Pharmaceutical Market Access and Drug Safety Act of 2007

S 657/Hr 727 Trauma Care Systems Planning and Development Act of 2007, Entire Bill S 242 MCAP Act, Entire Bill HR 2497/S1481, Fair and Reliable Medical Justice Act, Entire Bill

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-H.R. 2589, "Improving Pharmaceuticals for Children Act of 2007," regarding amending the Federal Food, Drug, and Cosmetics Act and the Public Health Service Act to reauthorize and amend the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. -S. 1156, Best Pharmaceuticals for Children Amendments of 2007, regarding amending the Federal Food, Drug, and Cosmetic Act to reauthorize the Best Pharmaceuticals for Children program; -S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, regarding amending the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs; -S. 251, Pharmaceutical Market Access Act of 2007, regarding amending the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs; -H.R. 4083 / S. 2311, "Non-Prescription Drug Modernization Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes; -S. 1951, "Fair Medicaid Drug Payment Act of 2007," regarding amending title XIX of the Social Security Act to ensure that individuals eligible for medical assistance under the Medicaid program continue to have access to prescription drugs, and for other purposes.

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

Norway IP, Finland IP, Poland (IP), Russa WTO accession (IP), Spain IP, Japan (IP), Korea FTA (IP), China (counterfeiting, IP), ASEAN (regulatory harmonization), Thailand (CLs), Philippines (IP), Intellectual Property Rights Enforcement Act (S. 522), Patent Reform Act (S 1145 & HR 1908), Canada (IP), Mexico (IP), Brazil (IP), Canada Market Access & Drug Safety (S 242), Algeria and Tunisia (IP), Egypt (IP), Saudi Arabia (IP), Per (FTA implementation), Argentina (IP), Chili (IP), European Union (market access) Follow-on biologics (HR 5629, HR 1956, S 623, S 1695, S 1505, HR 1038), IP Rights Enforcement Act (S 522)

Client expense: $2,860,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

United Kingdom (pricing reform), Italy (pricing and health care reform), Germany (pricing and health care reform), France (pricing and health care reform), Poland (market access & IP), Russia WTO accession (market access), European Union (market access), Spain (IP), Japan (pricing & regulatory reform), Korea FTA (pricing, regulatory & IP), ASEAN (regulatory harmonization), Thailand (CLs), Philippines (price control), Turkey (transparency & market access), Algeria (transparency), Latin America Free Trade Agreements, Canada (market access -- S 242), Norway (market access), China (pricing)

Client expense: $2,860,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Norway IP, Finland IP, Poland (IP), Russa WTO accession (IP), Spain IP, Japan (IP), Korea FTA (IP), China (counterfeiting, IP), ASEAN (regulatory harmonization), Thailand (CLs), Philippines (IP), Intellectual Property Rights Enforcement Act (S. 522), Patent Reform Act (S 1145 & HR 1908), Canada (IP), Mexico (IP), Brazil (IP), Canada Market Access & Drug Safety (S 242), Algeria and Tunisia (IP), Egypt (IP), Saudi Arabia (IP), Per (FTA implementation), Argentina (IP), Chili (IP), European Union (market access) Follow-on biologics (HR 5629, HR 1956, S 623, S 1695, S 1505, HR 1038), IP Rights Enforcement Act (S 522)

Client expense: $2,860,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

United Kingdom (pricing reform), Italy (pricing and health care reform), Germany (pricing and health care reform), France (pricing and health care reform), Poland (market access & IP), Russia WTO accession (market access), European Union (market access), Spain (IP), Japan (pricing & regulatory reform), Korea FTA (pricing, regulatory & IP), ASEAN (regulatory harmonization), Thailand (CLs), Philippines (price control), Turkey (transparency & market access), Algeria (transparency), Latin America Free Trade Agreements, Canada (market access -- S 242), Norway (market access), China (pricing)

Client expense: $2,860,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

S. 251, Pharmaceutical Market Access Act of 2007; S. 242/H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007; S. 2029/H.R. 5605, Physician Payment Sunshine Act of 2008; S. 558, Mental Health Parity Act of 2007; H.R. 1424, Paul Wellstone Health and Addiction Equity Act of 2007; S. 2723/H.R. 5549, Deamonte Driver Dental Access Act of 2008; H.R. 3580 - Food and Drug Administration Amendments Act of 2007

Client expense: $733,000 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

Medicare/General. H.R. 205, H.R. 748, H.R. 1218, H.R. 1277, H.R. 1310, H.R. 1521, H.R. 2009, H.R. 2056, H.R. 2065, H.R. 2149, H.R. 3025, H.R. 3061, H.R. 3162, H.R. 3932, H.R. 6331, S. 137, S. 250, S. 450, S. 706, S. 1887, S. 2089, S. 2115, S. 2219, S. 3101: provisions relating to enrollment periods and the late enrollment penalty, physician reimbursement rates, creating a Medicare-operated prescription drug plan, drug price negotiations, Medicare beneficiary improvements, repealing cost containment mandates, Medicare Advantage payments, Medicare Advantage stabilization fund, and comparative cost adjustment demonstration projects under the Medicare Modernization Act, therapy caps, liberalizing asset test limits, reducing the Part D benefit gap and guaranteeing prescription drug benefits. Medicare/Prescription Drug Price Negotiation. H.R. 4, H.R. 118, H.R. 5317, S. 3, S. 273: provisions pertaining to the negotiation of prescription drug prices under Medicare Part D. Medicare/Medicare Advantage. H.R. 2945: provision to provide beneficiary protections against excessive cost-sharing under the Medicare Advantage Program. Medicare/Importation of Prescription Drugs. S. 242, H.R. 380, S.Amdt. 4299: provisions pertaining to the importation of prescription drugs. Medicare/Outpatient Psychiatric Services. H.R. 1571, H.R. 1663, H.R. 4897, S. 1715, S. 1854: provisions to eliminate discriminatory copayment rates for outpatient psychiatric services under Medicare Part B. Medicare/Geriatric Assessments. H.R. 2244, S. 1340: provisions to provide Medicare beneficiaries with access to geriatric assessments and chronic care coordination services. Medicare/Generic Drugs Market Exclusivity. H.R. 1432, H.R. 1902, S. 316, S. 1088: pertaining to market exclusivity for generic drugs. Medicare/Prescription Drug Benefits for Low Income Beneficiaries. H.R. 470, H.R. 932, H.R. 1536, H.R. 2058, H.R. 3127, S. 1102, S. 1103, S. 1107, S. 1108, S. 2101: provisions affecting prescription drug benefits for low-income beneficiaries under Medicare Parts B and D. Medicare/Part B Late Enrollment. H.R. 2591: provision limiting the penalty for late enrollment under Medicare Part B. Medicare/Marketing. H.R. 2307, H.R. 4790, S. 1883, S. 2687: provisions relating to the marketing of Medicare Advantage and Medicare Part D plans. Medicare/Health Care Vouchers. H.R. 749: provision to establish health care vouchers for seniors. Medicare/Medicare Savings Accounts. H.R. 2639, S. 173, S. 1019: provisions pertaining to Medicare Savings Accounts. Medicare/End-of-Life Planning. S. 464, S. 465, S. 466: pertaining to advance directives and end-of-life planning. Medicare/Means-testing. H.R. 4295, H.R. 4330, S. 2414, S.Amdt. 4240: pertaining to means-testing of Medicare Part D. Medicare/Presidents Funding Warning. H.R. 5480, S. 2662: proposals responding to the Presidents Medicare funding warning. H. Res. 1368, to suspend section 803 of the Medicare Modernization Act of 2003 (known as the Medicare trigger") for the remainder of the 110th Congress. Medicare/24-month Waiting Period. H.R.154, S. 2101: provisions phasing out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits and eliminating the waiting period for individuals with life-threatening conditions. Medicaid/Federal Match. H.R. 5140: provisions pertaining to temporary increases in the federal Medicaid match. Medicaid/Targeted Case Management. Targeted Case Management: interim final rule to implement Section 6052 of the Deficit Medicaid/Targeted Case Management (continued). Reduction Act.

Client expense: $250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare/General. H.R. 205, H.R. 748, H.R. 1218, H.R. 1277, H.R. 1310, H.R. 1521, H.R. 2009, H.R. 2056, H.R. 2065, H.R. 2149, H.R. 3025, H.R. 3061, H.R. 3162, H.R. 3932, H.R. 6331, S. 137, S. 250, S. 450, S. 706, S. 1887, S. 2089, S. 2115, S. 2219, S. 3101: Medicare/General (continued). provisions relating to enrollment periods and the late enrollment penalty, physician reimbursement rates, creating a Medicare-operated prescription drug plan, drug price negotiations, Medicare beneficiary improvements, repealing cost containment mandates, Medicare Advantage payments, Medicare Advantage stabilization fund, and comparative cost adjustment demonstration projects under the Medicare Modernization Act, therapy caps, liberalizing asset test limits, reducing the Part D benefit gap and guaranteeing prescription drug benefits. Medicare/Prescription Drug Price Negotiation. H.R. 4, H.R. 118, H.R. 5317, S. 3, S. 273: provisions pertaining to the negotiation of prescription drug prices under Medicare Part D. Medicare/Medicare Advantage. H.R. 2945: provision to provide beneficiary protections against excessive cost-sharing under the Medicare Advantage Program. Medicare/Importation of Prescription Drugs. S. 242, H.R. 380, S.Amdt. 4299: provisions pertaining to the importation of prescription drugs. Medicare/Outpatient Psychiatric Services. H.R. 1571, H.R. 1663, H.R. 4897, S. 1715, S. 1854: provisions to eliminate discriminatory copayment rates for outpatient psychiatric services under Medicare Part B. Medicare/Geriatric Assessments. H.R. 2244, S. 1340: provisions to provide Medicare beneficiaries with access to geriatric assessments and chronic care coordination services. Medicare/Generic Drugs Market Exclusivity. H.R. 1432, H.R. 1902, S. 316, S. 1088: pertaining to market exclusivity for generic drugs. Medicare/Prescription Drug Benefits for Low Income Beneficiaries. H.R. 470, H.R. 932, H.R. 1536, H.R. 2058, H.R. 3127, S. 1102, S. 1103, S. 1107, S. 1108, S. 2101: provisions affecting prescription drug benefits for low-income beneficiaries under Medicare Parts B and D. Medicare/Part B Late Enrollment. H.R. 2591: provision limiting the penalty for late enrollment under Medicare Part B. Medicare/Marketing. H.R. 2307, H.R. 4790, S. 1883, S. 2687: provisions relating to the marketing of Medicare Advantage and Medicare Part D plans. Medicare/Health Care Vouchers. H.R. 749: provision to establish health care vouchers for seniors. Medicare/Medicare Savings Accounts. H.R. 2639, S. 173, S. 1019: provisions pertaining to Medicare Savings Accounts. Medicare/End-of-Life Planning. S. 464, S. 465, S. 466: pertaining to advance directives and end-of-life planning. Medicare/Means-testing. H.R. 4295, H.R. 4330, S. 2414, S.Amdt. 4240: pertaining to means-testing of Medicare Part D. Medicare/Presidents Funding Warning. H.R. 5480, S. 2662: proposals responding to the Presidents Medicare funding warning. H. Res. 1368, to suspend section 803 of the Medicare Modernization Act of 2003 (known as the Medicare trigger") for the remainder of the 110th Congress. Medicare/24-month Waiting Period. H.R.154, S. 2101: provisions phasing out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits and eliminating the waiting period for individuals with life-threatening conditions. Medicare/Identity Theft Prevention. H.R. 6600, provisions related to removal of Social Security numbers from Medicare cards. Medicaid/Federal Match. H.R. 5140: provisions pertaining to temporary increases in the federal Medicaid match. Medicaid/Targeted Case Management. Targeted Case Management: interim final rule to implement Section 6052 of the Deficit Reduction Act.

Client expense: $280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare/General. H.R. 205, H.R. 748, H.R. 1218, H.R. 1277, H.R. 1310, H.R. 1521, H.R. 2009, H.R. 2056, H.R. 2065, H.R. 2149, H.R. 3025, H.R. 3061, H.R. 3162, H.R. 3932, H.R. 6331, S. 137, S. 250, S. 450, S. 706, S. 1887, S. 2089, S. 2115, S. 2219, S. 3101: provisions relating to enrollment periods and the late enrollment penalty, physician reimbursement rates, creating a Medicare-operated prescription drug plan, drug price negotiations, Medicare beneficiary improvements, repealing cost containment mandates, Medicare Advantage payments, Medicare Advantage stabilization fund, and comparative cost adjustment demonstration projects under the Medicare Modernization Act, therapy caps, liberalizing asset test limits, reducing the Part D benefit gap and guaranteeing prescription drug benefits. Medicare/Prescription Drug Price Negotiation. H.R. 4, H.R. 118, H.R. 5317, S. 3, S. 273: provisions pertaining to the negotiation of prescription drug prices under Medicare Part D. Medicare/Medicare Advantage. H.R. 2945: provision to provide beneficiary protections against excessive cost-sharing under the Medicare Advantage Program. Medicare/Importation of Prescription Drugs. S. 242, H.R. 380, S.Amdt. 4299: provisions pertaining to the importation of prescription drugs. Medicare/Outpatient Psychiatric Services. H.R. 1571, H.R. 1663, H.R. 4897, S. 1715, S. 1854: provisions to eliminate discriminatory copayment rates for outpatient psychiatric services under Medicare Part B. Medicare/Geriatric Assessments. H.R. 2244, S. 1340: provisions to provide Medicare beneficiaries with access to geriatric assessments and chronic care coordination services. Medicare/Generic Drugs Market Exclusivity. H.R. 1432, H.R. 1902, S. 316, S. 1088: pertaining to market exclusivity for generic drugs. Medicare/Prescription Drug Benefits for Low Income Beneficiaries. H.R. 470, H.R. 932, H.R. 1536, H.R. 2058, H.R. 3127, S. 1102, S. 1103, S. 1107, S. 1108, S. 2101: provisions affecting prescription drug benefits for low-income beneficiaries under Medicare Parts B and D. Medicare/Part B Late Enrollment. H.R. 2591: provision limiting the penalty for late enrollment under Medicare Part B. Medicare/Marketing. H.R. 2307, H.R. 4790, S. 1883, S. 2687: provisions relating to the marketing of Medicare Advantage and Medicare Part D plans. Medicare/Health Care Vouchers. H.R. 749: provision to establish health care vouchers for seniors. Medicare/Medicare Savings Accounts. H.R. 2639, S. 173, S. 1019: provisions pertaining to Medicare Savings Accounts. Medicare/End-of-Life Planning. S. 464, S. 465, S. 466: pertaining to advance directives and end-of-life planning. Medicare/Means-testing. H.R. 4295, H.R. 4330, S. 2414, S.Amdt. 4240: pertaining to means-testing of Medicare Part D. Medicare/Presidents Funding Warning. H.R. 5480, S. 2662: proposals responding to the Presidents Medicare funding warning. Medicare/24-month Waiting Period. H.R.154, S. 2101: provisions phasing out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits and eliminating the waiting period for individuals with life-threatening conditions. Medicaid/Federal Match. H.R. 5140: provisions pertaining to temporary increases in the federal Medicaid match. Medicaid/Targeted Case Management. Targeted Case Management: Interim final rule to implement Section 6052 of the Deficit Reduction Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare/General. H.R. 205, H.R. 748, H.R. 1218, H.R. 1277, H.R. 1310, H.R. 1521, H.R. 2009, H.R. 2056, H.R. 2065, H.R. 2149, H.R. 3025, H.R. 3061, H.R. 3162, H.R. 3932, S. 137, S. 250, S. 450, S. 706, S. 1887, S. 2089, S. 2115, S. 2219: provisions relating to enrollment periods and the late enrollment penalty, physician reimbursement rates, creating a Medicare-operated prescription drug plan, drug price negotiations, Medicare beneficiary improvements, repealing cost containment mandates, Medicare Advantage payments, Medicare Advantage stabilization fund, and comparative cost adjustment demonstration projects under the Medicare Modernization Act, therapy caps, liberalizing asset test limits, Medicare Secondary Payer clarification, reducing the Part D benefit gap and guaranteeing prescription drug benefits. Medicare/Prescription Drug Price Negotiation. H.R. 4, H.R. 118, H.R. 5317, S. 3, S. 273: provisions pertaining to the negotiation of prescription drug prices under Medicare Part D. Medicare/Medicare Advantage. H.R. 2945: provision to provide beneficiary protections against excessive cost-sharing under the Medicare Advantage Program. Medicare/Importation of Prescription Drugs. S. 242, H.R. 380, S.Amdt. 4299: provisions pertaining to the importation of prescription drugs. Medicare/Outpatient Psychiatric Services. H.R. 1571, H.R. 1663, H.R. 4897, S. 1715, S. 1854: provisions to eliminate discriminatory copayment rates for outpatient psychiatric services under Medicare Part B. Medicare/Geriatric Assessments. H.R. 2244, S. 1340: provisions to provide Medicare beneficiaries with access to geriatric assessments and chronic care coordination services. Medicare/Generic Drugs Market Exclusivity. H.R. 1432, H.R. 1902, S. 316, S. 1088: pertaining to market exclusivity for generic drugs. Medicare/Prescription Drug Benefits for Low Income Beneficiaries. H.R. 470, H.R. 932, H.R. 1536, H.R. 2058, H.R. 3127, S. 1102, S. 1103, S. 1107, S. 1108, S. 2101: provisions affecting prescription drug benefits for low-income beneficiaries under Medicare Parts B and D. Medicare/Part B Late Enrollment. H.R. 2591: provision limiting the penalty for late enrollment under Medicare Part B. Medicare/Marketing. H.R. 2307, H.R. 4790, S. 1883, S. 2687: provisions relating to the marketing of Medicare Advantage and Medicare Part D plans. Medicare/Health Care Vouchers. H.R. 749: provision to establish health care vouchers for seniors. Medicare/Medicare Savings Accounts. H.R. 2639, S. 173, S. 1019: provisions pertaining to Medicare Savings Accounts. Medicare/End-of-Life Planning. S. 464, S. 465, S. 466: pertaining to advance directives and end-of-life planning. Medicare/Means-testing. H.R. 4295, H.R. 4330, S. 2414, S.Amdt. 4240: pertaining to means-testing of Medicare Part D. Medicare/Presidents Funding Warning. H.R. 5480, S. 2662: proposals responding to the Presidents Medicare funding warning. Medicare/24-month Waiting Period. H.R.154, S. 2101: provisions phasing out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits and eliminating the waiting period for individuals with life-threatening conditions. Medicaid/Federal Match. H.R. 5140: provisions pertaining to temporary increases in the federal Medicaid match. Medicaid/Targeted Case Management. Targeted Case Management: interim final rule to implement Section 6052 of the Deficit Reduction Act.

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

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

S.1082 Prescription Drug User Fee Amendments of 2007 H.R.2716 Reducing Fraudulant and Imitative Drugs Act of 2007 S.242/S.251 Pharmaceutical Marketing Access Act of 2007 The Prescription Drug Marketing Act and various other bills and amendments relating to anti-counterfeiting/pedigree issues. H.R.5839 Safeguarding America's Pharmaceuticals Act of 2008 Various bill and amendments relating to drug importation The Food and Drug Amendments Act of 2007 H.R.3610 Food and Drug Import Safety Act of 2007 Various bills and amendments relating to drug safety and inspection of foreign drug manufacturing facilities.

Client expense: $150,000 · Firm income: Not reported

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

S. 242 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 4854 False Claims Act Correction Act of 2007 S. 2029 False Claims Act Correction Act of 2007 H.R. 4703 Vaccine Shortage Preparedness Act of 2008 S. 2467 Vaccine Shortage Preparedness Act of 2008 S. 2476 Improved Vaccines Supply Act H.R. 3944 National Hepatitis B Act H.R. 5884 Sunshine in Litigation Act of 2008 S. 2449 Sunshine in Litigation Act of 2007 H.R. 5605 Physician Payments Sunshine Act of 2008 S. 2029 Physician Payments Sunshine Act of 2007 H.R. 3610 Food and Drug Import Safety Act of 2007 S. 3409 Drug and Device Accountability Act of 2008 H.R. 6381 Medical Device Safety Act of 2008 S. 3398 Medical Device Safety Act of 2008

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

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

S. 242 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 4854 False Claims Act Correction Act of 2007 S. 2029 False Claims Act Correction Act of 2007 H.R. 4703 Vaccine Shortage Preparedness Act of 2008 S. 2467 Vaccine Shortage Preparedness Act of 2008 S. 2476 Improved Vaccines Supply Act H.R. 3944 National Hepatitis B Act H.R. 5884 Sunshine in Litigation Act of 2008 S. 2449 Sunshine in Litigation Act of 2007 H.R. 5605 Physician Payments Sunshine Act of 2008 S. 2029 Physician Payments Sunshine Act of 2007 H.R. 3610 Food and Drug Import Safety Act of 2007 S. 3409 Drug and Device Accountability Act of 2008 H.R. 6381 Medical Device Safety Act of 2008 S. 3398 Medical Device Safety Act of 2008

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

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

IP -- Norway, Finland, Poland, Russia WTO accession, Spain, Japan, Korea FTA, China counterfeiting, Philippines, Canada, Mexico, Brazil, Algeria & Tunisia, Egypt, Saudia Arabia, Argentina, Chili; Intellectual Property Rights Enforcement Act (S 522), Patent Reform Act 2007 (S 1145 & HR 1908), Canada Market Access & Drug Safety (S 242)

Client expense: $2,895,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Security Agency (NSA), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 5839, Safeguarding America's Pharmaceuticals Act S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007 S. 596, Safe Internet Pharmacy Act of 2007 S. 251, Pharmaceutical Market Access Act of 2007 S. 207, Combat Methamphetamine Enhancement Act of 2007 H.R. 971, Community Pharmacy Fairness Act of 2007 S. 885, Community Pharmacy Fairness Act of 2007 H.R. 3140, Saving Our Community Pharmacies Act of 2007 H.R. 3193, Access to Community Pharmacy Preservation Act of 2007 H.R. 780, Counterfeit Drug Prevention Act of 2007 S. 2085, Patient and Pharmacy Protection Act of 2007 H.R. 6353, Online Pharmacy Consumer Act S. 1954, Pharmacy Access Improvement Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 3610, Food and Drug Import Safety Act of 2007 H.R. 5619, Combat Methamphetamine Enhancement Act of 2008

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

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

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: $520,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR.380, Pharmaceutical Market Access and Drug Safety Act of 2007 S.242, Pharmaceutical Market Access and Drug Safety Act of 2007 HR.2900, Food and Drug Administration Amendments Act of 2007 Diabetes treatment Comparative effectiveness Pharmaceutical import safety legislation Health care reform

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 H.R. 5629, Pathway for Biosimilars Act 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. 623, Access to Life-Saving Medicine Act, follow-on biologics Neglected Disease Issues Issues related to Drug Safety, Generic Biologics & Drug Approvals H.R. 380, "Pharmaceutical Market Access and Drug Safety Act of 2007" - Importation. S.251, Pharmaceutical Market Access & Drug Safety Act of 2007" - Importation. S.242, "Pharmaceutical Market Access & Drug Safety Act of 2007" H.R. 1561, Enhancing Drug Safety and Innovation Act of 2007 H.R. 3610 Food and Drug Import Safety Act of 2007 S. 4, Improving America's Security Act of 2007, cargo-screening provision

Client expense: $658,000 · Firm income: Not reported

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

H.R. 380/S. 242/S. 251, to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs. S. 596, to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of Internet pharmacies.

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

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 380/S. 242/S. 251, to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs. S. 596, to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of Internet pharmacies.

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

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

HR 380, S 623, Access to Life-Saving Medicine Act; Follow-on biologics, importation; HR 3610 Food and Drug Import Safety Act of 2007; Import safety; HR 5839, Safeguard Americans Pharmaceuticals Act; S 2029, Physician's Payment Sunshine Act; Reporting periodicity, pre-emption. HR 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; HR 3610, Food and Drug Import Safety Act of 2007: import safety HR 6151, Responsibilty in Drug and Device Advertising Act of 2008: Direct-to-consumer advertising; S 242, Pharmaceutical Market Acess and Drug Safety Act of 2007: importation; S 334, Healthy Americans Act: non-interference; S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs; S 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics; S 2663, CPSC Reform Act: importation; S 3398, Medical Device Safety Act of 2008: preemption issues; S 3409, Drug and Device Accountability Act of 2008: import safety

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 780, Counterfeit Drug Prevention Act, pharmaceutical counterfeiting S 2699, Neglected Diseases Elimination Act, promote R&D S 484, Enhancing Drug Safety and Innovation Act 2006 S 1082, FDA Revitalization Act 3/07 HR 2900, FDA Amendments Act 2007 S. 242, Pharmaceutical Market Access and Drug Safety Act 3/07 HR. 380, Pharmaceutical Market Access and Drug Safety Act 2/07

Client expense: $3,250,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

S. 242/H.R. 380- Pharmaceutical Market Access and Drug Safety Act of 2007- entire bill. S. 586/H.R. 1968- Community Health Workers Act of 2007- entire bill. S. 980/H.R. 6353- Online Pharmacy Consumer Protection Act of 2007- entire bill. S. 1240/H.R. 464- Compassionate Assistance for Rape Emergencies Act of 2007- entire bill. S. 1375- Mom's Opportunity to Access Health, Education, Research, and Support for Postpartum Depression Act/MOTHERS Act- entire bill. S. 1376/H.R. 2606- 340B Program Improvement and Integrity Act of 2007- entire bill. S. 2347/H.R. 4054- Prevention Through Affordable Access Act- entire bill. S. 1555/H.R. 2596- Access to Birth Control Act- entire bill. S.1800/H.R. 2064- Compassionate Care for Servicewomen Act- entire bill. S. 2731/ H.R. 5501- The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008- provisions related to family planning, sex education, abstinence, and abortion. H.R. 20- Melanie Blocker-Stokes Postpartum Depression Research and Care Act- entire bill. H.R. 1424- Paul Wellstone Mental Health and Addiction Equity Act of 2007- potential provision related to abortion and possible provision related to nominal drug pricing. H.R. 3014- The Health Equity and Accountability Act of 2007- entire bill. H.Res. 1131- Recognizing that the Centers for Disease Control and Prevention observes the month of April as National STD Awareness Month and urging the House of Representatives to focus greater attention on activities related to the prevention of STDs and screening and treatment for STDs- entire resolution. H.R. 6357- Protecting Records, Optimizing Treatment, and Easing Communication Through Health Care Technology Act- provisions on health care technology transition. H.R. 6100/S. 3040- Kid-Safe Chemicals Act of 2008- entire bill. H.R. 6906- H.I.V. Education and Prevention Act of 2008- entire bill. H.R. 6680- Community AIDS and Hepatitis Prevention Act- entire bill. H.R. 6358- Stop Abuse in Residential Treatment Programs Act of 2008- provision related to contraceptive access. H.R. 1237/S. 2510- Cytology Proficiency Improvement Act of 2008- entire bill. S. 20/ H.R. 7310- Protecting Patients and Health Care Act- entire bill. H.R. 7296- Midnight Rule Act- provision relating to the Department of Health and Human Services physician conscience regulation. S. 3297- Advancing Americas Priorities Act- provision related to nominal drug pricing. H.Con.Res. 400- Expressing the support of the Congress regarding the need to ensure health care for women and health care for all in national health care reform- entire resolution.

Client expense: $121,667 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation 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 H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: Direct-to-consumer drug advertising H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs

Client expense: $6,170,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

-H.R. 2589, "Improving Pharmaceuticals for Children Act of 2007," regarding amending the Federal Food, Drug, and Cosmetics Act and the Public Health Service Act to reauthorize and amend the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. -S. 1156, Best Pharmaceuticals for Children Amendments of 2007, regarding amending the Federal Food, Drug, and Cosmetic Act to reauthorize the Best Pharmaceuticals for Children program; -S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007, regarding amending the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs; -S. 251, Pharmaceutical Market Access Act of 2007, regarding amending the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs; -H.R. 4083 / S. 2311, "Non-Prescription Drug Modernization Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes; -S. 1951, "Fair Medicaid Drug Payment Act of 2007," regarding amending title XIX of the Social Security Act to ensure that individuals eligible for medical assistance under the Medicaid program continue to have access to prescription drugs, and for other purposes.

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

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

H.R. 3162, The Children's Health and Medicare Protection (CHAMP) Act of 2007 S. 2499, The Medicare, Medicaid and SCHIP Extension Act of 2007 H.R. 380/S. 242, Pharmaceutical Market Access Act of 2007 H.R. 1218, Medicare Prescription Drug Improvement Act of 2007

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S. 242 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 4854 False Claims Act Correction Act of 2007 S. 2029 False Claims Act Correction Act of 2007 H.R. 4703 Vaccine Shortage Preparedness Act of 2008 S. 2467 Vaccine Shortage Preparedness Act of 2008 S. 2476 Improved Vaccines Supply Act H.R. 3944 National Hepatitis B Act H.R. 5884 Sunshine in Litigation Act of 2008 S. 2449 Sunshine in Litigation Act of 2007 H.R. 5605 Physician Payments Sunshine Act of 2008 S. 2029 Physician Payments Sunshine Act of 2007 H.R. 3610 Food and Drug Import Safety Act of 2007 S. 3409 Drug and Device Accountability Act of 2008 H.R. 6381 Medical Device Safety Act of 2008 S. 3398 Medical Device Safety Act of 2008

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

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

S. 2029, Physicians Payment Sunshine Act: reporting periodicity, reporting amount, pre-emption. S. 558, Mental Health Parity Act of 2997: Medicaid rebate. H.R.380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation. H.R.1038, Access to Life Saving Medicine Act: follow-on biologics. H.R.3610, Food and Drug Import Safety Act of 2007: import safety. H.R. 5629, Pathway for Biosimilars Act: follow-on biologics. S.242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation. S.623, Access to Life-Saving Medicine Act: follow-on biologics. S.1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 2168, Identity Theft Enforcement and Restitution Act of 2007 H.R. 5938, To amend title 18, United States Code, to provide Secret Service protection to former Vice Presidents, and for other purposes H.R. 275, Global Online Freedom Act H.R. 5244, Credit Cardholders' Bill of Rights Act of 2008 H.R. 7323, FY09 Financial Services and General Government Appropriations H.R. 1776, Call Center Consumer's Right to Know Act H.R. 5793, Cell Tax Fairness Act of 2008 H.R. 853, Wellness and Prevention Act 2007 S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 1666, Health Care Price Transparency Promotion Act of 2007 S. 1019, Universal Health Care Choice and Access Act S. 2831, the Federal Trade Commission Reauthorization Act of 2008, including provisions related to FTC authority and the common carrier exemption.

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

Medicare/General. H.R. 205, H.R. 748, H.R. 1218, H.R. 1277, H.R. 1310, H.R. 1521, H.R. 2009, H.R. 2056, H.R. 2065, H.R. 2149, H.R. 3025, H.R. 3061, H.R. 3162, H.R. 3932, H.R. 6331, S. 137, S. 250, S. 450, S. 706, S. 1887, S. 2089, S. 2115, S. 2219, S. 3101: provisions relating to enrollment periods and the late enrollment penalty, physician reimbursement rates, creating a Medicare-operated prescription drug plan, drug price negotiations, Medicare beneficiary improvements, repealing cost containment mandates, Medicare Advantage payments, Medicare Advantage stabilization fund, and comparative cost adjustment demonstration projects under the Medicare Modernization Act, therapy caps, liberalizing asset test limits, reducing the Part D benefit gap and guaranteeing prescription drug benefits. Medicare/Prescription Drug Price Negotiation. H.R. 4, H.R. 118, H.R. 5317, S. 3, S. 273: provisions pertaining to the negotiation of prescription drug prices under Medicare Part D. Medicare/Medicare Advantage. H.R. 2945: provision to provide beneficiary protections against excessive cost-sharing under the Medicare Advantage Program. Medicare/Importation of Prescription Drugs. S. 242, H.R. 380, S.Amdt. 4299: provisions pertaining to the importation of prescription drugs. Medicare/Outpatient Psychiatric Services. H.R. 1571, H.R. 1663, H.R. 4897, S. 1715, S. 1854: provisions to eliminate discriminatory copayment rates for outpatient psychiatric services under Medicare Part B. Medicare/Geriatric Assessments. H.R. 2244, S. 1340: provisions to provide Medicare beneficiaries with access to geriatric assessments and chronic care coordination services. Medicare/Generic Drugs Market Exclusivity. H.R. 1432, H.R. 1902, S. 316, S. 1088: pertaining to market exclusivity for generic drugs. Medicare/Prescription Drug Benefits for Low Income Beneficiaries. H.R. 470, H.R. 932, H.R. 1536, H.R. 2058, H.R. 3127, S. 1102, S. 1103, S. 1107, S. 1108, S. 2101: provisions affecting prescription drug benefits for low-income beneficiaries under Medicare Parts B and D. Medicare/Part B Late Enrollment. H.R. 2591: provision limiting the penalty for late enrollment under Medicare Part B. Medicare/Marketing. H.R. 2307, H.R. 4790, S. 1883, S. 2687: provisions relating to the marketing of Medicare Advantage and Medicare Part D plans. Medicare/Health Care Vouchers. H.R. 749: provision to establish health care vouchers for seniors. Medicare/Medicare Savings Accounts. H.R. 2639, S. 173, S. 1019: provisions pertaining to Medicare Savings Accounts. Medicare/End-of-Life Planning. S. 464, S. 465, S. 466: pertaining to advance directives and end-of-life planning. Medicare/Means-testing. H.R. 4295, H.R. 4330, S. 2414, S.Amdt. 4240: pertaining to means-testing of Medicare Part D. Medicare/Presidents Funding Warning. H.R. 5480, S. 2662: proposals responding to the Presidents Medicare funding warning. H. Res. 1368, to suspend section 803 of the Medicare Modernization Act of 2003 (known as the Medicare trigger") for the remainder of the 110th Congress. Medicare/24-month Waiting Period. H.R.154, S. 2101: provisions phasing out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits and eliminating the waiting period for individuals with life-threatening conditions. Medicaid/Federal Match. H.R. 5140: provisions pertaining to temporary increases in the federal Medicaid match. Medicaid/Targeted Case Management. Targeted Case Management: interim final rule to implement Section 6052 of the Deficit Medicaid/Targeted Case Management (continued). Reduction Act.

Client expense: $250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.980: Online Pharmacy Consumer Protection Act of 2007 - Track and monitor. S.596: Safe Internet Pharmacy Act of 2007 - Track and monitor. S.554: Act For Our Kids - Track and monitor. HR 380: Pharmaceutical Market Access and Drug Safety Act of 2007 - Track and monitor. S. 242: Pharmaceutical Market Access and Drug Safety Act of 2007 - Track and monitor. H.R. 6353: Ryan Haight Online Pharmacy Consumer Protection Act of 2008 - Track and monitor.

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General healthcare issues related to pharmaceutical and biological products; Federal, Food, Drug and Cosmetic Act (21 USC 9); Public Health Service Act (42 USC 6A); Drug safety: Food and Drug Administration Amendments Act of 2007 (Public Law No: 110-85); Food and Drug Import Safety Act (HR 3610); Drug reimportation: Pharmaceutical Market Access Act (S. 251); Pharmaceutical Market Access and Drug Safety Act (S. 242/HR 380). Comparative Effectiveness: Comparative Effectiveness Research Act (S. 3408); Enhanced Health Care Value for All Act (HR 2184).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.1082 Prescription Drug User Fee Amendments of 2007 H.R.2716 Reducing Fraudulant and Imitative Drugs Act of 2007 S.242/S.251 Pharmaceutical Marketing Access Act of 2007 The Prescription Drug Marketing Act and various other bills and amendments relating to anti-counterfeiting/pedigree issues. H.R.5839 Safeguarding America's Pharmaceuticals Act of 2008 Various bill and amendments relating to drug importation The Food and Drug Amendments Act of 2007 H.R.3610 Food and Drug Import Safety Act of 2007 Various bills and amendments relating to drug safety and inspection of foreign drug manufacturing facilities.

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

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

S.1082 Prescription Drug User Fee Amendments of 2007 H.R.2716 Reducing Fraudulant and Imitative Drugs Act of 2007 S.242/S.251 Pharmaceutical Marketing Access Act of 2007 The Prescription Drug Marketing Act and various other bills and amendments relating to anti-counterfeiting/pedigree issues. H.R.5839 Safeguarding America's Pharmaceuticals Act of 2008 Various bill and amendments relating to drug importation The Food and Drug Amendments Act of 2007 H.R.3610 Food and Drug Import Safety Act of 2007 Various bills and amendments relating to drug safety and inspection of foreign drug manufacturing facilities.

Client expense: Not reported · Firm income: Not reported

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

General healthcare issues related to pharmaceutical and biological products; Federal, Food, Drug and Cosmetic Act (21 USC 9); Public Health Service Act (42 USC 6A); Drug safety: Food and Drug Administration Amendments Act of 2007 (Public Law No: 110-85); Food and Drug Import Safety Act (HR 3610); Drug reimportation: Pharmaceutical Market Access Act (S. 251); Pharmaceutical Market Access and Drug Safety Act (S. 242/HR 380). Follow-on biologics: Access to Life-Saving Medicine Act (HR 1038); Patient Protection and Innovative Biologic Medicines Act (HR 1956); Biologics Price Competition and Innovation Act (S. 1695); Pathway for Biosimilars Act (HR 5629). Comparative Effectiveness: Comparative Effectiveness Research Act (S. 3408); Enhanced Health Care Value for All Act (HR 2184).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General healthcare issues related to pharmaceutical and biological products; Federal, Food, Drug and Cosmetic Act (21 USC 9) Public Health Service Act (42 USC 6A); Drug safety: Food and Drug Administration Amendments Act of 2007 (Public Law No: 110-85); Food and Drug Import Safety Act (HR 3610); Drug reimportation: Pharmaceutical Market Access Act (S. 251); Pharmaceutical Market Access and Drug Safety Act (S. 242/HR 380). Follow-on biologics: Access to Life-Saving Medicine Act (HR 1038); Patient Protection and Innovative Biologic Medicines Act (HR 1956); Biologics Price Competition and Innovation Act (S. 1695); Pathway for Biosimilars Act (HR 5629). Comparative Effectiveness: Comparative Effectiveness Research Act (S. 3408); Enhanced Health Care Value for All Act (HR 2184).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007 S. 251, Pharmaceutical Market Access Act of 2007 S. 596, Safe Internet Pharmacy Act of 2007 H.R. 5839, Safeguarding America's Pharmaceuticals Act S. 207, Combat Methamphetamine Enhancement Act of 2007 H.R. 971, Community Pharmacy Fairness Act of 2007 S. 885, Community Pharmacy Fairness Act of 2007 H.R. 3140, Saving Our Community Pharmacies Act of 2007 H.R. 3193, Access to Community Pharmacy Preservation Act of 2007 H.R. 780, Counterfeit Drug Prevention Act of 2007 S. 2085, Patient and Pharmacy Protection Act of 2007 H.R. 6353, Online Pharmacy Consumer Act S. 1954, Pharmacy Access Improvement Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 3610, Food and Drug Import Safety Act of 2007 H.R. 5619, Combat Methamphetamine Enhancement Act of 2008

Client expense: Not reported · Firm income: $10,000

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

General healthcare issues related to pharmaceutical and biological products; Federal, Food, Drug and Cosmetic Act (21 USC 9); Drug safety: Food and Drug Administration Amendments Act of 2007 (Public Law No: 110-85); Food and Drug Import Safety Act (HR 3610); Drug reimportation: Pharmaceutical Market Access Act (S. 251); Pharmaceutical Market Access and Drug Safety Act (S. 242/HR 380

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 1893, Children's Health Insurance Program Reauthorization Act of 2007 (Expansion/extension of SCHIP ); S558/HR 1424, Mental Health Parity Act of 2007 (Secure equal treatment for mental health benefits); HR 1038/S 623, Access to Life-Saving Medicine Act (Biogenerics-approving generic Bio pharmaceuticals); S 316, Preserve Access to Affordable Generics Act (Regulate Generic/Brand patent settlements); S 1501/S 1695, Affordable Biologics for Consumers Act (Generic Bio-pharmaceuticals); S 334, Healthy Americans Act (Universal health coverage replaces employer coverage); S 1899, Universal Health Coverage Act of 2007 (Mandatory health insurance coverage); S 242/HR 380, Pharmaceutical Market Access and Drug Safety Act of 2007 (Drug importation-Canada, et al.); HR 1076/S616, HIPAA Recreational Injury Technical/Correction Act (Mandatory coverage for recretional activity); HR 676, United States National Health Insurance Act (National health insurance); HR 1368, Personalized Health Information Act of 2007 (Financial incentives for personal health records); S 1490, Federal Employees Electronic Personal Health Records Act of 2007 (health information technology); S 1544, Medicare Quality Enhancement Act of 2007 (CMS data release); S 1693, Wired for Health Care Quality Act (Health information technology); HR 1368, Personalized Health Information Act of 2007; HR 5422, TRUST in Health Information Act of 2008; S 1693, Wired for Health Care Quality Act; S 1814, Health Information Privacy and Security Act; HR 6357, ProTecht Act of 2008; HR 6898, Health Information Technology Act of 2008; HR 6582, Small Business Choice Act of 2008; S 2795, SHOP Act; HR 6210, SHOP Act; S 2818, Small Busienss Health Plans Act of 2008.

Client expense: $517,594 · Firm income: Not reported

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

S. 28 - To amend title XVIII of the Social Security Act to require the use of generic drugs under the Medicare part D prescription drug program when available unless the brand name drug is determined to be medically necessary. S. 1505 - Affordable Biologics for Consumers Act. S. 1695 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences, and for other purposes. S. 242 - Pharmaceutical Market Access and Drug Safety Act of 2007. S. 251 - Pharmaceutical Market Access Act of 2007. S. 1082 - Prescription Drug User Fee Amendments of 2007. H.R. 2900 - Food and Drug Administration Amendments Act of 2007. H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act. H.R. 1038 - Access to Life-Saving Medicine Act. H.R. 5629 - Pathway for Biosimilars Act H.R. 3610 - Food and Drug Import Safety Act of 2007 H.R. 3624 - Consumer Food Safety Act of 2007

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 780, Counterfeit Drug Prevention Act, pharmaceutical counterfeiting S 2699, Neglected Diseases Elimination Act, promote R&D S 484, Enhancing Drug Safety and Innovation Act 2006 S 1082, FDA Revitalization Act 3/07 HR 2900, FDA Amendments Act 2007 S. 242, Pharmaceutical Market Access and Drug Safety Act 3/07 HR. 380, Pharmaceutical Market Access and Drug Safety Act 2/07

Client expense: $3,070,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

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.5839, Safeguarding America's Pharmaceuticals Act S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007 S. 251, Pharmaceutical Market Access Act of 2007 S. 596, Safe Internet Pharmacy Act of 2007 S. 207, Combat Methamphetamine Enhancement Act of 2007 H.R. 971, Community Pharmacy Fairness Act of 2007 S. 885, Community Pharmacy Fairness Act of 2007 H.R. 3140, Saving Our Community Pharmacies Act of 2007 H.R. 3193, Access to Community Pharmacy Preservation Act of 2007 H.R. 780, Counterfeit Drug Prevention Act of 2007 S. 2085, Patient and Pharmacy Protection Act of 2007 H.R. 6353, Online Pharmacy Consumer Act S. 1954, Pharmacy Access Improvement Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 3610, Food and Drug Import Safety Act of 2007 H.R. 5619, Combat Methamphetamine Enhancement Act of 2008

Client expense: $205,000 · Firm income: Not reported

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