‘I Would Challenge Your Statement’: Becerra Pushes Back On Gus Bilirakis Over Testing At Schools

5 months ago

During a House Energy Committee hearing prior to the Congressional recess, Rep. Gus Bilirakis (R-FL) questioned HHS Sec. Xavier Becerra about helping communities with diseases, seniors and testing.

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Transcript

00:00 The gentleman's time has expired. The chair recognizes Mr. Billorakis for five minutes for questions.

00:04 Thank you. Thank you, Mr. Chairman. Thank you, Mr. Secretary, for being here.

00:08 As you know, I've been a long, strong advocate of research funding and federal efforts to advance

00:13 diagnostics and treatment for individuals with neurological conditions, including Alzheimer's

00:19 and Parkinson's diseases. We are making a significant amount of progress in Alzheimer's

00:25 and going through the HHS fiscal year 25 budget and brief document, I was glad to see some of the

00:32 proposed initiatives. However, I'm disappointed that Parkinson's disease is not mentioned once.

00:39 For reference, the term equity is listed 77 times in the document, but not one single mention

00:47 of Parkinson's disease initiatives. As the fastest growing neurological conditions,

00:52 what is your agency currently doing to address this rising public health need?

00:57 Congressman, thank you for the question. And I assure you that like Alzheimer's, Parkinson's,

01:06 and so many other of these devastating diseases are a focus at NIH and many of our programs within

01:13 CMS. The difficulty, of course, is that we have to follow. It's very similar to the answer I gave to

01:19 Congressman Reese. We have standards that we have to follow based on the laws that you have passed.

01:23 And so for us to, for example, provide more research money or to include a particular therapy

01:29 or treatment or drug as part of the Medicare program, we have to follow the process and make

01:36 sure that we check the boxes because otherwise, you probably saw an article that came out about

01:41 a week ago of a number of drugs that the FDA approved, said it were safe and effective,

01:47 but people took them, nothing happened. And so all of a sudden now all those drugs are not working.

01:54 And so what we have to make sure is that when we say we're going to help, there's really going to

01:58 be help coming. You said that nothing happened. Elaborate on that. So many of the people who

02:06 reportedly took some of these drugs, and I could try to make sure I get you that article. Many of

02:10 the people who were taking these drugs found that there was no improvement in their health as a

02:15 result of taking those drugs. What diseases are we talking about? Neurological diseases?

02:19 I don't think they were neurological. Okay, please give me that information.

02:23 I will send that to you. It just came out about a week ago.

02:25 Okay, thank you. It's been 1144 days since this administration took away seniors ability to access

02:32 innovative medical devices. When the Medicare coverage for innovative technologies rule,

02:38 M-SIT, was repealed, this administration promised patients it would quickly work on an alternative

02:45 proposal. Every year we ask that question. This year my colleagues, again, we want to know,

02:52 what is taking so long? And will you commit to finalizing this new rule by the end of

02:57 next month possibly? You know, seniors are waiting on this. They can't wait any longer.

03:03 Can you address that, please? Congressman, rather than try to commit to something like

03:07 within the next month that I can't guarantee that, how about we do this? Let me follow up with you

03:12 and tell you what the latest is. We can then share that publicly if you'd like. But I'd rather not

03:17 try to commit to something that I can't guarantee, but I understand the importance of this.

03:21 Yeah, it's very important to our constituents. I'm concerned that the administration is forging

03:27 ahead on a proposed rule that regulates laboratory-developed tests. And, you know, this is a

03:33 bipartisan issue. And academic institutions. Yeah. We recently held a hearing with stakeholders

03:40 talking about the rule where there's unanimous agreement on this, that the rule is misguided.

03:48 Is your department listening to the patients and provider communities here? Expand on it. And

03:55 answer that question if you can. And will you commit to ensuring that patients won't lose access

04:00 to these types of tests under a FDA regulatory regime? Can you respond to that, please?

04:08 Sure. First, I think everyone recognizes that having good testing practices is critical for

04:14 Americans to know what's going on, whether it's COVID or whatever else. Secondly, we like to make

04:18 sure that those are standardized so that one test will work because everyone uses it and it works

04:24 and we don't have issues that some tests aren't working, other tests are. We want to make sure

04:29 that that's a standard process. There should not be exceptions unless they're absolutely necessary.

04:34 Academic institutions are saying that they should be outside of the scope of that. We're saying

04:41 there's no reason why in the process of making sure all tests work well, that we should allow

04:46 academic institutions to be treated better or differently. And so I would challenge your

04:52 statement that there is unanimity in agreement that this rule is a bad one. I believe it's the

04:57 rule is a result of talking to all stakeholders and trying to make sure that we have a process

05:02 that fits for everyone. No one is special in this process as a laboratory. You have the same

05:07 obligations to make sure what you produce works for the American people. We want to make sure

05:12 whoever you are and we elevate those academic institutions. I went to a really great one,

05:17 Stanford University, but that doesn't mean Stanford University is so special that it

05:21 doesn't have to follow the same rules that other laboratories have to follow.

05:24 I know my time has expired. Thank you. Appreciate it.

05:29 Thank you. The gentleman yells back and the chair recognizes Ms. Kelly for five minutes

05:32 for questions. Thank you, Chair Guffrey and Ranking Member Eshoo and Secretary Becerra. Good

05:37 to see you. As you know, I'm a strong supporter of FDA's efforts to prohibit menthol cigarettes.

‘I Would Challenge Your Statement’: Becerra Pushes Back On Gus Bilirakis Over Testing At Schools

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