A new study has led to Health and Human Services Secretary Robert F. Kennedy, Jr. to order a “complete review” of the abortion pill, mifepristone, amid queries from Congress.
Sen. Josh Hawley (R-MO) and Sen. Steve Daines (R-MO) asked the Food and Drug Administration (FDA) to reinstate safety protocols for the drug in response to a study by the Ethics and Public Policy Center (EPPC).
At a hearing before the Senate Health, Education, Labor and Pensions Committee on May 14, Kennedy called the study alarming, “and clearly it indicates at the very least the [FDA] label should be changed.”
Kennedy did not provide a timeline but affirmed it would be a top priority and that any changes to safety protocols on the drug that were removed by the Biden administration would ultimately be made by President Trump.
Congressional Action
Hawley also introduced a bill, the Restoring Safeguards for Dangerous Abortion Drugs Act, which would require reinstatement of the protections and allow women who have suffered complications the legal right to sue telehealth providers and pharmacies for damages.
The bill would also ban foreign companies from mailing or importing mifepristone into the United States.
In 2024, the U.S. Supreme Court rejected a lawsuit calling for the court to rule the FDA’s approval of mifepristone in September 2000 was illegal. The procedural decision did not consider the merits of the case.
Serious Complications
The EPPC study, “The Abortion Pill Harms Women,” found close to 11 percent of women experience severe or life-threatening complications after using the drug to end pregnancies. The rate is 22 percent times that listed on the drug’s label.
Study authors Jamie Bryan Hall and Ryan T. Anderson say it is the “largest-known study of the abortion pill.” The study is “based on analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023,” the authors write.
The database, the authors say, is 28 times larger than the total included in all FDA-cited clinical trials. The authors’ dataset is also more recent than the data used to justify approval of mifepristone.
The rate of serious adverse events is at least 22 times as high as the “less than 0.5 percent” figure observed in the clinical trials and reported on the drug’s label, Hall and Anderson say.
Obliterated Objectivity
“Fierce debates about abortion in our society often prevent objective analysis of data on the topic; however, given that chemical abortions now account for two-thirds of all abortions, these findings deserve close scrutiny and attention,” wrote EPPC fellow Aaron Kheriarty in a Substack post about the study.
The findings of clinical trials may not coincide with what happens when a drug or procedure goes into widespread use, says Kheriarty.
“Real world data can sometimes differ from the findings of highly controlled and selective clinical trials, for example, if the patient selection criteria in clinical practice is less stringent than the controlled experimental conditions of a clinical trial,” writes Kheriarty.
“Furthermore, during the previous two administrations, the FDA relaxed the safety protocols for mifepristone, which may also contribute to these findings,” writes Kheriarty.
Kheriarty provides a chart showing the weakening of safeguards for the abortion pill during those presidential administrations (see graphic).
Outdated Data
The evidence supporting the approved “less than 0.5 percent” figure is “based on old studies conducted under extremely controlled conditions” and shows an “urgent need” for the FDA to immediately reinstate the previous safeguards, says Donna Harrison, M.D., a board-certified OB-GYN and director of research for the American Association of Pro-Life Obstetricians and Gynecologists.
“We’ve seen a lot of evidence pointing to the possibility that this drug’s real-world rate of complications is actually much higher, especially given the proliferation of mail-order abortion,” said Harrison.
The EPPC report and other studies highlight “the urgent need for the FDA to conduct further research into the safety of mifepristone and immediately reinstate the original safeguards on this drug that were in place when it was first approved,” says Harrison.
Risky Mail-Order Abortions
“Real-world data proves common sense: these drugs are dangerous,” said Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America. “A growing body of evidence shows the serious harm these drugs pose to women as well as their babies.”
“At a minimum, the Trump administration should reverse the Biden FDA’s reckless nationwide mail-order abortion drug policy,” said Dannenfelser. “We urge the Trump administration to reinstate basic measures that require real medical oversight.”
The FDA announced in 2023 it would allow pharmacies to mail mifepristone to customers, leading to pushback from 20 state attorneys general at the time.
Returning to the Clinton administration’s regulations on mifepristone would protect women from unsupervised abortions through mail-order drugs, says Harrison.
“Restoring the drug’s original regulations would, most importantly, end the reckless practice of mail-order abortion, through which women have been abandoned to undergo a risky and potentially traumatic or even life-threatening process with minimal medical supervision,” said Harrison.
Trump’s Take
Harrison says the Trump administration is taking a different tack.
“Luckily, the current administration has shown interest in investigating the safety of abortion drugs and potentially taking action to protect the safety of the women who take them,” said Harrison. “Our patients deserve better than the appalling quality of care that has been sold to them in the name of abortion access.”
The current policy on mifepristone is unfair to women, says Dannenfelser.
“Women and girls deserve better than high-risk drugs with no in-person doctor, no follow-up, and no accountability,” said Dannenfelser. “This isn’t health care; it’s harm.”
Harry Painter ([email protected]) writes from Oklahoma.
Internet info:
Jaimie Bryan Hall, Ryan T. Anderson, “The Abortion Pill Harms Women: Insurance Data Reveals One in Ten Patients Experiences a Serious Adverse Event,” Ethics and Public Policy Center, April 28, 2025: https://eppc.org/wp-content/uploads/2025/04/25-04-The-Abortion-Pill-Harms-Women.pdf
Harry Painter ([email protected]) writes from Brooklyn, New York.
