Abortion pill mifepristone survives Supreme Court challenge

By Eleanor Laise

Case threatened to unleash lawsuits challenging other FDA approval decisions

The U.S. Supreme Court on Thursday unanimously rejected a challenge to the abortion pill mifepristone, saying the plaintiffs in the case did not have the legal standing to sue.

Mifepristone is part of a two-drug regimen that is used in nearly all medication abortions in the U.S. and is also widely used in the treatment of miscarriages.

The case, Food and Drug Administration v. Alliance for Hippocratic Medicine, originated with anti-abortion advocacy groups and doctors who challenged the FDA's approval of mifepristone, saying the drug is unsafe and the FDA acted outside its authority in initially approving the drug and later relaxing the conditions for its use.

The plaintiffs "do not prescribe or use mifepristone," Justice Brett Kavanaugh wrote in the court's opinion. "And FDA is not requiring them to do or refrain from doing anything." While the plaintiffs wanted the FDA to make mifepristone more difficult to prescribe and for pregnant women to obtain, "a plaintiff's desire to make a drug less available for others does not establish standing to sue," Kavanaugh wrote.

The plaintiffs in the case initially scored a victory in a Texas district court, which in April 2023 suspended mifepristone's approval. The Biden administration appealed to the Fifth Circuit, which partially blocked the lower court's decision but left in place parts of the ruling that overturned FDA changes expanding access to the drug.

From the archives (March 2023): Trump appointee in single-judge federal district in Texas could bar nationwide access to the abortifacient mifepristone

Reproductive-rights advocates said that decades of research have proven medication abortion is safe. Mifepristone was first approved by the FDA in 2000, and the agency in 2016 and 2021 expanded access to the medication, allowing it to be prescribed via telemedicine without an in-person doctor visit. A brand-name version of the drug, called Mifeprex, is manufactured by Danco Laboratories, while GenBioPro makes a generic version.

A decision restricting access to mifepristone would have caused havoc for people seeking abortion care, reproductive-rights advocates said. Medication abortions accounted for 63% of total U.S. abortions last year, up from 53% in 2020, according to the Guttmacher Institute, a reproductive-rights research and policy group.

The U.S. Supreme Court's 2022 decision in Dobbs v. Jackson Women's Health Organization, which overturned Roe v. Wade, cleared the way for states to set their own abortion policies while also fueling debate over medication-abortion access. State abortion restrictions that sprung up in the wake of the Dobbs decision left medication abortion as the only viable option for some people seeking abortion care.

There were just over 1 million abortions within the formal U.S. healthcare system last year, according to the Guttmacher Institute - a 10% increase from 2020 and the highest number in more than a decade.

A finding that the plaintiffs do not have the legal standing to sue "would most likely just be a 'live to fight another day' scenario," Julia Kaye, senior staff attorney with the American Civil Liberties Union's Reproductive Freedom Project, said during a press briefing last week. "There is no doubt that we'll continue to see efforts to strip away access to medication abortion care nationwide," Kaye said. Those efforts could come through the legal system, in the form of copycat lawsuits, or through political maneuvers to use the Comstock Act, an 1873 anti-vice law, to restrict abortions nationwide, Kaye said.

Anti-abortion groups in the wake of Thursday's ruling also signaled more legal fights to come. "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," Katie Daniel, state policy director at Susan B. Anthony Pro-Life America, said in a statement. As the case returns to district court, Idaho, Kansas and Missouri are ready to "take up the challenge based on harms suffered by women in their states," the group said in a release Thursday.

While the ruling maintains mifepristone's availability, it "does not change the fact that the fight for reproductive freedom continues," President Joe Biden said in a statement Thursday. Calling attacks on medication abortion part of a Republican effort to ban abortion nationwide, Biden said women are "being turned away from emergency rooms, or forced to go to court to plead for care that their doctor recommended or to travel hundreds of miles for care."

The mifepristone case is about much more than medication abortion, legal experts said. The FDA's autonomy and pharmaceutical-industry impacts have also been in focus as the case threatened to unleash litigation challenging many other FDA-approved drugs, patient advocates and industry groups said.

If the appeals court's decision were allowed to stand, it would "create chaos for the drug development and approval processes," pharmaceutical companies, industry groups and investors said in a brief filed with the Supreme Court. "That decision casts a shadow of uncertainty over every FDA approval and invites spurious lawsuits challenging FDA's safety and effectiveness determinations."

The FDA early last year modified a drug-safety program for mifepristone, allowing the drug to be dispensed by certified retail pharmacies. CVS Health (CVS) and Walgreens Boots Alliance Inc. (WBA) said earlier this year that they had completed the FDA certification process and would begin filling mifepristone prescriptions in certain states.

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-Eleanor Laise

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06-13-24 1229ET

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