ahead of the health of women and girls when it impermissibly failed to study how dangerous the chemical abortion drug regimen is and when it unlawfully removed every meaningful safeguard that it previously implemented. The FDA should have to answer for the damage it has done to the rule of law and the harm it has caused to countless women and girls,” said ADF Senior Counsel Erin Hawley. “Federal agencies that act lawlessly must be held accountable. The FDA illegally approved dangerous chemical abortion drugs and has evaded its legal responsibility to answer the American people’s questions for two decades. The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law.”

Following a ruling from the U.S. District Court for the Northern District of Texas, Amarillo Division, Friday, the Biden administration and Danco Laboratories, the pharmaceutical company that manufactures chemical abortion drugs, filed emergency motions asking the 5th Circuit to halt the district court’s ruling. In response, ADF attorneys representing four medical associations and four doctors experienced in caring for pregnant and post-abortive women asked the appeals court to keep the district court’s ruling in place, which it did by requiring the FDA to implement critical safeguards.

“FDA’s own documents show that mifepristone bears no resemblance to ibuprofen,” the 5th Circuit wrote in its decision in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. “Ibuprofen’s label, which FDA helpfully provided in its stay addendum, obviously bears no resemblance to the ‘Black Box’ warning on mifepristone’s label. To the contrary, FDA has a special regulation regarding ibuprofen so all manufacturers of that over-the-counter medicine include the same information on their labels. It says nothing about REMS, surgery, emergencies, Emergency Rooms, or death.”

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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