The Supreme Court has unanimously rejected an attempt by doctors and anti-abortion groups to limit the use of the abortion pill mifepristone.
The Court on Thursday held that the plaintiffs failed to prove they would be injured by FDA label revisions that have broadened access to mifepristone. The ruling marks a win for the FDA and pharmaceutical industry, who have argued that siding with plaintiffs would upend the current drug approval process and allow courts to challenge the agency’s scientific expertise.
“We are pleased that FDA’s authority to review and approve new medicines for patients has been preserved,” industry group BIO told Endpoints News. “Regulatory certainty is critical to ensuring that vital research can make it from the lab bench to a patient’s bedside.”
Mifepristone has been on the market for decades and has been taken by millions of women. In 2016 and 2021, the FDA made changes that have allowed the drug to be distributed by mail, lowered the requirement for in-person clinical visits, and extended how late into pregnancy a patient may take it, from seven weeks to 10 weeks.
Pro-life doctors argued in court that those updates could force them to provide abortion-related care to patients against their conscience. Plaintiffs also argued that the label changes could divert resources or time away from other patients to treat mifepristone patients. The Fifth Circuit Court of Appeals sided with plaintiffs in August, affirming plaintiffs’ standing.
But the Supreme Court rejected those arguments, saying they were “too speculative or otherwise too attenuated to establish standing.” Justice Brett Kavanaugh wrote in the opinion that “the law has never permitted doctors to challenge the government’s loosening of general public safety requirements simply because more individuals might then show up at emergency rooms or in doctors’ offices with follow-on injuries.”
“A federal agency increases a speed limit from 65 to 80 miles per hour — does an emergency room doctor have standing to sue because he may have to treat more car accident victims?” the Court’s opinion reads. “The answer is no.”
Danco Laboratories, which manufactures the brand-name Mifeprex, previously said in court documents that fewer than one-tenth of the 2.5 million women who’ve taken mifepristone since 2015 have experienced side effects, and “only 0.035% had been hospitalized.”
“By rejecting the Fifth Circuit’s radical, unprecedented and unsupportable interpretation of who has standing to sue, the justices reaffirmed longstanding basic principles of administrative law,” Danco spokesperson Abigail Long said in a statement. “In doing so, they maintained the stability of the FDA drug approval process, which is based on the agency’s expertise and on which patients, healthcare providers and the US pharmaceutical industry rely.”
Maintaining FDA’s decision-making authority
A number of industry groups, former FDA officials, members of Congress and others have advocated over the last year to keep the FDA’s revisions to mifepristone’s label. In “friend of the court” briefs, they argued that the Fifth Circuit’s ruling was an overstep and that scientific judgments should be left to the FDA. Former FDA officials also expressed concern that upholding the Fifth Circuit’s decision would open the door to “constant legal challenges of drug approval decisions.”
FDA Commissioner Rob Califf said Thursday that the agency is “pleased” with the Supreme Court’s decision in a post on X, formerly Twitter. The FDA declined to comment further.
“This is a terrific outcome. It has broader implications as it upholds FDA approval and the related rigorous process as the standard for drug approvals,” Daphne Zohar, the CEO of Seaport Therapeutics and BIO board member, told Endpoints via email. “It would have been a dangerous precedent to usurp the autonomy of FDA which relies on rigorous science and clinical data.”
House Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ) hailed the decision as a “victory for science-based decision-making” in a statement on Thursday.
“We are pleased to see today’s decision from the US Supreme Court which helps provide innovative biopharmaceutical companies the certainty needed to bring future medicines to patients,” the pharma industry’s DC-based lobbying group PhRMA told Endpoints.
‘The wrong forum’
Kavanaugh added on Thursday that the “courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
“The plaintiffs may present their concerns and objections to the President and FDA in the regulatory process, or to Congress and the President in the legislative process. And they may also express their views about abortion and mifepristone to fellow citizens, including in the political and electoral processes,” the opinion reads.
President Joe Biden commended the decision in an announcement on Thursday, but added that “it does not change the fact that the fight for reproductive freedom continues.”
“It does mean that mifepristone, or medication abortion, remains available and approved. Women can continue to access this medication — approved by the FDA as safe and effective more than 20 years ago,” Biden said.
The American Association of Pro-Life Obstetricians and Gynecologists, which was named as a plaintiff in the case, criticized the decision in a statement.
“As an organization dedicated to serving both our maternal and pre-born patients, we are deeply alarmed that the FDA’s recklessness is permitted to continue unchecked, risking the lives and health of women across this country,” AAPLOG CEO Christina Francis said.
Zachary Brennan contributed reporting.