A federal appeals court has allowed the abortion pill mifepristone to remain on the U.S. market for now, but it imposed major restrictions on the medication that will significantly limit access.
The U.S. 5th Circuit Court of Appeals late Wednesday blocked U.S. District Judge Matthew Kacsmaryk’s order that suspended the Food and Drug Administration’s approval of mifepristone. The court said federal statutes of limitations appear to bar the anti-abortion groups who brought the lawsuit from challenging the agency’s more than two-decade-old approval of the drug.
But the court temporarily rolled back major changes the FDA has implemented over the years to make mifepristone easier to use and obtain. The order bars mail delivery of the abortion pill. Patients will now have to obtain the prescription drug from a doctor and will have to undergo several examinations in person while they are taking the medication.
The court changed the time frame when mifepristone can be administered to up to 49 days into the pregnancy, down from the previous 70 days.
The three judge panel voted 2-1 in favor of reimposing restrictions on mifepristone. Judges Kurt Engelhardt and Andrew Oldham, who were appointed by former President Donald Trump, voted in favor. Judge Catharina Haynes, who was appointed by former President George Bush, supported blocking Kacsmaryk’s entire order for a brief period.
The court has expedited the case to oral arguments at the next available date.
The Justice Department is certain to challenge the 5th Circuit’s decision. The government’s lawyers and Danco Laboratories, the distributor of mifepristone, have vowed to take the case to the Supreme Court if necessary.
The Planned Parenthood Federation of America condemned the 5th Circuit’s decision as a rejection of science and law that jeopardizes the health of millions of people by limiting access to medication abortion and undermines the drug approval system.
“The federal judiciary has — for the second time this week — rejected science and the law, and this time, the court decided they had the authority to re-write mifepristone’s label,” said Alexis McGill Johnson, president of Planned Parenthood. “If allowed to stand, the consequences of this decision will be catastrophic not just for medication abortion access, but the entire drug approval system.”
The Alliance Defending Freedom, the anti-abortion group that sued the FDA, said the appeals court decision restores critical safeguards while the litigation proceeds.
Mifepristone, used in combination with another drug, misoprostol, is the most common method used to terminate a pregnancy in the U.S. The order does not impact misoprostol, which is commonly used as a standalone abortion medication in other parts of the world.
The outcome of the court battle over the pill could alter access to abortion even in states where it remains legal after the Supreme Court overturned Roe v. Wade last year.
The appeals court said the FDA’s decision to lift the requirement that patients obtain the abortion pill in person created “a sea change in the legal framework governing mifepristone distribution.” That requirement was the FDA’s primary tool to ensure safe distribution or use of the drug, the court said.
The court cited a warning the FDA issued with its 2000 approval that surgery might be necessary if mifepristone results in an incomplete abortion, along with a form the agency requires patients to sign that indicates the drug may not work in 2 to 7 out of every 100 women who take mifepristone. That form instructs patients to contact a health-care provider immediately if they have a fever of 100.4 degrees or higher for more than four hours, heavy bleeding or severe stomach discomfort.
“FDA thus cannot deny that serious complications from mifepristone are certainly impending,” the judges wrote in their order. “Those complications are right there on the Patient Agreement Form that FDA itself approved and that Danco requires every mifepristone user to sign.”
The court cited testimony from physicians in the case who said they treated women who suffered adverse effects from mifepristone.
In a separate decision Friday, U.S. District Judge Thomas Rice in the Eastern District of Washington barred the FDA from “altering the status quo and rights as it relates to the availability of mifepristone” in the 17 states and the District of Columbia that sued to keep the medication on the market there.
The 5th Circuit did not mention the Washington state case. It wasn’t immediately clear whether the restrictions in the court’s ruling apply to those 17 states and D.C.
The court also indicated that it’s possible the Alliance Defending Freedom, the group that brought the lawsuit, could succeed in its challenge to the underlying approval of mifepristone at a later date in the litigation. The Alliance Defending Freedom represents a coalition of physicians, called the Alliance for Hippocratic Medicine, who are opposed to abortion.
“The women who use this drug cannot possibly go back to their non-doctor-prescribers for surgical abortions, so again, as the Patient Agreement Form itself says, they must instead seek emergency care from a qualified physician,” the judges said.
The FDA, hundreds of members of Congress, leading medical associations and drug law experts have strongly disputed the claims made against mifepristone. They argue that the scientific evidence has overwhelmingly shown that the medication is a safe and effective way to terminate an early pregnancy, and the FDA’s regulatory actions were thorough and legal.
The FDA first approved mifepristone in 2000. The agency imposed restrictions on how the pill is used and distributed to ensure patient safety. Those restrictions were long criticized by medical associations such as the American College of Obstetricians and Gynecologists, and faced litigation.
In 2016, the FDA rolled back the number of required in-person office visits to one. It also allowed nondoctors to prescribe mifepristone and lengthened the time frame during which patients can take the pill to up to 70 days into the pregnancy.
In January, the agency permanently lifted the in-person requirements and allowed the delivery of the pill by mail. It also allowed retail pharmacies to dispense mifepristone if they become certified under a federal monitoring program.
Walgreens and CVS announced in January that they would get certified under that program and dispense mifepristone in states where the law allows.
The 5th Circuit judges also discussed at length the Comstock Act, a 19th-century law that prohibits sending anything that would induce an abortion through the mail. The Justice Department has argued that the Comstock Act does not prohibit mailing abortion medication if the sender does not intend to break any laws, citing court cases dating back to the early 20th century that narrowed the act’s scope.
The court said it did not have time to conclusively explore the Comstock Act’s scope but said the uncertainty surrounding its application weighs in favor of anti-abortion groups.