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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)
City | Washington |
State | DC |
Zip Code | 20001 |
Country | USA |
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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 | 2019 |
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. | ||||||||
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 |
Signature | Digitally Signed By: Beth Anne Cole |
Date | 10/18/2019 3:15:49 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).
Generic Drug User Fee Amendments (GDUFA).
Biosimilar User Fee Act (BsUFA).
Labeling of Generic Drugs and Biosimilars.
Country of Manufacture Labeling.
Drug Compounding.
Drug Shortages.
Product Hopping.
H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019.
Biosimilars Naming.
Biosimilars Insulin.
Pass Through Payments 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.
Prescription Drug Costs.
American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
Proposed Anti-Kickback Statute (AKS) Rebates.
FDA Citizen Petitions.
Suitability Petitions.
S.660: Efficiency and Transparency in Petitions Act.
H.R.2387: STOP GAMES Act of 2019.
H.R.985: FAST Generics Act of 2019.
H.R.1506: FAIR Generics Act.
H.R.2455/S.1169: Ensuring Timely Access to Generics Act of 2019.
H.R.1503: Orange Book Transparency Act of 2019.
H.R.1520: Purple Book Continuity Act of 2019.
Drug Pricing.
S.64: Preserve Access to Affordable Generics and Biosimilars Act.
S.1416: Affordable Prescriptions for Patients Act of 2019.
H.R.2374/S.1224: Stop STALLING Act.
H.R.2376: Prescription Pricing for the People Act of 2019.
H.R.1499: Protecting Consumer Access to Generic Drugs 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.
H.R.1093/S.378: Stop Price Gouging Act.
H.R.3: Lower Drug Costs Now Act of 2019.
S.474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019.
S.440: Preserving Access to Cost Effective Drugs (PACED) Act.
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.
Orphan Drug Exclusivity.
Biologic Exclusivity.
H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act.
S.659: Biologic Patent Transparency Act.
Biologics Price Competition and Innovation Act (BPCIA).
Public Law 115-52: FDA Reauthorization Act of 2017.
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), Office of Management & Budget (OMB)
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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Chester |
Davis |
Jr. |
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Jeffrey |
Francer |
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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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Kristin |
Murphy |
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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.
H.R.448/S.99: Medicare Drug Price Negotiation Act.
H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019.
S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019.
H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019.
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), 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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Joseph |
Stewart |
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Karin |
Hessler |
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Erik |
Komendant |
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Kristin |
Murphy |
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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 CPT
16. Specific lobbying issues
Inter Partes Review (IPR) Process.
H.R.990/S.344: Hatch-Waxman Integrity Act of 2019.
Patent Settlements.
Patent Abuse.
Patent Obviousness.
BPCIA Patent Dance.
H.R.3666: STRONGER Patents Act of 2019.
Section 101 of the Patent Act.
New Chemical Entity Exclusivity (NCE).
REMEDY Act (Bill number not yet assigned).
S.440: Preserving Access to Cost Effective Drugs (PACED) Act.
H.R.2375: Preserve Access to Affordable Generics and Biosimilars Act.
S.1416: Affordable Prescriptions for Patients Act of 2019.
S.1617: Second Look at Drug Patents Act of 2019.
H.R.3199: Terminating the Extension of Rights Misappropriated Act of 2019.
Remedy of S.1209: Reforming Evergreening and Manipulation that Extends Drug Years 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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Jeffrey |
Francer |
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Karin |
Hessler |
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Erik |
Komendant |
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Kristin |
Murphy |
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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 BUD
16. Specific lobbying issues
FDA Funding.
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, Congressional Budget Office (CBO), 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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Jeffrey |
Francer |
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David |
Gaugh |
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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.
Trans-Pacific Partnership (TPP).
Biologic Exclusivity.
Pharmaceutical Exclusivity.
H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs Act.
United States-Mexico-Canada Agreement (USMCA).
North American Free Trade Agreement (NAFTA).
U.S.-UK Trade Agreement.
U.S.-Japan Trade Discussions.
U.S.-India Trade Discussions.
U.S.-European Trade Negotiations.
China Tariffs.
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), Federal Trade Commission (FTC), Health & Human Services - Dept of (HHS), Office of Management & Budget (OMB), State - Dept of (DOS), 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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Chester |
Davis |
Jr. |
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Jeffrey |
Francer |
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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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Kristin |
Murphy |
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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 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
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Chris |
Bowlin |
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David |
Gaugh |
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Karin |
Hessler |
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Erik |
Komendant |
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Kristin |
Murphy |
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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
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) |