The U.S. Supreme Court on Thursday tossed out a challenge to the FDA’s rules for prescribing and dispensing abortion pills.
By a unanimous vote, the court said the anti-abortion doctors who brought the challenge had failed to show they had been harmed, as they do not prescribe the medication, and thus, essentially, had no skin in the game.
The court said that the challengers, a group called the Alliance for Hippocratic Medicine, had no right to be in court at all since neither the organization nor its members could show they had suffered any concrete injury.
Writing for the court, Justice Brett Kavanaugh dismissed every conceivable argument that the anti-abortion doctors had advanced claiming they had a right to sue.
They had contended that there is a statistical possibility that some physicians would be called upon to treat emergency room patients suffering from complications after taking abortion pills. But Kavanaugh noted that federal law explicitly says that doctors cannot be forced to perform or assist in abortions, or to treat patients with complications from mifepristone. Moreover, he said, doctors "have never had standing to challenge FDA drug approvals simply on the theory that use of the drug by others may cause more visits to the doctor."
Similarly, he said that doctors have no generalized right to sue because they object to a general government policy. To illustrate the point, he said that if the government raises the speed limit, emergency room doctors couldn't challenge the policy on grounds that it increased the number of automobile accident cases.
The court’s unanimous decision amounted to a legal off-ramp, leaving the FDA rules in place, without directly addressing the regulations themselves.
The decision also avoided, at least for now, a challenge to the entire structure of the FDA’s regulatory power to approve drugs and continually evaluate their safety — a system that for decades has been widely viewed as the gold standard for both safety and innovation.
Carol Tobias, president of National Right to Life, condemned the decision, saying it deprived women of essential information about the dangers of the abortion pill. "It is sad that because of these FDA decisions, women will not get the information they deserve before making a permanent life or death decision," she said.
"It is a sad day for all who value women's health and unborn children's lives, but the fight to stop dangerous mail-order abortion drugs is not over," said SBA Pro-Life America state policy director Katie Daniel.
As abortion rights advocates were relieved, they know there will be more battles ahead. "This is not a sweeping victory," said NYU law professor Melissa Murray. It "likely is just a resting place, a way station. There will be another challenge to medication abortion."
She says that future challenges could come from conservative states that could reasonably argue that the FDA's accessibility regulations render restrictive state abortion laws moot. After all, she observes, "If you get it through the mail, it doesn't matter what the state is doing as a natter if public law."
Mary Zeigler, a law professor at UC Davis who has written extensively about the history and politics of abortion, also sees a fraught future.
She says that many prominent conservative groups and individuals who served in the first Trump Administration have focused their attention on getting Trump, if he is re-elected, to ban all abortion under the Comstock Act, an 1873 anti-obscenity law that also banned all contraception and abortion materials from the mail.
The law has not been enforced for at least a half century and likely much longer, Zeigler says, adding that "If you had told me that prominent conservative groups were going to be investing in turning the Comstock Act into a ban [on abortion] and making it the cornerstone of what they hoped a second Trump Administration would do, I wouldn't have believed you a few years ago. I would have said that's just way too politically counterproductive. And yet, here we are."
Since the court reversed Roe v. Wade and the right to abortion in 2022, pills have become the most popular abortion method in the U.S. More than half the women who choose to terminate a pregnancy use a combination of pills approved by the FDA, including mifepristone, manufactured by Danco Laboratories and marketed as Mifeprex.
The pill regimen was first approved 24 years ago, and over the past eight years, the agency has approved changes in the dosing regimen and eliminated some restrictions that it found to be unnecessary.
For instance, the pills can now be prescribed during the first 10 weeks of pregnancy, instead of the original seven weeks, and prescriptions can be filled by mail or at pharmacies, instead of at a doctor’s office. The result, according to Danco Labs, is that there have been fewer complications than when the drug was initially approved for just seven weeks in 2000.
Thursday's Supreme Court decision reversed a ruling by the Fifth Circuit Court of Appeals, widely viewed as the most conservative federal appeals court in the country. Of the 61 cases before the court this term, ten are appeals from the Fifth Circuit. The abortion pill case was the third reversal, and there are still seven Fifth Circuit appeals remaining
Siding with the FDA in the case were virtually all the major medical associations in the country, as well as almost all the pharmaceutical and bio-tech companies, big and small, that are regulated by the agency, making this the rare case in which a government regulator and the industry it regulates were on the same side. Dr. Jeremy Levin, the CEO of Ovid Therapeutics, one of the many pharmaceutical companies that sided with the FDA, earlier this year called the case “a dagger at the heart of the entire industry.”
For now, though, the prospect of dismantling the regulatory powers of the FDA has been averted. But the direct challenge to abortion pills and their accessibility has not been resolved, and could be revived in a different case.
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