US Health Secretary Robert F. Kennedy Jr. announced on Wednesday that he has instructed the FDA to evaluate potential regulations concerning the abortion pill mifepristone.
He mentioned that these reviews are necessary due to “new data.” A conservative anti-abortion group is pressuring the Trump administration to either impose stricter regulations on the drug or remove it entirely from the market.
“That’s definitely something we’re looking into,” Kennedy commented during a legislative hearing with Missouri Senator Josh Hawley. “Clearly, this suggests that we need to revise the labeling.”
The data under scrutiny hasn’t been peer-reviewed or published in medical journals. This came about after the FDA Director indicated a willingness to assess new safety data for these drugs, which account for a significant portion of abortions in the US.
According to conservative organizations, a recent paper they published argues that mifepristone poses a higher complication rate than previously acknowledged, leading them to advocate for restoring earlier restrictions on the drug, including bans on telehealth and limitations on its use in early pregnancy.
This 900-page report, organized by a right-leaning think tank, suggests that reintroducing these restrictions could enhance monitoring and help determine if mifepristone should remain available. The plan, referred to as Project 2025, outlines steps to revoke mifepristone’s approval entirely, starting with telehealth prescriptions.
Despite the emerging concerns, over 100 scientific studies have concluded that abortion medications are generally safe and effective. Telehealth services have allowed those in states with abortion bans to access these medications, which has frustrated anti-abortion activists.
Anti-abortion leaders plan to utilize this recent paper to lobby the FDA and lawmakers for tighter controls on the drug. They refer to this initiative as “Rolling Thunder.”
Representatives from various pro-life organizations emphasized that ending telemedicine prescribing is merely the first step in a broader campaign against mifepristone.
In a hearing earlier this year, Kennedy had asked Trump to review the safety data related to mifepristone. FDA Commissioner Marty Makary mentioned in March that he would analyze the data and take appropriate actions. Hawley has also been active, writing a letter urging a review of the recent findings.
Opponents of abortion have prioritized research by anti-abortion think tanks that claim mifepristone is unsafe, although some of these studies have been retracted. A Supreme Court ruling earlier had determined that the plaintiff, a physician advocating against abortion, lacked legal standing to sue the FDA.
The legal battle continues, with several Republican attorneys filing suit against the FDA on behalf of Missouri, Idaho, and Kansas.
Recently, a judge argued against the Biden administration’s earlier stance on the FDA’s actions regarding mifepristone, and while the Trump administration hasn’t defended these actions, it hasn’t opposed them either.
Health law experts have suggested that the administration might use these points in future discussions about drug regulations. Reproductive rights advocates, including Kirsten Moore, suggest that the movement against mifepristone is based on what they call “manufactured misinformation,” and they remain committed to protecting access to this safe and effective medication.
