During a House Energy Committee hearing before the Congressional Recess, Rep. Greg Landsman (R-OH) asked Acting Director for Center for Drug Evaluation and Research at the FDA Dr. Jacqueline Corrigan-Curay about wait times for new OTC drugs with updated FDA guidance.
00:00I will call on the gentleman from Ohio, Mr. Lansman, for his five minutes.
00:06Thank you, Madam Chairwoman and the ranking member, for having today's hearing,
00:11and for all of you witnesses for being here today.
00:14When MUFA was first signed into law, we got five years under our belt,
00:20it was aimed at increasing the efficiency at the FDA so that they could update the monographs more quickly,
00:29keep up with consumer health care needs, create a simpler pathway to the market for innovative products
00:36with safe, established ingredients.
00:40And like everybody else, my constituents rely on these over-the-counter drugs,
00:46and they want to be able to have a set of options, lots of options,
00:53and the most innovative and, you know, best products on the shelves when they go shopping.
01:01The challenge has been that over the course of the last five years,
01:05despite the attempt of this law to make things more efficient,
01:10there have been few sponsor-initiated OTC monograph changes.
01:16There haven't been many, right?
01:18And so the questions here for you, Ms. Corgan-Curry,
01:25as the acting director of the Center for Drug Evaluation and Research,
01:31have you seen the implementation of MUFA?
01:36I mean, are you watching this?
01:38I mean, what can you say?
01:40Yes, thank you for that question.
01:42And I think what we have to realize, we do have one, of course, new OMAR for sunscreen,
01:47and we've also issued orders to update safety labeling for acetaminophen.
01:53We've issued an order on phenylephrine and its efficacy or lack thereof.
01:59And then we, you know, when you build a program from really scratch,
02:04it's not like when we had the Pidufa, you know, we were approving Pidufa drugs.
02:08There's a time to build, and then we started, you know, meeting our meeting goals in year three,
02:13and that's when we start to get the innovation.
02:16So there is a lag in terms of building the first program and then seeing an OMAR come to fruition.
02:22But we have on our agenda, we're going to continue to update labels.
02:27We're, you know, willing to work with companies.
02:30We've told them, you know, the data that we need to examine.
02:33And we'll continue to work on innovation, including by giving them more opportunities to interact with us.
02:39So in a MUFA II, we'll expand meetings if needed.
02:42We'll look at protocol synopsis.
02:44We'll do more education on the GRACE standard.
02:47I mean, the time to build, I get.
02:51Three years seems like a long time, but I don't, I do this.
02:54I don't do what you do.
02:56So that piece aside, why have there been so few sponsors?
03:05I mean, like, you know, or is it really just that it took you a while?
03:09I mean, you just named a few five years later.
03:12Um, and I mean, are you expecting an explosion of, of, of approvals now?
03:20Um, or there's still, I mean, you know, it would be helpful to understand.
03:26And if, for example, if folks in my district have said that some of the data required for an over-the-counter monograph,
03:38uh, change is more rigorous than they would have expected for some products.
03:45Um, you mentioned time with your staff.
03:47Uh, you know, is data the, the requirements, you know, is that a big part of why we're seeing so few being approved?
03:57Well, I think one thing is that, you know, we need the data.
04:01The standard of safety effectiveness, the GRACE standard, is one that, you know, needs to be rigorous.
04:06Because these products are over-the-counter, they can be bought anywhere, they're not under the provision of a, um, a health care provider.
04:14Uh, so, we need to work with the companies so they understand what that data is.
04:19We will work on, each individual case is different, we'll have that conversation.
04:23Do you, do you feel like you have the flexibility, of course, the data, rigorous data is really important.
04:29Like, the question is, when does it become, so, so much data that, you know, you're, you're just keeping products from, there, there's just too much bureaucracy and it's taking too, too long.
04:40I mean, do you feel like you have the flexibility in your reviews of, of these monographs to allow for innovation while still ensuring product safety or, you know, do these applicants have to meet these, the same stringent standards?
04:57They have to meet the standard for safety effectiveness, but how they get there, we think we can be flexible.
05:02Well, we can look at alternative testings, we have the ability to figure out which data is fit for use.
05:08Um, I've run out of time, I'll submit my questions and thank you and I, I yield back.
05:13Well, can I, sorry, one of the things that would be great, I'm sorry, is to get a sense and we can follow up, but what can, what can I tell my folks that you all are going to do or are doing that will make this process what was envisioned five years ago, but I'll follow up.
Be the first to comment