PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA for PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
What was lobbied
5 issue areas, each in the filer's own words, with who lobbied on it and where.
Budget/Appropriations BUD
H.R. 2617: Consolidated Appropriations Act, 2023 (PL. 117-328) H.R. 3932: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 H.R. 8256: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2023 H.R. 8295: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 S. 2076: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections S. 4543: James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 FY 2023 Presidents Budget Request
| Lobbyist | Covered position, as disclosed |
|---|---|
| JENNIFER MIRANDA BRYANT | — |
| NATALIE BURKHALTER | — |
| ANNE ELIZABETH ESPOSITO | — |
| BART FORSYTH | — |
| PAUL GAGE | — |
| KELLY GOLDBERG | — |
| RYAN KAAT | — |
| DAVID KORN | — |
| NICHOLAS LISOWSKI | — |
| COLLEEN MALONEY | — |
| JOHN NAPPI | — |
| TOM O'BRIEN | — |
| ANNE PRITCHETT | — |
| LORI REILLY | — |
| BRIDGETT TAYLOR | — |
| JOCELYN ULRICH | — |
| ANNIE WOERPEL | — |
| SCOTT WOODS | — |
| MICHAEL PAUL WOODY | — |
Copyright/Patent/Trademark CPT
H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act of 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4704: Patent Examination and Quality Improvement Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
| Lobbyist | Covered position, as disclosed |
|---|---|
| NATALIE BURKHALTER | — |
| ANNE ELIZABETH ESPOSITO | — |
| BART FORSYTH | — |
| KELLY GOLDBERG | — |
| DAVID KORN | — |
| NICHOLAS LISOWSKI | — |
| COLLEEN MALONEY | — |
| JOHN NAPPI | — |
| ZACH SENTEMENTES | — |
| JOCELYN ULRICH | — |
Health Issues HCR
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
| Lobbyist | Covered position, as disclosed |
|---|---|
| SANDY AHN New | None |
| MERLIN BRITTENHAM | — |
| JENNIFER MIRANDA BRYANT | — |
| NATALIE BURKHALTER | — |
| ANNE ELIZABETH ESPOSITO | — |
| BART FORSYTH | — |
| PAUL GAGE | — |
| KELLY GOLDBERG | — |
| JAIMON M JACKSON | — |
| LISA JOLDERSMA | — |
| RYAN KAAT | — |
| DAVID KORN | — |
| NICHOLAS LISOWSKI | — |
| COLLEEN MALONEY | — |
| JOHN NAPPI | — |
| TOM O'BRIEN | — |
| ANNE PRITCHETT | — |
| LORI REILLY | — |
| BRIDGETT TAYLOR | — |
| JOCELYN ULRICH | — |
| ANNIE WOERPEL | — |
| SCOTT WOODS | — |
| MICHAEL PAUL WOODY | — |
Medicare/Medicaid MMM
Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Pharmacy Benefit Manager reform and policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Notice of Benefit and Payment Parameters (NBPP)
| Lobbyist | Covered position, as disclosed |
|---|---|
| SANDY AHN New | None |
| JENNIFER MIRANDA BRYANT | — |
| NATALIE BURKHALTER | — |
| RANDY BURKHOLDER | — |
| ANNE ELIZABETH ESPOSITO | — |
| BART FORSYTH | — |
| PAUL GAGE | — |
| KELLY GOLDBERG | — |
| LISA JOLDERSMA | — |
| NICHOLAS LISOWSKI | — |
| COLLEEN MALONEY | — |
| JOHN NAPPI | — |
| LORI REILLY | — |
| BRIDGETT TAYLOR | — |
| JOCELYN ULRICH | — |
| SCOTT WOODS | — |
| SYLVIA YU | — |
Trade (domestic/foreign) TRD
H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Russia/Ukraine policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver
| Lobbyist | Covered position, as disclosed |
|---|---|
| NATALIE BURKHALTER | — |
| ANNE ELIZABETH ESPOSITO | — |
| BART FORSYTH | — |
| PAUL GAGE | — |
| JAIMON M JACKSON | — |
| DAVID KORN | — |
| NICHOLAS LISOWSKI | — |
| COLLEEN MALONEY | — |
| LORI REILLY | — |
| ZACH SENTEMENTES | — |
| JOCELYN ULRICH | — |
Shown as published by the Senate Office of Public Records and the House Clerk under the Lobbying Disclosure Act. The official filing is the record; open it for the full form.