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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 950 F Street, NW |
Address2 | Suite 300 |
City | WASHINGTON |
State | DC |
Zip Code | 20004 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 31350-12
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6. House ID# 306540000
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TYPE OF REPORT | 8. Year | 2015 |
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: Paul J. Larsen |
Date | 4/20/2015 11:21:19 AM |
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
Sen. Con. Res. 11: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2016 and setting forth the appropriate budgetary levels for fiscal years 2017 through 2025 - Amendments related to the biopharmaceutical industry including compounding/right to try; patent litigation reform; and non-interference, among others
H. Con. Res. 27: Establishing the budget for the United States Government for fiscal year 2016 and setting forth appropriate budgetary levels for fiscal years 2017 through 2025 - Issues related to the biopharmaceutical industry including Part D and National Institutes of Health (NIH) funding
H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration
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
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Maya |
Bermingham |
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Jennifer |
Bryant |
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Randy |
Burkholder |
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Matt |
Sulkala |
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Jennifer |
Romans |
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Jeffrey |
Francer |
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Sarah |
Spurgeon |
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Sascha |
Haverfield-Gross |
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Cara |
Moon |
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Nick |
Shipley |
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John |
Castellani |
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Lisa |
Joldersma |
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Peter |
Fotos |
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Colleen |
Maloney |
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Pamela |
Smith |
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Charles |
Clapton |
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Anne |
Pritchett |
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Lori |
Reilly |
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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
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement
S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration
S. 632: Support Technology and Research for Our Nations Growth Patents Act of 2015 or STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion
H.R. 9: Innovation Act - Provisions related to patent litigation
H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval
H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration
H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (OPEN Act) - Provisions related to extension of marketing exclusivity
H.R. 1353: Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity
Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act (113th Congress)
Issues related to abuse deterrent exclusivity incentives
Patent litigation reform issues
Biopharmaceutical innovation and patent 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
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
David |
Korn |
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Matt |
Sulkala |
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Jennifer |
Romans |
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Sarah |
Spurgeon |
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Cara |
Moon |
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Nick |
Shipley |
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John |
Castellani |
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Peter |
Fotos |
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Colleen |
Maloney |
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Pamela |
Smith |
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Charles |
Clapton |
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Anne |
Pritchett |
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Chester (Chip) |
Davis |
Jr |
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James M. (Mit) |
Spears |
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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 HCR
16. Specific lobbying issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation
S. 289: American Cures Act - Provisions related to NIH funding
S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees
S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA)
S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling
S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA)
S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress)
H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA
H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling
H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act - Provisions related to expanded access
H.R. 1537: Advancing Hope Act of 2015 - Provisions related to making permanent pediatric rare disease voucher program
Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development
Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures
21st Century Cures Act (discussion draft) - Provisions related to biopharmaceutical discovery, development, delivery and transparency
Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development
Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges
Drug Supply Chain Security Act implementation issues
Physician Payment Sunshine Act implementation issues, such as Open Payments System issues
340B Drug Discount Program issues
General FDA advocacy
Biopharmaceutical and medical innovation policy issues
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)
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 |
David |
Korn |
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Maya |
Bermingham |
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Jennifer |
Bryant |
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Randy |
Burkholder |
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Matt |
Sulkala |
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Jennifer |
Romans |
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Jeffrey |
Francer |
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Kristin |
Van Goor |
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Sarah |
Spurgeon |
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Sascha |
Haverfield-Gross |
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Cara |
Moon |
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Nick |
Shipley |
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John |
Castellani |
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Lisa |
Joldersma |
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Peter |
Fotos |
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Colleen |
Maloney |
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Pamela |
Smith |
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Charles |
Clapton |
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Anne |
Pritchett |
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Lori |
Reilly |
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Chester (Chip) |
Davis |
Jr |
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James M. (Mit) |
Spears |
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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
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program
S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal
S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program
S. 861: Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2014 -Provisions related to anti-fraud proposals affecting federal programs
H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 - Provisions related to Sustainable Growth Rate (SGR) reform and other Medicare, Medicaid, and CHIP amendments
H.R. 1021: Protecting the Integrity of Medicare Act of 2015 - Provisions related to Part D lock-in program and other Medicare anti-fraud provisions
H.R. 1190: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to IPAB repeal
H.R. 1470: SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Provisions related to SGR reform and other Medicare, Medicaid, and CHIP amendments
H.R. 3796: Comprehensive Care Payment Innovation Act - Provisions related to ensuring access to innovative treatments in delivery reform model (113th Congress)
H.R. 4857: Ensuring Access to Treatment Act (discussion draft) - Provisions related to changes to Part B hospital outpatient drug payment policy (113th Congress)
H.R. 5183: Value Based Insurance Design for Better Care Act of 2014 - Provisions related to changes to the Medicare Advantage Program (113th Congress)
Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform
Cancer Care Payment Reform Act (discussion draft): Provisions related to oncology medical home demonstration
Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation
Medicare Part B Average Sales Price (ASP) issues
Part D lock-in related legislation
Medicare exclusion issues
Medicare Part D rebates issues
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)
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 |
Maya |
Bermingham |
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Jennifer |
Bryant |
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Randy |
Burkholder |
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Matt |
Sulkala |
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Jennifer |
Romans |
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Sarah |
Spurgeon |
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Cara |
Moon |
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Nick |
Shipley |
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John |
Castellani |
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Lisa |
Joldersma |
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Colleen |
Maloney |
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Pamela |
Smith |
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Charles |
Clapton |
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Anne |
Pritchett |
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Lori |
Reilly |
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Chester (Chip) |
Davis |
Jr |
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James M. (Mit) |
Spears |
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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
Biopharmaceutical innovation policy issues
China intellectual property and market access issues
India innovation, IP and market access issues
International market access and intellectual property issues
Issues related to PhRMAs Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues
Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues including mutual recognition of inspections
Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues
Trade Promotion Authority issues
Turkey market access issues
U.S.-Korea Free Trade Agreement: Implementation issues related to intellectual property and market access
Canada intellectual property and market access issues
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), State - Dept of (DOS)
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 |
David |
Korn |
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Matt |
Sulkala |
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Jennifer |
Romans |
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Jeffrey |
Francer |
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Sarah |
Spurgeon |
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Cara |
Moon |
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Nick |
Shipley |
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John |
Castellani |
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Colleen |
Maloney |
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Charles |
Clapton |
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Jay |
Taylor |
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United States Trade Representative (USTR) - Associate General Counsel, Assistant General Counsel |
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Chester (Chip) |
Davis |
Jr |
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James M. (Mit) |
Spears |
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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: http://www.phrma.org/about/member-companies
Name | Address |
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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 |