Access to the abortion pill mifepristone must be restricted, a U.S. appeals court ruled on Wednesday, ordering a ban on telemedicine prescriptions and shipments of the drug by mail, though the decision will not immediately take effect.
The New Orleans-based 5th U.S. Circuit Court of Appeals stopped short of ruling that the drug must be pulled off the market altogether, as a lower court had done.
A spokesperson for the U.S. Department of Justice said that the Biden administration will appeal the ruling to the U.S. Supreme Court. President Joe Biden, a Democrat, supports abortion rights and last year ordered the federal health agency to expand access to mifepristone.
The ruling will not take effect until the Supreme Court reviews it, which could occur in its upcoming term from October to June.
The three-judge 5th Circuit panel was reviewing an order in April by U.S. District Court Judge Matthew Kacsmaryk in Amarillo, Texas. While it was a preliminary ruling that applied while the case was pending, Kacsmaryk said he was ultimately likely to make it permanent.
The ruling stems from a lawsuit brought by four anti-abortion groups headed by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors who sued in November.
They contend the FDA used an improper process when it approved mifepristone in 2000 and did not adequately consider the drug's safety when used by minors.
"The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions," Erin Hawley of Alliance Defending Freedom, a lawyer for the anti-abortion groups challenging the pill's approval, said in a statement.
That view was echoed by Susan B. Anthony Pro-Life America, which said in a statement the FDA had been "reckless."
Alexis McGill Johnson, president of abortion rights group Planned Parenthood Federation of America, said the decision "makes it clear that mifepristone's approval is very much still at risk, as is the FDA's independence."
GenBioPro Inc, which sells a generic version of mifepristone, said in a statement from CEO Evan Masingill: "We remain concerned about extremists and special interests using the courts in an attempt to undermine science and access to evidence-based medication, as well as attempts to undermine the U.S. Food and Drug Administration’s regulatory authority."
CONSERVATIVE JUDGES
All three judges on the panel are staunchly conservative, with a history of opposing abortion rights. One of them, Circuit Judge James Ho, said he would have gone further and pulled mifepristone off the market, but the other two judges said the lawsuit came too late to challenge the original 2000 approval.
Instead, the majority of the panel rolled back FDA actions that had made the drug easier to access in recent years.
Those included its decision in 2021 to allow the drug to be prescribed by telemedicine and sent by mail, instead of requiring an in-person doctor visit. The court also reversed the agency's 2016 decision to allow mifepristone to be used to 10 weeks of pregnancy, up from seven.
Circuit Judge Jennifer Walker Elrod wrote in the majority opinion that those steps "were taken without sufficient consideration of the effects those changes would have on patients."
The U.S. Supreme Court last year overturned its landmark Roe v. Wade ruling that had legalized abortion nationwide.
Since then, at least 15 of the 50 states have banned abortion outright while many others prohibit it after a certain length of pregnancy, according to the Guttmacher Institute, a research organization that supports abortion rights.
Mifepristone is part of a two-drug regimen with misoprostol for medication abortions, which account for more than half of U.S. abortions.
Numerous medical studies and many years of real-world use have concluded that the drug is safe and effective.
Major medical associations, including the American College of Obstetricians and Gynecologists and the American Medical Association, have said that pulling mifepristone off the market would harm patients by forcing them to undergo more invasive surgical abortions.
(Reporting By Brendan Pierson in New York; Additional reporting by Patrick Wingrove in New York, Nate Raymond in Boston, Sharon Bernstein in Sacramento, California and Trevor Hunnicutt in Washington; Editing by Cynthia Osterman)