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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 777 6 Street, NW |
Address2 | Suite 510 |
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 | 2017 |
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 | 7/20/2017 5:34:52 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 Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA).
Biosimilar User Fee Act (BsUFA).
Labeling of Generic Drugs.
Biosimilars Naming.
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.
Prescription Drug Costs.
H.R.2841: FAST Generics Act of 2015.
H.R.2051: FAST Generics Act of 2017.
S.124: Preserve Access to Affordable Generics Act.
H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act.
H.R.1314: Bipartisan Budget Act of 2015.
Risk Evaluation and Mitigation Strategies (REMS).
Biologic Exclusivity.
Biologics Price Competition and Innovation Act (BPCIA).
H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act.
S.771: Improving Access To Affordable Prescription Drugs Act.
Pharmaceutical Exclusivity.
S.3056: CREATES Act of 2016.
H.R.2212/S.974: CREATES Act of 2017.
H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016.
S.297: Increasing Competition in Pharmaceuticals Act.
H.R.749: Lower Drug Costs through Competition Act.
Drug Importation.
H.R.2430/S.934: FDA Reauthorization Act of 2017.
FDA Commissioner Nomination.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), 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 |
John |
Billings |
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Chief of Staff/LD, Rep. Charles Bass; Chief of Staff, Dan Benishek; Policy Advisor, Rep. Mark Kirk |
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Chris |
Bowlin |
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Michael |
Brzica |
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Craig |
Burton |
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Dep. Assistant Sec. for Legislation, HHS; Staff, Senate HELP Committee; Staff, Senator Bill Frist |
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Christian |
Cruz |
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Chester |
Davis |
Jr. |
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Jeffrey |
Francer |
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Thomas |
Garrigan |
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David |
Gaugh |
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Erik |
Komendant |
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Christine |
Simmon |
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Heidi |
Wilson |
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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.
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 |
John |
Billings |
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Chief of Staff/LD, Rep. Charles Bass; Chief of Staff, Dan Benishek; Policy Advisor, Rep. Mark Kirk |
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Chris |
Bowlin |
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Michael |
Brzica |
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Craig |
Burton |
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Dep. Assistant Sec. for Legislation, HHS; Staff, Senate HELP Committee; Staff, Senator Bill Frist |
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Christian |
Cruz |
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Chester |
Davis |
Jr. |
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Thomas |
Garrigan |
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David |
Gaugh |
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Erik |
Komendant |
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Christine |
Simmon |
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Heidi |
Wilson |
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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.
Patent Settlements.
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 |
John |
Billings |
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Chief of Staff/LD, Rep. Charles Bass; Chief of Staff, Dan Benishek; Policy Advisor, Rep. Mark Kirk |
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Chris |
Bowlin |
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Michael |
Brzica |
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Christian |
Cruz |
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Jeffrey |
Francer |
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Erik |
Komendant |
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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 BUD
16. Specific lobbying issues
FDA Funding.
S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), 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 |
John |
Billings |
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Chief of Staff/LD, Rep. Charles Bass; Chief of Staff, Dan Benishek; Policy Advisor, Rep. Mark Kirk |
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Chris |
Bowlin |
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Michael |
Brzica |
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Christian |
Cruz |
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Jeffrey |
Francer |
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Thomas |
Garrigan |
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David |
Gaugh |
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Erik |
Komendant |
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Heidi |
Wilson |
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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).
Transatlantic Trade and Investment Partnership (TTIP).
Biologic Exclusivity.
USTR Confirmation.
North American Free Trade Agreement.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, 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 |
John |
Billings |
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Chief of Staff/LD, Rep. Charles Bass; Chief of Staff, Dan Benishek; Policy Advisor, Rep. Mark Kirk |
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Chris |
Bowlin |
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Michael |
Brzica |
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Christian |
Cruz |
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Jeffrey |
Francer |
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David |
Gaugh |
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Erik |
Komendant |
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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
Taxation Issues Related to Opioid Pharmaceuticals.
User Fee Programs.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Government Accountability Office (GAO)
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 |
John |
Billings |
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Chief of Staff/LD, Rep. Charles Bass; Chief of Staff, Dan Benishek; Policy Advisor, Rep. Mark Kirk |
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Chris |
Bowlin |
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Michael |
Brzica |
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Craig |
Burton |
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Dep. Assistant Sec. for Legislation, HHS; Staff, Senate HELP Committee; Staff, Senator Bill Frist |
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Christian |
Cruz |
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Chester |
Davis |
Jr. |
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Jeffrey |
Francer |
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Thomas |
Garrigan |
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David |
Gaugh |
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Erik |
Komendant |
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Heidi |
Wilson |
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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
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 |