In a way, it’s surprising it took this long.
Health and Human Services Secretary Robert F. Kennedy Jr. finally acceded to the anti-abortion movement, alerting Republican attorneys general last week that the Food and Drug Administration has begun a review of the “safety profile” of mifepristone.
“HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug,” he wrote in a letter dated September 19. “Given the 2016 FDA decision to eliminate the REMS requirement for certified prescribers to report non-fatal serious adverse events to the mifepristone sponsors, this review will contribute to the understanding of the drug’s safety profile.”
He cited a “study” produced by a right-wing think tank — that is not peer reviewed and refuses to publish its underlying data — claiming that one in 10 patients who take mifepristone suffers serious side effects. Republicans have glommed onto this study, flailing for a reason to turn the FDA against the abortion drug.
In reality, the FDA has long been used to unnecessarily restrict mifepristone, under Democratic and Republican administrations alike. Only recently, and prompted in large part by the COVID-19 pandemic and a major lawsuit, did some of those onerous restrictions start to lift. That recent and hugely significant progress is now endangered, as Kennedy promises to use the levers of the federal government to wind the clock back to a time when mifepristone is difficult — if not impossible — to obtain.
In 1989, a year after France approved the drug for use, the FDA banned its importation. President Clinton ordered the drug to be studied upon taking office, and it finally got FDA authorization in 2000 for use up to seven weeks into pregnancy.
Eleven years later, the FDA put the drug under a Risk Evaluation and Mitigation Strategy (REMS), meaning it could only be administered in a hospital or clinic. Less than three percent of FDA-regulated drugs have been placed under a REMS, and most of them are opioids.
In 2016, the FDA extended the window in which mifepristone could be taken to 10 weeks, and required fewer trips to the provider.
In 2020, as much of American life shut down during the COVID-19 pandemic, patients still had to make in-person visits to obtain a drug long proven safe and effective. The ACLU sued in federal court, and won an injunction temporarily pausing the in-person dispensing requirements, letting mifepristone be legally mailed. President Biden’s FDA announced soon after that it would stop enforcing the in-person requirement, and allowed certified pharmacies to dispense the drug — a sea change in bringing mifepristone into the realm of mainstream medicine. Those changes were formalized and made permanent in 2023.
The number of medication abortions, accordingly, has risen and stayed high despite the Supreme Court’s Dobbs decision, which overturned the right to an abortion. Delivery systems popped up across the country, enabling patients in states under abortion bans to obtain the medication.
Post-Dobbs litigation has focused almost exclusively on medication abortion, which anti-abortion activists recognize as the biggest impediment to eradicating the procedure. The Supreme Court turned back an attempt to remove the drug’s FDA authorization in 2024, finding that the anti-abortion doctors who brought the suit lacked standing. That case is back in Judge Matthew Kacsmaryk’s court (himself an avowed anti-abortion zealot), where red states are attempting to substitute in for the anti-abortion doctors.
But lawsuits aren’t enough for the increasingly antsy anti-abortion movement: Their allies control the White House, after all. Why not just use the machinery of the administration to restrict mifepristone out of accessibility?
Kennedy is finally responding. By leaning on the bogus study, FDA might decide that mifepristone is unusually dangerous and reimpose the in-person dispensing requirements, making it impossible for red-state patients to legally obtain the medication. It could go even further and try to yank mifepristone’s approval altogether.
If it does, it’ll be just the latest chapter in the agency’s refusal to treat mifepristone like it does apolitical drugs, barring Americans from necessary health care because some people in this country don’t like abortion.
