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
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)

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 CPT

16. Specific lobbying issues

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

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 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. 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

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), Office of Science & Technology Policy (OSTP), Health & Human Services - Dept of (HHS)

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. 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

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), Centers For Medicare and Medicaid Services (CMS)

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. 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

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), Executive Office of the President (EOP), Health & Human Services - Dept of (HHS)

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