2025 fourth_quarter Filing

Issues related to health care, the Food and Drug Administration (FDA), oncology coverage, mental health, opioid abuse, 340B Program, drug pricing, importation of biopharmaceuticals, international pharmaceutical supply chain, plasma therapy, step therapy, and PBM reform; Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; S.891, Bipartisan Health Care Act; Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients Executive Order.

General issues related to Medicare and Medicaid, including: Part D Medicare Program; Medicare Part B reimbursement; CMMI Drug Pricing Demonstration Programs; Drug Pricing; Inflation Reduction Act of 2022 (P.L.117-169) implementation; H.R.1, One Big Beautiful Bill Act (P.L.119-21) implementation.

Issues related to tax reform; R&D tax credit; orphan drug tax credit; Section 899.

Biopharmaceutical innovation and patent policy issues. Bayh-Dole march-in rights policy issues.

Issues related to pharmaceutical IP, supply chain, and tariffs; Section 232 tariff investigation on branded pharmaceuticals.