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.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

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. 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

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

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

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

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

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

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

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

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

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

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 369 Preserve Access to Affordable Generics Act; HR 573 FDCA to prohibit the marketing of authorized generic drugs Act; Importation issues, S. 1232 Preserve Access to Affordable Generics Act; HR 5175 DISCLOSE Act; HR 4678 Foreign Manufacturers Legal Accountiblity Act ; S525 Pharmaceutical Market Access & Drug Safety

Client expense: $550,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE, Treasury, Dept of

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

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

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

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

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3590, Patient Protection and Affordable Care Act H.R.4872, Reconciliation Act of 2010 H.R.616/S.511, Access to Durable Medical Equipment Act, related to the exemption of pharmacies from Medicare accreditation requirements. S.525, Pharmaceutical Market Access Act S.1232, Pharmaceutical Market Access and Drug Safety Act H.R.1970/S.956, Preserve Patient Access to Reputable DMEPOS Providers Act of 2009, as related to pharmacy exemption from Medicare Part B regulations. H.R.3108, the Medication Therapy Management Benefits Act, as related to expanded MTM services in the Medicare Part D program. H.R.3663, as related to the delay of pharmacy accreditation requirements under the Medicare DME program. H.R.3962, Affordable Health Care for America Act, as related to the role of pharmacy in healthcare reform, specifically in the Medicare and Medicaid programs. S.256, Combat Methamphetamine Enhancement Act of 2009, as related to the abuse of methamphetamine. S.1490, Personal Data Privacy and Security Act of 2009, as related to provider privacy requirements. H.R.2221, Data Accountability and rust Act, as related to provider privacy requirements. H.R.4489, The Federal Employees Health Benefits Program (FEHBP) Prescription Drug Integrity, Transparency, and Cost Savings Act, as related to pharmacy participation, reimbursement, and disclosure requirements in the FEHBP. S.3000, A bill to extend the increase in the FMAP provided in the American Recovery and Reinvestment Act of 2009 for an additional 6 months, as related to the increase in federal Medicaid matching funds. S.3543, The Medication Therapy Management, MTM, Expanded Benefits Act of 2010. H.R.5136, National Defense Authorization Act for Fiscal Year 2011. S.3454, National Defense Authorization Act for Fiscal Year 2011. H.R.5235, Medicare Access to Diabetes Supplies Act. S.80, Pharmaceutical Market Access Act of 2009. S.511, Access to Durable Medical Equipment Act. S.956, Preserve Patient Access to Reputable DMEPOS Providers Act of 2009.

Client expense: $360,000 · Firm income: Not reported

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

H.R. 3108, Medication Therapy and Management Benefits Act of 2009 S. 80, Pharmaceutical Market Access Act of 2009 S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009

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

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

H.R. 1392, to amend Title XVIII of the Social Security Act S. 1221, to amend Title XVIII of the Social Security Act H.R. 759, Food and Drug Administration Globalization Act of 2009 S. 525, a bill to amend the Federal Food, Drug and Cosmetic Act S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80, Pharmaceutical Market Access Act of 2009 S. 882, Drug and Device Accountability Act of 2009 S. 301, to amend the Title XI of the Social Security Act Health information technology issues

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

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

H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 882 Drug and Device Accountability Act of 2009 H.R. 1346 Medical Device Safety Act of 2009 S. 540 Medical Device Safety Act of 2009 H.R. 1508 Sunshine in Litigation Act of 2009 S.537 Sunshine in Litigation Act of 2009 S. 386 Fraud Enforcement and Recovery Act of 2009 S. 458 False Claims Act Clarification Act of 2009 H.R. 1298 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 1232 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 301 Physician Payments Sunshine Act of 2009 H.R. 1166 E-fencing Enforcement Act of 2009 H.R. 1173 Organized Retail Crime Act of 2009 S. 470 Combating Organized Retail Crime Act of 2009 H.R. 1788 False Claims Act Correction Act of 2009 H.R. 2892 Department of Homeland Security Appropriations, 2010 - provisions pertaining to Importation. H.R. 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 1504 Notice Pleading Restoration Act of 2009 S. 1679 Affordable Health Choices Act H.R. 3200 America's Affordable Health Choices Act of 2009 S. 1796 America's Affordable Health Choices Act of 2009 H.R. 3590 Patient Protection and Affordable Care Act America's Healthy Future Act of 2009 H.R. 3974 Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 H.R. 2596 No Child Left Unimmunized Against Influenza Act of 2009 S. 2964 Strengthening Program Integrity and Accountability in Health Care Act S. 3002 Dietary Supplement Safety Act of 2010 H.R. 4872 Health Care and Education Affordability Reconciliation Act H.R. 5516 Access to Appropriate Immunizations for Veterans Act of 2010 H.R. 5503 Securing Protections for the Injured from Limitations on Liability Act H.R. 4899 Supplemental Appropriations Act, 2010 - provisions pertaining to Bio-defense funding and the Ryan White CARE Act S. 3686 Fiscal Year 2011 Labor HHS Appropriations, all provisions pertaining to the Ryan White CARE Act as well as related House Fiscal Year 2011 Labor-HHS Appropriations Ryan White CARE Act provisions H.R. 5923 Patients Freedom to Choose Act, reimbursement of OTC drugs under Flexible and Health Savings accounts S. 3673 Patients Freedom to Choose Act, reimbursement of OTC drugs under Flexible and Health Savings accounts S. 3397 Secure and Responsible Drug Disposal Act, drug safety

Client expense: $1,600,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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 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: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 391/HR. 1321 - the "Healthy American's Act" regarding the role of pharmacy in healthcare and Title VI regarding shared responsibilities. S. 1232/S. 525/HR. 1298 the Pharmaceutical Market Access and Drug Safety Act of 2009 all provisions; regarding amending the federal food, drug, and cosmetic act to allow the importation of prescription drugs by pharmacies. Electronic Prescribing of Controlled Substances regarding the need for the DEA to publish rules that would allow for electronic prescribing of controlled substances no specific legislation. HR. 759 the Food and Drug Administration Globalization Act of 2009 Title II Drug and Device Safety all provisions relating to this title on drug and device safety. HR 5809 the "Safe Drug Disposal Act of 2010" All provisions regarding permitting an ultimate user who has lawfully obtained a controlled substance to deliver such substance to another person for purpose of disposal. S. 3397 the 'Secure and Responsible Drug Disposal Act of 2010" All provisions regarding allowing an ultimate user of a controlled substance who has lawfully obtained such substance to deliver that substance to another person for disposal,

Client expense: $340,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues 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. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, 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 and average manufacturer price (AMP) 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: 340B program and health reform fee 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. 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: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy

Client expense: $5,180,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Drug safety and drug counterfeiting including H.R. 579, the Food and Drug Administration Globalization act ; Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; Prescription drug advertising; animal health; and Federal preemption for prescription drugs.

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

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, Continuing Resolution, FY 2011 - Lobbied for funding for FDA Office of Generic Drugs and nutrition assistance.

Client expense: $4,710,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Federal Communications Commission (FCC), 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), Labor, Dept of (DOL), 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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1548, The Pathway for Biosimilars Act; H.R. 1427, Promoting Innovations and Lifesaving Medicines Act; S. 301, The Physician Payments Sunshine Act of 2009. Health care reform: H.R. 3200, America's Affordable Health Choices Act; 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, The Health Care and Education Reconciliation Act of 2010. S. 525, S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009. Issues pertaining to: prescription drug importation, comparative effectiveness, follow-on biologics, Medicare prescription drug coverage, Medicaid rebates.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3108, Medication Therapy and Management Benefits Act of 2009 S. 80, Pharmaceutical Market Access Act of 2009 S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009

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

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

H.R. 1392, to amend Title XVIII of the Social Security Act S. 1221, to amend Title XVIII of the Social Security Act H.R. 759, Food and Drug Administration Globalization Act of 2009 S. 525, a bill to amend the Federal Food, Drug and Cosmetic Act S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80, Pharmaceutical Market Access Act of 2009 S. 882, Drug and Device Accountability Act of 2009 S. 301, to amend the Title XI of the Social Security Act Health information technology issues

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), 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, as it relates to drug safety and pedigree and drug safety legislation.

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

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: $120,000

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: $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; 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

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: $1,842,000 · 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. 369 Preserve Access to Affordable Generics Act; HR 573 FDCA to prohibit the marketing of authorized generic drugs Act; General Importation issues, S. 1232 Preserve Access to Affordable Generics Act; Senators McCain, Vitter and Dorgan Importation amendments and various bills, Homeland Security Department and Justice Department Appropriations bills, HR 5175 DISCLOSE Act; HR 4678 Foreign Manufacturers Legal Accountiblity Act ; S525 Pharmaceutical Market Access & Drug Safety

Client expense: $510,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE