Pathway for Biosimilars Act

Issues related to healthcare reform implementation: Health Information Technology; ARRA Privacy and Security Rules; Generic Biologics; Importation of Prescription Drugs; Competitive Bidding; Home Infusion; Chronic Care Management; anit-PBM legislation, including disclosure of pricing and contracting information; healthcare delivery systems reforms, and cost containment. H.R. 1 - American Recovery and Reinvestment Act of 2009; Title VIII Department of Labor, Health and Human Services, and Education and related agencies; Healthcare Research and Qualtiy and Title XIII - Helath Information Technology for Exonomic and Clinical Helaht Act or the HITECT Act; all sections. HR 1321 and S 391 - Health Americans Act, all sections HR 1548 - Pathway for Biosimiars Act, all sections HR 3200 - America's Affordable Health Choices Act; all sections Public Law 111-148 - Patient Protection and Affordable Care Act; all sections (formerly HR 3500, H Con Res. 254, S 1790) Public Law 111-152 - Helath Care and Education Reconciliation Act of 2010, all health sections (formerly HR 4872 and S. Con Res. 13) HR 979 - The FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act; all sections HR 1041 - Fairness in Medicare Bidding Act (FIMBA); Section 2 HR 5 - Help Efficient, Accessible, Low Cost, Timely Healthcare Act of 2011, all sections

Client expense: $1,080,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Personnel Management (OPM), Postal Rate Commission, Postal Regulatory Commission, SENATE, U.S. Postal Service (USPS)

S 301 - Physician Payments Sunshine Act of 2009 HR 1191/S 1336 - Safe Drug Disposal Act of 2009 HR 1260/S 515 & 610 - Patent Reform Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1359/S 1292 - Secure and Responsible Drug Disposal Act of 2009 HR 1427/S 726 - Promoting Innovation and Access to Life-Saving Medicine Act HR 1548 - Pathway for Biosimilars Act HR 1706/S 369 - Protecting Consumer Access to Generic Drugs Act of 2009/Preserve Access to Affordable Generics Act of 2009 HR 3200/S 1796 - America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 HR 3590 - Patient Protection and Affordable Care Act HR 3962 - Affordable Health Care for America Act HR 4872 - Health Care and Education Reconciliation Act of 2010 HR 4956 - Stop Oxy Abuse Act of 2010 HR 756 - National Pain Care Policy Act of 2009 HR 5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 HR 5809/S 3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 HR 6165/S 4018 - Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S 301 - Physician Payments Sunshine Act of 2009 HR 1191/S 1336 - Safe Drug Disposal Act of 2009 HR 1260/S 515 & 610 - Patent Reform Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1359/S 1292 - Secure and Responsible Drug Disposal Act of 2009 HR 1427/S 726 - Promoting Innovation and Access to Life-Saving Medicine Act HR 1548 - Pathway for Biosimilars Act HR 1706/S 369 - Protecting Consumer Access to Generic Drugs Act of 2009/Preserve Access to Affordable Generics Act of 2009 HR 3200/S 1796 - America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 HR 3590 - Patient Protection and Affordable Care Act HR 3962 - Affordable Health Care for America Act HR 4872 - Health Care and Education Reconciliation Act of 2010 HR 4956 - Stop Oxy Abuse Act of 2010 HR 756 - National Pain Care Policy Act of 2009 HR 5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 HR 5809/S 3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 HR 6165/S 4018 - Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S 301 - Physician Payments Sunshine Act of 2009 HR 1191/S 1336 - Safe Drug Disposal Act of 2009 HR 1260/S 515 & 610 - Patent Reform Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1359/S 1292 - Secure and Responsible Drug Disposal Act of 2009 HR 1427/S 726 - Promoting Innovation and Access to Life-Saving Medicine Act HR 1548 - Pathway for Biosimilars Act HR 1706/S 369 - Protecting Consumer Access to Generic Drugs Act of 2009/Preserve Access to Affordable Generics Act of 2009 HR 3200/S 1796 - America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 HR 3590 - Patient Protection and Affordable Care Act HR 3962 - Affordable Health Care for America Act HR 4872 - Health Care and Education Reconciliation Act of 2010 HR 4956 - Stop Oxy Abuse Act of 2010 HR 756 - National Pain Care Policy Act of 2009 HR 5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 HR 5809/S 3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 HR 6165/S 4018 - Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S 301 - Physician Payments Sunshine Act of 2009 HR 1191/S 1336 - Safe Drug Disposal Act of 2009 HR 1260/S 515 & 610 - Patent Reform Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1359/S 1292 - Secure and Responsible Drug Disposal Act of 2009 HR 1427/S 726 - Promoting Innovation and Access to Life-Saving Medicine Act HR 1548 - Pathway for Biosimilars Act HR 1706/S 369 - Protecting Consumer Access to Generic Drugs Act of 2009/Preserve Access to Affordable Generics Act of 2009 HR 3200/S 1796 - America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 HR 3590 - Patient Protection and Affordable Care Act HR 3962 - Affordable Health Care for America Act HR 4872 - Health Care and Education Reconciliation Act of 2010 HR 4956 - Stop Oxy Abuse Act of 2010 HR 756 - National Pain Care Policy Act of 2009 HR 5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 HR 5809/S 3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 HR 6165/S 4018 - Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 1427: Promoting Innovation and Access to Life-Saving Medicine Act HR 1548: Pathway for Biosimilars Act FY12 Labor-HHS Appropriations Bill FY12 DoD Appropriations Bill FY12 DoD FY12 L-HHS

Client expense: Not reported · Firm income: $10,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

HR 1427: Promoting Innovation and Access to Life-Saving Medicine Act HR 1548: Pathway for Biosimilars Act FY12 Labor-HHS Appropriations Bill FY12 DoD Appropriations Bill HR 1475: CR FY12 DoD FY12 L-HHS

Client expense: Not reported · Firm income: $10,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

S.27 - Preserve Access to Affordable Generics Act S.301 - Physician Payments Sunshine Act of 2009 S.319 - Pharmaceutical Market Access and Drug Safety Act of 2011 H.R.2 - Repealing the Job-Killing Health Care Law Act H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1249/S.23 - America Invents Act H.R.1260/S.515/S.610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009/Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796 - America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 - Life Sciences Jobs and Investment Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Medical Liability Reform Orphan Drugs Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $60,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.27 - Preserve Access to Affordable Generics Act S.301 - Physician Payments Sunshine Act of 2009 S.319 - Pharmaceutical Market Access and Drug Safety Act of 2011 H.R.2 - Repealing the Job-Killing Health Care Law Act H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1249/S.23 - America Invents Act H.R.1260/S.515/S.610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009/Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796 - America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 - Life Sciences Jobs and Investment Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Medical Liability Reform Orphan Drugs Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $60,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.27 - Preserve Access to Affordable Generics Act S.301 - Physician Payments Sunshine Act of 2009 S.319 - Pharmaceutical Market Access and Drug Safety Act of 2011 H.R.2 - Repealing the Job-Killing Health Care Law Act H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1249/S.23 - America Invents Act H.R.1260/S.515/S.610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009/Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796 - America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 - Life Sciences Jobs and Investment Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Medical Liability Reform Orphan Drugs Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $60,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.27 - Preserve Access to Affordable Generics Act S.301 - Physician Payments Sunshine Act of 2009 S.319 - Pharmaceutical Market Access and Drug Safety Act of 2011 H.R.2 - Repealing the Job-Killing Health Care Law Act H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1249/S.23 - America Invents Act H.R.1260/S.515/S.610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009/Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796 - America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 - Life Sciences Jobs and Investment Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Medical Liability Reform Orphan Drugs Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $60,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to Healthcare Reform Act implementation: Health Information Technology; ARRA Privacy and Security Rules; Generic Biologics; Importation of Prescription Drugs; Competitive Bidding; Home Infusion; Chronic Care Management; Anti-PBM legislation, including disclosure of pricing and contracting information; healthcare delivery system reforms; and cost containment H.R. 1 - American Recovery and Reinvestment Act of 2009; Title VIII Department of Labor, Health and Human Services, and Education, and related agencies; Healthcare Research and Quality and Title XIII - Health Information Technology for Economic and Clinical Health Act or the HITECH Act; all sections H.R. 1548 - Pathway for Biosimilars Act; all sections H.R. 3200 - America's Affordable Health Choices Act; all sections Public Law 111-148 - Patient Protection and Affordable Care Act ("Affordable Care Act"); all sections (formerly H.R. 3590, H.Con.Res. 254, S. 1790) Public Law 111-152 - Healthcare and Education Recociliation Act of 2010; all sections (formerly H.R. 4872 and S.Con.Res. 13) H.R 979 - The FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act; all sections H.R. 1041 - Fairness in Medicare Bidding Act (FIMBA); section 2 H.R. 5 - Help Efficient, Accessible, Low Cost, Timely Healthcare (HEALTH) Act of 2011; all sections

Client expense: $490,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Postal Regulatory Commission, SENATE

HR 1427: Promoting Innovation and Access to Life-Saving Medicine Act HR 1548: Pathway for Biosimilars Act FY11 Labor-HHS Appropriations Bill FY11 DoD Appropriations Bill HR 1475: CR FY12 DoD FY12 L-HHS

Client expense: Not reported · Firm income: $10,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

S.27 - Preserve Access to Affordable Generics Act S.301 - Physician Payments Sunshine Act of 2009 S.319 - Pharmaceutical Market Access and Drug Safety Act of 2011 H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1260/S.515 & 610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009 / Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796- America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 -Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.27 - Preserve Access to Affordable Generics Act S.301 - Physician Payments Sunshine Act of 2009 S.319 - Pharmaceutical Market Access and Drug Safety Act of 2011 H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1260/S.515 & 610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009 / Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796- America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 -Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.27 - Preserve Access to Affordable Generics Act S.301 - Physician Payments Sunshine Act of 2009 S.319 - Pharmaceutical Market Access and Drug Safety Act of 2011 H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1260/S.515 & 610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009 / Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796- America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 -Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.27 - Preserve Access to Affordable Generics Act S.301 - Physician Payments Sunshine Act of 2009 S.319 - Pharmaceutical Market Access and Drug Safety Act of 2011 H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1260/S.515 & 610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009 / Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796- America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 -Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to healthcare reform implementation: Health Information Technology; ARRA Privacy and Security Rules; Generic Biologics; Importation of Prescription Drugs; Competitive Bidding; Home Infusion; Chronic Care Management; anti-PBM legislation, including disclosure of pricing and contracting information; healthcare delivery system reforms, and cost containment H.R. 1 - American Recovery and Reinvestment Act of 2009; Title VIII Department of Labor, Health and Human Services, and Education, and related agencies; Healthcare Research and Quality and Title XIII - Health Information Technology for Economic and Clinical Health Act or the HITECH Act; all sections H.R. 1321 and S. 391 - Healthy Americans Act, all sections H.R. 1548 - Pathway for Biosimilars Act; all sections H.R. 3200 - America's Affordable Health Choices Act; all sections Public Law 111-148 - Patient Protection and Affordable Care Act ("Affordable Care Act"); all sections (formerly H.R. 3590, H. Con. Res. 254, S. 1790) Public Law 111-152 - Health Care and Education Reconciliation Act of 2010; all sections (formerly H.R. 4872 and S. Con. Red. 13) H.R. 979 - The FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act; all sections H.R. 1041 - Fairness in Medicare Bidding Act (FIMBA); section 2 H.R. 5 - Help Efficient, Accessible, Low Cost, Timely Healthcare (HEALTH) Act of 2011; all sections

Client expense: $1,080,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Personnel Management (OPM), Postal Rate Commission, Postal Regulatory Commission, SENATE, U.S. Postal Service (USPS)

Avastin, Lucentis,FDA Appropriations; Issues concerning clincial trials. General health care reform (Patient Protection and Affordable Care Act). Congressional oversight issues; Legislation on public health preparedness and response to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels; FDA approval and enforcement issues; Presciption Drug User Fee Act (PDUFA), Avastin -use in breast cancer treatment, dry macular degeneration; S.726/HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act; HR 1548 - Pathway for Biosimilars Act, General support for Genentech products; HR1/1473 health care funding: FY 12 Labor HHS Appropriations legislation

Client expense: $1,248,359 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1427: Promoting Innovation and Access to Life-Saving Medicine Act HR 1548: Pathway for Biosimilars Act FY11 Labor-HHS Appropriations Bill FY11 DoD Appropriations Bill FY 12 DoD FY12 L-HHS

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Establishing a regulatory approval pathway for biogeneric drugs - H.R. 1427/S726 - Promoting Innovation and Access to Life Saving Medicine Act and H.R. 1548 - Pathway for Biosimilars Act Items related to the application of drug benenfits to public plans and health exchange, including PBM disclosure in H.R. 3000, S169 - America's Health Future Act, H.R. 3962, H.R. 3950 - Patient Protection and Affordable Care Act. H.R. 4872 - Health Care and Education Reconciliation Act of 2010 H.R. 4199 - Patient Health and Real Medication Access Cost Savings Act of 2009 H.R. 4813 - To provide for insurance reform (including health insurance reform) amend Title XVIII of the Social Security Act to reform medicare Advantage and reduce disparities in the Medicare Program, regulate the importation of prescription drugs, and for other purposes. H.R. 4489 - FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act

Client expense: $525,828 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Election Commission (FEC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA

Client expense: $1,000,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

S 1796, S 1679, HR 3962, HR 3590 (Health Care Reform). HR 1204 (Antitrust exemption for pharmacists) HR 1493 (Antitrust exemption for physicians) HR 1 (COBRA coverage subsidy; comparative effectiveness, wellness, HIT). HR 1427/S 726/ HR 1548 (FDA PAthway to approve generic Biopharmaceutical medicines). S. 369/HR 1706 (Generic/brand settlements). S. 93 (establish FEHBP for small employers) S. 391/H.R. 1321 (National health) H.R. 676/S. 703 (single payer); PL 111-148; PL 111-152.

Client expense: $1,641,400 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

Approval and regulation of biosimilars (H.R. 1427; H.R. 1548; S. 726; H.R. 3200; S. 1679; H.R. 4872)

Client expense: $3,220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

S. 515- Patent Reform Act of 2009. A bill to amend title 35, United States Code, to provide for patent reform. Our interest is all sections of the bill with specific attention to sections addressing damages, first to file, reexamination proceedings, fees and post-grant review. H.R.1260 Patent Reform Act of 2009. To amend title 35, United States Code, to provide for patent reform. Our interest is all sections of the bill with specific attention to sections addressing damages, first to file, reexamination proceedings, fees and post-grant review. S.726 / HR 1427. A bill to amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes. Our interest is all sections of the bill. HR 1548. A bill to amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. Our interest is all sections of bills.

Client expense: $51,766 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA

Client expense: $1,000,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Labor HHS appropriations stock piling anti-virals for pandemic influenza; Cancer Research Issues - S.3686/HR_, Labor, HHS Appropriations Bill for FY2011; Monitoring the implementation for the Patient Protection and Affordable Care Act, including provisions related to comparative effectiveness research and a regulatory pathway for biosimilars; H.R.1 - Pandemic influenza funding: H.R.1105 Omnibus Appropriations Act of 2010, Food Safety Bill, H.R. 4872 Health Care& Education Reconciliation Act of 2011; issues concerning clincial trials; general health care reform (Patient Protection and Affordable Care Act); Congressional oversight issues; FDA approval and enforcement issues; Pandemic preparedness; Tamiflu; Avastin-breast cancer; following all issues related to health care reform; S.726/HR 1427 - promotiong innovation and access to life-saving Medicine Act; HR 1548 - Pathway for Biosimilars Act; General support for Genentech products; monitor and report on issues relate to implementation to health care reform; H.R. 1548 - Pathway for Biosimilars Act

Client expense: $1,242,641 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare issues; payment policies for prescription drugs; implementation of H.R.1; Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus; physician payment disclosure including S.301; Physician Payments Sunshine Act of 2009; HR 3962, Affordable Health Care for Americans Act; HR 3590, Patient Protection and Affordable Care Act; H.R.4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S726/H.R. 1427 Promoting innovation and access to Life Savings Medicines Act; HR 3962, Affordable Health Care for America Act; Compartiveffectiveness legislation S. 1213; Patient-Centered Outcomes Research Act of 2009; HR 3200, America's Health Future Act; H.R. 1548-Pathway for Dissimilar Act; Legislative changes in health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act", Affordable Health Choice Act; American Health Future Act of 2009; Pharmaceutical Import Safety legislation.

Client expense: $1,242,641 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.301 - Physician Payments Sunshine Act of 2009 H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1260/S.515 & 610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009 / Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796- America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 -Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.301 - Physician Payments Sunshine Act of 2009 H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1260/S.515 & 610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009 / Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796- America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 -Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.301 - Physician Payments Sunshine Act of 2009 H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1260/S.515 & 610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009 / Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796- America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 -Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.301 - Physician Payments Sunshine Act of 2009 H.R.1191/S.1336 - Safe Drug Disposal Act of 2009 H.R.1260/S.515 & 610 - Patent Reform Act of 2009 H.R.1298/S.525 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.1359/S.1292 - Secure and Responsible Drug Disposal Act of 2009 H.R.1427/S.726 - Promoting Innovation and Access to Life-Saving Medicine Act H.R.1548 - Pathway for Biosimilars Act H.R.1706/S.369 - Protecting Consumer Access to Generic Drugs Act of 2009 / Preserve Access to Affordable Generics Act of 2009 H.R.3200/S.1796- America's Affordable Health Choices Act of 2009 / America's Healthy Future Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act H.R.3962 - Affordable Health Care for America Act H.R.4872 - Health Care and Education Reconciliation Act of 2010 H.R.4956 - Stop Oxy Abuse Act of 2010 H.R.756/S.660 - National Pain Care Policy Act of 2009 H.R.5712 - Veterans', Seniors', and Children's Health Technical Corrections Act of 2010 H.R.5809/S.3397 - Safe Drug Disposal/Secure and Responsible Drug Disposal Act of 2010 H.R.6165/S.4018 -Life Sciences Jobs and Investment Act of 2010 Anti- counterfeiting legislation concerning drugs (pedigree) Biosimilar Drugs Disposal of Drugs Drug Reimportation Healthcare Reform Hearings related to prescription drug abuse and prevention Life sciences research tax credit legislation Patent Settlements Pedigree Legislation Prescription Drug User Fee Act reauthorization RiskEvaluation and MitigationStrategies for controlled substances Tax on pharmaceutical companies (Senate Finance Committee draft of health care reform)

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 1548 - Pathway for Biosimilars Act Oppose Physician-Owned Hospital restrictions in H.R. 3200, H.R. 3962, H.R. 3590, and all health care reform measures H.R. 756/ S.660 - Support National Pain Care Policy Act of 2009 Oppose use of comparative effectiveness research to determine health care coverage or reimbursement decisions Support Health IT funding and standards Support Hagen/Enzi/Hatch Amendment to S. 325 Support HR 1894 and S. 769 Support Eshoo/Barton Amendment on biosimilars (to H.R. 3200) in House Energy and Commerce Committee Support increased Osteoporosis screening funds in health care reform bills Support request for House Oversight Committee hearings on prostate cancer, additional efforts to screen for and treat Oppose the establishment of a "Super MedPAC" Commission empowered to cut Medicare payments and benefits Oppose the Medicare cuts included in H.R. 3200, H.R. 3962, H.R. 3590, and all health care reform measures Oppose Senate Amendment 2793 Support McCain Motion to Recommit H.R. 3590 with instructions to remove all Medicare cuts Support Senate Amendment 2942 Support H.R. 3790 Support H.R. 2115 Support patient-centered comparative effectiveness research language passed by the Senate in H.R. 3590 Support 340B Federal Drug Discount Program purchasing provisions passed by the House and Senate in H.R. 3590 Oppose all efforts to shorten the 12-year exclusivity period provided (in both the House and Senate health care reform bills) for the original biologic drug as it pertains to a safe pathway for biosimilar "follow-on" drugs Support "Specialty Tier" pricing relief in Medicare Part D Drug Plans and in CMS rulemaking regarding those plans. Support increased funding to address the growing national burden of arthritis, including intervention and prevention plans. Support Efforts to Eliminate "Lifetime Caps" on health insurance benefits. Support Part D Medicare Coverage Gap Discount Program "draft guidance" to improve the program for beneficiaries. Oppose Recess Appointment of Dr. Donald Berwick as CMS Administrator. Support expanded screening for Osteoporosis for both women and men under new coverage rules. Support nomination of Peter Pitts for the Patient-Centered Outcomes Research Institute Board of Governors. Support Medicare reimbursement for Provenge to treat prostate cancer. Support the most stringent and rigorous testing of biosimilars that would or could be used as replacements for the original, innovator biologic drugs. Support the Council for American Medical Innovation comments to The National Commission on Fiscal Responsibility and Reform regarding the continuing need for spending to promote medical innovation to save lives and money. Support the Partnership to Fight Chronic Disease response to the Agency for Healthcare Research and Quality request for feedback on the National Quality Strategy and Plan development in regards to the Affordable Care Act.

Client expense: $76,368 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, White House Office

Issues related to comprehensive health care reform: Health Information Technology; ARRA Privacy and Security Rules; Generic Biologics; Comparative Effectiveness; Importation of Prescription Drugs; Competitive Bidding; Chronic Care Management; Healthcare Reform; and Healthcare Implementation H.R. 1 - American Recovery and Reinvestment Act of 2009; Title VIII Department of Labor, Health and Human Services, and Education, and related agencies; Healthcare Research and Quality and Title XIII - Health Information Technology for Economic and Clinical Health Act or the HITECH Act; all sections H.R. 1321 and S. 391 - Healthy Americans Act; all sections H.R. 1427 and S. 726 - Promoting Innovation and Access to Life-Saving Medicine Act; all sections H.R. 1548- Pathway for Biosimilars Act; all sections H.R. 3200 - America's Affordable Health Choices Act; all sections H.R. 3596 - Health Insurance Industry Antitrust Enforcement Act of 2009; all sections H.R. 3962 - Affordable Healthcare for America Act; all sections Public Law 111-148 - Patient Protection and Affordable Care Act; all sections (formerly H.R. 3590) H.R. 4199 - Patient Health and Real Medication Access Cost Savings Act; all sections Public Law 111-152 - Health Care and Education Reconciliation Act of 2010; all sections (formerly H.R. 4872 and S. Con. Res. 13) H.R. 4489 - The FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act of 2010; all sections H.R. 5235 - The Medicare Access to Diabetes Supplies Act; all sections H.R. 3790 - To Amend Title XVIII of the Social Security Act to repeal the Medicare Competitive Acquisition program for durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS); all sections Public Law 104-191 - Health Insurance Portability and Accountability Act (HIPAA); Title II H.R. 5440 - Genomics and Personalized Medicine Act of 2010; all sections

Client expense: $470,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Personnel Management (OPM), Postal Rate Commission, Postal Regulatory Commission, SENATE, U.S. Postal Service (USPS)

Patient Protection and Innovative Biologic Medicines Act of 2009 H.R. 1427and H.R. 1548 Affordable Biologics for Consumers H.R. 3200, health care reform legislation

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent reform; Medicare Part-D non-interference legislation; Medicaid rebates; Follow-on biologics (H.R. 1427; H.R. 1548); implementation of health care reform

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S. 515 Patent Reform Act of 2009. A bill to amend title 35, United States Code, to provide for patent reform. Our interest is all sections of the bill with specific attention to sections addressing damages, first to file, reexamination proceedings, fees and post-grant review. H.R.1260 Patent Reform Act of 2009. To amend title 35, United States Code, to provide for patent reform. Our interest is all sections of the bill with specific attention to sections addressing damages, first to file, reexamination proceedings, fees and post-grant review. S.726 / HR 1427. A bill to amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes. Our interest is all sections of the bill. HR 1548. A bill to amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. Our interest is all sections of bills.

Client expense: $54,202 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Physician payment disclosure including S. 301; Physician Payments Sunshine Act of 2009; H.R. 3962, Affordable Health Care for Americans Act; H.R. 3590, Patient Protection and Affordable Care Act; H.R. 4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S. 726/H.R. 1427, Promoting Innovation and Access to Life Savings Medicines Act; H.R. 3962, Affordable Health Care for America Act; Comparative effectiveness legislation including S. 1213; Patient-Centered Outcomes Research Act of 2009; H.R. 3200, America's Health Future Act; H.R. 1548- Pathway for Dissimilar Act; Legislative changes in the health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act."; S. 1679, Affordable Health Choice Act; S. 1796, America's Healthy Future Act of 2009; Pharmaceutical import safety legislation.

Client expense: Not reported · Firm income: $60,000

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

**see addendum page Biosimilars S. 726/H.R. 1427 Access to Life-Saving Medicine Act, Follow-on Biologics H.R. 1548 The Pathway for Biosimilars Act PL 111-148 The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation, Medicare and Medicaid reimbursement, Medicaid rebate, biosimilars, 340B, comparative effectiveness research, disclosure S. 301/H.R. 3138 - Physician Payments Sunshine Act of 2009, disclosure ***, no specific bill(s), health care reform, stem cell research

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1260, S 515, Patent Reform Act, damages provision for copyright or patent infringement and post-patent challenges HR 1548, Pathway for Biosimilars Act, extension of patent protection for follow-on biologics to 12 years, included in HR 3590, The Patient Protection and Affordable Care Act

Client expense: $110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Provisions of legislations dealing with Follow on Biologics Implimentation of Public Law No: 111-148 (formerly HR3590): Patient Protection and Affordable Care Act, H.R.4872: Health Care and Education Reconciliation Act of 2010 H.R. 1427, S726: Promoting Innovation and Access to Life-Saving Medicine Act - regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics; issues related to importation of pharmaceutical products from foreign countries.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Labor HHS appropriations stock piling anti-virals for pandemic influenza; Cancer Research Issues - S.3686/HR__, Labor, HHS Appropriations Bill for FY2011; Monitoring the implementation of the Patient Protection and Affordable Care Act, including provisions related to comparative effectiveness research and a regulatory pathway for biosimilars; H.R.1 - Pandemic influenza funding: H.R. 1105 Omnibus Appropriations Act of 2010, Food Safety Bill, H.R. 4872 Health Care & Education Reconciliation Act of 2010; issues concerning clincial trials; general health care refore (Patient Protection and Affordable Care Act); Congressional oversight issues; FDA approval and enforcement issues; Pandemic preparedness; Tamiflu; Avastin-breast cancer ; following all issues related to health care reform; S.726/HR 1427 - promoting innovation and access to life-saving Medicine Act; HR 1548 - Pathway for Biosimilars Act; General support for Genentech products; monitor and report on issues related to the implementation of health care reform; H.R. 1548 - Pathway for Biosimilars Act;

Client expense: $1,242,641 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare issues; payment policies for prescription drugs; implementation of H.R. 1; Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus; physician payment disclosure including S.301; Physician Payments Sunshine Act of 2009; HR 3962, Affordable Health Care for Americans Act; HR 3590, Patitient Protection and Affordable Care Act; H.R> 4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S. 726/H.R.1427, Promoting innovation and access to Life Savings Medicines Act; HR 3962, Affordable Health Care for America Act; Comparativ effectiveness legislation S. 1213; Patient-Centered Outcomes Research Act of 2009; HR 3200, America's Health Future Act; H.R. 1548-Pathway for Dissimilar Act; Legislative changes in health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act", Affordable Health Choice Act;, American Health Future Act of 2009; Pharmaceutical Import safety legislation.

Client expense: $1,242,641 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page S. 1213 - Patient-Centered Outcomes Research Act of 2009, comparative effectiveness Biosimilars S. 726/H.R. 1427 Access to Life-Saving Medicine Act, Follow-on Biologics H.R. 1548 The Pathway for Biosimilars Act Health care reform, drug importation, 340b, biosimilars PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE