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 order 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.
Mifepristone’s availability remains unchanged for now, following an emergency order from the U.S. Supreme Court in April preserving the status quo during the appeal.
The U.S. Food and Drug Administration, which approved the pill, and lawyers for the anti-abortion groups challenging the drug’s approval did not immediately respond to requests for comment.
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.
All three judges on the panel are staunchly conservative, with a history of opposing abortion rights. One of them, Circuit Judge William Ho, said he would have gone further and pulled mifepristone off the market altogether.
Instead, the majority of the panel rolled back FDA actions that had made the drug easier to access in recent years. Those included allowing distribution by mail, approving its use up to 10 weeks of pregnancy instead of seven weeks, reducing the dosage and cutting the number of required in-person doctor visits from three to one.
The decision will almost certainly be appealed first to the full 5th Circuit and then to the U.S. Supreme Court, which 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 in court filings that pulling mifepristone off the market would harm patients by forcing them to undergo more invasive surgical abortions.
Hundreds of biotech and pharmaceutical company executives have called or the reversal of Kacsmaryk’s ruling, saying it ignores decades of scientific evidence on the drug’s safety and undermines the FDA’s authority, potentially creating chaos for the industry that relies on the agency.
(Reuters)
