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 will review evidence about the safety and efficacy of mifepristone, 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 the drug.”
“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 in 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.
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 to ensure its safety. 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 like 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.
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