Supreme Court backs full access to widely used abortion pill

The U.S. Supreme Court preserved full access to a widely used abortion pill in a case that carried major stakes for reproductive rights and election-year politics.

The court unanimously overturned a federal appeals ruling that would have barred mail-order prescriptions for mifepristone, the drug now used in more than half of U.S. abortions. The lower court ruling would have reduced abortion access even in states where reproductive rights have broad support.

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The court stopped short of affirming Food and Drug Administration decisions to loosen restrictions on mifepristone starting in 2016. The majority instead said the anti-abortion doctors and organizations that sued lacked legal "standing" because they aren't directly affected by the FDA's actions.

"The federal courts are the wrong forum for addressing the plaintiffs' concerns about FDA's actions," Justice Brett Kavanaugh wrote for the court. "The plaintiffs may present their concerns and objections to the president and FDA in the regulatory process, or to Congress and the president in the legislative process."

The FDA expanded access to mifepristone with a series of steps that included a 2021 decision to permanently jettison the requirement that patients physically visit a medical provider. The FDA also extended the drug's approval to the 10th week of pregnancy — three weeks longer than was the case previously — and reduced the dosing regimen from 600 milligrams to 200.

The FDA didn't immediately return a call seeking comment.

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Lawyers for the doctors said they have the legal right to sue because they inevitably will have to treat women who are harmed by mifepristone and need emergency care.

Kavanaugh rejected that argument. "The law has never permitted doctors to challenge the government's loosening of general public safety requirements simply because more individuals might then show up at emergency rooms or in doctors' offices with follow-on injuries," he wrote.

State Challenge

The ruling leaves open the possibility of a renewed attack on mifepristone by other opponents. After the Supreme Court agreed to take up the case, U.S. District Judge Matthew Kacsmaryk said a Missouri-led group of states could intervene at the district court level to help press the challenge. The states contend they have standing to sue even if the doctors don't.

The 5th U.S. Circuit Court of Appeals, perhaps the nation's most conservative federal appeals court, said the FDA gave short shrift to safety concerns when it took those steps. 

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Kacsmaryk had gone even further by suspending the FDA's 2000 approval and barring the drug altogether. The 5th Circuit said the challenge to the initial approval was filed too late.

The Supreme Court issued an emergency order last year keeping mifepristone fully available until it resolved the case.

The case pitted the Biden administration against Alliance Defending Freedom, a Christian legal group that helped drive the effort to overturn Roe. The drug's manufacturer, Danco Laboratories, defended mifepristone alongside the administration.

"By rejecting the Fifth Circuit's radical, unprecedented and unsupportable interpretation of who has standing to sue, the justices reaffirmed longstanding basic principles of administrative law," Danco said in a statement. "In doing so, they maintained the stability of the FDA drug approval process, which is based on the agency's expertise and on which patients, health-care providers and the U.S. pharmaceutical industry rely."

Mifepristone is used as part of a two-pill regimen to end pregnancies and treat miscarriages. It is followed by misoprostol, which can also be used on its own to terminate a pregnancy.