OTC Monograph Drug User Fee Transparency Act

Issues related to competition in mobile app ecosystems; S.4746 American Innovation and Choice Online Act; S.2513 Open App Markets Act; H.R.3209 App Store Freedom Act; H.R.8413 SECURE Data Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General monitoring of legislative and administrative action related to health care policy; including the reauthorization of the OTC Monograph Drug User Fee Program (OMUFA); H R.5371 - Continuing Appropriations and Extensions Act, 2026, in particular provisions under Title V related to Over-the-Counter Monograph Drug User Fee Amendments. H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments; H.R.6868 - To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to apply the least burdensome appropriate means for supporting certain administrative order requests with respect to over-the-counter monograph drugs, and for other purposes. S.2292 - Over-the-Counter Monograph Drug User Fee Amendments; S.2513 - OTC Monograph Drug User Fee Transparency Act; S.3122 - Better FDA Act of 2025 General monitoring of legislative and administrative action related to womens health issues; General monitoring of legislative and administrative action related to over-the-counter consumer healthcare products; General monitoring of legislative and administrative action related to dietary supplements, multivitamin, and hunger issues; General monitoring of legislative and administrative action related to FDA monograph reform and user fees; General monitoring of legislative and administrative action related to the switch of prescription medications to over-the-counter medications; Review of coverage for medically necessary services in Medicare and Medicare Advantage, Review of legislation impacting the Dietary Supplement Health and Education Act of 1994; General review of legislation and amendments focusing on non-addictive, non-opioid pain management medications, with a focus on over-the-counter (OTC) options; and General monitoring and review of Executive Order 14273, particularly section 9(b) as related to improvements to the process through which prescription drugs can be reclassified as over-the-counter medications, including recommendations to optimally identify prescription drugs that can be safely provided to patients over the counter. Monitoring and review of federal rulemaking processes on Increasing Access to Nonprescription Drugs.

Client expense: $210,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

General monitoring of legislative and administrative action related to health care policy; including the reauthorization of the OTC Monograph Drug User Fee Program (OMUFA); H R.5371 - Continuing Appropriations and Extensions Act, 2026, in particular provisions under Title V related to Over-the-Counter Monograph Drug User Fee Amendments. H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments; S.2292 - Over-the-Counter Monograph Drug User Fee Amendments; S.2513 - OTC Monograph Drug User Fee Transparency Act; General monitoring of legislative and administrative action related to womens health issues; General monitoring of legislative and administrative action related to over-the-counter consumer healthcare products; General monitoring of legislative and administrative action related to dietary supplements, multivitamin, and hunger issues; General monitoring of legislative and administrative action related to FDA monograph reform and user fees; General monitoring of legislative and administrative action related to the switch of prescription medications to over-the-counter medications; Review of coverage for medically necessary services in Medicare and Medicare Advantage, Review of legislation impacting the Dietary Supplement Health and Education Act of 1994; General review of legislation and amendments focusing on non-addictive, non-opioid pain management medications, with a focus on over-the-counter (OTC) options; and General monitoring and review of Executive Order 14273, particularly section 9(b) as related to improvements to the process through which prescription drugs can be reclassified as over-the-counter medications, including recommendations to optimally identify prescription drugs that can be safely provided to patients over the counter.

Client expense: $220,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of