HHS Secretary Robert F. Kennedy Jr. tells FDA to review safety of mifepristone

The abortion pill mifepristone was approved by the U.S. Food and Drug Administration 25 years ago. Since then, according to Planned Parenthood Federation of America, the pill has been used safely and effectively by 7.5 million Americans as a more private method of ending a pregnancy than a surgical procedure. 

On May 14, Secretary of Health and Human Services Robert F. Kennedy Jr. directed the FDA to review the safety of the abortion drug. The order followed the publication on April 28 of a report titled “The Abortion Pill Harms Women,” published on April 28 by the Ethics and Public Policy Center. EPPC is a right-wing think tank and was an adviser in the creation of Project 2025, the Heritage Foundation agenda that is now the basis for many of the policies and actions implemented by the Trump administration. 

The study, which Glenn Kessler noted in the Washington Post was neither peer-reviewed nor published in a medical journal, says that a review of insurance claims for over 865,000 “prescribed mifepristone abortions” between 2017 and 2023 shows “The real-world rate of serious adverse events following mifepristone abortions is at least 22 times as high as the summary figure of ‘less than 0.5 percent’ in clinical trials reported on the drug label.” It claims nearly 11% of women experienced sepsis, infection, and hemorrhaging within 45 days after taking the pill.

Stella Dantas, MD, president of the American College of Gynecology, told AFP Fact Check, “Decades of reputable, peer-reviewed, scientific evidence and use data prove that medication abortion is safe and effective.” She said the EPPC report “manipulates data to drive a myth that medication abortion isn’t safe.”Numerous previous studies found that less than 1% of patients who took the drug had had serious complications. 

Ushma Upadhyay, a public health scientist and a professor in the Department of Obstetrics, Gynecology, & Reproductive Sciences at the University of California, San Francisco, said anti-abortion advocates are pushing for review of the drug’s safety, claiming there’s “new evidence to consider” based on “new junk science reports [that] were put up on the internet.” 

“I think the big question is, are they using gold standard science to review?” Upadhyay told the American Independent. “Are they adhering to gold standard principles, standard epidemiological principles, and reviewing science? And those would require limiting to peer-reviewed studies, really going through the weaknesses and limitations of each study, and getting a sense of the consensus of the research.” 

Asked to give an example of what in these reports anti-abortion advocates might point to in calling for safety reviews, Upadhyay noted that they call any visit to the emergency department  “a serious adverse event.” 

“We know that people go to the emergency room all the time when they don’t have their own primary care provider, or if they traveled hundreds of miles to get that care and they don’t have anyone local, like an abortion provider or an OB-GYN, who can check them out,” Upadhyay said.. 

“Medication abortion can be extremely scary for someone. People often go through it alone. They don’t know whether this amount of bleeding is normal. They have questions. … They might take the time after work, in the evening, and there’s no place to go. So there’s many reasons why people go to emergency rooms, and it’s not because they’re experiencing a serious adverse event,” she said. 

Upadhyay said she conducted a study that found 50% of all abortion-related emergency department visits were observation care only. Patients received no treatment and were released the same day.  In addition, due to hospital coding, it was impossible to tell whether the patients had had a surgical procedure or had taken mifepristone.

She continued: “So another issue is that they called — a large proportion of the serious adverse events were due to hemorrhage, but they don’t actually define ‘hemorrhage’ or use a standardized definition. Often, when people come in to the health care provider or an emergency room, it might say hemorrhage, but it just means that they’re bleeding, and to really qualify for a hemorrhage, they need to be treated. You know, you can’t call something a hemorrhage and not give them any treatments. That’s not a hemorrhage. It doesn’t meet the technical definition for hemorrhage. So that’s another example of how they overinflate that.”

Sold in the United States under the brand name Mifeprex, mifepristone stops a pregnancy from developing by blocking the hormone progesterone, which results in a softening of the cervix and shedding of the lining of the uterus. It is used in combination with a drug called misoprostol, which causes uterine cramping and bleeding and the expulsion of fetal tissue. The drug was used in 63% of all abortions performed in the country in 2023. 

Peter Lurie, a former associate commissioner for public health strategy and analysis at the FDA who is currently the president of the Center for Science in the Public Interest, says this latest safety review of mifepristone is concerning to him for several reasons. 

“The idea that a HHS secretary would pick out a particular drug for particular scrutiny is, if not unheard of, very, very unusual. That is just not the way things work,” Lurie said. “They shouldn’t be involved, because, you know, remember? Guy’s not a doctor. He’s got no qualifications at all. On what basis, other than politics, has this product been selected for particular scrutiny? That’s the question, and I don’t think there is. 

“They’ll point to this study or that study, but that’s the cherry-picking, and they’ll ignore the studies that establish safety and better-done studies that established safety, I mean, the original FDA studies. The most compelling data here is the FDA studies, because the FDA studies are the ones that look for adverse events actively,” Lurie said.  

Upadhyay said she suspects that the FDA review of mifepristone is being done to find evidence to justify reimposing in-person dispensing requirements for the drug and to eliminate telehealth prescribing. Telehealth has been the only way that patients in states with abortion bans have been able to access abortion care in those states since 2022, when the U.S. Supreme Court reversed Roe v. Wade and the constitutional right to abortion.  

She said that until 2023, telehealth services were not covered by insurance, so studies that look at insurance claims from before 2023 for evidence for or against telehealth prescribing of mifepristone are not helpful.

“What they need to do is look at the published literature on telehealth for medication abortion, and what they would find is that it is as safe and effective as in-person care,” Upadhyay said.