4th Quarter - Report

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

Period 4th Quarter 2009 Filed Jan 20, 2010 Signed by Paul J. Larsen - Deputy Compliance Officer & Assistant General Counsel

Official filing
Firm
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
Client
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
Income
—
Expenses
$6,300,520
Expense method
A: Lobbying Disclosure Act definitions

What was lobbied

5 issue areas, each in the filer's own words, with who lobbied on it and where.

Copyright/Patent/Trademark CPT

H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions 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 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 H.R. 3590, Patient Protection and Affordable Care Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, patent settlements, and authorized generics H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, and patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions 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

LobbyistCovered position, as disclosed
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
ROBERT FILIPPONE —
LEA FISHER Leg. Asst.-Rep. Bob Etheridge
JAMES BRYANT HALL —
MIMI KNEUER —
DAVID KORN —
KENDRA MARTELLO —
TOM MOORE —
BRIAN NAGLE —
BYRON PATTERSON —
ANNE PRITCHETT Sen. Policy Analyst-White House Drug Policy, Offc., Exec. Offc. of Pres.
LORI REILLY —
RICHARD SMITH —
HEATHER STRAWN —
MATTHEW L SULKALA —
BILLY TAUZIN —
STEVE TILTON —
MICHAEL PAUL WOODY —

Contacted: Health & Human Services, Dept of (HHS); Federal Trade Commission (FTC); State, Dept of (DOS); Agency for Healthcare Research & Quality (AHRQ); Commerce, Dept of (DOC); Centers For Medicare and Medicaid Services (CMS); Patent & Trademark Office (PTO); Congressional Budget Office (CBO); SENATE; U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Office of Management & Budget (OMB); White House Office; HOUSE OF REPRESENTATIVES; Medicare Payment Advisory Commission (MedPAC)

Bills named: H.R. 3590 (111th), H.R. 1260 (111th), H.R. 1706 (111th), H.R. 1548 (111th), S. 515 (111th), H.R. 573 (111th), S. 610 (111th), H.R. 3962 (111th), S. 369 (111th), H.R. 1427 (111th), S. 501 (111th), S. 726 (111th)

Medicare/Medicaid MMM

H.R. 3590, Patient Protection and Affordable Care Act: Part D coverage gap discounts, Part D rebates, Part D issues generally, Medicare payment issues, Medicaid rebate issues, transparency issues, comparative effectiveness, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: Part D coverage gap, Part D rebates, Part D issues generally, Medicaid rebate issues, transparency issues, comparative effectiveness, health reform issues generally S. 1796, Americas Healthy Future Act of 2009: Part D coverage gap discounts, Part D issues generally, Medicare payment issues, Medicaid rebate issues, comparative effectiveness, health reform fee, health reform issues generally

LobbyistCovered position, as disclosed
MAYA BERMINGHAM —
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 MIRANDA BRYANT —
RANDY BURKHOLDER —
ANDREA JEAN DOUGLAS —
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. Pol.-SSA; Pol. Analyst & Bud., Exam.-OMB
LEA FISHER Leg. Asst.-Rep. Bob Etheridge
GREGORY GIERER LA, LC-Sen. Christopher Dodd; Staff Asst.-Rep., Rosa DeLauro
JAMES BRYANT HALL —
VALERIE HARDIN JEWETT —
ANN KAPLAN —
MIMI KNEUER —
TOM MOORE —
BRIAN NAGLE —
BYRON PATTERSON —
ANNE PRITCHETT Sen. Policy Analyst-White Hse. Drug Policy, Offc., Exec. Offc. of the Pres.
LORI REILLY —
RICHARD SMITH —
HEATHER STRAWN —
MATTHEW L SULKALA —
JENNIFER ANNE SWENSON Staff Asst., LC, LA, Dep. LD-Sen. Pat Roberts
BILLY TAUZIN —
STEVE TILTON —
JENNIFER VAN METER —
MICHAEL PAUL WOODY —

Contacted: Medicare Payment Advisory Commission (MedPAC); Health & Human Services, Dept of (HHS); State, Dept of (DOS); SENATE; Commerce, Dept of (DOC); Federal Trade Commission (FTC); Office of Management & Budget (OMB); Patent & Trademark Office (PTO); Centers For Medicare and Medicaid Services (CMS); Agency for Healthcare Research & Quality (AHRQ); Food & Drug Administration (FDA); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; White House Office; Congressional Budget Office (CBO)

Bills named: H.R. 3590 (111th), H.R. 3962 (111th), S. 1796 (111th)

Budget/Appropriations BUD

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 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 H.R. 3288, Consolidated Appropriations Act: comparative effectiveness, NIH funding, pandemic funding

LobbyistCovered position, as disclosed
MAYA BERMINGHAM —
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
JAMES BRYANT HALL —
VALERIE HARDIN JEWETT —
MIMI KNEUER —
BRIAN NAGLE —
BYRON PATTERSON —
RICHARD SMITH —
MATTHEW L SULKALA —
BILLY TAUZIN —
STEVE TILTON —

Contacted: Food & Drug Administration (FDA); White House Office; Commerce, Dept of (DOC); Medicare Payment Advisory Commission (MedPAC); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Federal Trade Commission (FTC); SENATE; Agency for Healthcare Research & Quality (AHRQ); U.S. Trade Representative (USTR); Office of Management & Budget (OMB); State, Dept of (DOS); Congressional Budget Office (CBO); Patent & Trademark Office (PTO)

Bills named: S. 1298 (111th), H.R. 2892 (111th), H.R. 3288 (111th), H.R. 2997 (111th), S. 1406 (111th)

Trade (domestic/foreign) TRD

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 Trans-Pacific Strategic Economic Partnership Agreement (TPP): intellectual property issues International market access and intellectual property issues Trade enforcement issues

LobbyistCovered position, as disclosed
ROBERT FILIPPONE —
LEA FISHER Leg. Asst.-Rep. Bob Etheridge
TOM MOORE —
BYRON PATTERSON —
ANNE PRITCHETT Sen. Policy Analyst-White Hse. Drug Policy Offc.,, Exec. Offc. of the Pres.
BILLY TAUZIN —

Contacted: Medicare Payment Advisory Commission (MedPAC); Federal Trade Commission (FTC); White House Office; U.S. Trade Representative (USTR); State, Dept of (DOS); Food & Drug Administration (FDA); SENATE; Congressional Budget Office (CBO); Agency for Healthcare Research & Quality (AHRQ); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); Centers For Medicare and Medicaid Services (CMS); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS)

Bills named: H.R. 3012 (111th)

Health Issues HCR

H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues 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 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. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation [S.A. 2793], health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, health reform issues generally 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, importation S. 1796, Americas Healthy Future Act of 2009: comparative effectiveness, importation, health reform issues generally

LobbyistCovered position, as disclosed
MAYA BERMINGHAM —
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 MIRANDA BRYANT —
RANDY BURKHOLDER —
ANDREA JEAN DOUGLAS —
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. Pol.-SSA; Pol. Analyst & Bud., Exam.-OMB
ROBERT FILIPPONE —
LEA FISHER Leg. Asst.-Rep. Bob Etheridge
GREGORY GIERER LA, LC-Sen. Christopher Dodd; Staff Asst.-Rep., Rosa DeLauro
JAMES BRYANT HALL —
VALERIE HARDIN JEWETT —
ANN KAPLAN —
MIMI KNEUER —
HALLIE AMANDA MARANCHICK —
KENDRA MARTELLO —
TOM MOORE —
BRIAN NAGLE —
BYRON PATTERSON —
ANNE PRITCHETT Sen. Policy Analyst-White Hse. Drug Policy, Offc., Exec. Offc. of the Pres.
LORI REILLY —
RICHARD SMITH —
HEATHER STRAWN —
MATTHEW L SULKALA —
JENNIFER ANNE SWENSON Staff Asst., LC, LA, Dep. LD-Sen. Pat Roberts
BILLY TAUZIN —
STEVE TILTON —
MICHAEL PAUL WOODY —

Contacted: Agency for Healthcare Research & Quality (AHRQ); Patent & Trademark Office (PTO); Federal Trade Commission (FTC); White House Office; State, Dept of (DOS); Medicare Payment Advisory Commission (MedPAC); Health & Human Services, Dept of (HHS); SENATE; Commerce, Dept of (DOC); Congressional Budget Office (CBO); U.S. Trade Representative (USTR); Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES

Bills named: S. 1142 (111th), H.R. 2824 (111th), S. 1679 (111th), H.R. 2502 (111th), S. 488 (111th), H.R. 1859 (111th), H.R. 1427 (111th), S. 767 (111th), H.R. 444 (111th), S. 1796 (111th), S. 914 (111th), H.R. 3590 (111th), S. 1213 (111th), S. 525 (111th), S. 1232 (111th), H.R. 3962 (111th), H.R. 1298 (111th), S. 422 (111th), H.R. 1548 (111th), S. 726 (111th)

Shown as published by the Senate Office of Public Records and the House Clerk under the Lobbying Disclosure Act. The official filing is the record; open it for the full form.