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

Copyright/Patent/Trademark CPT

H.R. 243, Patent Lawsuit Reform Act of 2011: Provisions related to false patent marking 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. 1056, Patent Continuing Disclosure Act: Provisions related to false patent marking H.R. 1249, America Invents Act: Provisions related to patent reform H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 23, America Invents Act: Provisions related to patent reform 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 International intellectual property issues Biopharmaceutical innovation policy issues

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

Bills named: H.R. 1056 (112th), H.R. 1249 (112th), H.R. 243 (112th), H.R. 2182 (112th), S. 27 (112th), S. 23 (112th), S. 373 (112th), H.R. 741 (112th)

Health Issues HCR

H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse Health care reform implementation issues, including health reform fee and essential benefits General FDA advocacy User fee reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues

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

Bills named: S. 296 (112th), H.R. 2182 (112th), H.R. 1065 (112th), H.R. 1266 (112th), H.R. 2119 (112th), S. 319 (112th), S. 218 (112th), H.R. 5 (112th), S. 507 (112th), H.R. 2245 (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 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. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues 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

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

Bills named: S. 1206 (112th), S. 560 (112th), S. 454 (112th), S. 31 (112th), H.R. 452 (112th), H.R. 675 (112th), H.R. 2190 (112th), H.R. 2248 (112th), S. 668 (112th), H.R. 999 (112th), S. 44 (112th)

Budget/Appropriations BUD

H.R. 1, Full-Year Continuing Appropriations Act, 2011: Provisions relating to FDA, BARDA, Patents, USTR and NIH H.R. 1473, Department of Defense and Full-Year Continuing Appropriations Act, 2011: Provisions relating to FDA, BARDA, Patents, USTR and NIH 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. 2219, Department of Defense Appropriations Act, 2012: Provisions relating to various health accounts FY 2012 Budget Resolution: Budget for Federal agencies and programs and related authorizations and tax proposals

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

Bills named: H.R. 2219 (112th), H.R. 2112 (112th), H.R. 2017 (112th), H.R. 1 (112th), H.R. 1473 (112th)