Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

9. Check if this filing amends a previously filed version of this report

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code BUD

16. Specific lobbying issues

H.R. 1319: American Rescue Plan Act of 2021
H.R. 4350: National Defense Authorization Act for Fiscal Year 2022
H.R. 5376: Build Back Better Act
S. 2792: National Defense Authorization Act for Fiscal Year 2022
S. Con. Res. 14: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031
CARES Act, Pub. L. 116-136
FY 2022 Presidents Budget

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CPT

16. Specific lobbying issues

H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements
H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to intellectual property
H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights
H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs
H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021 - Provisions related to FDA policy and exclusivity
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
S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights
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
S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency
S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy
Biopharmaceutical innovation and patent policy issues
Bayh-Dole march-in rights policy issues

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HCR

16. Specific lobbying issues

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. 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. 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. 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. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research
H.R. 6000: Cures 2.0 Act - Provisions related to health research
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. 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. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways
S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations
21st Century Cures 2.0
American Jobs Plan
RFI for Advanced Research Projects Agency - Health (ARPA-H)
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
Biosimilar approval and reimbursement policy issues
Regulatory efficiencies policy issues
COVID-19 policy issues
Defense Production Act (DPA) policy issues
Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period)
Final Rule; Importation of Prescription Drugs
Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021)
Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Executive Office of the President (EOP)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MMM

16. Specific lobbying issues

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. 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. 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. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health
H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access
H.R. 5416: Give Kids a Chance Act - To amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities of the Food and Drug Administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes
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. 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
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
Inflation penalty policy issues
VA drug 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
Medicare prescription drug payments cards and related policy issues
Tenncare III 1115 Medicaid Demonstration - regarding closed formulary
Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility
Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TRD

16. Specific lobbying issues

H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing
H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles
H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property
H.R. 3236: AMIGOS Act - Provisions related to WTO TRIPS patent waivers and intellectual property
H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains
H.R. 3694: To direct the Secretary of Health and Human Services, in consultation with the United States Trade Representative and other heads of Federal agencies, to submit to Congress a report on the impact of a waiver of certain obligations of member nations under the Agreement on Trade-Related Aspects of Intellectual Property Rights on global COVID-19 vaccine access, and for other purposes - Provisions related to WTO TRIPS patent waivers and intellectual property
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. 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. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains
Biopharmaceutical innovation policy issues
International intellectual property and market access policy issues
Pricing and reimbursement policy issues
Supply chain policy issues
WTO TRIPS waiver

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Executive Office of the President (EOP)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

21. Client new principal place of business (if different than line 20)

22. New General description of client’s business or activities

LOBBYIST UPDATE

23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client

ISSUE UPDATE

24. General lobbying issue that no longer pertains

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address: http://www.phrma.org/about/members

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

FOREIGN ENTITIES

27. Add the following foreign entities:

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization

CONVICTIONS DISCLOSURE

29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery, extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
No Yes