Supreme Court agrees to hear ‘abortion pill access’ case (in election year)

The US Supreme Court will decide how available a widely used abortion pill will be, agreeing on Wednesday to hear the Biden administration’s appeal of a ruling that would bar mail-order prescriptions and require in-person doctor visits.

The case pulls the justices back into one of the nation’s most bitterly contested issues, setting up a ruling next year in the middle of the presidential campaign. It follows the high court’s 2022 decision overturning the constitutional right to abortion. 

Pill-induced abortion is now the most common method for terminating a pregnancy in the US. The drug at the center of the high court fight, mifepristone, has become a top target for anti-abortion advocates.

More broadly, the case will test the power of federal judges to overrule the Food and Drug Administration on the safety and effectiveness of pharmaceuticals and medical devices. A federal appeals court blocked recent steps taken by the FDA to broaden the drug’s availability, saying the agency gave short shrift to safety concerns,

The Biden administration said it believes the case marks the first time a court has ever restricted an FDA-approved drug on those grounds.

“FDA’s actions were supported by an exhaustive review of a record including dozens of scientific studies and decades of safe use of mifepristone by millions of women in the United States and around the world,” US Solicitor General Elizabeth Prelogar, the administration’s top Supreme Court lawyer, said in the appeal.

The court will also hear a similar appeal from the drug’s manufacturer, Danco Laboratories LLC. A group of anti-abortion doctors and organizations is challenging mifepristone’s availability.

Expanding access

The ruling by the New Orleans-based 5th US Circuit Court of Appeals partially upheld a federal trial judge’s decision that would have effectively banned the drug by suspending the FDA’s 2000 approval. The 5th Circuit decision would keep the drug on the market but block changes the FDA put in place starting in 2016 to expand access to mifepristone.

In addition to lifting a requirement that mifepristone be dispensed in person, the FDA has 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. Those changes now hang in the balance at the Supreme Court.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Walker Elrod wrote for the 5th Circuit.

The Supreme Court in April issued an emergency order keeping mifepristone fully available while the legal fight goes forward. Justices Clarence Thomas and Samuel Alito dissented.

A key issue at the high court will be whether the mifepristone opponents had the legal right to sue. The Biden administration said the organizations and doctors lack legal “standing” to sue because they aren’t directly affected by the FDA’s endorsement of mifepristone.

“They do not prescribe mifepristone, and FDA’s approval of the drug does not require them to do or refrain from doing anything,” Prelogar argued.

Complications alleged

The mifepristone opponents, represented by the Christian legal advocacy group Alliance Defending Freedom, say they have standing because they inevitably will have to care for women who will need emergency treatment after taking the drug.

“FDA cannot deny that many women will require surgery and emergency follow-up care because of chemical abortion complications,” they argued in court papers.

The opponents called the 5th Circuit ruling a “modest decision” that “merely restores the common-sense safeguards under which millions of women”  have taken mifepristone.

Related: DOJ urges Supreme Court to uphold abortion-pill access

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.

The Supreme Court declined to take up a separate appeal that aimed to remove mifepristone from the market altogether. The 5th Circuit said the challenge to the 2000 approval decision came too late, and the abortion opponents were seeking to overturn that aspect of the ruling.

The granted cases are Food and Drug Administration v. Alliance for Hippocratic Medicine, 23-235, and Danco Laboratories v. Alliance for Hippocratic Medicine, 23-236.  The Supreme Court Justices could hear arguments by the spring, raising the prospect that a ruling could come before the 2024 election.

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