WASHINGTON – The Biden administration on Friday asked the Supreme Court to uphold broad access to a commonly used one medicine abortion pill.
The court filing by the Department of Justice sets the stage for a possible final decision contentious legal fight filed by abortion rights opponents over federal approval of the drug mifepristone. The dispute lands in the Supreme Court in time for the justices to possibly receive it, hear oral arguments and announce a decision by next summer.
In urging the Supreme Court to intervene, Solicitor General Elizabeth Prelogar wrote that the case marks the first time a court has second-guessed the Food and Drug Administration’s “expert judgment” in approving a drug.
If lower court rulings were to be upheld, they would “impose serious harm on the government, mifepristone sponsors, women seeking medication abortions, and the public,” Prelogar added. Among other things, access to the mail-order pill – which was formally approved by the FDA in 2021 – would be curtailed.
Danco – manufacturer of Mifeprex, the branded version of mifepristone – file a similar appeal Friday.
Before making a decision on whether to hear the case, the magistrates will receive a response from the challengers as part of a process that can take months.
The magistrates have already intervened once, back in April, when they fully blocked a decision by Texas US District Judge Matthew Kacsmaryk that had invalidated the FDA’s original approval of the drug from more than 20 years ago. At the time, conservative justices Clarence Thomas and Samuel Alito said they would have allowed part of Kacsmaryk’s ruling to take effect.
Kacsmaryk’s decision threatened access to the pill, including its availability by mail, but the Supreme Court order resulted in it remaining available as usual while the litigation continued.
The challenge has been brought by a group of doctors and other medical professionals represented by the conservative Christian legal group Alliance Defending Freedom. They claim that the FDA’s approval in 2000, as well as later decisions that made the drug more accessible, were flawed in part because they failed to consider safety risks for women. The FDA and Danco say serious adverse effects are “extremely rare.”
Since the Supreme Court ruling in April, the case has moved normally through the appeals process, with the US 5th Circuit Court of Appeals in New Orleans last month maintain a part of Kacsmaryk’s decision on the steps the FDA took to loosen restrictions on the pill, including making it available by mail. That prompted the Biden administration and Danco to once again turn to the high court.
If the justices refuse to take the case, then the 5th Circuit’s decision will go into effect nationwide. This “would disrupt the regulatory regime for mifepristone, with harmful consequences for women seeking legal abortions and a health care system that depends on the drug’s availability under current conditions of use,” Prelogar said.
In that situation, access to the pill would be curtailed in significant ways. Women will no longer receive it by mail – and instead will need to make several trips, in person, to a doctor’s office. A higher dose of the medication will also be required, as the older dosing regimen was changed in 2016.
A White House spokesman said that if the 5th Circuit’s decision goes into effect, “it would have devastating consequences for women and undermine the FDA’s process for regulating safe and effective medicines that patients rely on.”
“The biopharma industry, doctors and medical institutions, former FDA and former DOJ officials, and patient advocates have made it clear: this lawsuit is an unprecedented threat to the FDA’s authority to review and approve a wide range of drugs safe and effective,” said the spokesperson. added up
Although the Supreme Court in 2022 overturned the landmark Roe v. Wade which ensured a constitutional right to abortion and has a 6-3 conservative majority, the mifepristone litigation raises very different legal issues, and the court’s earlier intervention means the challengers could face an uphill battle to prevail.
The FDA-approved regimen for medication abortion includes a combination of two drugs: mifepristone, which blocks the hormone progesterone, and misoprostol, which causes contractions. A majority of abortions in the United States are carried out using those pills, according to a survey led by the Guttmacher Institute, a research group that supports abortion rights. Access to misoprostol was not an issue in the lawsuit.
Lawrence Hurley reported from Washington, Laura Jarrett reported from New York.
This article was originally published on NBCNews.com
