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

Trade (domestic/foreign) TRD

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 Partnership (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 negotiationsTurkey Market Access Issues India innovation and market access issues Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other 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: Commerce, Dept of (DOC); State, Dept of (DOS); Federal Trade Commission (FTC); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Executive Office of the President (EOP); U.S. Trade Representative (USTR); White House Office; Natl Security Council (NSC); Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES; SENATE; Medicare Payment Advisory Commission (MedPAC)

Copyright/Patent/Trademark CPT

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions relating to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation S. 214, The Preserve Access to Affordable Generics Act: Provisions related to patent settlementsS. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements Patents for Humanity Program Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

Contacted: State, Dept of (DOS); Federal Trade Commission (FTC); Patent & Trademark Office (PTO); Medicare Payment Advisory Commission (MedPAC); HOUSE OF REPRESENTATIVES; Executive Office of the President (EOP); SENATE; U.S. Trade Representative (USTR); White House Office; Food & Drug Administration (FDA); Commerce, Dept of (DOC); Health & Human Services, Dept of (HHS); Natl Security Council (NSC)

Bills named: S. 214 (113th), H.R. 845 (113th), H.R. 22 (113th)

Health Issues HCR

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products (112th Congress)H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients (112th Congress) H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages (112th Congress) S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA Accelerated Approval policy issues Unapproved Use/Off-label policy issues 340B policy issues

Contacted: Natl Security Council (NSC); State, Dept of (DOS); White House Office; Patent & Trademark Office (PTO); Federal Trade Commission (FTC); Commerce, Dept of (DOC); SENATE; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); U.S. Trade Representative (USTR); Medicare Payment Advisory Commission (MedPAC); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES

Bills named: H.R. 6342 (113th), H.R. 6288 (113th), H.R. 1263 (113th), H.R. 6584 (113th), S. 1699 (113th), S. 296 (113th), S. 264 (113th), H.R. 2674 (113th), S. 3187 (113th)

Budget/Appropriations BUD

H.Con.Res. 25, FY 2014 Budget Resolution H.Con.Res.112, House Budget Resolution: Provisions relating to Part D, funding for all government agencies (FDA, HHS, PTO Homeland Security, DOD, USTR)H.J.Res.117, Continuing Appropriations Act: Provisions related sequester implementation, FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting H. 933, Consolidated and Further Continuing Appropriations Act, 2013: Provisions related sequester implementation, FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting S.Con.Res. 8, FY 2014 Budget Resolution

Contacted: Commerce, Dept of (DOC); Federal Trade Commission (FTC); Health & Human Services, Dept of (HHS); Executive Office of the President (EOP); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; SENATE; Natl Security Council (NSC); Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); State, Dept of (DOS); White House Office; Medicare Payment Advisory Commission (MedPAC)

Bills named: S.Con.Res. 8 (113th), H.Con.Res. 112 (113th), H.Con.Res. 25 (113th), H.J.Res. 117 (113th)

Medicare/Medicaid MMM

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013 H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 2190, Medicare Drug Savings Act of 2011: Provisions related to Part D issues (112th Congress)H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier (112th Congress) S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 S. 351, Protecting Seniors Access to Medicare Act of 2012 S. 408, Medicare Prescription Drug Savings and Choice Act of 2013 Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

Contacted: Commerce, Dept of (DOC); White House Office; U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Natl Security Council (NSC); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; State, Dept of (DOS); Food & Drug Administration (FDA); SENATE; Medicare Payment Advisory Commission (MedPAC); Health & Human Services, Dept of (HHS); Federal Trade Commission (FTC)

Bills named: H.R. 4209 (113th), H.R. 2190 (113th), S. 408 (113th), H.R. 351 (113th), S. 117 (113th), S. 351 (113th), H.R. 8 (113th), H.R. 928 (113th)