SARAH ARBES

Amending Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169); e-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions; Value-based payment arrangements; CMMI; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Efforts to improve coding, coverage, and access for rare disease therapies; Medicaid Drug Rebate Program proposed rule, specifically the stacking rule; Medicare patient access to rare disease therapies, Part B and Part D drugs; Centers for Medicare and Medicaid Innovation (CMMI) policy issues; Center for Medicare and Medicaid Innovation models; General issues related to diagnostic reimbursement; H.R. 5539/S. 3131 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act; HR1503/S2916 Prescription Information Modernization Act; H.R. 3876 Access to Genetic Counselor Services Act of 2023; H.R. 2666 Medicaid VBPs for Patients Act.

E-labeling; Issues related to the HR 7085, the BIOSECURE Act, and US manufacturing of pharmaceuticals; Issues related to PBM reform.

H.R. 5539/S.3131 ORPHAN Cures Act, amending orphan drug exclusion in IRA; Issues related to expanding orphan drug exclusion in IRA; Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); FDA modernization policy issues; Issues related to FDA proposed regulation of lab developed tests; Reauthorization of the pediatric priority review voucher program; Reauthorization of newborn screening programs; Medicare drug price negotiation; Medicaid Drug Rebate Program proposed rule; Medicare Part D reform and inflation penalties; Issues related to drug pricing; Issues related to reform of pharmacy benefit managers; PBM Reform (misc. bills); General issues related to health equity in rare disease and clinical trials; General issues related to rare disease and orphan drugs; Issues related to the price and manufacture of inhaled medicines; Education to Hill staff on next generation propellant and PFAS; AZ sustainability platform; Issues related to importation of drugs; Issues related to march-in rights; Issues related to RSV monoclonal antibody manufacture and distribution; Issues related to COPD patient access through CMMI demonstration models; Rare Pediatric Disease Priority Review Voucher; H.R.7085 BioSecure Act.

Issues related to COVID vaccine access and reimbursement; Issues related to the Orphan Drug Tax Credit; issues related to the deduction of research and development expenditures; H.R. 1350, Camerons Law; S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023.

Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform; Issues related to pharmaceutical intellectual property (IP); General patent issues; Issues related to FDA Orange Book patent listings.

H.R. 1350, Camerons Law S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023. Issues related to the Orphan Drug Tax Credit; issues related to the deduction of research and development expenditures

ASTRAZENECA PHARMACEUTICALS LP

ASTRAZENECA PHARMACEUTICALS LP

ASTRAZENECA PHARMACEUTICALS LP