U.S. Supreme Court justices on Tuesday did not appear ready to limit access to the abortion pill mifepristone, in a case that could have far-reaching implications for millions of American women and for scores of drugs regulated by the Food and Drug Administration.
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:
The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies. Last year the pill 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 suing the agency, argued the FDA “failed to consider or explain … its wholesale removal of safeguards” on the pill.
Read moreThe long and winding history of the war on abortion drugs
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 drug data and research, courts have long deferred to FDA’s scientific judgements on safety and effectiveness.
Justice Ketanji Brown Jackson pressed Hawley on the legal basis for 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?”
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 nationwide.
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?’”
The Biden administration argued that the plaintiffs — a group called the Alliance for Hippocratic Medicine — didn’t have the right to challenge the FDA’s actions on mifepristone.
The doctors who brought the suit argued that they might have to treat emergency room patients who experience serious complications after taking the drug.
But Prelogar told the court that the doctors don’t have to prescribe mifepristone and they can abstain from treating patients who have taken the pill if they oppose abortion.
“They don’t prescribe mifepristone,” Prelogar said. “They don’t take mifepristone, obviously. The FDA is not requiring them to do or refrain from doing anything. They aren’t required to treat women who take mifepristone.”
Justice Samuel Alito, however, repeatedly pressed the government on who did have the right to sue over FDA’s decisions.
“Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful?” Alito, who wrote the 2022 ruling that overturned Roe v. Wade, asked.
Several justices pressed Hawley to provide real-life examples of doctors who oppose abortion being forced to treat patients who had suffered from abortion pill complications.
They also took issue with how many hypothetical problems Hawley raised in her argument against the FDA’s loosening of abortion pill restrictions.
“I don’t want to hypothesize,” Jackson said to Hawley, asking her to provide an example of a doctor who was unable to object to providing an abortion.
At one point, Justice Amy Coney Barrett also questioned an example one of the doctors provided of a colleague who had to perform a “dilation and curettage” procedure on a patient with complications. Barrett pointed out that those procedures are not just performed in cases of abortions but for miscarriages as well.
Some of the justices also pointed out that doctors are already protected from performing abortions when they don’t want to by voicing conscience objection.
Justice Brett Kavanaugh raised that point early on: “Under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?”
For more than a century, the FDA has had sole authority over assessing the safety of drugs and approving their sale in the U.S.
The agency first approved mifepristone in 2000 following a four-year review, including detailed safety studies submitted by the French manufacturer. In 2016, FDA loosened restrictions on the drug to allow it to be prescribed up to 10 weeks of pregnancy and allowed nurses and other medical professionals to prescribe it. In 2021, the agency said the drug could be sent through the mail, doing away with a longstanding requirement that women to pick the drug up in person.
Jessica Ellsworth, an attorney representing the New York-based Danco Laboratories, which makes mifepristone, asked the justices to consider how the case could upend the FDA’s decades-old system for regulating drugs, vaccines and other life-saving medicines.
“I think this court should think hard about the mischief it would invite if it allowed agencies to start taking action based on statutory responsibilities that Congress has assigned to other agencies,” she said.
U.S. District Judge Matthew Kacsmaryk’s decision last year marked the first time a court had issued a decision to revoke approval of a drug FDA had deemed safe. An open letter signed by nearly 300 biotech and pharmaceutical company leaders last year slammed the ruling as undermining Congress’ delegated authority to the FDA to approve and regulate drugs. If justices can unilaterally overturn drug approvals, they said “any medicine is at risk.”
(AP)
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