Legislative Proposals to Maintain and Improve the Public Health Workforce, Rural Health, and Over-the-Counter Medicines
2025-07-16
Loading video...
Source: Congress.gov
Summary
No summary available.
Participants
Transcript
Subcommittee of Health will come to order, and I will take first a brief moment for a point of personal privilege. This is my first hearing as the new subcommittee chair, but I would be remiss if I didn't recognize the great work that my colleague, Buddy Carter, did. I understand he's trying to get a demotion and go over to the Senate, and I wish him well in that endeavor. but it made it so that he had to step aside, but that does not mean he's not gonna be an integral part of the running of this committee and of the philosophies and policies that he has championed. I think we're in agreement at least 99.9% of the time, and I will look to him for help and guidance on a number of the issues. So thank you, buddy, we appreciate your service. That said, I now recognize myself for five minutes for an opening statement. Today's legislative hearing is necessary to continue essential programs that are vital to our health care infrastructure. Many of the bills before us expire at the end of this fiscal year and must be reauthorized. One of the bills that will be discussed today is H.R. 4273, the over-the-county monograph drug user fee amendments led by Mr. Latta and Ranking Member DeGette. The Coronavirus Aid, Relief, and Economic Security CARES Act, which passed in 2020, modernized the regulation of over-the-counter monograph drugs and products. It also created a new user fee program to support this new framework, also known as OMUFA, or colloquially UMUFA. And I hope I pronounced the colloquialism right, but it's another one of those fees that we have that make things important. make important things happen. Generally, a company can market an over-the-counter drug if they either submit a new drug application or go through the over-the-counter monograph process. Prior to 2020, that involved a lengthy, burdensome three-phase rulemaking process.
This led to Congress creating a new regulatory framework that allows FDA to issue administrative orders determining a product is generally recognized as safe and effective or grace. and simultaneously establishing a new user fee program to help ensure this process is effective and is streamlined. This is the first reauthorization of OMUFA. We hope to work in a bipartisan way to address any outstanding issues to ensure this program is functioning how Congress initially intended, including minimizing regulatory burdens, supporting innovation and increasing access to products in a safe, and efficient manner. We will also consider other legislation that will help encourage the FDA to be more flexible in their review process. HR 3686, the Safe Sunscreen Standards Act, led by Dr. Joyce and Ms. Dingell, would require the FDA to consider the use of certain real-world evidence-based and non-animal testing methods when it comes to evaluating new sunscreen active ingredients in the United States. We are behind other countries in bringing innovative sunscreens to the market, and this bill will help to bridge the gap. During our last hearing on OMUFA, we had a robust discussion about the need for more innovative sunscreens to be available in the United States, and I look forward to the discussion around these policies today. Along similar lines, the FDA must keep pace with current technological advancements, which includes greater utilization of non-animal testing methods. H.R. 2821, led by Representatives Carter and Baragon, would help support FDA's efforts to do just that. Congress gave the FDA the ability in 2022 when FDA Modernization 2.0 was signed into law, but the FDA has failed to fully implement these practices. This legislation would require the FDA to finally update its regulations to account for non-animal testing. This bill does not require non-animal testing. It simply provides an option that if companies wish to pursue
less costly methods such as computer AI modeling or organ chip testing. There are also two important reauthorizations in front of us today that serve a vital role in helping our medical workforce, which are the Title VII and Title VIII reauthorizations. These programs allocate resources for scholarships and educational assistance so students from underserved backgrounds who are often from rural areas can pursue medical careers and help support the medical workforce that Americans widely rely upon. It is crucial for Congress to take a close look at these programs to ensure resources are going to areas and patients who need it most. We are also discussing legislation that will continue grants for certain healthcare services in rural areas to help to increase the use of telehealth so patients can access care more easily. Reauthorizing the Telehealth Resource Center's grant program will support our telehealth infrastructure that has become a lifeline for both providers and patients across the country, especially in rural areas. Considering each of these reauthorizations is an important step forward to ensure the program is working as intended. I look forward to hearing from our witnesses today regarding the importance of these programs and to ensure that they are reauthorized in a timely manner. That said, I would also say that The health subcommittee has great advantages in many ways. One of those being is that when somebody is sick or needs health care, they don't look at what party they identify with or what their philosophical background is. This subcommittee has a long history, and I hope to be a part of continuing that long history of doing bipartisan work for the betterment of the American people and the American patients. And I know that my colleague, the ranking member, Ms. DeGette,
Sign up for free to see the full transcript
Accounts help us prevent bots from abusing our site. Accounts are free and will allow you to access the full transcript.