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Biden administration and drug manufacturer ask court to block suspension of mifepristone approval

A table with medical pamphlets and a box of the abortion pill mifepristone

This story was updated on April 14 at 4:14 p.m.

Less than 10 months after the Supreme Court’s decision overturning the constitutional right to an abortion, both the Biden administration and a drug manufacturer have asked the justices to temporarily block a ruling by a federal judge in Texas that suspended the Food and Drug Administration’s approval of mifepristone, part of a two-drug protocol used to end pregnancies in their early stages. Stressing that no court has ever before invalidated the FDA’s approval of a drug “based on a disagreement with the agency’s judgment about safety or effectiveness,” U.S. Solicitor General Elizabeth Prelogar urged the court to allow the drug to remain in use for now while a challenge to the FDA’s approval continues.

Medication abortions account for over half of all abortions performed each year in the United States, according to a study published last year by the Guttmacher Institute. The Supreme Court’s ruling could therefore affect the availability of abortion throughout the country, including in states where abortion is currently legal.

Mifepristone, also known as RU-486 or Mifeprex, blocks the effect of one of the hormones necessary to maintain a pregnancy. It is used in conjunction with the drug misoprostol, which causes the uterus to contract, expelling the pregnancy.

The FDA first approved the use of mifepristone, subject to some conditions on its use, to end pregnancies in 2000. In the years that followed, the FDA made some changes to the conditions on the drug’s use, such as allowing health-care providers who are not physicians to prescribe it and allowing it to be used until the 70th day of pregnancy.

The dispute now before the Supreme Court was filed in the U.S. District Court for the Northern District of Texas by a group of doctors and medical groups opposed to abortion. Calling the drug regimen “unsafe,” they challenged both the FDA’s initial approval of mifepristone and the agency’s later actions relating to the drug.

In a lengthy opinion issued on April 7, U.S. District Judge Matthew Kacsmaryk agreed with the plaintiffs, finding that the FDA approved the use of mifepristone despite “legitimate safety concerns.” He concluded that allowing mifepristone to be distributed by mail also violates the federal Comstock Act, an 1873 law intended to bar the mailing of any “instrument, substance, drug, medicine, or thing” that can be used for an abortion.

Kacsmaryk suspended the FDA’s approval of mifepristone, but he put his order on hold for seven days, until April 14, to give the government time to appeal.

The Biden administration went quickly to the U.S. Court of Appeals for the 5th Circuit, asking that court to keep Kacsmaryk’s order on hold while it appeals or, at the very least, to act by Thursday, April 13. In an opinion issued late Wednesday night, the 5th Circuit gave the Biden administration only part of the relief it sought. The court of appeals temporarily blocked the portion of Kacsmaryk’s order that suspended the FDA’s 2000 approval of mifepristone. But it left in place the rest of Kacsmaryk’s order, which invalidated the FDA’s changes to the conditions on the drug’s use. The 5th Circuit also fast-tracked the administration’s appeal.

On the same day that Kacsmaryk issued his ruling suspending the FDA’s approval of mifepristone, a federal judge in Washington state barred the FDA from withdrawing mifepristone from the U.S. market. U.S. District Judge Thomas Rice issued an order in a lawsuit brought by 17 states with Democratic attorneys general, led by Washington, as well as the District of Columbia. The plaintiffs in those case argue that mifepristone “has proven incredibly safe – safer than many well-known over-the-counter drugs like Tylenol,” and they challenged a new set of rules imposed in January of this year that they say “needlessly limits patient access to this vital, time-sensitive medication” without any “basis in science or statute.” On Thursday, Rice clarified that his injunction “must be followed” regardless of Kacsmaryk’s decision or the 5th Circuit’s ruling.

Citing the “unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” the Biden administration came to the Supreme Court on Friday morning, asking the justices to put Kacsmaryk’s ruling on hold. Even the 5th Circuit’s ruling, if allowed to go into effect, “would be almost equally disruptive,” Prelogar explained, because (among other things) all of the mifepristone currently on the market “would immediately become misbranded” and the generic version would no longer be approved. By contrast, Prelogar continued, the challengers “have not shown that they will be injured at all, much less irreparably harmed, by maintaining the status quo they left unchallenged for years.”

Prelogar asked the justices to put Kacsmaryk’s order on hold to preserve the status quo while the government’s appeal continues in the 5th Circuit. But if the court declines to do so, Prelogar continues, it should order expedited briefing and oral argument in the case, with a decision before the justices’ summer recess.

Danco Laboratories, a New York pharmaceutical company that distributes mifepristone, filed its own request to put Kacsmaryk’s order on hold. The company is in an “untenable” position, it told the justices, because it “cannot legally market and distribute” its product.

In brief orders on Friday afternoon, Justice Samuel Alito, who fields emergency requests from the 5th Circuit, put Kacsmaryk’s order on hold until 11:59 p.m., EDT, on Wednesday, April 19. Alito’s order, known as an administrative stay, preserves the status quo until the justices can rule on the requests from the Biden administration and Danco Laboratories; it does not reflect the justices’ views on the merits of those requests. Alito ordered the challengers to respond by noon on Tuesday, April 18. 

This article was originally published at Howe on the Court

Recommended Citation: Amy Howe, Biden administration and drug manufacturer ask court to block suspension of mifepristone approval, SCOTUSblog (Apr. 14, 2023, 12:08 PM),