Robert F. Kennedy Jr. instructs the Food and Drug Administration to review mifepristone
Kennedy’s decision to review the drug appears to be based at least partly on a recent study published by a right-wing think tank.
On May 14, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. directed the Food and Drug Administration to review the abortion drug mifepristone, a medication that was approved 25 years ago as a safe method for the termination of pregnancy and is often used for miscarriage care.
Mifepristone, sold under the brand name Mifeprex, 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 second drug called misoprostol, which causes uterine cramping and bleeding and the expulsion of fetal tissue.
Over 5 million patients in the United States have used mifepristone since its approval, and it was used in 63% of all abortions performed in the country in 2023.
Kennedy’s decision to review the drug appears to be based partly on a study titled “The Abortion Pill Harms Women,” which was published on April 28 by the Ethics and Public Policy Center, a right-wing think tank and adviser in the creation of Project 2025, a 900-page mandate created by the Heritage Foundation in 2024 outlining the initiatives of a Republican presidency.
The Ethics and Public Policy Center study has come under fire from physicians and legal experts for its faulty methodology. It did not undergo a formal external peer review, according to reporting from the Washington Post, and Stella Dantas, president of the American College of Gynecology, criticized the study, telling AFP Fact Check, “Decades of reputable, peer-reviewed, scientific evidence and use data prove that medication abortion is safe and effective.”
The study alleges that a review of insurance claims for over 865,000 prescribed mifepristone abortions between 2017 and 2023 revealed that there had been “serious adverse events,” with nearly 11% of women experiencing sepsis, infection, and hemorrhaging within 45 days after taking the pill. This conclusion goes against numerous previous studies that found that less than 1% of patients taking the drug had serious complications.
The study also cites ectopic pregnancies, when a fertilized egg implants outside of the uterus, most often in the fallopian tubes, as a reason mifepristone should be solely administered in a clinic, hospital, or under the supervision of a physician.
Mifepristone does not harm patients with an ectopic pregnancy.
There have been 36 reports of deaths of patients who took mifepristone since its approval in September 2000, a 2024 FDA report concluded. Those deaths included just two cases of ectopic pregnancy and several fatalities related to sepsis.
However, the FDA said, “The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient.”
Carrie Flaxman is Democracy Forward’s senior legal adviser. She told the American Independent that restricting access to mifepristone is one of the objectives highlighted in Project 2025, and Kennedy’s directive to the FDA seems to align with that.
“You have over hundreds of studies demonstrating that this medication is safe and effective, you have real-world use by millions of patients over nearly 25 years, and this pseudo-study that has numerous flaws and that scientists don’t consider to be fact,” Flaxman said.
Despite multiple studies proving the safety of mifepristone, in his recent testimony before the Senate Health, Education, Labor, and Pensions Committee, Kennedy said, “Ultimately, policy changes will go through the White House.”
Flaxman said that considering the policies of the White House to assess drug approvals “is certainly not the way FDA has made decisions in the past, and certainly not the way FDA should be making decisions.”
She added that it should be people who “understand the science, understand medication safety and efficacy. It should be them making the decisions; they should not be subject to political pressure, either, you know, from anti-abortion extremists, and it shouldn’t be going through the White House.”
Mifepristone is regulated under the Risk Evaluation and Mitigation Strategy, a federal drug safety program used to determine the classification of a drug. Only a health care provider who is certified under the Mifepristone REMS Program can prescribe the drug. and it can only be dispensed by or under the supervision of a certified prescriber or by a certified pharmacy.
Mifepristone used with misoprostol has been recommended by notable health entities, including the World Health Organization.
