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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 1050 K STREET, NW, #800 |
Address2 |
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| 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# 16293-12
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6. House ID# 314610000
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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. | ||||||||
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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: William J. Schuyler |
Date | 4/20/2017 10:29:51 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
S.Con.Res 3: Budget Resolution - Provisions related to the biopharmaceutical industry including importation and non-interference
Continuing Resolution - Provisions related to HHS, FDA, and NIH funding and other issues
FY2018 Presidents Budget - Provisions related to HHS, FDA, and NIH funding and other issues
Senate and House budget process
S.Con.Res.3 - FY17 Budget ResolutionImportationMedicare Part D Non-Interference
FY 2018 Budget/AppropriationsPrescription Drug User Fee Agreement ReauthorizationDrug PricingMedicare Non-interferenceTax Reform
AHCAFY 17 continuing resolutionFY18 House and Senate Labor HHS appropriationsSenate Budget amendment on importationIPAB repeal
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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Jonathan |
Causey |
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Michael |
Calvo |
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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. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements
Biopharmaceutical innovation and patent policy issues
Patent litigation reform issues and issues related to post-grant proceedings at the PTO
Bayh-Dole march-in rights policy issues
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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Jonathan |
Causey |
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Michael |
Calvo |
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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. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation
S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation
S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness
S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals
S. 456: RACE for Children Act - Provisions related to pediatric studies
S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation
S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing
HR 394/S 85 - Restoring Access to Medication Act of 2017Monograph Reform legislation
H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug
approvals
H.R. 820: Childhood Cancer STAR Act - Provisions related to expanded access and other policy issues
H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness
H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls
H.R. 1231: RACE for Children Act - Provisions related to pediatric studies
H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation
HR 1271 - DXM Abuse Prevention Act of 2017
H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation
H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms
H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing
Repeal of the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148) and related policy issues including the pharmaceutical fee
Prescription Drug User Fee Act (PDUFA) reauthorization
Biologics User Fee Act (BsUFA) reauthorization
Biopharmaceutical innovation policy issues
Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA)
Drug cost and pricing policy issues
Transparency policy issues
Drug importation and counterfeiting policy issues
Prescription drug take back and secure disposal policy issues
Policy issues related to prescription drug abuse
Expanded access policy issues
Expedited drug approval policy issues
Generic drug approval process policy issues
Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors
Risk Evaluation and Mitigation Strategy (REMS) policy issues
Vaccines policy issues
Limited distribution systems in the pharmaceutical supply chain policy issues
FDA modernization policy issues
340B drug discount program policy issues
Orphan Drug Act policy issues
21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency
Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy
Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues
Food and Drug Administration Final Rule on Intended Use (82 Fed. Reg. 2193 (Jan. 9, 2017))
Biologics Price Competition and Innovation Act (BPCIA) implementation issues
Patient assistance program policy issues
Biosimilar approval and reimbursement policy issues
Biomarker policy issues
Drug compounding policy issues
Clinical trial policy issues
Cancer drug vial size policy issues
Antibiotic development policy issues
Nomination and Confirmation of Tom Price as HHS Secretary
Nomination and Confirmation of Scott Gottlieb as FDA Commissioner
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), White House Office, Executive Office of the President (EOP), 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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Jonathan |
Causey |
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Michael |
Calvo |
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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. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation
S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB)
S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB
S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D
S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers
Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs (no bill number at time of filing)
H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation
H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB
H.R. 1316: Prescription Drug Transparency Act - Provisions related to transparency of payment methodologies
H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal
S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal
Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation
Part D policy issues including non-interference and rebates policy issues
Part B reform including MedPAC recommendations and other policy issues
Drug cost and pricing policy issues
Transparency policy issues
Alternative payment models policy issues
Value-based purchasing arrangements policy issues
Center for Medicare and Medicaid Innovation (CMMI) policy issues
Medicaid rebates and reformulations policy issues
Prescription drug abuse 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), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), White House Office, 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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Jonathan |
Causey |
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Michael |
Calvo |
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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
Trade Agreements and related policy issues
Biopharmaceutical innovation policy issues
International market access and intellectual property policy issues
China intellectual property and market access policy issues
Canada intellectual property and market access policy 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), Commerce - Dept of (DOC)
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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Shira |
Kilcoyne |
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Jonathan |
Causey |
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Michael |
Calvo |
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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:
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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 |