EMERGENCY DOCKET
Mifepristone, manufactured by Danco, is the first pill in a two-step process used for medication abortion. (Robin Marty via Flickr)
The Supreme Court on Friday night granted a request from the Biden administration and a drug manufacturer to put on hold 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. The battle over medication abortions, which account for over half of all abortions performed in the United States each year, now returns to the U.S. Court of Appeals for the 5th Circuit, which is scheduled to hear oral argument in the case next month. The order means that the drug will remain widely available while litigation continues.
Two justices indicated that they would have denied the requests. Justice Clarence Thomas did not elaborate on his reasoning, but Justice Samuel Alito penned a four-page dissent in which he questioned the need for the court to act now.
The FDA originally approved mifepristone, which is also known as RU-486 or Mifeprex, in 2000. In the United States, the drug is used in conjunction with the drug misoprostol: Mifepristone blocks the effects of the hormones necessary to maintain a pregnancy, while misoprostol causes the uterus to contract, expelling the pregnancy.
A group of doctors and medical groups opposed to abortion went to a federal district court in Texas last year. Arguing that the drug regimen was “unsafe,” they sought to have the FDA’s approval of mifepristone rescinded.
Based on where it was filed, the case was automatically assigned to Kacsmaryk, who has issued a number of conservative rulings since he was appointed to the federal bench by President Donald Trump in 2017. Kacsmaryk agreed with the challengers. Finding that the FDA approved mifepristone despite “legitimate safety concerns,” Kacsmaryk suspended the agency’s approval of the drug, as well as the FDA’s later changes to the conditions on the use of the drug, which included allowing the drug to be used through the 10th week of pregnancy, reducing the number of in-person clinic visits, and allowing health-care providers who are not physicians to prescribe the drug. He put his order on hold for seven days, until April 14, to give the government time to appeal.
When the Biden administration asked the 5th Circuit to put Kacsmaryk’s order on hold, that court blocked only the part of the judge’s order suspending the FDA’s initial approval of mifepristone. But it refused to disturb the rest of Kacsmaryk’s order, which invalidated the FDA’s subsequent changes to the conditions on the drug’s use to expand access to it.
The Biden administration went to the Supreme Court immediately, asking the justices to keep Kacsmaryk’s order entirely on hold to preserve the status quo while the government’s appeal continues in the 5th Circuit.
U.S. Solicitor General Elizabeth Prelogar called the lower courts’ orders “unprecedented,” complaining that they “countermand[ed] FDA’s scientific judgment and unleash[ed] regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone.”
And although the 5th Circuit’s order partially blocked Kacsmaryk’s order, Prelogar explained, even allowing that aspect of the ruling to remain in effect would effectively keep the drug off the market as well, because (among other things) neither the current labeling nor the generic version would be approved.
Danco Labs, the company that distributes mifepristone, filed its own request to block Kacsmaryk’s order. It described itself as being in an “untenable limbo”. Without the FDA approvals of mifepristone in place, it explained, it cannot legally market and distribute the drug. But at the same time, it noted, an order by a federal judge in Washington state bars the FDA from withdrawing mifepristone from the market.
The challengers countered that, for decades, the FDA “has stripped away every meaningful and necessary safeguard on chemical abortion, demonstrating callous disregard for women’s well-being, unborn life, and statutory limits.” The lower courts’ orders suspending approval of mifepristone and the conditions on its use, they say, do not “second-guess the agency’s scientific determinations” but instead “merely require the agency to follow the law.”
The challengers also pushed back against the suggestion that keeping the 5th Circuit’s order in place will lead to chaos and effectively remove mifepristone from the market. Allowing the Fifth Circuit’s order to remain in place, they wrote, would simply mean that “women will still have access to chemical abortion drugs under the same restrictions that existed for the first 16 years of mifepristone’s use.” And in “a world where drug manufacturers can take a new vaccine from laboratory to market in a matter of months, it is disingenuous to say labels and documents that already exist cannot speedily be deployed,” they concluded.
On Friday, April 14, Alito had issued an administrative stay – that is, an order that continues to keep Kacsmaryk’s ruling on hold to give the court time to rule on the Biden administration’s request. The administrative stay was scheduled to expire at 11:59 p.m. on Wednesday. But on Wednesday afternoon, Alito extended the existing administrative stay until 11:59 p.m. on Friday.
In a brief, unsigned order issued just after 6:30 p.m. on Friday, the court granted the request to freeze Kacsmaryk’s ruling until the proceedings in the 5th Circuit and, if necessary, the Supreme Court have concluded.
Alito would have left the 5th Circuit’s ruling in place while the appeal continued. Doing so, he reasoned, would “not remove mifepristone from the market” but instead “simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016.” And with oral argument in the 5th Circuit scheduled in less than a month, he added, “there is reason to believe that they would get the relief they now seek—from either the Court of Appeals or this Court—in the near future if their arguments on the merits are persuasive.”
Alito criticized the FDA, accusing it of trying to “leverag[e]” the order in the Washington state case to create the “chaos” it said would ensue if even the 5th Circuit’s order were allowed to go into effect. Although the Washington court prohibited the FDA from withdrawing the drug from the market, Alito observed, “the FDA had never hinted it was contemplating” doing so. Moreover, Alito added, the FDA did not appeal the Washington court’s order, while at the same time opposing a request by seven states that might have appealed to intervene.
Alito was equally dismissive of Danco’s argument that, under the 5th Circuit’s order, it could not market mifepristone with its current labeling. That would only be a problem, Alito wrote, if “the FDA elected to use its enforcement discretion to stop Danco,” and there is “no reason to believe the FDA would make that choice.”
