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Mifepristone Access Upheld by US Supreme Court
The unanimous ruling maintains nationwide access to mifepristone for medical abortion, reversing a lower court's decision to restrict availability.
The Supreme Court has rejected a challenge from antiabortion doctors to limit access to mifepristone for medication abortion, allowing individuals to continue to obtain the pill nationwide.1
The unanimous ruling reversed a lower court decision to restrict access to mifepristone, which is used in more than 60% of abortions in the United States. The Supreme Court ruling was based on the idea that plaintiffs did not have a standing to bring the case rather than the contents of the case itself.
Following the Dobbs v Jackson Women's Health Organization decision to overturn the nationwide right to abortion in 2022, medical termination of pregnancy has become vital for successful abortion. This method has also been targeted because of the ready availability of mifepristone by mail even in states with abortion restrictions or bans.
The case was based on a decision from the US Court of Appeals for the Fifth Circuit arguing the FDA did not follow proper procedures or properly explain its reasons for loosening regulations surrounding mifepristone in 2016 and 2021. This led a group of antiabortion physicians to sue the FDA for not fully considering safety concerns.
Starting in 2016, the FDA allowed mifepristone to be used later in pregnancy and made it possible for patients to directly receive the medication by mail. Additionally, the FDA allowed medical providers besides doctors to prescribe mifepristone.
Mifepristone first received FDA approval in 2000, based on evidence of multiple instances of the drug being safe and effective when used in a medication abortion protocol alongside misoprostol. Data also indicated regulations targeted in the lawsuit do not impact the regimen’s safety and efficacy.
In March, pharmaceutical companies and former FDA officials spoke out in favor of mifepristone, urging the judges not to second-guess scientific experts. They also stated that a ruling against the FDA would adversely impact the regulatory system and investments in research and innovation.
Justices discussed whether the challengers had a legal right to file the lawsuit, with defenders of mifepristone arguing that the challengers were not directly harmed by the FDA’s decision to loosen restrictions. The 2023 decision was the first instance of a judge suspending longtime approval for a drug despite opposition from the drug manufacturer and the FDA.
The initial lawsuit was filed by individual physicians and the Alliance for Hippocratic Medicine. When accepting the case, the Supreme Court stated it would evaluate the rule changes in 2016 and 2021 that increased access to mifepristone and would not consider taking mifepristone off the market.
According to the Supreme Court, standing is established when a plaintiff proves they have suffered or will likely suffer an injury, that the injury was caused or will be caused by the defendant, and that the injury would be readdressed by the requested judicial relief.2 This screens out plaintiffs with a general legal, moral, ideological, or policy objection.
In this case, the plaintiffs supported a pro-life position and opposed elective abortion, displaying legal, moral, ideological, and policy objections to mifepristone availability. The Supreme Court concluded that none of the plaintiffs’ theories were strong enough to establish a standing.
“We are thrilled that a unanimous Supreme Court has rejected the ideologically driven lower court decisions on access to mifepristone, reversing an action that has already endangered too many people in need of healthcare," said the American Society for Reproductive Medicine. "The decision further affirms the robust drug safety program at the United States FDA."
