UPDATED: Fifth Circuit Preserves Abortion Pill Access While Upholding Certain Restrictions, DOJ to Appeal

Charlie Neibergall

UPDATE: The Department of Justice has announced it is, in fact, appealing the Fifth Circuit’s ruling to the Supreme Court.

“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Attorney General Merrick Garland said in a statement. “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”

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Original Story

The legal battle over the FDA’s authorization of mifepristone (the “abortion pill”) proceeds apace.

As RedState reported, last Friday, a U.S. District Court judge in Texas stripped the FDA’s approval of the drug. In that ruling, Judge Matthew Kacsmaryk wrote that the drug was unsafe and its approval process had been rushed.

“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in the 67-page opinion. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.” He added that the agency had faced “significant political pressure” to “increase ‘access’ to chemical abortion.”

Also on Friday, Judge Thomas Rice, who sits on the Eastern District of the U.S. District Court in Washington (state), issued a dueling opinion ruling that mifepristone is safe and effective and ordering the FDA to maintain the “status quo” in the states that brought the lawsuit to protect the medication’s approval.

The Texas ruling issued a nationwide injunction, which was stayed for seven days to allow time for an appeal — which the Justice Department and the drug’s manufacturer, Danco Laboratories, promptly filed that evening.

On Wednesday, the Fifth Circuit Court of Appeals ruled (in response to the appeal of the Texas ruling) that the drug could remain in use for now, but narrowed the scope of that use, reducing the time period in which it could be taken (back to the pre-2016 seven weeks) and prohibiting its being dispensed by mail.

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Just before midnight Wednesday, the 5th U.S. Circuit Court of Appeals in New Orleans ruled that the FDA’s initial approval of mifepristone in 2000 could remain in effect.

But in the 2-1 vote, the panel of judges put on hold changes made by the regulator since 2016 that relaxed the rules for prescribing and dispensing mifepristone. Those included extending the period of pregnancy when the drug can be used from seven weeks to 10, and also allowing it to be dispensed by mail, without any need to visit a doctor’s office.

The appeals court judges in the majority in Wednesday’s decision noted that the Biden administration and mifepristone’s manufacturer “warn us of significant public consequences” that would result if mifepristone were withdrawn entirely from the market under the lower court ruling.

But the judges suggested changes the FDA made making mifepristone easier to obtain since 2016 were less consequential than its initial approval of the drug in 2000. It would be “difficult” to argue the changes were “so critical to the public given that the nation operated — and mifepristone was administered to millions of women — without them for sixteen years” the judges wrote.

When the drug was initially approved in 2000, the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug misoprostol and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious consequences associated with the drug.

If the appeals court’s action stands, those would again be the terms under which mifepristone could be dispensed for now.

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The ruling is a procedural one, merely setting the framework for how the drug is to be handled pending a determination on the merits of the case. The Court has expedited the substantive appeal to the next available oral argument date. And, of course, ultimately, the matter will likely make its way to the Supreme Court. The full 42-page Order from the Fifth Circuit can be found here.

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