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. 133: Consolidated Appropriations Act, 2021
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
H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021
H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021
H.R. 8406: The Heroes Act - Provisions related to supplemental appropriations and federal health programs
H.R. 8900: Further Continuing Appropriations Act, 2021, and Other Extensions Act
S. 4049: National Defense Authorization Act for Fiscal Year 2021
S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020
S. 4381: Coronavirus Assistance for American Families Act
S. 4755: Delivering Immediate Relief to America's Families, Schools and Small Businesses Act
S. 4800: The Heroes Act
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

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. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity
H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings
H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings
H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to patents
H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation
H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents
H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods
H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures
H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior
S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements
S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights
S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures
S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents
S. 1636: Ensuring Innovation Act - Provisions related to new chemical entity exclusivity
Biopharmaceutical innovation and patent policy issues
Patent litigation reform issues and issues related to post-grant proceeding at the PTO
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. 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. 2374: Stop STALLING Act - Provisions related to citizen petitions
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. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements
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: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - 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. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency
H.R. 7647: To provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance coverage - Provisions related to accumulator adjustment programs
H.R. 8894: To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes - Provisions related to FDA authority and prescription drugs
H.R. 8920: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to anti-microbial resistant and prescription drug development
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. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions
S. 1224: Stop STALLING Act - Provisions related to citizen petitions
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. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing
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: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program
S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers
S. 4427: SAVE Act - Provisions related to the FDA drug approval process
S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls
S. 4760: The PASTEUR Act - Provisions related to anti-microbial resistant and prescription drug development
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
Expanded access policy issues
Antimicrobial resistance (AMR) policy issues
High deductible health plans/HSA policy issues
FDA modernization policy issues
340B drug discount program reform and 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
FDA mandatory recall authority policy issues
Pharmaceutical supply chain policy issues
COVID-19 policy issues
Final Rule; Importation of Prescription Drugs (RIN 0910-AI45)
Executive Order 13951, An America-First Healthcare Plan (September 24, 2020)
Executive Order 13950, Combating Race and Sex Stereotyping (September 22, 2020)
Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues
Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020)
Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020)
Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020)
Proposed Rule: Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25)
Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation (RIN 0906-AB26)

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), Office of Management & Budget (OMB), Homeland Security - Dept of (DHS), 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 - 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. 8624: Protecting Access to Innovation During COVID-19 Act - Provisions related to Medicare and prescription drug pricing
H.R. 8702: Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 - Provisions related to Part B and physician reimbursement
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. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions
S. 4199: Prescription Drug Pricing Reduction Act of 2020 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions
S. 4274: Legalizing Drug Discounts for Seniors Act of 2020 - Provisions related to Part D and manufacturer rebates
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
Medicare prescription drug payments cards and related issues
Medicare Part B policy issues relating to ASP reporting, payment for drugs with non-covered versions, and drug wastage rebates
AMP cap policy issues
Vial size 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 (RIN 0938-AT98)
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 (RIN 0938-AT82)
Final Rule: Transparency in Coverage (RIN 0938-AU04)
Interim Final Rule with comment period: Most Favored Nation (MFN) Model (RIN 0938-AT91)
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 (RIN 0936-AA08)

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. 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. 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
H.R. 8508: COVID-19 Vaccine Distribution and Production Act - Provisions related to prescription drug supply chains
H.R. 8943: 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, to elevate the Director of the Defense Logistics Agency as the head of the COVID-19 Joint Acquisition Task Force, to require the Director of the Defense Logistics Agency to establish a system for States and localities to access covered items during a covered emergency, and for other purposes - Provisions related to prescription drug supply chains
H.R. 8987: To amend the Public Health Service Act to incentivize the manufacture of certain medicines in the United States and to enhance the security of the United States pharmaceutical supply chain, and for other purposes - Provisions related to prescription drug manufacturing and supply chains
H.R. 8905: To amend the Federal Food, Drug, and Cosmetic Act to reduce the threat of counterfeit drugs to the pharmaceutical supply chain, and to make the pharmaceutical supply chain more robust, while ensuring the authenticity, content, purity, and manufacturing location and batch number of drugs (including COVID-19 therapeutics and vaccines) and allowing patient verification of authenticity, and for other purposes - Provisions related to prescription drug manufacturing and supply chains
H.R. 8921: To direct the Secretary of Health and Human Services to reimburse qualified health care providers for the costs of purchasing, leasing, installing, and operating qualified equipment for cold storage of COVID-19 vaccines - Provisions related to prescription drug manufacturing and supply chains
S. 3343: Medical Supply Chain 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. 3942: A bill to establish the position of Chief Pharmaceutical and Medical Supply Chain Negotiator in the Office of the United States Trade Representative, to be responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, to advance domestic production of life-saving medicines, and to secure the United States medical supply chain to eliminate reliance on foreign governments, and for other purposes - Provisions related to prescription drug supply chains
S. 4175: Pharmaceutical Supply Chain Defense and Enhancement Act - Provisions related to pharmaceutical supply chains and manufacturing
S. 4194: National Institute of Manufacturing Act - Provisions related to domestic manufacturing
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 and China Task Force 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

​

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