On Thursday, US Health Secretary Robert F. Kennedy Jr. reiterated the review is necessary after the Biden administration eliminated the in-person requirement for prescribing mifepristone, claiming in a post on X that, “Recent studies already point to serious risks when mifepristone is used without proper medical oversight.”
But while periodic reviews of approved drugs are routine, the political pressure surrounding this one is not.
Mifepristone, a hormone blocker sold under the brand name Mifeprex, was approved by the US Food and Drug Administration in 2000 for ending pregnancies after the first seven weeks. In 2016, the FDA extended the period for medical termination to 10 weeks. In 2023, the Biden administration expanded access to the drug through mail delivery and telehealth.
In a Sept. 19 letter to Republican attorneys general, Kennedy said the FDA review was prompted by new data, including a paper by the Ethics and Public Policy Center, a conservative Washington, D.C., think tank with ties to Project 2025. In the study, researchers analyzed insurance claims from 865,000 mifepristone prescriptions between 2017 and 2023 and found nearly 11 percent of women had a “serious adverse event” within 45 days of using it, including visits to the emergency room, heavy bleeding, and infection. Kennedy also said that, since the FDA stopped requiring prescribers to report nonfatal complications tied to mifepristone in 2016, the new analysis would help fill in data gaps.
The American College of Obstetricians and Gynecologists says there are decades of evidence that mifepristone is safe and effective and that complications are exceedingly rare. An analysis of FDA data published earlier this year by researchers at the University of California, San Francisco, noted that serious complications occur in fewer than 1 percent of cases.
As the FDA undertakes a review of mifepristone’s safety, it also approved a new generic version of the drug earlier this week — a move that could broaden availability even as the agency weighs whether to impose new restrictions.
“The FDA has very limited discretion in deciding whether to approve a generic drug,” HHS spokesperson Andrew Nixon said. “By law, the Secretary must approve an application if it shows the generic is identical to the brand-name version, and applicants are not required to submit independent evidence of safety and effectiveness. HHS is reviewing reported adverse effects of mifepristone to ensure the FDA’s risk-mitigation program adequately protects patients.”
It’s unknown how long the new review of mifepristone will take, Harvard law professor I. Glenn Cohen said.
“In announcing the review, the agency appears to be relying on a non–peer–reviewed study,” he said. “That suggests this may not reflect the FDA’s typical, careful process, but rather an effort aimed at restricting access.”
The most likely outcome, Cohen said, is a change to the terms under which mifepristone can be prescribed and dispensed, such as one that allows physicians to prescribe it after consulting with the patient remotely, or via telemedicine.
“A return to in-person administration requirements may be under discussion, and that would have a significant effect on telemedicine access to the drug,” Cohen said. “They may also reexamine up to what month of pregnancy the drug may be used, which would also have a major impact on usage.”
Harvard Medical School professor Jonathan Darrow noted the FDA has a range of options short of pulling the drug from the market, including sending new usage guidance directly to doctors, revising risk guidelines, and adding a black-box warning to the label. The black box is a bold border around the prescription to alert doctors and patients to the risk of severe or life-threatening side effects, and may mean that prescribers need to take extra precautions before prescribing.
Withdrawal of a drug, he added, is rare and typically happens voluntarily. “If the FDA were to act unilaterally, it would be an expensive and unusual process,” he said.
Any new barriers would have a broad impact since medication abortion accounts for about 60 percent of abortions in the United States. The most common method is a two-drug protocol that combines mifepristone with misoprostol. If the FDA narrows access to mifepristone, Cohen said, “there will likely be much greater interest in misoprostol-only abortions, which are common globally.”
Misoprostol-only abortions are safe but slightly less effective than using both drugs in combination.
The review comes amid a new round of political and legal fights over medication abortion. Over the last year, the federal government moved to restrict abortion care and counseling for veterans and pushed budget provisions that would cut Medicaid reimbursements for providers such as Planned Parenthood. At the local level, some 27 states have introduced 89 bills attacking medication abortion.
During a Senate hearing earlier this year, Kennedy said he would implement President Trump’s chosen policy on mifepristone, regardless of what the science says.
“The devil is in the details. If you’re telling me 99 percent of women did OK, but 1 percent died, I would say that is not a beneficial risk profile,” he said in response to questions by Wisconsin Senator Tammy Baldwin.
Dr. Angel Foster, a physician with Cambridge Reproductive Health Consultants, said she “welcomes a genuine scientific review [by the FDA] because science is on our side.”
“But what’s happening now is not a typical FDA process. This so-called study being cited would never normally be part of an FDA review. It’s not rigorous, not peer-reviewed, and comes from a partisan think tank.”
Foster said that if the FDA were truly following the data, the drug would be made even more accessible. “The agency has been cautious — more cautious than the evidence warrants,” she said. “Any evidence-based review should actually remove restrictions, not add new ones.”
Foster also described the scale of medication abortion provided by the Massachusetts Medication Abortion Access Project, which her group oversees. Since launching in October 2023, MAP has mailed mifepristone six days a week to about 2,000 to 2,500 patients each month. This year, Foster estimates the project will serve 30,000 patients. Roughly 95 percent of those patients live in states with near-total abortion bans.
Cohen said most patients find MAP through “Plan C” websites, which direct them to telehealth and mail services. Most are under nine weeks of pregnancy, confirmed by self-report of their last menstrual period.
She said MAP has not faced lawsuits as some physicians in New York and California have, and credits Massachusetts’ shield law, which protects providers from out-of-state prosecution.
“We are confident in the protections here,” Foster said. “We are a compliant, formal part of the health care system, and we’re very proud of the service we provide.”
Meanwhile, Governor Maura Healey and Attorney General Andrea Campbell are taking new steps to safeguard access.
On Monday, Campbell co-led a coalition of 20 attorneys general urging the FDA to resist political pressure from Republican counterparts seeking to restrict or withdraw the drug. “Medical decisions should be left between patients, their families, and their providers — and they should be guided by science, not political agendas,” the coalition said in a joint statement.
Also, the state is updating its stockpile of 15,000 doses of mifepristone, which Healey created in 2023 after the reversal of Roe v. Wade. Half of those doses were distributed to providers for patients seeking medication abortion, while roughly 7,500 remain in state hands with an expiration date of 2029.
“Mifepristone has been used safely and effectively for 25 years. This ‘review’ is nothing more than another ploy by Donald Trump and Robert Kennedy to further take away women’s reproductive rights,” Healey said in a statement to the Globe. “I stockpiled mifepristone because we are going to make sure that medication abortion remains accessible in Massachusetts.”
Sarah Rahal can be reached at sarah.rahal@globe.com. Follow her on X @SarahRahal_ or Instagram @sarah.rahal.
