2nd Quarter - Report

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

Firm
Client
Income
—
Expenses
$4,840,000
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.

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 Issues related to Special 301 and National Trade Estimate (NTE) submissions Preference Programs International market access and intellectual property issues Biopharmaceutical innovation policy issues

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

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

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. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration 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. 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. 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. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting 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

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

Bills named: S. 1002 (112th), H.R. 3839 (112th), H.R. 4095 (112th), H.R. 4274 (112th), H.R. 3204 (112th), S. 2113 (112th), H.R. 4223 (112th), S. 1584 (112th), H.R. 5651 (112th), S. 296 (112th), S. 1886 (112th), H.R. 3214 (112th), S. 3187 (112th), H.R. 4132 (112th), S. 2002 (112th), H.R. 3261 (112th), H.R. 3468 (112th), H.R. 1483 (112th), H.R. 4332 (112th), S. 2236 (112th), H.R. 4156 (112th), H.R. 2674 (112th), H.R. 2245 (112th), H.R. 2227 (112th), S. 1699 (112th), S. 2281 (112th)

Medicare/Medicaid MMM

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 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

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

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

Budget/Appropriations BUD

H.R. 4966, Sequester Replacement Act of 2012: Provisions related to overall healthcare related funding, government functions, and Medicare policy changes H.R. 5652, Sequester Replacement Reconciliation Act of 2012: Provisions related to overall healthcare related funding, government functions, and Medicare policy change H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013: FDA related provisions H. 5326, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2013: Provisions related to prescription drug abuse H. 5855, Department of Homeland Security Appropriations Act, 2013: Provisions related to Customs and Border Patrol funding and regulatory riders S. 2323, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2013: Provisions related to prescription drug abuse S. 2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013: FDA related provisions S. 3216, Department of Homeland Security Appropriations Act, 2013: Provisions related to Customs and Border Patrol funding and regulatory riders Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013: HHS related provisions [no bill number]

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

Bills named: S. 3216 (112th), S. 2323 (112th), S. 2375 (112th), H.R. 4966 (112th), H.R. 5973 (112th), H.R. 5652 (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. 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 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

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

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