ACCESS Through OTC Innovation Act

General monitoring of legislative and administrative action related to health care policy; including the reauthorization of the OTC Monograph Drug User Fee Program (OMUFA); S.3122 - Better FDA Act of 2025 S.2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches. S.3677 - Dietary Supplement Listing Act of 2026 H.R. 6868 - ACCESS Through OTC Innovation Act General monitoring and review of implementation of Title V of H.R.5371 - Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, specific to Over-the-Counter Monograph Drug User Fee Amendments. 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: $240,000 · 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

S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act, 2026 S.2491 - SAFE Sunscreen Standards Act S.2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches (SMART OTC Act) 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.3122 - Better FDA Act of 2025 H.R.7366 - Dietary Supplement Regulatory Uniformity Act - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use Rule - Dietary Supplement Drug Preclusion - legislation intended to clarify ingredients that can be used in dietary supplements.

Client expense: Not reported · Firm income: $159,409

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.

S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act, 2026 S.2491 - SAFE Sunscreen Standards Act S.2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches (SMART OTC Act) 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.3122 - Better FDA Act of 2025 - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use Rule - The Dietary Supplement Regulatory Uniformity Act - legislation that would restore a national standard for dietary supplements. - Dietary Supplement Drug Preclusion - legislation intended to clarify ingredients that can be used in dietary supplements.

Client expense: Not reported · Firm income: $245,484