Food and Drug Administration Safety Act of 2007

BAN: HR627, S414, HR1214, S500, S582, HR1456, HR3126; ECN: HR1664, HR1586, SB812, HR1, TARP II: HR384; Bankruptcy Reform: HR1106, HR200, HR225, SB257; Budget Resolutions: S. Con. Res. 13, H. Con. Res. 85; Mortgage: HR1728, HR788, HR1782; Derivatives: HR977

Client expense: Not reported · Firm income: Not reported

BAN: HR627, S414, HR1214, S500, S582, HR1456, HR3126; ECN: HR1664, HR1586, SB812, HR1, TARP II: HR384; Bankruptcy Reform: HR1106, HR200, HR225, SB257; Budget Resolutions: S. Con. Res. 13, H. Con. Res. 85; Mortgage: HR1728, HR788, HR1782; Derivatives: HR977

Client expense: Not reported · Firm income: Not reported

S. 251 Pharmaceutical Market Access Act of 2007; S. 468 Food and Drug Administration Safety Act of 2007; S. 484 Enhancing Drug Safety and Innovation Act of 2007; H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007; H.R. 788 Food and Drug Administration Safety Act of 2007; H.R. 2117 Health Freedom Protection Act of 2007; H.R. 1561 Enhancing Drug Safety and Innovation Act of 2007

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans; -H.R. 1494 / S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediatric medical devices; -H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; -H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; -H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; -H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; -H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; -H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; -S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; -S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; -S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; -S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; -S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; -S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; -H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; -H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; -H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; -S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; -H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; -H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products; -H.R. 5839, "Safeguarding America's Pharmaceuticals Act of 2008", To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, regarding all provisions; -S. 334, "Healthy Americans Act", A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away, regarding all provisions; -H.R. 6381, "Medical Device Safety Act of 2008", To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions; -S. 438, "Fair Prescription Drug Competition Act", A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs, regarding all provisions; -S.2274, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan", and for other purposes, regarding all provisions. -S.3409 "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration", and for other purposes; regarding all provisions. -S.1378 "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan", and for other purposes; regarding all provisions. -S. 3408, "Comparative Effectiveness Research Act of 2008", A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes, regarding all provisions; -S. 1276, "Methamphetamine Production Prevention Act of 2008", A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions. -Proposed Rule (CMS-1403-P), Regarding revisions to Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions; -S.2424, "A bill to ensure that all Americans have basic health literacy skills to function effectively as patients and health care consumers", regarding all provisions.

Client expense: $1,440,000 · 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.1165, "Swift Approval, Full Evaluation Drug Act or the 'SAFE Drug Act," regarding amending the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs and to establish whistleblower protections for certain individuals; -H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans; -H.R. 1494 / S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediatric medical devices; -H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; -H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; -H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; -H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; -H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; -H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; -S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; -S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; -S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; -S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; -S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; -S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; -H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; -H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; -H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; -S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; -H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; -H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products; -H.R. 5839, "Safeguarding America's Pharmaceuticals Act of 2008", To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, regarding all provisions; -S. 334, "Healthy Americans Act", A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away, regarding all provisions; -H.R. 6381, "Medical Device Safety Act of 2008", To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions; -S. 438, "Fair Prescription Drug Competition Act", A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs, regarding all provisions; -S. 3408, "Comparative Effectiveness Research Act of 2008", A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes, regarding all provisions; -S. 1276, "Methamphetamine Production Prevention Act of 2008", A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions. -Proposed Rule (CMS-1403-P), Regarding revisions to Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions;

Client expense: $1,500,000 · 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.1165, "Swift Approval, Full Evaluation Drug Act or the 'SAFE Drug Act," regarding amending the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs and to establish whistleblower protections for certain individuals; H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision o mental health and substance-related disorder benefits under group health plans; H.R. 1494 / S. 830, "Pediactric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediactric medical devices; H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products; H.R. 5839, "To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs", regarding all provisions; S. 334, "A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away", regarding all provisions; H.R. 6381, "To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices", regarding all provisions; S. 438, "A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs", regarding all provisions.

Client expense: $1,700,000 · Firm income: Not reported

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

S. 251 Pharmaceutical Market Access Act of 2007; S. 468 Food and Drug Administration Safety Act of 2007; S. 484 Enhancing Drug Safety and Innovation Act of 2007; H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007; H.R. 788 Food and Drug Administration Safety Act of 2007; H.R. 2117 Health Freedom Protection Act of 2007; H.R. 1561 Enhancing Drug Safety and Innovation Act of 2007

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 788, Food and Drug Administration Safety Act of 2007, provisions relating to follow-on biologics. S 468, Food and Drug Administration Safety Act of 2007, provisions relating to follow-on biologics.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.1165, "Swift Approval, Full Evaluation Drug Act or the 'SAFE Drug Act," regarding amending the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs and to establish whistleblower protections for certain individuals; H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision o mental health and substance-related disorder benefits under group health plans; H.R. 1494 / S. 830, "Pediactric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediactric medical devices; H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products.

Client expense: $1,440,000 · Firm income: Not reported

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

S. 251 Pharmaceutical Market Access Act of 2007; S. 468 Food and Drug Administration Safety Act of 2007; S. 484 Enhancing Drug Safety and Innovation Act of 2007; H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007; H.R. 788 Food and Drug Administration Safety Act of 2007; H.R. 2117 Health Freedom Protection Act of 2007; H.R. 1561 Enhancing Drug Safety and Innovation Act of 2007

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

S 468, Food and Drug Administration Safety Act of 2007; HR 788, Food and Drug Administration Safety Act of 2007 S 1082, Food and Drug Administration Revitalization Act; HR 2900, Food and Drug Administration Amendments Act of 2007; HR 1561, Enhancing Drug Safety and Innovation Act of 2007; S 484, Enhancing Drug Safety and Innovation Act of 2007

Client expense: $402,773 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Postal Regulatory Commission, SENATE, U.S. Copyright Office, U.S. Postal Service (USPS)

S. 2311 - Non-Prescription Drug Modernization Act of 2007 H.R. 788 - Food and Drug Administration Safety Act of 2007 H.R. 1561 - Enhancing Drug Safety and Innovation Act of 2007 H.R. 2900 - Food and Drug Administration Amendments Act of 2007 H.R. 4083 - Non-Prescription Drug Modernization Act of 2007 FDA request for comments on verbal and visual presentations and "fair balance" in drug ads Proposals to ban or restrict advertising of prescription drugs S. 468 - Food and Drug Administration Safety Act of 2007 S. 484 - Enhancing Drug Safety and Innovation Act of 2007 S. 1082 - Food and Drug Administration Revitalization Act

Client expense: $480,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

HR 788 Food and Drug Administration Safety Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1666 Health Care Price Transparency Promotion Act of 2007

Client expense: Not reported · Firm income: $105,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR.788/S.468, Food & Drug Administration Safety Act of 2007; HR.970/S.1378, Dextromethorphan Distribution Act of 2007; HR.1952, National Health Information Incentive Act of 2007; S.1082/HR.2900, Prescription Drug User Fee, FDA Act of 2007; S.1753, The Healthy Workforce Act of 2007

Client expense: $1,282,429 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Energy, Dept of, Executive Office of the President (EOP), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

S. 251 Pharmaceutical Market Access Act of 2007; S. 468 Food and Drug Administration Safety Act of 2007; S. 484 Enhancing Drug Safety and Innovation Act of 2007; S. 1082 Food and Drug Administration Revitalization Act 2007; H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007; H.R. 788 Food and Drug Administration Safety Act of 2007; H.R. 2117 Health Freedom Protection Act of 2007; H.R. 1561 Enhancing Drug Safety and Innovation Act of 2007; H.R. 2900 Food and Drug Administration Amendments of 2007

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

HR 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007,” regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans; HR 1494 / S 830, “Pediatric Medical Device Safety and Improvement Act of 2007,” regarding improving the process for the development of needed pediatric medical devices; HR 1956, “Patient Protection and Innovative Biologic Medicines Act of 2007,” regarding amending the Public Health Service Act to provide for the approval of similar biological products; HR 2193, “Animal Protection Accountability Improvement Act,” regarding amending the Animal Welfare Act to increase the penalties for violations of such Act and to prohibit the use of animals for marketing medical devices; HR 2349 / S 1413, “Uterine Fibroid Research and Education Act of 2007,” regarding providing for research and education with respect to uterine fibroids; HR 3333 / S. 1576, “Minority Health Improvement and Health Disparity Elimination Act,” regarding amending the Public Health Service Act to improve the health and healthcare of racial and ethnic minority groups; HR 788 / S 468, “Food and Drug Administration Safety Act of 2007,” regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; HR 2900, “Food and Drug Administration Amendments Act of 2007,” regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; S 1082, “Food and Drug Administration Revitalization Act,” regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; S 1695, “Biologics Price Competition and Innovation Act of 2007,” regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products and to promote innovation in the life sciences; S 467, “Fair Access to Clinical Trials Act of 2007 or the `FACT Act',” regarding amending the Public Health Service Act to expand the clinical trials drug data bank; S 558, “Mental Health Parity Act of 2007,” regarding all provisions; S 628, “Critical Access to Health Information Technology Act of 2007,” regarding providing grants for rural health information technology development activities; S 993, “Pediatric Research Improvement Act,” regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine.   HR 1165, “Swift Approval, Full Evaluation Drug Act or the `SAFE Drug Act',” regarding amending the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs and to establish whistleblower protections for certain individuals;

Client expense: $3,820,000 · Firm income: Not reported

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

S. 1082: FDA Revitalization Act S. 623: Access to Life-Saving Medicine Act H.R. 1038: Access to Life-Saving Medicine Act H.R. 1368: Personalized Health Information Act S. 1695: Biologics Price Competition and Innovation Act S. 1693: Wired for Health Care Quality Act H.R. 2900: FDA Amendments Act S. 334 Healthy Americans Act H.R. 1535 Children’s Health First Act S. 895 Children’s Health First Act S. 628 Critical Access to Health Information Technology Act of 2007 S. 1408 Health Information Technology Act of 2007 S. 1577 Patient Safety and Abuse Prevention Act of 2007 H.R. 2723 Children’s Health Care Quality Act S. 1226 Children’s Health Care Quality Act S. 1364 Healthy Kids Act of 2007 H.R. 1368 Personalized Health Information Act of 2007 S. 1714 Small Business Children’s Health Education Act of 2007 H.R. 2132 Small Business Health Plans Act of 2007 S. 158 Access to Affordable Health Care Act H.R. 2147 Health Kids Act of 2007 S. 401 Keep Children Covered Act of 2007 S. 1753 Health Workforce Act of 2007 S. 1455 National Health Information Technology and Privacy Advancement Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 S 28 Generics First Act of 2007 S 158 Access to Affordable Health Care Act S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 468 Food and Drug Administration Safety Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 1505 Affordable Biologics for Consumers Act Antitrust and Health Insurance Reform: S 618 “Insurance Industry Competition Act of 2007” Health Information Technology Standards; Electronic Health Records; ICD 10 Implementation; HR1368 “Personalized Health Information Act of 2007” ; S 1693 and S 1783 “Wired for Health Care Quality Act”; Insurance Market Reform; Association Health Plans; Uninsured: S 1019 “Health Care Choice of 2007” Genetic Non-discrimination: HR 493 and S 358 “Genetic Information Nondiscrimination Act of 2007 Mental Health Parity: HR 1424 “Paul Wellstone Mental Health and Addiction Equity Act of 2007” and S 558 “Mental Health Parity Act of 2007” H.R. 2184 Enhanced Health Care Value for All Act S. 1490 Federal Employees Electronic Personal Health Records Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 468 Food and Drug Administration Safety Act of 2007; HR 788 Food and Drug Administration Safety Act of 2007 S 1082, Food and Drug Administration Revitalization Act; HR 2900 Food and Drug Administration Amendments Act of 2007; HR 1561 Enhancing Drug Safety and Innovation Act of 2007; S 484 Enhancing Drug Safety and Innovation Act of 2007

Client expense: $570,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Copyright Office, U.S. Postal Service (USPS)

S.5/H.R.3 S.1082 H.R. 2900 S.468/H.R 788

Client expense: $160,804 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 788 - Food and Drug Administration Safety Act of 2007 H.R. 1561 - Enhancing Drug Safety and Innovation Act of 2007 H.R. 2900 - Food and Drug Administration Amendments Act of 2007 Proposals to ban or restrict advertising of prescription drugs S. 468 - Food and Drug Administration Safety Act of 2007 S. 484 - Enhancing Drug Safety and Innovation Act of 2007 S. 1082 - Food and Drug Administration Revitalization Act

Client expense: $460,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

HR.788/S.468, Food & Drug Administration Safety Act of 2007 HR.970/S.1378, Dextromethorphan Distribution Act of 2007 HR.1952, National Health Information Incentive Act of 2007 S.1082/HR.2900 Prescription Drug User Fee, FDA Act of 2007

Client expense: $687,138 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Energy, Dept of, Executive Office of the President (EOP), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 S 28 Generics First Act of 2007 S 158 Access to Affordable Health Care Act S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 468 Food and Drug Administration Safety Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 1082 Prescription Drug User Fee Amendments of 2007 S 1408 Health Information Technology Act of 2007 S 1505 Affordable Biologics for Consumers Act S 1695 Biologics Price Competition and Innovation Act of 2007 S 628 Critical Access to Health Information Technology Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act

Client expense: Not reported · Firm income: $105,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 3 Medicare Prescription Drug Price Negotiation Act of 2007 S 28 Generics First Act of 2007 S 130 Medicare Cost Contract Extension and Refinement Act of 2007 S 137 Preserving Medicare for All Act of 2007 S 158 Access to Affordable Health Care Act S 173 Medicare Health Savings Accounts Act of 2007 S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 250 The Medicare Enhancements for Needed Drugs Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 355 The Social Security and Medicare Solvency Commission Act S 358 Genetic Information Nondiscrimination Act of 2007 S 468 Food and Drug Administration Safety Act of 2007 S. 628 - Critical Access to Health Information Technology Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 885 Community Pharmacy Fairness Act of 2007 S 980 Online Pharmacy Consumer Protection Act of 2007 S 1082 Prescription Drug User Fee Amendments of 2007 S 1108 Medicare Part D Outreach and Enrollment Enhancement Act of 2007 S 1161 Medicare Medical Nutrition Therapy Act of 2007 S 1198 Catastrophic Health Coverage Promotion Act S 1218 Medicare for All Act S 1307 Medicare Provider Accountability Act S 1338 Access to Medicare Imaging Act of 2007 HR 4 Medicare Prescription Drug Price Negotiation Act of 2007 HR 205 Medicare Prescription Drug Enrollment Extension Act of 2007 HR 493 Genetic Information Nondiscrimination Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 971 Community Pharmacy Fairness Act of 2007 HR 1218 Medicare Prescription Drug Improvement Act HR 1277 Medicare Prescription Drug Benefits Gap Elimination Act of 2007 HR 1282 Medigap Access Improvement Act of 2007 HR 1310 Relief and Elimination of the Medicare Enrollment Deadline Penalty (REMEDY) Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 1521 Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2009 To repeal the Medicare cost containment provisions contained in subtitle A of title VIII of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. HR 2043 Medicare for All Act HR 2058 Helping Fill the Medicare Rx Gap Act of 2007 HR 2065 Medicare Drug Savings Through Choice Act of 2007 HR 2149 Healthcare Eligibility for Late Participants (HELP) in Medicare Part D Act of 2007 HR 2231 Medicare Access to Complex Rehabilitation and Assistive Technology Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2307 Preventing Medicare Seniors from being Confused due to Abusive Marketing (Prevent Medicare SCAMs) Act of 2007 HR 2549 . Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2007 HR 2567 Medicare Home Infusion Therapy Coverage Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2606 340B Program Improvement and Integrity Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 HR 2827 Medicare Equity and Accessibility Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 HR 2914 Medicare IVIG Access Act of 2007 See next page

Client expense: $890,000 · Firm income: Not reported

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

S 3 Medicare Prescription Drug Price Negotiation Act of 2007 S 28 Generics First Act of 2007 S 130 Medicare Cost Contract Extension and Refinement Act of 2007 S 137 Preserving Medicare for All Act of 2007 S 158 Access to Affordable Health Care Act S 173 Medicare Health Savings Accounts Act of 2007 S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 250 The Medicare Enhancements for Needed Drugs Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 355 The Social Security and Medicare Solvency Commission Act S 358 Genetic Information Nondiscrimination Act of 2007 S 468 Food and Drug Administration Safety Act of 2007 S. 628 - Critical Access to Health Information Technology Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 885 Community Pharmacy Fairness Act of 2007 S 980 Online Pharmacy Consumer Protection Act of 2007 S 1082 Prescription Drug User Fee Amendments of 2007 S 1108 Medicare Part D Outreach and Enrollment Enhancement Act of 2007 S 1161 Medicare Medical Nutrition Therapy Act of 2007 S 1198 Catastrophic Health Coverage Promotion Act S 1218 Medicare for All Act S 1307 Medicare Provider Accountability Act S 1338 Access to Medicare Imaging Act of 2007 HR 4 Medicare Prescription Drug Price Negotiation Act of 2007 HR 205 Medicare Prescription Drug Enrollment Extension Act of 2007 HR 493 Genetic Information Nondiscrimination Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 971 Community Pharmacy Fairness Act of 2007 HR 1218 Medicare Prescription Drug Improvement Act HR 1277 Medicare Prescription Drug Benefits Gap Elimination Act of 2007 HR 1282 Medigap Access Improvement Act of 2007 HR 1310 Relief and Elimination of the Medicare Enrollment Deadline Penalty (REMEDY) Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 1521 Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2009 To repeal the Medicare cost containment provisions contained in subtitle A of title VIII of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. HR 2043 Medicare for All Act HR 2058 Helping Fill the Medicare Rx Gap Act of 2007 HR 2065 Medicare Drug Savings Through Choice Act of 2007 HR 2149 Healthcare Eligibility for Late Participants (HELP) in Medicare Part D Act of 2007 HR 2231 Medicare Access to Complex Rehabilitation and Assistive Technology Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2307 Preventing Medicare Seniors from being Confused due to Abusive Marketing (Prevent Medicare SCAMs) Act of 2007 HR 2549 . Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2007 HR 2567 Medicare Home Infusion Therapy Coverage Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2606 340B Program Improvement and Integrity Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 HR 2827 Medicare Equity and Accessibility Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 HR 2914 Medicare IVIG Access Act of 2007 See next page

Client expense: $890,000 · Firm income: Not reported

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

S 3 Medicare Prescription Drug Price Negotiation Act of 2007 S 28 Generics First Act of 2007 S 130 Medicare Cost Contract Extension and Refinement Act of 2007 S 137 Preserving Medicare for All Act of 2007 S 158 Access to Affordable Health Care Act S 173 Medicare Health Savings Accounts Act of 2007 S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 250 The Medicare Enhancements for Needed Drugs Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 355 The Social Security and Medicare Solvency Commission Act S 358 Genetic Information Nondiscrimination Act of 2007 S 468 Food and Drug Administration Safety Act of 2007 S. 628 - Critical Access to Health Information Technology Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 885 Community Pharmacy Fairness Act of 2007 S 980 Online Pharmacy Consumer Protection Act of 2007 S 1082 Prescription Drug User Fee Amendments of 2007 S 1108 Medicare Part D Outreach and Enrollment Enhancement Act of 2007 S 1161 Medicare Medical Nutrition Therapy Act of 2007 S 1198 Catastrophic Health Coverage Promotion Act S 1218 Medicare for All Act S 1307 Medicare Provider Accountability Act S 1338 Access to Medicare Imaging Act of 2007 HR 4 Medicare Prescription Drug Price Negotiation Act of 2007 HR 205 Medicare Prescription Drug Enrollment Extension Act of 2007 HR 493 Genetic Information Nondiscrimination Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 971 Community Pharmacy Fairness Act of 2007 HR 1218 Medicare Prescription Drug Improvement Act HR 1277 Medicare Prescription Drug Benefits Gap Elimination Act of 2007 HR 1282 Medigap Access Improvement Act of 2007 HR 1310 Relief and Elimination of the Medicare Enrollment Deadline Penalty (REMEDY) Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 1521 Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2009 To repeal the Medicare cost containment provisions contained in subtitle A of title VIII of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. HR 2043 Medicare for All Act HR 2058 Helping Fill the Medicare Rx Gap Act of 2007 HR 2065 Medicare Drug Savings Through Choice Act of 2007 HR 2149 Healthcare Eligibility for Late Participants (HELP) in Medicare Part D Act of 2007 HR 2231 Medicare Access to Complex Rehabilitation and Assistive Technology Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2307 Preventing Medicare Seniors from being Confused due to Abusive Marketing (Prevent Medicare SCAMs) Act of 2007 HR 2549 . Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2007 HR 2567 Medicare Home Infusion Therapy Coverage Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2606 340B Program Improvement and Integrity Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 HR 2827 Medicare Equity and Accessibility Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 HR 2914 Medicare IVIG Access Act of 2007 See next page

Client expense: $890,000 · Firm income: Not reported

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

S 3 Medicare Prescription Drug Price Negotiation Act of 2007 S 28 Generics First Act of 2007 S 130 Medicare Cost Contract Extension and Refinement Act of 2007 S 137 Preserving Medicare for All Act of 2007 S 158 Access to Affordable Health Care Act S 173 Medicare Health Savings Accounts Act of 2007 S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 250 The Medicare Enhancements for Needed Drugs Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 355 The Social Security and Medicare Solvency Commission Act S 358 Genetic Information Nondiscrimination Act of 2007 S 468 Food and Drug Administration Safety Act of 2007 S. 628 - Critical Access to Health Information Technology Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 885 Community Pharmacy Fairness Act of 2007 S 980 Online Pharmacy Consumer Protection Act of 2007 S 1082 Prescription Drug User Fee Amendments of 2007 S 1108 Medicare Part D Outreach and Enrollment Enhancement Act of 2007 S 1161 Medicare Medical Nutrition Therapy Act of 2007 S 1198 Catastrophic Health Coverage Promotion Act S 1218 Medicare for All Act S 1307 Medicare Provider Accountability Act S 1338 Access to Medicare Imaging Act of 2007 HR 4 Medicare Prescription Drug Price Negotiation Act of 2007 HR 205 Medicare Prescription Drug Enrollment Extension Act of 2007 HR 493 Genetic Information Nondiscrimination Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 971 Community Pharmacy Fairness Act of 2007 HR 1218 Medicare Prescription Drug Improvement Act HR 1277 Medicare Prescription Drug Benefits Gap Elimination Act of 2007 HR 1282 Medigap Access Improvement Act of 2007 HR 1310 Relief and Elimination of the Medicare Enrollment Deadline Penalty (REMEDY) Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 1521 Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2009 To repeal the Medicare cost containment provisions contained in subtitle A of title VIII of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. HR 2043 Medicare for All Act HR 2058 Helping Fill the Medicare Rx Gap Act of 2007 HR 2065 Medicare Drug Savings Through Choice Act of 2007 HR 2149 Healthcare Eligibility for Late Participants (HELP) in Medicare Part D Act of 2007 HR 2231 Medicare Access to Complex Rehabilitation and Assistive Technology Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2307 Preventing Medicare Seniors from being Confused due to Abusive Marketing (Prevent Medicare SCAMs) Act of 2007 HR 2549 . Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2007 HR 2567 Medicare Home Infusion Therapy Coverage Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2606 340B Program Improvement and Integrity Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 HR 2827 Medicare Equity and Accessibility Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 HR 2914 Medicare IVIG Access Act of 2007 See next page

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

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

S 3 Medicare Prescription Drug Price Negotiation Act of 2007 S 28 Generics First Act of 2007 S 130 Medicare Cost Contract Extension and Refinement Act of 2007 S 137 Preserving Medicare for All Act of 2007 S 158 Access to Affordable Health Care Act S 173 Medicare Health Savings Accounts Act of 2007 S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 250 The Medicare Enhancements for Needed Drugs Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 355 The Social Security and Medicare Solvency Commission Act S 358 Genetic Information Nondiscrimination Act of 2007 S 468 Food and Drug Administration Safety Act of 2007 S. 628 - Critical Access to Health Information Technology Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 885 Community Pharmacy Fairness Act of 2007 S 980 Online Pharmacy Consumer Protection Act of 2007 S 1082 Prescription Drug User Fee Amendments of 2007 S 1108 Medicare Part D Outreach and Enrollment Enhancement Act of 2007 S 1161 Medicare Medical Nutrition Therapy Act of 2007 S 1198 Catastrophic Health Coverage Promotion Act S 1218 Medicare for All Act S 1307 Medicare Provider Accountability Act S 1338 Access to Medicare Imaging Act of 2007 HR 4 Medicare Prescription Drug Price Negotiation Act of 2007 HR 205 Medicare Prescription Drug Enrollment Extension Act of 2007 HR 493 Genetic Information Nondiscrimination Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 971 Community Pharmacy Fairness Act of 2007 HR 1218 Medicare Prescription Drug Improvement Act HR 1277 Medicare Prescription Drug Benefits Gap Elimination Act of 2007 HR 1282 Medigap Access Improvement Act of 2007 HR 1310 Relief and Elimination of the Medicare Enrollment Deadline Penalty (REMEDY) Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 1521 Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2009 To repeal the Medicare cost containment provisions contained in subtitle A of title VIII of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. HR 2043 Medicare for All Act HR 2058 Helping Fill the Medicare Rx Gap Act of 2007 HR 2065 Medicare Drug Savings Through Choice Act of 2007 HR 2149 Healthcare Eligibility for Late Participants (HELP) in Medicare Part D Act of 2007 HR 2231 Medicare Access to Complex Rehabilitation and Assistive Technology Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2307 Preventing Medicare Seniors from being Confused due to Abusive Marketing (Prevent Medicare SCAMs) Act of 2007 HR 2549 . Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2007 HR 2567 Medicare Home Infusion Therapy Coverage Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2606 340B Program Improvement and Integrity Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 HR 2827 Medicare Equity and Accessibility Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 HR 2914 Medicare IVIG Access Act of 2007 See next page

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

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

S 3 Medicare Prescription Drug Price Negotiation Act of 2007 S 28 Generics First Act of 2007 S 130 Medicare Cost Contract Extension and Refinement Act of 2007 S 137 Preserving Medicare for All Act of 2007 S 158 Access to Affordable Health Care Act S 173 Medicare Health Savings Accounts Act of 2007 S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 250 The Medicare Enhancements for Needed Drugs Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 355 The Social Security and Medicare Solvency Commission Act S 358 Genetic Information Nondiscrimination Act of 2007 S 468 Food and Drug Administration Safety Act of 2007 S. 628 - Critical Access to Health Information Technology Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 885 Community Pharmacy Fairness Act of 2007 S 980 Online Pharmacy Consumer Protection Act of 2007 S 1082 Prescription Drug User Fee Amendments of 2007 S 1108 Medicare Part D Outreach and Enrollment Enhancement Act of 2007 S 1161 Medicare Medical Nutrition Therapy Act of 2007 S 1198 Catastrophic Health Coverage Promotion Act S 1218 Medicare for All Act S 1307 Medicare Provider Accountability Act S 1338 Access to Medicare Imaging Act of 2007 HR 4 Medicare Prescription Drug Price Negotiation Act of 2007 HR 205 Medicare Prescription Drug Enrollment Extension Act of 2007 HR 493 Genetic Information Nondiscrimination Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 971 Community Pharmacy Fairness Act of 2007 HR 1218 Medicare Prescription Drug Improvement Act HR 1277 Medicare Prescription Drug Benefits Gap Elimination Act of 2007 HR 1282 Medigap Access Improvement Act of 2007 HR 1310 Relief and Elimination of the Medicare Enrollment Deadline Penalty (REMEDY) Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 1521 Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2009 To repeal the Medicare cost containment provisions contained in subtitle A of title VIII of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. HR 2043 Medicare for All Act HR 2058 Helping Fill the Medicare Rx Gap Act of 2007 HR 2065 Medicare Drug Savings Through Choice Act of 2007 HR 2149 Healthcare Eligibility for Late Participants (HELP) in Medicare Part D Act of 2007 HR 2231 Medicare Access to Complex Rehabilitation and Assistive Technology Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2307 Preventing Medicare Seniors from being Confused due to Abusive Marketing (Prevent Medicare SCAMs) Act of 2007 HR 2549 . Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2007 HR 2567 Medicare Home Infusion Therapy Coverage Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2606 340B Program Improvement and Integrity Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 HR 2827 Medicare Equity and Accessibility Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 HR 2914 Medicare IVIG Access Act of 2007 See next page

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

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

S 3 Medicare Prescription Drug Price Negotiation Act of 2007 S 28 Generics First Act of 2007 S 130 Medicare Cost Contract Extension and Refinement Act of 2007 S 137 Preserving Medicare for All Act of 2007 S 158 Access to Affordable Health Care Act S 173 Medicare Health Savings Accounts Act of 2007 S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 250 The Medicare Enhancements for Needed Drugs Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 355 The Social Security and Medicare Solvency Commission Act S 358 Genetic Information Nondiscrimination Act of 2007 S 468 Food and Drug Administration Safety Act of 2007 S. 628 - Critical Access to Health Information Technology Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 885 Community Pharmacy Fairness Act of 2007 S 980 Online Pharmacy Consumer Protection Act of 2007 S 1082 Prescription Drug User Fee Amendments of 2007 S 1108 Medicare Part D Outreach and Enrollment Enhancement Act of 2007 S 1161 Medicare Medical Nutrition Therapy Act of 2007 S 1198 Catastrophic Health Coverage Promotion Act S 1218 Medicare for All Act S 1307 Medicare Provider Accountability Act S 1338 Access to Medicare Imaging Act of 2007 HR 4 Medicare Prescription Drug Price Negotiation Act of 2007 HR 205 Medicare Prescription Drug Enrollment Extension Act of 2007 HR 493 Genetic Information Nondiscrimination Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 971 Community Pharmacy Fairness Act of 2007 HR 1218 Medicare Prescription Drug Improvement Act HR 1277 Medicare Prescription Drug Benefits Gap Elimination Act of 2007 HR 1282 Medigap Access Improvement Act of 2007 HR 1310 Relief and Elimination of the Medicare Enrollment Deadline Penalty (REMEDY) Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 1521 Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2009 To repeal the Medicare cost containment provisions contained in subtitle A of title VIII of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. HR 2043 Medicare for All Act HR 2058 Helping Fill the Medicare Rx Gap Act of 2007 HR 2065 Medicare Drug Savings Through Choice Act of 2007 HR 2149 Healthcare Eligibility for Late Participants (HELP) in Medicare Part D Act of 2007 HR 2231 Medicare Access to Complex Rehabilitation and Assistive Technology Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2307 Preventing Medicare Seniors from being Confused due to Abusive Marketing (Prevent Medicare SCAMs) Act of 2007 HR 2549 . Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2007 HR 2567 Medicare Home Infusion Therapy Coverage Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2606 340B Program Improvement and Integrity Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 HR 2827 Medicare Equity and Accessibility Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 HR 2914 Medicare IVIG Access Act of 2007 See next page

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

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

S 3 Medicare Prescription Drug Price Negotiation Act of 2007 S 28 Generics First Act of 2007 S 130 Medicare Cost Contract Extension and Refinement Act of 2007 S 137 Preserving Medicare for All Act of 2007 S 158 Access to Affordable Health Care Act S 173 Medicare Health Savings Accounts Act of 2007 S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 250 The Medicare Enhancements for Needed Drugs Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 355 The Social Security and Medicare Solvency Commission Act S 358 Genetic Information Nondiscrimination Act of 2007 S 468 Food and Drug Administration Safety Act of 2007 S. 628 - Critical Access to Health Information Technology Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 885 Community Pharmacy Fairness Act of 2007 S 980 Online Pharmacy Consumer Protection Act of 2007 S 1082 Prescription Drug User Fee Amendments of 2007 S 1108 Medicare Part D Outreach and Enrollment Enhancement Act of 2007 S 1161 Medicare Medical Nutrition Therapy Act of 2007 S 1198 Catastrophic Health Coverage Promotion Act S 1218 Medicare for All Act S 1307 Medicare Provider Accountability Act S 1338 Access to Medicare Imaging Act of 2007 S 1376 340B Program Improvement and Integrity Act of 2007 S 1408 Health Information Technology Act of 2007 S 1505 Affordable Biologics for Consumers Act S 1507 Access to Medicare Data Act of 2007 S 1544 Medicare Quality Enhancement Act of 2007 S 1695 Biologics Price Competition and Innovation Act of 2007 HR 4 Medicare Prescription Drug Price Negotiation Act of 2007 HR 205 Medicare Prescription Drug Enrollment Extension Act of 2007 HR 493 Genetic Information Nondiscrimination Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 971 Community Pharmacy Fairness Act of 2007 HR 1218 Medicare Prescription Drug Improvement Act HR 1277 Medicare Prescription Drug Benefits Gap Elimination Act of 2007 HR 1282 Medigap Access Improvement Act of 2007 HR 1310 Relief and Elimination of the Medicare Enrollment Deadline Penalty (REMEDY) Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 1521 Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2009 To repeal the Medicare cost containment provisions contained in subtitle A of title VIII of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. HR 2043 Medicare for All Act HR 2058 Helping Fill the Medicare Rx Gap Act of 2007 HR 2065 Medicare Drug Savings Through Choice Act of 2007 HR 2149 Healthcare Eligibility for Late Participants (HELP) in Medicare Part D Act of 2007 HR 2231 Medicare Access to Complex Rehabilitation and Assistive Technology Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2307 Preventing Medicare Seniors from being Confused due to Abusive Marketing (Prevent Medicare SCAMs) Act of 2007 HR 2549 . Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2007 HR 2567 Medicare Home Infusion Therapy Coverage Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2606 340B Program Improvement and Integrity Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 HR 2827 Medicare Equity and Accessibility Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 HR 2914 Medicare IVIG Access Act of 2007 See next page

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

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

S 3 Medicare Prescription Drug Price Negotiation Act of 2007 S 28 Generics First Act of 2007 S 130 Medicare Cost Contract Extension and Refinement Act of 2007 S 137 Preserving Medicare for All Act of 2007 S 158 Access to Affordable Health Care Act S 173 Medicare Health Savings Accounts Act of 2007 S 242 Pharmaceutical Market Access and Drug Safety Act of 2007 S 250 The Medicare Enhancements for Needed Drugs Act of 2007 S 251 Pharmaceutical Market Access Act of 2007 S 273 Prescription Drug and Health Improvement Act of 2007 S 316 Preserve Access to Affordable Generics Act S 355 The Social Security and Medicare Solvency Commission Act S 358 Genetic Information Nondiscrimination Act of 2007 S 468 Food and Drug Administration Safety Act of 2007 S. 628 - Critical Access to Health Information Technology Act of 2007 S 976 Genomics and Personalized Medicine Act of 2007 S 885 Community Pharmacy Fairness Act of 2007 S 980 Online Pharmacy Consumer Protection Act of 2007 S 1082 Prescription Drug User Fee Amendments of 2007 S 1108 Medicare Part D Outreach and Enrollment Enhancement Act of 2007 S 1161 Medicare Medical Nutrition Therapy Act of 2007 S 1198 Catastrophic Health Coverage Promotion Act S 1218 Medicare for All Act S 1307 Medicare Provider Accountability Act S 1338 Access to Medicare Imaging Act of 2007 S 1376 340B Program Improvement and Integrity Act of 2007 S 1408 Health Information Technology Act of 2007 S 1505 Affordable Biologics for Consumers Act S 1507 Access to Medicare Data Act of 2007 S 1544 Medicare Quality Enhancement Act of 2007 S 1695 Biologics Price Competition and Innovation Act of 2007 HR 4 Medicare Prescription Drug Price Negotiation Act of 2007 HR 205 Medicare Prescription Drug Enrollment Extension Act of 2007 HR 493 Genetic Information Nondiscrimination Act of 2007 HR 788 Food and Drug Administration Safety Act of 2007 HR 971 Community Pharmacy Fairness Act of 2007 HR 1218 Medicare Prescription Drug Improvement Act HR 1277 Medicare Prescription Drug Benefits Gap Elimination Act of 2007 HR 1282 Medigap Access Improvement Act of 2007 HR 1310 Relief and Elimination of the Medicare Enrollment Deadline Penalty (REMEDY) Act of 2007 HR 1368 Personalized Health Information Act of 2007 HR 1432 Preserve Access to Affordable Generics Act HR 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 1521 Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D HR 1666 Health Care Price Transparency Promotion Act of 2007 HR 1902 Protecting Consumer Access to Generic Drugs Act of HR 1952 National Health Information Incentive Act of 2007 HR 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 HR 2009 To repeal the Medicare cost containment provisions contained in subtitle A of title VIII of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. HR 2043 Medicare for All Act HR 2058 Helping Fill the Medicare Rx Gap Act of 2007 HR 2065 Medicare Drug Savings Through Choice Act of 2007 HR 2149 Healthcare Eligibility for Late Participants (HELP) in Medicare Part D Act of 2007 HR 2231 Medicare Access to Complex Rehabilitation and Assistive Technology Act of 2007 HR 2273 Food and Drug Administration Improvement Act of 2007 HR 2307 Preventing Medicare Seniors from being Confused due to Abusive Marketing (Prevent Medicare SCAMs) Act of 2007 HR 2549 . Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2007 HR 2567 Medicare Home Infusion Therapy Coverage Act of 2007 HR 2592 Safe and Effective Drug Development Act of 2007 HR 2606 340B Program Improvement and Integrity Act of 2007 HR 2626 Comprehensive HealthCARE Act of 2007 HR 2827 Medicare Equity and Accessibility Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 HR 2914 Medicare IVIG Access Act of 2007 See next page

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

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