Federal agencies are studying safety of abortion drug mifepristone, driving new concerns about limits on access

By Meg Tirrell, Deidre McPhillips, Jamie Gumbrecht, CNN

(CNN) — The US Food and Drug Administration is reviewing evidence about the safety and efficacy of one of the drugs used in medication abortion to investigate how it can be safely dispensed, US Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary wrote in a new letter to 22 Republican attorneys general.

Kennedy and Makary said the FDA would conduct “its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy” of mifepristone.

“This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” they wrote in the letter, sent September 19.

The letter is driving concern among abortion advocates that the federal government may put new limits on access to medication abortion, which has been more broadly available through telehealth in recent years.

Kennedy already told senators earlier this month that the FDA is collecting new data for a safety review of mifepristone and said “those studies are progressing and that they’re ongoing.” Kennedy claimed in the hearing that the Biden administration “twisted the data” on mifepristone to “bury one of the safety signals,” but didn’t provide additional details about what the safety issue could be.

“We’re getting data in all the time — new data that we’re reviewing,” Kennedy told the US Senate Committee on Finance.

The Republican attorneys general cited a report from the Ethics and Public Policy Center — which describes itself as “pushing back against the extreme progressive agenda while building a consensus for conservatives” — as evidence that mifepristone is risky and requires more oversight.

Kennedy and Makary said in their new response that the report indicates “potential dangers that may attend offering mifepristone without sufficient medical support or supervision.” But many experts consider the report to be “junk science,” and it has not been peer-reviewed or published in a medical journal.

Lack of transparency is a key concern, said Dr. Ushma Upadhyay, an associate professor in the department of obstetrics, gynecology and reproductive science at the University of California, San Francisco, who put together a 10-point review of major flaws in the report. There’s very little information provided about the source of the data, she said.

The level of risk the report found to be associated with mifepristone is overstated, she said. Any visit to an emergency room was counted as a serious adverse event, including those visits that did not require any treatment; other research suggests that about half of abortion-related emergency department visits are for observation only.

The Society of Family Planning, a nonprofit organization focused on research related to abortion and contraception, has urged the FDA to dismiss the paper for its lack of scientific standards.

“In short, this paper is not a methodologically rigorous, evidence-based resource, and does not warrant consideration, particularly in scientific spaces,” the group wrote in a letter to Makary.

Mifepristone is commonly used along with another drug, misoprostol, for medication abortion in the United States. The FDA approved mifepristone in 2000, and it has long been shown to be safe and effective. It is cleared to end a pregnancy through 10 weeks of gestation.

Clinical studies and decades of use have established the drug’s safety and effectiveness. Since its approval in the US in 2000, there have been 5 deaths associated with mifepristone for every 1 million people who used it, according to the FDA. That means the death rate is 0.0005%. Mifepristone’s safety is on par with those of common over-the-counter pain relievers like ibuprofen and acetaminophen, studies show.

Major medical groups, including the American College of Obstetricians and Gynecologists, have repeatedly called for more mifepristone accessibility. During the Covid-19 pandemic, the Biden administration began allowing certified providers to prescribe the drug via telehealth and ship it by mail, which significantly expanded access, particularly in rural areas with few abortion clinics.

But anti-abortion advocates have claimed that the drug is not safe and that the FDA didn’t study it enough. Republican officials have repeatedly called for the government to rescind the telemedicine policy for mifepristone and restrict distribution to in-person visits only. The US Supreme Court declined in June 2024 to block the drug’s availability but left the door open for future regulatory changes, placing the spotlight back on federal agencies such as the FDA.

In 2024, there were more than 1 million abortions in the US for the second year in a row, according to the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health that supports abortion rights.

Since the US Supreme Court’s Dobbs decision revoked the federal right to abortion in June 2022, 20 states have enacted bans or severely restricted access, and some have implemented new protections for abortion care. Expanded access to clinics that provide medication abortion through telehealth has contributed to the rise in abortions in the US, according to Guttmacher: About 14% of abortions in 2024 were provided by online-only clinics, up from 10% in 2023 – or an increase of about 40,000 abortions.

The-CNN-Wire
™ & © 2025 Cable News Network, Inc., a Warner Bros. Discovery Company. All rights reserved.

CNN’s Jacqueline Howard contributed to this report.