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 PHA

16. Specific lobbying issues

Implementation of Food and Drug Administration Reauthorization Act (FDARA).
Generic Drug User Fee Amendments (GDUFA).
Biosimilar User Fee Act (BsUFA).
Labeling of Generic Drugs and Biosimilars.
Country of Manufacture Labeling.
S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes.
S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes.
FDA Priority MAPP 5240.3 REV 5.
H.R.5668: MODERN Labeling Act of 2020.
Drug Shortages.
S.2723: Mitigating Emergency Drug Shortages Act.
Product Hopping.
H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019.
Biosimilars Naming.
Biosimilars Insulin.
H.R.4244: MAGIC Act.
Pass Through Payments for Biosimilars.
Cost Sharing for Biosimilars.
S.1140: Protecting Access to Biosimilars Act of 2019.
H.R.4455: BIOSIM Act.
H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019.
H.R.4629: Star Rating for Biosimilars Act.
H.R.5982: Safe Medicine Act.
Prescription Drug Costs.
Drug Pricing.
American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
H.R.1506: FAIR Generics Act.
H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes.
180-Day Exclusivity.
S.3092: Expanding Access to Low-Cost Generics Act of 2019.
S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019.
S.64: Preserve Access to Affordable Generics and Biosimilars Act.
S.1416: Affordable Prescriptions for Patients Act of 2019.
H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019.
H.R.465/S.102: Prescription Drug Price Relief Act of 2019.
S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020.
H.R.3: Lower Drug Costs Now Act of 2019.
S.1895: Lower Health Care Costs Act.
H.R.965/S.340: CREATES Act of 2019.
Public Law 115-123: Bipartisan Budget Act of 2018.
Risk Evaluation and Mitigation Strategies (REMS).
Pharmaceutical Exclusivity.
30-Month Stays.
Biologic Exclusivity.
S.659: Biologic Patent Transparency Act.
Biologics Price Competition and Innovation Act (BPCIA).
H.R.2214: NO BAN Act.
H.R.4793: Budgeting for Opioid Addiction Treatment Act.
Issues Related to COVID-19.
H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act.
H.R.6201: Families First Coronavirus Response Act.
S. ___Facilitating Innovation to Fight Coronavirus Act.
Rubio Coronavirus Plan.
Commission on Americas Medical Security Act.
Buy American Proposals.
S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), 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

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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 MMM

16. Specific lobbying issues

Medicare Part D Program and Generic Drugs.
Medicare Reimbursement for Biosimilars.
Medicaid Rebate Penalty.
Medicare Part D Low Income Subsidy (LIS) Program.
Medicare Part D Coverage Gap Discount Program.
H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes.
Medicare Shared Savings Program.
H.R.6179: Increasing Access to Biosimilars Act of 2020.
S.1895: Lower Health Care Costs Act.

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), 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 CPT

16. Specific lobbying issues

Patent Settlements.
Patent Abuse.
Accelerating the Patent Dance.
BPCIA Patent Dance.
H.R.3666: STRONGER Patents Act of 2019.
S.1416: Affordable Prescriptions for Patients Act of 2019.
H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019.
H.R.3812/S.1209: Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.

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

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

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 BUD

16. Specific lobbying issues

FDA Funding.
H.R.1865: Further Consolidated Appropriations Act, 2020.
Section 605 of H.R.1865: Further Consolidated Appropriations Act, 2020.
Public Law 115-123: Bipartisan Budget Act of 2018.
Public Law 115-141: Consolidated Appropriations Act of 2018.

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA)

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

General Trade Issues.
Biologic Exclusivity.
Pharmaceutical Exclusivity.
Quality Supply Chain.
Drug Supply Chain.
H.R.6049/S.3343: Medical Supply Chain Security Act.
S. ___Strengthening Americas Supply Chain and National Security Act.
S. ___More Accurate Supply Chain Information.
H.R.___LOSS Act.
Air Transport of Pharmaceuticals.
United States-Mexico-Canada Agreement (USMCA).
U.S.-UK Trade Agreement.
U.S.-Kenya Trade Discussions.
U.S.-India Trade Discussions.
U.S.-European Trade Discussions.
U.S.-China Trade Discussions.
U.S.-China Phase 1 Trade Deal.
Secretary Azar Importation Plan.

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Commerce - Dept of (DOC), Health & Human Services - Dept of (HHS), Natl Economic Council (NEC), U.S. Trade Representative (USTR)

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 TAX

16. Specific lobbying issues

User Fee Programs.

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

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

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:

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