The Supreme Court unanimously ruled in FDA v. Alliance for Hippocratic Medicine that the plaintiffs lacked a legal right to challenge the federal health agency’s actions regarding the approval of abortion pill mifepristone.
In a 9-0 decision handed down Thursday morning, the court ruled that while the plaintiffs had “sincere legal, moral, ideological, and policy objections” to elective abortion and the FDA’s relaxed regulation of mifepristone, those objections alone did not established a justiciable case or controversy under Article III of the Constitution.
“Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions,” Justice Brett Kavanaugh wrote in the unanimous order. Justice Clarence Thomas wrote a concurring opinion.
The Supreme Court added that the Alliance for Hippocratic Medicine may present their concerns and objections to the president or the FDA through the regulatory process, or to Congress or the president through the legislative process.
The Alliance for Hippocratic Medicine expressed its disappointment in a press release shortly after the ruling was issued.
“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,” the organization stated. “The FDA recklessly leaves women and girls to take these high-risk drugs all alone in their homes or dorm rooms, without requiring the ongoing, in-person care of a doctor.”
Timeline of mifepristone case
This legal saga began in more than two decades ago, when the FDA approved mifepristone in 2000.
More than 15 years later, the agency expanded the approved time period for use of the pill from seven to 10 weeks of pregnancy.
Spurred on by the COVID-19 pandemic, the FDA removed in-person dispensing requirements in 2021, which allowed patients to access the pill via telemedicine and mail.
However, following the Dobbs decision in 2022, anti-abortion groups took aim at access to mailed abortion pills and challenged the grounds for mifepristone’s approval.
In April 2023, Judge Matthew Kacsmaryk of the Northern District of Texas issued a preliminary ruling in the case that would become known as Alliance for Hippocratic Medicine v. FDA and invalidated the agency’s approval of mifepristone.
Kacsmaryk was presented with oral arguments asserted the FDA’s original approval of the pill was unlawful and ignored evidence that the medication was unsafe in subsequent reviews.
“The Court does not second-guess FDA’s decision-making lightly,” he wrote in his ruling. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
In response to Kacsmaryk’s decision, the Department of Justice, FDA and Danco Laboratories, which manufactures the drug, filed notices of appeal with the Fifth Circuit Court of Appeals.
However, at the time, Judge Thomas O. Rice of the Eastern District of Washington, ordered U.S. authorities to not make any changes that would hinder access to mifepristone in 17 Democratic-led states that sued over the issue.
Months later, Fifth Circuit Court vacated the District Court’s earlier ruling in part, signaling that the FDA’s approval of mifepristone would remain in effect.
Ultimately, in December, the Supreme Court agreed to review the lower court decision. Oral arguments were held in late March, where the justices appeared openly skeptical to the plaintiff’s arguments.
“We’ve had, one might call it, a rash of universal injunctions,” Justice Neil Gorsuch said in the hearing. “And this case seems like a prime example of turning a lawsuit into a nationwide legislative assembly on an FDA rule or any other federal government action.”
Closely followed by pharma
The case was much-followed by reproductive rights advocates as a bellwether test for post-Roe America given that the pill was used for about 63% of all abortions last year.
The case was also closely watched by the pharma industry as well since the regulatory authority of the FDA was called into question in court.
In April 2023, Pfizer CEO Albert Bourla signed a pharma industry letter supporting the FDA’s authority to regulate medicine.
Several prominent pharma and biotech leaders also signed the letter, including Nkarta Therapeutics CEO Paul Hastings, Biogen President Alisha Alaimo, Merck executive Christopher Tan and Jazz Pharmaceuticals COO Daniel Swisher, among others.
At the time, PhRMA also offered its thoughts on the situation, calling the FDA the “gold standard for determining whether a medicine is safe and effective for people to use.”
In an amicus brief submitted to the Supreme Court ahead of oral arguments this spring, drugmakers reiterated their support of the FDA, noting that the Fifth Circuit’s decision in this case “radically alters the new drug application (NDA) process through which drug applicants seek and maintain FDA approval of pharmaceutical products for sale and marketing, destabilizing the drug development and investment landscape and depriving patients of the benefits of scientific advancement.”
Reactions pour in
In the hours after the ruling came out, reactions poured in from the Biden administration cheering on the unanimous decision.
“The Justice Department is gratified that today’s unanimous decision in FDA v. Alliance for Hippocratic Medicine ensures that mifepristone remains available for women across the country on the terms approved by the FDA,” Attorney General Merrick Garland said in a statement.
Health and Human Services Secretary Xavier Becerra applauded the decision but noted how it comes amid a larger challenge to easy access of women’s health services.
“Today, this critical medication remains approved and available,” he stated. “But let’s be clear: women’s health remains under attack. The overturning of Roe v. Wade paved the way for attacks on reproductive rights and women’s ability to make their own decisions about abortion, birth control, and IVF.”
Additionally, the American Medical Association cheered the decision and continued access to mifepristone.
Reproductive health advocates also welcomed the ruling while noting that this is a development in a larger legal and legislative battle.
“Today, the Supreme Court did the bare minimum by rejecting this case on standing and allowing mifepristone to remain FDA approved and without new restrictions. However, with the case returning to the district court, the fight is not over,” Planned Parenthood CEO Alexis McGill Johnson said in a statement.
Kristin Rowe-Finkbeiner, CEO of MomsRising, added that the Supreme Court “rightly and decisively” rejected an “outrageous attempt by anti-abortion extremists to take away” access to mifepristone.
This story has been updated.