1st Quarter - Report

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

Period 1st Quarter 2010 Filed Apr 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
$7,010,000
Expense method
A: Lobbying Disclosure Act definitions

What was lobbied

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

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 Special 301 submission: intellectual property protection and enforcement Preference Program Reform: market access issues, intellectual property protection and enforcement International market access and intellectual property issues Trade enforcement issues

LobbyistCovered position, as disclosed
ROBERT FILIPPONE —
LEA FISHER Leg. Asst.-Rep. Bob Etheridge
VALERIE HARDIN JEWETT —
ANNE PRITCHETT Sen. Policy Analyst-White Hse. Drug Policy, Offc., Exec. Offc. of President
MATTHEW L SULKALA —

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

Bills named: H.R. 3012 (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, and health reform issues generally H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee and 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 —
ANN KAPLAN —
MIMI KNEUER —
HALLIE AMANDA MARANCHICK —
TOM MOORE —
BRIAN NAGLE —
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 —

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

Bills named: H.R. 4752 (111th), H.R. 3590 (111th), H.R. 3962 (111th), H.R. 4872 (111th)

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 —
TOM MOORE —
BRIAN NAGLE —
ANNE PRITCHETT Sen. Policy Analyst-White Hse. Drug Policy, Offc., Exec. Offc. of Pres.
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: Federal Trade Commission (FTC); Agency for Healthcare Research & Quality (AHRQ); U.S. Trade Representative (USTR); White House Office; HOUSE OF REPRESENTATIVES; SENATE; Office of Management & Budget (OMB); Patent & Trademark Office (PTO); Congressional Budget Office (CBO); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Executive Office of the President (EOP); Commerce, Dept of (DOC); State, Dept of (DOS); Centers For Medicare and Medicaid Services (CMS)

Bills named: S. 726 (111th), H.R. 1706 (111th), S. 515 (111th), H.R. 1548 (111th), H.R. 573 (111th), H.R. 3590 (111th), S. 501 (111th), S. 369 (111th), S. 610 (111th), H.R. 3962 (111th), H.R. 1260 (111th), H.R. 1427 (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. 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, health reform fee and 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, and health reform issues generally H.R. 4489, To amend chapter 89 of title 5, United States Code, to ensure program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program: PBM transparency H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program issues, health reform fee and other heath care reform issues 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. 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 Health and environment issues User fee issues

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 —
DAVID KORN —
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 —
JENNIFER VAN METER —
MICHAEL PAUL WOODY —

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

Bills named: H.R. 3590 (111th), H.R. 4489 (111th), H.R. 1298 (111th), H.R. 2502 (111th), S. 1213 (111th), S. 726 (111th), H.R. 1427 (111th), H.R. 4872 (111th), H.R. 3962 (111th), H.R. 444 (111th), S. 1142 (111th), S. 1679 (111th), H.R. 1548 (111th), S. 1232 (111th), H.R. 2824 (111th), S. 525 (111th), S. 914 (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.