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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 601 New Jersey Ave NW |
Address2 | Suite 850 |
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# 16032-12
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6. House ID# 314630000
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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: Beth Anne Cole |
Date | 7/20/2022 12:45:48 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 PHA
16. Specific lobbying issues
Prescription Drug Costs.
Drug Pricing.
H.R.2868: Protecting Access to Affordable Medicines Act of 2021.
S.2910: Expanding Access to Low-Cost Generics Act of 2021.
H.R.5237: Reduced Costs and Continued Cures Act of 2021.
H.R.6000: Cures 2.0 Act.
H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022.
H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act.
H.R.5030/S.2706: DIVERSE Trials Act.
H.R.3085/S.1548: ENACT Act of 2021.
H.R.6584: DEPICT Act.
Pre-Hatch-Waxman ANDAs (PANDAs).
H.R.6963: Accelerated Approval Integrity Act of 2022.
H.R.6996: Accelerating Access for Patients Act of 2022.
S.3576: ADPT 2.0 Act.
H.R.7008: Pre-approval Information Exchange Act of 2022.
H.R.2831: Prompt Approval of Safe Generic Drugs Act.
H.R.6431: Data Transparency and Drug Safety Act of 2022.
Civil Monetary Penalties.
Pharmaceutical Exclusivity.
180-Day Exclusivity.
H.R.2853: BLOCKING Act of 2021.
Labeling of Generic Drugs and Biosimilars.
H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022.
Section 505(j)(10) Labeling [Legislation not yet introduced].
S.2628: Better ODDS To Reduce Diversion Act of 2021.
S.1462: Simplifying the Generic Drug Application Process Act.
Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva.
Generic Formulations.
H.R.7473: Generic Substitution Noninterference Act.
Incentivize domestic manufacturing.
H.R.6381/S.3521: CREATE Act of 2022.
Drug Shortages.
Stockpile of Generic Drugs.
Generic Drug User Fee Amendments (GDUFA).
GDUFA III Negotiations.
Biosimilar User Fee Act (BsUFA).
BsUFA III Negotiations.
Biosimilars Insulin.
Cost Sharing for Biosimilars.
H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act.
Hybrid Biosimilar Applications [Legislation not yet introduced].
505(b)(2) Biosimilar Proposal.
Same Strength Requirement for Biosimilars.
H.R.2565/S.2952: FDA Modernization Act of 2021.
H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act.
FDA Inspections.
Inspections Legislative Proposals.
Energy and Commerce Factory Inspection Legislation.
H.R.7006: INSPECTIONS Act.
H.R.6980: HHS Inspections Pilot Program.
S.3509: Creating Efficiency in Foreign Facility Inspections Act.
FDA-PTO Collaboration.
FDA Genus Decision.
FDA Catalyst Decision.
506I Marketing Status Updates.
H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022.
H.R.7667: Food and Drug Amendments of 2022.
H.R.6988: Drug Manufacturing Innovation Act of 2022.
S.4348: FDASLA Act of 2022.
H.R.7035: Biologics Market Transparency Act of 2022.
Buy American Proposals.
Issues Related to COVID-19.
H.R.748/S.S.3548: CARES Act Reporting.
H.R.5376: Build Back Better Act.
S.3799: PREVENT Pandemics Act.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), 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 |
Craig |
Burton |
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David |
Gaugh |
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Karin |
Hessler |
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Jonathan |
Kimball |
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Erik |
Komendant |
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Daniel |
Leonard |
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Katherine |
Raab |
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Joseph |
Russo |
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Steven |
Selde |
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Christine |
Simmon |
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Polly |
Webster |
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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
Medicare Part D Reform.
Medicare Part D Program and Generic Drugs.
Medicare Part D Low Income Subsidy (LIS) Program.
Medicare Part D Coverage Gap Discount Program.
Medicare Part D Tiering.
H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021.
Medicare Reimbursement for Biosimilars.
Medicaid Rebate Penalty.
H.R.2868: Protecting Access to Affordable Medicines Act of 2021.
Medicare Price Negotiation.
H.R.5260: Reduced Costs and Continued Cures Act.
Medicare Shared Savings Program.
H.R.2869/S.1427: Increasing Access to Biosimilars Act of 2021.
ASP+8%.
H.R.2815:BIOSIM Act.
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), 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 |
Craig |
Burton |
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Karin |
Hessler |
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Erik |
Komendant |
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Daniel |
Leonard |
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Katherine |
Raab |
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Joseph |
Russo |
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Steven |
Selde |
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Christine |
Simmon |
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Polly |
Webster |
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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
Patent Settlements.
Patent Abuse.
Skinny Labeling.
REMEDY Act.
Patent Listings in Orange Book.
Inter Partes Review.
Impact of IPR decisions on 30-month stay.
Section 101 of the Patent Act.
Product Hopping.
TAB Appointments Clause (Arthrex Case).
Enhancing Quality of Patents through the PTAB.
H.R._/S.2891: Restoring the America Invents Act.
S.4417: Patent Trial and Appeal Board Reform Act of 2022.
S.4430: Interagency Patent Coordination and Improvement Act of 2022.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), Patent & Trademark Office (PTO)
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 |
Karin |
Hessler |
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Erik |
Komendant |
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Daniel |
Leonard |
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Katherine |
Raab |
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Joseph |
Russo |
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Polly |
Webster |
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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 BUD
16. Specific lobbying issues
FDA Funding.
E-Labeling Prohibition in FY22 Ag-FDA Appropriations.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, 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 |
Karin |
Hessler |
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Erik |
Komendant |
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Katherine |
Raab |
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Joseph |
Russo |
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Polly |
Webster |
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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
General Trade Issues.
Drug Supply Chain.
Sterile Injectable Supply Chain challenges.
AAM Blueprint to Enhance the Security of the U.S. Supply Chain.
H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021.
Shipping Delays.
US-India Trade Discussions.
US-UK Intellectual Property Policies.
S.3799: PREVENT Pandemics Act.
H.R.4521: America COMPETES Act of 2022.
S.1260: United States Innovation and Competition Act of 2021.
H.R.3927/S.2082: MADE in America Act.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Commerce - Dept of (DOC), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), U.S. Trade Representative (USTR), 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 |
Craig |
Burton |
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Karin |
Hessler |
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Jonathan |
Kimball |
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Erik |
Komendant |
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Katherine |
Raab |
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Joseph |
Russo |
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Polly |
Webster |
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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:
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) |
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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) |