Abortion-Pill Case Gets Election-Year Supreme Court Review
(Bloomberg) -- The US Supreme Court will decide how available a widely used abortion pill will be, agreeing to hear the Biden administration’s appeal of a ruling that would bar mail-order prescriptions and require in-person doctor visits.
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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.
Read more: What’s Mifepristone? What’s the Fight Over It About?: QuickTake
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.
The Supreme Court declined to take up a separate appeal filed by pill opponents in an effort to remove mifepristone from the market altogether.
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 suspended the FDA’s 2000 approval. Although the 5th Circuit said the challenge to the approval was filed too late, the appeals court’s ruling would 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.
A lawyer with the Christian legal group Alliance Defending Freedom, which is representing the challengers, said the changes were politically motivated.
“The FDA has harmed the health of women and undermined the rule of law by illegally removing every meaningful safeguard from the chemical abortion drug regimen,” Erin Hawley, the group’s lead attorney in the case, said in a statement after the court’s announcement.
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.
Standing to Sue
A key issue at the high court will 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.
The mifepristone opponents 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.
Danco said the pill will continue to be available under the latest FDA rules until the court issues a decision. “Danco remains confident in the safety and effectiveness of Mifeprex,” the company said, referring the drug’s brand name.
Abortion-rights advocates applauded the high court’s decision to take the case.
“Now the question is whether the court will do the right thing and reject the radical arguments of the plaintiffs in what should be a clear cut case,” said Nancy Northup, president of the Center for Reproductive Rights. “The court has never invalidated a long-standing FDA approval like they are being asked to do here.”
White House Press Secretary Karine Jean-Pierre said in a statement that the 5th Circuit ruling “threatens to undermine the FDA’s scientific, independent judgment and would reimpose outdated restrictions on access to safe and effective medication abortion.”
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 granted cases are Food and Drug Administration v. Alliance for Hippocratic Medicine, 23-235, and Danco Laboratories v. Alliance for Hippocratic Medicine, 23-236.
--With assistance from Fiona Rutherford.
(Updates with reaction starting in 12th paragraph.)
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