WASHINGTON, D.C. – Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Health, delivered the following opening statement at today’s hearing titled Legislative Proposals to Maintain and Improve the Public Health Workforce, Rural Health, and Over-the-Counter Medicines.

Subcommittee Chairman Griffith’s opening statement as prepared for delivery:

“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-Counter 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.  

“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, this 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 that a product is generally recognized as safe and effective, or GRASE (GRACE), and simultaneously establishing a new user fee program to help ensure this process is effective and 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 processes.  

“H.R. 3686, the SAFE Sunscreen Standards Act, led by Dr. Joyce and Mrs. 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 market, and this bill would help to bridge that gap. 

“During our last hearing on OMUFA, we had a robust discussion around the need for more innovative sunscreens to be available in the United States.  

“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 Reps. Carter and Barragan, would help support FDA’s efforts to do just that.  

“Congress gave FDA this ability in 2022 when the 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 the option 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 health care services in rural areas and help to increase the use of telehealth, so patients can access care more easily. 

“Reauthorizing the Telehealth Resource Centers 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 each program is working as intended. 

“I look forward to hearing from our witnesses today regarding the importance of these programs, and to ensure they are reauthorized in a timely manner.”  

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