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. 6395: National Defense Authorization Act for Fiscal Year 2021
H.R. 6800: The Heroes Act - Provisions related to supplemental appropriations and federal health programs
S. 4049: National Defense Authorization Act for Fiscal Year 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, Health & Human Services - Dept of (HHS), State - Dept of (DOS)

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. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug pricing, patent settlements, and other issues
H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents
H.R. 6196: Trademark Modernization Act of 2020 - Provisions related to trademarks
S. 3449: Trademark Modernization Act of 2020 - Provisions related to trademarks
S. 3630: Facilitating Innovation to Fight Coronavirus Act - Provisions on patent terms
Biopharmaceutical innovation and patent policy issues
Trademark legislative proposals
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, Commerce - Dept of (DOC), Patent & Trademark Office (PTO), U.S. Trade Representative (USTR), State - Dept of (DOS), Treasury - Dept of, Health & Human Services - Dept of (HHS), Natl Economic Council (NEC)

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. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development
H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency
H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling
H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements
H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access
H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access
H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity
H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals
H.R. 6390: Medical Supply Chain Emergency Act of 2020 - Provisions related to the Defense Production Act
H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act
H.R. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing
H.R. 6457: Disaster and Emergency Pricing Abuse Prevention Act - Provisions related to prescription drug and medical device pricing
H.R. 6472: COVID-19 Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing
H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing
H.R. 7269: To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes - Provisions related to FDA provisional approval pathways
H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency
H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency
S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation
S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising
S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval
S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates
S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency
S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising
S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers
S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development
S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity
S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues
S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions
S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing
S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing
S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues
S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design
S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals
S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways
S. 3932: TRICARE Retail Pharmacy Prescription Medication Expansion Act of 2020 - Provisions related to DoD TRICARE pharmacy benefits program
S. 4010: Creating Hope Reauthorization Act - Provisions related to priority review vouchers
Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft)
Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market
Following the Coronavirus Outbreak (June 22, 2020)
Department of Homeland Security cybersecurity policy issues
HHS PREP Act declaration relating to COVID-19
Drug cost and pricing policy issues
Drug importation and counterfeiting policy issues
HHS Safe Importation Action Plan
Prescription drug take back and secure disposal policy issues
Expanded access policy issues
Antimicrobial resistance (AMR) policy issues
High deductible health plans/HSA policy issues
FDA modernization policy issues
PDUFA 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
Foreign manufacturing policy issues
Biosimilar approval and reimbursement policy issues
Drug shortages policy issues
Regulatory efficiencies policy issues
COVID-19 policy issues
Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45)
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, Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), Centers For Medicare and Medicaid Services (CMS), State - Dept of (DOS), Centers For Disease Control & Prevention (CDC), Natl Institutes of Health (NIH), Executive Office of the President (EOP), Office of the Vice President of the United States, Homeland Security - Dept of (DHS)

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 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions
H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions
H.R. 1425: Patient Protection and Affordable Care Enhancement Act - Provisions related to affordability fund
S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues
S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions
S. 2650: Medicare Prescription Drug Savings and Choice Act of 2019 - Provisions related to Part D and prescription drug pricing
S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions
S. 3457: Preserving Patient Access to Home Infusion Act - Provisions related to Medicare and prescription drug access
Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues
Part D policy issues including non-interference and rebates policy issues
Part B reform including MedPAC recommendations and other policy issues and local coverage decisions
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
ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM)
Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-F)
CMS Proposed 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 Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)

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

​

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. 2209: Fixing Global Freeloading Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues
H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain
H.R. 5430: United States-Mexico-Canada Agreement Implementation Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues
H.R. 6049: Medical Supply Chain Security Act - Provisions related to prescription drug supply chains and drug safety
H.R. 6393: Strengthening America's Supply Chain and National Security Act - Provisions related to prescription drug supply chains
H.R. 6482: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains
H.R. 6690: Bring Entrepreneurial Advancements To Consumers Here In North America Act - Provisions related to prescription drug supply chains and manufacturing tax incentives
H.R. 6731: Securing America's Pharmaceutical Supply Chain Act - Provisions related to prescription drug supply chains
H.R. 6879: Buy American Medical Supply Chain Act of 2020 - Provisions related to prescription drug and medical device supply chains
H.R. 6930: MADE in America Act of 2020 - Provisions related prescription drug supply chains and manufacturing tax incentives
S. 3343: Medical Supply Chain Security Act - Provisions related to prescription drug supply chains and drug safety
S. 3478: Commission on America's Medical Security Act - Provisions related to prescription drug supply chains and drug safety
S. 3537: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains and drug safety
S. 3538: Strengthening America's Supply Chain and National Security Act - Provisions related to prescription drug supply chains and drug safety
S. 3635: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains
S. 3781: PART Act - Reporting provisions
S. 3942: Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Provisions related to prescription drug supply chains
S. 3945: Bring Entrepreneurial Advancements To Consumers Here in North America Act - Provisions related to prescription drug supply chains and manufacturing tax incentives
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), Natl Economic Council (NEC), Commerce - Dept of (DOC), Patent & Trademark Office (PTO), State - Dept of (DOS), Treasury - Dept of, 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