On Thursday, the Supreme Court just handed down its most important ruling on reproductive rights since it overturned the 2022 Roe v. Wade, the historic decision that protected the national right to abort. The court upheld the U.S. Food and Drug Administration’s approval of the abortion pill mifepristone.
In a 9-0 decision in FDA v. Alliance for Hippocratic Medicine, the judges determined that the plaintiffs in a lawsuit seeking to remove the drug from the market lacked standing, that is, they did not have the right to take the case to court. “
The plaintiffs do not prescribe or use mifepristone. And the FDA doesn’t require them to do or refrain from doing anything. Rather, plaintiffs want the FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain,” Judge Kavanaugh writes in the decision. “A plaintiff’s desire to make a drug less available to others does not establish standing to sue. The plaintiffs’ other current theories are not sufficient either. Therefore, plaintiffs lack standing to challenge the FDA’s actions.”
The Supreme Court’s decision ends a tangle of legal disputes in lower courts that has caused widespread confusion over the legal status of mifepristone. It means that the drug will remain legal for use in states that allow abortion and can continue to be distributed by mail.
Medical experts and health care providers applauded the court’s decision.
“Mifepristone is safe, effective, and a crucial part of expanding abortion access in this post-Roe world,” says Kiki Freedman, CEO and co-founder of abortion telehealth provider HeyJane, adding that the company will continue to offer services based on in evidence, compassionate medical abortion care.
Mifepristone was first approved by the FDA in 2000. It is used in combination with a second pill, misoprostol, to induce an abortion within the first 10 weeks of pregnancy. It works by blocking a hormone called progesterone that is necessary for pregnancy to continue, while misoprostol causes uterine contractions. In the United States, pills are now more common than abortion procedures and will account for more than six in 10 abortions by 2023, according to the Guttmacher Institute.
Despite mifepristone’s established safety record, a group of anti-abortion activists and doctors known as the Alliance for Hippocratic Medicine filed a lawsuit in November 2022 seeking to overturn the FDA’s approval of the drug, claiming it is too dangerous for be in the market. In the lawsuit, the alliance argued that mifepristone has caused an increase in emergency room visits, citing a 2021 study that was retracted earlier this year after an independent review found its authors reached inaccurate conclusions.
In April 2023, Judge Matthew Kacsmaryk of the Northern District of Texas sided with the alliance and vacated the FDA’s approval of mifepristone, effectively instituting a nationwide ban on the drug’s use. The ruling caused a stir, as it showed that courts could revoke a drug’s approval and nullify the FDA’s expertise.
