A U.S. appeals court ruled Wednesday that access to the abortion drug mifepristone must be restricted and ordered a ban on telemedicine prescriptions and drug shipments by mail. However, the decision is not expected to take effect immediately.
The 5th Circuit Court of Appeals, based in New Orleans, stopped short of ruling that the drug must be pulled off the market altogether, as had been done in a lower court.
A U.S. Department of Justice spokesperson said the Biden administration plans to appeal the ruling to the U.S. Supreme Court. Democrat President Joe Biden supports abortion rights and ordered the federal health agency to expand access to mifepristone just last year.
The appeals court ruling won’t take effect until the Supreme Court reviews it, which could happen in its next term, which runs from October to June.
The three-judge 5th Circuit panel reviewed an order in April by U.S. District Court Judge Matthew Kacsmaryk in Amarillo, Texas. Although it was a preliminary ruling while the case is pending, Kacxmaryk said he would likely make it permanent.
The ruling is rooted in a lawsuit brought by four anti-abortion doctors and four anti-abortion groups headed by the recently formed Alliance for Hippocratic Medicine who sued in November.
They contend the FDA used an improper process when mifepristone was approved in 2000 and didn’t 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,” said Erin Hawley of Alliance Defending Freedom. Hawley is a lawyer for the anti-abortion groups challenging the pill’s approval in a statement.
The view was echoed by Susan B. Anthony Pro-Life America, which said the FDA had been “reckless” in their released statement.
President of the abortion rights group Planned Parenthood Federation of America, Alexis McGill Johnson, 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 markets a generic version of mifepristone, said in a statement from its 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.”
Three-judge panel is solidly conservative and agreed to roll back FDA actions
Three-judge panel is solidly conservative, with a lengthy history of opposing abortion rights. One judge, Circuit Judge James Ho, stated he would have taken mifepristone off the market, but the other two judges said the lawsuit came too late to mount a challenge to the original approval in 2000.
Instead, the panel rolled back the FDA actions that had made the drug easier to access over recent years.
One action that was rolled back was a 2021 decision to allow the drug to be prescribed by telemedicine and sent in the mail instead of requiring a doctor’s visit in person. The court also reversed a 2016 decision by the agency to allow mifepristone to be used for ten weeks of pregnancy, an increase from the prior seven weeks.
Jennifer Walker Elrod, Circuit Judge, wrote in the majority opinion that the steps “were taken without sufficient consideration of the effects those changes would have on patients.”
Last year, the U.S. Supreme Court overturned the landmark Roe v. Wade ruling that had legalized abortion across the country.
Since then, at least 15 of the 50 states have outright banned abortion while several others prohibit it after a certain length of pregnancy, according to the research organization Guttmacher Institute, which supports abortion rights.
Mifepristone is part of a regimen of two drugs, along with misoprostol for medication abortions, which account for over half of abortions in the U.S.
Major medical associations, including the American Medical Association and the American College of Obstetricians and Gynecologists, have said that pulling mifepristone off the market would ultimately harm patients by forcing them to undergo more invasive surgical abortions.
