IP and Antitrust; H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435- Affordable Prescriptions for Patients Act of 2021 S. 1425- Stop STALLING Act Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees; Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 6000-CURES Act 2.0 H.R. 5030/ S. 2706- DIVERSE Trials Act H.R. 6584- DEPICT Act H.R. 3085/S. 1548- ENACT Act of 2021 H.R. 7845- NIH Clinical Trial Diversity Act of 2022 H.R. 1946/, S. 1873- Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts. H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1425- Stop STALLING Act S. 1435- Affordable Prescriptions for Patients Act of 2021 TRIPS / IP Waiver Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform, and Antitrust; H.R. 2617,Consolidated Appropriations Act, 2023 H.R. 7559 E-labeling; and issues related to appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts (PI). H.R. 8239/S. 4661, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act H.R. 8295/S. 4659,Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, H. Rept. 117-392, H. Rept. 117-403, H. Res. 1531. CTD, accelerated approval in the Omnibus year end, Consolidated Appropriations Act, 2023; P.L. 117-328. H.R. 2623 - Camerons Law H.R. 5376 - Build Back Better Act Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform S. 749/H.R 1304 - American Innovation and Jobs Act IP and Antitrust; H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435- Affordable Prescriptions for Patients Act of 2021 S. 1425- Stop STALLING Act Trade; Supply Chain and Manufacturing; H.R. 4521-United States Innovation and Competition Act of 2021, H. Rept. 117-235 Trade; Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines H.R. 7559 E-labeling; and issues related to appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts (PI). 340B; Issues related to the 340B drug discount program H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 1946, S. 1873. Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 2617-accelerated approval in the Omnibus year end H.R. 4065, S. 1971 (section 101), P.L. 117-328, H.R. 2617 Kidney disease screening, Expanding Medicare annual wellness benefit to include kidney disease screening. H.R. 5260 - Reduced Costs and Continued Cures Act; HR. 5376- Inflation Reduction Act; Build Back Better Act; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Preventative healthcare services and screenings Issues related to preventative services and screenings for underrepresented communities IRA implementation, Pub. L. 117-169 Medicare Reform(s); Issues related to Medicare Part B and Part D pricing reform. 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; Center for Medicare and Medicaid Innovation (CMMI) policy issues; 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 diagnostic reimbursement H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 1730/S. 670- Speeding Therapy Access Today Act H.R. 1946, S. 1873. Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 5030/ S. 2706 DIVERSE Trials Act HR 5376, Inflation Reduction Act reconciliation bill; Medicare price negotiation provision and Part D redesign; Preventative healthcare services and screenings; Issues related to preventative services and screenings for underrepresented communities H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 Accelerating Access for Patients Act; H.R.7667 - Food and Drug Amendments of 2022; S. 1548, H.R. 3085/H.R. 7845. ENACT Act of 2021 S.4348 - FDASLA Act of 2022; General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases; general issues related to pharmacy benefit managers (PBMs); general issues related to insurance coverage of specialty treatments Issues related to clinical trial diversity COVID-19; COVID-19 vaccine and therapy development Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts. E-Labeling EVUSHELD Issues related to repeal of the Medicaid AMP Cap. Issues related to drug pricing, IRA Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees;
LBR - Labor Issues/Antitrust/Workplace MED - Medical/Disease Research/Clinical Labs ENV - Environment/Superfund CPT - Copyright/Patent/Trademark BUD - Budget/Appropriations TAX - Taxation/Internal Revenue Code TRD - Trade (domestic/foreign) PHA - Pharmacy MMM - Medicare/Medicaid HCR - Health Issues
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