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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 |
Address2 |
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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 | 2024 |
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: Sarah Arbes |
Date | 4/22/2024 3:08:34 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.7085 Biosecure Act
H.R. 5539/S.3131 ORPHAN Cures Act, expanding orphan drug exclusion in IRA
H.R.5378, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), Pharmacy Benefit Manager Reform Act
Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties
Patent listings of drug-device combinations
Reauthorization of newborn screening programs
Reauthorization of the pediatric priority review voucher program
RSV Vaccine issues
FDA modernization policy issues
Medicare drug price negotiation
Medicaid Drug Rebate Program proposed rule
PBM Reform (misc. bills)
Issues related to reform of pharmacy benefit managers
Issues related to FDA proposed regulation of lab developed tests
Issues related to the orphan drug exclusion of the Inflation Reduction Act
Issues related to the price and manufacture of inhaled medicines
Issues related to march-in rights
Issues related to drug pricing
Issues related to importation of drugs
Sustainability issues as a general topic
General issues related to health equity in rare disease and clinical trials
General issues related to diagnostics for patients with rare diseases
General issues related to rare disease and orphan drugs
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA)
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 |
Katie |
Jones |
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Sarah |
Arbes |
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Caroline |
Quat |
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Art |
Motta |
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Policy Advisor and Floor Assistant, Rep. Eric Swalwell (CA-15)
Legislative Assistant, Rep. Eric Swalwell (CA-15)
Legislative Aide, Rep. Eric Swalwell (CA-15) |
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. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA)
H.R. 3876 Access to Genetic Counselor Services Act of 2023
H.R. 2666 Medicaid VBPs for Patients Act
H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA)
Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169)
Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169
CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure
Centers for Medicare and Medicaid Innovation (CMMI) policy issues
Value-based payment arrangements
Medicare patient access to rare disease therapies, Part B and Part D drugs
Medicaid Drug Rebate Program proposed rule, specifically the stacking rule
Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies
General issues related to diagnostic reimbursement
Value-based payment arrangements
Efforts to improve coding, coverage, and access for rare disease therapies
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 |
Katie |
Jones |
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Sarah |
Arbes |
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Caroline |
Quat |
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Art |
Motta |
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Policy Advisor and Floor Assistant, Rep. Eric Swalwell (CA-15)
Legislative Assistant, Rep. Eric Swalwell (CA-15)
Legislative Aide, Rep. Eric Swalwell (CA-15) |
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
Issues related to Pharmacy Benefit Managers (PBMs)
Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169)
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 |
Katie |
Jones |
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Sarah |
Arbes |
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Caroline |
Quat |
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Art |
Motta |
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Policy Advisor and Floor Assistant, Rep. Eric Swalwell (CA-15)
Legislative Assistant, Rep. Eric Swalwell (CA-15)
Legislative Aide, Rep. Eric Swalwell (CA-15) |
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. 1350, Camerons Law
H.R. 5376 - Share the Savings with Seniors Act
S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023.
Issues related to the Orphan Drug Tax Credit;
issues related to the deduction of research and development expenditures
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 |
Katie |
Jones |
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Sarah |
Arbes |
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Caroline |
Quat |
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Art |
Motta |
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Policy Advisor and Floor Assistant, Rep. Eric Swalwell (CA-15)
Legislative Assistant, Rep. Eric Swalwell (CA-15)
Legislative Aide, Rep. Eric Swalwell (CA-15) |
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
TRIPS Waiver
General patent issues
Issues related to pharmaceutical intellectual property (IP)
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 |
Katie |
Jones |
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Sarah |
Arbes |
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Caroline |
Quat |
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Art |
Motta |
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Policy Advisor and Floor Assistant, Rep. Eric Swalwell (CA-15)
Legislative Assistant, Rep. Eric Swalwell (CA-15)
Legislative Aide, Rep. Eric Swalwell (CA-15) |
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 |
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 |
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) |