Access to Life-Saving Medicine Act

H.R. 6257: Access to Life-Saving Medicine Act S. 4016: Access to Life-Saving Medicine Act S. 3807: Enhancing Drug Safety and Innovation Act of 2006 Implementation of H.R. 1 Medicare Prescription Drug & Modernization Act of 2003 Medicare and Medicaid Reimbursement Follow-On-Biologics FDA Drug Safety Oversight

Client expense: $5,620,000 · Firm income: Not reported

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

S. 3175, Life-Saving Medicines Export Act of 2006. H.R. 6257, Access to Life-Saving Medicine Act. S. 4016, Access to Life-Saving Medicine Act. Matters relating to the Best Pharmaceuticals for Children Act reauthorization and Pediatric Research Equity Act reauthorization. Matters relating to the Prescription Drug User Fee Act reauthorization. S. 3695, A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs. H.R. 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs. S. 3981, Citizen Petition Fairness and Accuracy Act of 2006. S. 2300, Lower PRICED Drugs Act. H.R. 6022, Lower PRICED Drugs Act. H.R. 5533, Biodefense and Pandemic Vaccine and Drug Development Act of 2006. S. 2564, Biodefense and Pandemic Vaccine and Drug Development Act of 2006, Sec. 5.

Client expense: $680,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

including generic access and comparative effectiveness (including H.R. 6257, S. 4016 and H.R. 6022, S. 2300) and policies that promote competition in the pharmaceutical marketplace -Advocated for value-based health care purchasing, including pay-for-performance legislation and health information technology -Advocated for policies promoting broad health coverage reform, including support for initiatives designed to reform retiree health liabilities that undermine competitiveness -Advocated for pharmaceutical cost-containment policies

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

including generic access and comparative effectiveness (including H.R. 6257, S. 4016 and H.R. 6022, S. 2300) and policies that promote competition in the pharmaceutical marketplace -Advocated for value-based health care purchasing, including pay-for-performance legislation and health information technology -Advocated for policies promoting broad health coverage reform, including support for initiatives designed to reform retiree health liabilities that undermine competitiveness -Advocated for pharmaceutical cost containment issues

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

including generic access and comparative effectiveness (including H.R. 6257, S. 4016 and H.R. 6022, S. 2300) and policies that promote competition in the pharmaceutical marketplace -Advocated for value-based health care purchasing, including pay-for-performance legislation and health information technology -Advocated for policies promoting broad health coverage reform, including support for initiatives designed to reform retiree health liabilities that undermine competitiveness -Advocated for pharmaceutical cost containment issues

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Generic Biologics (HR 6257, S 4016) The Lower Priced Drugs Act (S 2300, HR 6022) Release of Medicare Claims Database (Medicare Quality Enhancement Act, S 3900) Medicare Implementation issues Office of Generic Drug funding (HR 5384, FY 2007 Agriculture Appropriations) Transparency of Price and Quality Standards Bioshield/Biodefense legislation (S 1873, HR 5533, S 2564, S 3678) Comparative Effectiveness (HR 5647, S 3708, Labor-HHS FY 2007 Appropriations) Health Information Technology (S 1418, HR 4157) Health Savings Accounts (HR 4511, S 3585, HR 5743, HR 6111)

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

S. 3981, the Citizen Petition Fairness and Accuracy Act Abbreviated New Drug Application No. 76-396 for calcitonin-salmon nasal spray Hatch-Waxman Amendments S. 3582, the Preserve Access to Affordable Generics Act S. 3695, HR. 5993, to prohibit Authorized Generics during 180 day exclusivity HR 6257 & S. 4016, the Access to Life Saving Medicines Act S. 2300 & HR 6022, the Lower Priced Drugs Act

Client expense: $102,200 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 5 - Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2005; H.R. 4544 - 340B Program Revision and Expansion Act of 2005; S. 1840/H.R. 3547 Safety Net Inpatient Drug Affordability Act of 2005; S.4/S. 1503 - Healthy America Act of 2005; S. 1420/H.R. 3423 - Medical Device User Fee Stabilization Act of 2005; H.R. 2234 - 21st Century Health Information Act of 2005; S. 3685/H.R. 5993 - To amend the Federal Food, Drug and Comestic Act to prohinit the marketing of authorized generic drug; S. 1903 - Generic Presription Drug Fairness Act of 2005; S. 3582 - Preserve Access to Affordable Generic Act of 2006; S. 4016/H.R. 6257 - Access to Life-Saving Medicine Act of 2006; S. 306/H.R. 1227 - Genetic Information Non-Discrimination act of 2005 S. 334/S. 109 - Pharmacetuical Market Access and Drug Safety Act of 2005; S. 1418 - Wired for Health Care Quality Act of 2005; S. 1233 - Information Technology for Health Care Quality Act of 2005

Client expense: $1,040,000 · Firm income: Not reported

Biodefense (S 975) Authorized Generics FDA Administrative Issues Access to Generic Drugs Generic biologics ( HR 6257, S 4016) Pharmaceutical Patent Issues (HR 5120, HR 2795, S 3818) U.S. Free Trade Agreements (Korea, Malaysia, Peru) Appropriations (Agriculture - HR 5384) Medicaid - Deficit Reduction Act

Client expense: $311,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

Drug importation, drug safety issues, clinical trials Conflict of Interest, PDUFA, Drug pricing S 2766, national Defense Authorization Act for Fiscal Year 2007; drug pricing. HR 2090, Food and Drug Administration Improvement Act of 2005 HR 328, Pharmaceutical Market Access Act of 2005. S 3807, Enhancing Drug Safety and Innovation Act of 2006 S 4016, Access to Life-Saving Medicine Act HR 6257, Access to Life-Saving Medicine Act HR 700, Pharmaceutical Market Access and Drug Safety Act of 2005, Importation. S 109, Pharmaceutical Market Access Act of 2005. S 334 Pharmaceutical Market Access and Drug Safety Act of 2005. S 930, Food and Drug Administration Safety Act of 2005.

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

HR. 5009, Ryan White CARE Act Amendments of 2006 Issues relating to pharmaceutical compounding Issues relating to Medicare Part D Issues relating to CFC Supply and essentiality S. 3807, Enhancing Drug Safety and Innovation Act of 2006 S. 4016 and HR. 6257, Access to Life Saving Medicine Act S. 3695, relating to the prohibition of authorized generic drugs HR. 328, Pharmaceutical Market Access Act of 2005 S. 109, Pharmaceutical Market Access Act of 2005 HR. 6143, The Ryan White HIV/AIDS Treatment Modernization Act S. 2339, Ryan White CARE Act Amendments of 2006

Client expense: $713,336 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS)