Literal source text
Lobbying issues and bill citations
HCR · Health Issues
CMMI GENEROUS Demo Medicare Part B ASP compliance 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 direct-to-consumer drug delivery policy options 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 next generation propellant and PFAS Issues related to the US manufacturing of pharmaceuticals Issues related to the price and manufacture of inhaled medicines Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to vaccine access and vaccine R&D Issues related to FDA Orange Book patent listings 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 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 ACIP recommendations Policies related to international reference pricing for pharmaceuticals Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program 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 HR 6166, the Lowering Drug Costs for American Families Act
Literal federal measure citations: HR 946, S 1862, HR 1262, S 932, HR 4132, S 2027, HR 6166
MMM · Medicare/Medicaid
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 340B rebate model Part B and Part D drugs Medicare drug price negotiation Medicare Part D reform and inflation penalties Medicaid Drug Rebate Program proposed rule 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 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 Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement
PHA · Pharmacy
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 HR 4132/S 2027, Prescription Information Modernization Act
Literal federal measure citations: HR 4132, S 2027
TAX · Taxation/Internal Revenue Code
Potential for a second reconciliation bill and potential offsets (increase in corporate tax rate, Sec 899 taxation) Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal IRS guidance on R&D tax credit Base Erosion and Anti-Abuse Tax (BEAT) tax Corporate alternative minimum tax (CAMT) interaction with R&D expensing Global Intangible Low-Taxed Income (GILTI), Foreign-Derived Intangible Income (FDII) deduction OECD Pillar Two side by side deal Workforce Tax Credits USMCA negotiations Pharmaceutical pricing negotiations Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Interaction of state and federal R&D credits Issues related to international tax rules including HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit S.1605 - International Competition for American Jobs Act
Literal federal measure citations: HR 591, HR 1414, S.1605
CPT · Copyright/Patent/Trademark
Issues related to patents and intellectual property
TAR · Tariff (miscellaneous tariff bills)
Commerce Section 232 tariffs on pharmaceuticals Section 301 investigations Tariffs/trade policies related to tariffs on pharmaceuticals Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) Pharmaceutical manufacturing (general education)
TRD · Trade (domestic/foreign)
Most favored nation policies related to pharmaceuticals Most Favored Nation voluntary agreement implementation Issues related to critical supply chains reshoring investments Issues related to importation of drugs 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)
