US appeals court backs c restrictions; Supreme Court appeal expected

US appeals court backs c restrictions; Supreme Court appeal expected

Access to the abortion pill mifepristone must be restricted, a US 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 US 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 US Supreme Court in April preserving the status quo during the appeal.

The latest decision will not take effect until the Supreme Court reviews it, which is likely to happen and could occur in its upcoming term from October to June.

The US Food and Drug Administration and the White House did not immediately respond to requests for comment.

The three-judge 5th Circuit panel was reviewing an order in April by US 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.

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.”

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 US 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 US 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 for 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 the agency governs.

Danco Laboratories, which makes mifepristone under the brand name Mifeprex, intervened in the case to defend its drug. GenBioPro Inc, which sells a generic version, also filed a friend-of-the-court brief.

“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 US Food and Drug Administration’s regulatory authority,” GenBioPro CEO Evan Masingill said in a statement.

Published On:

Aug 17, 2023

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