The Supreme Court on Thursday threw out a lawsuit seeking to roll back access to mifepristone, a drug widely used in medication abortions. In a unanimous decision, the court ruled that the doctors and medical groups challenging the FDA’s expanded access to the drug in 2016 and 2021 lack the legal standing required to sue.
Writing for the court, Justice Brett Kavanaugh recognized the challengers’ “sincere legal, moral, ideological, and policy objections” to elective abortion and the relaxed regulation of mifepristone by the FDA. However, Kavanaugh stated the challengers had not demonstrated that they would be directly harmed by the FDA’s policies. He suggested that the proper avenue for such objections is within the political or regulatory arenas (SCOTUSblog).
This ruling ensures that mifepristone will continue to remain broadly available in the United States, where it is utilized in over 60% of medication abortions. Nevertheless, this decision does not preclude future challenges to the FDA’s actions. Earlier this year, Idaho, Missouri, and Kansas, states with Republican attorneys general, joined the dispute in the lower courts.
The decision follows less than two years after the Supreme Court’s 2022 ruling in Dobbs v. Jackson Women’s Health Organization, which eliminated the constitutional right to abortion. Post-Dobbs, 21 states have either banned or severely restricted access to abortion.
This current case began when several doctors and medical groups opposed to abortion on religious or moral grounds filed a lawsuit in federal court in Texas. They contended that mifepristone is unsafe and that the FDA’s approval process was flawed. They sought to reverse the FDA’s approval of mifepristone in 2000 and its expanded access decisions in 2016 and 2021.
In response, the FDA and prominent medical bodies, including the American College of Obstetricians and Gynecologists and the American Medical Association, presented extensive evidence of mifepristone’s safety and efficacy. Despite this, U.S. District Judge Matthew Kacsmaryk suspended the FDA’s approval and conditions allowing the expanded use of mifepristone. This suspension included provisions allowing the drug to be used through the 10th week of pregnancy, prescribing by non-physicians, and dispensing without an in-person visit.
The FDA and Danco Laboratories, which manufactures mifepristone, appealed to the U.S. Court of Appeals for the 5th Circuit. The 5th Circuit ruled that the challengers’ attempt to invalidate the FDA’s initial approval of the drug was untimely but upheld the rolling back of the expanded access.
Subsequently, the Supreme Court stayed the 5th Circuit’s ruling, maintaining continued access to the drug, and agreed to review the case in December. On Thursday, the Supreme Court reversed the lower court’s ruling and remanded the case for further proceedings.
Justice Kavanaugh’s opinion dismissed the challengers’ claims that the FDA’s relaxed regulation of mifepristone would require them to provide emergency treatment for complications. Federal law protects doctors from performing abortions or treatments violating their consciences. Kavanaugh also rejected the notion that potential increases in insurance costs and resource diversion due to treating complications established sufficient standing.
Finally, Kavanaugh addressed the issue of standing, arguing that even if no other party has standing to challenge the FDA’s actions, it does not justify granting standing to the current challengers. Some issues, he concludes, are better left to political and democratic processes rather than federal court litigation (Howe on the Court).