Supreme Court upholds FDA's mifepristone approval

A year and a half after four organizations and four physicians filed a lawsuit against the FDA's approval of mifepristone to terminate a pregnancy, the Supreme Court unanimously ruled June 13 in favor of the FDA. 

The dispute has been winding its way through the courts since November 2020, when four organizations and four physicians sued the FDA over its 2000 approval of mifepristone. The drug is part of a two-drug regimen indicated to end a pregnancy in the first 10 weeks of gestation.  

The regimen accounts for 63% of all abortions in the U.S., according to the Guttmacher Institute.

The FDA approved mifepristone in 2000 to end a pregnancy within the first seven weeks, and in 2016, the agency expanded the indication to 10 weeks. In 2021, the FDA again loosened requirements, allowing clinicians to prescribe the regimen without an initial in-person visit. (Some states ban the drugs, and others require an in-person physician visit.)

The lawsuit, filed in Texas, questioned the FDA's authority to approve mifepristone, the 2016 and 2021 decisions that expanded access and its approval of a generic option in 2019. 

In a final ruling, the Supreme Court said plaintiffs do not have standing to sue: "A plaintiff's desire to make a drug less available for others does not establish standing to sue," the opinion said, including the italics. "Nor do the plaintiffs' other standing theories suffice."

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