Appeals court rules mifepristone will remain available under restrictions for now

Mifeprex, the brand name of mifepristone, will continue to be administered in the United States, though under stricter regulations, after an appeals court partially sided with its manufacture, Danco Laboratories, on Wednesday. File Photo by Bill Greenblatt/UPI

April 13 (UPI) — A federal appeals court ruled late Wednesday that the abortion pill mifepristone will remain available in the United States amid ongoing litigation but with considerable restrictions.

The greatly anticipated ruling keeps the future of mifepristone, which is used to abort pregnancies up to 10 weeks’ gestation and to manage early miscarriages, in jeopardy as the case moves through the courts.

Though the Wednesday ruling permits its ongoing use, it shrinks the pregnancy window during which it can be taken to seven weeks, requires in-person visits to obtain the pill and bars it from being distributed through the mail, among other restrictions.

The lawsuit against the state and the drug’s manufacturer, Danco Laboratories, was brought by the Alliance for Hippocratic Medicine, a conservative coalition of doctors, in November challenging the Food and Drug Administration‘s 2000 approval of the drug as well as subsequent actions the federal agency has taken regulating its administration.

Last week, U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trumpruled in the alliance’s favor, suspending the FDA’s approval of the abortion-inducing medication, which attracted a request for a stay from the federal government and Danco, as well as amicus briefs in support of the ruling from Republican lawmakers and those against by Democrats and women’s rights advocates.

The alliance had argued that the FDA was wrong in its initial approval of the drug, including not properly studying its safety.

Following Kacsmaryk’s ruling on Friday, the Justice Department filed its request for a stay, saying ending the use of mifepristone will harm the entire country and undermine healthcare systems.

On Wednesday, the three-judge panel of the Fifth U.S. Circuit Court of Appeals ruled partially in the government’s favor, granting it a stay against the alliance’s challenge of the FDA’s initial approval of the drug, stating it exceeded the statute of limitations.

The panel though sided with the plaintiffs concerning their challenges to FDA actions starting in 2016 and through the subsequent years, saying the state agencies “have not shown that the plaintiffs are unlikely to succeed on the merits of their timely challenges.”

“As the stay applicants, defendants bear the burden of showing why ‘extraordinary circumstances’ demand that we exercise discretion in their favor. To the extent the defendants make any such showing, they do so only with respect to the 2000 Approval — not the plaintiffs’ alternative arguments challenging FDA’s 2016 Major Rems Changes and all subsequent actions,” the judges said.

The judges, all appointed by former Republican presidents, also ordered the appeal expedited.

Judge Catharina Haynes, an appointee of former President George W. Bush, added in the ruling that she only agrees with Judges Kurt Engelhardt and Andrew Oldham, Trump appointees, in part as she would have granted the government an administrative stay for the period of the appeal.

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