WASHINGTON — The Biden administration filed an emergency application to the Supreme Court on Friday asking the justices to pause parts of an appeals court ruling that limited the availability of a common abortion pill.
The application, in the first major abortion case to reach the justices since they eliminated the constitutional right to abortion in June, asked the court to allow the pill, mifepristone, to remain widely available while the government pursues an appeal.
The brief was harshly critical of a ruling from a federal judge suspending approval of the drug.
"The district court countermanded a scientific judgment F.D.A. has maintained across five administrations; nullified the approval of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a health care system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies,” the government’s brief said.
On Wednesday night, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit, in New Orleans, issued a mixed decision, staying the most sweeping aspects of a decision from Judge Matthew J. Kacsmaryk that would have wholly overridden the Food and Drug Administration’s approval of the pill.
But the appeals court, in an unsigned order from a divided three-judge panel, temporarily let stand other aspects of Judge Kacsmaryk’s ruling, including by requiring in-person visits with doctors, rolling back the availability of the pills from the first 10 weeks of pregnancy to seven weeks and barring dispensing them by mail.
The panel’s ruling was provisional, and the court put the appeal itself on a fast track.
In the emergency application, Solicitor General Elizabeth B. Prelogar, representing the F.D.A., wrote that the plaintiffs lacked standing to challenge a drug they neither take nor prescribe and that they had provided no basis for second-guessing the agency’s scientific judgment.
Had Judge Kacsmaryk’s ruling fully come into force, it would have even more severely disrupted the availability of mifepristone, part of the most commonly used method for ending pregnancies in the United States.
Understand the U.S. Supreme Court’s Term
A race to the right. After a series of judicial bombshells in June that included eliminating the right to abortion, a Supreme Court dominated by conservatives returned to the bench in October — and there are few signs that the court’s rightward shift is slowing. Here’s a closer look at the term:
Affirmative action. The marquee cases of the term are challenges to the race-conscious admissions programs at Harvard and the University of North Carolina. While the court has repeatedly upheld affirmative-action programs, a six-justice conservative supermajority may put more than 40 years of precedent at risk.
Voting rights. The role race may play in government decision-making also figures in a case that is a challenge under the Voting Rights Act to an Alabama electoral map that a lower court had said diluted the power of Black voters. The case is a major new test of the Voting Rights Act in a court that has gradually limited the law’s reach in other contexts.
Discrimination against gay couples. The justices heard an appeal from a web designer who objects to providing services for same-sex marriages in a case that pits claims of religious freedom against laws banning discrimination based on sexual orientation. The court last considered the issue in 2018 in a similar dispute, but failed to yield a definitive ruling.
Tech companies’ legal shield. The court is reviewing a sweeping law that prevents tech companies such as Facebook and Google from being held responsible for the content posted on their site. The case could have potentially seismic ramifications for social media platforms and alter the very structure of the internet.
Student loan cancellation challenges. The justices heard arguments about President Biden’s plan to forgive an estimated $400 billion in federal student loan debt. Conservative states have called the plan an abuse of executive authority. The court is exploring whether the states are even entitled to sue.
The case was brought by several doctors and medical groups, including the Alliance for Hippocratic Medicine, which was incorporated in August in Amarillo, Texas, where the case was filed. Judge Kacsmaryk, a Trump appointee who is a longtime opponent of abortion, is the only federal judge in the Amarillo division in the U.S. District Court of the Northern District of Texas.
The appeals court majority wrote that the statute of limitations appeared to bar a challenge to the F.D.A.’s initial approval of the pill in 2000. But it said that later expansions of access to the pill were properly before the judge and that there were authentic safety concerns warranting suspension of regulations making it easier to obtain the pills.
The majority added that the plaintiffs appeared to have standing to sue because they might have to treat complications from the use of the pill.
Two judges in the majority on the appeals court panel, Kurt D. Engelhardt and Andrew Oldham, are appointees of President Donald J. Trump. The third judge on the appeals court panel who was effectively in dissent, Catharina Haynes, was appointed by President George W. Bush.
Ms. Prelogar, representing the agency, responded that the plaintiffs could not show that they had experienced the sort of direct and concrete injury that would give them standing to sue. Rather, she wrote, they relied on implausible speculation.
“They neither take nor prescribe mifepristone, and F.D.A.’s approval of the drug does not require them to do or refrain from doing anything,” she wrote. “Yet the Fifth Circuit held that the associations have standing because some of their members might be asked to treat women who are prescribed mifepristone by other providers and who then suffer an exceedingly rare adverse event.”
In a second brief, filed by Danco Laboratories, which makes the branded version of mifepristone, called Mifeprex, the company’s lawyers said the appeals court’s ruling had created “regulatory chaos.”
“Leaving the Fifth Circuit’s ruling in place will irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations,” the company’s brief said. “The lack of emergency relief from this court will also harm women, the health care system, the pharmaceutical industry, states’ sovereignty interests and the separation of powers.”
Judge Kacsmaryk once worked for First Liberty Institute, which says it is the largest legal organization in the nation focused exclusively on defending religious freedom. Democrats voted against confirming him to the bench in 2019 because of his history of opposing L.G.B.T.Q. rights.
In his ruling, Judge Kacsmaryk adopted the language of abortion opponents, referring to abortion providers as “abortionists,” to the challenged procedure as “chemical abortion” and to the fetus as an “unborn human” or “unborn child.” Legal scholars said the judge had relied on questionable scientific studies.
The case has returned the Supreme Court to an issue it not long ago said it was ceding to elected officials in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade, the 1973 decision that established a constitutional right to abortion. Writing for the majority, Justice Samuel A. Alito Jr. wrote that the political branches, rather than the courts, should set abortion policy.
The Dobbs decision concerned the Constitution, while Judge Kacsmaryk’s ruling mostly turned on principles of administrative law. But the new case demonstrated that legal disputes over abortion will continue to engage the justices.
Are Abortion Pills Safe? Here’s the Evidence.
The Times reviewed 101 studies of medication abortion, spanning continents and decades. All concluded that the pills are a safe method for terminating a pregnancy.
The stakes are high. More than five million women have used mifepristone to terminate their pregnancies in the United States, and many studies have found it to be safe and effective. The drug is also approved for use in dozens of other countries.
In the United States, the protocol typically involves mifepristone in combination with a second drug, misoprostol, that are used in the first 10 weeks of pregnancy. About 60 percent of abortions in that time employ the two drugs rather than surgery.
More on the U.S. Supreme Court
The first drug blocks the effects of progesterone, a hormone without which the lining of the uterus begins to break down. The second one, taken 24 to 48 hours later, induces contractions of the uterus that expel its contents.
If access to mifepristone is limited, abortion providers may rely solely on misoprostol, which can be used on its own but is somewhat less effective and more prone to cause side effects.
The appeals court’s order is in conflict with ones issued by a federal judge in Washington State in another lawsuit related to mifepristone. That lawsuit, filed against the F.D.A. by Democratic attorneys general from 17 states and the District of Columbia, challenged extra restrictions that the agency imposes on mifepristone and asked the judge to prevent it from limiting access to the drug.
Judge Thomas O. Rice of the U.S. District Court for the Eastern District of Washington, an Obama appointee, did not lift the additional restrictions but ordered the F.D.A. to maintain the status quo. He blocked the agency from curbing the availability of mifepristone in the states that filed the lawsuit.
Lawyers for Danco wrote that the dueling orders put it “in an impossible position.”
The F.D.A., they wrote, “cannot permit Danco to simultaneously operate two separate distribution networks for two different parts of the country; that simply is not how the federal regulation of pharmaceuticals works.”
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