2nd Quarter - Report

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA for PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

Firm
Client
Income
—
Expenses
$6,430,000
Expense method
A: Lobbying Disclosure Act definitions

What was lobbied

5 issue areas, each in the filer's own words, with who lobbied on it and where.

Trade (domestic/foreign) TRD

H.R. 1024: COVID-19 Supply Chain Resiliency Act of 2021 - Provisions related to medical supply chains H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3788: To establish limitations on modifications to trade agreements, and for other purposes H.R. 3811: To direct the President to oppose any waiver of obligations of members of the World Trade Organization under the Agreement on Trade-Related Aspects of Intellectual Property Rights unless a statute is enacted expressly authorizing such a waiver - Provisions related to WTO TRIPS patent waivers and intellectual property S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1366: Pharmaceutical Supply Chain Defense and Enhancement Act - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 1693: To amend the Public Health Service Act to authorize the use of the Strategic National Stockpile to enhance medical supply chain elasticity and establish and maintain domestic reserves of critical medical supplies, and for other purposes - Provisions related to medical supply chains Protecting American Innovation Act - Provisions related to waiver Trade Agreements including USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

Contacted: Executive Office of the President (EOP); Office of Science & Technology Policy (OSTP); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); SENATE; Health & Human Services, Dept of (HHS)

Bills named: H.R. 2731 (117th), H.R. 3035 (117th), H.R. 1024 (117th), S. 1693 (117th), S. 1366 (117th), S. 1388 (117th), S. 1367 (117th), H.R. 3788 (117th), S. 1203 (117th), H.R. 3811 (117th), S. 1683 (117th), S. 1260 (117th)

Copyright/Patent/Trademark CPT

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 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 - 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 Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

Contacted: Centers For Medicare and Medicaid Services (CMS); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Office of Science & Technology Policy (OSTP); U.S. Trade Representative (USTR); SENATE; Health & Human Services, Dept of (HHS)

Bills named: H.R. 2148 (117th), S. 415 (117th), H.R. 2873 (117th), S. 1428 (117th), H.R. 2884 (117th), S. 250 (117th), S. 1435 (117th)

Medicare/Medicaid MMM

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. 1167: Advancing Enrollment and Reducing Drug Costs Act of 2021 - Provisions related to Part D H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 2868: Protecting Access to Affordable Medicines Act of 2021 - Provisions related to Medicaid and prescription drug pricing and rebates S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 1323: End Price Gouging for Medications Act - Provisions related to Medicare, Medicaid and prescription drug pricing S. 2164: A bill to provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, and for other purposes Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models 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 Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Final Rule; Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

Contacted: Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); SENATE; Office of Science & Technology Policy (OSTP); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES

Bills named: S. 908 (117th), S. 1123 (117th), H.R. 2139 (117th), S. 983 (117th), H.R. 19 (117th), S. 833 (117th), H.R. 2010 (117th), S. 386 (117th), H.R. 2868 (117th), S. 1323 (117th), S. 2164 (117th), H.R. 3 (117th), H.R. 2071 (117th), H.R. 1227 (117th), H.R. 1976 (117th), H.R. 1167 (117th)

Budget/Appropriations BUD

H.R. 1319: American Rescue Plan Act of 2021 CARES Act, Pub. L. 116-136 FY2022 Presidents Budget FY2022 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act FY2022 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act FY2022 Commerce, Justice, Science, and Related Agencies Appropriations Act Senate infrastructure bills (no bill numbers)

Contacted: Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); Office of Science & Technology Policy (OSTP); HOUSE OF REPRESENTATIVES; Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS); SENATE

Bills named: H.R. 1319 (117th)

Health Issues HCR

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. 796: Coverage for COVID-19 Treatment Act of 2021 - Provisions related to COVID-19 treatments H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 2078: Social and Economic Equity Promotion Act - CBO analyses H.R. 2366: STOP Fentanyl Act of 2021 H.R. 2484: Lowest Price for Patients Act - Provisions related to prescription drug pricing and transparency H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3932: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to antimicrobial resistance policy issues 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. 1523: Drug Price Transparency Act of 2021 - Provisions related to prescription drug pricing transparency S. 1524: Health Care PRICE Transparency Act - Provisions related to prescription drug pricing transparency S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to antimicrobial resistance policy issues 21st Century Cures 2.0 (discussion draft) American Jobs Plan American Families Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Prescription drug take back and secure disposal policy issues PDUFA reauthorization BsUFA reauthorization Competition 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 Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) Interim Final Rule with comment period; Most Favord Nation (MFN) Model Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Contacted: Office of Science & Technology Policy (OSTP); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); Executive Office of the President (EOP); SENATE

Bills named: H.R. 3932 (117th), S. 1462 (117th), H.R. 2883 (117th), H.R. 349 (117th), S. 259 (117th), H.R. 853 (117th), H.R. 5 (117th), S. 154 (117th), H.R. 1730 (117th), S. 1524 (117th), H.R. 796 (117th), S. 562 (117th), S. 2076 (117th), S. 920 (117th), H.R. 2843 (117th), H.R. 2484 (117th), S. 1425 (117th), S. 1644 (117th), S. 773 (117th), S. 1523 (117th), S. 164 (117th), S. 1645 (117th), H.R. 2078 (117th), H.R. 2366 (117th)

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.