H.R.946 - Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) Issues related to Inflation Reduction Act (IRA) consideration of small molecule drugs, biologics, and genetically targeted technologies Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to e-labeling Issues related to the price and manufacture of inhaled medicines Issues related to the IRAs drug price negotiation program Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to FDA Orange Book patent listings Issues related to environmental sustainability Issues related to FDA modernization Policies related to international reference pricing for pharmaceuticals Policies related to 340B rebate model for IRA compliance Policies related to the definition of a qualifying single source drug under the IRA Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Company sustainability policy issues General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Education to Hill staff on next generation propellant and PFAS FDA modernization policy issues Tariffs/trade policies related to tariffs on pharmaceuticals
Definition of Qualified Single Source Drug (QSSD) for purposes of Medicare drug price negotiation E-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions Medicare patient access to rare disease therapies Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies Medicare drug price negotiation 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 General issues related to diagnostic reimbursement
e-labeling- allowing health care providers to receive prescribing information for drugs electronically rather than in paper form from manufacturers Issues related to PBM reform US manufacturing of pharmaceuticals
H.R.591 - Defending American Jobs and Investment Act HR 1414 - Cameron's Law, to restore orphan drug research tax credit H.R.1990 - American Innovation and R&D Competitiveness Act of 2025 H.R.4695 - Unfair Tax Prevention Act Expiring provisions of the Tax Cut and Jobs Act law Tax reform in budget reconciliation Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) pharmaceutical manufacturing (general education) Issues related to tariffs Issues related to the deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation
Issues related to IP and patents Issues related to FDA Orange Book patent listings