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

Trade (domestic/foreign) TRD

Korea Free Trade Agreement: Provisions 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 Russia Permanent Normal Trade Relations (PNTR) 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: Centers For Medicare and Medicaid Services (CMS); Treasury, Dept of; Natl Security Council (NSC); State, Dept of (DOS); Food & Drug Administration (FDA); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); White House Office; Executive Office of the President (EOP); SENATE; Health & Human Services, Dept of (HHS)

Copyright/Patent/Trademark CPT

H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision 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 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. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues

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

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

Health Issues HCR

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages 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. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Best Pharmaceuticals for Children Act (BPCA) reauthorization Pediatric Research Equity Act (PREA) reauthorization Health care reform implementation issues General HHS and FDA related advocacy Prescription Drug User Fee Act (PDUFA) reauthorization Anti-counterfeiting and supply chain issues Biopharmaceutical innovation policy issues

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

Bills named: S. 2672 (112th), H.R. 1483 (112th), S. 1699 (112th), H.R. 2245 (112th), S. 1584 (112th), S. 296 (112th)

Medicare/Medicaid MMM

H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues 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. 2248 Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues H.R. 3765, Temporary Payroll Tax Cut Continuation Act of 2011: Provisions related to Medicare S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues 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 and drug rebates Advocacy on Medicare/Medicaid issues being considered by the Joint Select Committee on Deficit Reduction

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

Bills named: S. 560 (112th), H.R. 3765 (112th), S. 365 (112th), S. 1251 (112th), H.R. 2190 (112th), S. 1206 (112th), H.R. 2248 (112th), H.R. 999 (112th), H.R. 675 (112th), S. 668 (112th), H.R. 452 (112th), S. 44 (112th), S. 1699 (112th), S. 31 (112th)

Budget/Appropriations BUD

H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2055, Consolidated Appropriations Act, 2012: Provisions relating to health and trade H.R. 2608, Continuing Appropriations Act, 2012: FDA funding and related provisions H.R. 3671, Consolidated Appropriations Act, 2012: Provisions relating to health and trade S. 1599, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2012: HHS related provisions H.J. RES. 79, Continuing Appropriations Resolutions, 2012

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

Bills named: H.R. 2055 (112th), H.R. 2112 (112th), H.J.Res. 79 (112th), H.R. 2608 (112th), S. 1599 (112th), H.R. 2017 (112th), H.R. 3671 (112th)