On September 4, 2025, the debate over abortion access and drug safety took center stage in Washington as Health and Human Services Secretary Robert F. Kennedy Jr. faced tough questioning from senators and mounting pressure from advocacy groups. The focus: the abortion pill mifepristone, its safety profile, and the controversial rollback of long-standing federal safeguards.
At a Senate Finance Committee hearing, Kennedy accused the Biden administration of having "twisted the data" on mifepristone's safety. "We know that during the Biden administration, they actually twisted the data, to bury one of the safety signals, a very high safety signal, around 11%, so we’re going to make sure that that doesn’t happen anymore," Kennedy told lawmakers, according to Bloomberg Law. The comment came in response to a request from Senator James Lankford (R-Okla.) for an update on the status of a review Kennedy had ordered in May 2025 into mifepristone’s safety.
Pressed for details, Kennedy declined to offer a timeline for the review, stating, "We’re getting data in all the time, new data on that, we’re reviewing." He noted he had spoken with Food and Drug Administration Commissioner Marty Makary about the issue just a day earlier. The review, Kennedy emphasized, would be driven by science and not politics—a point he reiterated several times during the hearing.
The scrutiny comes as Republican lawmakers ramp up efforts to restrict access to mifepristone. On September 3, the Texas legislature passed a bill allowing any Texan to sue abortion pill manufacturers or distributors, a move that could have far-reaching implications for medication abortion nationwide. According to Fox News Digital, more than 20 Republican attorneys general have also called on Kennedy and the FDA to reinstate the safety protocols that were rolled back during the Biden administration.
At the heart of the controversy is the Biden-era decision to relax Risk Evaluation and Mitigation Strategy (REMS) requirements for mifepristone. These federal safeguards, in place for over two decades, originally mandated that the drug be dispensed in person by a certified provider, ensuring women were screened for potential complications such as ectopic pregnancy. Under the new rules, mifepristone can be prescribed via telehealth and delivered by mail, a change that dramatically expanded access but drew fierce criticism from opponents.
The Restoration of America Foundation (ROAF), a conservative advocacy group, has been particularly vocal in its opposition. In a letter to the Senate Finance Committee, ROAF argued that the rollback "eliminated essential safeguards that protected women’s health for over two decades," and that it "leaves women more vulnerable and shifts costs to taxpayers." Doug Truax, ROAF’s founder and CEO, told Fox News Digital, "The removal of key Risk Evaluation and Mitigation Strategy (REMS) requirements for mifepristone has eliminated essential safeguards that protected women’s health for over two decades." He added, "We urge the Senate to demand clear answers about why these safety protocols were removed and when they will be reinstated."
Truax further warned, "Allowing these powerful drugs to be ordered online and sent through the mail without proper medical screening puts women at serious risk. Women deserve to know about potential complications and have immediate access to emergency care if needed." ROAF cited a recent New York Post investigation, which claimed that nearly 11 percent of chemical abortions resulted in serious complications such as hemorrhage, infection, or sepsis—figures that are more than 20 times higher than the FDA’s previously cited rates.
This 11 percent figure, however, has become a flashpoint in the debate. The statistic originates from an analysis by the Ethics & Public Policy Center (EPPC), a conservative think tank. According to The Guardian, the EPPC’s study claimed that one in ten users of mifepristone experienced significant adverse health events within 45 days of taking the drug. Yet, public health experts have criticized the study’s methodology and pointed out that it was neither peer-reviewed nor published in a medical journal. Critics argue that the analysis counts complications like ectopic pregnancies—which mifepristone neither causes nor worsens—as adverse events, skewing the results.
Despite the pushback, anti-abortion groups have seized on the EPPC’s findings to bolster their case for stricter regulations. The controversy has only intensified as medication abortion has become the most common method of terminating pregnancies in the United States, especially after the Supreme Court’s 2022 decision to overturn Roe v. Wade.
During Thursday’s hearing, the Biden-era changes and their impact on women’s health were not the only topics under scrutiny. Senators also questioned Kennedy about his broader leadership of the Department of Health and Human Services, particularly his overhaul of the Centers for Disease Control and Prevention and shifting vaccine policies. Democratic senators led much of the criticism, but even Republican Bill Cassidy (La.), whose vote was pivotal in Kennedy’s confirmation, adopted a critical tone.
Senator Steve Daines (R-Mont.) pressed Kennedy on whether the HHS planned to replicate research critical of medication abortion and asked if he would repeal the Covid-era changes that made mifepristone accessible via telemedicine. Kennedy replied that he was unsure of the White House’s position on the issue and would have to follow up.
Amid the heated exchanges, HHS spokeswoman Emily G. Hilliard sought to reassure the public that the review of mifepristone would be rigorous and science-based. "As previously mentioned, Secretary Kennedy asked Commissioner Makary to review the latest data on mifepristone," Hilliard told Fox News Digital. "Commissioner Makary will ensure gold standard science is used while incorporating practical, common-sense considerations to its regulatory processes."
The hearing highlighted the deep partisan divide on abortion policy in the United States. While conservative groups and Republican lawmakers argue that loosening restrictions on mifepristone puts women at risk and undermines public health, supporters of expanded access point to decades of research showing the drug is safe and effective. According to The Guardian, more than 100 studies across dozens of countries have found that mifepristone and misoprostol are a reliable way to end a pregnancy, with serious complications remaining rare.
In the end, the future of mifepristone’s regulation remains uncertain. Kennedy’s promise to keep politics out of the process and ensure a thorough scientific review will be closely watched by both sides of the debate. As lawmakers, advocates, and medical experts await the results, the stakes—both political and personal—could hardly be higher.
