By Reproductive-rights advocates are pushing back against the review of the abortion medication mifepristone ordered by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.
Kennedy directed the Food and Drug Administration (FDA) to review the medication during a Senate hearing Wednesday because of findings laid out in a new study conducted by the Ethics and Public Policy Center (EPPC), a conservative think tank.
Advocates say Kennedy is using inaccurate data on the drug to justify going against the existing science on mifepristone. They say the “new data” Kennedy mentioned comes from a flawed analysis that anti-abortion groups across the country are using to persuade the Trump administration to impose restrictions on the medication or ban its use.
“It’s clear they are ignoring decades of peer-reviewed research demonstrating mifepristone safety and the FDA’s own review of this research,” said Ushma Upadhyay, professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.
“The FDA could be doing even more to eliminate medically unjustified barriers to these medications. Instead, there is now an effort to use junk science as a basis for even more restrictions,” she added.
Kennedy has said in the past that mifepristone should be reviewed, most notably during his Senate confirmation hearing in January when he said President Trump had asked him to study the safety of the drug.
“Patients should not be losing access to the safest and most effective regimen for care based on junk science for political wins,” said Julia Kaye, senior staff attorney with the American Civil Liberties Union’s Reproductive Freedom Project.
Medication abortions typically involve the use of two drugs, mifepristone and misoprostol. Mifepristone stops a pregnancy from continuing, and misoprostol is used to induce cramping and bleeding in order to empty the uterus.
Mifepristone was first approved by the FDA in 2000 for the medical termination of a pregnancy up to seven weeks after conception, according to the agency’s website. And the drug was approved for the termination of a pregnancy up to 10 weeks of gestation in 2016.
“Right now, mifepristone is available, but that reality is in jeopardy,” said Jen Castle, national director of abortion care and access at the Planned Parenthood Federation of America.
“A back-door effort like this undermines the FDA’s credibility and puts our entire drug approval system in the balance.”
The Supreme Court recently ruled to preserve access to medication abortions, but such access continues to change. There are 28 states that restrict access to abortion medication in some way, either due to total abortion bans or regulations on who can prescribe it and how patients can receive it, according to the Guttmacher Institute, an abortion and reproductive rights nonprofit.
Research shows that medication abortions have a roughly 99 percent success rate when terminating a pregnancy, with a 0.4 percent risk of serious complications and a mortality rate of 0.001 percent. More than 100 scientific studies have been conducted to examine the safety and efficacy of using mifepristone and misoprostol to end a pregnancy. All of them found that both medications are safe.
More than 7.5 million people have used mifepristone to end a pregnancy or to treat a miscarriage since it was first approved 25 years ago, according to Planned Parenthood.
In 2023, 63 percent of all abortions in the country were performed using medication, according to data from the Guttmacher Institute.
“The safety and efficacy of mifepristone is well established. Disinformation attempts to mislead the public on the safety and efficacy of mifepristone are also not new,” said Skye Perryman, president and CEO of Democracy Forward. Perryman was also the former general counsel for the American College of Obstetricians and Gynecologists and was involved in litigation requiring the FDA to allow mifepristone to be sent to patients in the mail.
“It is alarming to see the Secretary respond to political pressure and suggest that science and evidence are evaluated at the White House, as opposed to by career experts who have studied and evaluated mifepristone for decades.”
Reproductive-rights groups and scientists alike have questioned the findings and methodology of the new study Kennedy referenced during his Senate hearing earlier this week.
The EPPC said the study, released last month, is an analysis of insurance claims for more than 85,000 medication abortions from 2017 to 2023 that shows almost 11 percent of women experienced a serious adverse event after ingesting the drugs, nearly 22 times higher than what the FDA reports.
Upadhyay said one of the biggest flaws of the study is its inclusion of emergency room visits as one of the “serious adverse events” that can occur after taking abortion medication.
In the study, “serious adverse events” are broken down into categories. Some of those categories include hemorrhage, sepsis, transfusion and emergency room. It appears that the trips to the emergency room were counted as an adverse event even if health care workers deemed the patient fine and released them without any treatment, according to Upadhyay.
The clumping of all emergency room visits without a clear explanation for the visit and its outcome appears to be an attempt by the study’s crafters to “artificially and inaccurately” inflate the health risks associated with mifepristone, she added.
The highest number of abortion complications fall under the category of “other abortion-specific complications,” and nowhere in the study does it clearly explain what those complications are.
The study also does not name the insurance claim database used, saying only that it is compiled from a “commercially available all-payer health insurance claims database including de-identified data” purchased by the organization.
A spokesperson for HHS said the FDA continues to be committed to safeguarding public health by “ensuring the safety, efficacy, and quality of the products it regulates.”
“The agency rigorously evaluates the latest scientific data, leveraging gold standard science to make informed decisions. With a steadfast focus on protecting consumers, the FDA applies a balanced, science-based approach while incorporating practical, common-sense considerations to its regulatory processes,” HHS spokesperson Andrew Nixon wrote in an email to The Hill.
An EPPC spokesperson said the group could not share the source of its data due to restrictions imposed on it by the data vendor.
“We are committed to honoring those contractual obligations,” EPPC spokesperson Hunter Estes wrote. “However, I will note that this insurance data is available from approximately a dozen data brokers and is widely used by researchers and health professionals.”
Estes referred to a recently published FAQ document about the report in response to questions on the “serious adverse events” categories.