U.S. Senator Tommy Tuberville (R-AL) and several Republican senators have called on the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to reconsider the approval of a generic version of mifepristone, a drug used for chemical abortions. In a letter addressed to HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Martin Makary, the senators expressed concern about the safety of mifepristone, citing recent comments from both officials that questioned data surrounding abortion pill safety.
The senators wrote, “We commend your recent statements acknowledging the data discrepancies surrounding abortion pill safety and your commitment to reviewing the science. We are also encouraged by HHS’s recent announcement that it will review prior Risk Evaluation and Mitigation Strategies (REMS) approvals given the recent studies raising concerns about the drug’s safety. Given this commitment, however, we are deeply concerned about the FDA’s approval of a new generic version of mifepristone. While we recognize the FDA’s statutory responsibility in evaluating drug applications, the timing of this approval appears inconsistent with the comprehensive safety reassessment your agencies have prioritized. Out of respect for this important review, and with full confidence in your dedication to protecting women’s health, states’ rights, and unborn life, we urge you to take decisive action to reevaluate whether this generic version of mifepristone is suitable to enter the market.”
The letter was signed by Tuberville along with more than 40 other Republican lawmakers from various states.
In their correspondence, they stated: “Under your leadership, we have seen a strong commitment to reevaluating the policies that affect the most vulnerable among us—the unborn. We applaud your acknowledgment of the concerns surrounding the FDA’s approval and regulation of the abortion pill regimen–mifepristone and misoprostol–and your commitment to following the science to ensure the safety and well-being of women and unborn children alike.”
The senators criticized previous regulatory changes under Democratic administrations that allowed for easier access to abortion pills via mail order without direct medical supervision or verification procedures. They argued these policies could lead to misuse by abusers or minors.
They further wrote: “Contrary to the narrative peddled by the media that taking abortion pills is ‘safer than taking Tylenol,’ evidence shows that the risk of serious medical complications after taking mifepristone is at least twenty-two times higher than reported on the drug label. In fact, more than 1 in 10 women who take mifepristone will experience a serious adverse event.”
The letter referenced research reviewing over 865,000 medically-induced abortions between 2017 and 2023—after changes in FDA reporting practices—that found an increased rate of serious adverse events related to chemical abortions.
Senator Tuberville serves on several Senate committees including Armed Services; Agriculture; Veterans’ Affairs; Health, Education, Labor & Pensions; and Aging.
