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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 601 New Jersey Ave NW |
Address2 | Suite 850 |
| City | Washington |
State | DC |
Zip Code | 20001 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 16032-12
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6. House ID# 314630000
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| TYPE OF REPORT | 8. Year | 2020 |
Q1 (1/1 - 3/31) | Q2 (4/1 - 6/30) | Q3 (7/1 - 9/30) | Q4 (10/1 - 12/31) |
9. Check if this filing amends a previously filed version of this report
| 10. Check if this is a Termination Report | Termination Date |
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11. No Lobbying Issue Activity |
| INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13 | |||||||||
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| 12. Lobbying | 13. Organizations | ||||||||
| INCOME relating to lobbying activities for this reporting period was: | EXPENSE relating to lobbying activities for this reporting period were: | ||||||||
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| Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income for the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). | 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options. | ||||||||
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Method A.
Reporting amounts using LDA definitions only
Method B. Reporting amounts under section 6033(b)(8) of the Internal Revenue Code Method C. Reporting amounts under section 162(e) of the Internal Revenue Code |
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| Signature | Digitally Signed By: Beth Anne Cole |
Date | 1/20/2021 5:33:26 PM |
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).
FDA Inspections.
Consent to FDA Approval.
Generic Drug User Fee Amendments (GDUFA).
GDUFA III Negotiations.
Biosimilar User Fee Act (BsUFA).
BsUFA III Negotiations.
Biosimilar Insulin.
Labeling of Generic Drugs and Biosimilars.
S.1681: Advancing Education on Biosimilars Act of 2020.
Labeling Carve-Outs.
GSK v. Teva.
H.R.5668: MODERN Labeling Act of 2020.
S.1636: Ensuring Innovation Act.
Drug Shortages.
Stockpile of Generic Drugs.
H.R.7507: State Stockpile Readiness Act of 2020.
H.R.8479: Essential Medicines Strategic Stockpile Act of 2020.
Pass Through Payments for Biosimilars.
Cost Sharing for Biosimilars.
H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020.
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.
Prescription Drug Costs.
Drug Pricing.
Executive Order 13947/13948: Lowering Drug Prices by Putting America First.
American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
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.
Forfeiture of 180-Day Exclusivity.
12-Year Exclusivity.
S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019.
H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019.
S.844: Short on Competition Act.
H.R.465/S.102: Prescription Drug Price Relief Act of 2019.
H.R.3: Lower Drug Costs Now Act of 2019.
H.R.8529: Protecting Access to Affordable Medicines Act of 2020.
S.3092: Expanding Access to Low-Cost Generics Act of 2019.
S.1895: Lower Health Care Costs Act.
Pharmaceutical Exclusivity.
H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020.
S.659: Biologic Patent Transparency Act.
Biologics Price Competition and Innovation Act (BPCIA).
H.R.1503: Orange Book Transparency Act of 2020.
H.R.1520: Purple Book Continuity Act of 2020.
Issues Related to COVID-19.
Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act.
Buy American Proposals.
Buy American Executive Order.
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), Federal Trade Commission (FTC), 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
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Chris |
Bowlin |
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Craig |
Burton |
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David |
Gaugh |
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Karin |
Hessler |
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Jonathan |
Kimball |
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Erik |
Komendant |
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Daniel |
Leonard |
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Kristin |
Murphy |
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Katherine |
Raab |
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Christine |
Simmon |
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Joseph |
Stewart |
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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
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.
Medicare Shared Savings Program.
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
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Chris |
Bowlin |
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Craig |
Burton |
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Karin |
Hessler |
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Erik |
Komendant |
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Daniel |
Leonard |
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Kristin |
Murphy |
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Katherine |
Raab |
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Christine |
Simmon |
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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
Patent Settlements.
Patent Abuse.
BPCIA Patent Dance.
Inter Partes Review.
H.R.4850/S.659: Biologic Patent Transparency Act.
Section 101 of the Patent 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
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Chris |
Bowlin |
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Karin |
Hessler |
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Erik |
Komendant |
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Kristin |
Murphy |
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Daniel |
Leonard |
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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.133: Consolidated Appropriations Act, 2021.
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
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Chris |
Bowlin |
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Craig |
Burton |
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Karin |
Hessler |
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Erik |
Komendant |
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Kristin |
Murphy |
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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.
Pharmaceutical Exclusivity.
Quality Supply Chain.
Drug Supply Chain.
Pharmaceutical Supply Chain.
AAM Blueprint to Enhance the Security of the U.S. Supply Chain.
Carter Supply Chain Legislation.
United States-Mexico-Canada Agreement (USMCA).
U.S.-UK Trade Agreement.
U.S.-China Trade Discussions.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, 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
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Chris |
Bowlin |
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Craig |
Burton |
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Karin |
Hessler |
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Jonathan |
Kimball |
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Erik |
Komendant |
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Daniel |
Leonard |
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Kristin |
Murphy |
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Katherine |
Raab |
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Christine |
Simmon |
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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
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21. Client new principal place of business (if different than line 20)
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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
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ISSUE UPDATE
24. General lobbying issue that no longer pertains
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AFFILIATED ORGANIZATIONS
25. Add the following affiliated organization(s)
Internet Address:
| Name | Address |
Principal Place of Business (city and state or country) |
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26. Name of each previously reported organization that is no longer affiliated with the registrant or client
| 1 | 2 | 3 |
FOREIGN ENTITIES
27. Add the following foreign entities:
| Name | Address |
Principal place of business (city and state or country) |
Amount of contribution for lobbying activities | Ownership percentage in client | ||||||||||
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28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization
| 1 | 3 | 5 |
| 2 | 4 | 6 |
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?
| Lobbyist Name | Description of Offense(s) |