Abortion pills may be FDA's first test under Trump
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While the early focus on a Trump administration Food and Drug Administration has been on vaccine policy, one of its first moves could be overhauling the federal rules that have made it easier to access the widely used abortion pill mifepristone.
Why it matters: Use of the drug has surged as states enacted near or total abortion bans after Roe v. Wade was overturned in 2022. But new agency leadership could quickly move to roll back some of the policies that were the focus of a closely watched Supreme Court case this year.
- Legal and reproductive health experts say that would undermine the agency's credibility and underscore the role politics could play over science in regulatory decision-making.
"It is likely that they will revisit the conditions in which the medication abortions, which now account for nearly two-thirds of all abortions in this country, can be provided," said Alina Salganicoff, KFF's director for women's health policy.
Zoom in: Anti-abortion forces and doctors who brought the Supreme Court case have keyed on a set of policies that since 2016 loosened restrictions on mifepristone, saying the FDA didn't sufficiently factor safety concerns.
- The policies expanded who could prescribe the drugs, allowed patients to take it later in pregnancy and adjusted in-person visit requirements.
- In 2023, the Biden administration released further guidance that made COVID-era flexibilities — allowing the drug to be prescribed online and mailed directly to patients — permanent.
Revoking those policies could set off a huge legal fight, with challenges likely coming from abortion rights groups who'd argue the agency acted arbitrarily.
- "As an agency, they'll still be held accountable to what they've said in the past," said Rachel Rebouché, dean of Temple University's law school.
- Drug companies could also join in, as they did in the Supreme Court case, over concerns such actions could undercut the FDA's authority to regulate medicines.
Friction point: The basis for such a rollback is contained in Project 2025, the Heritage Foundation blueprint for the next Republican administration, which calls for the FDA to reverse the telehealth flexibilities, its 2016 label change for expanded availability of mifepristone and, ultimately, the approval of abortion drugs.
- "The FDA is statutorily charged with guaranteeing the safety and efficacy of drugs and therefore should withdraw this drug that is proven to be dangerous to women and by definition fatally unsafe for unborn children," it reads.
- Even reversing the Biden administration guidance guidance that allowed people to get abortion pills by mail rather than a requiring an in-person visit would dramatically alter the post-Roe abortion landscape.
- Mifepristone is part of a two-pill regimen that many studies have found is safe and effective, and that medical organizations like the American College of Obstetricians and Gynecologists support.
The big picture: During his campaign, President-elect Trump cast abortion rights as an issue for states to decide and said that he wouldn't sign a national abortion ban if Congress sent one his way. Medication abortion has been banned in 14 states.
- But Trump wouldn't need Congress in order to further restrict access to mifepristone in states that support abortion access.
- Beyond an FDA rules rollback, his Justice Department could implement a policy change by determining that a 19th century anti-obscenity law known as the Comstock Act applies to mailing the drug.
Robert F. Kennedy Jr.'s nomination to head the Department of Health and Human Services signals a clear challenge to how the agency operates and norms around how scientific evidence is weighed.
- But Kennedy in the past has supported abortion rights — and his selection could be a sign that abortion pill access isn't among Trump's top priorities, experts say.
- "I'd be surprised if they went that far that fast," Greer Donley, an associate professor of law at the University of Pittsburgh School of Law, told Axios. "It's not like they have popular opinion on their side. It's hard to overstate how unpopular that would be."
- Former Vice President Mike Pence on Friday criticized Kennedy's selection to lead HHS on abortion grounds and urged Senate Republicans to reject the nomination,
What to watch: The Supreme Court's recent overturning of the doctrine known as "Chevron deference," which limits executive branch agencies' discretionary power, has left abortion rights advocates with a bigger opening to sue if the FDA restricts medication abortion, Rebouché pointed out.
