Biodefense and Pandemic Vaccine and Drug Development Act of 2005

HR 5533, Biodefense and Pandemic Vaccine and Drug Development Act of 52006 S 3678, pandemic and All-Hazards Preparedness Act. S 1873, Biodefense and Pandemic Vaccine and Drug Development Act of 2005 Anti-trust exemption.

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

Government targets: Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S 1873 - Biodefense and Pandemic vaccine and Drug Development Act of 2006. Liability reform for Vaccine, Pandemic Flu, Bitterroots Legislation. HR 5122 - National Defense Authorization Act for Fiscal Year 2007. S 2766 - Department of Defense Authorization Act for Fiscal Year 2007. HR 5533 - Biodefense and Pandemic Vaccine and Drug Development Act of 2006. S 3678 - Pandemic and All Hazards Preparedness Act.

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

Government targets: Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Bioshield reauthorization. S 1873 - Biodefense and Pandemic Vaccine and Drug Development Act of 2005. S 1437 - Bioterror and Pandemic Preparedness Protection Act. HR 5533 - Biodefense and Pandemic Vaccine and Drug Development Act of 2006. S 3807, Enhancing Drug Safety and Innovation Act of 2006. HR 6257, Access to Life-Saving Medicine Act. S 4016, Access to Life-Saving Medicine Act. HR 6143, Ryan White HIV/AIDS Treatment Modernization Act of 2006 Drug Safety, Clinical Trials, drug importation. HR 700/S 334 - Pharmaceutical Market Access and Drug Safety Act of 2005. S 109/HR 328 - Pharmaceutical Market Access Act of 2005. S 930 - Food and Drug Administration Safety Act of 2005.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Legislation regarding pandemic vaccine production: H.R.3970, Bioterror Pandemic Preparedness Protection Act; H.R.4062, Pandemic Preparedness Response Act; H.R.4603, Pandemic Seasonal Influenza Act of 2005; S.1437, Bioterror Pandemic Preparedness Protection Act;S.1821, Pandemic Preparedness Response Act; S.1873, Biodefense Pandemic Vaccine Drug Development Act of 2005; S.1880, National Biodefense Pandemic Preparedness Act of 2005. Preserve Access to Affordable Drugs Act of 2005; S.873, Medicare Prescription drug Savings and Choice Act of 2005; S.930, Food and Drug Administration Safety Act of 2005. Legislation controlling access to precursor chemicals for meth production and/or combating meth: H.R.1056, Methamphetamine Precursor Control Act of 2005; H.R.13, Clean, Learn, Educate, Abolish, Neutralize, and Undermine Production (CLEAN-UP) of Methamphetamine Act; H.R.1350, Methamphetamine Blister Pack Loophole Elimination Act of 2005; H.R.2335, Meth-Endangered Children Protection Act of 2005; H.R.313, Exile Meth Act; H.R.314, Combat Meth Act of 2005; H.R.3199, Patient Act H.R.1572, Preserving Access to Affordable Drugs Act of 2005; H.R.1626, Medicare Prescription Drug Improvement Act; H.R.1669, Pharmacy Benefit Manager Transparency Act of 2005; H.R.328, Pharmaceutical Market Access Act of 2005; H.R.417, Medical Innovation Prize Act of 2005; H.R.4660, Requiring Emergency Pharmaceutical Access for Individual Relief (REPAIR) Act of 2006; H.R.4663, Authorize the Secretary of HHS to Reimburse States for Expenditures Associated with the Implementation of the Medicare Prescription Drug Benefit for Dual Eligible Individuals; H.R.4665, Amend Title XIX of the Social Security Act to Provide for an Offset from the Medicaid Clawback for State Emergency Prescription Drug Expenditures for Medicare Dual-Eligible Individuals; H.R.4675, Medicare State Reimbursement Act of 2006; H.R.4685, Medicare Prescription Drug Emergency Guarantee Act of 2006; H.R.4715, Amend Title XVIII of the Social Secruity Act to Estend the 2006 Annual Coordinated Election Period for Medicare Prescription Drug Plans through August 15, 2006; H.R.4719, Patients Before Profits Act of 2006; H.R.4721, Require Secretary of HHS To Provide Federal Medicaid for State Costs Associated with Ensuring Access to Prescription Drug Benefits to Part D Eligible Individuals; H.R.700, Pharmaceutical Market Access and Drug Safety Act of 2005; H.R.752, Medicare Prescription Drug Savings and Choice Act of 2005; H.R.870, Pharmaceutical research and Manufacturers Accountability Act of 2005, PhRMA Act of 2005; S.109, Pharmaceutical Market Access Act of 2005; S.1128, Pharmaceutical Advertising and Prudent Purchasing Act; S.334, Pharmaceutical Market Access and Drug Safety Act of 2005; S.354, HEALTH Act of 2005, Health Efficient, Accessible, Low-Cost, timely Healthcare Act of 2005; S.764, Preserve Access to Affordable Drugs Act of 2005; S.873, Medicare Prescription drug Savings and Choice Act of 2005; S.930, Food and Drug Administration Safety Act of 2005. Methamphetamine Precursor Control Act of 2005; H.R.13, Clean, Learn, Educate, Abolish, Neutralize, and Undermine Production (CLEAN-UP) of Methamphetamine Act; H.R.1350, Methamphetamine Blister Pack Loophole Elimination Act of 2005; H.R.152, Preserving Access to Affordable Drugs Act of 2005; H.R.1572, Preserving Access to Affordable Drugs Act of 2005; H.R.1626, Medicare Prescription Drug Improvement Act; H.R.1669, Pharmacy Benefit Manager Transparency Act of 2005; H.R.2335, Meth-Endangered Children Protection Act of 2005; H.R.313, Exile Meth Act; H.R.314, Combat Meth Act of 2005; H.R.3199, Patient Act Reauthorization; H.R.328, Pharmaceutical Market Access Act of 2005; H.R.3324, Arrest Methamphetamine Act of 2005; H.R.3889, The Methamphetamine Elimination Act; H.R.3970, Bioterror Pandemic Preparedness Protection Act; H.R.4062, Pandemic Preparedness Response Act; H.R.4603, Pandemic Seasonal Influenza Act of 2005; H.R.4660, Requiring Emergency Pharmaceutical Access for Individual Relief (REPAIR) Act of 2006; H.R.4663, Authorize the Secretary of HHS to Reimburse States for Expenditures Associated with the Implementation of the Medicare Prescription Drug Benefit for Dual Eligible Individuals; H.R.4665, Amend Title XIX of the Social Security Act to Provide for an Offset from the Medicaid Clawback for State Emergency Prescription Drug Expenditures for Medicare Dual-Eligible Individuals; H.R.4675, Medicare State Reimbursement Act of 2006; H.R.4685, Medicare Prescription Drug Emergency Guarantee Act of 2006; H.R.4715, Amend Title XVIII of the Social Secruity Act to Estend the 2006 Annual Coordinated Election Period for Medicare Prescription Drug Plans through August 15, 2006; H.R.4719, Patients Before Profits Act of 2006; H.R.4721, Require Secretary of HHS To Provide Federal Medicaid for State Costs Associated with Ensuring Access to Prescription Drug Benefits to Part D Eligible Individuals; H.R.700, Pharmaceutical Market Access and Drug Safety Act of 2005; H.R.417, Medical Innovation Prize Act of 2005; H.R.752, Medicare Prescription Drug Savings and Choice Act of 2005; H.R.798, Methamphetamine Remediation Act of 2005; H.R.870, Pharmaceutical research and Manufacturers Accountability Act of 2005, PhRMA Act of 2005; S.103, Combat Meth Act of 2005; S.109, Pharmaceutical Market Access Act of 2005; S.1128, Pharmaceutical Advertising and Prudent Purchasing Act; S.1361, A bill to amend the Controlled Substances Act to treat drug offenses involving crystal meth similarly to drug offenses involving crack cocaine; S.1437, Bioterror Pandemic Preparedness Protection Act; S.1821, Pandemic Preparedness Response Act; S.1873, Biodefense Pandemic Vaccine Drug Development Act of 2005; S.1880, National Biodefense Pandemic Preparedness Act of 2005; S.334, Pharmaceutical Market Access and Drug Safety Act of 2005; S.354, HEALTH Act of 2005, Health Efficient, Accessible, Low-Cost, timely Healthcare Act of 2005; S.764, H.CON.RES.75, Expressing the sense of the congress that the illegal importation of prescription drugs severely undermines the regulatory protections afforded to the United States consumers, and for other purposes; H.R.1056,

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2795 Patent Reform Act of 2005. Various biodefense and vaccine and drug development bills including S.3, S. 975, S. 2564, S. 1873, and S. 3678.

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

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Council of Economic Advisers (CEA), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Highway Traffic Safety Administration (NHTSA), Natl Security Council (NSC), Natl Transportation Safety Board (NTSB), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of Thrift Supervision (OTS), Office of the Comptroller of the Currency (OCC), Overseas Private Investment Corp (OPIC), SENATE, State, Dept of (DOS), Surface Transportation Board (STB), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)

Flu vaccine, specifically CDC recommendations S.3673,Pandemic and All Hazards Preparedeness Act of 2005 - provisions relating to pandemic vaccine development S.3, Protecting Americans in the war on Terror Act of 2005 - provisions dealing with vaccines S.1873,Biodefense and Pandemic Vaccine and Drug Development Act of 2005 - provisions relating to pandemic vaccine development

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

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

H.R. 3199--USA PATRIOT and Terrorism Prevention Reauthorization Act--research initiatives H.R. 4437--Border Protection, Antiterrorism, and Illegal Immigration Control Act of 2005--research initiatives (continued on next page) H.R. 4659--Amendment of USA PATRIOT Act to extend sunset--research initiatives H.R. 4830--Border Tunnel Prevention Act of 2006--research initiatives H.R. 4954--Security and Accountability for Every Port (SAFE) Act--homeland security and research initiatives H.R. 5337--National Security Foreign Investment Reform and Strengthened Transparency Act--research initiatives H.R. 5441--FY2007 Homeland Security Appropriations Bill--funding for research initiatives H.R. 5825--Electronic Surveillance Modernization Act--research initiatives H.R. 6061--Secure Fence Act of 2006--research initiatives H.R. 6094--Community Protection Act of 2006--research initiatives S. 975--Project BioShield II Act--funding for research initiatives S. 1873--Biomedical Advanced Research and Development Authority--funding for research initiatives S. 2271--USA PATRIOT Act, Additional Reauthorizing Amendments--research initiatives S. 2453--National Security Act of 2006--research initiatives S. 2455--Terrorism Surveillance Act of 2006--research initiatives S. 2564--Biodefense and Pandemic Vaccine and Drug Development Act of 2006--funding for vaccine development and drug discovery research S. 3001--Foreign Intelligence Surveillance Improvement and Enhancement Act of 2006--research initiatives S. 3678--Pandemic and All-Hazards Preparedness Act--research initiatives S. 3929--Authorization of Military Commissions to Bring Terrorists to Justice and Modernize Surveillance Capabilities--research initiatives S. 3931--Terrorist Surveillance Act of 2006--research initiatives

Client expense: $260,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3010-Appropriations for the Departments of Labor/HHS/Education-funding for research initiatives & student financial aid H.R. 5356-Research for Competitiveness Act-student and teacher training for competitive economy (continued on next page) H.R. 5646-Promotion of Energy Efficient Computer Servers-student and faculty IT needs H.R. 6164--NIH Health Reform Act--funding for research initiatives S. 1873--Biomedical Advanced Research and Development Authority--funding for research initiatives S. 2754--Alternative Pluripotent Stem Cell Therapies Enhancement Act of 2006--stem cell research S. 3504--Fetus Farming Prohibition Act--stem cell research S. 3708--FY2007 Labor/HHS/Education Appropriations Bill--research funding and student financial aid

Client expense: $260,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 3 - Protecting America in the War on Terror Act of 2005; S.2564/H.R. 5533 - BioDefense and Pandemic Vaccine and Drug Development Act of 2006; S. 1873 - BioDefence and Pandemic Vaccine and Drug Development Act of 2005; S. 3678 Pandemic and ALL-Hazards Preparedness Act

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

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

H.R. 5533 & S. 1873 - Biodefense and Pandemic Vaccine and Drug Development Act - provisions relating to Avian flue preparedness; S. 975 - Project BioShield II Act of 2005 - all provisions; S. 3678 - Pandemic and All-Hazards Preparedness Act - all provisions (became P.L. 109 - 417).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.5533, Biodefense and pandemic vaccine and drug development act of 2006, all provisions related to pandemic preparedness. S.2564, A bill to prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness and for other purposes, all provisions related to pandemic preparedness. S.3678, A bill to amend the Public Health Service Act with respect to public health security and all-hazards preparedness and response, and for other purposes, all provisions related to pandemic preparedness. P.L.109-417, The Pandemic and All-Hazards Preparedness Act, all provisions related to pandemic preparedness. S.975, Project BioShield II Act of 2005, all provisions related to pandemic preparedness. H.J.RES.102, A bill making further continuing appropriations for the fiscal year 2007, and for other purposes, all provisions related to preparedness and FDA (DOD, Agriculture). P.L.109-383, A bill making further continuing appropriations for fiscal year 2007, and for other purposes, all provisions related to preparedness and FDA (DOD, Agriculture). S.1873, Biodefense and Pandemic Vaccine and Drug Development Act of 2005, all provisions related to pandemic preparedness. S.2766, National Defense Authorization Act for 2007, all provisions relating to influenza preparedness and monies allocated for the U.S. Army medical research for infectious disease. H.R.5631, A bill to provide Department of Defense appropriations, all provisions relating to influenza preparedness and monies allocated for the US Army medical research for infectious disease.

Client expense: $610,861 · Firm income: Not reported

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

HR 5115-U.S Healthcare Technologies Competitiveness Act of 2006 (Bill to modernize the tax treatment as related to medical devices and biomedical research corporations) HR 4388-Tax Revision Act of 2005 (Bills to amend the Internal Revenue Code of 1986 to extend certain expiring provisions) HR 4297-Tax Relief Extension Reconciliation Act of 2005 (Bill to extend credit for increasing research activities) HR 4845-Innovation and Competitiveness Act HR 1736/S 627-Investment in America Act of 2005 (Bills to make permanent the tax credit for increasing research activities) S 978-Healthcare Tax Relief for the Uninsured Act of 2005 HR 1872-Health Coverage for the Uninsured Act of 2005 (Bills to provide tax incentives for the purchase of quality health care, and for other purposes) HR 5-Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2005 (Bill to provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system) HR 6406-The Tax Relief and Health Care Act of 2006 (Bill to improve temporarily certain rates of duty and make other technical amendments to the trade laws, and to extend certain trade preference programs) S Cong Res 67/H Cong Res 311-Concurrent resolution urging Japan to honor its commitments under the 1986 Market-Oriented Sector-Selective (MOSS) Agreement on Medical Equipment and for other purposes (Bill to reduce regulatory barriers to the approval and adoption of new medical technologies) S 2467-United States Trade Enhancement Act of 2006 (Congressional resolutions on trade enforcement efforts as relates to trade with China) S 295-To authorize appropriate action if the negotiations with the People’s Republic of China’s undervalued currency are not successful) (Bill to impose an additional duty of 27.5% on Chinese imports) HR 3004-Currency Harmonization Initiative through Neutralizing Action Act of 2005 (Bill to impose additional tariffs on Chinese imports on the basis of the rate of manipulation by that country of the rate of exchange between the Chinese currency and the U.S dollar) HR 3283/S 1421-United States Trade Rights Enforcement Act (Bills to enhance resources to enforce U.S trade rights) HR 4157-Health Information Technology Promotion Act of 2005 (Bill to provide for establishment of uniform confidentiality and security standards with respect to individually identifiable patient health information) S 1355-Better Healthcare Through Information Technology Act S 1418-Wired for Health Care Quality Act (Bills to enhance the adoption of health information technology and to improve the quality and reduce the cost of healthcare in the United States) S 1952-Critical Access to Health Information Technology Act of 2005 (Bill to provide for grants to states to increase access to health care in rural areas by improving health information technology) S 1223-Information Technology for Health Care Quality and Improvement Act (Bill to improve the quality and efficiency of health care delivery through improvements in health care information technology) S 1262-Health Technology to Enhance Quality Act of 2005 (Bill to reduce healthcare costs, improve efficiency and healthcare quality through the development of a nation-wide interoperable health information technology system) S 2480-Contact Lens Consumer Protection Act (Bill to amend the Fairness to Contact Lens Consumers Act with respect to the availability of contact lenses) HR 6111-Tax Relief and Health Care Act of 2006 (President Bush signed into Public Law # 109-432 on 12/20/2006) HR 5975-Prescription Drug Comparative Effectiveness Act of 2006 (Bill to require the Agency for Healthcare Research and Quality, in consultation with NIH Director, to conduct research to develop valid scientific evidence regarding clinical effectiveness, outcomes, and appropriateness as relates to medical devices and procedures and for other purposes) S 4098-Pediatric Medical Devices and Safety Improvement Act of 2006 (Bill to improve the process for development of needed pediatric medical devices) S 3778-Small Business Reauthorization and Improvements Act of 2006 HR 5352-Small Business Reauthorization Act of 2006 (Bills to reauthorize programs to assist small business concerns) S 1263-Save America’s Biotechnology Innovative Research Act of 2005 HR 2943-Save Biotechnology Innovative Research Act of 2005 (Bills to establish eligibility requirements for business concerns to receive awards under the Small Business Innovative Research program) S 3678-Pandemic and All Hazards Preparedness Act (Bill with respect to public health security and all-hazards preparedness and response, and for other purposes) HR2863-Division E – Public Readiness and Emergency Preparedness Act (Division E provisions of the bill as relates to targeted liability for pandemic and epidemic products and security countermeasures) S 2564/HR 5533-Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S 1873-Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (Bills to prepare and strengthen the development of countermeasures or pandemic or epidemic products against deliberate, accidental, and natural outbreaks of illness) S-1880-National Biodefense and Pandemic Preparedness Act of 2005 (Bill to enhance biodefense and pandemic preparedness activities) S 2792-Emergency Preparedness and Response Security, Accountability, and Flexibility Enhancement Act (SAFE Act) (Bill to revise provisions relating to bioterrorism and other public health emergencies preparedness grants including development of measurable critical benchmarks and performance standards) S 3-Protecting American in the War on Terror Act of 2005 (Bill sets provisions concerning bioterrorism preparedness and defense as pertaining to medical devices and for other purposes) S 975-The Project Bioshield II Act of 2005 (Bill to provide incentives to increase research by private sector entities to develop medial countermeasures to prevent, detect, identify, contain, and treat illnesses, including those associated with biological, chemical, nuclear, or radiological weapons attack or an infectious disease outbreak) S 22/S23-Malpractice Liability Reform Bill (a.k.a. Medical Care Access Protection Act of 2006, MCAP Act) (Bills setting forth provisions regulating lawsuits for health care liability claims related to the provision of health care services) HR 2090- Food and Drug Administration Improvement Act of 2005 (Bill related to FDA Advisory panels) S. 3807-Enhancing Drug Safety and Innovation Act of 2006 (Draft bill to improve oversight as related to drugs includes medical devices in some provisions)

Client expense: $1,404,102 · Firm income: Not reported

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

generic biologics/HR6257; Health IT/HR 4157/S1418; Bioterrorism Preparedness/S1873/S2564 (patent exculsivity provisions)

Client expense: $370,000 · Firm income: Not reported

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

S 2766, National Defense Authorization Act for Fiscal Year 2007. HR 6164, National Institutes of Health Reform Act of 2006. Avian Flu Legislation. HR 5122, National Defense Authorization Act for Fiscal Year 2007. HR 5533, Biodefense and Pandemic Vaccine and Drug Development Act of 2006. S 3678, Pandemic and All Hazards Preparedness Act. S 1873, Biodefense and Pandemic Vaccine and Drug Development Act of 2006.

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

Government targets: Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE

S.1873 - Biodefense and Pandemic Vaccine and Drug Developement Act of 2005 S.2564 / H.R. 5533 Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S.975 Project Bioshield II FY 2007 Labor-HHS Appropriations Act (H.R. 5647) S. 3678 Pandemic and All-Hazards Preparedness Act of 2005.

Client expense: Not reported · Firm income: $240,000

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

HR 3010, HR 1775, S.473/HR215, S1873

Client expense: $240,000 · Firm income: Not reported

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

HR 3010, HR 1775, S.473/HR215, S1873

Client expense: $240,000 · Firm income: Not reported

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

S. 975 - Project Biopsies II Act of 2005 - same issues as above; H.R. 5647 - Departments of Labor, Health & Human Services, and Education, and Related Agencies Act, 2007 - same issues as above; S. 3678 - Pandemic and All-Hazards Preparedness Act - same issues as above. Became P.L. 109 - 417. S. 1873 - Biodefense and Pandemic Vaccine and Drug Development Act of 2005 - all provisions relating to development, acquisition and stockpiling of abridgements vaccines; S. 2564/H.R. 5533 - Abridgements & Pandemic Vaccine & Drug Development Act of 2006 - same as above;

Client expense: Not reported · Firm income: $240,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 975 - Project BioShield II Act of 2005 - same issues as above; H.R. 5647 - Departments of Labor, Health & Human Services, and Education, and Related Agencies Act, 2007 - same issues as above; S. 3678 - Pandemic and All-Hazards Preparedness Act - same issues as above. Became P.L. 109 - 417. S. 1873 - Abridgements and Pandemic Vaccine and Drug Development Act of 2005 - all provisions relating to development, acquisition and stockpiling of abridgements vaccines; S. 2564/H.R. 5533 - Abridgements & Pandemic Vaccine & Drug Development Act of 2006 - same as above;

Client expense: Not reported · Firm income: $240,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 975 - Project BioShield II Act of 2005 - same isses as above; H.R. 5647 - Departments of Labor, Health & Human Services, and Education, and Related Agencies Act, 2007 - same issues as above; S. 3678 - Pandemic and All-Hazards Preparedness Act - same issues as above. Became P.L. 109 - 417. S. 1873 - Biodefense and Pandemic Vaccine and Drug Development Act of 2005 - all provisions relating to development, asquisitino and stockpiling of biodefense vaccines; S. 2564/H.R. 5533 - Biodefense & Pandemic Vaccine & Drug Development Act of 2006 - same as above;

Client expense: Not reported · Firm income: $240,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2564/H.R.5533, Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 1873, Biodefense and Pandemic Vaccine and Drug Development Act of 2005

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Fiscal Year 2007 Labor-HHS Appropriations (H.R. 5647); Act of 2005- Pandemic and All-Hazards Preparedness Act (S. 3678) S.1873- Biodefense and Pandemic Vaccine and Drug Development Act of 2005 S. 2564/H.R. 5533- Biodefense&Pandemic vaccine & Drug Development Act of 2006-same as above; S. 975 Project Bioshield II

Client expense: $1,160,000 · Firm income: Not reported

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

S. 975: A bill to provide incentives to increase research by private sector entities to develop medical counter measures to prevent, detect, identify, contain, and treat illnesses, including those associated with biological, chemical, nuclear, or radiological weapons attack or an infectious disease outbreak, and for pandemic preparedness provisions. "S. 1873: A bill to prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness, and for other purposes. Lobbied for a vaccine liability and compensation program for Pandemic Vaccines. H.R. 1815, S. 1042: National Defense Authorizations Act for Fiscal Year 2006. Lobbied for a vaccine liability and compensation program for Pandemic Vaccines. H.R. 2601: To authorize appropriations for the Department of State for Fiscal Years 2006 and 2007. Lobbied for sufficient funding for bioterrorist medical counter measures. S. 3: A bill to strengthen and protect America in the war on terror. Lobbied for incentives to manufacture biomedical counter measures.

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

H.R.650: To establish reasonable legal reforms that will facilitate the manufacture of vital, life-saving vaccines, and for other purposes. Lobbied for the interests of the vaccine industry. H.R.1297: To amend the Public Health Service Act with respect to the National Vaccine Injury Compensation Program. Lobbied for the interests of the vaccine industry. H.R.840, S.399: A bill 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.1808, S.334: To amend the Federal Food, Drug, and Cosmetic Act to create a uniform certification standard for Internet pharmacies and to prohibit Internet pharmacies from engaging in certain advertising activities, to prohibit the use of certain bank instruments for purchases associated with illegal Internet pharmacies, and for other purposes. Lobbied to ensure that the internet would not be used to import counterfeit and defective medical products. S.1873: A bill to prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness, and for other purposes. Lobbied for a vaccine liability and compensation program for Pandemic Vaccines. H.R.3052, S.1527: Vaccine Access and Supply Act, lobbied for provisions to strengthen the domestic vaccine industry. H.R.3970: Bioterror and Pandemic Preparedness Protection Act, lobbied in support of provisions to assure domestic pandemic preparedness. S.1821: Pandemic Preparedness and Response Act, lobbied in support of provisions to assure domestic pandemic preparedness. S.1828: Influenza Vaccine Security Act of 2005, lobbied in support of provisions to assure as strong domestic vaccine industry. S.1912: Global Network for Avian Influenza Surveillance Act, lobbied in support of domestic pandemic preparedness. S.375: Flu Protection Act of 2005, lobbied in support of domestic influenza provisions to stabilize production and supply. S.969: Attacking Viral Influenza Across Nations Act of 2005, lobbied in support of influenza provisions. General matters related to vaccine industry stability, pandemic preparedness, avian influenza. S.969,H.R.3369: A bill to amend the Public Health Service Act with respect to preparation for an influenza pandemic, including an avian influenza pandemic, and for other purposes. Lobbied for the interests of the vaccine industry.

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

-Wired for Health Care Act, S. 1418 -Health Information Technology Promotion Act, HR 4157 -Bioterrorism Preparedness, S. 1873, S. 2564, S. 3678 -Issues relating to HHS' regulations on Stark/Fraud and Abuse for Health IT

Client expense: $380,000 · Firm income: Not reported

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

HJ Res 10 -- Constitutional Amendment Related to the Physical Desecration of the United States Flag HR 581 -- Free Flow of Information Act HR 867 -- Open Government Act HR 1360 -- Fairness in Asbestos Injury Resolution Act HR 1620 -- Faster FOI Act HR 1974 -- Flag Protection ActHR 2331 -- Restore Open Government Act HR 3323 -- Free Flow of Information Act S 340 -- Free Flow of Information Act S 394 -- Open Government Act S 589 -- Faster FOI Act S J Res 12 -- Constitutional Amendment Relating to the Physical Desecration of the United States Flag S 852 -- Fairness in Asbestos Injury Resolution Act S 1181 -- Relating to amendments to the Freedom of Information Act S 1370 -- Flag Protection Act S 1419 -- Free Flow of Information Act S 1873 -- Biodefense and Pandemic Vaccine and Drug Development Act S 1911 -- Flag Protection Act

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

S. 975: Project BioShield II Act of 2005 S. 3: Protecting America in the War on Terror Act of 2005 S. 1873: The Biodefense and Pandemic Vaccine and Drug Development Act of 2005

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

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

S. 3: A bill to strengthen and protect America in the war on terror. Lobbied for incentives to manufacture biomedical counter measures. S. 975: A bill to provide incentives to increase research by private sector entities to develop medical counter measures to prevent, detect, identify, contain, and treat illnesses, including those associated with biological, chemical, nuclear, or radiological weapons attack or an infectious disease outbreak, and for pandemic preparedness provisions.S. 1873: A bill to prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness, and for other purposes. Lobbied for a vaccine liability and compensation program for Pandemic Vaccines. H.R. 1815, S. 1042: National Defense Authorizations Act for Fiscal Year 2006. Lobbied for a vaccine liability and compensation program for Pandemic Vaccines. H.R. 2601: To authorize appropriations for the Department of State for Fiscal Years 2006 and 2007. Lobbied for sufficient funding for bioterrorist medical counter measures.

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

S. 16: A bill to reduce to the cost of quality health care coverage and improve the availability of health care coverage for all Americans. Lobbied to protect the interests of the Biotech drug industry. S. 109, H.R. 328: A bill entitled the "Pharmaceutical Market Access Act of 2005". Lobbied for an exemption for biologics.S.184,H.R. 753: A bill to amend the Federal Food, Drug, and Cosmetic Act to protect the public health from the unsafe importation of prescription drugs and from counterfeit prescription drugs, and for other purposes. Lobbied for an exemption for biologics. S. 334, H.R. 700: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes. Lobbied for an exemption for biologics. H.R. 563: To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate and disclose lowest possible prices for prescription drug prices for Medicare beneficiaries, and with respect to the Federal Food, Drug, and Cosmetic Act, to provide waivers that permit such beneficiaries to import prescription drugs from Canada. Lobbied for an exemption for biologics. H.R. 578: To amend the Internal Revenue Code of 1986 with respect to the purchase of prescription drugs by individuals who have attained retirement age, and to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs and the sale of such drugs through Internet sites. Lobbied for an exemption for biologics. H.R.1626: To amend part D of the title XVIII of the Social Security Act to authorize the Secretary of Health and Human Services to negptiate for lower prices for Medicare prescription drugs and to eliminate the gap in coverage of Medicare prescrition durg benefits, to the Secretary of Health and Human Services to promulgate regulations for the reimportation of prescription drugs, and for other purposes. Lobbied for an exemption for biologics. H.R. 2599: To improve the quality, availability, diversity, personal privacy, and innovation of health care in the United States. Lobbied for an exemption for biologics.. H.R.16: To authorize the use of Federal funds for research on human embryonic stem cells irrrespective of the date on which such stem cells were derived, and for other purposes. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. H.R. 596, S. 681: To amend the Public Health Service Act to establish a National Cord Blood Stem Cell Bank Network to prepare, store, and distribute human umbilical cord blood stem cells for the treatment of patients and to support peer-reviewed research using such cells. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. H.R. 810, S. 471: To amend the Public Health Service Act to provide for human embryonic stem cell research. H.R.1650: To amend the Internal Revenue Code of 1986 to allow tax credits to holders of stem cell research bonds. Lobbied to prevent the unreasonable restriciton of legitimate medical research or clinical trials. H.R. 1822, S. 876: To prohibit human cloning and protect stem cells research. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. H.R. 2541: To amend the Public Health Service Act to provide for the expansion, intensification, and coordination of the activities of the National Institutes of Health regarding qualifying adult stem cell research, and for other purposes. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. H.R.2520, S.1317: To provide for the collection and maintenance of human cord blood stem cells for the treatment of patients and research, and to amend the Public Health Service Act to authorize the C.W. Bill Young Cell Transplantation Program. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. H.R. 2574: To amend the Public Health Service Act to provide for a program at the National Institutes of Health to conduct and support research on animals to develop techniques for the derivation of stem cells from embryos that do not harm the embryos, and for other purposes. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. S.1392: A bill to reauthorize the Federal Trade Commission. (Dorgan/Snowe Drug Importation Amendment). Lobbied for an exemption for biologics. H.R.3144: To amend the Public Health Service Act to provide for a program at the National Institutes of Health to conduct and support research in the derivation and use of human pluripotent stem cells by means that do not harm human embryos, and for other purposes. Lobbied for the interests of the vaccine industry. H.R.3423,S.1420: To amend the Federal Food, Drug, and Cosmetic Act with respect to medical device user fees. Lobbied for the interests of the medical device industry. S.226: A bill to amend the Public Health Service Act to improve immunization rates by increasing the supply of vaccines. Lobbied for the interst of the vaccine industry. S.521,H.R.1290: A bill to amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish, promote, and support a comprehensive prevention, research, and medical management referral program for hepatitis C virus infection. Supported bill. S.969,H.R.3369: A bill to amend the Public Health Service Act with respect to preparation for an influenza pandemic, including an avian influenza pandemic, and for other purposes. Lobbied for the interests of the vaccine industry. S.1422,H.R.881: A bill to amend the Federal Food, Drug, and Cosmetic Act to reduce human exposure to mercury through vaccines. Lobbied for the interests of the vaccine industry. H.R.650: To establish reasonable legal reforms that will facilitate the manufacture of vital, life-saving vaccines, and for other purposes. Lobbied for the interests of the vaccine industry. H.R.1297: To amend the Public Health Service Act with respect to the National Vaccine Injury Compensation Program. Lobbied for the interests of the vaccine industry. S.930: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. Lobbied to prevent the unreasonable restricition of legitimate medical research or clinical trials. S.470: A bill to amend the Public Health Service Act to expand the clinical trials drug data bank. Lobbied to provide the best information to the patient. H.R.2090: To amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, and for other purposes. Lobbied for provisions that promoted the development safe and effective drugs. H.R.2124,H.R.2308: To amend the Public Health Service Act to provide for clinical research support grants, clinical research infrastructure grants, and a demonstration program on partnerships in clinical research, and for other purposes. Lobbied for reasonable provisions that support research and clinical trials. H.R.2650: To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to protect consumers in managed care plans and other health coverage. Lobbied for the interests of the industry. H.R.2792: To permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests, and for other purposes. Lobbied for the interests of the industry. H.R.3196,H.R.2259,S.1012: To amend the Public Health Service Act to expand the scope of information required for the data bank on clinical trials of drugs, and for other purposes. Lobbied for reasonable provisions that support research and clinical trials. S.1128: A bill to amend title XIX of the Social Security Act to provide for increased rebates under the medicaid program for prescription drugs that are directly advertised to consumers, to require other Federal programs purchasing or reimbursing for such drugs to establish payment and reimbursement mechanisms that reduce the costs of those drugs, and for other purposes. Lobbied to ensure that any enacted restrictions would not impede access of the consumer to accurate information about pharmaceutical products. H.R.840,S.399: A bill 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.1808,S.334: To amend the Federal Food, Drug, and Cosmetic Act to create a uniform certification standard for Internet pharmacies and to prohibit Internet pharmacies from engaging in certain advertising activities, to prohibit the use of certain bank instruments for purchases associated with illegal Internet pharmacies, and for other purposes. Lobbied to ensure that the internet would not be used to import counterfeit and defective medical products. H.R.4395: To amend titles XVIII and XIX of the Social Security Act to provide for an improved voluntary Medicare prescription drug benefit, to provide greater access to affordable pharmaceuticals, and for other purposes. Lobbied for an exemption for biologics in the Drug Importation section. S.470: A bill to amend the Public Health Service Act to expand the clinical trials drug data bank. Lobbied to prevent the unreasonable restriction of legitimate medical research or clinical trials. S.930: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. Lobbied to prevent the unreasonable restricition of legitimate medical research or clinical trials. S.1873: A bill to prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness, and for other purposes. Lobbied for a vaccine liability and compensation program for Pandemic Vaccines. H.R.2345: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. Lobbied in support of enhanced FDA authorities over counterfeit products. H.R.3052,S.1527: Vaccine Access and Supply Act, lobbied for provisions to strengthen the domestic vaccine industry. H.R.3970: Bioterror and Pandemic Preparedness Protection Act, lobbied in support of provisions to assure domestic pandemic preparedness. S.1821: Pandemic Preparedness and Response Act, lobbied in support of provisions to assure domestic pandemic preparedness. S.1828: Influenza Vaccine Security Act of 2005, lobbied in support of provisions to assure as strong domestic vaccine industry. S.1912: Global Network for Avian Influenza Surveillance Act, lobbied in support of domestic pandemic preparedness. S.375: Flu Protection Act of 2005, lobbied in support of domestic influenza provisions to stabilize production and supply. S.969: Attacking Viral Influenza Across Nations Act of 2005, lobbied in support of influenza provisions. General matters related to vaccine industry stability, pandemic preparedness, avian influenza.

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE