Supreme Court rejects challenge to FDA's approval of mifepristone
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.
The court’s action amounted to a legal off-ramp, leaving the FDA rules in place, without directly addressing the regulations themselves.
The court’s 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.
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 seven 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.
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.
