Promoting Innovation and Access to Life-Saving Medicine Act

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

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

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

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

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

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

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

S. 726 Promoting Innovation and Access to Life-Saving Medicine Act P.L. 111-148 Patient Protection and Affordable Care Act implementation P.L. 111-152 Health Care and Education Reconciliation Act of 2010 implementation

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

Government targets: Education, Dept of, HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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.3590, Patient Protection and Affordable Care Act - Lobbied in support of and on implementation of health care legislation that would reform the health care system to provide affordable quality health care and expand access to long-term services and supports. Provided information on the need for nursing education capacity and the retention of newer and older nurses in the workplace (no bill). S.1569/H.R.3185, Medicare Graduate Nursing Education Act - Advocated for modernizing Medicare funding so that nursing education funds are directed to advanced nurse practice programs to help produce more highly-skilled nurses to care for the Medicare population. S. 623/HR 1558, Pre-existing Condition Patient Protection Act of 2009 - Lobbied in support of bill that would prohibit insurers from denying health insurance or delaying coverage for people with pre-existing conditions. H.R. 2778, Health Equity and Accountability through Research Act of 2009 - Lobbied in support of bill that would address racial and ethnic disparities in care. S. 979/HR 2360, Small Business Health Options Programs Act - Lobbied in support of bill that would establish a nationwide health insurance purchasing pool for small businesses and the self-employed that would offer a choice of private health plans and make health coverage more affordable, predictable and accessible. S.1213, Patient-Centered Outcomes Research Act - Lobbied in support of bill that would create a public-private partnership to conduct and disseminate comparative effectiveness research. S. 726/H.R. 1427, Promoting Innovation and Access to Life Saving Medicines - Discussed legislation which would create a pathway for approval of safe, effective biosimilar and generic biologic drugs. H.R. 3090, Health Equity and Accountability Act - Discussed need to end racial and ethnic disparities in care. S. 3686, Labor, HHS, Education and Related Agencies Appropriations Act FY 2011 - Lobbied for funding for healthcare services, research and training involving NIH, AHRQ, CMS, HRSA, HHS and AOA. H.R. 3082, H.R. 3081, H.J. Res.101, H.J. Res. 105, Continuing Appropriations and Surface Transportation Extensions Act, 2011 - Lobbied for funding for various federal programs serving Older Americans, most notably SSA Administrative expenses, LIHEAP, aging services, HECM reverse mortgage subsidy and Section 202, Housing for the Elderly. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of health care law which makes improvements such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act and implementation of some provisions. H.R. 5364, Special Care Dentistry Act - Discussed bill that would require states to provide oral health coverage for aged, blind,or disabled individuals through a separate state adult dental program, with 100% federal match. H.R. 4213, American Workers, State and Business Relief Act/American Jobs and Closing Tax Loopholes Act - Lobbied for extension of UI, COBRA, FMAP, and SGR. H.R. 3081, Continuing Resolution, FY 2011 - Lobbied for funding for SSA, various health care, employment, aging services and nutrition programs. H.R. 4224, Together We Care Act - Bill creates a three-year pilot program to train public housing residents to provide covered home-based health services. H.R. 5853, Fiscal Responsibility and Retirement Security Act - Bill requires review and approval by law prior to collection of premiums under the CLASS program, to require notice to individuals prior to enrollment, and to require termination of the program in the event of actuarial unsoundness, and for other purposes. S. 2814, Home Health Care Planning Improvement Act of 2010 - Bill recognizes and authorizes nurse practitioners, clinical nurse specialists, certified nurse-midwives and physician assistants as eligible health care professionals who can order home health services under Medicare. H.R. 4993, Home Health Care Planning Improvement Act of 2010 - Bill recognizes and authorizes nurse practitioners, clinical nurse specialists, certified nurse-midwives and physician assistants as eligible health care professionals who can order home health services under Medicare.

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.3590, Patient Protection and Affordable Care Act - Lobbied in support of and on implementation of health care legislation that would reform the health care system to provide affordable quality health care and expand access to long-term services and supports. Provided information on the need for nursing education capacity and the retention of newer and older nurses in the workplace (no bill). S.1569/H.R.3185, Medicare Graduate Nursing Education Act - Advocated for modernizing Medicare funding so that nursing education funds are directed to advanced nurse practice programs to help produce more highly-skilled nurses to care for the Medicare population. S. 623/HR 1558, Pre-existing Condition Patient Protection Act of 2009 - Lobbied in support of bill that would prohibit insurers from denying health insurance or delaying coverage for people with pre-existing conditions. H.R. 2778, Health Equity and Accountability through Research Act of 2009 - Lobbied in support of bill that would address racial and ethnic disparities in care. S. 979/HR 2360, Small Business Health Options Programs Act - Lobbied in support of bill that would establish a nationwide health insurance purchasing pool for small businesses and the self-employed that would offer a choice of private health plans and make health coverage more affordable, predictable and accessible. S.1213, Patient-Centered Outcomes Research Act - Lobbied in support of bill that would create a public-private partnership to conduct and disseminate comparative effectiveness research. S. 726/H.R. 1427, Promoting Innovation and Access to Life Saving Medicines - Discussed legislation which would create a pathway for approval of safe, effective biosimilar and generic biologic drugs. H.R. 3090, Health Equity and Accountability Act - Discussed need to end racial and ethnic disparities in care. S. 3686, Labor, HHS, Education and Related Agencies Appropriations Act FY 2011 - Lobbied for funding for healthcare services, research and training involving NIH, AHRQ, CMS, HRSA, HHS and AOA. H.R. 3082, H.R. 3081, H.J. Res.101, H.J. Res. 105, Continuing Appropriations and Surface Transportation Extensions Act, 2011 - Lobbied for funding for various federal programs serving Older Americans, most notably SSA Administrative expenses, LIHEAP, aging services, HECM reverse mortgage subsidy and Section 202, Housing for the Elderly. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of health care law which makes improvements such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act and implementation of some provisions. H.R. 5364, Special Care Dentistry Act - Discussed bill that would require states to provide oral health coverage for aged, blind,or disabled individuals through a separate state adult dental program, with 100% federal match. H.R. 4213, American Workers, State and Business Relief Act/American Jobs and Closing Tax Loopholes Act - Lobbied for extension of UI, COBRA, FMAP, and SGR. H.R. 3081, Continuing Resolution, FY 2011 - Lobbied for funding for SSA, various health care, employment, aging services and nutrition programs. H.R. 4224, Together We Care Act - Bill creates a three-year pilot program to train public housing residents to provide covered home-based health services. H.R. 5853, Fiscal Responsibility and Retirement Security Act - Bill requires review and approval by law prior to collection of premiums under the CLASS program, to require notice to individuals prior to enrollment, and to require termination of the program in the event of actuarial unsoundness, and for other purposes. S. 2814, Home Health Care Planning Improvement Act of 2010 - Bill recognizes and authorizes nurse practitioners, clinical nurse specialists, certified nurse-midwives and physician assistants as eligible health care professionals who can order home health services under Medicare. H.R. 4993, Home Health Care Planning Improvement Act of 2010 - Bill recognizes and authorizes nurse practitioners, clinical nurse specialists, certified nurse-midwives and physician assistants as eligible health care professionals who can order home health services under Medicare.

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

S 803 The Healthy Workforce Act of 2009, provisions relating to a tax credit for employers for costs of implementing wellness programs HR 1427 Promoting Innovation and Access to Life-Saving Medicines Act, provisions relating to FDA approval of affordable access to biotech drugs (i.e. generic drugs) for long-term savings for patients and payers S 726 Promoting Innovation and Access to Life-Saving Medicine Act, support provisions to require the support of the FDA to approve affordable copies of biotech drugs (i.e. generic drugs) for long-term savings for patients and payers HR 1322 The Emergency Retiree Health Benefits Protection Act of 2009, provisions which prohibit employers who currently provide retiree health benefits from reducing those benefits for retirees, and in some instances, require restoration of benefits S 1679 The Affordable Health Choices Act, as it relates to insurance reform, employer mandates, health IT, public plan option and ERISA HR 3590 The Patient Protection and Affordable Care Act, implementation of provisions related to ERISA, employer mandates, retiree drug subsidies/taxes and vouchers

Client expense: $2,910,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

S 726 Promoting Innovation and Access to Life-Saving Medicine Act To amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other products. Sponsor: Schumer (D - NY)

Client expense: $380,000 · Firm income: Not reported

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relative to generic pharmaceuticals and generic biologics; FY 2011 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill (Title VI - Related Agencies and Food and Drug Administration Department of Health and Human Services); funding FDA Office of Generic Drugs; H.R. 1427, S. 726 - Promoting Innovation and Access to Life-Saving Medicine Act (entire bill); S. 369 - Preserve Access to Affordable Generics Act (entire bill)

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

Government targets: Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

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

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

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

**see addendum page S. 301/H.R. 3138 Physician Payments Sunshine Act of 2009, disclosure Biosimilars S. 726/H.R. 1427 Access to Life-Saving Medicine Act, Follow-on Biologics H.R. 1548 The Pathway for Biosimilars Act PL 111-148 The Patient Protection and Affordable Care Act, implementation, health care reform, drug importation, follow-on biologics, 340b, comparative effectiveness, gift disclosure, Medicaid and Medicare reimbursement

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

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

S. 726/HR 1427 Promoting Innovation and Access to Life-Saving Medicine Act; HR 1548 Pathway for Biosimilars Act; General support for Genentech products.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 515, H.R. 1260 Patent Reform Act of 2009 H.R. 1427, S. 726 Promoting Innovation and Access to Life-Saving Medicine Act H.R. 1548 Pathway for Biosimilars Act S. 623 Access to Life Saving Medicine Act S. 369, Preserve Access to Affordable Generics Act of 2009 H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009

Client expense: $370,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Medicare Payment Advisory Commission (MedPAC), SENATE

S. 726 by DURBIN (D-IL) Development, Relief and Education for Alien Minors Act of 2010 S. 2851 by GRASSLEY (R-IA) to permanently extend and improve higher education expiring tax provisions S. 3447 by AKAKA (D-HI) Post 9/11 Veterans Educational Assistance Improvement Act of 2010 S. 3590 by BAUCUS (D-MT) Senate health care reform legislation S. 3987 by THUNE (R-SD) Red Flag Program Clarification Act of 2 H.R. 386 by DOGGETT (D-TX) Education Tax Incentives Simplification Legislation H.R. 1250 by POMEROY (D-ND) IRA Rollover Act of 2009 H.R. 3081 by OBEY (D-WI) First Continuing Resolution making further appropriations for FY 2011 through 12/03/10 H.J. Res 101 by OBEY (D-WI) Second Continuing Resolution making further appropriations for FY 2011 through 12/18/10 H.J. Res. 105 Third Continuing Resolution making further appropriations for FY 2011 through 12/21/10 H.R. 3082 by OBEY (D-WI) Fourth Continuing Resolution making further appropriations for FY 2011 through 03/04/11 H.R. 3590 by RANGEL (D-NY) The Patient Protection and Affordable Care Act H.R. 4065 by HOLT (D-NJ) To amend the ESEA to establish a partnership program in foreign languages H.R. 4213 by RANGEL (D-NY) American Jobs and Closing Tax Loopholes Act of 2010 H.R. 4853 by OBERSTAR (D-MN) Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010 H.R. 5078 by HIGGINS (D-NY) The Higher Education Affordability and Equity Act of 2010 H.R. 5448 by SPRATT (D-SC) Perkins Loan Extension Act H.R. 5600 by POMEROY (D-ND) legislation to permanently extend IRC Sec. 127 H.R. 5933 by MINNICK (D-ID) Post 9/11 Veterans Educational Assistance Improvement Act of 2010 H.R. 6430 by MINNICK (D-ID) Post-9/11 Veterans Educational Assistance Improvement Act of 2010 H.R. 6497 by BERMAN (D-CA) Development, Relief and Education for Alien Minors Act of 2010

Client expense: $54,000 · Firm income: Not reported

Government targets: Education, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office

biosimilars, follow-on biologics S. 726 Promoting Innovation and Access to Life-Saving Medicine Act P.L. 111-148 Patient Protection and Affordable Care Act implementation P.L. 111-152 Health Care and Education Reconciliation Act of 2010 implementation

Client expense: $330,000 · Firm income: Not reported

Government targets: Education, Dept of, HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

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

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

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

Access to Affordable Generics (H.R.4899 / S. 369, S.3677) Anti-Counterfeiting and Piracy Legislation (S. 3804) Biosimilars (H.R.1427, H.R.1548, S.726) CJS Appropriations Legislation (S. 3636) Continuing Resolution, PTO Funding (H.R. 3081) Continuing Resolution/Potential Omnibus, PTO Funding (H.R. 3082) Continuing Resolution, PTO Funding (H.J.Res. 105) Copyright Technical Corrections Bill (S. 3689) Design Rights (H.R.3059 / S.1368) Drug Re-Importation (S.80, S.525, H.R.1298) Ending Fee Diversion at USPTO (H.R. 1260, S.515, H.R. 5233) False Patent Marketing Bill Addressing Qui Tam Actions (H.R. 4954/S.515) Fashion Design (H.R. 2196/S.3728) Genetically Modified Crops (H.R. 5579) Hague Agreement Implementation (TBA) Implementation of Patent Law Treaty (TBA) Oil Spill Accountability and Environmental Protection Act (Oberstar) (H.R. 5629) Oil Spill Liability Bill (Conyers) (H.R. 5503) Open Access to the Courts (H.R.4115) Orphan Works Legislation (TBA) Patent Litigation Reform - Sunshine in Litigation Act (H.R. 1508/S.537) Patent Reform (H.R. 1260, S.515, S.610) Patent Specialist Judicial Pilot (H.R.628, S.299, S.515) Pay for Administrative Patent and Trademark Judges (TBA) Repatriation Legislation (H.R. 5980) USPTO Funds for Travel Related Expenses (TBA)

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

Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

HR 1204 (Antitrust exception for Pharmacists). HR 1493 (Antitrust exemption for physicians). HR 1 (COBRA coverage subsidy; comparative effectiveness, wellness, HIT finding and privacy). HR 1427/S. 726/ HR 1548 (FDA pathwqy to approve generic Biopharmaceutical medicines). S. 369/HR 1706 (generic/brand "settlements"). S. 93 (establish FEHBP for small employers. S. 391/ HR 1321 (National health insurance). HR 676/S. 703 (single-payer health plan) HR 193 (Medicare "for all"). A. 1796, S. 1679 (Health Care Reform); HR 676/S. 703 (Single payer): PL 111-148; PL 111-152.

Client expense: $998,150 · Firm income: Not reported

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