5 takeaways from the abortion pill case before the U.S. Supreme Court

By Matthew Perrone, Amanda Seitz and Christine Fernando, Associated Press

WASHINGTON (AP) — U.S. Supreme Court justices on Tuesday did not appear ready to limit Americans’ access to the abortion pill mifepristone, in a case that could have major implications for the Food and Drug Administration’s oversight of thousands of medications.

It’s the first abortion-related case the court has taken since a majority of the current justices struck down the constitutional right to abortion in 2022.

A group of anti-abortion doctors had asked the court to restrict access to mifepristone and to limit when in a pregnancy it could be used.

Key moments from the arguments:

ABORTION PILL SAFETY UNDER MICROSCOPE

The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies. Last year it was used in more than six in 10 of the abortions in the U.S.

The central argument of the conservative group challenging mifepristone is that the Food and Drug Administration overlooked serious problems with the drug when it eased restrictions on the drug, including making it available via mail in 2021.

Erin Hawley, who represented the doctors and group suing the agency, argued the FDA “failed to consider or explain … its wholesale removal of safeguards” on the pill.

But the FDA has long argued its decision to drop in-person appointments to get mifepristone, among other requirements, came after 20 years of monitoring its safety. In that period the agency reviewed dozens of studies in thousands of women in which serious problems — including hospitalization — occurred less than 0.3% of the time.

Hawley pointed out that FDA’s own prescribing label mentions that 2.9% to 4.6% of women taking the drug go to the emergency room. But Solicitor General Elizabeth Prelogar pointed to studies showing that half of women who go to the emergency room don’t get any treatment at all.

“Many women might go because they’re experiencing heavy bleeding, which mimics a miscarriage, and they might just need to know whether or not they’re having a complication, ” Prelogar said.

Because of the highly technical nature of reviewing drugs, courts have long deferred to FDA’s scientific judgements on drug safety and effectiveness.

Justice Ketanji Brown Jackson pressed Hawley on the consequences of second-guessing the agency’s regulators.

“So what deference do we owe them at all with respect to their assessment that these studies establish what it is that they say they do about safety and efficacy?”

HOW FAR TO GO

Hawley ran into questions as she argued that a nationwide rule curtailing mifepristone use was needed.

She was repeatedly interrupted by Justice Neil Gorsuch, who voiced objections to such sweeping injunctions.

The case “seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule or any other federal government action,” said Gorsuch.

Normally when a court issues an injunction about a government policy it only applies to the individuals or groups in the case. But in recent years a growing number of justices on lower courts have issued “universal injunctions,” blocking federal regulations.

Gorsuch noted that there have been roughly 60 such rulings in the last four years.

Chief Justice John Roberts also seemed skeptical that a ruling reversing the FDA’s scientific judgments was necessary.

“Why can’t the court specify that this relief runs to precisely the parties before the court as opposed to looking to the agency in general and saying, ‘Agency, you can’t do this anywhere?’”

RIGHT TO SUE

The Biden administration argued that the plaintiffs — a group of anti-abortion doctors — didn’t have the right to challenge the FDA’s approval of mifepristone.