Clerk of the House of Representatives Legislative Resource Center B-106 Cannon Building Washington, DC 20515 http://lobbyingdisclosure.house.gov Secretary of the Senate Office of Public Records 232 Hart Building Washington, DC 20510 http://www.senate.gov/lobby LOBBYING REPORT Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page 1. Registrant Name Organization/Lobbying Firm Self Employed Individual 2. Address Check if different than previously reported Address1 950 F Street, NW WASHINGTON Address2 City State Zip Code 20004 - Country DC Suite 300 USA 3. Principal place of business (if different than line 2) City State Zip Code - Country 4a. Contact Name b. Telephone Number International Number PAUL J. LARSEN c. E-mail 5. Senate ID# 7. Self Check if client is a state or local government or instrumentality 2009 (202) 835-3428 6. House ID# TYPE OF REPORT 8. Year 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 plarsen@phrma.org 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 31350-12 306540000 INCOME relating to lobbying activities for this reporting period was: Less than $5,000 $5,000 or more $ Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income from the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). EXPENSE relating to lobbying activities for this reporting period were: Less than $5,000 $5,000 or more $ 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options. Method A. Method B. Method C. $ 6,790,000.00 Reporting amounts using LDA definitions only Reporting amounts under section 6033(b)(8) of the Internal Revenue Code Reporting amounts under section 162(e) of the Internal Revenue Code Signature Filed Electronically Date 10/20/2009 Page 1 of 22
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 BUDGET/APPROPRIATIONS (one per page) 16. Specific lobbying issues H.R. 2847, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010: trade infringement H.R. 2892, Department of Homeland Security Appropriations Act, 2010: importation H.R. 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding 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 Maya Bermingham Covered Official Position (if applicable) New Bryant Valerie Mimi Kendra Thomas Brian Byron Lori Hall Jewett Kneuer Martello Moore Nagle Patterson Reilly 19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None Page 2 of 22
ADDENDUM for General Lobbying Issue Area: BUD - BUDGET/APPROPRIATIONS H.R. 3293, Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2010, and for other purposes: comparative effectiveness, NIH funding, pandemic funding S. 1298, Department of Homeland Security Appropriations Act, 2010: importation S. 1406, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding Page 3 of 22
ADDENDUM for General Lobbying Issue BUD - BUDGET/APPROPRIATIONS Name Covered Official Position (if applicable) New First Last Suffix Matt Sulkala Billy Tauzin Steve Tilton David Boyer Spec. Asst. to Pres. for Leg. Affrs.-White Hse.; Asst. Comm'r for Leg.-FDA; Spec. Asst. for Oversight-HHS; Spec. Asst. to Sec.-HHS; Spec. Asst. Offc. of Asst. Sec. for Leg.-HHS; Spec. Asst. Offc. of White Hse. Liaison-DOD; Conf. Asst. Offc. of Sec.-DOL Lea Fisher Leg. Asst.-Rep. Bob Etheridge Jennifer Swenson Staff Asst., LC, LA, Dep. LD-Sen. Pat Roberts Page 4 of 22
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 COPYRIGHT/PATENT/TRADEMARK (one per page) 16. Specific lobbying issues H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics 17. House(s) of Congress and Federal agencies Check if None U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Commerce - Dept of (DOC), Patent & Trademark Office (PTO), U.S. Trade Representative (USTR), 18. Name of each individual who acted as a lobbyist in this issue area First Name Last Name Suffix Maya Bermingham Covered Official Position (if applicable) New Robert Bryant Mimi David Kendra Thomas Brian Byron Filippone Hall Kneuer Korn Martello Moore Nagle Patterson 19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None Page 5 of 22
ADDENDUM for General Lobbying Issue Area: CPT - COPYRIGHT/PATENT/TRADEMARK H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues Page 6 of 22
ADDENDUM for General Lobbying Issue CPT - COPYRIGHT/PATENT/TRADEMARK Name Covered Official Position (if applicable) New First Last Suffix Richard Smith Heather Strawn Matt Sulkala Billy Tauzin Jennifer Van Meter Michael Woody David Boyer Spec. Asst. to Pres. for Leg. Affrs.-White Hse.; Asst. Comm'r for Leg.-FDA; Spec. Asst. for Oversight-HHS; Spec. Asst. to Sec.-HHS; Spec. Asst. Offc. of Asst. Sec. for Leg.-HHS; Spec. Asst. Offc. of White Hse. Liaison-DOD; Conf. Page 7 of 22
ADDENDUM for General Lobbying Issue CPT - COPYRIGHT/PATENT/TRADEMARK Name Covered Official Position (if applicable) New First Last Suffix Asst. Offc. of Sec.-DOL Anne Pritchett Sen. Policy Analyst-White House Drug Policy Offc., Exec. Offc. of Pres. Page 8 of 22
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 ENVIRONMENT/SUPERFUND (one per page) 16. Specific lobbying issues H.R. 1145, National Water Research and Development Initiative Act of 2009: water quality issues H.R. 1191, Safe Drug Disposal Act of 2009: drug take back H.R. 1359, Secure and Responsible Drug Disposal Act of 2009: drug take back H.R. 3202, Water Protection and Reinvestment Act of 2009: water quality issues 17. House(s) of Congress and Federal agencies Check if None U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Office of Natl Drug Control Policy (NDCP) 18. Name of each individual who acted as a lobbyist in this issue area First Name Last Name Suffix Bryant Hall Covered Official Position (if applicable) New Valerie Kendra Brian Jewett Martello Nagle Matt Lea Sulkala Fisher Leg. Assist.-Rep. Bob Etheridge 19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None Page 9 of 22
ADDENDUM for General Lobbying Issue Area: ENV - ENVIRONMENT/SUPERFUND S. 1005, Water Infrastructure Financing Act: water quality issues Page 10 of 22
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 HEALTH ISSUES (one per page) 16. Specific lobbying issues H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues (drug pricing program for covered entities) H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics 17. House(s) of Congress and Federal agencies Check if None U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, White House Office, Natl Economic Council (NEC), Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), Congressional Budget Office (CBO), Agency for Health Care Policy & Research, Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB) 18. Name of each individual who acted as a lobbyist in this issue area First Name Last Name Suffix Maya Bermingham Covered Official Position (if applicable) New Randy Andrea Robert Bryant Valerie Ann Mimi Hallie Burkholder Douglas Filippone Hall Jewett Kaplan Kneuer Maranchick 19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None Page 11 of 22
ADDENDUM for General Lobbying Issue Area: HCR - HEALTH ISSUES H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3200, Americas Affordable Health Choices Act: regulatory approval pathway for follow-on biologics, 340B program issues, comparative effectiveness S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow on biologics, 340B program issues Americas Healthy Future Act of 2009 Chairmans Mark Senate Finance Committee: comparative effectiveness Page 12 of 22
ADDENDUM for General Lobbying Issue HCR - HEALTH ISSUES Name Covered Official Position (if applicable) New First Last Suffix Kendra Martello Thomas Moore Brian Nagle Byron Patterson Lori Reilly Richard Smith Heather Strawn Matt Sulkala Billy Tauzin Steve Tilton Jennifer Van Meter Page 13 of 22
ADDENDUM for General Lobbying Issue HCR - HEALTH ISSUES Name Covered Official Position (if applicable) New First Last Suffix Michael Woody David Boyer Spec. Asst. to Pres. for Leg. Affrs.-White Hse.; Asst. Comm'r for Leg.-FDA; Spec. Asst. for Oversight-HHS; Spec. Asst. to Sec.-HHS; Spec. Asst. Offc. of Asst. Sec. for Leg.-HHS; Spec. Asst. Offc. of White Hse. Liaison-DOD; Conf. Asst. Offc. of Sec.-DOL Jennifer Bryant Daniel Durham Act. Dep. Asst. Sec. Health Pol., Dep. to Dep. Asst. Sec. Health Pol., Sen. Advr. Health Pol.- HHS; Act. Assoc. Comm'r. & Dep. Assoc. Page 14 of 22
ADDENDUM for General Lobbying Issue HCR - HEALTH ISSUES Name Covered Official Position (if applicable) New First Last Suffix Comm'r. Ret. Policy-SSA; Policy Analyst & Budget Exam.-OMB Lea Fisher Leg. Asst.-Rep. Bob Etheridge Gregory Gierer LA, LC-Sen. Christopher Dodd; Staff Asst.- Rep. Rosa DeLauro Anne Pritchett Sen. Policy Analyst-White Hse. Drug Policy Offc., Exec. Offc. of the Pres. Jennifer Swenson Staff Asst., LC, LA, Dep. LD-Sen. Pat Roberts Page 15 of 22
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 MEDICARE/MEDICAID (one per page) 16. Specific lobbying issues H.R. 684, Medicare Prescription Drug Savings and Choice Act: Part D issues H.R. 3200, Americas Affordable Health Choices Act: Medicaid rebate issues, Part D issues, health reform issues S. 301, Physician Payments Sunshine Act of 2009: transparency issues 17. House(s) of Congress and Federal agencies Check if None U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, White House Office, Centers For Medicare and Medicaid Services (CMS), Agency for Health Care Policy & Research, Health & Human Services - Dept of (HHS), Congressional Budget Office (CBO), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB) 18. Name of each individual who acted as a lobbyist in this issue area First Name Last Name Suffix Maya Bermingham Covered Official Position (if applicable) New Jennifer Randy Andrea Robert Bryant Ann Mimi Hallie Bryant Burkholder Douglas Filippone Hall Kaplan Kneuer Maranchick 19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None Page 16 of 22
ADDENDUM for General Lobbying Issue Area: MMM - MEDICARE/MEDICAID S. 330, Medicare Prescription Drug Savings and Choice Act: Part D issues S. 1110, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009: Medicare payment issues S. 1380, Medicare Payment Advisory Commission Reform Act of 2009: Medicare payment issues Americas Healthy Future Act of 2009 Chairmans Mark Senate Finance Committee: Medicaid rebate issues, Part D issues, health reform issues Senate Finance Committee options papers Page 17 of 22
ADDENDUM for General Lobbying Issue MMM - MEDICARE/MEDICAID Name Covered Official Position (if applicable) New First Last Suffix Thomas Moore Brian Nagle Byron Patterson Lori Reilly Richard Smith Heather Strawn Matt Sulkala Billy Tauzin Steve Tilton Jennifer Van Meter Michael Woody Page 18 of 22
ADDENDUM for General Lobbying Issue MMM - MEDICARE/MEDICAID Name Covered Official Position (if applicable) New First Last Suffix David Boyer Spec. Asst. to Pres. for Leg. Affrs.-White Hse.; Asst. Comm'r for Leg.-FDA; Spec. Asst. for Oversight-HHS; Spec. Asst. to Sec.-HHS; Spec. Asst. Offc. of Asst. Sec. for Leg.-HHS; Spec. Asst. Offc. of White Hse. Liaison-DOD; Conf. Asst. Offc. of Sec.-DOL Daniel Durham Act. Dep. Asst. Sec. Health Pol., Dep. to Dep. Asst. Sec. Health Pol., Sen. Advr. Health Pol.- HHS; Act. Assoc. Comm'r. & Dep. Assoc. Comm'r. Ret. Policy-SSA; Policy Analyst & Budget Exam.-OMB Page 19 of 22
ADDENDUM for General Lobbying Issue MMM - MEDICARE/MEDICAID Name Covered Official Position (if applicable) New First Last Suffix Lea Fisher Leg. Asst.-Rep. Bob Etheridge Gregory Gierer LA, LC-Sen. Christopher Dodd; Staff Asst.- Rep. Rosa DeLauro Jennifer Swenson Staff Asst., LC, LA, Dep. LD-Sen. Pat Roberts Page 20 of 22
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 TRADE (DOMESTIC/FOREIGN) (one per page) 16. Specific lobbying issues H.R. 3012, Trade Reform, Accountability, Development, and Employment Act of 2009 (TRADE Act of 2009): trade agreements Korea Free Trade Agreement: intellectual property, market access and public health International market access and intellectual property issues Trade enforcement issues 17. House(s) of Congress and Federal agencies Check if None U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, U.S. Trade Representative (USTR), Commerce - Dept of (DOC), State - Dept of (DOS) 18. Name of each individual who acted as a lobbyist in this issue area First Name Last Name Suffix Robert Filippone Covered Official Position (if applicable) New Bryant Thomas Billy Byron Hall Moore Tauzin Patterson 19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None Page 21 of 22
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 First Name Last Name Suffix 3 First Name Last Name Suffix 2 4 ISSUE UPDATE 24. General lobbying issue that no longer pertains AFFILIATED ORGANIZATIONS 25. Add the following affiliated organization(s) Internet Address: http://www.phrma.org/about_phrma/member_company_list/members/ Name Address Street Address City State/Province Zip Country Principal Place of Business (city and state or country) City State Country City State 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 Street Address City State/Province Country Principal place of business (city and state or country) Amount of contribution for lobbying activities Ownership percentage in client City State Country % 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 Page 22 of 22