EMERGENCY DOCKET

Federal government and drug manufacturer ask court to review ruling restricting access to abortion medication

The Biden administration and a drug manufacturer on Friday night asked the Supreme Court to review a decision by a federal appeals court that would significantly restrict access to a drug used in medication abortions, which account for over half of all abortions performed in the United States. The filings created the prospect that the justices will weigh in on the issue of abortion for the first time since their decision last year in Dobbs v. Jackson Women’s Health Organization, overruling the constitutional right to an abortion. If the justices take up the case, they could hear oral argument early next year and issue a decision by late June – in the middle of the 2024 presidential election.

The petitions from the Biden administration and the drug manufacturer Danco came four-and-a-half months after the court issued a temporary order that allows the drug to remain widely available until the dispute is resolved – so that the U.S Court of Appeals for the 5th Circuit’s Aug. 16 ruling did not have an immediate effect.

The drug at the center of the case, mifepristone, is part of a two-drug protocol used to end pregnancies in their early stages. The FDA initially approved the drug in 2000, and in 2016 and 2021 it made several changes to the conditions on the use of the drug – allowing the drug to be used through the 10th week of pregnancy, rather than only through the 7th week, allowing health-care providers who are not physicians to prescribe the drugs, and allowing the drug to be prescribed through telehealth appointments and sent through the mail.

A group of doctors and medical groups opposed to abortion challenged the FDA’s approval of the drug last year, arguing that the drug regimen was “unsafe.”

U.S. District Judge Matthew Kacsmaryk, who has issued a number of conservative rulings since he was appointed to the bench by President Donald Trump in 2017, found that the FDA had approved the drug despite “legitimate safety concerns.” He suspended both the FDA’s approval of the drug and the later changes to the conditions on the use of the drug.

After the 5th Circuit put only part of Kacsmaryk’s order on hold, the Biden administration and Danco went to the Supreme Court, asking the justices to freeze the entire order to maintain the status quo until the dispute is resolved. The justices agreed to do so in a brief unsigned order on April 21, with two justices – Justices Clarence Thomas and Samuel Alito – indicating that they would have denied the request.

The case then went back to the 5th Circuit, which heard oral argument in May. In a 62-page decision issued last month, the court of appeals ruled that the doctors and medical groups had brought their challenge to the FDA’s initial 2000 approval of mifepristone too late, and it left the agency’s 2019 approval of generic mifepristone in place. But the court of appeals agreed with Kacsmaryk that the FDA’s 2016 and 2021 actions increasing access to the drug, such as allowing it to be used later in pregnancy and allowing it to be prescribed through telehealth appointments, should be put on hold.

The Biden administration and Danco appealed to the Supreme Court three weeks later. U.S. Solicitor General Elizabeth Prelogar, representing the federal government, emphasized that the FDA’s original approval had rested on the agency’s “scientific judgment that the drug is safe and effective,” and that the agency had “modified the original conditions of approval as decades of experience have further confirmed the drug’s safety.” She told the justices that allowing the ruling by the 5th Circuit to stand would have “damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use.” But more broadly, she noted, it was “the first time any court has restricted access to an FDA-restricted drug based on disagreement with FDA’s expert judgment about the conditions required to assure that drug’s safe use—much less done so after those conditions had been in effect for years.”

In its own filing, Danco told the justices that the core question in the case was “whether courts can disregard constitutional and statutory limits on judicial review of executive action in order to overrule an agency decision they dislike.” Echoing the Biden administration’s arguments, it argued that for “the women and teenage girls, health care providers, and States that depend on FDA’s actions to ensure safe and effective reproductive health care is available, this case matters tremendously.” And Danco cautioned that “for the pharmaceutical and biotechnology industry, permitting judicial second-guessing of FDA’s scientific evaluations of data will have a wildly destabilizing effect.”

The challengers have 30 days to respond to the petitions for review filed on Friday, although they may seek an additional 30-day extension. In any event, the justices are likely to announce this fall whether they will take up the case.

This article was originally published at Howe on the Court.