by Sofia Resnick, Missouri Independent
May 16, 2025

The Trump administration has agreed to review the safety and efficacy of abortion pills, based on white papers funded by far-right organizations, which reproductive health experts say are unscientific and contradict decades of research showing low rates of serious adverse events for the most common form of abortion.

But during a U.S. Senate hearing Wednesday, Health and Human Services Secretary Robert F. Kennedy Jr. called the findings “alarming.” He said he would order the Food and Drug Administration to “do a complete review” of the mifepristone-misoprostol regimen — but first he suggested the drug label “should be changed,” based on the data the anti-abortion movement has used to lobby Trump officials for the past two weeks.

Kennedy was answering a question from U.S. Sen. Josh Hawley (R-Missouri), whose attorney wife argued against the safety of mifepristone before the U.S. Supreme Court in 2024. The senator has been part of a strategy, which began after FDA approval in 2000, to restrict or ban medication abortion at the federal level. Earlier Wednesday, more than 100 groups sent the HHS secretary and the FDA commissioner a petition to restrict the use of the two-drug regimen.

Some anti-abortion activists see this as a significant win.

“The opportunity that this information provides to all of us, I believe, is the single biggest pro-life breakthrough since the overturn of Roe versus Wade, and we all know what a huge landmark that was,” said longtime movement leader David Bereit on a webcast Wednesday night. “And now we have an opportunity to continue to advance the cause of life.”

Bereit is the executive director of the Life Leadership Conference, a multimillion-dollar venture founded this year to help fund anti-abortion projects, according to the National Catholic Register.  

Data-driven strategy to convince Trump’s FDA to review abortion drug 

Self-published in late April by the Ethics & Public Policy Center and the Foundation for the Restoration of America, the white papers found that about 11% patients who took mifepristone experienced serious adverse events, which is 22 times higher than what’s on the current drug label for mifepristone.

The FDA’s prescribing label for mifepristone under the brand name Mifeprex says that based on U.S. and non-U.S. clinic studies, serious adverse reactions were reported in less than 0.5% of women.

The Ethics & Public Policy Center (EPPC) and the Foundation for the Restoration of America papers say their high sample size (865,727 “prescribed mifepristone abortions”) and recent time frame (2017 to 2023) make theirs the most comprehensive studies on the matter and trump the hundreds of peer-reviewed studies that have to-date found low rates of serious adverse effects. 

Reproductive health researchers and fact-checkers have criticized the EPPC’s broad classification of serious adverse events and pointed out that the analysis still shows low rates of the more serious risks typically linked to medication abortion, such as sepsis (0.1%), transfusion (0.15%), and hospitalization related to the abortion (0.66%).

Wednesday’s joint letter to HHS and the FDA, signed by Americans United for Life and more than 100 anti-abortion groups, describe their evidence as sufficient proof for the FDA to, even before evaluating new data, “reinstate the previous protections for women prescribed mifepristone.”

The FDA lifted “previous protections” between 2016 and 2021, following emerging safety data, that allowed people to get medication abortions up to 10 weeks’ gestation instead of seven, no longer required multiple in-clinic visits, and allowed the medicines to be prescribed via telemedicine and sent through the mail. These changes have made medication abortion the most accessible form of termination and have allowed abortion rates to rise in a country where more than half the states have banned abortion partially or outright.

That’s why medication abortions have become a target of the anti-abortion movement.

Previous papers finding that mifepristone was unsafe were produced by the Charlotte Lozier Institute in 2021 and 2022 and cited by a federal judge in a lawsuit brought by anti-abortion doctors that was rejected by the U.S. Supreme Court last year. It has since been revived with new plaintiffs. Those papers were peer-reviewed and published by the major academic publisher Sage. But under scrutiny, they were eventually retracted for methodological flaws and undisclosed conflicts of interest related to the peer review. The Charlotte Lozier researchers took legal action against Sage, arguing the retractions were political and that a pro-abortion bias exists in science and academia. A spokesperson for Susan B. Anthony Pro-Life America, which is the parent organization of  Charlotte Lozier, said neither organization was involved in producing or funding the most recent analysis.

This time, the groups sharing these claims with federal and state lawmakers have not publicly disclosed the source of the data nor the people who conducted the research.

“In the research that went into this, there were a number of doctors and scientists and data scientists who helped with this analysis, but for fear of reprisal, for fear of retaliation, they need to keep their names quiet,” said John T. Anderson, the Ethics & Public Policy Center’s president, who co-authored his organization’s white paper with director of data analysis Jamie Bryan Hall, on Wednesday’s webcast.

John Mize, the CEO of Americans United for Life, said he proposed using health insurance claims data to uncover health harms from medication abortion during an interview with the organization last year.

Mize said he quickly learned that groups in the anti-abortion movement were already beginning to comb claims data. The Ethics & Public Policy Center paper has spread as part of a multifaceted legal and messaging strategy, which Politico recently reported has been internally dubbed “Rolling Thunder” and includes trying to bring False Claims Act cases against doctors who tell patients the drugs are safe, based on the paper.

Mize acknowledged this paper was not peer-reviewed or published in a journal, which is standard in credible scientific research, but he said it wasn’t meant to stand as evidence alone. He said the goal was to get the FDA to review medication-abortion safety, and reconsider new regulations.

“I’m not saying that this is, like, definitive proof,” Mize told States Newsroom. “But it points in the direction that the FDA should say, ‘You know what? Maybe we need to do more to research this.’”

The Ethics & Public Policy Center advocates for policies restricting abortion and helps train physicians to testify against abortion in legislatures and in the courts. The organization was on the advisory board of the Heritage Foundation’s Project 2025, the controversial presidential blueprint that President Donald Trump distanced himself from during the campaign but has since begun to implement, including on abortion.

On EPPC’s board of directors sit two powerhouses of the Christian right movement: Princeton University professor Robert P. George and Leonard Leo, the co-chairman of the influential legal network the Federalist Society. Leo is credited with hand-picking Trump’s first three Supreme Court nominees, whom Trump promised were open to overturning Roe v. Wade, and with it almost 50 years of federal abortion rights.

EPPC’s communications director Hunter Estes said their research project began last fall and was done separately from the paper published by the Foundation for the Restoration of America, a nonprofit run by far-right political operative Doug Truax. Truax is also the founder and CEO of a health insurance group based in Illinois. He declined to comment. The Foundation paper lists no author and credits the research to “our clinical team of board-certified obstetrician-gynecologists.”

Breaking down the claims 

Reproductive health experts told States Newsroom that the sweeping claims in the white papers largely rely on stretching the standard definition of serious adverse events, lumping in deadly infections like sepsis with emergency visits that could be merely observational; preexisting chronic conditions; and instances where an additional treatment was needed to complete the abortion.

“The coding of all emergency department visits as serious adverse events to me suggests they don’t understand abortion,” said Ushma Upadhyay, an epidemiologist at the University of California San Francisco, who has been researching mifepristone safety for most of her career. “There’s demonstrated research that people are more likely to go to the emergency room if they live further away from the abortion provider and … they want reassurance about their symptoms. That is not a serious adverse event.”

Estes defended including emergency room visits in the list of serious adverse events, even though the FDA does not explicitly. He said his team only counted emergency room visits that were related to the abortion and were more serious than “mild cramping.”

“Thus, if a woman took the chemical abortion pill and then got into a car accident or broke a bone, that did not count,” Estes told States Newsroom in an email. “This led us to exclude 72% of emergency room visits that took place within 45 days of abortion from our analysis.”

Another major red flag for reproductive health researchers is that the anti-abortion groups have not named their data source or specific codes used.

Both groups say they analyzed commercially available all-payer health insurance claims for the years 2017 through 2023. The EPPC paper says the database it used “includes information on hospital and office visits, diagnoses, procedures, and prescriptions processed through private health insurance, Medicaid, Medicare, TRICARE, and the Department of Veterans Affairs (VA). The data excludes transactions for which the insurer is also the provider (as is the case with some HMOs and much VA care), as well as cash pay transactions (which are disproportionately common for abortion). This dataset provides longitudinal tracking of medical diagnoses, procedures, and prescriptions for each patient.”

Estes said the paper’s description of their dataset should be enough to replicate it.

“We are not legally permitted to share that information or provide the data set,” Estes said. “However, these datasets are both widely used. … Large companies throughout the health care and health insurance industries almost certainly have access to the data we used, as do many researchers who publish in academic journals.”

But Julia Strasser, a reproductive health researcher and professor at George Washington University’s Fitzhugh Mullan Institute for Health Workforce Equity who regularly works with claims data, said she couldn’t identify the EPPC’s data source. She said there’s a high learning curve for understanding and analyzing this data. And she said claims databases vary widely.

“It might be the highest number of patients, but there are a lot of problems with this study,” Strasser said. “In public health in general, it’s rare that there is one single study or one single publication that is sort of the silver bullet that proves or disproves something. It’s about the totality of the evidence. And we have 100 studies about mifepristone in the real-world context in the last 25 years that are showing that it’s safe and effective.”

But it’s enough to compel the Trump administration to take action on medication abortion, something abortion-rights advocates say could create major barriers to getting care even in states with major abortion bans or restrictions. The EPPC paper does not report any findings related to telemedicine abortion, but asserts the FDA should return to previous protocols that did not include telemedicine while reviewing the data further. It also suggests the agency should “reconsider its approval altogether.” The administration has not yet announced any restrictions on medication abortion.

“It is terrifying to think that our access to safe FDA-approved medications turns on President Trump’s gut instinct rather than credible scientific evidence,” said Americans Civil Liberties Union attorney Julia Kaye on a webinar with other abortion-access advocates Thursday. “There is still time for President Trump to make good on his campaign promise not to strip away access to medication abortion, but all signs right now suggest that this FDA review based on junk science is just about fulfilling the wish list of anti-abortion extremists.”

Missouri Independent is part of States Newsroom, a nonprofit news network supported by grants and a coalition of donors as a 501c(3) public charity. Missouri Independent maintains editorial independence. Contact Editor Jason Hancock for questions: info@missouriindependent.com.

The post Feds agree to review mifepristone safety based on anti-abortion research appeared first on missouriindependent.com

Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.

Political Bias Rating: Far-Right

The content shows a clear alignment with anti-abortion perspectives, highlighting claims made by far-right organizations regarding the safety of mifepristone and presenting criticism of the scientific consensus that supports its safety. The article emphasizes concerns raised by conservative and anti-abortion figures such as Robert F. Kennedy Jr. and groups like the Ethics & Public Policy Center, which advocate for restricting abortion access. The tone suggests that the actions of the Trump administration, including the review of mifepristone, align with a broader ideological push from far-right factions to limit reproductive rights. This focus on anti-abortion activists and their interpretations of data, while critiquing the established medical research, frames the article as advocating for the far-right political agenda on abortion policy.