00:00I recognize the gentleman from New Jersey, Mr. Keene.
00:03Thank you, Mr. Chairman.
00:05New Jersey is a hub of ingenuity in many industries, including in over-the-counter drugs.
00:11A number of OTC companies have a strong presence in New Jersey,
00:15where they manufacture and they develop their innovative products.
00:19Unlike prescription drugs, Americans see these products on store shelves every day
00:25and use them for common ailments or to help their kids when they are sick.
00:30In fact, many of these products and their active ingredients have been on shelves, in some cases, for decades.
00:36But this does not mean that these companies do not innovate.
00:40Additions of already approved active ingredients to an existing monograph can increase the effectiveness of a product.
00:48Creating a more convenient route of administration for a product can also increase a patient's adherence
00:54and, therefore, their overall health.
00:56Enabling innovation is one of the reasons that five years ago, Congress, industry, and the FDA
01:04worked together to reform the OTC drug approval process.
01:09Now we get the opportunity to evaluate these reforms and make any changes needed to ensure
01:15that the OTC monograph program continues to foster innovation.
01:20Dr. Corrigan-Couré, could you please give us a quick summary of the two distinct approval pathways at FDA
01:29that were established five years ago in the CARES Act and the difference between the two?
01:34Dr. Corrigan-Couré, in terms of the OTC monograph, this was really to change from sort of a rulemaking to a regulatory provision.
01:46I'm not sure the other approval pathway, I'm sorry, that you're referencing from CARES Act.
01:51And then, so, I ask this because I've heard concerns from some OTC manufacturers that when they choose to choose a more streamlined pathway,
02:02initiate a change from a monograph through OMOR, their concern is that there's a lack of clarity at FDA
02:08on what data they need to determine whether a proposed change is a grace.
02:16And this leads to more of a drawn out and back and forth between the FDA and manufacturers
02:22that can delay the approval of innovative products.
02:26Wouldn't you agree that knowing at the beginning of the process what the guardrails and expectations are
02:33for an OMOR can provide certainty to manufacturers, increase their investment in innovative ideas?
02:40Yes, thank you.
02:40We would, and we are going to give more clarity.
02:43That's one of our objectives in AMUFA, too, to give more clarity about an OMOR
02:47where you're bringing a new active ingredient into the market.
02:50And we definitely are also going to, across the industry, provide more education on the grace standard
02:56so it's well understood and our expectations are understood under that standard.
03:01Dr. Chen, changing gears here, I wanted to highlight one of the bills that we are considering here today
03:09to reauthorize the Title VII Public Health Workforce Programs.
03:13I recently heard from the Virtua Health College of Medicine and Life Science from Rowan University
03:19that is a recipient of the Geriatric Workforce Enhancement Program that is reauthorized in this legislation.
03:27Since there are not enough specialists in geriatrics,
03:29this college is adapting by working with educational institutions in New Jersey
03:34like Rutgers and health systems like Hackensack, Meridian Health to educate all members of the healthcare workforce
03:41on how to effectively care for New Jersey's aging population.
03:44Can you speak to how this effort in New Jersey to broadly educate healthcare providers instead of relying solely on
03:52geriatric specialists will continue to help our seniors?
03:55Dr. Thank you for your interest, again, I think in the geriatrics programs.
04:03In taking care of older adults with complex illnesses, often has multiple chronic conditions,
04:10dementia takes a real team and it takes both the combination, I think, of specialists and people who have been trained to provide that specialized care,
04:18as well as the integration with primary care and the wider healthcare system.
04:24And that is what the Geriatric Workforce Education Program supports.
04:29I'll be back.
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