Enhanced Access to Affordable Medicines Act of 2022

H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products HR 1978 - Protecting Seniors Through Immunization Act H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing, patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Issues related to HFC's Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Veterans' Affairs issues related to product sampling Provisions related to the importation of HFCs, necessary for MDI production. P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)

Client expense: $860,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Client expense: $6,610,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1676, Jack Reynolds Memorial Medigap Extension Act H.R. 2934, Renal Anemia Innovation Support and Expansion (RAISE) Act S. 4011, Capping Drug Costs for Seniors Act of 2022 H.R. 4065, The Chronic Kidney Disease Improvement in Research and Treatment Act H.R. 4417, Capping Drug Costs for Seniors Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 6973, Enhanced Access to Affordable Medicines Act of 2022 H.R. 7634, Protecting Health Care for All Patients Act of 2022 S. 1971, Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 S. 2317, Seniors Prescription Drug Relief Act Issues related to Medicare Part D coverage for drugs indicated to treat patients with chronic kidney disease; Quality Improvement Program (QIP) in the End Stage Renal Disease (ESRD) prospective payment system; CY 2022 Medicare End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Improvement Program (QIP) rule making; CY 2022 policy and technical issues changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; Centers for Medicare and Medicaid Innovation (CMMI) ESRD Treatment Choices (ETC) model; Implementation of expanded Medicare immunosuppressive drug coverage for kidney transplant patients; Implementation of Executive Order 13879, Advancing American Kidney Health; Telehealth flexibilities for nephrologists and kidney patients on dialysis.

Client expense: $310,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Consolidated Appropriations Act of 2023, H.R. 2617 (provisions related to pharmaceuticals and healthcare). H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.

Client expense: $480,000 · Firm income: Not reported

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---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 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---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 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 ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---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 ---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 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---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 ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act ---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Opioid Crisis ---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.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---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 ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4509 Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $3,740,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; pharmaceutical supply chain; policies impacting Medicare coverage and reimbursement for prescription drugs; Prescription Drug User Fee Act (PDUFA) Reauthorization; Generic Drug User Fee Amendments (GDUFA) Reauthorization; H.R.153, Protecting Consumer Access to Generic Drugs Act of 2021; H.R.6973/S.4351, Enhanced Access to Affordable Medicines Act of 2022; H.R.7032/S.4338, Increasing Transparency in Generic Drug Applications Act of 2022; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.7559, Prescription Information Modernization Act of 2022; H.R.2617, Consolidated Appropriations Act, 2023.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021 (H.R. 2846), biosimilar uptake, Medicare generics penalty, generic drugs issues, supply chain issues, e-labeling provision in the FY2022 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill (H.R. 4356), and Military Construction, Veterans Affairs, and Related Agencies appropriations bill (H.R. 4355), Prescription Drug Pricing Dashboard Act (S. 1773); drug pricing; Enhanced Access to Affordable Medicines Act of 2022 (H.R. 6973); Increasing Transparency in Generic Drug Applications Act of 2022 (H.R. 7032); Generic Drug User Fee Amendments; FY 2023 Omnibus Appropriations Bill.

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers HR 5605 PrEP Assistance Act H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act H.R. 5376 Inflation Reduction Act - provisions related to vaccines and pharmaceuticals H.R. 4127: DISARM Act Act Provisions related to antimicrobial drug development H.R. 3932/S. 2076: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. H.R. 3655: Vaccine Injury Compensation Modernization Act H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) S. 912/H.R. 1978: Protecting Seniors Through Immunization Act H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Dietary Supplement Health and Education Act Reform Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Final Rule; Importation of Prescription Drugs Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022 Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property

Client expense: $1,390,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1676, Jack Reynolds Memorial Medigap Extension Act H.R. 2934, Renal Anemia Innovation Support and Expansion (RAISE) Act S. 4011, Capping Drug Costs for Seniors Act of 2022 H.R. 4065, The Chronic Kidney Disease Improvement in Research and Treatment Act H.R. 4417, Capping Drug Costs for Seniors Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 6973, Enhanced Access to Affordable Medicines Act of 2022 H.R. 7634, Protecting Health Care for All Patients Act of 2022 S. 1971, Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 S. 2317, Seniors Prescription Drug Relief Act Issues related to Medicare Part D coverage for drugs indicated to treat patients with chronic kidney disease; Quality Improvement Program (QIP) in the End Stage Renal Disease (ESRD) prospective payment system; CY 2022 Medicare End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Improvement Program (QIP) rule making; CY 2022 policy and technical issues changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; Centers for Medicare and Medicaid Innovation (CMMI) ESRD Treatment Choices (ETC) model; Implementation of expanded Medicare immunosuppressive drug coverage for kidney transplant patients; Implementation of Executive Order 13879, Advancing American Kidney Health; Telehealth flexibilities for nephrologists and kidney patients on dialysis.

Client expense: $300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Client expense: $7,270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities --- In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment (Discussion Draft) ---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.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---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 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---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 ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)

Client expense: $3,220,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.

Client expense: $720,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; pharmaceutical supply chain; policies impacting Medicare coverage and reimbursement for prescription drugs; Prescription Drug User Fee Act (PDUFA) Reauthorization; Generic Drug User Fee Amendments (GDUFA) Reauthorization; H.R.153, Protecting Consumer Access to Generic Drugs Act of 2021; H.R.6973/S.4351, Enhanced Access to Affordable Medicines Act of 2022; H.R.7032/S.4338, Increasing Transparency in Generic Drug Applications Act of 2022; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.7559, Prescription Information Modernization Act of 2022.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.

Client expense: $670,000 · Firm income: Not reported

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

Issues related to drug pricing; issues related to pharmaceutical supply chain; issues related to FDA facility inspections, including HR 7006, Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; issues related to modernization of prescribing information for physicians and pharmacists; HR 6973, Enhanced Access to Affordable Medicines Act of 2022; HR 7032, Increasing Transparency in Generic Drug Applications Act of 2022.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug shortages, formulary tiering, Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021 (H.R. 2846), biosimilar uptake, Medicare generics penalty, generic drugs issues, supply chain issues, e-labeling provision in the FY2022 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill (H.R. 4356), and Military Construction, Veterans Affairs, and Related Agencies appropriations bill (H.R. 4355), Prescription Drug Pricing Dashboard Act (S. 1773); drug pricing; Build Back Better Act (H.R. 5376); Enhanced Access to Affordable Medicines Act of 2022 (H.R. 6973); Increasing Transparency in Generic Drug Applications Act of 2022 (H.R. 7032); Generic Drug User Fee Amendments.

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing; issues related to pharmaceutical supply chain; issues related to FDA facility inspections, including HR 7006, Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; issues related to modernization of prescribing information for physicians and pharmacists; HR 6973, Enhanced Access to Affordable Medicines Act of 2022; HR 7032, Increasing Transparency in Generic Drug Applications Act of 2022.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 4127: DISARM Act - Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing and patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S 2938 - Bipartisan Safer Communities Act - budget offset provisions related to Rebate Rule S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Dietary Supplement Health and Education Act Reform Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022

Client expense: $1,110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

H.R. 5: Equality Act H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Projects Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Client expense: $6,340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1676, Jack Reynolds Memorial Medigap Extension Act H.R. 2934, Renal Anemia Innovation Support and Expansion (RAISE) Act S. 4011, Capping Drug Costs for Seniors Act of 2022 H.R. 4065, The Chronic Kidney Disease Improvement in Research and Treatment Act H.R. 4417, Capping Drug Costs for Seniors Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 6973, Enhanced Access to Affordable Medicines Act of 2022 H.R. 7634, Protecting Health Care for All Patients Act of 2022 S. 1971, Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 S. 2317, Seniors Prescription Drug Relief Act Issues related to Medicare Part D coverage for drugs indicated to treat patients with chronic kidney disease; Quality Improvement Program (QIP) in the End Stage Renal Disease (ESRD) prospective payment system; CY 2022 Medicare End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Improvement Program (QIP) rule making; CY 2022 policy and technical issues changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; Centers for Medicare and Medicaid Innovation (CMMI) ESRD Treatment Choices (ETC) model; Implementation of expanded Medicare immunosuppressive drug coverage for kidney transplant patients; Implementation of Executive Order 13879, Advancing American Kidney Health; Telehealth flexibilities for nephrologists and kidney patients on dialysis.

Client expense: $320,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.

Client expense: $740,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; pharmaceutical supply chain; policies impacting Medicare coverage and reimbursement for prescription drugs; Prescription Drug User Fee Act (PDUFA) Reauthorization; Generic Drug User Fee Amendments (GDUFA) Reauthorization; H.R.153, Protecting Consumer Access to Generic Drugs Act of 2021; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6973/S.4351, Enhanced Access to Affordable Medicines Act of 2022; H.R.7032/S.4338, Increasing Transparency in Generic Drug Applications Act of 2022; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.

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

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Biosimilars ---H.R.7035: Biologics Market Transparency Act ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Families First Coronavirus Response Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---TRIPS IP Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.4472: Better Empowerment Now To Enhance Framework and Improve Treatments (BENEFIT) Act ---H.R.4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1644 Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies ADAPT Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4351: Enhanced Access to Affordable Medicines Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Counterfeiting ---Drug Shortages ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4418: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Implementation of Consolidated Appropriations Act for FY 2021 ---Pricing and Rebates Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---S.4184 Retaining Access and Restoring Exclusivity (RARE) Act ---Build Back Better Act (Discussion Draft Senate) ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of Consolidated Appropriations Act for FY 2021 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Recovery of Routine Immunizations ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021

Client expense: $3,120,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office

Drug shortages, formulary tiering, Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021 (H.R. 2846), biosimilar uptake, Medicare generics penalty, generic drugs issues, supply chain issues, e-labeling provision in the FY2022 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill (H.R. 4356), and Military Construction, Veterans Affairs, and Related Agencies appropriations bill (H.R. 4355), Prescription Drug Pricing Dashboard Act (S. 1773); drug pricing; Build Back Better Act (H.R. 5376); Enhanced Access to Affordable Medicines Act of 2022 (H.R. 6973); Increasing Transparency in Generic Drug Applications Act of 2022 (H.R. 7032); Generic Drug User Fee Amendments.

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform

Client expense: $1,100,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

Issues related to drug pricing; issues related to pharmaceutical supply chain; issues related to FDA facility inspections, including HR 7006, Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; issues related to modernization of prescribing information for physicians and pharmacists; HR 6973, Enhanced Access to Affordable Medicines Act of 2022; HR 7032, Increasing Transparency in Generic Drug Applications Act of 2022.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.

Client expense: $830,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Part D Formulary Design and Generic Drug Tiering Electronic Labeling of Prescription Drugs FDA facility inspections Medicare incentives for biosimilar utilization Generic Drug User Fee Amendments (GDUFA) Complex Generic Drug Approvals H.R. 3 - Lower Drug Costs Now Act H.R. 2846 - Ensuring Access to Lower-Cost Medicines for Seniors Act Biosimilar interchangeability H.R. 5376 - Build Back Better Act H.R. 6973, Enhanced Access to Affordable Medicines Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022

Client expense: $670,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform

Client expense: $830,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.

Client expense: $2,050,000 · Firm income: Not reported

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

H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - To amend the Public Health Service Act to improve the diversity of participants in research on Alzheimers disease, and for other purposes S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Nomination of Robert Califf to FDA Commissioner Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Client expense: $8,070,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS)

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; pharmaceutical supply chain; policies impacting Medicare coverage and reimbursement for prescription drugs; Prescription Drug User Fee Act (PDUFA) Reauthorization; Generic Drug User Fee Amendments (GDUFA) Reauthorization; Implementation of H.R.748, CARES Act (P.L.116-136); H.R.153, Protecting Consumer Access to Generic Drugs Act of 2021; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6973, Enhanced Access to Affordable Medicines Act of 2022; H.R.7032, Increasing Transparency in Generic Drug Applications Act of 2022.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug shortages, formulary tiering, Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021 (H.R. 2846), biosimilar uptake, Medicare generics penalty, generic drugs issues, supply chain issues, e-labeling provision in the FY2022 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill (H.R. 4356), and Military Construction, Veterans Affairs, and Related Agencies appropriations bill (H.R. 4355), Prescription Drug Pricing Dashboard Act (S. 1773); drug pricing; Build Back Better Act (H.R. 5376); Enhanced Access to Affordable Medicines Act of 2022 (H.R. 6973); Increasing Transparency in Generic Drug Applications Act of 2022 (H.R. 7032); Generic Drug User Fee Amendments.

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE