3rd Quarter - Report

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

Period 3rd Quarter 2012 Filed Oct 22, 2012 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
$4,140,000
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.

Health Issues HCR

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

LobbyistCovered position, as disclosed
MICHAEL ANWAY —
MAYA BERMINGHAM —
RANDY BURKHOLDER —
JOHN J CASTELLANI —
CHESTER (CHIP) DAVIS —
ANDREA JEAN DOUGLAS —
LEO FARBER —
ROBERT FILIPPONE —
LEA FISHER —
JEFFREY FRANCER —
SASCHA HAVERFIELD-GROSS —
VALERIE HARDIN JEWETT —
DAVID KORN —
KIMBERLY LOVE —
COLLEEN MALONEY —
KENDRA MARTELLO —
CARA MOON —
ANNE PRITCHETT —
LORI REILLY —
JENNIFER ROMANS —
RICHARD SMITH —
JAMES M SPEARS —
MATTHEW L SULKALA —

Contacted: Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); White House Office; Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS); Congressional Budget Office (CBO); Commerce, Dept of (DOC); Natl Economic Council (NEC); SENATE; Office of Management & Budget (OMB); Natl Security Council (NSC); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Treasury, Dept of; State, Dept of (DOS); Health & Human Services, Dept of (HHS)

Bills named: S. 1584 (112th), H.R. 3839 (112th), S. 1002 (112th), H.R. 2674 (112th), S. 3187 (112th), H.R. 2245 (112th), H.R. 2227 (112th), S. 2113 (112th), H.R. 4223 (112th), S. 1699 (112th), H.R. 4274 (112th), S. 2281 (112th), S. 2236 (112th), S. 2002 (112th), H.R. 4156 (112th), H.R. 4332 (112th), H.R. 1483 (112th), H.R. 4095 (112th), S. 810 (112th), S. 296 (112th), H.R. 5651 (112th), H.R. 4132 (112th)

Medicare/Medicaid MMM

H.R. 5, Protecting Access to Healthcare Act: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B, 340B, least costly alternative, and other provisions Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

LobbyistCovered position, as disclosed
MICHAEL ANWAY —
MAYA BERMINGHAM —
RANDY BURKHOLDER —
JOHN J CASTELLANI —
CHESTER (CHIP) DAVIS —
ANDREA JEAN DOUGLAS —
ROBERT FILIPPONE —
LEA FISHER —
VALERIE HARDIN JEWETT —
ANN KAPLAN —
KIMBERLY LOVE —
COLLEEN MALONEY —
KENDRA MARTELLO —
CARA MOON —
LORI REILLY —
JENNIFER ROMANS —
RICHARD SMITH —
JAMES M SPEARS —
MATTHEW L SULKALA —

Contacted: Food & Drug Administration (FDA); Commerce, Dept of (DOC); Centers For Medicare and Medicaid Services (CMS); State, Dept of (DOS); U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); Natl Security Council (NSC); Treasury, Dept of; Office of Management & Budget (OMB); SENATE; Congressional Budget Office (CBO); Patent & Trademark Office (PTO); White House Office; HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); Executive Office of the President (EOP)

Bills named: H.R. 2190 (112th), S. 668 (112th), H.R. 5 (112th), S. 1251 (112th), S. 1206 (112th), H.R. 999 (112th), H.R. 4209 (112th), S. 1699 (112th), H.R. 452 (112th), S. 365 (112th)

Budget/Appropriations BUD

H.R. 2693, Budget Control Act of 2011: Sequestration implementation H.R. 5856, Department of Defense Appropriations Act, 2013: Provisions related to defense health accounts, biodefense funding/projects, and defense contracting H.J.Res. 117, Continuing Appropriations Resolution, 2013 FY 2013 Labor, Health and Human Services, and Education Appropriations bill [no bill number]: Provisions related to comparative effectiveness research, NIH funding, BARDA funding, ACA implementation funding, 340B, IPAB

LobbyistCovered position, as disclosed
MICHAEL ANWAY —
MAYA BERMINGHAM —
RANDY BURKHOLDER —
JOHN J CASTELLANI —
CHESTER (CHIP) DAVIS —
ANDREA JEAN DOUGLAS —
ROBERT FILIPPONE —
LEA FISHER —
VALERIE HARDIN JEWETT —
KIMBERLY LOVE —
COLLEEN MALONEY —
CARA MOON —
LORI REILLY —
JENNIFER ROMANS —
RICHARD SMITH —
JAMES M SPEARS —
MATTHEW L SULKALA —

Contacted: White House Office; SENATE; Commerce, Dept of (DOC); State, Dept of (DOS); Executive Office of the President (EOP); Congressional Budget Office (CBO); Treasury, Dept of; Natl Security Council (NSC); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Patent & Trademark Office (PTO); Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 5856 (112th), H.R. 2693 (112th), H.J.Res. 117 (112th)

Trade (domestic/foreign) TRD

H.R. 6083, Federal Agriculture Reform and Risk Management Act of 2012: Provisions related to WTO Brazil cotton dispute S. 3240, Agriculture Reform, Food, and Jobs Act of 2012: Provisions related to WTO Brazil cotton dispute S. 3285, A bill to authorize the extension of nondiscriminatory treatment (normal trade relations treatment) to products of the Russian Federation Intellectual Property Attache Act: Provisions related to the government intellectual property attache program [no bill number] Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Colombia Free Trade Agreement: Implementation issues related to intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): Provisions related to intellectual property, market access and public health issues Mexico and Canada IP and market access issues in context of invitation to join TPP negotiations Turkey market access issues India innovation and market access issues EU/US trade liberalizing agreement Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Biopharmaceutical innovation policy issues

LobbyistCovered position, as disclosed
MAYA BERMINGHAM —
JOHN J CASTELLANI —
CHESTER (CHIP) DAVIS —
LEO FARBER —
ROBERT FILIPPONE —
LEA FISHER —
VALERIE HARDIN JEWETT —
DAVID KORN —
CARA MOON —
ANNE PRITCHETT —
JAMES M SPEARS —

Contacted: Food & Drug Administration (FDA); U.S. Trade Representative (USTR); Natl Security Council (NSC); SENATE; White House Office; Centers For Medicare and Medicaid Services (CMS); Congressional Budget Office (CBO); Executive Office of the President (EOP); Patent & Trademark Office (PTO); Commerce, Dept of (DOC); Treasury, Dept of; Natl Economic Council (NEC); Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); State, Dept of (DOS); HOUSE OF REPRESENTATIVES

Bills named: S. 3240 (112th), H.R. 6083 (112th), S. 3285 (112th)

Copyright/Patent/Trademark CPT

H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 3486, Patent Law Treaties Implementation Act of 2012: Patent law treaties Patents for Humanity Program Improvements Act of 2012: Provisions related to transferability of PTO acceleration certificates [no bill number] Technical changes to America Invents Act [H.R. 1249 and S.23] International intellectual property issues Biopharmaceutical innovation policy issues

LobbyistCovered position, as disclosed
MICHAEL ANWAY —
JOHN J CASTELLANI —
CHESTER (CHIP) DAVIS —
LEO FARBER —
ROBERT FILIPPONE —
LEA FISHER —
DAVID KORN —
CARA MOON —
ANNE PRITCHETT —
JAMES M SPEARS —
MATTHEW L SULKALA —

Contacted: HOUSE OF REPRESENTATIVES; Natl Security Council (NSC); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Treasury, Dept of; Food & Drug Administration (FDA); White House Office; Office of Management & Budget (OMB); State, Dept of (DOS); Executive Office of the President (EOP); SENATE; Commerce, Dept of (DOC); Patent & Trademark Office (PTO); Congressional Budget Office (CBO); U.S. Trade Representative (USTR); Natl Economic Council (NEC)

Bills named: H.R. 3995 (112th), S. 3486 (112th), S. 1886 (112th), S. 968 (112th), S. 23 (112th), S. 373 (112th), H.R. 741 (112th), S. 27 (112th), H.R. 3261 (112th), H.R. 3468 (112th), H.R. 3497 (112th), S. 1734 (112th), S. 1882 (112th), H.R. 1249 (112th), H.R. 2182 (112th)

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.