|
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 |
Address2 |
|
| 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# 16293-12
|
||||||||
|
6. House ID# 314610000
|
||||||||
| 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 |
|
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: Michael J. Calvo |
Date | 4/20/2022 6:37:11 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. 1319: American Rescue Plan Act of 2021 - Public Law 117-2
H.R. 2471: Consolidated Appropriations Act, 2022 - Public Law 117-103
H.R. 4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022
Veterans' Affairs issues related to product sampling
H.R. 4350: National Defense Authorization Act for Fiscal Year 2022
H.R. 4356: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022
H.R. 5376: Build Back Better Act
S. 2599: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022
S. 2792: National Defense Authorization Act for Fiscal Year 2022
S. 3062: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2022
Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates
S. Con. Res. 14 Setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031.
340B Drug Pricing Program
CARES Act, Pub. L. 116-136
FY 2023 Presidents Budget Request
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Office of Management & Budget (OMB)
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 |
Michael |
Calvo |
|
|
|
Philip |
Thevenet |
|
|
|
Alec |
Hinojosa |
|
|
|
Curtis |
Rhyne |
|
|
|
Amy |
Efantis |
|
|
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
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements
H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights
H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs
H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights
H.R. 2853: BLOCKING Act of 2021 - Provisions related to FDA exclusivity periods
H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents
H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement
H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements
S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights
S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs
S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity
S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements
S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents
S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency
S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy
Biopharmaceutical innovation and patent policy issues
Bayh-Dole march-in rights policy issues
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, 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 |
Michael |
Calvo |
|
|
|
Philip |
Thevenet |
|
|
|
Alec |
Hinojosa |
|
|
|
Curtis |
Rhyne |
|
|
|
Amy |
Efantis |
|
|
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
H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines
H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization)
H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process
H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation
H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines
H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research
H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products
H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation
H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research
H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing
H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals
H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing
H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions
H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes)
H.R. 3761: Promising Pathways Act - Provisions related to FDA policy
H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues
H.R. 4127: DISARM Act Provisions related to antimicrobial drug development
H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program
H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy
H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act
H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity
H.R. 5416: Give Kids a Chance Act
H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research
H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing
H.R. 6000: Cures 2.0 Act - Provisions related to health research
H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing
H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes
H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022
H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval
H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations
H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling
H.R. 6988: Drug Manufacturing Innovation Act of 2022
H.R. 6996: Accelerating Access for Patients Act of 2022
H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act
H.R. 7008: Pre-Approval Information Exchange Act of 2022
H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022
H.R. 7035: Biologics Market Transparency Act of 2022
H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act
S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process
S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products
S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation
S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions
S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research
S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program
S. 912/H.R. 1978: Protecting Seniors Through Immunization Act
S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation
S. 1425: Stop STALLING Act - Provisions related to citizen petitions
S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing
S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals
S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act
S. 1644: Promising Pathway Act - Provisions related to FDA policy
S. 1645: ADAPT Act - Provisions related to FDA policy
S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues
S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act
S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act
S. 2706: DIVERSE Trials Act - Provisions related to FDA policy
S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program
S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways
S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance
S. 3449: Registration of Certain Foreign Establishments Act
S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act
Cancer Moonshot Initiative
21st Century Cures 2.0
RFI for Advanced Research Projects Agency - Health (ARPA-H)
Department of Homeland Security cybersecurity policy issues
Drug cost and pricing policy issues
Principles for drug pricing reform
Drug importation policy issues
Drug counterfeiting policy issues
PDUFA reauthorization
BsUFA reauthorization
Competition policy issues
Orphan Drug Act (ODA) policy issues
Health Advanced Research Projects Agency (HARPA) proposal
Expanded access policy issues
Antimicrobial resistance (AMR) policy issues
High deductible health plans/HSA policy issues
Supply chain and foreign manufacturing policy issues
Real world evidence policy issues
Clinical trial diversity policy issues
FDA modernization policy issues
340B drug discount program policy issues
Patient assistance program policy issues
Biosimilar approval and reimbursement policy issues
Drug shortages policy issues
Regulatory efficiencies policy issues
COVID-19 policy issues/Emergency supplemental funding
Pandemic preparedness policy issues
Defense Production Act (DPA) policy issues
Final Rule; Importation of Prescription Drugs
Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Nomination of Robert Califf to FDA Commissioner
HSA/FSA for Dietary Supplements
Dietary Supplement Health and Education Act Reform
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), Office of Management & Budget (OMB)
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 |
Michael |
Calvo |
|
|
|
Philip |
Thevenet |
|
|
|
Alex |
Hinojosa |
|
|
|
Curtis |
Rhyne |
|
|
|
Elizabeth |
Brewer |
|
|
|
Amy |
Efantis |
|
|
|
Jonathan |
Martinez |
|
|
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 - Provisions related to prescription drug pricing, non-interference, and intellectual property
H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs
H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference
H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference
H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference
H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, provisions related to patents
H.R. 4121, PRO Seniors Act, provisions related to drug rebates
H.R. 5801 HELP Copays Act, provisions related to patient assistance
H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing
H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access
S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers
S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference
S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access
S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing
Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues
Part D redesign and policy issues including non-interference and rebates policy issues
Part B policy issues
Drug cost and pricing policy issues
Alternative payment models policy issues
Value-based purchasing arrangements policy issues
Anti-Kickback Statute policy issues
Center for Medicare and Medicaid Innovation (CMMI) policy issues
Medicaid rebates and waiver policy issues
Medicare prescription drug payments cards and related policy issues
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), Centers For Medicare and Medicaid Services (CMS), Office of Management & Budget (OMB)
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 |
Michael |
Calvo |
|
|
|
Philip |
Thevenet |
|
|
|
Alec |
Hinojosa |
|
|
|
Curtis |
Rhyne |
|
|
|
Amy |
Efantis |
|
|
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. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency
H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing
H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles
H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property
H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains
H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property
H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing
H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator
H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
H.R. 4521: United States Innovation and Competition Act of 2021
H.R. 5388: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency
S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains
S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing
S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency
S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property
S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains
S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing
Biopharmaceutical innovation policy issues
International intellectual property and market access policy issues
Pricing and reimbursement policy issues
Supply chain policy issues
WTO TRIPS waiver
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, 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 |
Shira |
Kilcoyne |
|
|
|
Michael |
Calvo |
|
|
|
Philip |
Thevenet |
|
|
|
Alec |
Hinojosa |
|
|
|
Curtis |
Rhyne |
|
|
|
Amy |
Efantis |
|
|
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) |