|
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)
| City |
|
State |
|
Zip Code |
|
Country |
|
|
5. Senate ID# 16032-12
|
||||||||
|
6. House ID# 314630000
|
||||||||
| TYPE OF REPORT | 8. Year | 2021 |
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 |
|
11. No Lobbying Issue Activity |
| INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 12. Lobbying | 13. Organizations | ||||||||
| INCOME relating to lobbying activities for this reporting period was: | EXPENSE relating to lobbying activities for this reporting period were: | ||||||||
|
|
||||||||
|
|
||||||||
| 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 | 10/20/2021 4:10:08 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.
Biden Executive Order on Drug Pricing.
Pre-Hatch-Waxman ANDAs (PANDAs).
Pharmaceutical Exclusivity.
H.R.2831: The Prompt Approval of Safe Generic Drugs Act.
180-Day Exclusivity.
Forfeiture of 180-Day Exclusivity.
12-Year Exclusivity.
Contract Genericization.
30-Month Stays.
Labeling of Generic Drugs and Biosimilars.
Modern Labeling.
Carter Bill on Section 505(j)(10) Labeling.
Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva.
Legislation to incentivize domestic manufacturing.
H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021.
Orange Book.
Drug Shortages.
H.R.2870: Essential Medicines Strategic Stockpile Act of 2021.
Stockpile of Generic Drugs.
Generic Drug User Fee Amendments (GDUFA).
GDUFA III Negotiations.
H.R.5388/S.2740: PREPARE Act.
Expediting Review of Facility Changes.
Biosimilar User Fee Act (BsUFA).
BsUFA III Negotiations.
Biosimilars Naming.
Biosimilars Insulin.
Pass-through Payments for Biosimilars.
Cost Sharing for Biosimilars.
Biosimilars Misinformation.
FDA Inspections.
FDA and Future Public Health Emergencies.
FDA-PTO Collaboration.
Buy American Proposals.
Issues Related to COVID-19.
Citizens Petitions.
H.R.2843: STOP GAMES Act of 2021.
H.R.2883/S.1425: Stop Stalling Access to Affordable Medications.
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), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), U.S. Trade Representative (USTR)
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 |
|
|
|
David |
Gaugh |
|
|
|
Karin |
Hessler |
|
|
|
Jonathan |
Kimball |
|
|
|
Erik |
Komendant |
|
|
|
Daniel |
Leonard |
|
|
|
Katherine |
Raab |
|
|
|
Joseph |
Russo |
|
SAP & Dep. Director/Director of Business Outreach/Assoc. Director/Dep. Assoc. Director, WH Office of Public Liaison; Coalitions Director, House Judiciary Committee; Legislative Correspondent, Rep. Bob Goodlatte |
|
Steven |
Selde |
|
Legislative Counsel, U.S. Senator Deb Fischer |
|
Christine |
Simmon |
|
|
|
Polly |
Webster |
|
Health Policy Director, U.S. Representative Diana DeGette; Fellow, Senate Finance Committee; Fellow, U.S. Senator Jay Rockefeller |
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 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), Health & Human Services - Dept of (HHS), Natl Economic Council (NEC)
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 |
|
|
|
Erik |
Komendant |
|
|
|
Daniel |
Leonard |
|
|
|
Katherine |
Raab |
|
|
|
Joseph |
Russo |
|
|
|
Steven |
Selde |
|
|
|
Christine |
Simmon |
|
|
|
Polly |
Webster |
|
|
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.
H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act.
H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021.
Patent Abuse.
H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act.
REMEDY Act.
BPCIA Patent Dance.
Inter Partes Review.
Section 101 of the Patent Act.
Product Hopping.
H.R.2873/S.1435: Affordable Prescriptions for Patients Act of 2021.
TAB Appointments Clause (Arthrex Case).
Enhancing Quality of Patents through the PTAB.
Restoring the America Invents Act (Leahy IPR Bill).
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Patent & Trademark Office (PTO), Natl Economic Council (NEC)
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 |
|
|
|
Erik |
Komendant |
|
|
|
Joseph |
Russo |
|
|
|
Polly |
Webster |
|
|
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 |
|
|
|
Erik |
Komendant |
|
|
|
Joseph |
Russo |
|
|
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.
S.1176: Onshoring Essential Antibiotics Act.
H.R.2870: Essential Medicines Strategic Stockpile Act of 2021.
H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021.
S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act.
S.1367: United States Pharmaceutical Supply Chain Review Act.
AAM Blueprint to Enhance the Security of the U.S. Supply Chain.
US-India Trade Discussions.
TRIPS Waivers.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Commerce - Dept of (DOC), Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), U.S. Trade Representative (USTR)
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 |
|
|
|
Karin |
Hessler |
|
|
|
Jonathan |
Kimball |
|
|
|
Erik |
Komendant |
|
|
|
Daniel |
Leonard |
|
|
|
Joseph |
Russo |
|
|
|
Christine |
Simmon |
|
|
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
| Address |
|
||||||
| City |
|
State |
|
Zip Code |
|
Country |
|
21. Client new principal place of business (if different than line 20)
| City |
|
State |
|
Zip Code |
|
Country |
|
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
|
|
||||||||
| 1 |
|
3 |
|
||||||
| 2 |
|
4 |
|
ISSUE UPDATE
24. General lobbying issue that no longer pertains
|
|
|
|
|
|
|
|
|
AFFILIATED ORGANIZATIONS
25. Add the following affiliated organization(s)
Internet Address:
| Name | Address |
Principal Place of Business (city and state or country) |
||||||||||||
| ||||||||||||||
|
||||||||||||||
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 | ||||||||||
| ||||||||||||||
|
% | |||||||||||||
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) |