During a House Energy Committee hearing before the Congressional Recess, Rep. Troy Balderson (R-OH) asked Acting Director for Center for Drug Evaluation and Research at the FDA Dr. Jacqueline Corrigan-Curay about new over-the-counter drugs.
00:00Recognize the gentleman from Ohio, Mr. Balderson, for five minutes.
00:06Thank you, Madam Chair. Good to see you over there.
00:09Thank you all for being here today, and my questions will be directed predominantly to Dr. Corrigan-Carray.
00:15Thank you for being here.
00:18This committee has heard concerns that the FDA moves goalposts in regard to what is asked of sponsors during reviews.
00:26Do you believe that this has been an issue within the over-the-counter drug program as well?
00:33I would say we don't try to move goalposts, but when we ask for a study, you know, you can ask for a study to answer a question, and those are scientific studies.
00:44It is possible that the study doesn't yield the information that's necessary, and we need additional information,
00:51but we do our best to only ask for the information that we need and to be least burdensome in our approach to the information we're asking to evaluate for safety and effectiveness.
01:04Okay. Thank you.
01:05Do you think the FDA can provide greater consistency and predictability moving forward?
01:10That is always our goal, and we will take that, you know, criticism that we may not be meeting that goal
01:16and try and implement greater consistency and predictability.
01:19Okay. I'll follow up with you again also, Doctor.
01:24Congress has made clear its intent for the FDA to incorporate real-world evidence and new alternative testing methods
01:31during its review and approval processes.
01:34However, we've heard concerns that the agency has been slow to implement these tools.
01:40Can you explain how the FDA is currently using RWE and NAT and sunscreen evaluations
01:46and what steps the FDA is taking to ensure that this aligns with both the letter and the spirits of congressional direction?
01:56Thank you for that question.
01:58We certainly will rely on real-world evidence when, you know, it is appropriate and it can answer the question.
02:04You know, in the area of sunscreens, it may seem somewhat counterintuitive that they're used all the time
02:10and so there must be a lot of data in real-world data that we should be accessing and making our determinations.
02:16There is a couple things when you're trying to look for what we're saying causality.
02:20Is there a – does it cause some effect?
02:23You need to know what the exposure is.
02:25And unlike a prescription drug where we have in medical records exactly how much you took, when you took it,
02:30when we're talking about sunscreens, you know, they can be used over many years.
02:34It's very difficult for people to quantify or remember which sunscreen, how long.
02:39And that can be a key issue that we need.
02:42But we'll continue to look at whatever data we can.
02:45In terms of, you know, the alternative methods, as I said, we're very excited about the roadmap.
02:50We're working hard to develop the science that we can replace, reduce animal testing.
02:55We don't use skin irritation is no longer done with animals.
02:58Eye irritation is no longer done with animals.
03:01And we continue to look for other alternative methods, and we certainly will apply them to sunscreens.
03:06Okay. Thank you.
03:08Lastly, five years ago, Congress worked with the first Trump administration to enact the OTC Monograph Drug User Fee Act program.
03:19I know this was a critical step in modernizing the regulation of OTC products for the American people
03:24and taking key steps to empower consumers with more choices in meeting their health care needs.
03:32A key goal of enacting OMUFA was to improve the regulatory certainty around FDA's OTC work.
03:39But as Congress assesses what has worked well in the first five years of this program and where we have opportunities to improve it with this year's reauthorization,
03:49what suggestions do you have for how there can be more transparency with sponsors to further improve regulatory certainty when it comes to these products?
04:00We certainly have learned from OMUFA I, and that's reflected in OMUFA II.
04:05You know, we are going to provide greater, more guidance or education on the GRACE standard,
04:09but we're first going to seek clarity from sponsors in terms of what are the questions they have.
04:16We know we need to provide more guidance on when you're bringing in a proposed order for a new active ingredient,
04:23more guidance on how we treat confidential data.
04:26Also on exclusivity, we're going to do transparency on exclusivity, transparency on fees, who's paying fees and who is not paying fees.
04:35We're going to continue to provide guidance in areas that industry needs to understand that predictability and what our expectations are.
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