⚡️ NIMITZ HEALTH NEWS FLASH ⚡️ 

“Reauthorization of the Over-the-Counter Monograph Drug User Fee Program”

Senate HELP Committee

June 4th, 2025 (recording linked here)

WITNESS & TESTIMONY

• Dr. Jacqueline Corrigan-Curay: Acting Director, Center for Drug Evaluation and Research at the FDA

HEARING HIGHLIGHTS

MEMBER OPENING STATEMENTS

• Chair Cassidy (R-LA) opened the hearing by emphasizing the importance of over-the-counter (OTC) medications in maintaining Americans’ health and reducing healthcare costs. He explained that the previous drug monograph process was outdated and slow, often delaying safety updates and new product approvals. Cassidy stressed that as the Over-the-Counter Monograph Drug User Fee program (OMUFA) approaches expiration, Congress must evaluate its progress and explore further improvements, especially regarding the FDA’s failure to ease regulatory hurdles for OTC transitions and its ongoing delays in approving modern sunscreen ingredients.

• Ranking Member Kaine (D-VA) underscored the widespread reliance on OTC medications, noting that 8 in 10 Americans use them and that the U.S. spent over $40 billion on these products in 2024. He highlighted the financial benefits of OTC drugs, estimating over $50 billion in savings by reducing reliance on prescriptions, but cautioned that misuse still causes approximately 178,000 hospitalizations annually. Kaine expressed concern about FDA workforce reductions, citing a recent CBO report and administrative chaos that may undermine the agency’s ability to fulfill its mission. He called for answers on how layoffs were decided, their impact on the Center for Drug Evaluation and Research, and the broader implications for FDA oversight and public health.

WITNESS OPENING STATEMENT

• Dr. Corrigan-Curay praised the impact of the OTC Monograph User Fee program, calling it a transformative step toward modernizing a regulatory process that had not been updated in decades. She outlined progress made under OMUFA, including digitizing review systems, issuing 33 final and 5 proposed orders, and hiring 85 staff to oversee drug safety and innovation. She noted that recent FDA proposals could enable more accessible drug formats, like chewables and dissolvable films, especially beneficial for children and those who struggle with swallowing pills. Corrigan-Curay warned that failure to reauthorize OMUFA would halt progress, result in staff losses, and stall innovations and safety updates, jeopardizing public trust and consumer protection.

QUESTION AND ANSWER SUMMARY

• Chair Cassidy asked why so few drugs had shifted from prescription to OTC despite FDA’s authority, questioning whether Congress needed to act. Dr. Corrigan-Curay said the agency relied on sponsor applications and hoped a new rule allowing “additional conditions for nonprescription use” would expand access. She added examples were still in development and that sponsors must demonstrate safe self-selection under labeling or app-based tools.

  Chair Cassidy pressed on the low number of recent OTC conversions. Dr. Corrigan-Curay confirmed the number was small and noted the FDA encourages sponsors but cannot initiate switches on its own.

• Sen. Kim (D-NJ) asked if the Office of Nonprescription Drugs lost staff during the RIF and if FDA could meet hiring goals under OMUFA II. Dr. Corrigan-Curay declined to discuss RIF details due to litigation but said FDA leadership was working to meet hiring needs.

  Sen. Kim asked why no new sunscreen ingredients had been approved since 1999. Dr. Corrigan-Curay said systemic absorption and endocrine risks required extensive safety data, which few companies had submitted.

  Sen. Kim raised pediatric acetaminophen dosing. Dr. Corrigan-Curay said FDA would prioritize guidance on weight-based dosing under OMUFA II.

• Sen. Marshall (R-KS) asked how FDA defines success. Dr. Corrigan-Curay cited modernized systems, guidance issuance, and meeting sponsor engagement goals.

  Sen. Marshall pressed for measurable outcomes. Dr. Corrigan-Curay said FDA tracks timelines and publishes a three-year agenda, though no dashboard exists yet.

  Sen. Marshall asked about oversight of inactive ingredients. Dr. Corrigan-Curay said FDA can act on safety issues and recently issued color additive guidance.

  Sen. Marshall asked about reducing animal studies. Dr. Corrigan-Curay described progress in irritation testing and efforts to validate AI and non-animal methods for complex effects.

• Sen. Hickenlooper (D-CO) asked for support of the "Skinny Labels" bill and about generic competition efforts. Dr. Corrigan-Curay supported the bill and highlighted FDA’s guidance work, science meetings, and 59 first generic approvals in 2024.

  Sen. Hickenlooper asked about AI tool “ELSA” and data security. Dr. Corrigan-Curay said ELSA assists reviewers with document summarization but does not train on industry data.

  Sen. Hickenlooper criticized FOIA staffing cuts and vaccine advisory committee bypasses. Dr. Corrigan-Curay emphasized FDA’s ongoing commitment to transparency, including webinars and OMUFA-related disclosures.

• Sen. Tuberville (R-AL) asked how FDA is preparing for reauthorization and upcoming user fee negotiations. Dr. Corrigan-Curay said public meetings were scheduled and internal planning was underway.

  Sen. Tuberville asked about labeling origins and drug manufacturing locations. Dr. Corrigan-Curay said country-of-origin isn’t currently required on labels but FDA applies consistent safety standards globally.

  Sen. Tuberville raised concerns about sunscreen safety and rising skin cancer. Dr. Corrigan-Curay said FDA-approved sunscreens are effective if used correctly, and safety studies are ongoing for absorbed ingredients.

• Sen. Markey (D-MA) criticized FDA layoffs and asked how the agency would recover lost institutional knowledge. Dr. Corrigan-Curay said FDA continues to meet most review deadlines and is managing staff turnover, though some delays occur.

• Sen. Husted (R-OH) asked how FDA could reduce costs and accelerate access. Dr. Corrigan-Curay described priority reviews, expanded generics/biosimilars, and reliance on analytical models to shorten timelines.

  Sen. Husted asked about AI and quantum computing. Dr. Corrigan-Curay said FDA uses modeling and AI in drug development and generic science, and will provide more details.

  Sen. Husted asked how to speed generic approvals. Dr. Corrigan-Curay said FDA meets timelines and is using AI to streamline paperwork and reviews.

  Sen. Husted asked what laws should change. Dr. Corrigan-Curay cited Q1/Q2 ingredient transparency, eliminating biosimilar “interchangeable” distinctions, and patent clarity legislation.

• Sen. Hassan (D-NH) asked if FDA is improving pregnancy labeling for OTC drugs. Dr. Corrigan-Curay said new warnings, starting with NSAIDs, are under review.

  Sen. Hassan raised patent abuse blocking generics. Dr. Corrigan-Curay said FDA is working with PTO and FTC to address coordination issues.

  Sen. Hassan asked about avoiding OTC shortages. Dr. Corrigan-Curay said FDA lacks authority to require demand-related reporting and requested earlier market signal authority.

• Sen. Moody (R-FL) asked for a timeline on new sunscreen ingredient reviews. Dr. Corrigan-Curay said the process takes 17 months due to public comment and wide product scope.

  Sen. Moody asked what lessons FDA learned from the rapid naloxone approval. Dr. Corrigan-Curay said clearer sponsor meetings and guidance helped streamline the process and would be emphasized under OMUFA II.

• Sen. Alsobrooks (D-MD) criticized the RIF and asked about the role of FDA staff in public health. Dr. Corrigan-Curay said staff oversee drug reviews, advertising, generics, biosimilars, and quality inspections, all of which are essential.

  Sen. Alsobrooks asked about the Office of Pharmaceutical Quality. Dr. Corrigan-Curay said it ensures manufacturing standards, facilitates inspections, and supports domestic production and advanced technologies.

• Sen. Banks (R-IN) asked what improvements OMUFA reauthorization would bring. Dr. Corrigan-Curay said it would support innovative dosage forms and increased sponsor guidance to improve drug accessibility.

  Sen. Banks asked how FDA will better use OMUFA authority to boost innovation. Dr. Corrigan-Curay said FDA will expand educational tools, allow updated test methods, and improve transparency for sponsors.

  Sen. Banks asked about foreign inspections. Dr. Corrigan-Curay said inspections are risk-based and that OMUFA lacks a pre-market trigger like other programs.

• Ranking Member Kaine reiterated frustration over lack of data on RIF totals and veteran impact. Dr. Corrigan-Curay again declined to provide numbers due to litigation but said she would follow up post-resolution.

• Ranking Member Kaine proposed adding transparency requirements in OMUFA reauthorization. Dr. Corrigan-Curay supported improvements and said the new rule on OTC switches would increase regulatory flexibility and access.