Tribal Firearm Access Act

340B Drug Discount Program - 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight 340B Drug Discount Program - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Alternative Funding Programs Drug Shortages Supply Chain Integrity and Traceability Drug Patenting S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 COVID-19 Pricing Related Provisions PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act H.R. 5378: Lower Costs, More Transparency Act CMMI Authority Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues

Client expense: $1,010,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Various issues relating to the reciprocity of concealed firearms permits; Extreme Risk Protection Orders; firearm purchase requirements; proposed changes to firearm prohibitions; and related matters. H.R.38 H.R.1508 S.741 S.909 H.R.1709 H.R.768 S.247 S.1680 H.R.3212 H.R.3155 H.R. 3091 S.1875 H.R.5767 S.2911 H.R.5561 H.R.5508 H.Res.684 S.1323 S.2860 H.R.5110 S.2736 S.3529 H.R.7450 S.4075 H.Res. 1267 H.R.8818

Client expense: $440,000 · Firm income: Not reported

1.Americas Outdoor Recreation Act (S.873); 2.Americas Wildlife Habitat Conservation Act (H.R.7408); 3.Bipartisan Public Lands in Public Hands Act (H.R.7430); 4.Bipartisan Safer Communities Act (Public Law No: 117-159); 5.Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) Engaged in the Business as a Dealer in Firearm / Stopping Unconstitutional Background Checks Act (H.R.6734); 6.Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) Unlawful Disclosure of Firearm Trace Data; 7.Bureau of Industry and Securitys October 27, 2023, Firearms Pause & Review: Frequently Asked Questions Policy Guidance; 8.Commercial Sale of Ammunition manufactured at Government owned, contractor operated facilities; 9.Fair Access to Banking Act (S.293 / H.R.2743) / Discrimination in lending; 10.Federal Firearms Licensee Protection Act (S.1907 / H.R.2620); 11.EXPLORE Act (H.R.6492) / Range Access Act (H.R.1614); 12.Exporting ammunition; 13.FIREARM Act (S.3812 / H.R.7471); 14.Firearm Industry Nondiscrimination (FIND) Act (S.428 / H.R.53); 15.FY25 Appropriations- Agriculture, Rural Development, Food and Drug Administration; 16.FY25 Appropriations-Commerce, Justice, Science and Related Agencies; 17.FY25 Appropriations-Interior, Environment, and Related Agencies; 18.FY25 Appropriations-Military Construction, Veterans Affairs, and Related Agencies; 19.Gary v Glock; 20.National Defense Authorization Act for Fiscal Year 2025; 21.Permanent Electronic Duck Stamp Act / Duck Stamp Modernization Act (S.788 / H.R. 2872); 22.Protecting Access for Hunters and Anglers Act (S.1185/H.R.615); 23.Protect American Gun Exporters Act (S.3531/H.R.6504); 24.Protecting Privacy in Purchases Act (S.4075 / H.R.7450); 25.Protecting the Mailing of Firearms Act (H.R.7195); 26.RIFLE Act (H.R.7042); 27.Second Amendment For Every Registrable (SAFER) Voter Act (H.R.6782); 28.Tax Stamp Revenue Transfer for Wildlife and Recreation Act (H.R.6352); 29.Travelers Gun Rights Act (H.R.1508); 30.Tribal Firearm Access Act (S.909/H.R.1709); 31.U.S. Fish and Wildlife Service (USFWS) Final Rule to ban the use of traditional lead ammunition on National Wildlife Refuges (NWRs); and 32.USML to CCL Transition / Export Control Reform.

1.Americas Outdoor Recreation Act (S.873); 2.Americas Wildlife Habitat Conservation Act (H.R.7408); 3.Bipartisan Public Lands in Public Hands Act (H.R.7430); 4.Bipartisan Safer Communities Act (Public Law No: 117-159); 5.Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) Engaged in the Business as a Dealer in Firearm / Stopping Unconstitutional Background Checks Act (H.R.6734); 6.Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) Unlawful Disclosure of Firearm Trace Data; 7.Bureau of Industry and Securitys October 27, 2023, Firearms Pause & Review: Frequently Asked Questions Policy Guidance; 8.Commercial Sale of Ammunition manufactured at Government owned, contractor operated facilities; 9.Fair Access to Banking Act (S.293 / H.R.2743) / Discrimination in lending; 10.Federal Firearms Licensee Protection Act (S.1907 / H.R.2620); 11.EXPLORE Act (H.R.6492) / Range Access Act (H.R.1614); 12.Exporting ammunition; 13.FIREARM Act (S.3812 / H.R.7471); 14.Firearm Industry Nondiscrimination (FIND) Act (S.428 / H.R.53); 15.FY25 Appropriations- Agriculture, Rural Development, Food and Drug Administration; 16.FY25 Appropriations-Commerce, Justice, Science and Related Agencies; 17.FY25 Appropriations-Interior, Environment, and Related Agencies; 18.FY25 Appropriations-Military Construction, Veterans Affairs, and Related Agencies; 19.Gary v Glock; 20.National Defense Authorization Act for Fiscal Year 2025; 21.Permanent Electronic Duck Stamp Act / Duck Stamp Modernization Act (S.788 / H.R. 2872); 22.Protecting Access for Hunters and Anglers Act (S.1185/H.R.615); 23.Protect American Gun Exporters Act (S.3531/H.R.6504); 24.Protecting Privacy in Purchases Act (S.4075 / H.R.7450); 25.Protecting the Mailing of Firearms Act (H.R.7195); 26.RIFLE Act (H.R.7042); 27.Second Amendment For Every Registrable (SAFER) Voter Act (H.R.6782); 28.Tax Stamp Revenue Transfer for Wildlife and Recreation Act (H.R.6352); 29.Travelers Gun Rights Act (H.R.1508); 30.Tribal Firearm Access Act (S.909/H.R.1709); 31.U.S. Fish and Wildlife Service (USFWS) Final Rule to ban the use of traditional lead ammunition on National Wildlife Refuges (NWRs); and 32.USML to CCL Transition / Export Control Reform.

Various issues relating to the reciprocity of concealed firearms permits; Extreme Risk Protection Orders; firearm purchase requirements; proposed changes to firearm prohibitions; and related matters. H.R.38 H.R.1508 S.741 S.909 H.R.1709 H.R.768 S.247 S.1680 H.R.3212 H.R.3155 H.R. 3091 S.1875 H.R.5767 S.2911 H.R.5561 H.R.5508 H.Res.684 S.1323 S.2860 H.R.5110 S.2736 S.3529 H.R.7450

Client expense: $540,000 · Firm income: Not reported

Various issues relating to the reciprocity of concealed firearms permits; Extreme Risk Protection Orders; firearm purchase requirements; proposed changes to firearm prohibitions; and related matters. H.R.38 H.R.1508 S.741 S.909 H.R.1709 H.R.768 S.247 S.1680 H.R.3212 H.R.3155 H.R. 3091 S.1875 H.R.5767 S.2911 H.R.5561 H.R.5508 H.Res.684 S.1323 S.2860 H.R.5110 S.2736 S.3529

Client expense: $550,000 · Firm income: Not reported

1.Americas Outdoor Recreation Act (S.873) / Range Access Act (H.R.1614); 2.Bipartisan Safer Communities Act (Public Law No: 117-159); 3.Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) Engaged in the Business as a Dealer in Firearm / Stopping Unconstitutional Background Checks Act (H.R.6734); 4.Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) Factoring Criteria for Firearms With Attached Stabilizing Braces Rule; 5.Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) Zero-tolerance Policy; 6.Bureau of Industry and Securitys October 27, 2023, Firearms Pause & Review: Frequently Asked Questions Policy Guidance; 7.Concealed Carry Reciprocity Act (S.214 / H.R.38); 8.Fair Access to Banking Act (S.293 / H.R.2743) / Discrimination in lending; 9.Farm Bill; 10.Federal Firearms Licensee Protection Act (S.1907 / H.R.2620); 11.Financial Regulatory Accountability Act of 2023 (S.2335); 12.Firearm Industry Nondiscrimination (FIND) Act (S.428 / H.R.53); 13.Freight Carrier Discriminatory Practices Against Firearms & Ammunition; 14.FY24 Appropriations- Agriculture, Rural Development, Food and Drug Administration; 15.FY24 Appropriations-Commerce, Justice, Science and Related Agencies; 16.FY24 Appropriations- Financial Services and General Government; 17.FY24 Appropriations-Interior, Environment, and Related Agencies; 18.FY24 Appropriations- Labor, Health and Human Services, Education; 19.FY24 Appropriations-Military Construction, Veterans Affairs, and Related Agencies; 20.GOSAFE Act (S.3369); 21.Hearing Protection Act (S.401 / H.R. 152); 22.Merchant Category Code (S.898, H.R. 3021); 23.Military and Veterans in Parks Act (H.R.6342); 24.National Defense Authorization Act for Fiscal Year 2024 (S.2226 / H.R.2670); 25.No GRISHAM Act (H.R.5767); Condemning the actions of Governor of New Mexico, Michelle Lujan Grisham, for subverting the Second Amendment to the Constitution and depriving the citizens of New Mexico of their right to bear arms (H. Res. 684); 26.Outdoor Recreational Outfitting and Guiding Act (H.R. 6128); 27.Permanent Electronic Duck Stamp Act (H.R. 2872); 28.Protecting Access for Hunters and Anglers Act (S.1185/H.R.615); 29.Protect American Gun Exporters Act (S.3531/H.R.6504); 30.Protecting Hunter Education (S. 2736, S.2828, H.R. 5110/H.R. 5161/S. 2735); 31.Protecting the Right to Keep and Bear Arms Act (S.2911/H.R.5561); 32.Respect for the Second Amendment Act (S.840/H.R. 5508); 33.Responsible Ownership of Firearms Act; 34.To terminate the Office of Gun Violence Prevention in the Executive Office of the President and prohibit the establishment of any similar successor office, and for other purposes (H.R. 5948); 35.Tribal Firearm Access Act (S.909/H.R.1709); 36.U.S. Fish and Wildlife Service (USFWS) Final Rule to ban the use of traditional lead ammunition on National Wildlife Refuges (NWRs); 37.USML to CCL Transition / Export Control Reform; 38.Veterans 2nd Amendment Protection Act (S. 1875/H.R. 705); 39.White House Office of Gun Violence

Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing H.R. 1613/S. 1038, Drug Price Transparency in Medicaid Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 2666, Medicaid for VBPs for Patients (MVP) Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3285, Fairness for Patient Medications Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Inflation Reduction Act Impact on Innovative Pharmaceuticals Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues Advanced Safe Testing at Residence Telehealth Act of 2023 S. 2052, Protect Patient Access to Pharmacies Act S. 476/HR. 5567, The Maintaining Investments in New Innovations (MINI) Act H.R. 5539, ORPHAN Cures Act Value-Based Purchasing (VBP) Rule CBO modeling H.R.2139/S.908: Medicare Drug Price Negotiation Act H.R.2148/S.909: Prescription Drug Price Relief Act H.R.5125: Strengthening Innovation in Medicare and Medicaid Act S.127: Pharmacy Benefit Manager Transparency Act of 2023 S.142: Preserve Access to Affordable Generics and Biosimilars Act S.150: Affordable Prescriptions for Patients Act of 2023 S.775: Increasing Transparency in Generic Drug Applications Act S.1067: Ensuring Timely Access to Generics of 2023 COVID-19 Pricing-Related Provisions National Coverage Determination Alternative Payment Arrangements for Gene Therapies Average Manufacturer Price Calculations Medicaid Drug Rebate Program Rule (MDRP) Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Protected Classes Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications

Various issues relating to the reciprocity of concealed firearms permits; Extreme Risk Protection Orders; firearm purchase requirements; proposed changes to firearm prohibitions; and related matters. H.R.38 H.R.1508 S.741 S.909 H.R.1709 H.R.768 S.247 S.1680 H.R.3212 H.R.3155 H.R. 3091 S.1875 H.R.5767 S.2911 H.R.5561 H.R.5508 H.Res.684 S.1323 S.2860 H.R.5110 S.2736

Client expense: $570,000 · Firm income: Not reported

1.Americas Outdoor Recreation Act (S.873) / Range Access Act (H.R.1614); 2.Assault Weapons Ban of 2023 (S. 25 / H.R. 698); 3.Bipartisan Safer Communities Act (Public Law No: 117-159); 4.BLM proposed rule on Conservation and Landscape Health; 5.Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) Zero-tolerance Policy; 6.Concealed Carry Reciprocity Act (S.214 / H.R.38); 7.Ensuring Sound Guidance (ESG) Act (H.R.4237); 8.Expressing the sense of the House of Representatives that mandates imposed on manufacturers requiring inclusion of unproven and unreliable technology in firearms is costly and punitive, and the prohibition of firearms without such features is an infringement on the rights of citizens under the Second Amendment (H.Res.244); 9.Fair Access to Banking Act (S.293 / H.R.2743) / Discrimination in lending; 10.Federal Firearms Licensee Protection Act (S.1907 / H.R.2620); 11.Firearm Industry Nondiscrimination (FIND) Act (S.428 / H.R.53); 12.Freight Carrier Discriminatory Practices Against Firearms & Ammunition; 13.FY24 Appropriations- Agriculture, Rural Development, Food and Drug Administration; 14.FY24 Appropriations-Commerce, Justice, Science and Related Agencies; 15.FY24 Appropriations-Interior, Environment, and Related Agencies; 16.Gun-owner Registration Information Protection (GRIP) Act (S.1680/H.R.3492); 17.Hearing Protection Act (S.401 / H.R. 152); 18.Merchant Category Code (S.898, H.R. 3021); 19.National Defense Authorization Act for Fiscal Year 2024 (S.2226 / H.R.2670); 20.Permanent Electronic Duck Stamp Act (H.R. 2872); 21.Protecting Access for Hunters and Anglers Act (S.1185/H.R.615); 22.Protection of Lawful Commerce in Arms Act (Public Law No: 109-92); 23.Providing for Congressional Disapproval Under Chapter 8 of Title 5, United States Code, of the Rule Submitted by the Bureau of Alcohol, Tobacco, Firearms, and Explosives Relating to Factoring Criteria for Firearms with Attached Stabilizing Braces (S.J.Res.20 / H.J.Res.44); 24.Respect for the Second Amendment Act (S.840); 25.Responsible Ownership of Firearms Act; 26.SHUSH Act; 27.Travelers Gun Rights Act (S.741/H.R. 1508); 28.Tribal Firearm Access Act (S.909 / H.R.1709); 29.U.S. Fish and Wildlife Service (USFWS) Final Rule to ban the use of traditional lead ammunition on National Wildlife Refuges (NWRs); and 30.USML to CCL Transition / Export Control Reform

Various issues relating to the reciprocity of concealed firearms permits; Extreme Risk Protection Orders; firearm purchase requirements; proposed changes to firearm prohibitions; and related matters. H.R.38 H.R.1508 S.741 S.909 H.R.1709 H.R.768 S.247 S.1680 H.R.3212 H.R.3155 H.R. 3091 S.1875

Client expense: $565,000 · Firm income: Not reported

Various issues relating to the reciprocity of concealed firearms permits; Extreme Risk Protection Orders; firearm purchase requirements; proposed changes to firearm prohibitions; and related matters. H.R.38 H.R.1508 S.741 S.909 H.R.1709 H.R.768 S.247

Client expense: $620,000 · Firm income: Not reported

340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing ---Seniors Prescription Drug Relief Act Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Access to Innovative Treatments Act ---Affordable Prescriptions for Patients Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---Prescription Pricing for the People Act Medicaid ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid VBPs for Patients (MVP) Act ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.2327: Seniors Prescription Drug Relief Act ---Access to Innovative Treatments Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---Medicare Prescription Drug Price Negotiation Act ---National Coverage Determination ---New Opportunities for Value that Extend Lives (NOVEL) Act ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Access to Innovative Treatments Act ---DISARM Act ---National Coverage Determination ---Vaccine Injury Compensation Program ---Value of vaccines and vaccine confidence ---Vaccine safety net and vaccine infrastructure

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act Accelerated Approval Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---Disease X ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Biosimilars ---BIOSIM Act ---BSUFA Negotiations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Interchangeability and Pharmacy Substitution ---Protecting Consumer Access to Generic Drugs Act ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4317: SAFE TO WORK Act ---S.4509: Vaccine And Coverage Certainty (VACC) Act ---Access to Generic Drugs Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Access to Innovative Treatments Act ---Affordable Prescriptions for Patients Act ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Lower Costs, More Cures Act ---National Coverage Determination ---Pharmacy Benefit Manager Transparency Act ---Prescription Pricing for the People Act Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---National Defense Authorization Act for FY 2023 ---DISARM Act ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---S.148: Stop STALLING Act ---Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.1730: Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.2327: Seniors Prescription Drug Relief Act ---Access to Innovative Treatments Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Access to Innovative Treatments Act ---Adult Immunization ---DISARM Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---Vaccine Access Improvement Act ---Vaccine Injury Compensation Modernization Act ---VICP CICP (Discussion Draft)