Supreme Court dismisses challenge to abortion drug mifepristone in unanimous ruling

Court writes that 'plaintiffs lack Article III standing to challenge FDA's actions'

Mifepristone, the first medication in a medical abortion, is prepared for a patient at Alamo Women's Clinic in Carbondale, Illinois, U.S., April 20, 2023. The U.S. Supreme Court dismissed a challenge to the rules for availability for the abortion drug mifepristone in a unanimous decision June 13. (OSV News photo/Evelyn Hockstein, Reuters) (Courtesy photo of EVELYN HOCKSTEIN)

WASHINGTON (OSV News) -- The Supreme Court June 13 unanimously dismissed a challenge to mifepristone, a pill commonly used for abortion, finding that the challengers lacked standing to bring the case.

In a unanimous opinion written by Justice Brett Kavanaugh, the court found in FDA v. Alliance for Hippocratic Medicine that the "plaintiffs lack Article III standing to challenge FDA's actions regarding the regulation of mifepristone."

"Plaintiffs are pro-life, oppose elective abortion, and have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others," Kavanaugh wrote. "Because plaintiffs do not prescribe or use mifepristone, plaintiffs are unregulated parties who seek to challenge FDA's regulation of others."

"Plaintiffs advance several complicated causation theories to connect FDA's actions to the plaintiffs' alleged injuries in fact. None of these theories suffices to establish Article III standing," he added.

The ruling was not unexpected, as during March oral arguments in the case, justices from across the court's ideological spectrum appeared skeptical that the coalition of pro-life doctors challenging the reduced regulations had legal standing to bring the lawsuit, with the question of standing becoming more of a focus than whether the FDA acted lawfully.

A coalition of pro-life opponents of mifepristone, which is the first of two drugs used in a medication or chemical abortion, filed suit over loosened restrictions on the drug by the Food and Drug Administration, which included making it available by mail, arguing the government violated its own safety standards in doing so.

The FDA argued the drug poses statistically little risk to the mother in the early weeks of pregnancy.

"Today's Court ruling on procedural grounds will continue to put the health of women and girls at risk," Chieko Noguchi, spokesperson for the U.S. Conference of Catholic Bishops, said in a statement, adding that as the USCCB's pro-life chair, Bishop Michael F. Burbidge of Arlington, Virginia, has stated, "Abortion is not health care." "The Church will continue to advocate for women's health and safety, and to lovingly serve mothers in need," she added.

Bishop Burbidge told OSV News in an interview June 13 that the ruling was "procedural" and "really didn't rule on the merit of the case or the substance."

Still, "it's disappointing because, again, what it does is it makes this abortion pill even more accessible and available," he told OSV News. "And we know the horrific damage it does to life itself and even to women."

Bishop Burbidge, who along with USCCB's president, Archbishop Timothy P. Broglio of the U.S. Archdiocese for the Military Services, led a nationwide novena for life in March in anticipation of the case's oral arguments, said the church will continue to pray for life and will continue to "educate the communities about the dangers of this pill and its devastating effects."

President Joe Biden said in a statement, "Today's decision does not change the fact that the fight for reproductive freedom continues. It does not change the fact that the Supreme Court overturned Roe v. Wade two years ago, and women lost a fundamental freedom. 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."

"It does mean that mifepristone, or medication abortion, remains available and approved. Women can continue to access this medication -- approved by the FDA as safe and effective more than 20 years ago," he said.

Erin Hawley, senior counsel at Alliance Defending Freedom and vice president of the ADF Center for Life and Regulatory Practice, who had argued on behalf of the pro-life organizations before the court, told reporters on a press call June 13 that the ruling was a "based on a legal technicality," and "ADF and our clients will continue to advocate for women's health and seek to restore common sense safeguards for abortion drugs."

Hawley indicated that other challenges to the FDA's approval of the drug will continue, in cases from Idaho, Kansas and Missouri.

"The court did find that our clients don't have standing, but we are very hopeful," added Hawley, who also is the wife of Sen. Josh Hawley, R-Mo. "The Supreme Court again did not address the merits. And we are very hopeful that the federal courts will have the chance to hold the FDA accountable for its unlawful actions in removing these long-standing safeguards for women."

Dr. Ingrid Skop, a board-certified OB-GYN who has practiced in Texas and is a senior fellow and director of medical affairs at the Charlotte Lozier Institute, said in a statement, "It is deeply disappointing that the FDA was not held accountable today for its reckless decisions."

"As a practicing OB-GYN with over 30 years' experience, I have seen firsthand that mail-order abortion drugs harm my patients, both mothers and their unborn children," she said. "Abortion advocates and corporate media ignore their stories as they shamelessly promote mail-order distribution of dangerous drugs without a single in-person doctor visit. As a tragic result, I expect to see more women need blood transfusions, emergency surgery and other drastic measures and our emergency medical systems overwhelmed. This is not health care, it's abandonment and the pro-life community will never stop advocating for patients."

Rachel O'Leary Carmona, executive director of Women's March, said in a statement, "We are deeply relieved that the Supreme Court recognized the unfounded legal challenge to the Food and Drug Administration's power to authorize mifepristone, and preserved access to the safe and effective abortion medication nationwide."

Katie Daniel, state policy director for SBA Pro-Life America, called it "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. Abortion drugs send approximately one in 25 women to the ER according to the FDA's own label, yet the abortion lobby gaslights women about the risks and seeks to block states from even collecting safety data."

She added, "Planned Parenthood boasts about dispensing these high-risk drugs by app, 'completely free of face-to-face interaction with a clinician,' to anyone with a mailing address. … The old talking point that abortion is a 'choice between a woman and her doctor' has been exposed as a lie."

First approved by the FDA in 2000, mifepristone blocks the hormone progesterone, which maintains proper conditions in the uterus during pregnancy. The drug is paired with misoprostol (initially created to treat gastric ulcers) as part of a chemical regimen for early abortion. Regulations on the drug were eased in 2016 and 2021, allowing it to be administered a few weeks later in pregnancy and for its distribution by mail.

The same pill combination also is sometimes prescribed to women who experience early pregnancy miscarriage in order to expel any fetal remains and residual pregnancy tissue from the womb. The American College of Obstetricians and Gynecologists updated its protocols to recommend a combination of mifepristone and misoprostol as more effective than misoprostol alone for early miscarriage care based on research published since 2018.

Data from the Centers for Disease Control and Prevention shows that more than half of the abortions performed in the U.S. are chemical or medical, rather than surgical. The ruling maintains the current availability of the drug.

The case was the first major case involving abortion on its docket since the high court overturned its previous abortion precedent in 2022.

Kate Scanlon is a national reporter for OSV News covering Washington. Follow her on X (formerly Twitter) @kgscanlon.