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

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

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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. 1857: To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity - Provisions related to FDA policy and exclusivity
H.R. 2148: To significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries - Provisions related to prescription drug pricing and march-in rights
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. 908: To significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries - Provisions related to prescription drug pricing and intellectual property
S. 917: A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages
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, 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

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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. 387: Vaccinate More Americans Act of 2021 - Provisions related to COVID-19 vaccines
H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments
H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to drug pricing and COVID-19 vaccines and treatments
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. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program
H.R. 1391: Taxpayer Research and Coronavirus Knowledge Act of 2021 - Provisions related to COVID-19 health research
H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products
H.R. 2078: Social and Economic Equity Promotion Act - CBO analyses
H.R. 2181: 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 - Provisions related to prescription drug importation
H.R. 2347: To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes - Provisions related to COVID-19 vaccines
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: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions - Provisions related to citizen petitions
S. 670: To amend the Federal Food, Drug, and Cosmetic Act to accelerate development of therapies across the spectrum of rare diseases and conditions and facilitate patient access to such therapies, and for other purposes - 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. 898: A bill to require reporting regarding certain drug price increases, and for other purposes - Provisions related to prescription drug pricing transparency
S. 917: A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages
S. 920: 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 - Provisions related to prescription drug importation
HHS PREP Act declaration relating to COVID-19
Drug cost and pricing policy issues
Drug importation policy issues
Expanded access policy issues
Supply chain policy issues
Real world evidence policy issues
Regenerative medicine policy issues
Antimicrobial resistance (AMR) policy issues
High deductible health plans/HSA policy issues
FDA modernization policy issues
340B drug discount program policy issues
Patient assistance program policy issues
Foreign manufacturing policy issues
Biosimilar approval and reimbursement policy issues
Drug shortages policy issues
Regulatory efficiencies 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 13948, Lowering Drug Prices by Putting America First (September 13, 2020)
Interim Final Rule with comment period; Most Favored 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
Nomination of HHS Secretary Xavier Becerra
Nominaton of USTR Katherine Tai
Nomination of HHS Assistant Secretary Rachel Levine
Nomination of OMB Deputy Director Shalanda Young
Nomination of CMS Administrator Chiquita Brooks-LaSure

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), 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: Lower Drug Costs Now Act of 2019 [116th Congress]
H.R. 19: Lower Costs, More Cures Act of 2019 [116th Congress]
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: To establish an improved Medicare for All national health insurance program - Provisions related to Part D and non-interference
H.R. 2010: To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Provisions related to Part D and non-interference
H.R. 2071: To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - Provisions related to Part D and non-interference
H.R. 2139: To amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes - Provisions related to Part D and non-interference
H.R. 2170: To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid - Provisions related to COVID-19 vaccines
S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference
S. 833: A bill to amend XVIII of the Social Security Act to allow the Secretary of Health and Human Services to negotiate fair prescription drug prices under part D of the Medicare program - Provisions related to Part D and non-interference
S. 983: A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Provisions related to Part D and non-interference
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
Medicare prescription drug payments cards and related policy issues
Tenncare III 1115 Medicaid Demonstration - Closed formulary policy issues
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; 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; 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
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), 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 TRD

16. Specific lobbying issues

H.R. 171: Resilient Manufacturing Task Force Act of 2021 - Provisions related to medical supply chains and domesic manufacturing
H.R. 1024: COVID-19 Supply Chain Resiliency Act of 2021 - Provisions related to medical supply chains
H.R. 1186: Supply Chain Security and Pharmaceutical Authentication Act of 2021 - Provisions related to medical supply chains
H.R. 2279: To establish the Office of Manufacturing and Industrial Innovation Policy and strategic national manufacturing policy for the United States, to provide manufacturing and industrial perspective and advice to the President, to provide for a comprehensive survey and cross administration management of efforts to ensure global leadership in manufacturing critical to the long-term economic health and national security of the United States, and for other purposes - Provisions related to medical supply chains
S. 298: Pharmacy Benefit Manager Accountability Study Act of 20201 - To require the Government Accountability Office to study the role pharmaceutical benefit managers play in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations, and for other purposes
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

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

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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