Daines to FDA: Protect Women’s Health, Release Safety Review of Abortion Pill

• September 15, 2026

WASHINGTON, D.C. - U.S. Senator Steve Daines today spoke in a Senate Finance Committee hearing with Chris Klomp, nominee to be Deputy Secretary of Health and Human Services. They discussed the FDA's ongoing safety review of mifepristone as well as Most-Favored Nation drug pricing policies.

Watch the full exchange HERE.

Daines on the dangers of the abortion pill:

Daines: We want to make sure we let the data speak as it relates to mifepristone. What does the data tellus? There was analysis done of 865,000 mifepristone prescriptions compiled from insurance claims. That's a large data set. They found that nearly 11 percent of women experienced a serious adverse event. And let me define the serious adverse event.In most cases that meant going to the emergency room for some serious condition within 45 days oftaking mifepristone. That's 22 times higher than the FDA's long-standing estimate,which is less than 0.5 percent. So a big gap between what we're seeing in insurance claims andwhat the FDA said when they originally released it. During the Biden administration,I believe they had some reckless COVID-era policies that removed, as you mentioned,the in-person dispensing requirement. And serious questions remain whether onlineprescribers can adequately assess gestational age, rule out an atopic pregnancy,or identify situations involving coercion or abuse without a direct in-person evaluation.Secretary Kennedy has stated the FDA is conducting its own comprehensive study ofmifepristone. I'm encouraged by this and continue to urge the agency to complete its review.in a timely manner. Let the data speak, not politics here up on Capitol Hill.

Klomp: Senator, we strongly agree on this point. We have an obligation always to follow the evidence.

Daines: The hope here is that we take the temperature down on the politics of this sensitive issue and let the data speak, frankly, let the women speak, who are seeing a 22-time higher adverse effect from the use of this drug than what the FDA claimed. Specifically, Mr. Klomp, given that the FDA is legally required to file an official update on the status detailing the progress of the safety review by October 7th of this year that's coming up do you believe the agency will be able to release the full review before the calendar year ends?

Klomp: I checked in on this with the agency just a couple of days ago. I do believe that we are on target to file that interim update and I do believe that we are on target as a department to produce the finished study and results before the end of the year.

Daines on Most-Favored Nation drug pricing concerns:

Daines: I'd like to turn to the issue of most favored nation drug pricing and the GLOBE and GUARD models under review by the Office of Management and Budget. We greatly appreciate the administration's efforts to lower drug costs for Americans. I know the folks back home in Montana will be standing on their chairs cheering for that ambition. And I do believe President Trump has done more to achieve this goal than any of his predecessors. With this said, I do have some serious concerns having just come from back from China two weeks ago, looking at the innovation ecosystem going on right now in the biosciences and biotech space. The impact these models could have on the American biotech industry, especially at this moment when China is rapidly closing the innovation gap and seeking to overtake the United States as a global leader in biotech. I've heard from a lot of smaller and midsize companies about how these models could have a negative outsized impact on their ability to engage in R&D, attract investment, and pursue complex or uncertain therapies. These are companies who are responsible for more than half of FDA-approved medicines and involve nearly 75 percent of American clinical trials. It truly is the lifeblood of biotech innovation. Mr. Klomp, was the risk to the U.S. innovation base a consideration before GLOBE and GUARD were advanced?

Klomp: Senator, thank you for that question. The president was unequivocal in a joint mandate that he gave our team. Lower prices for Americans at the pharmacy counter by getting other wealthy countries to pay their fair share so that we don't pay three times what they do for the same drug, same box, same manufacturer. And number two, do not harm American leadership and biotechnology. And so we have worked to do just that.

Daines: The latest I just saw, you talked about the large molecules crossing the 50% threshold first time ever coming out of China. They can do a phase one clinical trial now in half the time at 20 percent of the cost. And so it's game on, and what we need to do is be able to go faster and be more efficient.

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