(CN) — A divided Fifth Circuit panel on Wednesday found the federal government had improperly allowed the abortion medication mifepristone to be dispensed through the mail. But it said a lower court should not have suspended approval of the drug.
Counsel for a group of doctors and national medical associations who are against abortions and challenged the Food and Drug Administration’s approval of mifepristone in a federal lawsuit celebrated Wednesday’s order.
They noted however that the decision has no immediate effect on the drug’s availability due to a stay the U.S. Supreme Court issued this spring.
“We are very pleased with the Fifth Circuit’s decision, that decision restores the original 2000 safeguards to a dangerous chemical drug regimen,” said Erin Hawley, senior counsel of the Alliance Defending Freedom and wife of U.S. Senator Josh Hawley, a Missouri Republican.
A three-judge panel of appellate judges agreed with the challengers that the FDA violated the Administrative Procedure Act in 2021 when it did away with requirements that mifepristone be dispensed in person and allowed it to be sent through the mail.
The FDA “failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person,” U.S. Circuit Judge Jennifer Walker Elrod wrote in her 61-page majority opinion.
The panel also agreed with the plaintiffs that the FDA improperly loosened safeguards in 2016 by extending the period mifepristone could be taken, from seven weeks' gestation up to 10 weeks; allowing nonphysicians to prescribe the drug; and removing a requirement for an in-person follow-up appointment.
Mifepristone causes miscarriages by blocking the hormone progesterone, which readies the uterus to carry an embryo. In the U.S., it is usually prescribed in tandem with misoprostol, which causes contractions that clear the uterus.
The method has surpassed surgical abortions in recent years. In 2020, 53% of the more than 900,000 abortions in the U.S. were done by pill, rising from 39% in 2017.
After the U.S. Supreme Court’s conservative judges eliminated the constitutional right to an abortion in June 2022, giving states leave to craft their own rules, the anti-abortion movement set its sights on mifepristone.
Led by a newly incorporated group called the Alliance for Hippocratic Medicine, the challengers filed their lawsuit targeting medication abortion in Amarillo federal court this past November.
They knew the case would be assigned to U.S. District Judge Matthew Kacsmaryk due to a jurisdictional loophole.
A Trump appointee, former federal prosecutor and one-time general counsel of the Christian legal organization First Liberty Institute, Kacsmaryk once criticized the Supreme Court’s 1973 Roe v. Wade decision that legalized abortion nationwide, complaining that seven of its justices had found an “unwritten ‘fundamental right’ to abortion” in the Constitution.
In a ruling bemoaned by abortion-rights advocates as blatant judicial activism, Kacsmaryk concluded the FDA should have not have approved mifepristone in 2000, and issued a preliminary injunction suspending that 23-year-old decision.
He determined the FDA had caved to political pressure and greenlit use of the drug with insufficient information about its safety. He also found the agency’s 2021 move authorizing mailing of the medication violated the Comstock Act of 1873.
Two weeks later, the Biden administration and Danco Laboratories, the maker of mifepristone which intervened as a defendant in the case, obtained an emergency stay from the Supreme Court that returned mifepristone’s availability pending resolution of the appeal.
The Supreme Court’s stay also remains in effect pending disposition of any petition for review filed with the high court.
The Justice Department said it "strongly disagrees" with the Fifth Circuit's order and will ask the Supreme Court to overturn it.
That means mifepristone will remain on the market without any rollbacks of FDA actions taken in 2016 and 2021 that eased access.
Though the two Fifth Circuit judges in the majority Wednesday — Elrod, a George W. Bush appointee, and U.S. Circuit Judge Cory T. Wilson, a Trump appointee — agreed with Kacsmaryk that the FDA should not have made it easier to get a mifepristone prescription, they decided the plaintiffs had waited too long to challenge the FDA’s approval of the drug and that claim was barred by a six-year statute of limitations.
Their colleague U.S. Circuit Judge James Ho, another Trump appointee, said in a partial dissent he fully endorsed Kacsmaryk’s findings.
“I agree with the panel majority that the FDA’s 2016 and 2021 revisions to its mifepristone regulations must be set aside as arbitrary and capricious under the APA. I would add that the FDA’s initial approval of mifepristone in 2000 also violates the agency’s own rules and thus must be set aside under the APA as well,” he wrote his in 29-page opinion.
The FDA approved mifepristone under its Subpart H regulations — an accelerated process for drugs that treat serious or life-threatening illnesses.
“Pregnancy is plainly not an illness. So it was unlawful for the FDA to approve mifepristone under Subpart H,” Ho added.
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