The anti-abortion doctors who challenged the Food and Drug Administration’s approval of the abortion pill mifepristone lack standing to sue the federal agency, the Supreme Court ruled on Thursday.
The justices unanimously rejected the challenge and dismissed the case, preserving the FDA’s existing approval of the drug.
The opinion, authored by Justice Brett Kavanaugh, says that the plaintiffs advanced “several complicated causation theories to connect FDA’s actions to the plaintiffs’ alleged injuries in fact.” But none of the theories “suffices to establish Article III standing,” which requires the plaintiffs to possess a personal stake in the dispute.
Thursday’s ruling comes two years after the Supreme Court’s 6-3 conservative majority overturned Roe v. Wade. Abortion opponents were clearly disappointed by the new ruling.
“Nothing in today’s decision changes the fact that the FDA’s own label says that roughly one in 25 women who take chemical abortion drugs will end up in the emergency room—a dangerous reality the doctors and medical associations we represent in this case know all too well,” said Erin Hawley, a lawyer with Alliance Defending Freedom, the conservative legal firm that represented the plaintiffs.
“The FDA recklessly leaves women and girls to take these high-risk drugs all alone in their homes or dorm, without requiring the ongoing, in-person care of a doctor,” she said in an email.
In an emailed statement, Ingrid Skop, vice president of the pro-life Charlotte Lozier Institute, called the ruling “deeply disappointing.” Katie Daniel, the state policy director of Susan B. Anthony Pro-Life America said in an emailed statement, “It is a sad day for all who value women’s health and unborn children’s lives, but the fight to stop dangerous mail-order abortion drugs is not over.”
President Joe Biden applauded the decision, but said in a statement that it “does not change the fact that the right for a woman to get the treatment she needs is imperiled if not impossible in many states.”
The case stems from a lawsuit filed in November 2022 by ADF on behalf of the Alliance for Hippocratic Medicine, an organization of pro-life medical groups, as well as four pro-life doctors. The lawsuit claimed that the FDA never had the authority to approve the two-pill chemical-abortion regimen when it did so nearly a quarter century ago.
The FDA approved the use of the abortion-pill regimen under a section of federal code known as Subpart H, which allows for expedited approval of potentially dangerous drugs that can be used to treat “serious or life-threatening illnesses.” ADF argued that the FDA had no business approving the pills under Subpart H because pregnancy is not an illness but is rather a “normal physiological state that many females experience one or more times during their childbearing years.”
The lawsuit also challenged changes the FDA made in 2016 and 2021 that relaxed restrictions on the drug, including increasing the gestational age for which the drug could be used from seven weeks to ten, reducing the number of office visits required to get the drug from three to one, allowing non-doctors to prescribe the pills, and eliminating the requirement for prescribers to report non-fatal adverse events involving the pills.
During the Covid-19 pandemic, the FDA allowed the pills to be delivered through the mail.
Lawyers for the government argued that the drugs are safe and effective, and that the FDA’s 2000 approval process was appropriate. More than half of all abortions in the U.S. are now done using chemical-abortion pills.
In his opinion, Kavanaugh wrote that the anti-abortion plaintiff doctors “have not shown that they could be forced to participate in an abortion or provide abortion-related medical treatment over their conscience objections.” The court also did not agree that the plaintiffs had standing because, as a result of the FDA’s loosened restrictions in 2016 and 2021, they could be forced to divert resources away from other patients to treat patients with mifepristone complications.
“Moreover, the law has never permitted doctors to challenge the government’s loosening of general public safety requirements simply because more individuals might then show up at emergency rooms or in doctors’ offices with follow-on injuries,” the opinion says. “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.”
In her emailed statement, Hawley with ADF said that during arguments before the Supreme Court, lawyers for the government reversed their position on whether federal law would protect the plaintiff doctors from being forced to participate in abortions, in violationon of their conscience rights. “This about-face explains why the Supreme Court parted ways with every other court to consider this case,” she said.
The Supreme Court’s ruling seems to end what had been a winding legal saga.
Last spring, U.S. District Judge Matthew Kacmaryk in Texas ruled in favor of the plaintiffs, suspending the FDA’s approval of mifepristone. But less than a week later, a three-judge panel with the Fifth Circuit Court of Appeals voted to restore access to the drug, finding that the legal challenge appeared to have been filed after the statute of limitations.
In August, the Fifth Circuit ruled that while mifepristone should remain on the market, the FDA went too far when it relaxed restrictions in 2016 and 2021. But that ruling never took effect, because by then the Supreme Court had already issued a full legal stay in the case, preserving access to the drug until all of the appeals were played out.
Some Democratic lawmakers cheered the court’s ruling on Thursday. Congresswoman Ayanna Pressley of Massachusetts said on X that the ruling is a “major relief & victory for anyone who has ever or will ever need essential medication abortion care.”
Senator Elizabeth Warren said the challenge was “meritless from the start,” and that chemical-abortion pills are “safe and effective.”
“Make no mistake: Donald Trump and Republican politicians will not stop marching us toward a nationwide abortion ban,” she said on X. “We must protect reproductive freedom everywhere.”