Dan Crenshaw: Some Of The FDA's Systems Have 'Not Kept Up With Modern Science'

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During a House Energy and Commerce Committee hearing in July, Rep. Dan Crenshaw (R-TX) spoke about the Food And Drug Administration.

Transcript

00:00I now recognize the gentleman from Texas, Mr. Crenshaw.

00:03Thank you, Mr. Chairman.

00:05We all know the FDA plays a very critical role in protecting the health and safety of Americans,

00:10but we also know some of the systems have not kept up with modern science and consumer needs.

00:16It's one of the reasons I'm proud to support the bipartisan reauthorization of the over-the-counter

00:21monograph user fee program, and it has some smart updates to it. I think it helps the FDA

00:26keep everyday medicines like allergy meds, cold remedies, sunscreen safe and up-to-date,

00:31but without adding red tape. It brings more transparency, scientific flexibility,

00:35and accountability to a system that over 90% of Americans rely on. OTC products help people

00:41manage their health. They avoid unnecessary doctor visits, and that's good for families,

00:46good for our rural communities, it's good for a sustainable workforce. So fixing the system,

00:51making it work better for everyone, I think is in our interest. Dr. Corrigan-Carré,

00:59this legislation formally allows the use of voluntary consensus standards and alternative

01:04testing methods for monograph updates. Help us understand that. How does that change the

01:10scientific flexibility and efficiency of the review process?

01:13Well, I think the voluntary consensus standards using those, you know, they're known,

01:18they're transparent, they can be relied on. And, you know, alternative standards, we have,

01:24we have asked in a MUFA II, we want to have a new tier, what we call a tier two proposed order,

01:30so that we can update some of the outdated tests that may be in some of the monographs. So I think we're

01:36willing to work with that and try and use, how do we get, use the most up-to-date testing that gets us to

01:44the answer that we need. And, of course, you know, update some of these testing standards that were in

01:48the monographs. You know, we're talking about over-the-counter monographs. What about applying

01:55those kind of standards to other pathways in FDA? Do you have any comments on that? I don't want to throw

02:02you up something out of left field there, but. Sure. You know, in all of us, when we're looking at any

02:07alternative method to gather data, for example, you know, the alternatives to animal testing,

02:12we're going to use those across the board. So if they can answer a question of safety in an OTC

02:19drug, and they can answer it in a prescription drug, then we're going to use it. I would mention that,

02:24you know, there are many places we don't, you know, use animal studies. For example,

02:28in our biosimilar program, when we're improving new biosimilars, most of our generics don't need

02:32animal studies. Those are a lot of medications that are used every day. But we, any test that's

02:37fit for purpose, we'll use across for other products. Yeah, and I'll reiterate over and over,

02:45and I hope one of our goals in this committee is, well, maintaining safety standards for the American

02:50people, but making the FDA an efficient process that does not destroy the last remaining innovative

02:57industry in the world, which is in the United States. And I hope that's a goal of our administration,

03:03and I think it should be a goal of this committee. Mr. Morris, you know, in many rural communities,

03:09access to a physician can be limited to a part-time clinic or a distant hospital. For residents in

03:16those areas, how essential is it to have reliable over-the-counter medications available for managing

03:21common health needs? And to follow up, are you hearing concerns, whether from patients, providers,

03:27states, that outdated or ineffective OTC drugs are still in circulation, simply because the FDA

03:33hasn't had the resources to review them? Congressman, thank you for that question. It's

03:39outside of my knowledge base. I was referring to my colleague at FDA on that. I would think the same

03:45challenge. Feel free to jump in if that's fine. You know, we're overseeing and looking at the safety

03:51effectiveness. As you know, we have an order to update the acetaminophen safety for a rare side

03:56effect. We also have the proposed phenylephrine order we're trying to work through, which would,

04:02you know, on efficacy, the lack of efficacy there. And so, we also, on our agenda, we're going to do

04:08some updates in the pediatric dosing for acetaminophen by weight-based, as well as, you know, update NSAIDs

04:14for some issues for pregnant women. So, we're continuing to work through, and I think, you know,

04:20we're effectively making sure that they are safe and effective. Okay, I appreciate that. I have

04:27more questions. I'm almost out of time, so I yield back.

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