Pediatric Medical Device Safety and Improvement Act of 2007

-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

S. 555, SIMPLE Cafeteria Plan Act of 2007 H.R. 6898, Health-e Information Technology Act of 2008 H.R. 6357, Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 H.R. 2497/S.1481, Fair and Reliable Medical Justice Act of 2007 S. 2499, Medicare, Medicaid, and SCHIP Extension Act of 2007 S. 1544, Medicare Quality Enhancement Act of 2007 H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007 H.R.1666, Health Care Price Transparency Promotion Act of 2007 H.R. 3717/S. 1753, Healthy Workforce Act of 2007 H.R. 853, Wellness and Prevention Act of 2007 H.R. 5719, Taxpayer Assistance and Simplification Act of 2008, healthcare provisions S. 3118, A bill to amend titles XVIII and XIX of the Social Security Act to preserve beneficiary access to care by preventing a reduction in the Medicare physician fee schedule, to improve the quality of care by advancing value based purchasing, electronic health records, and electronic prescribing, and to maintain and improve access to care in rural areas, and for other purposes. S.2041, To amend the False Claims Act H.R. 4854, False Claims Act Correction Act of 2007 H.R. 3800, To advance the adoption of nationwide interoperable health information technology and to improve health care quality and reduce health care costs in the United States. H.R. 6049, Energy Improvement and Extension Act of 2008, healthcare provisions H.R. 2851, Michelle's Law, healthcare provisions H.R. 6983, Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 H.R. 6288, Retiree Health Account Act of 2008 H.R. 1494, Pediatric Medical Device Safety and Improvement Act of 2007 H. Con. Res. 405, Recognizing the first full week of April as `National Workplace Wellness Week' H.R. 6582, Small Business CHOICE Act of 2008 H.R. 5884/S.2449, Sunshine in Litigation Act of 2008 Issues related to the Medicare Modernization Act of 2003 including provisions dealing with Health Savings Accounts (no specific legislation introduced)

Client expense: $24,030,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Postal Regulatory Commission, SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

-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. 6331, Medicare Act of 2008 H.R. 1424, Mental Health and Addiction Equity Act of 2007 S. 558, Mental Health Parity Act of 2008 H.R. 6357, PRO(TECH)T Act of 2008 S. 1693, Wired for Health Care Quality Act S. 3101, Medicare Act of 2008, provisions on Electronic Prescribing, Medicare, Medicare Advantage and inclusion of care coordination projects, H.R. 5719, Taxpayer Assistance and Simplification Act of 2008 S. 2818, the Small Business Health Plans Act of 2008 H.R. 6288, Retiree Health Accounts Act H. Con. Res. 405, Workplace Wellness resolution H.R. 2851, Michelle's Law S. 555, SIMPLE Cafeteria Plan Act 2007 H Con Res 405, Recognizing the first full week of April as `National Workplace Wellness Week'. (Introduced in House) H.R. 5884/S.2449, Sunshine in Litigation Act of 2008 H.R. 4854/S.2041, To Amend the False Claims Act H.R. 3800, To amend the Public Health Service Act to promote the adoption of health information technology, and for other purposes H.R. 6049, Energy and Tax Extenders Act of 2008 H.R. 6983, Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 H.R. 6288, Retiree Health Account Act of 2008 H.R. 1494, Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 493/S. 358, Genetic Information Nondiscrimination Act of 2007 H.R. 4296/S. 2480, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 H.R. 6898, Health-e Information Technology Act of 2008 H.R. 2639, Promoting Health for Future Generations Act of 2007 S. 3234, Promoting Health for Future Generations Act of 2007 H.R. 2497, Fair and Reliable Medical Justice Act S.1481, Fair and Reliable Medical Justice Act H.R. 2499, Medicaid, and SCHIP Extension Act of 2007 S. 1544, Medicare Quality Enhancement Act of 2007 H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007 S. 1951, Fair Medicaid Drug Payment Act of 2007 H.R. 3140, Saving Our Community Pharmacies Act of 2007 H.R.241, Small Business Health Fairness Act of 2007 H.R.1666, Health Care Price Transparency Promotion Act H.R. 3717, Healthy Workforce Act of 2007 H.R. 853, Wellness and Prevention Act of 2007 H.R. 6357, Health Information Technology Act H.R. 6852, Small Business Cooperatives for Healthcare Options to Improve Coverage for Employees Act of 2008 (CHOICE) S. 1753, Healthy Workforce Act of 2007 S. 2795, Small Business Health Options Program Act of 2008 H.R. 3947, To amend the Internal Revenue Code of 1986 to provide for a carryforward of unused benefits in health flexible spending arrangements H.R. 3580, Food and Drug Administration Amendments Act of 2007 S. 3118, A bill to amend title XVIII of the Social Security Act to improve access to health care under the Medicare program for beneficiaries residing in rural areas. Implementation of Medicare Modernization Act of 2003 (Health Savings Accounts provisions)

Client expense: $20,600,000 · Firm income: Not reported

Government targets: Bureau of Land Management (BLM), Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Minerals Management Service, Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 1494 Pediatric Medical Device Safety and Improvement Act of 2007 issues relating to disclosure of payments to providers issues relating to the implementation of MDUFMA

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Improve the care and treatment of people with diabetes in H.R. 4836 and S. 2742, the National Diabetes Coordinator Act; H.R. 3544 and S. 2479, Catalyst for Better Diabetes Care Act; H.R. 2922 and S. 1302 (partial), the Preventing Diabetes in Medicare Act; H.R. 2762 and H.R. 1494, Reauthorize Special Diabetes Programs

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

S.1082/H.R. 2900 - Food and Drug Revitalization Act: to provide for reasonable limits for conflicts of interest on FDA advisory committees and to stimulate pediatric device development. Also, to include unique device identification systems for medical devices. H.R. 2900/S.1082 - Food and Drug Amendments Act of 2007: to provide for reasonable limits for conflicts of interest on FDA advisory committees and to stimulate pediatric device development. Also, to provide unique identification systems for medical devices. S.830/H.R. 1494 - Pediatric Medical Devices Safety and Improvement Act: to stimulate development of necessary medical devices for the pediatric population. H.R. 1956/H.R. 5629/H.R. 1038/S.623 - Regulation Devices Biologics and Combination Products by the FDA: to provide a pathway for follow-on biologics that would not allow for interchangeability without express physician approval. The Food and Drug Administration Globalization Act of 2008: to provide for the safety of medical devices manufactured in foreign countries. H.R. 6381 - Medical Device Safety Act of 2008: to amend the Food, Drug and Cosmetic Act with respect to liability under state and local requirements for medical devices.

Client expense: $271,000 · Firm income: Not reported

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

Improve the care and treatment of people with diabetes in H.R. 4836 and S. 2742, the National Diabetes Coordinator Act; H.R. 3544 and S. 2479, Catalyst for Better Diabetes Care Act; H.R. 2922 and S. 1302 (partial), the Preventing Diabetes in Medicare Act; H.R. 2762 and H.R. 1494, Reauthorize Special Diabetes Programs

Client expense: $350,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), 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.1082/H.R. 2900 - Food and Drug Revitalization Act: to provide for reasonable limits for conflicts of interest on FDA advisory committees and to stimulate pediatric device development. Also, to include unique device identification systems for medical devices. H.R. 2900/S.1082 - Food and Drug Amendments Act of 2007: to provide for reasonable limits for conflicts of interest on FDA advisory committees and to stimulate pediatric device development. Also, to provide unique identification systems for medical devices. S.830/H.R. 1494 - Pediatric Medical Devices Safety and Improvement Act: to stimulate development of necessary medical devices for the pediatric population. H.R. 1956/H.R. 5629/H.R. 1038/S.623 - Regulation Devices Biologics and Combination Products by the FDA: to provide a pathway for follow-on biologics that would not allow for interchangeability without express physician approval. The Food and Drug Administration Globalization Act of 2008: to provide for the safety of medical devices manufactured in foreign countries. H.R. 6381 - Medical Device Safety Act of 2008: to amend the Food, Drug and Cosmetic Act with respect to liability under state and local requirements for medical devices.

Client expense: $410,000 · Firm income: Not reported

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

H.R. 1494 Pediatric Medical Device Safety and Improvement Act of 2007 issues relating to disclosure of payments to providers issues relating to the implementation of MDUFMA

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

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

HR 2900, Food and Drug Administration Amendments Act of 2007 S 1082, Prescription Drug User Fee Amendments of 2007 HR1494 / S 830, Pediatric Medical Device Safety and Improvement Act of 2007 HR 2406, Healthcare Information Technology Enterprise Integration Act HR 3023, Drug and Medical Device Company Gift Disclosure Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Improve the care and treatment of people with diabetes in H.R. 4836 and S. 2742, the National Diabetes Coordinator Act; H.R. 3544 and S. 2479, Catalyst for Better Diabetes Care Act; H.R. 2922 and S. 1302 (partial), the Preventing Diabetes in Medicare Act; H.R. 2762 and H.R. 1494, Reauthorize Special Diabetes Programs

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

H.R. 1494 Pediatric Medical Device Safety and Improvement Act of 2007 Issues relating to disclosure of payments to providers Issues relating to the implementation of MDUFMA Issues relating to CHAMP Act

Client expense: Not reported · Firm income: $15,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

- HR 2900 Food and Drug Administration Amendments Act of 2007 - S. 1082 Food and Drug Administration Revitalization Act - HR 1494 Pediatric Medical Device Safety and Improvement Act of 2007 - Update to International Classification of Diseases coding to 10th revision (ICD-10) - HR 2419 Farm Bill

Client expense: $980,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Communications Commission (FCC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), UNDETERMINED, Veterans Affairs, Dept of (VA)

S. 1082/H.R. 2900 Reuthorization of the Medical Device User Fee and Modernization Act H.R. 1494/S.830 The Pediatric Medical Device Safety and Improvement Act

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

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

H.R. 3023, "Drug and Medical Device Company Gift Disclosure Act." H.R. 3580, "Food and Drug Administration Amendments Act of 2007." H.R. 1494/S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007"

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2900, Food and Drug Administration Amendments Act of 2007; S. 1082, Prescription Drug User Fee Amendments of 2007; HR 1494/S. 830, Pediatric Medical Device Safety and Improvement Act of 2007; HR 2406, Healthcare Information Technology Enterprise Integration Act; HR 3023, Drug and Medical Device Company Gift Disclosure Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- HR 2900 Food and Drug Administration Amendments Act of 2007 - S. 1082 Food and Drug Administration Revitalization Act - HR 1494 Pediatric Medical Device Safety and Improvement Act of 2007 - Update to International Classification of Diseases coding to 10th revision (ICD-10)

Client expense: $980,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Communications Commission (FCC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

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

HR 782-Fair Currency Act of 2007. A bill to provide that exchange-rate misalignment by any foreign nation is a counterviable export subsidy, and for other purposes. S. 364-Strengthening America’s Trade Laws Act. A bill to strengthen United States trade laws, and for other purposes. S. 460-Trade Complaint and Litigation Accountability Improvement Measures Act (Trade CLAIM Act). A bill to make determinations by the USTR reviewable by the Court of International Trade and to ensure that USTR considers petitions to enforce US Trade rights. S. 571-A bill to withdraw national trade relations treatment from, and apply certain provisions of title IV of the Trade Act of 1974 to, the products of the People’s Republic of China. HR 910-American Competitiveness and Adjustment Act. A bill to make certain modifications to the trade adjustment assistance program. HR 1042-Trade Promotion Authority Extension and Enhancement Act of 2007. A bill to extend trade promotion authority. HR-1127-American Manufacturing Competitiveness Act. A bill, as related to medical device manufacturers, to allow them that use products subject to countervailing or antidumping duty proceedings or use domestic like products to participate in those proceedings as interested parties, and for other purposes. HR 2900/ S. 1082-Prescription Drug User Fee Amendments of 2007. Bills to revise and extend user fees program including for medical devices, to enhance the postmarket authorities of the FDA with respect to the safety of medical devices, and for other programs. HR-1561/ S. 484-Enhancing Drug Safety and Innovation Act of 2007. Bills to improve oversight as related to drugs includes safety of medical devices in some provisions. HR-788/ S. 468-Food and Drug Administration Safety Act of 2007. Bills to create an electronic databank for clinical trials as relates to medical devices. HR 1494/ S. 830-Pediatric Medical Device Safety and Improvement Act of 2007. Bills to improve the process for development of needed pediatric medical devices. S. 1408-Health Information Technology Act of 2007. Bill to improve quality in health care by providing incentives for adoption of modern information technology. HR-2474-Consumer Product Safety Act. Bill to provide for an increased maximum civil penalty for violations under the Consumer Product Safety Act. HR 1908/ S. 1145-Patent Reform Act of 2007. Bills to provide for patent reform related to medical devices. S. 1256-Small Business Lending Reauthorization and Improvements Act of 2007. Bill to amend the Small Business Act to reauthorize loan programs under that Act, and for other purposes. HR 2138-Investment in America Act of 2007. Bill to permanently extend research credit and strengthen the alternative simplified credit for qualified research expenses. S. 41-Research Competitiveness Act of 2007. HR-1712-Research and Development Tax Credit Act of 2007. Bills to provide incentives to improve America’s research competitiveness, and for other purposes. HR 2419-Farm, Nutrition and Biotechnology Act of 2007. HR 1280-Pet Safety and Protection Act of 2007. HR-2193-Animal Protection Accountability Improvement Act. Bills to prohibit the use of live animals for marketing medical devices, and for other purposes. S. 122-Trade Adjustment Assistance Improvement Act of 2007. Bill to provide trade adjustment assistance as related to workers adversely affected by import competition. S. 1677-Currency Reform and Financial Markets Access Act of 2007. Bill to amend the Exchange Rates and International Economic Coordination Act of 1988. HR 1229-Nonmarket Economy Trade Remedy Act of 2007. Bill to amend the tariff Act of 1930 related to applying countervailing duties to nonmarket economy countries. HR-321-Currency Harmonization Initiative Through Neutralizing Action Act of 2005. HR 571-A bill to require additional tariffs on products on any nonmarket economy until the President certifies to Congress that the country is a market economy country, and to direct the Secretary of the Treasury to deposit the amounts generated from the tariffs into the Social Security trust funds. Bills to require additional tariffs to be imposed on Chinese products on the basis of rate of manipulation between the RMB and the Dollar, and for other purposes. HR 708-Trade Law Reform Act of 2007. Bill to amend US trade laws to address more effectively import crisis, and for other purposes. HR-2273-Food and Drug Administration Improvement Act of 2007. Bill to provide for deposit in the general fund of the Treasury of fees that are collected from manufacturers as related to medical devices and to terminate the authority of FDA to negotiate with manufacturers of medical devices on uses of the fees, and for other purposes.

Client expense: $1,550,356 · Firm income: Not reported

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

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

Comparative effectivness provisions in H.R. 2184, "Enhanced Health Care Value for All Act of 2007" Comparative effectiveness provisions in S. 3, "Medicare Prescription Drug Price Negotiation Act of 2007" H.R. 2900/S. 1082, Medical Device User Fee and Modernization Act reauthorizations H.R. 1494/S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007" Device safety provisions in H.R. 1561, "Enhancing Drug Safety and Innovation Act of 2007"

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Federal Communications Commission (FCC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Indian Health Service, Labor, Dept of (DOL), Natl Transportation Safety Board (NTSB), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, White House Office