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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 |
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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 | 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: William J. Schuyler |
Date | 1/20/2016 11:51:32 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. 1314: Bipartisan Budget Act of 2015 - Provisions in this general budget bill related to the pharmaceutical industry
H.R. 2029: Consolidated Appropriations Act, 2016 - Provisions in this general appropriations bill related to the pharmaceutical industry
17. House(s) of Congress and Federal agencies Check if None
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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Chief of Staff, Cong. Larry Bucshon
1/11-10/15,
Leg. Dir.,Sen. Elizabeth Dole
10/07-1/09,
Chief of Staff, Cong. Patrick McHenry
1/05-10/07,
Leg. Asst, Cong. Robin Hayes
3/02-12/04,
Leg. Corp., Sen. Jesse Helms
6/01-3/02 |
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. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements
S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion
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
S. 1890: Defend Trade Secrets Act of 2015 - Provisions related to improving trade secret protection
S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements
S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements
S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data
S. 2041: Promoting Life-Saving New Therapies for Neonates 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. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity
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
Patent settlement policy 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
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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Chief of Staff, Cong. Larry Bucshon
1/11-10/15,
Leg. Dir.,Sen. Elizabeth Dole
10/07-1/09,
Chief of Staff, Cong. Patrick McHenry
1/05-10/07,
Leg. Asst, Cong. Robin Hayes
3/02-12/04,
Leg. Corp., Sen. Jesse Helms
6/01-3/02 |
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. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population
S. 289: American Cures Act - Provisions related to NIH funding
S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees
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. 683: Compassionate Access, Research Expansion, and Respect States Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research
S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress)
S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation
S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products
S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation
S. 2055 - the Medical Countermeasure Innovation Act of 2015
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. 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. 1321: Microbead-Free Waters Act of 2015 - Provisions related to bills applicability to prescription drugs
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. 1538: Compassionate Access, Research Expansion, and Respect States Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research
H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs
H.R. 1635: Charlottes Web Medical Access Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research
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. 2536: Recovery Enhancement for Addiction Treatment Act - Provisions related to the treatment of drug addiction
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. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse
H.R. 2820: Stem Cell Therapeutic and Research Reauthorization Act of 2015 - Provisions related to the reauthorization of the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program
H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing
H.R. 2872: Opioid Addiction Treatment Modernization Act - Provisions related to the treatment of opioid addiction
H.R. 3014: Medical Controlled Substances Transportation Act of 2015 - Provisions related to the transport of controlled substances by physicians in certain situations
HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015
H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research
H.R. 3680: Co-Prescribing to Reduce Overdoses Act of 2015 - Provisions related to the prescribing of opioid overdose reversal drug to at-risk patients
H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act - Provisions related to amending and withdrawing funding from the Affordable Care Act
The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments
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
Drug Supply Chain Security Act issues including the Charitable Donation Exemption
Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA)
Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues
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
Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] Provisions related to 340B program
Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy
Proposed HRSA 340B program mega-guidance - Provisions related to 340B program
Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges
Physician Payment Sunshine Act implementation issues, such as Open Payments System issues
340B Drug Discount Program policy issues
General FDA advocacy
Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization
Biopharmaceutical and medical innovation policy issues
Drug development ecosystem policy issues
Drug cost and pricing policy issues
Transparency policy issues
NIH Funding policy issues
Precision Medicine Initiative
Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers
Rogue Internet Pharmacy policy issues
Prescription drug abuse policy issues
Drug compounding policy issues
Nomination of Robert Califf to FDA Commissioner
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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Chief of Staff, Cong. Larry Bucshon
1/11-10/15,
Leg. Dir.,Sen. Elizabeth Dole
10/07-1/09,
Chief of Staff, Cong. Patrick McHenry
1/05-10/07,
Leg. Asst, Cong. Robin Hayes
3/02-12/04,
Leg. Corp., Sen. Jesse Helms
6/01-3/02 |
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. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage
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
S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option
S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program
S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures
H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry
H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal
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. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures
H.R. 3819: Surface Transportation Extension Act of 2015 - Medicare related offsets to the biopharmaceutical industry
H.R. __, S. __: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to Hospital Outpatient Department (HOPD) reimbursement rates
Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to Medicaid
Medicaid Program; Covered Outpatient Drugs; Proposed Rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP)
Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P)
Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P)
Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform
Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation
Medicare Part B Average Sales Price (ASP) policy issues
Medicare Part D rebates policy issues
Drug cost and pricing policy issues
Transparency policy issues
Medication adherence policy issues
Alternative payment models policy issues
Chronic Care Working Group - Medicare policy affecting drugs
HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014
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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Chief of Staff, Cong. Larry Bucshon
1/11-10/15,
Leg. Dir.,Sen. Elizabeth Dole
10/07-1/09,
Chief of Staff, Cong. Patrick McHenry
1/05-10/07,
Leg. Asst, Cong. Robin Hayes
3/02-12/04,
Leg. Corp., Sen. Jesse Helms
6/01-3/02 |
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
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), Commerce - Dept of (DOC), State - Dept of (DOS), White House Office
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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Chief of Staff, Cong. Larry Bucshon
1/11-10/15,
Leg. Dir.,Sen. Elizabeth Dole
10/07-1/09,
Chief of Staff, Cong. Patrick McHenry
1/05-10/07,
Leg. Asst, Cong. Robin Hayes
3/02-12/04,
Leg. Corp., Sen. Jesse Helms
6/01-3/02 |
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 |