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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 | 7/20/2015 1:25:22 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 BUD
16. Specific lobbying issues
H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration
H.R. 1735: National Defense Authorization Act for Fiscal Year 2016 - Provisions related to Tricare prescription reimbursement in this bill, which authorizes FY2016 appropriations and sets forth policies for Department of Defense (DOD) programs and activities
FY 2016 Labor, Health and Human Services, and Education Appropriations Bill - Provisions related to drug reimbursement, Part D, and biopharmaceutical research
FY 2016 Agriculture Appropriations Bill - Provisions related to compounding and e-labeling
The Presidents FY 2016 Budget - Provisions related to prescription drug reimbursement and data exclusivity
FY 2016 Budget Resolution - Provisions related to biopharmaceutical policy issues
Budget Control Act - Provisions related to 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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John |
Castellani |
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Peter |
Fotos |
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Jeffrey |
Francer |
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Sascha |
Haverfield-Gross |
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Lisa |
Joldersma |
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Colleen |
Maloney |
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Cara |
Moon |
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Lori |
Reilly |
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Jennifer |
Romans |
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Nick |
Shipley |
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Pamela |
Smith |
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Sarah |
Spurgeon |
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Matt |
Sulkala |
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Sylvia |
Yu |
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Anne |
Pritchett |
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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: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion
S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law
S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO)
S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity
H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO
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 - Provisions related to extension of marketing exclusivity
H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity
H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law
H.R. 1832: Innovation Protection Act - Provisions related to patent office fees
H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters
Issues related to abuse deterrent exclusivity incentives
Patent litigation reform issues and issues related to post-grant proceedings at the PTO
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), Congressional Budget Office (CBO)
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 |
Castellani |
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Peter |
Fotos |
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Sascha |
Haverfield-Gross |
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David |
Korn |
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Colleen |
Maloney |
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Cara |
Moon |
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Lori |
Reilly |
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Jennifer |
Romans |
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Nick |
Shipley |
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Pamela |
Smith |
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James M. (Mit) |
Spears |
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Sarah |
Spurgeon |
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Matt |
Sulkala |
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Courtney |
Lee-Ashley |
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Assistant to the Chief of Staff, US Senator Ben Nelson |
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Charles |
Clapton |
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Chester (Chip) |
Davis |
Jr |
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Anne |
Pritchett |
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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 National Institutes of Health (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)
S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding
H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency
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. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development
H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit
H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access
H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union
H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program
H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products
H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review
H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products
H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients
H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing
Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development
ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances
Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website
Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA)
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
Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy
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
Drug development ecosystem issues
Drug cost and pricing policy issues
NIH Funding issues
Precision Medicine Initiative
Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers
Rogue Internet Pharmacy issues
Prescription drug abuse 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), Food & Drug Administration (FDA), Office of Science & Technology Policy (OSTP)
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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John |
Castellani |
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Peter |
Fotos |
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Jeffrey |
Francer |
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Sascha |
Haverfield-Gross |
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Lisa |
Joldersma |
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David |
Korn |
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Colleen |
Maloney |
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Cara |
Moon |
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Lori |
Reilly |
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Jennifer |
Romans |
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Nick |
Shipley |
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Pamela |
Smith |
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James M. (Mit) |
Spears |
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Sarah |
Spurgeon |
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Matt |
Sulkala |
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Kristin |
Van Goor |
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Charles |
Clapton |
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Chester (Chip) |
Davis |
Jr |
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Anne |
Pritchett |
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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. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program
S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program
S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D
S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology
S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program
H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal
H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program
H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates
H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program
H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program
H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program
H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit
S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program
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
Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs
Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation
Medicare Part B Average Sales Price (ASP) issues
Medicare exclusion issues
Medicare Part D rebates issues
Drug cost and pricing 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), Office of Science & Technology Policy (OSTP)
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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John |
Castellani |
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Lisa |
Joldersma |
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Colleen |
Maloney |
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Cara |
Moon |
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Lori |
Reilly |
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Jennifer |
Romans |
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Nick |
Shipley |
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Pamela |
Smith |
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James M. (Mit) |
Spears |
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Sarah |
Spurgeon |
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Matt |
Sulkala |
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Sylvia |
Yu |
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Charles |
Clapton |
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Chester (Chip) |
Davis |
Jr |
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Anne |
Pritchett |
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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
H.R. 1314: Trade Act of 2015 - Provisions related to Trade Promotion Authority
H.R. 2146: Defending Public Safety Employees' Retirement Act (Title I is the Bipartisan Congressional Trade Priorities and Accountability Act of 2015) - Provisions related to trade authority
S. 995: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 - Provisions related to trade authority
Biopharmaceutical innovation policy issues
China intellectual property and market access issues
India innovation, intellectual property, 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
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), 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 |
Castellani |
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Jeffrey |
Francer |
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David |
Korn |
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Colleen |
Maloney |
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Cara |
Moon |
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Jennifer |
Romans |
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Nick |
Shipley |
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James M. (Mit) |
Spears |
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Sarah |
Spurgeon |
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Matt |
Sulkala |
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Jay |
Taylor |
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Courtney |
Lee-Ashley |
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Assistant to the Chief of Staff, US Senator Ben Nelson |
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Charles |
Clapton |
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Chester (Chip) |
Davis |
Jr |
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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
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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 |