At Thursday's Senate Health Committee hearing, Sen. Josh Hawley (R-MO) questioned James O'Neill, nominee to be Deputy HHS Secretary.
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00:00Dr. Neal, nice to see you. I enjoyed our conversation, our visit the other day.
00:04Let me just start with this. You're familiar, I think, with the recent insurance claim
00:08study regarding mifeprestone. Is that correct?
00:12Yes, Senator. I've not read the study, but I'm familiar with it.
00:15This is a study of 865,727 prescribed mifeprestone abortions, chemical abortions,
00:22between 2017 and 2023. It's the largest such study of mifeprestone ever conducted.
00:30The only major study conducted now in years, and as I think you know, the results were really
00:35quite startling. They showed that 10.93% of women who use the chemical abortion drug experience a
00:42major serious adverse health event, like sepsis, infection, hemorrhaging, often necessitating
00:50emergency room visits, often leading to life-threatening situations. The real dramatic
00:59result of this, I mean, I think the takeaway of this is that this is a much, much higher rate
01:04of serious adverse health events than what the FDA currently reports, 22 times higher than what
01:10the FDA has currently reported. So my question is, in light of this new data, and it is true,
01:14it's an enormous data set, just an enormous data set, isn't it time for the FDA, number one,
01:21to put back in place the reporting requirements of serious adverse health events? As you know,
01:26in 2016, the FDA eliminated, at the behest of the Obama administration, eliminated the requirement
01:32that physicians and others report non-life-threatening, but yet serious adverse health events.
01:37Shouldn't we put those back in place in light of this data?
01:40Senator, FDA has a responsibility to ensure that all drugs are safe and effective,
01:49and sometimes new data comes in and it needs a review. Mifeprestone actually has a REMS,
01:54meaning it's been designated for a long time as something that needs periodic review of safety data.
02:00The Secretary has pledged to do a safety review of Mifeprestone, and I strongly support that review.
02:05Good, and you'll help him carry out that review, that safety review?
02:08Absolutely.
02:09And this study that is out just this last week just underscores the need for ongoing safety review,
02:14and for a look, I think a fresh look at all the data. Would you agree with that?
02:18It does look that way.
02:19Yeah, and would you also agree that it's time for the FDA, as part of that thorough top-to-bottom review,
02:24to think about reinstating the other long-standing safety protocols on this drug? Until the Biden
02:30administration eliminated them, Mifeprestone for 20-plus years had always required
02:35physician dispensing, in-person dispensing, physician follow-up visits. The Biden administration
02:41eliminated all of those things. Now, telehealth providers, you don't even have to be in this
02:44country now to send this drug to prescribe it, quote-unquote. You don't have to be a doctor.
02:50You don't have to see your patient. You don't have to be in America. You can mail it into states,
02:55regardless of state law, what state law is. And this is one of the reasons we're seeing such incredibly
03:01high adverse health events. Don't you think it's time to reconsider and to revisit, imposing,
03:05putting back in place those long-standing safety protocols?
03:08Senator, a lot of patients have a lot of trouble getting prescriptions filled across state lines,
03:14even medicines that have much less safety concerns than this drug. And, of course, every approval
03:22that FDA does or reviews can state the appropriate and inappropriate ways of prescribing or dispensing
03:30a drug. And so all of that should be subject to review, absolutely.
03:33Okay, good. All of it's subject to review. The Secretary was very clear on this, that he will
03:38conduct a full-scale safety review. He's required to by law, as you pointed out. But I think what this
03:43latest study shows is that the information that is coming into HHS, it's time that you took a serious
03:48look at the scope of that information because, again, the FDA in 2016 eliminated the requirement
03:53to report much of this. This is why this study is so significant, because it looks at all insurance
03:58claims, 865,000 of them between 2017 and 2023. So just to be clear, your commitment is you will do
04:05a safety review, you will look at this top to bottom, you will take this data into account. Do I have that
04:09right? I believe the Secretary has already committed to that, and I will promise you to fully support that.
04:15Good. Okay. Let me ask you about your work on conscience protections in an earlier
04:21administration. I think in one of the Bush administrations, the Bush 43 administrations,
04:25you worked on conscience protection rules for healthcare providers. Do I have that correct?
04:28Yes, that's correct, Senator. Would you support reinstating and fully implementing
04:33conscience protections for healthcare providers? That would be up to the Secretary and the President,
04:38but if they decide to go in that direction, I would know exactly how to do it.
04:43Would you advise them to do so? I believe I already have, Senator.
04:46Good. And that should be easy, because the Secretary, when he sat right where you were sitting, said
04:51unequivocally that he supported conscience protections, that he would put them back into
04:56place. The President said he supports conscience protections. In fact, the President had them in
05:00place in his first administration. So I'm glad to hear that. We'll hold you to that. Let me talk to
05:04you for just a second here. Well, actually, all right, Mr. Chairman, I see I'm out of time,
05:07and I'm always, I'm always so good about obeying my time limits, aren't I, Senator Cain? I'll have a few,
05:13that's a joke. I'll have a few more questions for you for the record, Mr. O'Deal. Thank you,
05:16thank you, Mr. Chairman.
05:26you