HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability 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 use of AI in R&D and manufacturing
Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare patient access to cancer screening Medicare drug price negotiation Value-based payment arrangements Definition of Qualified Single Source Drug (QSSD) for purposes of Medicare drug price negotiation Medicare patient access to rare disease therapies Efforts to improve coding, coverage, and access for rare disease therapies Part B and Part D drugs Medicare Part D reform and inflation penalties Medicaid Drug Rebate Program proposed rule Issues related to the digital communication of prescribing information for drugs Issues related to e-labeling and allowing FDA to finalize a rule to allow digital versions of prescriptions Issues related to a Most Favored Nations policy in Medicare and Medicaid Most Favored Nation drug pricing proposals Policies related to the use of international reference pricing in Medicare/Medicaid General issues related to diagnostic reimbursement Issues related to the digital communication of prescribing information for drugs
E-labeling (allowing health care providers to receive prescribing information for drugs electronically rather than in paper form from manufacturers) Issues related to increasing production of US manufacturing
Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) 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 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation
Trade (country specific and sectoral tariffs, US trade negotiations) Trade - country specific and sectoral tariffs, US trade negotiations, non-tariff barriers (regulatory harmonization) OECD Pillar Two negotiations Treasury implementation of One Big Beautiful Bill Act law
Comments for USTR Section 301 investigation into Brazil (patent reforms) Comments for USTR 2026 National Trade Estimate (NTE) report (patent barriers) Patent/IP protections needed for medicines (National Security Commission on Emerging Biotechnology) Issues related to FDA Orange Book patent listings Issues related to patents and intellectual property
S.998 - Medical Supply Chain Resiliency Act Section 232 tariffs on pharmaceuticals Section 301 investigations Comments for USTR 2026 National Trade Estimate (NTE) report (tariff and non-tariff barriers) Supply Chain and trade barriers that need addressing (National Security Commission on Emerging Biotechnology) Department of Commerce Bureau of Industry and Security API survey Issues related to critical supply chains reshoring investments Issues related to importation of drugs Most favored nation policies related to pharmaceuticals Tariffs/trade policies related to tariffs on pharmaceuticals Issues related to direct-to-consumer advertising by pharmaceutical manufacturers Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) Pharmaceutical manufacturing (general education)