On this 2018 photo, mifepristone and misoprostol pills are provided at a Carafem clinic for medication abortions in Skokie, Illinois.
Erin Hooley | Tribune News Service | Getty Images
The Biden administration will ask the Supreme Court to intervene within the legal fight across the abortion pill mifepristone, after a federal appeals court allowed the drug to remain in the marketplace but imposed restrictions on its use.
In a press release Thursday, Attorney General Merrick Garland said the Justice Department “strongly disagrees” with the U.S. fifth Circuit Court of Appeals decision. He added that the administration will “be in search of emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to secure and effective reproductive care.”
The appeals court 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 difficult the agency’s greater than two-decade-old approval of the drug.
However the court temporarily rolled back major changes the FDA has implemented over time to make mifepristone easier to make use of and acquire. The order bars mail delivery of the abortion pill. Patients will now must obtain the prescription drug from a physician and can have to undergo several examinations in person while they’re taking the medication.
The court modified the timeframe when mifepristone will be administered to as much as 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 transient period.
The court has expedited the case to oral arguments at the subsequent available date.
The Planned Parenthood Federation of America condemned the fifth Circuit’s decision as a rejection of science and law that jeopardizes the health of thousands and thousands of individuals 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’d the authority to re-write mifepristone’s label,” said Alexis McGill Johnson, president of Planned Parenthood. “If allowed to face, the results of this decision will likely be catastrophic not only for medication abortion access, but your 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 together with one other drug, misoprostol, is probably the most common method used to terminate a pregnancy within the U.S. The order doesn’t impact misoprostol, which is usually used as a standalone abortion medication in other parts of the world.
The final result of the court battle over the pill could alter access to abortion even in states where it stays legal after the Supreme Court overturned Roe v. Wade last yr. The bench has a 6-3 conservative majority, including three justices appointed by Trump.
The appeals court said the FDA’s decision to lift the requirement that patients obtain the abortion pill in person created “a sea change within the legal framework governing mifepristone distribution.” That requirement was the FDA’s primary tool to make sure secure distribution or use of the drug, the court said.
The court cited a warning the FDA issued with its 2000 approval that surgery could be essential if mifepristone leads to an incomplete abortion, together with a form the agency requires patients to sign that indicates the drug may not work in 2 to 7 out of each 100 women who take mifepristone. That form instructs patients to contact a health-care provider immediately in the event that they have a fever of 100.4 degrees or higher for greater than 4 hours, heavy bleeding or severe stomach discomfort.
“FDA thus cannot deny that serious complications from mifepristone are definitely impending,” the judges wrote of 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 within the case who said they treated women who suffered hostile effects from mifepristone.
In a separate decision Friday, U.S. District Judge Thomas Rice within the Eastern District of Washington barred the FDA from “altering the established order and rights because it pertains to the provision of mifepristone” within the 17 states and the District of Columbia that sued to maintain the medication in the marketplace there.
Washington state Attorney General Bob Ferguson said Thursday that Rice’s ruling fully preserves access to mifepristone within the 17 states and D.C. that joined the lawsuit he spearheaded. The fifth Circuit’s decision doesn’t limit access to the drug in those states, he said.
“There is a federal judge in Washington who has said the status quo must remain in effect for mifepristone. No judge in Texas gets to change that. We’ve a ruling that is crystal clear and our full expectation is that the FDA will honor it,” Ferguson told CNBC.
The court also indicated that it’s possible the Alliance Defending Freedom, the group that brought the lawsuit, could achieve its challenge to the underlying approval of mifepristone at a later date within the litigation. The Alliance Defending Freedom represents a coalition of physicians, called the Alliance for Hippocratic Medicine, who’re against abortion.
“The ladies who use this drug cannot possibly return to their non-doctor-prescribers for surgical abortions, so again, because the Patient Agreement Form itself says, they need to as an alternative seek emergency care from a professional physician,” the judges said.
The FDA, tons of 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 secure and effective option 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 make sure patient safety. Those restrictions were long criticized by medical associations reminiscent of the American College of Obstetricians and Gynecologists, and faced litigation.
In 2016, the FDA rolled back the variety of required in-person office visits to 1. It also allowed nondoctors to prescribe mifepristone and lengthened the timeframe during which patients can take the pill to as much as 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 in the event that they grow to be certified under a federal monitoring program.
Walgreens and CVS announced in January that they’d get certified under that program and dispense mifepristone in states where the law allows.
The fifth Circuit judges also discussed at length the Comstock Act, a Nineteenth-century law that prohibits sending anything that will induce an abortion through the mail. The Justice Department has argued that the Comstock Act doesn’t prohibit mailing abortion medication if the sender doesn’t intend to interrupt any laws, citing court cases dating back to the early twentieth century that narrowed the act’s scope.
The court said it didn’t have time to conclusively explore the Comstock Act’s scope but said the uncertainty surrounding its application weighs in favor of anti-abortion groups.