WASHINGTON USA - FDAnews€¦ · Fisher Leg. Assist.-Rep. Bob Etheridge Sulkala 9 22 ENVIRONMENT/SUPERFUND U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Office of Natl Drug Control

Clerk of the House of RepresentativesLegislative Resource CenterB-106 Cannon BuildingWashington, DC 20515

Secretary of the SenateOffice of Public Records232 Hart BuildingWashington, DC 20510

LOBBYING REPORTLobbying 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 Address2

City State Zip Code - Country

3. Principal place of business (if different than line 2)


4a. Contact Name b. Telephone NumberInternational Number

c. E-mail 5. Senate ID#

6. House ID#7. Client Name Self Check if client is a state or local government or instrumentality

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

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 EXPENSErelating to lobbying activities for this reporting periodwas: were:

Less than $5,000

$5,000 or more $

relating to lobbying activities for this reporting period

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 allpayments to the registrant by any other entity for lobbyingactivities on behalf of the client).

14. REPORTINGaccounting method. See instructions for description of options.

Check box to indicate expense

Method A.

Method B.

Method C.

Reporting amounts using LDA definitions only

Reporting amounts under section 6033(b)(8) of theInternal Revenue CodeReporting amounts under section 162(e) of the InternalRevenue Code

Signature Date

Printed Name and Titlev6.0.1f

http://lobbyingdisclosure.house.gov http://www.senate.gov/lobby

✔

2009

✔

DC

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA✔

306540000

Filed Electronically

20004

(202) 835-3428

22Page ______ of ______

[email protected]

USA

1

$ 6,790,000.00

✔

✔

31350-12

Paul J. Larsen, Deputy Compliance Officer & Assistant General Counsel

Suite 300950 F Street, NWWASHINGTON

PAUL J. LARSEN

10/20/2009

Registrant Client Name

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrantengaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provideinformation as requested. Add additional page(s) as needed.

15. General issue area code (one per page)

16. Specific lobbying issues

17. House(s) of Congress and Federal agencies Check if None

18. Name of each individual who acted as a lobbyist in this issue area

Covered Official Position (if applicable) NewFirst Name Last Name Suffix

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None


Reilly

Moore

Martello

22

Patterson

2

BUDGET/APPROPRIATIONS

Nagle

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE


Byron

Brian

Lori

Valerie

Mimi

Kendra


Thomas

Kneuer

Jewett

MayaHallBryant


BUD

Bermingham

✔

Page ______ of ______

H.R. 2847, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010: trade infringementH.R. 2892, Department of Homeland Security Appropriations Act, 2010: importationH.R. 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010:importation, FDA funding

ADDENDUM for General Lobbying Issue Area:

Printed Name and Titlev6.0.1f 22Page ______ of ______3

H.R. 3293, Making appropriations for the Departments of Labor, Health and Human Services, andEducation, and related agencies for the fiscal year ending September 30, 2010, and for other purposes:comparative effectiveness, NIH funding, pandemic fundingS. 1298, Department of Homeland Security Appropriations Act, 2010: importationS. 1406, Agriculture, Rural Development, Food and Drug Administration, and Related AgenciesAppropriations Act, 2010: importation, FDA funding


BUD - BUDGET/APPROPRIATIONS


ADDENDUM for General Lobbying Issue

Name Covered Official Position (if applicable) New

First Last Suffix


Asst. Offc. of Sec.-DOL

Asst. Offc. of White Hse. Liaison-DOD; Conf.

Asst. Offc. of Asst. Sec. for Leg.-HHS; Spec.

Oversight-HHS; Spec. Asst. to Sec.-HHS; Spec.

Asst. Comm'r for Leg.-FDA; Spec. Asst. for

Spec. Asst. to Pres. for Leg. Affrs.-White Hse.;

Leg. Asst.-Rep. Bob Etheridge

Staff Asst., LC, LA, Dep. LD-Sen. Pat RobertsSwenson

Fisher

"

"

22

"

4

"

"


"

"

"

Steve

David

"


"

Boyer

Tilton

Tauzin

Matt Sulkala


Billy

Page ______ of ______

BUD - BUDGET/APPROPRIATIONS

Jennifer

Lea










Patterson

Martello

Korn

22

Nagle

5

COPYRIGHT/PATENT/TRADEMARK

Moore

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Commerce - Dept of (DOC), Patent & TrademarkOffice (PTO), U.S. Trade Representative (USTR),


Brian

Thomas

Byron

Bryant

Mimi

David


Kendra

Kneuer

Hall

MayaFilipponeRobert


CPT

Bermingham

✔

Page ______ of ______

H.R. 1260, Patent Reform Act of 2009: reforms of the patent lawsH.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway forfollow-on biologics, including provisions on data exclusivity and patent procedures for biologics



H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, includingprovisions on data exclusivity and patent procedures for biologicsH.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlementsS. 369, Preserve Access to Affordable Generics Act: patent settlementsS. 515, Patent Reform Act of 2009: reforms of the patent lawsS. 610, Patent Reform Act of 2009: reforms of the patent lawsS. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway forfollow-on biologics, including provisions on data exclusivity and patent procedures for biologicsInternational intellectual property issues


CPT - COPYRIGHT/PATENT/TRADEMARK




First Last Suffix






Asst. Offc. of White Hse. Liaison-DOD; Conf."

"

"

Woody

22

Van Meter

7

"

Boyer


"

David

"

Matt

Billy

Jennifer


Michael

Tauzin

Sulkala

Strawn

Richard Smith


Heather

Page ______ of ______


"

"




First Last Suffix



Offc., Exec. Offc. of Pres.

Sen. Policy Analyst-White House Drug Policy

228


"


"

Pritchett

" "


Anne

Page ______ of ______











Leg. Assist.-Rep. Bob EtheridgeFisher

Sulkala

229

ENVIRONMENT/SUPERFUND

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Office of Natl Drug Control Policy (NDCP)


Kendra

Brian

Matt


Lea

Nagle

Martello

BryantJewettValerie


ENV

Hall

✔

Page ______ of ______

H.R. 1145, National Water Research and Development Initiative Act of 2009: water quality issuesH.R. 1191, Safe Drug Disposal Act of 2009: drug take backH.R. 1359, Secure and Responsible Drug Disposal Act of 2009: drug take backH.R. 3202, Water Protection and Reinvestment Act of 2009: water quality issues



S. 1005, Water Infrastructure Financing Act: water quality issues


ENV - ENVIRONMENT/SUPERFUND










Maranchick

Jewett

Hall

22

Kneuer

11

HEALTH ISSUES

Kaplan

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)


Mimi

Ann

Hallie

Andrea

Robert

Bryant


Valerie

Filippone

Douglas

MayaBurkholderRandy


HCR

Bermingham

✔

Page ______ of ______

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: importationH.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologicsH.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics



H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailingH.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectivenessH.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectivenessH.R. 3200, Americas Affordable Health Choices Act: regulatory approval pathway for follow-on biologics,340B program issues, comparative effectivenessS. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: newdrug application requirementsS. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trialsS. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importationS. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway forfollow-on biologicsS. 767, Independent Drug Education and Outreach Act of 2009: academic detailingS. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basicresearch and developmentS. 1142, Informed Health Care Decision Making Act: drug labelingS. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectivenessS. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importationS. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow onbiologics, 340B program issuesAmericas Healthy Future Act of 2009 Chairmans Mark Senate Finance Committee: comparativeeffectiveness


HCR - HEALTH ISSUES




First Last Suffix


Van Meter

Tilton

Tauzin

Smith

22

Reilly

13

Sulkala

Strawn


Matt

Heather

Billy

Brian

Byron

Lori


Richard

Patterson

Nagle

Moore

Kendra Martello


Thomas

Page ______ of ______

HCR - HEALTH ISSUES

Jennifer

Steve




First Last Suffix


Act. Dep. Asst. Sec. Health Pol., Dep. to Dep.







Asst. Sec. Health Pol., Sen. Advr. Health Pol.-

HHS; Act. Assoc. Comm'r. & Dep. Assoc."

"

Durham

"

22

"

14

Bryant

"


Jennifer

"

Daniel

"

"

"


"

"

"

Boyer

Michael Woody


David

Page ______ of ______

HCR - HEALTH ISSUES

"

"




First Last Suffix


Comm'r. Ret. Policy-SSA; Policy Analyst &

Staff Asst., LC, LA, Dep. LD-Sen. Pat Roberts

Offc., Exec. Offc. of the Pres.

Sen. Policy Analyst-White Hse. Drug Policy

Rep. Rosa DeLauro

LA, LC-Sen. Christopher Dodd; Staff Asst.-


Budget Exam.-OMB

Pritchett

22

"

15

Swenson

"


Jennifer

"

Lea

Gregory

"


Anne

Gierer

Fisher

"

" "


"

Page ______ of ______

HCR - HEALTH ISSUES










Maranchick

Hall

Filippone

22

Kneuer

16

MEDICARE/MEDICAID

Kaplan

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, White House Office, Centers For Medicare andMedicaid Services (CMS), Agency for Health Care Policy & Research, Health & Human Services - Dept of(HHS), Congressional Budget Office (CBO), Medicare Payment Advisory Commission (MedPAC), Office ofManagement & Budget (OMB)


Mimi

Ann

Hallie

Randy

Andrea

Robert


Bryant

Douglas

Burkholder

MayaBryantJennifer


MMM

Bermingham

✔

Page ______ of ______

H.R. 684, Medicare Prescription Drug Savings and Choice Act: Part D issuesH.R. 3200, Americas Affordable Health Choices Act: Medicaid rebate issues, Part D issues, health reform issuesS. 301, Physician Payments Sunshine Act of 2009: transparency issues



S. 330, Medicare Prescription Drug Savings and Choice Act: Part D issuesS. 1110, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009: Medicare paymentissuesS. 1380, Medicare Payment Advisory Commission Reform Act of 2009: Medicare payment issuesAmericas Healthy Future Act of 2009 Chairmans Mark Senate Finance Committee: Medicaid rebate issues,Part D issues, health reform issuesSenate Finance Committee options papers


MMM - MEDICARE/MEDICAID




First Last Suffix


Woody

Van Meter

Tilton

Strawn

22

Smith

18

Tauzin

Sulkala


Billy

Matt

Steve

Byron

Lori

Richard


Heather

Reilly

Patterson

Nagle

Thomas Moore


Brian

Page ______ of ______


Michael

Jennifer




First Last Suffix



HHS; Act. Assoc. Comm'r. & Dep. Assoc.

Asst. Sec. Health Pol., Sen. Advr. Health Pol.-

Act. Dep. Asst. Sec. Health Pol., Dep. to Dep.






Comm'r. Ret. Policy-SSA; Policy Analyst &

Budget Exam.-OMB"

"

"

"

22

"

19

"

Durham


"

Daniel

"

"

"

"


"

"

"

"

David Boyer


"

Page ______ of ______


"

"




First Last Suffix



Staff Asst., LC, LA, Dep. LD-Sen. Pat Roberts

Rep. Rosa DeLauro

LA, LC-Sen. Christopher Dodd; Staff Asst.-

2220


"

Jennifer


Swenson

"

Gierer

Lea Fisher


Gregory

Page ______ of ______











Patterson

2221

TRADE (DOMESTIC/FOREIGN)

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, U.S. Trade Representative (USTR), Commerce - Deptof (DOC), State - Dept of (DOS)


Thomas

Billy

Byron


Tauzin

Moore

RobertHallBryant


TRD

Filippone

✔

Page ______ of ______

H.R. 3012, Trade Reform, Accountability, Development, and Employment Act of 2009 (TRADE Act of 2009): trade agreementsKorea Free Trade Agreement: intellectual property, market access and public healthInternational market access and intellectual property issuesTrade enforcement issues


Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

Address


21. Client new principal place of business (if different than line 20)


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

1First Name Last Name Suffix

3First Name Last Name Suffix

2 4

ISSUE UPDATE24. General lobbying issue that no longer pertains

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address:

NameAddress

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 ENTITIES27. Add the following foreign entities

Name

AddressPrincipal place of business(city and state or country)

Amount of contributionfor lobbying activities

Ownershippercentage inclient

Street Address

City State/Province Country

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


%

http://www.phrma.org/about_phrma/member_company_list/members/

2222Paul J. Larsen, Deputy Compliance Officer & Assistant General Counsel

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

Page ______ of ______

Documents

WASHINGTON USA - FDAnews€¦ · Fisher Leg. Assist.-Rep. Bob Etheridge Sulkala 9 22 ENVIRONMENT/SUPERFUND U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Office of Natl Drug Control