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  • 4/15/2024
At a House Oversight Committee hearing on Thursday, Rep. Jamie Raskin (D-MD) ripped into Rep. Paul Gosar (R-AZ) over his remarks to FDA Commissioner Robert Califf.

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Transcript
00:00Mr. Chairman, thank you. I am going to follow up on this, because this exchange to me was
00:07extremely illuminating, because what we have here is the commissioner who is the head of
00:12the Food and Drug Administration, and then we get a drive-by spray of propaganda, disinformation,
00:22and ideological attacks. So let me try to sort some of this out, and maybe we will help
00:27to illuminate why we have a Food and Drug Administration, rather than leaving it to
00:32politicians and state legislatures or in Congress to make decisions based on ideological whim.
00:39But let's start with ivermectin, which I believe is an animal deworming agent that some people
00:47were advocating for use to treat COVID-19. Has this been approved as a form of treatment
00:55or a cure for COVID-19?
00:57No, it has not, if I may. I should also point out it also has benefit for humans with worms,
01:02which is a huge problem in Asia. So it actually won a Nobel Prize, because it is an amazing
01:07drug both for animals and humans who have worms. And there is a good reason to think
01:12it may work in the case of COVID, and that is why, thankfully, the community, including
01:17the NIH, did a number of randomized clinical trials. There is just no benefit. And, you
01:23know, that is true of most things that we try. There is nothing wrong with thinking
01:26it might work. It just didn't.
01:29What about hydroxychloroquine, which was another thing that was advocated?
01:33Basically the same story. There was really exciting preliminary work in the laboratory
01:37that said hydroxychloroquine may have activity against COVID. So the randomized trials were
01:42done. Unfortunately, no benefit. Again, nothing wrong with thinking it may work and trying
01:49it out in a randomized trial. But then we have the data now. So that leads you to the
01:54conclusion. So we have not been able to grant an application for those.
01:58I mean, I am aware of a lot of political attacks and criticism against the FDA, but I can never
02:04figure out the coherence of it. Sometimes they seem to be saying, get out of the way
02:08and just let anybody advocate whatever they want and use whatever they want without any
02:14testing and without the various protocols you go through. And then other times they
02:19attack you because you don't have enough authority to do the things that we would want
02:23you to do in order to make kids' cinnamon applesauce clean, for example.
02:29So let's take that one, which has caught my eye since we certainly ate a lot of cinnamon
02:34applesauce in our house when our kids were little. Let's see. FDA-regulated products
02:43are manufactured or handled at something like 275,000 or 280,000 different registered
02:51facilities across the land. So what keeps you from inspecting every private manufacturing
02:58facility that produces things like cinnamon applesauce or peanut butter?
03:02Well, if I may, I will try to do this very quickly. I think the best way to think about
03:08FDA in general is that we are referees. You all in Congress actually write the rule book,
03:13much like in any sport. It is the leadership that writes the rule book. We enact what is
03:18in the rule book. And in the case of food establishments, like most sports, the first
03:25line of defense are the players in the game, which is the industry that produces the products.
03:30And by and large, they do a great job, but sometimes they don't. And as referees, we
03:36have to be really wise about where we step in because we don't have an unlimited budget.
03:40So what keeps us from inspecting all 275,000? You don't have to be a brilliant mathematician
03:45to know how many people you would have to have. But what we can do, for example, in
03:50food for children is to have the manufacturers be required to do the testing, which is the
03:56way the drug system works. The manufacturers of drugs have to test every batch. And in
04:02the case of cinnamon applesauce, if there had been mandatory testing, when it got imported
04:07into the U.S. from Ecuador, the stores that were selling it probably would have picked
04:13it up at that point.
04:14And those kids ended up with lead poisoning, right?
04:16Right. Lead poisoning is a very serious problem, as you know, and it causes chronic issues.
04:21So you advocated mandatory testing. You would like us to give you that regulatory authority.
04:26Yes.
04:28And I do hope that's something that our colleagues on the Republican side of the aisle would
04:33join us in. In the case of infant formula shortages, last Congress we passed a bipartisan
04:38bill to help address those shortages, but nearly 200 House Republicans voted against
04:44a second bill to give FDA resources to strengthen its oversight and inspection of facilities
04:50to prevent shortages like that from happening.
04:52So we can't have it both ways. If we want an effective, strong regulator, we've got
04:56to give them the authority and the resources to get the job done.
05:00Thank you very much, Mr. Chairman. I yield back.

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