Vaccine Shortage Preparedness Act of 2008

H.R. 4703, S. 2467, H.R. 4991 -- Vaccine Shortage Preparedness Act of 2008 S. 2467, H.R. 4703, H.R. 4991 -- A bill to amend the Social Security Act, the Federal Food, Drug and Cosmetic Act, and the Public Health Service Act issues related to pandemic flu preparedness funding S. 3678 -- Pandemic All Hazards Preparedness Act (Biodefense) S. 103 Combat Meth Act H.R. 1908 and S. 1710 -- Patient Reform Act H.R. 3162 -- Children's Health and Medicare Protection Act S. 1505 -- Affordable Biologics for Consumers Act S. 1695 -- Biolgoics Price Competition and Innovation Act Comparative effectiveness research Drug importation Direct to consumer advertising Drug safety legislation FDA funding Issues related to the use of thimerisol in vaccines

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5348 - American Health Benefits Program (AHBP) Act H.R. 6680 - The Community and AIDS and Hepatitis Act H.R. 2994/ S. 3387 - National Pain Care Policy Act of 2007 H.R. 5348 - American Health Benefits Program (AHBP) Act S. 1693 - Wired for Health Care Quality Act H.R. 4991 - Vaccine Shortage Preparedness Act of 2008 H.R. 4992 - Medicare Improvement Act of 2007 H.R. 4993 - Vaccines for the Uninsured Adult Act of 2008 S. 2476 - Improved Vaccine Supply Act H.R. 1108/ S. 625 - The Family Smoking Prevention and Tobacco Control Act (Docket Number: HHS-OS-2008-0011) HHS Proposed Rule on Ensuring that Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices In Violation of Federal Law (Docket Number: RIN-0906-AA44) HHS Proposed Rule on Designation of Medically Underserved Populations and Health Professional Shortage Areas

Client expense: $196,642 · Firm income: Not reported

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

Vaccine Issues Pandemic Influenza H. R. 4703, Vaccine Shortage Preparedness Act of 2008 H. R. 4704, Medicare Improvement Act of 2007 H.R. 4705, Vaccines for the Uninsured Adult Act of 2008 S. 3678 / PL 109-417 All Pandemic and All-Hazards Act Section 317 program issues H.R. 4993, Vaccines for the Uninsured Adult Act of 2008 H.R. 4992, Medicare Improvement Act of 2007 H.R. 4991, Vaccine Shortage Preparedness Act of 2008 H.R. 4990, Vaccines for Children Access Act of 2008 S.2466, Vaccines for the Uninsured Adult Act of 2008 S.2465, Vaccines for Children Access Act of 2008 S.2464, Medicare Improvement Act of 2007 S.2467, Vaccine Shortage Preparedness Act of 2008

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

HR 4703, S 2467, HR 4991 - Vaccine Shortage preparedness Act of 2008 S 2464, HR 4992, HR 4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare Part B S 2465 - Vaccines for Children Access Act of 2008 HR 5839 - Safeguarding America's Pharmaceuticals Act of 2008 S 3408 - Comparative Effectiveness Research Act of 2008 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 S 2467 - Vaccine shortage preparedness Act of 2008 S 3678 - /PL 109-417 All pandemic and all-hazards act - Section 317 program issues HR 970 and S 1378 - Dextromethorphan Distribution Act of 2007 S 103 - Combat Meth Act of 2005 HR 2207 - Agricultural Disaster Assistance and Western States Emergency - Unfinished business Appropriations Act of 2007 HR 1908 and S 1710 Patent Reform Act of 2007 HR 1 - Implementing the 9/11 Commission recommendations Act of 2007 HR 3162 - Children's Health and Medicare Protection Act of 2007 S 1505 - Affordable Biologics for Consumers Act S 1695 - Biologics Price Competition and Innovation Act of 2007 HR 1956 - Patent Protection and Innovative Biologic Medicines Act of 2007 HR 1038, S623 - Access to Life-Saving Medicine Act HR 4083 - Non-prescription Drug Modernization Act of 2007 HR 1308 - Legal Immigrant Children's Health Improvement Act of 2007 HR 5629 - Pathway for Biosimilars Act Comparative Effectiveness Research Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension

Client expense: $1,377,211 · Firm income: Not reported

H.R. 4703, S. 2467, H.R. 4991 - Vaccine Shortage Preparedness Act of 2008 S. 2464, H.R. 4992, H.R. 4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare, Part B S. 2465, H.R. 4702, H.R. 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program S. 2467, H.R. 4703, H.R. 4991 - a bill to amend the Social Security Act, the Federal Food, Drug and Cosmetic Act, and the Public Health Service Act to ensure a sufficient supply of vaccines and for other purposes Opposed efforts to amend the Federal Food, Drug and Cosmetic Act with respect to the sale of prescription drugs through the internet, and for other purposes. Lobbied to ensure that the Internet would not be used to import counterfeit and defective medical products H.R. 4705 - Vaccines for the Uninsured Adult Act of 2008 S. 3678 - Pandemic All Hazards Preparedness Act (Biodefense) S. 1505 - Affordable Biologics for Consumers Act S. 1695 Biologics Price Competition and Innovation Act of 2007, support enactment and follow-on Biologics legislation with amendments that strengthen FDA pathway and provide data exclusivity H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 1038 Access to Life-Saving Medicine Act S. 623 - Access to Life-Saving Medicine Act General matters related to vaccine industry stability, pandemic preparedness, avian influenza

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

H.R. 4703, S. 2467, H.R. 4991 -- Vaccine Shortage Preparedness Act of 2008 S. 2467, H.R. 4703, H.R. 4991 -- A bill to amend the Social Security Act, the Federal Food, Drug and Cosmetic Act, and the Public Health Service Act issues related to pandemic flu preparedness funding S. 3678 -- Pandemic All Hazards Preparedness Act (Biodefense) S. 103 Combat Meth Act H.R. 1908 and S. 1710 -- Patient Reform Act H.R. 3162 -- Children's Health and Medicare Protection Act S. 1505 -- Affordable Biologics for Consumers Act S. 1695 -- Biolgoics Price Competition and Innovation Act Comparative effectiveness research Drug importation Direct to consumer advertising Drug safety legislation FDA funding Issues related to the use of thimerisol in vaccines

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Vaccine Issues Pandemic Influenza H. R. 4703, Vaccine Shortage Preparedness Act of 2008 H. R. 4704, Medicare Improvement Act of 2007 H.R. 4705, Vaccines for the Uninsured Adult Act of 2008 S. 3678 / PL 109-417 All Pandemic and All-Hazards Act Section 317 program issues H.R. 4993, Vaccines for the Uninsured Adult Act of 2008 H.R. 4992, Medicare Improvement Act of 2007 H.R. 4991, Vaccine Shortage Preparedness Act of 2008 H.R. 4990, Vaccines for Children Access Act of 2008 S.2466, Vaccines for the Uninsured Adult Act of 2008 S.2465, Vaccines for Children Access Act of 2008 S.2464, Medicare Improvement Act of 2007 S.2467, Vaccine Shortage Preparedness Act of 2008

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

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

HR 4703, S 2467, HR 4991 - Vaccine Shortage preparedness Act of 2008 S 2464, HR 4992, HR 4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare Part B S 2465 - Vaccines for Children Access Act of 2008 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 S 2467 - Vaccine shortage preparedness Act of 2008 S 3678 - /PL 109-417 All pandemic and all-hazards act - Section 317 program issues HR 970 and S 1378 - Dextromethorphan Distribution Act of 2007 S 103 Combat Meth Act of 2005 HR 2207 - Agricultural Disaster Assistance and Western States Emergency - Unfinished business Appropriations Act of 2007 HR 1908 and S 1710 Patent Reform Act of 2007 HR 1 - Implementing the 9/11 Commission recommendations Act of 2007 HR 3162 - Children's Health and Medicare Protection Act of 2007 S 1505 Affordable Biologics for Consumers Act S 1695 Biologics Price Competition and Innovation Act of 2007 HR 1956 - Patent Protection and Innovative Biologic Medicines Act of 2007 HR 1038, S623 - Access to Life-Saving Medicine Act HR 4083 - Non-prescription Drug Modernization Act of 2007 HR 1308 - Legal Immigrant Children's Health Improvement Act of 2007 HR 5629 - Pathway for Biosimilars Act Comparative Effectiveness Research Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension

Client expense: $1,345,921 · Firm income: Not reported

H.R. 4703, S. 2467, H.R. 4991 - Vaccine Shortage Preparedness Act of 2008 S. 2464, H.R. 4992, H.R. 4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare, Part B S. 2465, H.R. 4702, H.R. 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program S. 2467, H.R. 4703, H.R. 4991 - a bill to amend the Social Security Act, the Federal Food, Drug and Cosmetic Act, and the Public Health Service Act to ensure a sufficient supply of vaccines and for other purposes Opposed efforts to amend the Federal Food, Drug and Cosmetic Act with respect to the sale of prescription drugs through the internet, and for other purposes. Lobbied to ensure that the Internet would not be used to import counterfeit and defective medical products H.R. 4705 - Vaccines for the Uninsured Adult Act of 2008 S. 3678 - Pandemic All Hazards Preparedness Act (Biodefense) S. 1505 - Affordable Biologics for Consumers Act S. 1695 Biologics Price Competition and Innovation Act of 2007, support enactment and follow-on Biologics legislation with amendments that strengthen FDA pathway and provide data exclusivity H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 1038 Access to Life-Saving Medicine Act S. 623 - Access to Life-Saving Medicine Act General matters related to vaccine industry stability, pandemic preparedness, avian influenza

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

H.R. 4703, S. 2467, H.R. 4991 -- Vaccine Shortage Preparedness Act of 2008 S. 2467, H.R. 4703, H.R. 4991 -- A bill to amend the Social Security Act, the Federal Food, Drug and Cosmetic Act, and the Public Health Service Act H.R. 970 and S. 1378 -- Dextromethorphan Distribution Act S. 3678 -- Pandemic All Hazards Preparedness Act (Biodefense) S. 103 Combat Meth Act H.R. 1908 and S. 1710 -- Patient Reform Act H.R. 3162 -- Children's Health and Medicare Protection Act S. 1505 -- Affordable Biologics for Consumers Act S. 1695 -- Biolgoics Price Competition and Innovation Act Comparative effectiveness research Drug importation Direct to consumer advertising Drug safety legislation FDA funding Issues related to the use of thimerisol in vaccines

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR4703, S2467, HR4991 - Vaccine Shortage Preparedness Act of 2008 S2464, HR4992, HR4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare part B S. 2465, HR 4702, HR 4990 A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. S. 2467, HR 4703, HR 4991 A bill to amend the Social Security Act, the Federal Food, Drug and Cosmetic Act, and the Public Health Service Act to ensure a sufficient supply of vaccines, and for other purposes. HR4705 - Vaccines for the Uninsured Adult Act of 2008 S3678 H.R. 970 and S. 1378 - Dextromethorphan Distribution Act of 2007 S.3678 Pandemic All Hazards Preparedness Act (Biodefense) S.103 Combat Meth Act of 2005 H.R. 2207 - Agricultural Disaster Assistance and Western States Emergency Unfinished Business Appropriations Act of 2007 H.R. 1908 and S. 1710 - Patent Reform Act of 2007 H.R 1 - Implementing the 9/11 Commission Recommendations Act of 2007 H.R. 3162 - Children's Health and Medicare Protection Act of 2007 S. 1505 Affordable Biologics for Consumers Act S. 1695 Biologics Price Competition and Innovation Act of 2007 H.R. 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 1038 Access to Life-Saving Medicine Act S.623 Access to Life-Saving Medicine Act H.R. 4083 Non-Prescription Drug Modernization Act of 2007 S. 2311 Non-Prescription Drug Modernization Act of 2007 Comparative Effectiveness Research Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension Best Pharmaceuticals for Children's Act Pediatric Research Equity Act Pharmaceuticals in water FDA Funding Reagan/Udall Foundation Counter Detailing

Client expense: $1,250,450 · Firm income: Not reported

Docket No. RIN 0919-AA01 Patient Safety and Quality Improvement Proposed Rule S. 2456 Influenza Vaccine Security Act S. 2465 Vaccines for Children Access Act of 2008 H.R. 4990 Vaccines for Children Access Act of 2008 H.R. 4702 Vaccines for Children Access Act of 2008 S. 2467 Vaccine Shortage Preparedness Act of 2008 H.R. 4703 Vaccine Shortage Preparedness Act of 2008 H.R. 4991 Vaccine Shortage Preparedness Act of 2008 S. 2476 Improved Vaccine Supply Act H.R. 4251 Flu Vaccine Availability Act of 2008 H.R. 4331 Attacking Viral Influenza Across Nations Act of 2008 S. 2466 Vaccines for the Uninsured Adult Act of 2008 H.R. 4705 Vaccines for the Uninsured Adult Act of 2008 H.R. 4993 Vaccines for the Uninsured Adult Act of 2008

Client expense: $164,946 · Firm income: Not reported

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

H.R. 4703, S. 2467, HR 4991 -- Vaccine Shortage Preparedness Act of 2008 S 2467, HR 4703, HR 4991 -- A bill to amend the Social Security Act, the Federal Food, Drug and Cosmetic Act, and the Public Health Service Act HR 970 and S 1378 -- Dextromethorphan Distribution Act of 2007 S 3678 -- Pandemic All Hazards Preparedness Act (Biodefense) S 103 Combat Meth Act of 2005 HR 1908 -- and S 1710 -- Patent Reform Act of 2007 HR 3162 -- Children's Health and Medicare Protection Act of 2007 S 1505 -- Affordable Biologics for Consumers Act S 1695 Biologics Price Competition and Innovation Act of 2007 Comparative effectiveness research Drug importation Direct to consumer advertising Drug safety legislation FDA funding Issues related to the use of thimerisol in vaccines

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4703, S. 2467, HR 4991 -- Vaccine Shortage Preparedness Act of 2008 S 2467, HR 4703, HR 4991 -- A bill to amend the Social Security Act, the Federal Food, Drug and Cosmetic Act, and the Public Health Service Act HR 970 and S 1378 -- Dextromethorphan Distribution Act of 2007 S 3678 -- Pandemic All Hazards Preparedness Act (Biodefense) S 103 Combat Meth Act of 2005 HR 1908 -- and S 1710 -- Patent Reform Act of 2007 HR 3162 -- Children's Health and Medicare Protection Act of 2007 S 1505 -- Affordable Biologics for Consumers Act S 1695 Biologics Price Competition and Innovation Act of 2007 Comparative effectiveness research Drug importation Direct to consumer advertising Drug safety legislation FDA funding Issues related to the use of thimerisol in vaccines

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4703, S. 2467, H.R. 4991 - Vaccine Shortage Preparedness Act of 2008 S. 2464, H.R. 4992, H.R. 4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare part B S. 2465, H.R. 4702, H.R. 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program S. 2467, H.R. 4703, H.R. 4991 - a bill to amend the Social Security Act, the Federal Food, Drug and Cosmetic Act, and the Public Health Service Act to ensure a sufficient supply of vaccines and for other purposes Opposed efforts to amend the Federal Food, Drug and Cosmetic Act with respect to the sale of prescription drugs through the internet, and for other purposes. Lobbied to ensure that the Internet would not be used to import counterfeit and defective medical products H.R. 4705 - Vaccines for the Uninsured Adult Act of 2008 S. 3678 - Pandemic All Hazards Preparedness Act (Biodefense) S. 1505 - Affordable Biologics for Consumers Act S. 1695 Biologics Price Competition and Innovation Act of 2007, support enactment and follow-on Biologics legislation with amendments that strengthen FDA pathway and provide data exclusivity H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 1038 Access to Life-Saving Medicine Act S. 623 - Access to Life-Saving Medicine Act General matters related to vaccine industry stability, pandemic preparedness, avian influenza

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

Medicaid Rebates H.R. 3162; H.R. 2764 S. 2499 Pharmaceutical Anti-Counterfeiting H.R. 3580; H.R. 2900 S. 1082 340B of the Public Health Service Act/Drug Prices for Covered Entitites Coverage of Different Entities S. 2499 Comparative Effectiveness Program Initiatives S. 2499 H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963 Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 Vaccines and Medicare Part B/Part D H.R. 4992

Client expense: $3,560,000 · Firm income: Not reported

Drug Safety H.R. 3580; H.R. 2900 S. 1082 Medicaid Rebates H.R. 3162 H.R. 2764 S. 2499 Comparative Effectiveness Program Initiatives H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963 S. 2499 Stem Cell Research Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Funding for Food and Drug Administration (Critical Path Initiative; Human Drug Review) H.R. 3161 S. 1859 H.R. 2764 340B of the Public Health Service Act/Drug Prices for Covered Entitites Coverage of Different Entities S. 2499 FDA Regulatory Processes for First-Time Filers Food & Drug Administration Amendments Act/Food & Drug Administration Revitalization Act (H.R. 3580; H.R. 2900; S. 1082) User Fees/FDA Waivers for Small Businesses Risk Management Plans and Post-market Authorities Clinical Trial Registry and Results Databases Preemption Pharmaceutical Anti-Counterfeiting Priority Review Vouchers for Approved New Tropical Disease Therapies Civil Monetary Penalties FDA Advisory Panels/Conflict of Interest Possible Follow-on Biologics Amendments Follow-on Biologics H.R. 1038 H.R. 1956 S. 1695 S. 623 Presciption Drug User Fees H.R. 3580; H.R. 2900 S. 1082 Vaccines for Children Program H.R. 4990 Vaccines for Uninsured Adults H.R. 4993 National Vaccine Immunization Rates National Vaccine Program Office Working Paper on Adolescent Immunization Influenza Immunization Physician Quality Reporting Inititiative Vaccine Financing National Vaccine Program Office Draft White Paper on Vaccine Financing Vaccines and Medicare Part B/Part D H.R. 4992 Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S. 1710; H.R. 2764) Emerging Diseases Regulatory Processes Emergency Use Authorization Genetic Testing Regulatory Oversight Infectious Disease Research Tax Credit S. 2351 Funding for State Children's Health Insurance Program S. 2086; S. 1893; S. 2499 H.R. 3162; H.R. 3963; H.R. 976 Pharmaceutical Anti-Counterfeiting H.R. 3580; H.R. 2900 S. 1082 Erythropiesis Stimulating Agents CMS National Coverage Decision

Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S.1710; H.R. 2764) Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764

Client expense: $3,560,000 · Firm income: Not reported

Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456

Client expense: $2,960,000 · Firm income: Not reported