Reproductive rights advocates are voicing concerns about HHS Director Robert F. Kennedy Jr.’s recent actions. During a Senate hearing, Kennedy instructed the FDA to reassess the medication, referencing findings from a study conducted by the Ethics and Public Policy Center (EPPC), a conservative think tank.
Critics argue that Kennedy is using questionable data to undermine established science regarding Mifepristone, suggesting that the “new data” he cited comes from flawed analyses pushed by anti-abortion groups to influence the Trump administration’s policies on medication.
“They are clearly ignoring decades of peer-reviewed studies that affirm Mifepristone’s safety and even the FDA’s earlier reviews,” said Ushima Upadyay, a professor at the University of California, San Francisco.
She expressed concern that instead of working to eliminate unnecessary barriers to accessing these drugs, there seems to be a move to employ dubious science as a foundation for imposing new restrictions.
Kennedy has previously stated that Mifepristone warrants further examination, particularly during a confirmation hearing in January when President Trump urged him to evaluate its safety.
“Patients shouldn’t have their access restricted based on unscientific claims for political reasons,” commented Julia Kay, a senior attorney at the ACLU’s Reproductive Freedom Project.
The process of drug abortion typically involves two medications: Mifepristone, which halts pregnancy, and Misoprostol, which induces contractions and bleeding to clear the uterus.
The FDA approved Mifepristone in 2000 for medical abortion up to seven weeks after conception, extending this permission to 10 weeks in 2016.
“While Mifepristone is still available, the future access is in jeopardy,” commented Jencastle, a national director focused on reproductive healthcare in the U.S.
“This clandestine approach could compromise the integrity of the FDA and the drug approval system,” she added.
Recent shifts in Supreme Court rulings are affecting access to medication abortion, and according to the Guttmacher Institute, there are currently multiple restrictions on accessing abortion medications, contingent on state laws and prescribing regulations.
Research indicates that drug abortions have a high success rate of approximately 99%, with serious complications occurring in around 0.4% of cases and mortality rates at about 0.001%. A plethora of studies have reviewed the safety and efficacy of Mifepristone and Misoprostol, consistently underscoring their safety.
Since its approval, over 7.5 million individuals have used Mifepristone for abortive care and miscarriage management, with data revealing that in 2023, 63% of abortions in the U.S. were medication-based, according to the Guttmacher Institute.
“There’s a solid foundation of safety and efficacy for Mifepristone, and attempts to mislead the public are not new,” noted Skye Perryman, head of Democracy Forward and a former advisor on obstetric practices.
“It’s surprising to see political influence affecting expert evaluations, especially given the longstanding work of career professionals in this field,” she continued.
Many reproductive rights groups and scientists are casting doubt on the findings of the new research Kennedy referenced in the Senate hearing.
The recent study analyzed over 85,000 cases of medication abortion from 2017 to 2023, claiming that nearly 11% of women faced serious adverse effects after taking the drugs—almost 22 times higher than FDA statistics.
Upadhyay pointed out that one critical flaw in the study is counting emergency room visits as “serious adverse events,” which could misrepresent the actual risks associated with Mifepristone. “Just visiting the emergency room doesn’t mean there was an actual medical issue,” she explained.
The study fails to specify what constitutes “other abortion-specific complications,” and it doesn’t identify the claims database utilized, merely describing it as a compilation from various insurance claims.
A spokesperson for HHS reassured that the FDA remains dedicated to public health, emphasizing their intent to rigorously examine the latest scientific data to inform their decisions.
The EPPC spokesperson mentioned that they were unable to disclose the data source due to contractual limitations, reiterating their commitment to honoring these obligations.
For further details on the findings, the EPPC has recently published a FAQ document addressing the “Serious Adverse Events” mentioned in their study.
