Background

In April 2023, Judge Matthew Kacsmaryk issued a ruling invalidating FDA's approval of mifepristone, arguing that the agency didn't adequately review scientific evidence or follow the proper protocols when it approved the drug in 2000.

In response to Kacsmaryk's ruling, more than 200 pharmaceutical companies signed a statement calling for the reversal of the decision. More than 400 leaders from some of the most prominent companies in the drug and biotech industry criticized Kacsmaryk for issuing the ruling, noting that he has "no scientific training" and warning that the decision has "undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American."

In addition, "[t]he decision ignores decades of scientific evidence and legal precedent," the drugmakers wrote. "Judge Kacsmaryk's act of judicial interference has set a precedent for diminishing FDA's authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry," they wrote.

Later that month, SCOTUS ruled that mifepristone could remain on the market with no new restrictions while the case against FDA's approval of the drug played out, and in March, SCOTUS heard oral arguments in the case.

SCOTUS unanimously rejects challenge to mifepristone

On Thursday, SCOTUS ruled that the plaintiffs in the case, the Alliance for Hippocratic Medicine, lacked legal standing to challenge FDA's decision on mifepristone, meaning the lawsuit will be dismissed and that mifepristone can remain widely available.

Writing for the court, Justice Brett Kavanaugh said that the court recognizes "that many citizens, including the plaintiff doctors here, have sincere concerns about and objections to others using mifepristone and obtaining abortions. But citizens and doctors do not have standing to sue simply because others are allowed to engage in certain activities — at least without the plaintiffs demonstrating how they would be injured by the government's alleged under-regulation of others."

"Under Article III of the Constitution, a plaintiff's desire to make a drug less available for others does not establish standing to sue," Kavanaugh wrote.

The plaintiffs did not show they suffered any injury, meaning that "the federal courts are the wrong forum for addressing the plaintiffs' concerns about FDA's actions," Kavanaugh added.

"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," Kavanaugh wrote in the opinion. "And they may also express their views about abortion and mifepristone to fellow citizens, including in the political and electoral processes."

Reaction

"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" said Abigail Long, a spokeswoman for Danco Laboratories, the manufacturer of mifepristone. "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."

However, Ellie Honig, a legal analyst for CNN, said it's possible the legal dispute over mifepristone could come back in the future.

"This does not mean that the legal dispute over mifepristone is over," Honig said. "It means it's failed for now because this particular group of plaintiffs did not have legal standing."

Honig added that in the future, if someone can establish proper legal standing, they can try to revive the case; however, that could take years to work through the federal courts and back up to the Supreme Court. And while the case could be revived in the future, the court's decision will make it more difficult for other potential plaintiffs, according to Steve Vladeck, a professor at the University of Texas School of Law.

"Today's decision doesn't cut off the possibility of future challenges to mifepristone, including by a handful of red states that were already allowed to intervene in the district court in this case," Vladeck said. "But the reasoning of the case should make those challenges less likely to succeed, because those plaintiffs (and others) will have a hard time showing that they were harmed by the FDA's actions."

Advisory Board's resources on women's health

For more insights into women's health, including maternity care, check out Advisory Board's library of resources.

We have several resources on the top drivers of change in the maternal and reproductive health market, as well as the outlook for women's health service line.

These ready-to-use-slides can help you understand the trends impacting maternal and reproductive care and how they will impact cross-industry stakeholders. We also have research on health plans' top three priorities for maternal care.

To learn more about ways to improve women's health in the United States, this report outlines six key factors to take into consideration, including the roles of various healthcare stakeholders and the importance of cross-industry collaboration.

Advisory Board also has several resources on how to utilize technology in maternity care, including this cheat sheet on telehealth and maternity care and a case study on how digital solutions can improve access to maternity care.

For resources specifically related to abortion, we offer this infographic explaining the potential health outcomes for individuals denied abortions in their state, as well as an expert insight on the groups that are disproportionately impacted by abortion restrictions. This expert insight also explains how leaders can help their clinical workforce amid changing abortion laws. (Hurley, NBC News, 6/13; Sherman, Associated Press, 6/13; Owermohle, STAT, 6/13; Fritze, CNN, 6/13; Chowdhury, CNN, 6/13; Quinn, CBS News, 6/13)