SCOTUS Maintains Abortion Pill Access, Pharma Industry Praises Ruling

The U.S. Supreme Court unanimously dismissed a legal challenge to the FDA's approval process for the abortion pill mifepristone on Thursday, thus maintaining broad access to the drug. The court's decision, penned by Justice Brett Kavanaugh, centered on procedural grounds, particularly the issue of legal standing.

Justice Kavanaugh emphasized that the anti-abortion plaintiffs lacked the legal standing required to sue the FDA over its relaxed safety guidelines for mifepristone. Kavanaugh stated that citizens and doctors cannot simply sue because others are permitted to engage in particular activities unless they can demonstrate a direct injury caused by the government's alleged under-regulation. In this case, he noted, the plaintiffs failed to show a direct causal link.

Furthermore, Kavanaugh described the plaintiffs' argument—that looser safety regulations around mifepristone could harm their medical practice by diverting time and resources from other patients—as "highly speculative." The plaintiffs did not provide evidence to support claims of resource and time diversion, nor did they show that they faced increased costs or legal liabilities related to mifepristone treatment.

Kavanaugh suggested that those opposing the FDA’s regulations should seek recourse through the Executive and Legislative branches rather than the courts. Citizens and doctors may petition for greater regulatory or legislative restrictions on certain activities if they object to what current law permits.

Following the verdict, various pharmaceutical industry stakeholders expressed approval, highlighting the decision's support for the FDA's authority and expertise. Jim Stansel, executive vice president and general counsel of the Pharmaceutical Research and Manufacturers of America, remarked that the court's ruling provides pharmaceutical companies with the certainty needed to continue developing future medications.

Abby Long, vice president of marketing and public affairs at Danco Laboratories—a petitioner in the lawsuit alongside the FDA—stated that the Supreme Court's decision reaffirms fundamental principles of administrative law and preserves the stability of the FDA's drug approval process.

The legal conflict over mifepristone began in November 2022 when the Alliance for Hippocratic Medicine sued the FDA, seeking to revoke the drug's approval. In April 2023, Texas federal judge Matthew Kacsmaryk issued a preliminary injunction to block the sale of mifepristone, which was partially stayed by the U.S. 5th Circuit Court of Appeals shortly thereafter.

This ruling did not alter the Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization, which rescinded the constitutional right to abortion across the United States. Since that decision, multiple states have either banned or severely restricted access to abortion services.