S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo FDA modernization policy Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) BIOSECURE Act implementation Issues related to the Medicare title in the One Big Beautiful Bill Act Issues related to the IRA definition of a drug for purposes of price negotiation selection Duplicate discounts as required by IRA Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues related to 340B Rebate Model Pilot Program for IRA compliance Issues related to the US manufacturing of pharmaceuticals Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals
H.R. 9599 The SECURE 340B Act Pharmaceutical supply chain manufacturing Policies related to the use of international reference pricing in Medicare/Medicaid 340B rebate model Part B and Part D drugs Medicare drug price negotiation Medicare Part D reform Definition of Qualified Single Source Drug (QSSD) for purposes of Medicare drug price negotiation Medicare patient access to cancer screening Medicare patient access to rare disease therapies Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements
Pharmaceutical pricing negotiations Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) Pharmaceutical manufacturing (general education)
Issues related to patents and intellectual property Patent/IP protections needed for medicines
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1911 - To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments HR 1990 - American Innovation and R&D Competitiveness Act of 2025 S.1605 - International Competition for American Jobs Act S.1639 - American Innovation and Jobs Act S.3841 - Last Sale Valuation Act of 2026 Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Most Favored Nations and pharmaceutical R&D innovation Most Favored Nation drug pricing proposals Pharmaceutical investment and pricing issues in ex-US countries US trade tools (investigations, tariffs, trade agreements, congressional oversight, rules of origin, CBP enforcement, investment screening) US-Mexico-Canada trade agreement (USMCA)
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) Most Favored Nations and pharmaceutical R&D innovation Most Favored Nation drug pricing proposals US trade tools (investigations, tariffs, trade agreements, congressional oversight, rules of origin, CBP enforcement, investment screening) US-Mexico-Canada trade agreement (USMCA)
Work Opportunity Tax Credit renewal Support for federal and state workforce programs (grants, technical assistance, partnership with federal and state agencies) Support for federally registered apprenticeship programs Support for manufacturing workforce development
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) Tariffs/trade policies related to tariffs on pharmaceuticals Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 1911 - To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments S 1605 - International Competition for American Jobs Act S 1639 - American Innovation and Jobs Act