2nd Quarter - Report

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

Period 2nd Quarter 2009 Filed Jul 20, 2009 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
$6,150,000
Expense method
A: Lobbying Disclosure Act definitions

What was lobbied

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

Health Issues HCR

H.R. 1, American Recovery and Reinvestment Act of 2009: comparative effectiveness H.R. 444, 340B Program Improvement and Integrity Act: issues related to 340B program (drug pricing program for covered entities) H.R. 759, Food and Drug Administration Globalization Act of 2009: import safety H.R. 1256, Family Smoking Prevention and Tobacco Control Act: importation 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 House Tri-Committee Health Reform Discussion Draft S. 1, American Recovery and Reinvestment Act of 2009: comparative effectiveness S. 350, American Recovery and Reinvestment Act of 2009: 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. 717, 21st Century Cancer ALERT (Access to Life-Saving Early detection, Research and Treatment) Act: reimbursement and clinical trial issues 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. 882, Drug and Device Accountability Act of 2009: import safety 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. __, Affordable Health Choices Act: health reform, regulatory approval pathway for follow on biologics, 340B program issues Confirmation of Kathleen Sebelius for Department of Health and Human Services Secretary Confirmation of Margaret Hamburg for Commissioner of Food and Drugs

LobbyistCovered position, as disclosed
MAYA BERMINGHAM —
DAVID BOYER Special Assist. to the President for Legislative, Affairs - White House, Assist. Comm'r for, Legislation - FDA, Special Assist. for Over-, sight - HHS, Special Assist. to the Secretary -, HHS, Special Assist. in Office of Assist., Secretary for Legislation - HHS, Special Assist., in Office of White House Liaison - Dept. of, Defense, Confidential Assist. in Office of, Secretary - Dept. of Labor
RANDY BURKHOLDER —
ANDREA JEAN DOUGLAS —
DANIEL DURHAM New Acting Dep. Assist. Sec. Health Policy, Dep. to, Dep. Assist. Sec. Health Policy, Senior Advisor, Health Policy - HHS, Acting Assoc. Comm'r &, Dep. Assoc. Comm'r Retirement Policy - SSA,, Policy Analyst & Budget Examiner - OMB
ROBERT FILIPPONE —
LEA FISHER New Leg. Assist. - Rep. Bob Etheridge
GREGORY GIERER New Leg. Assist., Leg. Corresp. - Sen. Christopher, Dodd, Staff Assist. - Rep. Rosa DeLauro
JAMES BRYANT HALL —
VALERIE HARDIN JEWETT Leg. Director - Rep. Rodney Frelinghuysen
ANN KAPLAN —
MIMI KNEUER —
HALLIE AMANDA MARANCHICK —
KENDRA MARTELLO —
TOM MOORE —
BRIAN NAGLE —
BYRON PATTERSON —
ANNE PRITCHETT New Senior Policy Analyst - White House Drug, Policy Office, Executive Office of the Pres.
LORI REILLY —
RICHARD SMITH —
HEATHER STRAWN —
MATTHEW L SULKALA —
JENNIFER ANNE SWENSON Staff Assist., Leg. Correspondent, Leg. Assist.,, Deputy Leg. Director - Senator Pat Roberts
BILLY TAUZIN —
STEVE TILTON —
JENNIFER VAN METER —
MICHAEL PAUL WOODY Professional Staff - Senate HELP Committee

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

Bills named: S. 717 (111th), H.R. 444 (111th), H.R. 1298 (111th), S. 767 (111th), S. 525 (111th), H.R. 2824 (111th), S. 1232 (111th), S. 1 (111th), S. 726 (111th), H.R. 1256 (111th), H.R. 1548 (111th), H.R. 1427 (111th), H.R. 1859 (111th), S. 350 (111th), S. 914 (111th), H.R. 2502 (111th), S. 422 (111th), S. 882 (111th), H.R. 759 (111th), S. 1213 (111th), S. 488 (111th), H.R. 1 (111th), S. 1142 (111th)

Medicare/Medicaid MMM

H.R. 2, Childrens Health Insurance Program Reauthorization Act of 2009: SCHIP reauthorization, Medicaid rebate, 340B H.R. 684, Medicare Prescription Drug Savings and Choice Act: Part D issues H.R. 904, Medicaid Prescription Drug Rebate Equalization Act of 2009: managed care organization (MCO) rebate H.R. 1788, False Claims Act Correction Act of 2009: liability issues S. 275, Childrens Health Insurance Reauthorization Act of 2009: SCHIP reauthorization, Medicaid rebate S. 301, Physician Payments Sunshine Act of 2009: transparency issues S. 330, Medicare Prescription Drug Savings and Choice Act: Part D issues S. 458, False Claims Act Clarification Act of 2009: liability issues S. 1110, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009: Medicare payment issues Health care reform issues Senate Finance Committee options papers

LobbyistCovered position, as disclosed
MAYA BERMINGHAM —
DAVID BOYER Spec. Assist. to Pres. for Leg. Affairs - White, House, Assist. Comm'r for Leg. - FDA, Special, Assist. for Oversight - HHS, Spec. Assist. to, Sec. - HHS, Spec. Assist. in Office of Assist., Sec. for Legis. - HHS, Spec. Assist. in Office, of White House Liaison - Dept. of Defense,, Conf. Assist. in Office of Sec. - Dept. of Labor
JENNIFER MIRANDA BRYANT New —
RANDY BURKHOLDER —
ANDREA JEAN DOUGLAS —
DANIEL DURHAM New Acting Dep. Assist. Sec. Health Policy, Deputy, to Deputy Assist. Sec. Health Policy, Senior, Advisor Health Policy - HHS, Acting Assoc., Comm'r & Dep. Assoc. Comm'r Retirement, Policy - SSA, Policy Analyst & Budget, Examiner - OMB
LEA FISHER New Leg. Assist. - Rep. Bob Etheridge
GREGORY GIERER New Leg. Assist., Leg. Corresp. - Sen. Christopherr, Dodd, Staff Assist. - Rep. Rosa DeLauro
JAMES BRYANT HALL —
VALERIE HARDIN JEWETT Leg. Director - Rep. Rodney Frelinghuysen
ANN KAPLAN —
MIMI KNEUER —
HALLIE AMANDA MARANCHICK —
TOM MOORE —
BRIAN NAGLE —
BYRON PATTERSON —
LORI REILLY —
RICHARD SMITH —
HEATHER STRAWN —
MATTHEW L SULKALA —
JENNIFER ANNE SWENSON Staff Assist., Leg. Correspondent, Leg. Assist.,, Dep. Leg. Director - Sen. Pat Roberts
BILLY TAUZIN —
STEVE TILTON —
JENNIFER VAN METER —
MICHAEL PAUL WOODY Professional Staff - Senate HELP Committee

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

Bills named: H.R. 904 (111th), H.R. 1788 (111th), S. 1110 (111th), S. 458 (111th), H.R. 2 (111th), S. 275 (111th), H.R. 684 (111th), S. 330 (111th), S. 301 (111th)

Budget/Appropriations BUD

H.R. 2346, Supplemental Appropriations Act, 2009: pandemic flu funding 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 S. 1298, Department of Homeland Security Appropriations Act, 2010: importation H.Con.Res. 85, 2010 Budget Resolution: health care reform funding provisions S.Con.Res.13, 2010 Budget Resolution: health care reform funding provisions Labor - Health and Human Services - Education Appropriations for Fiscal Year 2010: comparative effectiveness, NIH funding, pandemic flu funding

LobbyistCovered position, as disclosed
MAYA BERMINGHAM —
DAVID BOYER Special Assist. to the President for Legislative, Affairs - White House, Assist. Comm'r for, Legislation - FDA, Special Assist. for Over-, sight - HHS, Special Assist. to the Secretary -, HHS, Special Assist. in Office of Assist., Secretary for Legislation - HHS, Special Assist., in Office of White House Liaison - Dept. of, Defense, Confidential Assist. in Office of, Secretary - Dept. of Labor
ROBERT FILIPPONE —
LEA FISHER New Leg. Assist. - Rep. Bob Etheridge
GREGORY GIERER New Leg. Assist., Leg. Correspondent - Sen., Christopher Dodd, Staff Assist. - Rep. Rosa, DeLauro
JAMES BRYANT HALL —
VALERIE HARDIN JEWETT Leg. Director - Rep. Rodney Frelinghuysen
MIMI KNEUER —
KENDRA MARTELLO —
TOM MOORE —
BRIAN NAGLE —
BYRON PATTERSON —
LORI REILLY —
RICHARD SMITH —
MATTHEW L SULKALA —
JENNIFER ANNE SWENSON Staff Assist., Leg. Correspondent, Leg. Assist.,, Deputy Leg. Director - Senator Pat Roberts
BILLY TAUZIN —
STEVE TILTON —

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

Bills named: H.R. 2892 (111th), H.R. 2847 (111th), H.Con.Res. 85 (111th), H.R. 2346 (111th), S.Con.Res. 13 (111th), S. 1298 (111th), H.R. 2997 (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 Peru Free Trade Agreement: intellectual property, market access and public health U.S. Assistance for Global HIV/AIDS Programs International market access and intellectual property issues Trade enforcement issues

LobbyistCovered position, as disclosed
ROBERT FILIPPONE —
TOM MOORE —

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

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

Environment/Superfund ENV

H.R. 1145, National Water Research and Development Initiative Act of 2009: water 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 S. 1005, Water Infrastructure Financing Act: water issues

LobbyistCovered position, as disclosed
VALERIE HARDIN JEWETT Leg. Director - Rep. Rodney Frelinghuysen
KENDRA MARTELLO —
BRIAN NAGLE —

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

Bills named: S. 1005 (111th), H.R. 1191 (111th), H.R. 1359 (111th), H.R. 1145 (111th)

Copyright/Patent/Trademark CPT

H.R. 1260, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation 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 S. 299, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: establishing a pilot program for district court judges concerning patent litigation S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 515, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation S. 610, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation 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 Special Assist. to the President for Legislative, Affairs - White House, Assist. Comm'r for, Legislation - FDA, Special Assist. for Over-, sight - HHS, Special Assist. to the Secretary, HHS, Special Assist. in Office of Assist., Secretary for Legislation - HHS, Special Assist., in Office of White House Liaison - Dept. of, Defense, Confidential Assist. in Office of, Secretary - Dept. of Labor
ROBERT FILIPPONE —
LEA FISHER New Leg. Assist. - Rep. Bob Etheridge
JAMES BRYANT HALL —
MIMI KNEUER —
DAVID KORN —
HALLIE AMANDA MARANCHICK —
TOM MOORE —
BRIAN NAGLE —
BYRON PATTERSON —
ANNE PRITCHETT New Senior Policy Analyst - White House Drug, Policy Office, Executive Office of the Pres.
LORI REILLY —
RICHARD SMITH —
HEATHER STRAWN —
MATTHEW L SULKALA —
BILLY TAUZIN —
STEVE TILTON —
JENNIFER VAN METER —
MICHAEL PAUL WOODY Professional Staff - Senate HELP Committee

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

Bills named: H.R. 1706 (111th), H.R. 1260 (111th), H.R. 1427 (111th), H.R. 1548 (111th), S. 369 (111th), S. 726 (111th), S. 610 (111th), S. 299 (111th), S. 515 (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.