⚡️ NIMITZ HEALTH NEWS FLASH ⚡️ 

“Legislative Proposals to Maintain and Improve the Public Health Workforce, Rural Health, and Over-the-Counter Medicines”

House Energy & Commerce Health Subcommittee

July 16th, 2025 (recording linked here)

WITNESS & TESTIMONY

• Dr. Jacqueline Corrigan-Curay, JD, MD: Acting Director for Center for Drug

  Evaluation and Research (CDER), U.S. Food and Drug Administration

• Dr. Candice Chen, MD, MPH: Acting Associate Administrator for Health

  Workforce, U.S. Health Resources and Services Administration

• Mr. Tom Morris, MPA: Associate Administrator for Rural Health Policy, U.S.

  Health Resources and Services Administration

HEARING HIGHLIGHTS

MEMBER OPENING STATEMENTS

• Chair Griffith (R-VA) introduced the legislative hearing as essential to reauthorizing critical health programs set to expire at the end of the fiscal year. He highlighted H.R. 4273, which reauthorizes the OTC Monograph Drug User Fee program (OMUFA), and praised its role in modernizing FDA’s drug regulation. Griffith emphasized bipartisan cooperation to reduce regulatory burdens, support innovation, and expand access to safe products, especially in rural areas through programs supporting telehealth, non-animal testing, and medical workforce development.

• Ranking Member DeGette (D-CO) expressed strong support for reauthorizing the OTC monograph program and voiced pride in its past successes. DeGette sharply criticized a recently passed Republican tax bill, arguing it will result in Medicaid cuts and loss of coverage for 17 million Americans, which she described as a cruel and fiscally irresponsible move. She called for a return to bipartisan collaboration within the committee and urged the majority to engage with Democrats in shaping meaningful health policy.

• Full Committee Chair Guthrie (R-KY) stressed the importance of reauthorizing the OMUFA program to maintain oversight of widely used OTC products and to promote innovation and transparency. Guthrie also focused on the importance of supporting rural health programs administered by HRSA, especially in light of the unique challenges facing states like Kentucky. He concluded by calling for renewed bipartisan cooperation to address these public health priorities effectively.

• Full Committee Ranking Member Pallone (D-NJ) criticized Republicans for passing legislation that he claimed would strip health coverage from 17 million Americans. He reiterated support for reauthorizing the OTC monograph user fee program but raised concerns about a proposed sunscreen bill that he believes could undermine FDA safety standards. Pallone also endorsed reauthorization of workforce programs like Titles VII and VIII, warning that political attacks on terms like “diversity” threaten essential public health initiatives. He supported continuing programs such as Healthy Start and newborn screening, emphasizing their importance in maternal and child health.

WITNESS OPENING STATEMENTS

• Dr. Corrigan-Curay emphasized the importance of OTC medications in everyday American life and explained how the OMUFA program modernized FDA’s outdated regulatory process. She detailed the program’s successes, including 33 administrative orders, new forms of medications for children, and hiring 85 specialized staff. She warned that without reauthorization, the program’s progress would halt, resulting in job losses, delays in safety improvements, and stalling of innovation. Dr. Corrigan-Curay urged Congress to maintain the program to ensure continued transparency, safety, and modernization of OTC drug oversight.

• Dr. Chen described widespread shortages across healthcare occupations and HRSA’s efforts to address these through scholarship and loan repayment programs like the National Health Service Corps and Nurse Corps. Dr. Chen highlighted the success of teaching health center graduate medical education and behavioral health workforce programs, which help train providers for underserved communities. She concluded by affirming her commitment to expanding and strengthening the health workforce nationwide.

• Mr. Morris stressed the importance of reauthorizing flexible, locally driven grant and telehealth programs. He explained that rural communities face higher rates of chronic disease, provider shortages, and geographic barriers but often respond with resilience and innovation. Morris highlighted the Rural Health Care Outreach Program and telehealth investments as key success stories, noting their impact on access to primary and specialty care.

QUESTION AND ANSWER SUMMARY

• Rep. Griffith asked whether Title VII and VIII programs should prioritize geographic need over race or ethnicity. Dr. Chen replied that shortages affect both rural and non-rural areas and require broad targeting.

  Chair Griffith then asked about funding distribution for telehealth resource centers; Mr. Morris said allocations consider need and program viability.

  Chair Griffith also suggested expanding the number of centers to reduce coverage areas, which Mr. Morris supported as telehealth becomes more decentralized and patient-centered.

• Rep. DeGette emphasized widespread provider shortages, including in urban Denver, and Dr. Chen confirmed that over 22% of Americans live in primary care shortage areas. Dr. Chen projected a national shortage of 87,000 primary care doctors by 2037.

  Ranking Member DeGette expressed concern about geriatric workforce shortages and criticized the administration’s proposal to eliminate Title VII geriatrics programs. She also flagged the cancellation of scholarships for disadvantaged students, which Dr. Chen confirmed were halted due to funding decisions made across federal agencies.

• Rep. Guthrie asked what worked under OMUFA I and what changes OMUFA II would bring. Dr. Corrigan-Curay cited major gains in transparency, guidance, and innovation, and said OMUFA II will focus on longer meetings, clearer data protocols, and improved facility assessments.

  Rep. Guthrie then asked how HRSA measures success in rural health programs; Mr. Morris said they track health outcomes, project sustainability, and economic impact, with over 90% of grantees showing positive results. Dr. Chen added that Titles VII and VIII help train providers in high-need areas and should be reauthorized.

• Rep. Pallone criticized the proposed sunscreen bill, citing safety concerns, and asked what risks FDA assesses. Dr. Corrigan-Curay explained that FDA evaluates systemic absorption and long-term toxicity, using both company-submitted and FDA-led studies.

  Rep. Pallone then asked if HRSA would implement workforce programs if Congress reauthorized and funded them; Dr. Chen confirmed it would.

  Rep. Pallone stressed the need to grow the domestic health workforce rather than relying on international recruitment.

• Rep. Harshbarger (R-TN) asked how “disadvantaged” is defined in Title VII and VIII programs. Dr. Chen said it varies by statute and offered to follow up.

  Rep. Harshbarger then asked about integrating community paramedics into rural care models. Mr. Morris supported the concept and noted HRSA has funded such programs, though payment structures remain a barrier.

  Rep. Harshbarger asked about the OTC ACNU pathway, and Dr. Corrigan-Curay explained it allows extra safety steps like digital screening to expand access to chronic disease treatments while maintaining proper use.

• Rep. Ruiz (D-CA) emphasized the importance of HRSA grants in improving rural health outcomes and supported H.R. 2493. Mr. Morris responded that over 90% of grantees reported better health outcomes and sustained services post-grant, largely due to collaborative, consortium-based models.

  Rep. Ruiz highlighted elevated rural mortality rates and the threat posed by hospital closures, arguing that a Republican-backed bill would close 20% of rural hospitals. He also warned that capping federal student loans and eliminating the Graduate PLUS program would worsen physician shortages, especially in underserved areas.

• Rep. Bilirakis (R-FL) asked for clarification on FDA’s standards for determining OTC drug safety. Dr. Corrigan-Curay explained the GRAS/E standard mirrors prescription drug criteria, and FDA collaborates with companies to define necessary data.

  Rep. Bilirakis then asked about geriatrics training. Dr. Chen said GWEPs both train providers and improve care delivery, which is increasingly vital with an aging population.

• Rep. Dingell (D-MI) warned that OMUFA reauthorization delays could lead to termination of 44% of FDA staff in the OTC division, stalling innovation and reviews. Dr. Corrigan-Curay confirmed this would halt progress on key products like new sunscreens.

  Rep. Dingell also raised concerns about outdated sunscreen ingredient approvals and asked if Congress could help modernize testing requirements. Dr. Corrigan-Curay expressed willingness to collaborate, emphasizing the need for safety data due to systemic absorption concerns.

• Rep. Carter (R-GA) promoted H.R. 2493 and the FDA Modernization Act, focusing on rural health and reducing chronic disease. Mr. Morris cited the success of early screening, care coordination, and community health workers in addressing rural chronic conditions.

  Rep. Carter also pushed for ending unnecessary animal testing; Dr. Corrigan-Curay said FDA is advancing alternative testing methods and updating relevant guidance.

• Rep. Schrier (D-WA) praised newborn screening and rural health legislation she co-led. She criticized recent Republican proposals to cut Medicaid and cap student loans, arguing they would shutter rural hospitals and hinder healthcare training. Mr. Morris deferred specifics but acknowledged the importance of funding stability. Dr. Chen affirmed the effectiveness of Title VII and Title VIII programs in addressing workforce shortages.

• Rep. Crenshaw (R-TX) supported OTC monograph modernization and praised new flexibility through voluntary consensus standards and alternative methods. Dr. Corrigan-Curay said FDA is applying such approaches to outdated testing, including efforts to update acetaminophen and NSAID safety guidance.

  Rep. Crenshaw stressed the need to preserve innovation while maintaining safety and questioned FDA on outdated OTC drugs. Dr. Corrigan-Curay noted active updates, including pediatric dosing reforms.

• Rep. Veasey (D-TX) condemned the sudden dissolution of the federal newborn screening advisory committee (ACHDNC), arguing it risked children’s lives by halting updates to the recommended screening panel. He cited a powerful case from his district involving two brothers with Duchenne muscular dystrophy—one diagnosed too late and one saved by early screening. Rep. Veasey called for immediate reinstatement of the committee to protect consistent national standards.

• Rep. Joyce (R-PA) criticized the FDA for failing to approve any new sunscreen ingredients since 1999, despite rising rates of melanoma and other skin cancers. He highlighted the Safe Sunscreen Standards Act and called on FDA to expedite access to new products. Dr. Corrigan-Curay confirmed FDA’s interest in expanding options while ensuring safety.

• Rep. Fletcher (D-TX) criticized the reauthorization of health programs without adequate funding or staffing, citing proposed eliminations of HRSA and cuts to programs like the Children’s Hospitals Graduate Medical Education (CHGME) program. She challenged Republicans to oppose these cuts and requested Dr. Chen submit written comments on how CHGME helps address pediatric workforce shortages.

• Rep. Balderson (R-OH) raised concerns about regulatory unpredictability in the FDA's OTC drug program. Dr. Corrigan-Curay emphasized the agency aims to be scientifically grounded and minimally burdensome.

  Rep. Balderson questioned FDA use of real-world evidence and alternatives to animal testing, especially in sunscreen reviews. He concluded by urging more transparency and clarity in OMUFA II, which Dr. Corrigan-Curay said would include guidance on exclusivity, fees, and regulatory expectations.

• Rep. Ocasio-Cortez (D-NY) highlighted high U.S. maternal and infant mortality rates and advocated for reauthorizing the bipartisan Healthy Start program. She criticized the FDA's 25-year delay in approving new sunscreen filters and urged modernization. Dr. Corrigan-Curay explained regulatory differences, noting other countries classify sunscreens as cosmetics, while the U.S. treats them as drugs.

• Rep. Miller-Meeks (R-IA) focused on rural and geriatric healthcare needs, praising programs like GWEP. Dr. Chen affirmed the importance of workforce investments as the population ages.

  Rep. Miller-Meeks raised concerns about FDA’s ACNU rule allowing concurrent Rx/OTC marketing. Dr. Corrigan-Curay cited the need for access options when additional use conditions are involved.

  Rep. Miller-Meeks also promoted workforce loan repayment programs, which Dr. Chen supported.

• Rep. Auchincloss (D-MA) warned against political interference at FDA and questioned the legality of the proposed Commissioner’s National Priority Voucher (CNPV) program. Dr. Corrigan-Curay confirmed drug approval is based on safety and efficacy, not price, and said she was unaware of statutory authority for the voucher.

  Rep. Auchincloss argued that unvetted approval pathways risk favoritism and undermine scientific integrity.

• Rep. Kean (R-NJ) highlighted New Jersey’s OTC drug industry and asked how FDA could provide clearer expectations for the OMOR process. Dr. Corrigan-Curay confirmed that increased guidance on OMOR submissions and the “GRASE” standard is planned under OMUFA II.

  Rep. Kean also spotlighted New Jersey’s geriatric training collaborations and asked how training across specialties improves elder care; Dr. Chen emphasized the need for both specialists and broad-based provider education.

• Rep. Landsman (D-OH) questioned why few OTC monograph changes had occurred since OMUFA was enacted. Dr. Corrigan-Curay explained that the agency had to build the program from scratch, resulting in a slow start. She said progress is accelerating and OMUFA II will increase sponsor engagement and education on data standards.

  Rep. Landsman asked if the FDA was too rigid, and Dr. Corrigan-Curay affirmed the agency has flexibility to evaluate fit-for-use data.

• Rep. Miller (R-OH) endorsed the Improving Care in Rural America Reauthorization Act and described rural hospital closures in his Ohio district. He stressed the need to preserve access to basic services, promote telehealth, and ensure geography doesn’t dictate health outcomes. He voiced strong bipartisan support for increased rural health investment and yielded back.

• Rep. Latta (R-OH) questioned whether FDA had fully honored congressional intent, especially around reasonable data expectations. Dr. Corrigan-Curay responded that the FDA moved to electronic systems, issued 33 final orders, and is promoting innovation, including new dosage forms. She outlined further goals under OMUFA II, including greater sponsor interaction, protocol feedback, and exclusivity transparency.