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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 1800 CONCORD PIKE, P.O. BOX 15437 |
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City | WILMINGTON |
State | DE |
Zip Code | 19850-5437 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 54073-12
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6. House ID# 349750000
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TYPE OF REPORT | 8. Year | 2022 |
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: Kate Belinski |
Date | 10/20/2022 4:18:05 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 HCR
16. Specific lobbying issues
H.R. 1730/S. 670- Speeding Therapy Access Today Act;
H.R. 483/S. 350 - Newborn Screening Saves Lives Act;
H.R. 6000 Cures 2.0 Act;
H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act;
S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act;
H.R. 6963 - Accelerated Approval Integrity Act;
H.R. 6996 - Accelerating Access for Patients Act -
General issues related to rare disease and orphan drugs;
General issues related to drug pricing;
Reauthorization of the FDA User Fee Act;
FDA modernization policy issues;
Reauthorization of newborn screening programs;
Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients;
General issues related to health equity in rare disease and clinical trials;
General issues related to diagnostics for patients with rare diseases
Cancer screening, diagnosis & treatment
Prescription drug electronic labeling
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act;
H.R. 19 - Lower Costs, More Cures Act;
H.R. 5260 - Reduced Costs and Continued Cures Act;
H.R. 5376 - Build Back Better Act;
H.R. 7667 - Food and Drug Amendments of 2022;
S.4348 - FDASLA Act of 2022
H.R. 7845 - NIH Clinical Trial Diversity Act of 2022;
H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022;
H.R. 2883, Stop Stalling Access to Affordable Medications
Issues related to COVID-19 vaccines and therapies;
Items related to the Administrations Cancer Moonshot
Prescription Drug User Fee Act (PDUFA)
H.R. 4128/S. 2209, VALID Act
S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022
Pharmaceutical Innovation, generally;
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), White House Office, 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 |
Helen |
Dwight |
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Aaron |
Hunter |
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Elizabeth |
Brooks |
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Thad |
Flood |
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Katie |
Jones |
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Caroline |
Quat |
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Sarah |
Arbes |
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Asst Secretary for Legislation, Dept of Health and Human Services; Principal Deputy Assistant Secretary for Legislation, Dept of Health and Human Services; Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor and Pension |
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
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act;
H.R. 19 - Lower Costs, More Cures Act;
H.R. 5260 - Reduced Costs and Continued Cures Act;
H.R. 5376 - The Inflation Reduction Act of 2022;
General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients;
Center for Medicare and Medicaid Innovation (CMMI) policy issues;
Value-based payment arrangements;
Efforts to improve coding, coverage, and access for rare disease therapies;
Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement
S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021
Issues related to preventative services and screenings for underrepresented communities
H.R 4065/S. 1971 (Section 101) - Expanding Medicare annual wellness benefit to include kidney disease screening
CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure
General issues related to diagnostic reimbursement
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS)
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 |
Helen |
Dwight |
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Thad |
Flood |
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Aaron |
Hunter |
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Elizabeth |
Brooks |
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Caroline |
Quat |
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Katie |
Jones |
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Sarah |
Arbes |
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Asst Secretary for Legislation, Dept of Health and Human Services; Principal Deputy Assistant Secretary for Legislation, Dept of Health and Human Services; Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor and Pension |
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 PHA
16. Specific lobbying issues
H.R. 7559 and issues related to an appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts
Issues related to the 340B drug discount program
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 |
Helen |
Dwight |
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Aaron |
Hunter |
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Elizabeth |
Brooks |
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Caroline |
Quat |
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Thad |
Flood |
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Katie |
Jones |
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Sarah |
Arbes |
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Asst Secretary for Legislation, Dept of Health and Human Services; Principal Deputy Assistant Secretary for Legislation, Dept of Health and Human Services; Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor and Pension |
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. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act
H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
H.R. 2883, Stop Stalling Access to Affordable Medications
H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act
H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022
H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022
S. 1435, the Affordable Prescriptions for Patients Act
S. 1425, Stop STALLING Act
Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines
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 |
Aaron |
Hunter |
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Helen |
Dwight |
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Elizabeth |
Brooks |
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Katie |
Jones |
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Thad |
Flood |
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Caroline |
Quat |
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Sarah |
Arbes |
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Asst Secretary for Legislation, Dept of Health and Human Services; Principal Deputy Assistant Secretary for Legislation, Dept of Health and Human Services; Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor and Pension |
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
H.R. 2623 - Camerons Law
H.R. 5376 - Build Back Better Act
Issues related to the Orphan Drug Tax Credit
Issues related to the deduction of research and development expenditures
Issues related to corporate and international tax reform
S. 749/H.R 1304 - American Innovation and Jobs Act
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 |
Helen |
Dwight |
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Elizabeth |
Brooks |
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Katie |
Jones |
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Thad |
Flood |
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Caroline |
Quat |
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Aaron |
Hunter |
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Sarah |
Arbes |
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Asst Secretary for Legislation, Dept of Health and Human Services; Principal Deputy Assistant Secretary for Legislation, Dept of Health and Human Services; Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor and Pension |
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
Appropriations, FY 2023;
H.R 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023
H.R. 6833, P.L 117-180, Affordable Insulin Now Act
H.R. 8294, ransportation, Housing and Urban Development, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, and Veterans Affairs Appropriations Act, 2023
H.R. 8295/S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023
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 |
Helen |
Dwight |
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Aaron |
Hunter |
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Elizabeth |
Brooks |
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Thad |
Flood |
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Katie |
Jones |
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Caroline |
Quat |
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Sarah |
Arbes |
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Asst Secretary for Legislation, Dept of Health and Human Services; Principal Deputy Assistant Secretary for Legislation, Dept of Health and Human Services; Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor and Pension |
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
Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
S. 4417, the PTAB Reform Act
TRIPS IP Waiver
Issues related to manufacturer patent protections at the World Health Organization
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 |
Helen |
Dwight |
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Aaron |
Hunter |
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Elizabeth |
Brooks |
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Thad |
Flood |
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Katie |
Jones |
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Caroline |
Quat |
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Sarah |
Arbes |
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Asst Secretary for Legislation, Dept of Health and Human Services; Principal Deputy Assistant Secretary for Legislation, Dept of Health and Human Services; Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor and Pension |
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 ENV
16. Specific lobbying issues
Sustainability & Zero Carbon; Items related to environmental sustainability and our Ambition Zero Carbon efforts
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 |
Thad |
Flood |
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Katie |
Jones |
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Caroline |
Quat |
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Aaron |
Hunter |
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Elizabeth |
Brooks |
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Helen |
Dwight |
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Sarah |
Arbes |
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Asst Secretary for Legislation, Dept of Health and Human Services; Principal Deputy Assistant Secretary for Legislation, Dept of Health and Human Services; Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor and Pension |
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 FOR
16. Specific lobbying issues
Amendment to Montreal Protocol ("Kigali Amendment")
17. House(s) of Congress and Federal agencies Check if None
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 |
Caroline |
Quat |
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Sarah |
Arbes |
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Asst Secretary for Legislation, Dept of Health and Human Services; Principal Deputy Assistant Secretary for Legislation, Dept of Health and Human Services; Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor and Pension |
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:
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 |
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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 |
CONVICTIONS DISCLOSURE
29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery,
extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
Lobbyist Name | Description of Offense(s) |