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

Copyright/Patent/Trademark CPT

H.R. 243, Patent Lawsuit Reform Act of 2011: false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generics H.R. 1056, Patent Continuing Disclosure Act: false patent marking H.R. 1249, America Invents Act: reforms of the patent laws S. 23, America Invents Act: reforms of the patent laws and other provisions S. 27, Preserve Access to Affordable Generics Act: patent settlements S. 373, Fair Prescription Drug Competition Act: authorized generics International intellectual property issues Biopharmaceutical innovation policy issues

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

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

Health Issues HCR

H.R. 1065, Pill Mill Crackdown Act of 2011: prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: prescription drug abuse S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: FDA and product liability issues S. 296, Preserving Access to Life-Saving Medications Act: prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: prescription drug abuse Health care reform implementation issues including health reform fee and essential benefits General FDA advocacy Biopharmaceutical innovation policy issues

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

Bills named: H.R. 1065 (112th), H.R. 1266 (112th), S. 507 (112th), S. 296 (112th), S. 319 (112th), S. 218 (112th)

Medicare/Medicaid MMM

H.R. 452, Medicare Decisions Accountability Act of 2011: Independent Payment Advisory Board (IPAB) H.R. 675 Strengthening Medicare Anti-Fraud Measures Act of 2011: exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 31, Prescription Drug and Health Improvement Act of 2011: Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Part D issues S. 668, Health Care Bureaucrats Elimination Act: Independent Payment Advisory Board (IPAB) Medicaid rebate issues

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

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

Budget/Appropriations BUD

H.R. 1, Full-Year Continuing Appropriations Act, 2011: FDA funding and related matters FY 2012 Budget Resolution: Budget for Federal agencies and programs and related authorizations and tax proposals

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

Bills named: H.R. 1 (112th)

Trade (domestic/foreign) TRD

Korea Free Trade Agreement: intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP): intellectual property issues Special 301 submission issues Preference Program Reform International market access and intellectual property issues Biopharmaceutical innovation policy issues

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