On June 13, 2024, the US Supreme Court handed the Biden Administration, reproductive health advocates, and the US Food and Drug Administration (FDA) an important win. The Court鈥檚 unanimous opinion allowed mifepristone, one of 2 drugs approved by the FDA in a regimen for medication abortion, to remain widely available in the United States.¹ This case was one of the most anticipated of this term, particularly as roughly 63% of abortions are now facilitated with the use of mifepristone.² In its ruling, the Court let stand scientific decisions of the FDA to expand access to mifepristone without the reimposition of onerous requirements that had been in place prior to 2016.

Yet the Court鈥檚 ruling should not be misinterpreted as revisiting its position on abortion rights or charting a pathway toward a reversal of its 2022 ruling in Dobbs v Jackson Women鈥檚 Health Organization,³ which overturned Roe v Wade.⁴ To the contrary, the Court issued a narrow technical ruling to address a procedural question鈥攏ot the substance of abortion rights. Indeed, challenges to mifepristone are far from over. As the Court itself suggested, other avenues are available to antiabortion advocates, including appealing to state legislatures.

The origins of this case began shortly after the Supreme Court overturned Roe on June 24, 2022. In 2000, the FDA approved mifepristone for use in the termination of pregnancies after a multiyear review and findings that the drug is safe and effective. Nevertheless, the Alliance for Hippocratic Medicine (AHM)鈥攖he litigants who challenged the FDA鈥檚 approval of mifepristone鈥攃hose to incorporate in Amarillo, Texas, 2 months after the Dobbs ruling, with the explicit goal of eliminating access to mifepristone nationwide. Incorporation in Amarillo provided a key advantage: it allowed the antiabortion organization to file its lawsuit in the Northern District Court of Texas before Judge Matthew Kacsmaryk, the lone federal judge in Amarillo鈥攁 practice known as judicial shopping. For AHM, bringing this case before Judge Kacsmaryk was particularly important, given his outspoken views against reproductive rights that predated his judicial nomination by President Trump and confirmation to the district court.

On April 7, 2023, Judge Kacsmaryk issued a stunning, far-reaching opinion that effectively banned mifepristone throughout the United States.⁵ On appeal, while the Fifth Circuit reversed Judge Kacsmaryk鈥檚 decision to overturn the approval of mifepristone, it nevertheless reinstated restrictions, known as risk evaluation and mitigation strategies, which had been lifted by the FDA after its careful review of years of medical and scientific evidence. In that review process, the FDA concluded that the restrictions on mifepristone were medically unnecessary. Among other things, the Fifth Circuit reimposed restrictions on access to the drug, including physician-only prescribing requirements, mandating in-clinic administration of mifepristone (thus prohibiting the use of telemedicine), and reducing the approved indication from 70 days鈥� gestation to 49 days鈥� gestation.⁶

The manufacturer of mifepristone joined the litigation to defend the FDA鈥檚 actions, while hundreds of other pharmaceuticals manufacturers came forward to express their alarm. The pharmaceutical industry recognized the threat to prescription drugs if litigants could second-guess the agency鈥檚 scientific determinations.

As many health law scholars expected, the unanimous opinion, authored by Justice Brett Kavanaugh, rested on standing, allowing the Court to bypass any substantive discussion on the right to abortion or the authority of the FDA to remove certain restrictions initially imposed on mifepristone. The Court held that the plaintiffs did not meet the basic requirements to bring the case鈥攏amely, the plaintiffs failed to demonstrate a cognizable injury or harm that they experienced by mifepristone being in the market place. For example, the plaintiff physicians do not prescribe or use mifepristone, nor are they required to. According to the Court, 鈥渁 plaintiff鈥檚 desire to make a drug less available for others does not establish standing to sue.鈥�

Notably, the Court reiterated several arguments made on behalf of the FDA during oral arguments. First, the Court noted that federal conscience laws protect physicians from being required to perform abortions or other care that violates their consciences. Second, the Court stated that none of the plaintiffs had identified any situations in which they were required to provide care after raising a conscience objection. Third, the Court also rejected the plaintiffs鈥� arguments about downstream economic injuries that may result from diverting time and resources to care for patients who present with mifepristone complications. According to the Court, 鈥渢he law has never permitted doctors to challenge the government鈥檚 loosening of general public safety requirements simply because more individuals might then show up鈥� for medical care. To decide otherwise would be to lead courts down an 鈥渦ncharted path鈥� that 鈥渨ould seemingly not end until virtually every citizen had standing to challenge virtually every government action they do not like.鈥� In other words, if the Court had allowed AHM to sue the FDA, it could open the litigation floodgates against other controversial medications.

This case must be read with caution and contemplation about future strategies to attack science, undermine FDA authority, and constrain abortion rights. Looming battles remain in the fight to protect women鈥檚 health care access. We offer 4 clear reasons for our restraint and concerns that remain after this Supreme Court ruling.

First, a ruling on standing simply means that these particular plaintiffs lacked the legal requirements to sue. Thus, another better-suited group could bring a similar case. In the Court鈥檚 own language, 鈥渋t is not clear that no one else would have standing to challenge FDA鈥檚 relaxed regulation of mifepristone.鈥� Indeed, several conservative states have expressed an interest in restricting access to mifepristone.

Second, the ruling does nothing to curtail the many restrictions and bans on abortion at the state level. This includes strategies like in Louisiana, which recently reclassed mifepristone and misoprostol as Schedule IV drugs under their Uniform Controlled Dangerous Substances Law. Violation of the law could result in criminal punishment, including 10 years of incarceration.

Third, this case鈥檚 retrenchment of conscience laws is problematic, especially given another abortion case on the Supreme Court鈥檚 docket this term involving the Emergency Medical Treatment and Labor Act (EMTALA). Justice Kavanaugh underscored our concern, stating that 鈥淓MTALA does not require doctors to perform abortions or provide abortion-related medical treatment over their conscience objections.鈥� This would have a major adverse effect on health care provided to pregnant individuals in emergency situations.

And last, although the opinion does not mention the Comstock Act鈥攖he 1873 law that bans obscene, lewd, and lascivious materials from being transported in the mail or through courier services鈥擩ustices Thomas and Alito made frequent reference to the law during oral arguments. Even though this law has been dormant for decades, antiabortion groups view it as a pathway to banning the transportation of mifepristone across state lines and through the mail. We find the Justices鈥� questions about Comstock applying to abortion-related care worrying and a cause for alarm, especially because Comstock was not a question the Court was asked to address in this case. We predict that antiabortion advocates will attempt to revive the Comstock Act to further undermine abortion rights.

Thus, while the Supreme Court鈥檚 decision offers relief to women who seek abortions and vindication for the FDA and the manufacturer of mifepristone, we approach this moment with caution and concern, particularly as we anticipate the further deployment of strategies that will undermine women鈥檚 health and chill the ability of physicians to provide care to their patients.⁷

Corresponding Author: Lawrence O. Gostin, JD, O鈥橬eill Institute for National and Global Health Law, Georgetown University Law Center, 600 New Jersey Ave, NW, Washington, DC 20001 (gostin@georgetown.edu).

Published Online: June 24, 2024. doi:10.1001/jama.2024.13161

Conflict of Interest Disclosures: None reported.