The US health secretary,Robert F Kennedy Jr, said on Wednesday that he had directed the FDA to review the regulations around the abortion pill mifepristone.
The review, he said, was necessary due to “new data” – data that emerged from aflawedanalysisthat top US anti-abortion groups are now using to pressure the Trump administration to reimpose restrictions on the abortion pill, if not pull it from the market entirely.
“It’s alarming,” Kennedy told the Missouri senator Josh Hawley, a Republican, during a congressional hearing. “Clearly, it indicates that, at very least, the label should be changed.”
The analysis, which has not been peer-reviewed or published in a medical journal, came after the Food and Drug Administration commissioner said he wasopento reviewing new safety data on the pills, which are used in nearlytwo-thirdsof abortions nationwide.
The conservative organizations arerallyingbehind apaperpublished on April 28 by a rightwing thinktank, the Ethics and Public Policy Center, which claims there are higher complication rates from taking mifepristone than previously known.
The paper hasattractedscrutinyfor appearing todramatically overstatewhat it characterizes as “serious adverse effects” associated with the pill, according to medical experts. For example, it counts ectopic pregnancies – when an embryo implants somewhere other than the uterine lining – as a serious complication.
Mifepristonedoes not causean ectopic pregnancy and taking it will not harm someone with an ectopic. It also claims that needing an in-clinic procedure to complete the abortion is a complication, when patients arecounseledin advance about the pills’ failure rate of about 3 to 4%.
The data, the authors say, means the FDA should reinstate earlier restrictions on mifepristone, including a ban on telemedicine and limiting use to the first seven weeks of pregnancy – but they do not intend to stop there.
The authors note that restoring the limits could lead to better monitoring that could help “determine whether this drug should remain on the market”, statements that echo proposals found in Project 2025, the 900-page playbook published by the Heritage Foundation and for which the EPPC was an advisory board member.
Project 2025 calls to end telemedicine prescriptions of abortion pills as an “interim step” to revoking mifepristone’s approval altogether.
More than 100 scientific studieshave found the medications cited in the paper are safe and effective for ending a pregnancy.
Telehealth, plus blue-state “shield laws”, have enabled thousands of people living in states where abortion is banned to continue to access mifepristone and misoprostol, which frustrates abortion opponents. One in five abortions nationwide are done via telemedicine, and in spring 2024, mail providers facilitated more than7,700 abortions per monthin states with total or six-week abortion bans.
Anti-abortion leaders said during a private Zoom call that they intend to use the EPPC paper to pressure the FDA and lawmakers to dramatically roll back access to the drug, “if not suspend” their approval entirely, Politicoreported. It is part of a plan they are privately calling “Rolling Thunder”.
Activists on that call – which included representatives from Americans United for Life, Live Action, Students for Life, and Susan B Anthony Pro-Life America – stressed that they viewed ending telemedicine prescriptions only as a “first step”.
According to the Politico report, the EPPC president, Ryan Anderson, argued on the call that this plan aligns with Donald Trump’s stated desire to leave abortion policy to the states because, he said, “you’re not leaving it to states if California can mail pills to Texas”.
Activists tried to push back on criticism that the paper was not peer-reviewed by arguing that academia is “broken” and they could not trust journals or reviewers not to “sabotage” their effort or leak it to the press. Politico reported that one medical professional on the call, Christina Francis, the CEO of the American Association of Pro-Life OBGYNs, warned her colleagues not to misrepresent the paper, acknowledging that the report was “not a study in the traditional sense” and “not conclusive proof of anything”. Still, Francis argued that it warranted government action and more research.
During his January confirmation hearing, Kennedy said that Trumpasked himto review mifepristone’s safety data. The FDA commissioner, Marty Makary,saidin March that he, too, would “do a review of the data”, and would act if necessary. Hawley, the Missouri senator, laterwrotea letter to Makary asking him to review the paper the day it was published; Hawley alsointroduced a billto end telemedicine of mifepristone. It is not expected to pass Congress, but the FDA could take action on its own, especially under pressure from groups on the call.
While abortion opponents have promoted researchlinkedto anti-abortion thinktanks claiming that mifepristone is dangerous, some studies havebeen retracted, including one cited heavily by a federal judge in a case seeking to roll back the pill’s availability that went to the supreme court last term. The court ruled unanimously that the plaintiffs, anti-abortion doctors, did not have legal standing to sue the FDA.
That case is still ongoing, with three Republican attorneys general suing the FDA on behalf of the states of Missouri, Idaho and Kansas.
The Trump administration made news last week whenit arguedin a filing that the judge should dismiss the case, the same position taken by the Biden administration earlier this year. But the Trump administration did not defend the FDA’s actions on mifepristone, instead saying only that the plaintiffs were not the right people to sue.
As a health law expertrecently toldthe Guardian, the administration could use that argument in the future if it chooses to restrict the drug and Democratic-led states sue over the changes.
Kirsten Moore, director of the Expanding MedicationAbortionAccess Project, told the Guardian she was not surprised by either the existence of a plan to restrict the drugs or that the push is based on what she called “manufactured misinformation”.
Moore said that reproductive rights supporters had long known that anti-abortion advocates “will stop at nothing to put mifepristone – a safe, effective FDA-approved medication that has been used for 25 years in this country to end a pregnancy at 10 weeks or less – back under lock and key”.
Carter Sherman contributed to this report