Pharmaceutical Market Access and Drug Safety Act of 2009

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

Drug safety including H.R. 579, the Food and Drug Administration Globalization Act; FDA-PDUFA reauthorization. Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act; Drug company settlements including S. 369, Preserve Access to Affordable Generics Act; H.R. 1706, Protecting Consumer Access to Generic Drugs Act; and FY 2011 Financial Services and General Government Appropriations bill; Federal preemption for drugs and devices including H.R. 1346/S. 540, Medical Device Safety Act of 2009; Prescription drug advertising; Congressional oversight issues; and General health care reform (Patient Protection and Affordable Care Act).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, 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

Drug safety including H.R. 579, the Food and Drug Administration Globalization Act; FDA-PDUFA reauthorization. Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act; Drug company settlements including S. 369, Preserve Access to Affordable Generics Act; H.R. 1706, Protecting Consumer Access to Generic Drugs Act; and FY 2011 Financial Services and General Government Appropriations bill; Federal preemption for drugs and devices including H.R. 1346/S. 540, Medical Device Safety Act of 2009; Prescription drug advertising; Congressional oversight issues; and General health care reform (Patient Protection and Affordable Care Act).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Red Flags Rule; gift cards; S. 2934 - to amend the Federal Food, Drug and Cosmetic Act to ensure the safety of imported seafoodcommunication of retail industry views; H.R. 875 to establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness - communication of retail industry views; H.R. 1298 to amend the Federal Food, Drug and Cosmetic Act with respect to the importation of prescription drugs communication of retail industry views; RFID technology- privacy issues; H.R.2749, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes, provisions relating to increased penalties, reporting requirements and traceability requirements; Online behavioral advertising and related privacy issues, including draft Boucher privacy legislation and H.R. 5777, the BEST PRACTICES Act; and Federal Trade Commission reauthorization provisions considered as part ofH.R. 4173 , Wall Street Reform and Consumer Protection Act. Printed Name

Client expense: $840,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Maritime Commission, Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office

Red Flags Rule; gift cards; S. 2934 - to amend the Federal Food, Drug and Cosmetic Act to ensure the safety of imported seafoodcommunication of retail industry views; H.R. 875 to establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness - communication of retail industry views; H.R. 1298 to amend the Federal Food, Drug and Cosmetic Act with respect to the importation of prescription drugs communication of retail industry views; RFID technology- privacy issues; H.R.2749, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes, provisions relating to increased penalties, reporting requirements and traceability requirements; Online behavioral advertising and related privacy issues, including draft Boucher privacy legislation and H.R. 5777, the BEST PRACTICES Act; and Federal Trade Commission reauthorization provisions considered as part ofH.R. 4173 , Wall Street Reform and Consumer Protection Act. Printed Name

Client expense: $840,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Maritime Commission, Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office

H.R. 1298, S. 525 & S. 1232, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. H.R. 3081 and H.R. 4899 - Appropriations for AIDS Drug Assistance Program - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. H.R. 3974, Viral Hepatitis and Liver Cancer Control and Prevention Act - Lobbied for passage of the bill to increase funding for education, awareness, and surveillance activities related to Viral Hepatitis. H.R. 1438, Promoting increased awareness and diagnosis of peripheral arterial disease (PAD) to address the high mortality rate of this treatable disease - Lobbied to educate members on peripheral arterial disease and for passage of bill. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding changes to the 340B drug pricing program, the Fee on pharmaceutical sales in government programs, the Independent Payment Advisory Board (IPAB), follow-on biologics, and the Patient-Centered Outcomes Research Institute (PCORI).

Client expense: $509,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

H.R. 1298, S. 525 & S. 1232, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. H.R. 3081 and H.R. 4899 - Appropriations for AIDS Drug Assistance Program - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. H.R. 3974, Viral Hepatitis and Liver Cancer Control and Prevention Act - Lobbied for passage of the bill to increase funding for education, awareness, and surveillance activities related to Viral Hepatitis. H.R. 1438, Promoting increased awareness and diagnosis of peripheral arterial disease (PAD) to address the high mortality rate of this treatable disease - Lobbied to educate members on peripheral arterial disease and for passage of bill. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding changes to the 340B drug pricing program, the Fee on pharmaceutical sales in government programs, the Independent Payment Advisory Board (IPAB), follow-on biologics, and the Patient-Centered Outcomes Research Institute (PCORI).

Client expense: $389,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

H.R. 1298, S. 525 & S. 1232, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. H.R. 3081 and H.R. 4899 - Appropriations for AIDS Drug Assistance Program - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. H.R. 3974, Viral Hepatitis and Liver Cancer Control and Prevention Act - Lobbied for passage of the bill to increase funding for education, awareness, and surveillance activities related to Viral Hepatitis. H.R. 1438, Promoting increased awareness and diagnosis of peripheral arterial disease (PAD) to address the high mortality rate of this treatable disease - Lobbied to educate members on peripheral arterial disease and for passage of bill. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding changes to the 340B drug pricing program, the Fee on pharmaceutical sales in government programs, the Independent Payment Advisory Board (IPAB), follow-on biologics, and the Patient-Centered Outcomes Research Institute (PCORI).

Client expense: $389,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

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

S. 525, S. 1232 / H.R. 1298, The Pharmaceutical Market Access & Drug Safety Act, as it relates to the importation of biologicals and pedigree. H.R. 759, the FDA Globalization Act and H.R. 6543, The Drug Safety Enhancement Act as they relate to drug safety and pedigree issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Red Flags Rule; gift cards; S. 2934 - to amend the Federal Food, Drug and Cosmetic Act to ensure the safety of imported seafood - communication of retail industry views; H.R. 875 to establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness communication of retail industry views; H.R. 1298 to amend the Federal Food, Drug and Cosmetic Act with respect to the importation of prescription drugs communication of retail industry views; RFID technology - privacy issues; H.R.2749, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes, provisions relating to increased penalties, reporting requirements and traceability requirements; Online behavioral advertising and related privacy issues, including draft Boucher privacy legislation and H.R. 5777, the BEST PRACTICES Act; and Federal Trade Commission reauthorization provisions considered as part of H.R. 4173, Wall Street Reform and Consumer Protection Act.

Client expense: $840,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Maritime Commission, Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office

Drug disposal legislation (Secure and Responsible Drug Disposal Act of 2009 H.R. 1359, Safe Drug Disposal Act of 2009 H.R. 1191, H.R. 5809, S. 3397, S. 1292 & S. 1336); drug reimportation issues (Pharmaceutical Market Access and Drug Safety Act of 2009, S. 525 & H.R. 1298); reauthorization of Prescription Drug User Fee Act; health care technical corrections (H.R. 5712); life sciences research tax credit legislation (H.R. 6165).

Client expense: $680,000 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, SENATE

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3590, Patient Protection and Affordable Care Act - Lobbied in support of and implementation of health care legislation to reform the health care system to provide quality health care and expand access to long-term services and supports. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of and implementation of health care law which makes improvements, such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act. S. 3606, Agriculture, Rural Development, FDA and related agencies Appropriations Act, FY 2011 - Lobbied for increased funding for the FDA Office of Generic Drugs to reduction of application backlog. H.R. 3081, H.R. 3082, H.J.Res. 105, H.J.Res.101, Continuing Resolution, FY 2011 - Lobbied for funding for FDA Office of Generic Drugs and nutrition assistance. S.3690, the Drug Safety and Accountability Act of 2010 - Requires drug manufacturers to implement quality management plans and document the manufacturing supply chain to ensure the quality and safety of drugs. The bill also would expand FDA authority to recall unsafe drugs, uncluding over the counter drugs, and offers protection to whistle blowers. H.R.5809,would amend the Controlled Substances Act to provide for the take back and safe disposal of controlled substances. The bill provides for an educational effort about proper drug disposal, an EPA report on the same and a GAO report on the effectiveness of disposal programs.

Client expense: $9,120,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3590, Patient Protection and Affordable Care Act - Lobbied in support of and implementation of health care legislation to reform the health care system to provide quality health care and expand access to long-term services and supports. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of and implementation of health care law which makes improvements, such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act. S. 3606, Agriculture, Rural Development, FDA and related agencies Appropriations Act, FY 2011 - Lobbied for increased funding for the FDA Office of Generic Drugs to reduction of application backlog. H.R. 3081, H.R. 3082, H.J.Res. 105, H.J.Res.101, Continuing Resolution, FY 2011 - Lobbied for funding for FDA Office of Generic Drugs and nutrition assistance. S.3690, the Drug Safety and Accountability Act of 2010 - Requires drug manufacturers to implement quality management plans and document the manufacturing supply chain to ensure the quality and safety of drugs. The bill also would expand FDA authority to recall unsafe drugs, uncluding over the counter drugs, and offers protection to whistle blowers. H.R.5809,would amend the Controlled Substances Act to provide for the take back and safe disposal of controlled substances. The bill provides for an educational effort about proper drug disposal, an EPA report on the same and a GAO report on the effectiveness of disposal programs.

Client expense: $9,120,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2751, FDA Food Safety Modernization Act: importation H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: health reform fee issues H.R. 4994, Medicare and Medicaid Extenders Act of 2010: 340B program and other health care issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 510, FDA Food Safety Modernization Act: importation S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy Biopharmaceutical innovation policy issues

Client expense: $4,900,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), 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), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Drug safety and drug counterfeiting including H.R. 579, the Food and Drug Administration Globalization Act; Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; Legislation affecting the 340B program including H.R. 4213, American Jobs and Closing Tax Loopholes Act Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act Prescription drug advertising; and federal preemption for prescription drugs.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare and Medicaid reimbursement issues for certain drugs and biologicals; all issues related to Medicare coverage of pre-ESRD education. S. 701 / H.R. 2002, Medicare IVIG Access Act as it relates to Medicare coverage of IVIG services. H.R. 1765, as it relates to Medicare coverage and payment for IVIG administered in the home. H.R. 5597, To establish a Medicare patient IVIG access demonstration project. H.R. 5712, Physician Payment and Therapy Relief Act and H.R. 4994, Medicare and Medicaid Extenders Act, as they relate to Medicare coverage of IVIG services. S. 525, S. 1232 / H.R. 1298, the Pharmaceutical Market Access & Drug Safety Act, as it relates to the importation of biologicals and pedigree. Drug safety issues, including H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree and H.R. 6543, The Drug Safety Enhancement Act.

Client expense: Not reported · Firm income: $57,500

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

S. 1232/HR. 1298- the "Pharmaceutical Market Access and Drug Safety Act of 2009"- all provisions; regarding amending the federal food, drug, and cosmetic act to allow importation of prescription drugs by pharmacies. HR 5809 the "Safe Drug Disposal Act of 2010" All provisions regarding permitting an ultimate user who has lawfully obtained a controlled substance to deliver such substance to another person for purpose of disposal. S. 3397 the 'Secure and Responsible Drug Disposal Act of 2010" All provisions regarding allowing an ultimate user of a controlled substance who has lawfully obtained such substance to deliver that substance to another person for disposal. S. 510- the "FDA Food Safety Modernization Act," no specific provisions-regarding any amendments or discussions looking to add language to allow importation of prescription drugs by pharmacies.

Client expense: $300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

**see addendum page Import Safety H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 510 - FDA Food Safety Modernization Act Importation S. 525/H.R. 1298 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80 Pharmaceutical Market Access Act of 2009 ***, no specific bill(s), Drug Safety, Prescription Drug Importation, Import Safety

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug safety and drug counterfeiting including H.R. 579, the Food and Drug Administration Globalization Act; Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009; Legislation affecting 340B Program including H.R. 4213, American Jobs and Closing Tax Loopholes Act; Federal preemption for prescription drugs; Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act; Drug company settlements including S. 369, Preserve Access to Affordable Generics Act; H.R. 1706, Protecting Consumer Access to Generic Drugs Act, and FY 2011 Financial Services and General Government Appropriations bill; and Prescription drug advertising.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug safety and drug counterfeiting including H.R. 579, the Food and Drug Administration Globalization Act; Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act; Drug company settlements including S. 369, Preserve Access to Affordable Generics Act; H.R. 1706, Protecting Consumer Access to Generic Drugs Act, and FY 2011 Financial Services and General Government Appropriations bill; Prescription drug advertising; Federal preemption for prescription drugs; and Legislation concerning civil litigation including S. 357, Sunshine in Litigation Act of 2009.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug safety and drug counterfeiting including H.R. 579, the Food and Drug Administration Globalization Act; Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; 340 B Program including H.R. 4213, American Jobs and Closing Tax Loopholes Act; Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act; Drug company settlements including S. 369, Preserve Access to Affordable Generics Act; H.R. 1706, Protecting Consumer Access to Generic Drugs Act, and FY 2011 Financial Services and General Government Appropriations bill; Prescription drug advertising; Federal preemption for prescription drugs; Legislation affecting telemedicine; and Legislation concerning civil litigation including S. 357, Sunshine in Litigation Act of 2009.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug safety and drug counterfeiting including H.R. 579, the Food and Drug Administration Globalization Act; Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; 340 B Program including H.R. 4213, American Jobs and Closing Tax Loopholes Act; Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act; Drug company settlements including S. 369, Preserve Access to Affordable Generics Act; H.R. 1706, Protecting Consumer Access to Generic Drugs Act, and FY 2011 Financial Services and General Government Appropriations bill; Stem cell research including S. 487/H.R. 873, Stem Cell Research Enhancement Act of 2009; Prescription drug advertising; Federal preemption for prescription drugs; and Legislation concerning civil litigation including S. 357, Sunshine in Litigation Act of 2009.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug safety including H.R. 579, the Food and Drug Administration Globalization Act; Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act; Drug company settlements including S. 369, Preserve Access to Affordable Generics Act; H.R. 1706, Protecting Consumer Access to Generic Drugs Act; and FY 2011 Financial Services and General Government Appropriations bill; Federal preemption for drugs and devices including H.R. 1346/S. 540, Medical Device Safety Act of 2009; Prescription drug advertising; Congressional oversight issues; and General health care reform (Patient Protection and Affordable Care Act).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page Import Safety H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 510 FDA Food Safety Modernization Act Importation S. 525/H.R. 1298 - Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80 - Pharmaceutical Market Access Act of 2009 ***, no specific bill(s), prescription drug importation, import safety

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page Importation of prescription drugs (S.525/H.R. 1298) RX Pedigree Methamphetamine/Pseudoephedrine Regulation (S. 256/H.R. 2923) Pharmacy Benefit Management Issues (H.R. 4489) Drug Disposal (S. 3397, H.R. 5809) PDMP Funding/NASPER reauthorization (H.R. 5710) Drug Safety Enhancement Act (H.R. 6543)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

**see addendum page **, no specific bill(s), Prescription Drug Importation, Import Safety Import Safety H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 510 FDA Food Safety Modernization Act Importation S. 525/H.R. 1298 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80 Pharmaceutical Market Access Act of 2009

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Budget Reconcilliation, Implementation of Health Care Reform, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, 340B Drug Pricing Program, and generic drugs S.501 - Fair Prescription Drug Competition Act, all provisions S.882 - Drug and Device Accountability Act of 2009, Title I Subtitle A, B, C, and D and Title II H.R. 759 - Food and Drug Administration Globalization Act of 2009, Title II S.525, S.1232, and H.R.1298 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act, Title VII - Improving Access to Innovative Medical Therapies H.R.4872 - Reconciliation Bill, Section 1101, Closing the Medicare Prescription Drug "Donut Hole" H.R.4213 - American Jobs and Closing Tax Loopholes Act H.R.4899 - War Supplemental S.1315 - Drug Price Competition Act of 2009

Client expense: $342,888 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

H.R. 1298, S. 525 & S. 1232, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. H.R. 3081 and H.R. 4899 - Appropriations for AIDS Drug Assistance Program - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. H.R. 3974, Viral Hepatitis and Liver Cancer Control and Prevention Act - Lobbied for passage of the bill to increase funding for education, awareness, and surveillance activities related to Viral Hepatitis. H.R. 1438, Promoting increased awareness and diagnosis of peripheral arterial disease (PAD) to address the high mortality rate of this treatable disease - Lobbied to educate members on peripheral arterial disease and for passage of bill. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding changes to the 340B drug pricing program, the Fee on pharmaceutical sales in government programs, the Independent Payment Advisory Board (IPAB), follow-on biologics, and the Patient-Centered Outcomes Research Institute (PCORI).

Client expense: $384,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

In support of Drug Reimportation: H.R. 163 and H.R. 1298 and S. 525 and S. 1232 and S. 80, In support of Medicare Part D Improvement: S. 266 and H.R. 3418, In support of Preventing Waste, Fraud and Abuse in Medicare: S. 975 and H.R. 2417

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)

Client expense: $240,240 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Natl Institutes of Health (NIH), SENATE, White House Office

Importation of prescription drugs (S. 525/H.R. 1298); Drug Safety Enhancement Act (H.R. 6543); Rx Pedigree; Methamphetamine/Pseudoephedrine Regulation (S. 256/H.R. 2923); Pharmacy Benefit Management (PBM) issues (H.R. 4489); Drug Disposal (S. 3397, H.R. 5809); PDMP Funding/NASPER Reauthorization (H.R. 5710)

Client expense: $214,000 · Firm income: Not reported

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

S. 525, H.R. 1298 - drug reimportation H.R. 1191, H.R. 1359, S. 1292, S. 1336 - disposal of drugs; PDUFA reauthorization H.R. 5712 -- health care technical corrections H.R. 6165, S. 4018 - Life sciences research tax credit legislation

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1427, Promoting Innovations and Lifesaving Medicines Act; H.R. 3590, Patient Protection and Affordable Care Act; H.R. 4872, The Health Care and Education Reconciliation Act of 2010. S. 525, S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009. Issues pertaining to: prescription drug importation, comparative effectiveness, follow-on biologics, Medicare prescription drug coverage, Medicaid rebates. H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues. H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation. H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness. H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness. H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring. H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances. S. 1203, Grow Research Opportunities with Taxcredits' Help Act: R&D tax credit provisions. S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness. S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues. S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 525, H.R. 1298: Drug Reimportation PDUFA Reauthorization, Office of Orphan Drug H.R. 5712: 340b Orphan Provisions; health care technical concerns H.R. 6165: Life Sciences research tax credit legislation

Client expense: $278,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

In support of Drug Reimportation: H.R. 163 and H.R. 1298, and S. 525, S. 1232 and S. 80; In support of Medicare Part D Improvement: S. 266 and H.R. 3418; In support of Preventing Waste, Fraud and Abuse in Medicare: S. 975 and H.R. 2417

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE