Pediatric Research Improvement Act

H.R.1585, National Defense Authorization Act for Fiscal Year 2008; H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.2900, Food and Drug Administration Amendments Act of 2007; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; H.R.4083, Non-prescription Drug Modernization Act od 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.2331, Non-prescription Drug Modernization Act of 2007; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legisaltive proposals to extend federal contract prices to the retail section in the TRICARE program: H.R.1585, National Defense Authorization Act for Fiscal Year 2008; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legilsative proposals permitting importation of prescription drugs from overseas: H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.1082, Food and Drug Administration Revitalization Act; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legislative proposals regarding drug safety, clinical trial registries, DTC adverstising, and reauthorization of the Prescription Drug User Fee Act, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act: H.R.2900, Food and Drug Administration Amendments Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legislative proposals regarding FDA funding: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative proposals to ensure access to meth-safe alternative medicines: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development , Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative propsals to reform the OTC monograph system: H.R.4083, Non-prescription Drug Modernization Act of 2007; S.2331, Non-prescription Drug Modernization Act of 2007. Response to congressional investigation regarding ENHANCE study.

Client expense: $500,000 · Firm income: Not reported

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 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;

H.R.1585, National Defense Authorization Act for Fiscal Year 2008; H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.2900, Food and Drug Administration Amendments Act of 2007; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; H.R.4083, Non-prescription Drug Modernization Act od 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.2331, Non-prescription Drug Modernization Act of 2007; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legisaltive proposals to extend federal contract prices to the retail section in the TRICARE program: H.R.1585, National Defense Authorization Act for Fiscal Year 2008; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legilsative proposals permitting importation of prescription drugs from overseas: H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.1082, Food and Drug Administration Revitalization Act; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legislative proposals regarding drug safety, clinical trial registries, DTC adverstising, and reauthorization of the Prescription Drug User Fee Act, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act: H.R.2900, Food and Drug Administration Amendments Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legislative proposals regarding FDA funding: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative proposals to ensure access to meth-safe alternative medicines: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development , Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative propsals to reform the OTC monograph system: H.R.4083, Non-prescription Drug Modernization Act of 2007; S.2331, Non-prescription Drug Modernization Act of 2007. Response to congressional investigation regarding ENHANCE study.

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.

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.1585, National Defense Authorization Act for Fiscal Year 2008; H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.2900, Food and Drug Administration Amendments Act of 2007; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; H.R.4083, Non-prescription Drug Modernization Act od 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.2331, Non-prescription Drug Modernization Act of 2007; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legisaltive proposals to extend federal contract prices to the retail section in the TRICARE program: H.R.1585, National Defense Authorization Act for Fiscal Year 2008; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legilsative proposals permitting importation of prescription drugs from overseas: H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.1082, Food and Drug Administration Revitalization Act; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legislative proposals regarding drug safety, clinical trial registries, DTC adverstising, and reauthorization of the Prescription Drug User Fee Act, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act: H.R.2900, Food and Drug Administration Amendments Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legislative proposals regarding FDA funding: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative proposals to ensure access to meth-safe alternative medicines: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development , Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative propsals to reform the OTC monograph system: H.R.4083, Non-prescription Drug Modernization Act of 2007; S.2331, Non-prescription Drug Modernization Act of 2007. Response to congressional investigation regarding ENHANCE study.

SCHIP (Senate), Medicare cuts to finance SCHIP expansion H. R. 3162, CHAMP Act, Medicare cuts to finance SCHIP expansion S. 1376, 340B Program Improvement and Integrity Act of 2007, 340 B drug price expansion H. R. 2606, 340B Program Improvement and Integrity Act of 2007, 340 B drug price expansion S. 623, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, PDUFA, drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA, drug safety provisions H. R. 2900, Food and Drug Administration Amendments Act of 2007, PDUFA, drug safety provisions S. 467, FACT Act, clinical trials/drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions S. 1024, Safer DATA Act, clinical trials/drug safety provisions H. Con. Res. 99, Budget Resolution, drug importation, comparative effectiveness provisions S. Con. Res. 21, Budget Resolution, drug importation, comparative effectiveness provisions

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

H.R. 2723, S. 1226, "Children's Health Care Quality Act," all provisions. H.R. 1308, S. 764, "Legal Immigrant Children's Health Improvement Act," all provisions. S. 1156, "Best Pharamaceuticals For Children Amendments of 2007," all provisions. H.R. 2589, "Imporving Pharamecuticals for Children Act of 2007," all provisions. S. 993, "Pediatric Research Improvement Act," all provisions. H.R. 1494, S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007," all provisions. S. 1082, "Food and Drug Administration Revitalization Act," provisions relating to pharmaceutical and medical device testing for children. H.R. 2900, "Food and Drug Administration Amendments Act of 2007," provisions relating to pharmaceutical and medical device testing for children S. 1970, Addressing the Disaster Needs of Children Act, all provisions. S. 911/H.R. 1553, Conquer Childhood Cancer Act, all provisions. H.R. 4450, Pediatric, Adolescent, and Young Adult Cancer Survivorship Research and Quality of Life Act, all provisions.

Client expense: $834,165 · Firm income: Not reported

H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, PDUFA, drug safety provisions H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics H. R. 2638, Homeland Security Appropriations Act, drug importation provisions H. R. 2764, Foreign Operations and Related Programs Appropriations Act, 2008 H. R. 2900, Food and Drug Administration Amendments Act of 2007, PDUFA, drug safety provisions H. R. 3043, Labor-HHS-Education and Related Agencies Appropriations Act, diabetes research funding H. R. 3580, Food and Drug Administration Amendments Act of 2007 S. 1024, Safer DATA Act, clinical trials/drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA, drug safety provisions S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1644, Homeland Security Appropriations Act, drug importation provisions S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 1710, Labor-HHS-Education and Related Agencies Appropriations Act, diabetes research funding S. 1745, Commerce, Justice, Science and Related Agencies Appropriations Act, DEA drug importation language S. 2029, Physician Payments Sunshine Act of 2007 S. 467, FACT Act, clinical trials/drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions S. 1156, Best Pharmaceuticals for Children Amendments of 2007, pediatric exclusivity provisions in FDARA/PDUFA bill S. 623, Access to Life-Saving Medicine Act, follow-on biologics

H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics H. R. 2900, Food and Drug Administration Amendments Act of 2007, PDUFA, drug safety provisions H. R. 3580, Food and Drug Administration Amendments Act of 2007 S. 1024, Safer DATA Act, clinical trials/drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA, drug safety provisions S. 1156, Best Pharmaceuticals for Children Amendments of 2007, pediatric exclusivity provisions in FDARA/PDUFA bill S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 2029, Physician Payments Sunshine Act of 2007 S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions S. 4, Improving America's Security Act of 2007, cargo-screening provision S. 467, FACT Act, clinical trials/drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 623, Access to Life-Saving Medicine Act, follow-on biologics S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions H. R. 1, Implementing the 9/11 Commission Recommendations Act of 2007, cargo-screening provision H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, PDUFA, drug safety provisions

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

H. R. 2638, Homeland Security Appropriations Act, drug importation provisions H. R. 2764, Foreign Operations and Related Programs Appropriations Act, 2008, (Division A, Division G) H. R. 2900, Food and Drug Administration Revitalization Act, drug safety provisions H. R. 3093, Departments of Commerce and Justice, Science, and Related Agencies Appropriations Act, DEA drug importation language H.R. 3043, Labor, Heath/Human Services/Education/Related Agencies Appropriations Act, 2008 H.R. 3580, Food and Drug Administration Amendments Act of 2007 S. 1024, Safer DATA Act, clinical trials/drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, drug safety provisions S. 1156, Best Pharmaceuticals for Children Amendments of 2007, pediatric exclusivity provisions in FDARA/PDUFA bill S. 1505, Affordable Biologics for Consumers Act, follow-on biologics S. 1644, Homeland Security Appropriations Act, drug importation provisions S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 1710, Labor, Heath/Human Services/Education/Related Agencies Appropriations Act, 2008 S. 1745, Departments of Commerce and Justice, Science, and Related Agencies Appropriations Act, DEA drug importation language S. 2029, Physician Payments Sunshine Act of 2007 S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions S. 467, FACT Act, clinical trials/drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 623, Access to Life-Saving Medicine Act, follow-on biologics S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, drug safety provisions H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics

S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.2331, Non-prescription Drug Modernization Act of 2007; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legisaltive proposals to extend federal contract prices to the retail section in the TRICARE program: H.R.1585, National Defense Authorization Act for Fiscal Year 2008; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legilsative proposals permitting importation of prescription drugs from overseas: H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.1082, Food and Drug Administration Revitalization Act; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legislative proposals regarding drug safety, clinical trial registries, DTC adverstising, and reauthorization of the Prescription Drug User Fee Act, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act: H.R.2900, Food and Drug Administration Amendments Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legislative proposals regarding FDA funding: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative proposals to ensure access to meth-safe alternative medicines: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative propsals to reform the OTC monograph system: H.R.4083, Non-prescription Drug Modernization Act of 2007; S.2331, Non-prescription Drug Modernization Act of 2007. Response to congressional investigation regarding ENHANCE study. H.R.1585, National Defense Authorization Act for Fiscal Year 2008; H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.2900, Food and Drug Administration Amendments Act of 2007; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; H.R.4083, Non-prescription Drug Modernization Act od 2007;

H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, PDUFA/drug safety H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics H. R. 2638, Homeland Security Appropriations Act, drug importation provisions H. R. 2764, Foreign Operations and Related Programs Appropriations Act, 2008, (Division A & G) H. R. 2900, Food and Drug Administration Revitalization Act, PDUFA/drug safety H. R. 3043, Labor-HHS-Education and Related Agencies Appropriations Act, Medicare, healthcare, and drug pricing provisions H. R. 3580, Food and Drug Administration Amendments Act of 2007 S. 1024, Safer DATA Act, clinical trials/drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA/drug safety S. 1156, Best Pharmaceuticals for Children Amendmentsk, pediatric exclusivity provisions in FDARA/PDUFA bill S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1644, Homeland Security Appropriations Act, drug importation provisions S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 1710, Labor-HHS-Education and Related Agencies Appropriations Act, Medicare, healthcare, and drug pricing provisions S. 2029, Physician Payments Sunshine Act of 2007 S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 623, Access to Life-Saving Medicine Act, follow-on biologics S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions H. R. 1585, National Defense Authorization Act, drug pricing provisions S. 1547, National Defense Authorization Act, drug pricing provisions S. 467, FACT Act, clinical trials/drug safety provisions

H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, PDUFA and drug safety H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics H. R. 2764, Foreign Operations and Related Programs Appropriations Act, 2008, (Division A & G) H. R. 2900, Food and Drug Administration Amendments Act of 2007, PDUFA and drug safety H. R. 3043, Labor-HHS-Education and Related Agencies Appropriations Act, Medic H. R. 3580, Food and Drug Administration Amendments Act of 2007 S. 1024, Safer DATA Act, clinical trials and drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA and drug safety S. 1156, Best Pharmaceuticals for Children Amendments of 2007, pediatric exclusivity provisions in FDARA/PDUFA bill S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1644, Homeland Security Appropriations Act, drug importation provisions S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 1710, Labor-HHS-Education and Related Agencies Appropriations Act, Medicare, healthcare, and drug pricing provisions S. 2029, Physician Payments Sunshine Act of 2007 S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions S. 467, FACT Act, clinical trials and drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials and drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials and drug safety provisions S. 623, Access to Life-Saving Medicine Act, follow-on biologics S. 993, Pediatric Research Improvement Act, clinical trials and drug safety provisions S. 1745, Commerce, Justice, Science, and Related Agencies Appropriations Act, DEA drug importation language H. R. 2638, Homeland Security Appropriations Act, drug importation provisions

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;

H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, PDUFA, drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA, drug safety provisions H. R. 2900, Food and Drug Administration Amendments Act of 2007, PDUFA, drug safety provisions S. 467, FACT Act, clinical trials/drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions S. 1024, Safer DATA Act, clinical trials/drug safety provisions H. Con. Res. 99, Budget Resolution, drug importation, comparative effectiveness provisions S. Con. Res. 21, Budget Resolution, drug importation, comparative effectiveness provisions S. 1745, Commerce, Justice, Science and Related Agencies Appropriations Act, DEA drug importation language H. R. 2638, Homeland Security Appropriations Act, drug importation provisions S. 1644, Homeland Security Appropriations Act, drug importation provisions S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions S. 1156, Best Pharmaceuticals for Children Amendments of 2007, pediatric exclusivity provisions in FDARA/PDUFA bill S. 623, Access to Life-Saving Medicine Act, follow-on biologics

Client expense: Not reported · Firm income: $100,000

S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legisaltive proposals to extend federal contract prices to the retail section in the TRICARE program: H.R.1585, National Defense Authorization Act for Fiscal Year 2008; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legilsative proposals permitting importation of prescription drugs from overseas: H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.1082, Food and Drug Administration Revitalization Act; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legislative proposals regarding drug safety, clinical trial registries, DTC adverstising, and reauthorization of the Prescription Drug User Fee Act, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act: H.R.2900, Food and Drug Administration Amendments Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legislative proposals regarding FDA funding: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative proposals to ensure access to meth-safe alternative medicines: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008. H.R.1585, National Defense Authorization Act for Fiscal Year 2008; H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.2900, Food and Drug Administration Amendments Act of 2007; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007;

S. 1644, Homeland Security Appropriations Act, drug importation provisions H. Con. Res. 99, Budget Resolution, drug importation and comparative effectiveness provisions S. Con. Res. 21, Budget Resolution, drug importation and comparative effectiveness provisions S. 467, FACT Act, clinical trials and drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials and drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials and drug safety provisions S. 993, Pediatric Research Improvement Act, clinical trials and drug safety provisions S. 1024, Safer DATA Act, clinical trials and drug safety provisions H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, PDUFA and drug safety S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA and drug safety H. R. 2900, Food and Drug Administration Amendments Act of 2007, PDUFA and drug safety S. 623, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 1156, Best Pharmaceuticals for Children Amendments of 2007, pediatric exclusivity provisions in FDARA/PDUFA bill S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions S. 1745, Commerce, Justice, Science, and Related Agencies Appropriations Act, DEA drug importation language H. R. 2638, Homeland Security Appropriations Act, drug importation provisions

Client expense: Not reported · Firm income: $100,000

S. 4, Improving America's Security Act of 2007, cargo-screening provision S. 467, FACT Act, clinical trials/drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions S. 1024, Safer DATA Act, clinical trials/drug safety provisions H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, PDUFA, drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA, drug safety provisions H. R. 2900, Food and Drug Administration Amendments Act of 2007, PDUFA, drug safety provisions S. 623, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 1156, Best Pharmaceuticals for Children Amendments of 2007, pediatric exclusivity provisions in FDARA/PDUFA bill S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions H. Con. Res. 99, Budget Resolution, drug importation and comparative effectiveness provisions S. Con. Res. 21, Budget Resolution, drug importation and comparative effectiveness provisions H. R. 1, Implementing the 9/11 Commission Recommendations Act of 2007, cargo-screening provision

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

H. R. 2606, 340B Program Improvement and Integrity Act of 2007, 340 B drug price expansion S. 623, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, PDUFA, drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA, drug safety provisions H. R. 2900, Food and Drug Administration Amendments Act of 2007, PDUFA, drug safety provisions S. 467, FACT Act, clinical trials/drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions S. 1024, Safer DATA Act, clinical trials/drug safety provisions H. Con. Res. 99, Budget Resolution, drug importation, comparative effectiveness provisions S. Con. Res. 21, Budget Resolution, drug importation, comparative effectiveness provisions SCHIP (Senate), Medicare cuts to finance SCHIP expansion H. R. 3162, CHAMP Act, Medicare cuts to finance SCHIP expansion S. 1376, 340B Program Improvement and Integrity Act of 2007, 340 B drug price expansion

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

H. R. 3093, Departments of Commerce and Justice, Science, and Related Agencies Appropriations Act, DEA drug importation language H. R. 2642, Military Construction-VA and related Agencies Appropriations Act, diabetes care provisions S. 1645, Military Construction-VA and related Agencies Appropriations Act, diabetes care provisions H. Con. Res. 99, Budget Resolution, drug importation provisions S. Con. Res. 21, Budget Resolution, drug importation provisions S. 467, FACT Act, clinical trials/drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions S. 1024, Safer DATA Act, clinical trials/drug safety provisions H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, drug safety provisions H. R. 2900, Food and Drug Administration Revitalization Act, drug safety provisions S. 623, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics S. 1505, Affordable Biologics for Consumers Act, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 1156, Best Pharmaceuticals for Children Amendments of 2007, pediatric exclusivity provisions in FDARA/PDUFA bill S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions S. 1745, Departments of Commerce and Justice, Science, and Related Agencies Appropriations Act, DEA drug importation language H. R. 2638, Homeland Security Appropriations Act, drug importation provisions S. 1644, Homeland Security Appropriations Act, drug importation provisions

S. 1644 Homeland Security Appropriations Act, drug importion provisions H.Con Res. 99 Budget Resolution, drug importation and comparative effectiveness provisions S. Con. Res 21 Budget Resolution, drug imporatation and comparative effectiveness provisions S. 467, FACT Act, clinical trials and drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials and drug safety provisions S. 484, Enhancing Drug safety and Innovation Act of 2007, clinical trials and drug safety provisions S. 993, Pediatric Research Improvement Act, clinical trials and drug safety provisions S. 1024, Safe DATA Act, clinical trials and drug safety provisions HR 1561, Enhancing Drug safety and Innovation Act of 2007, PDUFA and Drug Safety S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA and drug safety HR 2900, Food and Drug Administration Amendments Act of 2007, PDUFA and drug safety S. 623, Access to Life-Saving Medicine Act, Follow-on Biologics HR 1038, Access to Life Saving Medicine Act, follow-on Biologics HR 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, Follow-on Biologics S. 1505, Affordable Biologics for Consumers Act of 2007, Follow-on Biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, Follow-on Biologics S. 1156, Best Pharmaceuticals for Children Amendments of 2007, pediatric exclusivity provisions in FDARA / PDUFA Bill S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions S. 1745 Commerce, Justice, Science, and Related Agencies Appropriations Act, DEA Drug importation language HR 2638, Homeland Security Appropriations Act, Drug Importation Provisions Product approval discussions with Deputy Director, Food and Drug Administration

Client expense: $920,000 · Firm income: Not reported

S. 1156, “Best Pharmaceuticals For Children Amendments of 2007,” all provisions. H.R. 2589, “Improving Pharmaceuticals for Children Act of 2007,” all provisions. S. 993, “Pediatric Research Improvement Act,” all provisions. H.R. 1494, S. 830, “Pediatric Medical Device Safety and Improvement Act of 2007,” all provisions. S. 1082, “Food and Drug Administration Revitalization Act,” provisions relating to pharmaceutical and medical device testing for children. H.R. 2900, “Food and Drug Administration Amendments Act of 2007,” provisions relating to pharmaceutical and medical device testing for children. H.R. 2723, S. 1226, “Children’s Health Care Quality Act,” all provisions. H.R. 1308, S. 764, “Legal Immigrant Children’s Health Improvement Act,” all provisions.

Client expense: $1,234,877 · Firm income: Not reported

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

S. 623, Access to Life-Saving Medicine Act, follow-on biologics H.R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics S. 1505, Affordable Biolgoics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics H.R. 1561, Enhancing Drug Safety and Innovaction Act of 2007, PDUFA, drug safety provisions S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA, drug safety provisions H.R. 2900, Food and Drug Administratio Amendments Act of 2007, PDUFA, drug safety provisions S. 467, FACT Act, clinical trials/drug safety provisions S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions S. 1024, Safer DATA Act, clinical trials/drug safety provisions H. Con. Res. 99, Budget Resolution, drug importation, comparative effectiveness provisions S. Con. Res. 21, Budget Resolution, drug importation, comparative effectiveness provisions SCHIP (Senate); Medicare cuts to finance SCHIP expansion H.R. 3162; CHAMP Act; Medicare cuts to finance SCHIP expansion S. 1376; 340B Program Improvement and Integrity Act of 2007, 340 B Drug Price Expansion H.R. 2606, 340B Proram Improvement and Intergrity Act of 2007, 340 B Drug Price Expansion

Client expense: $941,000 · Firm income: Not reported

S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 484, Enhancing Drug Safety and Innovation Act of 2007, clinical trials/drug safety provisions S. 993, Pediatric Research Improvement Act, clinical trials/drug safety provisions S. 1024, Safer DATA Act, clinical trials/drug safety provisions H. R. 1561, Enhancing Drug Safety and Innovation Act of 2007, PDUFA/drug safety S. 1082, Prescription Drug User Fee Amendments of 2007, PDUFA/drug safety H. R. 2900, Food and Drug Administration Revitalization Act, PDUFA/drug safety S. 623, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 1156, Best Pharmaceuticals for Children Amendmentsk, pediatric exclusivity provisions in FDARA/PDUFA bill S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, drug importation provisions H. R. 1585, National Defense Authorization Act, drug pricing provisions S. 1547, National Defense Authorization Act, drug pricing provisions S. 467, FACT Act, clinical trials/drug safety provisions

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

Appropriate Physician payment levels/systems Medical Records Confidentiality Deficit Reduction Act Children's access to health insurance Immunizations WIC national Immunizations program (administration) The Start Healthy, Stay Healthy Act Medikids Health Insurance Act of 2007 Ephedrine Alkaloid Consumer Protection Act Immunization Coding Issues Paul Wellstone Mental Health and Addiction Equity Act (HR 1424) Health Care Coverage Expansion and Quality Improvement Act Children's Access to Vision Improvement Act Pandemic Influenza Health Information Technology/Electronic Health Records Emergency Medical Services for Children Act Reauthorization Injury Prevention Best Pharmaceuticals for Children Act (HR 2589) Pediatric Research Equity Act (S.993) Children and Families HIV/AIDS Care and Research Act Pediatric Medical Device Safety and Improvement Act of 2007 (HR 1494/S. 830) Ryan White CARE Act Child Health Care Crisis Relief Act Enhancing Drug Safety and Innovation Act Mental Health Parity Lower PRICED Drugs Preemie Act Pediatrics Disaster Preparedness Education Begins at Home Act Child Maltreatment Foster Care and Adoption Native American Child Health Genetic Nondiscrimination Reauthorization of SCHIP S. 588 Resident Physician Shortage Reduction Act HR 3/S. 5 Stem Cell Research Enhancement Act HR 881 Mercury Free Vaccines Act HR 2184 Enhanced Health Care Value For All Act HR 2584 High Heed Physician Workforce Incentives Act S. 1576 Minority Health Improvement and Health Disparity Elimination Act HR 1153 Parental Right to Decide Protection Act Access to Life-Saving Medicine Act Biologics Price Competition and Innovation Act of 2007 Food and Drug Administration Revitalization Act S. 1082 Food and Drug Administration Amendments Act of 2007 HR 2900 Improving Pharmaceuticals for Children Act of 2007 HR 2589 Best Pharmaceuticals for Children Amendments of 2007 S. 1156 Pediatric Research Improvement Act S. 993 School-Based Health Clinics Establishment Act Early Hearing and Detection and Intervention Family Smoking Prevention and Tobacco Control Act Prescription Drug User Fee Act FACT Act State Children's Health Insurance Program (SCHIP) Managed Care Reform

Stem Cell Research Enhancement Act of 2005 HR 3/S.5 Clinical Trials Registry National Children's Study Preservation of Antibiotics of Medical Treatment Act Pediatric Medical Device Study and Improvement Act of 2007 HR 1424/S. 830 Ryan White CARE Act Patient Safety and Quality Improvement Act Best Pharmaceuticals for Children Act Preemie Act HR 2184 Enhanced Health Care Value For All Act S. 1576 Minority Health Improvement and Health Disparity Elimination Act Pediatric Research Equity Act Access to Life-Saving Medicine Act Biologics Price Competition and Innovation Act of 2007 Food and Drug Administration Revitalization Act S. 1082 Food and Drug Administration Amendments Act of 2007 HR 2900 Improving Pharmaceuticals for Children Act of 2007 HR 2589 Best Pharmaceuticals for Children Amendments of 2007 S. 1156 Pediatric Research Improvement Act S. 993 School-Based Health Clinics Establishment Act Early Hearing and Detection and Intervention Family Smoking Prevention and Tobacco Control Act Prescription Drug User Fee Act FACT Act

Client expense: $160,000 · Firm income: Not reported