After a Texas court decided that approval of the abortion pill, mifepristone, was invalid and ordered the drug off the market, an appeals court has decided to temporarily allow access, but is requiring the Food and Drug Administration to restore critical safeguards to chemical abortion drugs while the lawsuit proceeds.
According to Alliance Defending Freedom (ADF), a non-profit legal organization whose attorneys are handling the case, the 5th Circuit Court of Appeals ruled late Wednesday that although the drug can remain available until the case is decided on its merits, 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.
In addition, the ruling roles back a 2016 extension by the FDA to permit the 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 ADF attorneys that the FDA’s approval of generic mifepristone was unlawful, and that the manufacturer must cease production by Friday.
All of these restrictions are to be effective on Friday, April 14.
“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.
The 42-page decision frequently sides with the plaintiffs and even uses pro-life terminology such as one instance where it refers to a fetus or embryo as an “unborn child.” While it did not evaluate all of the safety issues of the case, it did say that the FDA “cannot deny that serious complications from mifepristone” occur, noting that the agreement form patients are required to sign acknowledges those risks.
The ruling also disputed the FDA’s claim that mifepristone was “as safe as ibuprofen”, saying that the “F.D.A.’s own documents show that mifepristone bears no resemblance to ibuprofen.”
The plaintiff’s argument that the sending of pills through the mail violates the Comstock Act, a law that prevents the mailing of drugs used for abortion, was also accepted by the court.
As for the FDA claim that the plaintiffs did not have legal standing to bring the case because the group of doctors and medical associations involved did not incur damage or harm, the appeals court disagreed. It ruled that the doctors’ claims of injury due to having to divert medical resources from other patients to treat women harmed by chemical abortions, and being forced to complete these abortions even though this violated their consciences, was sufficient evidence of harm.
The ruling stated that “as a result of F.D.A.’s failure to regulate this potent drug, these doctors have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects. This harm is sufficiently concrete.”
It went on to add that the plaintiffs “also face an injury from the irreconcilable choice between performing their jobs and abiding by their consciences.”
“Federal agencies that act lawlessly must be held accountable,” Hawley said. “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.”
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.
The Justice Department has decided to appeal this case to the U.S. Supreme Court.
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