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  • 5 months ago
During a House Energy Committee hearing before the Congressional Recess, Rep. Frank Pallone (D-NJ) asked Acting Director for Center for Drug Evaluation and Research at the FDA Dr. Jacqueline Corrigan-Curay about sunscreen safety.
Transcript
00:00Those back now recognize the ranking member of the full committee, Mr. Pallon, for five minutes of question.
00:04Thank you, Mr. Chairman. I wanted to ask a few questions of Dr. Corrigan Curray.
00:12First, starting with sunscreen, which is an important topic right now at the Jersey Shore,
00:17which I represent for the summer, of course. Everybody uses sunscreen and worries about the type.
00:23At our stakeholder hearing in April, we heard that the current review system
00:27has caused delays in getting new sunscreens to market,
00:30but we also heard the importance of ensuring safety of the product.
00:34So, given those concerns, I don't think that the language in the sunscreen legislation we're considering today
00:39is the right approach. In fact, in a statement from the Environmental Working Group,
00:44they said, and I quote, that the bill would lower the bar for sunscreen safety.
00:48So, Mr. Chair, I'd like to offer the statement from the Environmental Working Group on the sunscreen bill to the record.
00:55Without objection?
00:56Thank you, Mr. Chairman. So, Dr. Corrigan Curray, from what I can tell,
01:02because they are regulated as drugs, for sunscreen products to come to market,
01:06FDA requires rigorous safety data. What are some of the harms that the agency is concerned about?
01:12Briefly, because I have two more questions for you.
01:15Sure, thank you. The harms that we're worried about is if these products are absorbed systemically,
01:21they can have systemic effects across. So, that can be the endocrine system,
01:25you know, your hormones in development. They can also affect cells,
01:31and we could have abnormal growth or tumors. So, these are the kinds of tests that any drug that reaches systemic levels,
01:37we test for, whether it's an over-the-counter or a prescription drug.
01:41Those are kind of the tests that we do. Well, thank you. So, what kinds of studies does FDA need to show products are safe from these risks?
01:51In other words, has the FDA worked with manufacturers in getting data that show products are safe from these risks that you just mentioned?
02:00Yes. So, the first thing we had done was we published the MUST studies, which is the first thing you need to do and see what level these are absorbed.
02:09And then once they, you know, if they are absorbed, then we, you know, we have, you know, studies that, including animal studies,
02:16that will tell us whether there are any unexpected toxicities. And, you know, we are very much supportive of, you know, what we're doing,
02:24including the roadmap that Dr. McCary and the work that we've done to reducing or even eliminating animal studies.
02:32But at this time, for some of those more complex multi-organ system toxicities, we are using animal studies. We don't have a replacement.
02:40But are these federal studies or are these studies that the companies are doing that make sunscreen?
02:45These would be studies that the company would do. We did the MUST studies ourselves to show that they could be done,
02:51and to provide sort of a roadmap for that.
02:54Okay. Well, let me go to the provider workforce issue.
03:01HRSA's National Center for Workforce Analysis has said there's a projected shortage of over 187,000 physicians
03:09and a projected 6% shortage of registered nurses by 2037. However, oh, this actually is of Dr. Chen. I'm sorry. I want to move to you.
03:20However, Dr. Chen, many of the programs within Title VII and VIII were proposed to be eliminated in the President's budget,
03:27even though health workforce shortages only continue to increase.
03:30So if I could ask Dr. Chen, if Congress reauthorizes these programs and appropriates funding for them,
03:37can you confirm that HRSA will follow the law and carry out these programs?
03:41And, you know, we're always worried that we authorize things or we fund things and then, you know, the administration zeros them out or just freezes the funding.
03:52Can you comment on that?
03:54What I can say is that if Congress authorizes and appropriates for these programs, we will implement them.
04:00All right. Well, that's really important. I really appreciate your telling me that because I do think that these workforce programs are more important than ever.
04:07And any attempt to eliminate them or, you know, it's really going to exacerbate the country's workforce shortages.
04:17You know, the other thing I would say, too, is I know that we have relied a lot in the past on going overseas to get doctors and to get nurses.
04:28And I mean, you know, I mean, that's fine in theory because we have such a shortage.
04:32But I really would much prefer that, you know, we train those people here and don't have to rely on other countries,
04:39because a lot of times I think it drains the doctors and the nurses in the other countries.
04:44I mean, people tell me that that's not the case, but it's hard for me to believe that it's not the case.
04:49So thank you. And thank you, Mr. Chairman.
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