The Supreme Court has preserved access to mifepristone, a medication that was used in nearly two-thirds of all abortions in the U.S. last year, in the court’s first abortion case since conservative justices overturned Roe v. Wade two years ago.
In a unanimous decision, the high court ruled that abortion opponents who challenged the the Food and Drug Administration's approval of the medication, and subsequent actions to ease access to it, lacked the legal right or standing to sue. The court notes that the doctors and groups suing the FDA "do not prescribe or use mifepristone," nor is the FDA requiring them to do so.
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"Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain," Justice Brett Kavanaugh wrote for the court's opinion. Kavanaugh was part of the majority to overturn Roe.
The “federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions," the opinion states, adding that "given the broad and comprehensive conscience protections guaranteed by federal law, the plaintiffs have not shown — and cannot show — that FDA's actions will cause them to suffer any conscience injury."
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The case had threatened to restrict access to mifepristone across the country, including in states where abortion remains legal. Health care providers have said that if mifepristone is no longer available or is too hard to obtain, they would switch to using only misoprostol, which is somewhat less effective in ending pregnancies.
President Joe Biden’s administration and drug manufacturers had warned that siding with abortion opponents in this case could undermine the FDA’s drug approval process beyond the abortion context by inviting judges to second-guess the agency’s scientific judgments. The Democratic administration and New York-based Danco Laboratories, which makes mifepristone, argued that the drug is among the safest the FDA has ever approved.
The decision “safeguards access to a drug that has decades of safe and effective use,” Danco spokeswoman Abigail Long said in a statement.
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.
Mifepristone blocks the hormone progesterone and primes the uterus to respond to the contraction-causing effect of a second drug, misoprostol. The two-drug regimen has been used to end a pregnancy through 10 weeks gestation.
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.
During oral argument in March, 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.
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?”
Kavanaugh acknowledged what he described as the opponents' “sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone.”
But he said they went to the wrong forum and should instead direct their energies to persuading lawmakers and regulators to make changes.
Those comments pointed to the stakes of the 2024 election and the possibility that an FDA commissioner appointed by Republican Donald Trump, if he wins the White House, could consider tightening access to mifepristone.
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.”
