The U.S. Supreme Court on Thursday upheld access to the abortion pill mifepristone, unanimously rejecting a challenge by a group of anti-abortion doctors seeking to undo the FDA’s approval of the drug.
The U.S. Supreme Court on Thursday unanimously rejected a challenge to the FDA’s approach to approving the abortion pill mifepristone, preserving wide access to the drug based on procedural grounds.
Justice Brett Kavanaugh, who penned the court’s opinion, noted that the anti-abortion plaintiffs do not have legal standing to sue the regulator for its loosening of the safety guidelines around the use of mifepristone.
“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,” Kavanaugh wrote, noting that the plaintiffs in this case had failed to convincingly establish a direct causal link.
Kavanaugh also argued that the plaintiff doctors’ argument—that relaxing the safety regulations around mifepristone use could injure their practice by diverting time and resources from other patients—is “highly speculative.”
The doctors failed to provide evidence of such resource and time diversion, according to Kavanaugh, nor did the plaintiffs provide proof that they had been subject to higher costs or legal liability related to mifepristone treatment.
Instead of petitioning the courts, “citizens and doctors who object to what the law allows others to do may always take their concerns to the Executive and Legislative Branches and seek greater regulatory or legislative restrictions on certain activities,” Kavanaugh wrote in the opinion.
In response to the ruling, several pharma players and groups applauded the Supreme Court, noting that the decision helps solidify the FDA’s expertise and authority.
Jim Stansel, executive vice president and general counsel of the trade group Pharmaceutical Research and Manufacturers of America, said in a statement that the court’s ruling “provides innovative biopharmaceutical companies the certainty needed to bring future medicines to patients.”
Abby Long, vice president of marketing and public affairs of Danco Laboratories, one of the petitioners in the lawsuit alongside the FDA, said that by rejecting the plaintiffs’ case against mifepristone the Supreme Court “reaffirmed longstanding basic principles of administrative law.” In doing so, the ruling “maintained the stability of the FDA drug approval process.”
The recent legal tussle over the abortion pill started in November 2022 when the Alliance for Hippocratic Medicine sued the FDA, seeking to withdraw the approval of mifepristone. In April 2023, Texas federal judge Matthew Kacsmaryk issued a preliminary injunction to block the sales of mifepristone, which was only partially blocked by the U.S. 5th Circuit Court of Appeals a few days later.
Thursday’s ruling did not impact the Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization, which eliminated a constitutional right to abortion nationwide. Since then, dozens of states have banned or limited access to the procedure.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
