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

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. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions 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: Provisions 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 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.2002, Online Pharmacy Safety Act: Provisions 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: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

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

Bills named: H.R. 2227 (112th), S. 2113 (112th), H.R. 2674 (112th), S. 2002 (112th), H.R. 4095 (112th), H.R. 3839 (112th), H.R. 4132 (112th), S. 1584 (112th), H.R. 4156 (112th), H.R. 3204 (112th), S. 1699 (112th), H.R. 4274 (112th), H.R. 2245 (112th), H.R. 4223 (112th), H.R. 1483 (112th), S. 2281 (112th), H.R. 3214 (112th), S. 1002 (112th), S. 2236 (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. 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: All provisions including Medicare Part B and 340B Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking: Provisions related to the AMP calculation, definition of line extension, and extension of the rebate to the territories Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking: Provisions related to implementation of the Sunshine reporting provisions of the Affordable Care Act Dual eligibles coordination policy issues

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

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

Budget/Appropriations BUD

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013: FDA related provisions (no bill number) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013: HHS related provisions (no bill number) FY 2013 Budget Resolution: Health related provisions

Contacted: Executive Office of the President (EOP); Treasury, Dept of; Patent & Trademark Office (PTO); White House Office; Natl Security Council (NSC); Commerce, Dept of (DOC); SENATE; Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); State, Dept of (DOS); U.S. Trade Representative (USTR); 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: 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. 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 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 S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues

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

Bills named: S. 27 (112th), S. 1882 (112th), H.R. 3995 (112th), S. 1886 (112th), H.R. 741 (112th), H.R. 3261 (112th), H.R. 2182 (112th), S. 373 (112th), H.R. 3468 (112th), S. 968 (112th), S. 1734 (112th), H.R. 3497 (112th)