ASTRAZENECA PHARMACEUTICALS LP for ASTRAZENECA PHARMACEUTICALS LP

Taxation/Internal Revenue Code TAX

Issues related to international and corporate tax reform. Build Back Better Act - Issues related to the Orphan Drug Tax Credit

Contacted: Centers For Medicare and Medicaid Services (CMS); SENATE; HOUSE OF REPRESENTATIVES; White House Office; Office of Science & Technology Policy (OSTP); Food & Drug Administration (FDA)

Trade (domestic/foreign) TRD

Issues relating to Intellectual Property protections for Covid-19 treatments and vaccines. S. 1435, the Affordable Prescriptions for Patients Act. H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act. H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform S. 2428, the False Claims Amendments

Contacted: Office of Science & Technology Policy (OSTP); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); SENATE; Centers For Medicare and Medicaid Services (CMS); White House Office

Bills named: H.R. 2873 (117th), S. 2428 (117th), H.R. 2884 (117th), S. 1435 (117th)

Health Issues HCR

H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. H.R. 19 / S. 2164, the Lower Costs, More Cures Act. H.R. 3749, To amend title XXVII of the Public Health Services Act to expand the availability of coverage for lunch cancer screenings without the imposition of cost sharing. Issues related to Cures 2.0. Issues related to drug pricing. COVID-19 vaccine and therapy development. Issues related to health equity and clinical trials Build Back Better Reconciliation Bill Issues related to drug regulation & approval pathways S.2911, Seniors Prescription Drug Relief Act Issues related to value-based arrangements Oncology Care Model / Oncology Care First H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act Diverse and Equitable Participation in Clinical Trials Act Discussion Draft General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnostics and treatment

Contacted: Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); White House Office; HOUSE OF REPRESENTATIVES; Office of Science & Technology Policy (OSTP); SENATE

Bills named: H.R. 3749 (117th), H.R. 19 (117th), H.R. 3 (117th), S. 2164 (117th), H.R. 1730 (117th), S. 670 (117th), S. 350 (117th), S. 2911 (117th), H.R. 483 (117th)

Medicare/Medicaid MMM

Issues related to Medicare Parts B and D pricing reform, H.R. 3684, S. 2327, Senate S. 1971, the Chronic Kidney Disease Improvement in Research and Treatment Act. Issues related to CMS rulemaking [CMS-4190-F3, CMS-2482-P2]. S. 2614, the NOVEL Act Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 1946; H.R. 5260 - Reduced Costs and Continued Cures Act; Build Back Better Act General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to telemedicine Issues related to 340B

Contacted: White House Office; Office of Science & Technology Policy (OSTP); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); SENATE; Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 1946 (117th), S. 1971 (117th), S. 2614 (117th), S. 2327 (117th), H.R. 5260 (117th), H.R. 3684 (117th)

Pharmacy PHA

Issues related to the 340B drug discount program. Discussions related to an appropriations hold on funding for a 2014 FDA rule that would move package inserts (PI) from paper to digital form-e-labeling. FY2022 Budget Resolution (S.Con.Res.14) and Budget Reconciliation (H.R.5376)

Contacted: Office of Science & Technology Policy (OSTP); SENATE; White House Office; Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA)

Bills named: H.R. 5376 (117th), S.Con.Res. 14 (117th)