Pharmaceutical Market Access and Drug Safety Act of 2009

HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) 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 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 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 Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA

Client expense: $1,129,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) 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 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 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 Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA

Client expense: $1,631,812 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

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

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

HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) 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 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 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 Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA

Client expense: $1,918,136 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

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

HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine 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 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 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 Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA

Client expense: $1,650,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

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

Biosimilars, Pre-emption; Legal Reform; Importation; Health Care Reform S. 525 Pharmqaceutical Market Access and Drug Safety Act of 2009

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

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

S. 525 and related legislative proposals regarding prescription drug importation and safety issues

Client expense: $660,000 · Firm income: Not reported

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

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)

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

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.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

Medicaid Drug Rebates. Reforms to Medicare Part D. S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009. Changes to the 340b program. H.R.4213, American Jobs and Closing Tax Loopholes Act of 2010: AMP provision; 340b provisions. S.369, Preserve Access to Affordable Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009. Changes to the 340b program. S.369, Preserve Access to Affordable Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Medicaid Drug Rebates. Reforms to Medicare Part D. S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009. Changes to the 340b program. S.369, Preserve Access to Affordable Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009. Changes to the 340b program. S.369, Preserve Access to Affordable Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009. Changes to the 340b program. S.369, Preserve Access to Affordable Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicaid Drug Rebates. Reforms to Medicare Part D. S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009. Changes to the 340b program. H.R.4213, American Jobs and Closing Tax Loopholes Act of 2010: AMP provision; 340b provisions. S.369, Preserve Access to Affordable Generics Act.

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

Government targets: 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

Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implemenation of Public Law 111-152, The Reconciliation Act of 2010 S. 422 Heart Disease Education, Analysis Research, and Treatment for Women Act H.R. 5501, Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, TB & Malaria Act H.R. 5440 - Genomics and Personalized Medicine Act of 2010 H.R. 3974: Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 Policies for FDA product approval reform

Client expense: $1,750,000 · Firm income: Not reported

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

S. 525 and related legislative proposals regarding prescription drug importation and safety issues

Client expense: $660,000 · Firm income: Not reported

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

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

**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