Hawley demands congressional oversight of abortion pill after FDA fails to complete promised safety study
Sen. Josh Hawley, R-Mo., is calling for a crackdown on the abortion pill Mifepristone, saying it is time for Congress to increase oversight of the drug and reinstate what he describes as basic safety guardrails.
"The issue is that there are more abortions in the United States now than there were when Roe was still… law," Hawley told Fox News Digital Tuesday in an interview.
"I mean, think about it, it is extraordinary," Hawley said. "Abortions are going up every single year. What's driving that is Mifepristone. You know, it's the chemical abortion drug that is getting mailed into every state in the country. Doesn't matter what the state laws are. It doesn't matter if your state restricts abortion, bans abortion, or bans Mifepristone, it doesn't matter."
"It's getting mailed into every single state without a doctor visit, many times, really without even a doctor's prescription," he continued. "No follow-up. It's unbelievable."
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Mifepristone, the abortion pill originally made by Danco Laboratories, blocks progesterone, a hormone needed to sustain pregnancy, and is followed by Misoprostol to complete the process.
"A study of 875,000 insurance claims on Mifepristone is that it has an 11% adverse health event rate," Hawley said. "This means 11% of women who use it end up in the emergency room or with a very serious health condition. And yet, that's not what's on the label of the drug."
The study, conducted by the Ethics and Public Policy Center, was authored by Ryan T. Anderson, president of the Ethics and Public Policy Center, and Jamie Bryan Hall, its director of data analysis.
It reviewed a claims' database that included 865,727 prescribed Mifepristone abortions from 2017 to 2023.
The report found that 10.93% of women, nearly 11%, "experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a Mifepristone abortion."
In October, Hawley accused the Food and Drug Administration (FDA) of endangering women’s health, saying the agency approved the chemical abortion drug Mifepristone without the thorough safety review it had promised.
"The FDA, the commissioner, Marty Makary, promised me he would do a study," Hawley told Fox News Digital. "And I just think that that study is nowhere close to being done. I don't know if it'll ever be done. So I just, I have concluded that that's a dead end, but I think Congress is gonna have to approach this in a different way."
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The Missouri senator said he would at least like to see what he called "minimal" safeguards, including in-person doctor visits before prescriptions are issued and screening for ectopic pregnancies.
"I mean, we're talking about really minimal things," Hawley said. "I mean number one, a in-person doctor visit with a doctor actually making the prescription. There needs to be the screening for ectopic pregnancies as part of that because if you take Mifoprestone with an ectopic pregnancy, it could lead to fatal hemorrhaging. There needs to be a follow-up doctor visit."
"And I believe there needs to be in-person administration of the drug," he continued. "You know, a doctor actually needs to be there to administer the drug in case there are any side effects. And these are very minor regulations that were in place in President Trump's first term. President Biden removed them. But really – that's just the very, that's the bare, bare minimum."
Hawley said that he thinks Congress must "do more" in its oversight of the drug.
"I think we're gonna have to do more," he said. "And, you know, I hope to have more to say about that in the coming weeks. It's becoming clear to me that this safety review that I hoped would catalyze action at the FDA is just not happening."
"I mean, it doesn't look to me like it has any timeframe on it," Hawley said. "You know, listen, the FDA made a commitment to do that study a year ago, and they are nowhere on it, as near as I could tell. Just nowhere at all. So that to me looks like a complete dead end. And I just think Congress is going to have to step in."
Makary and the FDA did not immediately respond to requests for comment from Fox News Digital.
Fox News’ Greg Wehner contributed to this report.