U.S. Senator Steve Daines questioned Robert F. Kennedy, Jr., Secretary of the United States Department of Health and Human Services, during a Senate Finance Committee session about the safety of the abortion pill mifepristone and oversight by the Food and Drug Administration (FDA). Daines cited a recent study that analyzed 865,000 insurance claims, which found that nearly 11 percent of women experienced a serious adverse event within 45 days of taking mifepristone. He noted this rate is significantly higher than the FDA’s long-standing estimate of less than 0.5 percent.
Daines stated, “I want to begin my time by talking about the issue of federal deregulation of chemical abortion drugs Since mifepristone was approved in 25 years ago, the FDA has steadily stripped away safeguards related to this drug no longer requiring a doctor’s prescription, no follow-up visits, no adverse event reporting, and now allowing it to be sent through the mail. Earlier this year there was a new study and analyzed 865,000 real-world insurance claims and it found that nearly 11 percent of women experienced a serious adverse event within 45 days of taking mifepristone. To put that in perspective, that is 22 times higher than the FDA’s long standing estimate of less than 0.5 percent. Well, these findings alone are shocking. My conversations with those in the medical profession, credible medical professionals, lead me to believe that even this study may indeed under represent the scale of the problem. For years we’ve heard the misleading and frankly very harmful lie that’s being sold to women that this drug is, and I quote, “safe as Tylenol.” These lies sadly have real-world consequences. Just last year, two women died as a result of taking chemical abortion pills because they were able to access them without appropriate medical oversight. And by the way, that’s all allowed by the FDA. Mr. Secretary, I am grateful that you and FDA Commissioner Makary have already begun the process of reviewing this new data on the safety of a first and we talked about this during your confirmation hearing. The question is could you provide any updates on the status and the scope of that review and whether the FDA intends to replicate studies like the one that I referenced?”
Kennedy responded: “Those studies are progressing and they’re ongoing. So I will keep your office informed at every stage.”
Daines also addressed concerns about telehealth prescriptions for abortion drugs: “Given the legitimate safety concerns surrounding mifepristone and your actions to roll back other COVID emergency measures, will you repeal the COVID-era telemedicine allowance, given that we’re repealing these COVID-era regulations and emergency measures, would you repeal the COVID-era telemedicine allowance for chemical abortion drugs and restore the requirement for an in-person doctor visit?”
Kennedy replied: “Senator, I need to get back to you on that I don’t know if the White House has yet taken a position on that.”
In addition to discussing mifepristone regulation, Daines brought up Montana’s Medicaid expansion program: “I want to close with a Montana question earlier this week the state of Montana submitted a Medicaid demonstration waiver application with CMS [Centers for Medicare and Medicaid Services] to strengthen the state’s Medicaid expansion program. This waiver seeks to require community engagement and enhance cost sharing for working-age able-bodied adults enrolled in the program. I applaud our Governor, Gianforte, and Director Brereton for their proactive leadership in this space. My question is, Mr. Secretary, could you commit the CMS will work quickly in its consideration of Montana’s waiver application?”
Kennedy answered: “Absolutely.”
The exchange reflects ongoing debates over federal health policy regarding both reproductive health regulations and state-level Medicaid program changes.
