Drug and Device Accountability Act of 2008

S1695/HR5629/HR1038 Biologics. HR6344 Responsive Government Act. S3409 Foriegn Inspections. HR 5839 Pedigree. Authorized Generics

Client expense: $270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S1695/HR5629/HR1038 Biologics. HR6344 Responsive Government Act. S3409 Foriegn Inspections. HR 5839 Pedigree.

Client expense: $320,000 · Firm income: Not reported

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 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

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2008 Clinical Trial Registry and Results Databases Drug Safety Cont... Heparin Contamination FDA Globalization Act of 2008 E-Pedigree and Anti-counterfeiting H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 S.3409: The Drug and Device Accountability Act of 2008 Funding for the Food and Drug Administration S.3289:Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Stem Cell Research Medicaid Rebates Medicaid/Medicare Packages Dual Proportionality Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 Federal Trade Commission Review of Competition & IP Issues FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) S: 3230: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP + 4% Proposed Regulation Medicare Reimbursement in Hospital Outpatient Setting Comparative Effectiveness Program Initiatives S. 3101 S.3408 International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness Funding for National Institutes of Health S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Funding for Bioterrorism and Emergency Preparedness S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Funding for Pandemic Influenza Preparedness S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Drug Importation S.3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S. 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Genetically Engineered (GE) Animals FDA and USDA Draft Regulation of GE Animals Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Heparin Contamination E-Pedigree and Anti-counterfeiting H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 S.3409: The Drug and Device Accountability Act of 2008 Drug Importation S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence European Union Low Level Presence Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking S: 3289: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for Food Safety at the Food and Drug Administration S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Comparative Effectiveness Program Initiatives S. 3101 S.3408 Medicaid Rebates Medicaid/Medicare Packages Dual Proportionality Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP+ 4% Proposed Regulation Medicare Reimbursement in Hospital Outpatient Department Setting Drug Importation S.3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S. 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Heparin Contamination FDA Globalization Act of 2008 E-Pedigree and Anti-counterfeiting H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 S.3409: The Drug and Device Accountability Act of 2008 Funding for the Food and Drug Administration S.3289:Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

H.R. 3014-Health Disparities, provisions relating to the treatment of heart disease patients in minority populations with a focus on SCA; S 1576-Health Disparities, provisions relating to the treatment of heart disease patients in minority populations with a focus on SCA; H.R. 2994-National Pain Care Policy Act of 2008, provisions related to pain care management and treatment;H.R. 6381- Medical Device Safety Act - provision related to preserving statutory federal preemption; S. 3398 - Medical Device Safety Act - provision related to preserving statutory federal preemption; S. 3387 - National Pain Care Policy Act of 2008 - provisions related to pain care management and treatment S. 3408 - Comparative Effectiveness Research Act of 2008 - provisions related to the establishment of a new entity to conduct comparative effectiveness research. S. 3409 - Drug and Device Accountability Act of 2008 - provisions related to device and drug import safety H.R. 4926 - Josh Miller Hearts Act - provisions related to establishing a grant program to ensure every elementary and secondary school in the country can obtain AEDs. H.R. 5839 - Safeguarding America's Pharmaceuticals Act of 2008 - provisions that might affect combination products H.R. 1028 - To create a Rural Policing Institute as part of the Federal Law Enforcement Training Center- provisions that might affect combination products H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 - provisions that might affect combination products S. 1695 - Follow-on Biologics - provisions that might affect combination products S. 1693 - Health Information Technology - provisions related to enhancing the adoption of nationwide interoperable health information technology system, improving health care quality and reducing health care costs in the United States. H.R. 3800 - Promoting Health Information Technology Act - provisions related to advancing the adoption of nationwide interoperable health information technology system, improving health care quality and reducing health care costs in the United States. H.R. 2184 - Enhanced Healthcare Value for All Act of 2007- provisions to expand comparative effectiveness research S.2221 - Transparency in Medical Device Pricing Act - provisions related to pricing for medical devices S.2029 - Physician Payments Sunshine Act of 2007- provisions related to providing transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies H.R. 3023 - Drug and Medical Device Company Gift Disclosure Act - provisions requiring manufacturers, packers and distributors of prescription drugs and medical devices to disclose certain gifts provided in connection with detailing, promotional, or other marketing activities, and for other purposes H.R. 5839 - Safeguarding America's Pharmaceuticals Act. Provisions that require tagging of pharmaceuticals with standardized numerical identifiers to track drug in all parts of supply chain. S. 3568 - To amend the Controlled Substances Act relative to the use of intrathecal pumps.

Client expense: $1,130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Vaccine Injury Compensation Program Follow developments within the Administration relating to global health policies concerning U.S. government participation in WHO and UN health initiatives; international public health issues; U.S. sanctions policies; international vaccine issues; vaccine policy at the Pan American Health Organization; HR 3610 HR 5629 Childhood immunizations Dietary supplement issues Implementation issues concerning P.L. 108-173 - The Medicare Prescription Drug, Improvement and Modernization Act of 2003 Drug compounding Alzheimer's care Comparative effectiveness - S.3408 - Comparative Effectiveness Research Act of 2008 S. 1695 Biologics Price Competition and Innovation Act of 2007 H.R. 1812 - Menopausal Hormone Replacement Therapies and Alternative Treatments and Fairness Act Pediatric Studies and Trials Drug Safety/Clinical Trials H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 S. 623/HR 1038 - Access to Life Saving Medicine Act, Follow-on Biologics S. 1505 - Affordable Biologics for Consumers Act H.R. 3610 - Food and Drug Import Safety Act of 2007 S.2029 - Vaccine Safety and Payment Health care issues Drug approvals Reimbursement rates S. 334 The Healthy Americans Act H.Con.Res. 342 (BHRT) FDA Pre-emption S.3613, H.R. 7114 - Independence at Home Act S.3409-Drug and Device Accountability Act of 2008 Follow-on biologics Drug importation and counterfeiting Drug advertising Comparative effectiveness Physician payment disclosure Hormone replacement therapies Chronic Illness International public health issues International vaccine issues

Client expense: $1,047,210 · Firm income: Not reported

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), Justice, Dept of (DOJ), Natl Security Agency (NSA), Natl Security Council (NSC), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 S. 623/HR 1038 - Access to Life-Saving Medicine Act, Follow-on Biologics S.1695 - Biologics Price Competition and Innovation Act of 2007 S.1505- Affordable Biologics for Consumers Act H.R. 5629 - "Pathway for Biosimilars Act" H.R. 3610 - Food and Drug Import Safety Act of 2007 S.3409 - Drug and Device Accountability Act of 2008 Biosimilars Drug Safety Prescription Drug Importation Import Safety Compoundin

Client expense: $1,047,210 · Firm income: Not reported

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), Justice, Dept of (DOJ), Natl Security Agency (NSA), Natl Security Council (NSC), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 3610, Food and Drug Import Safety Act of 2007; H.R.3967, Imported Food Safety Improvement Act of 2007; S. 654, Safe Food Act of 2007; S. 1776, Imported Food Security Act of 2007; H.R. 3624, Consumer Food Safety Act of 2007; H.R. 5409, Safe Food Enforcement Assessment Standards and Targeting Act of 2008; H.R. 5839, Safeguarding America's Pharmaceutical Act of 2008 S.3385 FDA Food Safety Modernization Act S.3409 Drug and Device Accountability Act S.3422 Food Tracking Improvement Bill S.3633 Transparency in Drug Labeling act

Client expense: $995,422 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), 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)

H.R. 1148, to establish the Food Safety Administration to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination. H.R. 1344, to improve federal nutrition programs. H.R. 2108/S. 1274, to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of food for humans and pets. H.R. 2117, to amend the Federal Food, Drug, and Cosmetic Act concerning foods and dietary supplements. H.R. 2718, to ensure that the goals of DSHEA are met by authorizing appropriations to fully enforce and implement such law. H.R. 2719, to allow amounts paid for foods for special dietary use, dietary supplements, or medical foods be treated as medical exp. H.R. 5069, to require manufacturers to demonstrate sufficient means to cover, for certain products distributed in commerce, costs of potential recalls, and for other purposes; jointly to Energy & Commerce and Agriculture. H.R. 5827, to amend the Federal Food, Drug, and Cosmetic Act to improve food safety; to Energy & Commerce. H.R. 5839, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs; to Energy & Commerce. H.R. 5904, to amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements to improve the safety of food, whether produced and distributed domestically or imported into the United States, by providing for improved information technology to identify high-risk imports and for enhanced capacity in the United States and in foreign governments to identify and address food safety issues on a scientific basis, and for other purposes; to Energy & Commerce. H.R. 6127, to require the president to call a White House conference on food and nutrition; to Agriculture. H.R. 6270, to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes; jointly to Energy & Commerce and Ways & Means. H. Res. 926, recognizing the importance of food, product safety, and U.S. trade policy; jointly to Ways & Means; Energy & Commerce; and Agriculture. H. R. 1249, to include dehydroepiandrosterone as an anabolic steroid. H.R. 2997, to require the secretary of agriculture and the commissioner of the Food and Drug Administration to establish a program requiring a certificate of assured safety for imported food items. H.R. 3484, to amend the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act to provide for improved public health and food safety through enhanced enforcement, and for other purposes. H.R. 3485, to amend the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act to improve the safety of food, meat, and poultry products through enhanced traceability, and for other purposes. H.R. 3937, to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of imported food. H.R. 3967, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of imported food. H.R. 6636, to amend the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act, and the Poultry Products Inspection Act to require that food that contains a genetically-engineered material, or that is produced with a genetically-engineered material, be labeled accordingly. S. 404, to amend the Agricultural Marketing Act of 1946 to require the implementation of country of origin labeling requirements by Sept. 30, 2007. S. 1776, to amend the Federal Food, Drug, and Cosmetic Act to establish a user fee program to ensure food safety, and for other purposes. S. 2245, to establish a commission to ensure food safety in the United States, and for other purposes. S. 2914, to ensure the safety of seafood and seafood products being imported into the United States. S. 3108, to require the president to call a White House conference on food and nutrition; to Agriculture. S. 3385, to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. S. 3409, to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes. S. 3422, to amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, and for other purposes. S. 3575, to amend the Federal Food, Drug, and Cosmetic Act with respect to nutrition labeling of food offered for sale in food service establishments.

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. 1148, to establish the Food Safety Administration to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination. H.R. 1344, to improve federal nutrition programs. H.R. 2108/S. 1274, to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of food for humans and pets. H.R. 2117, to amend the Federal Food, Drug, and Cosmetic Act concerning foods and dietary supplements. H.R. 2718, to ensure that the goals of DSHEA are met by authorizing appropriations to fully enforce and implement such law. H.R. 2719, to allow amounts paid for foods for special dietary use, dietary supplements, or medical foods be treated as medical exp. H.R. 5069, to require manufacturers to demonstrate sufficient means to cover, for certain products distributed in commerce, costs of potential recalls, and for other purposes; jointly to Energy & Commerce and Agriculture. H.R. 5827, to amend the Federal Food, Drug, and Cosmetic Act to improve food safety; to Energy & Commerce. H.R. 5839, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs; to Energy & Commerce. H.R. 5904, to amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements to improve the safety of food, whether produced and distributed domestically or imported into the United States, by providing for improved information technology to identify high-risk imports and for enhanced capacity in the United States and in foreign governments to identify and address food safety issues on a scientific basis, and for other purposes; to Energy & Commerce. H.R. 6127, to require the president to call a White House conference on food and nutrition; to Agriculture. H.R. 6270, to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes; jointly to Energy & Commerce and Ways & Means. H. Res. 926, recognizing the importance of food, product safety, and U.S. trade policy; jointly to Ways & Means; Energy & Commerce; and Agriculture. H. R. 1249, to include dehydroepiandrosterone as an anabolic steroid. H.R. 2997, to require the secretary of agriculture and the commissioner of the Food and Drug Administration to establish a program requiring a certificate of assured safety for imported food items. H.R. 3484, to amend the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act to provide for improved public health and food safety through enhanced enforcement, and for other purposes. H.R. 3485, to amend the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act to improve the safety of food, meat, and poultry products through enhanced traceability, and for other purposes. H.R. 3937, to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of imported food. H.R. 3967, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of imported food. H.R. 6636, to amend the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act, and the Poultry Products Inspection Act to require that food that contains a genetically-engineered material, or that is produced with a genetically-engineered material, be labeled accordingly. S. 404, to amend the Agricultural Marketing Act of 1946 to require the implementation of country of origin labeling requirements by Sept. 30, 2007. S. 1776, to amend the Federal Food, Drug, and Cosmetic Act to establish a user fee program to ensure food safety, and for other purposes. S. 2245, to establish a commission to ensure food safety in the United States, and for other purposes. S. 2914, to ensure the safety of seafood and seafood products being imported into the United States. S. 3108, to require the president to call a White House conference on food and nutrition; to Agriculture. S. 3385, to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. S. 3409, to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes. S. 3422, to amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, and for other purposes. S. 3575, to amend the Federal Food, Drug, and Cosmetic Act with respect to nutrition labeling of food offered for sale in food service establishments.

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

House FDA Import Safety Draft Legislation, S. 3409 A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes.

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

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

HR 6381/S. 3398 - to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. [Julie Cohen, Brett Loper, Elizabeth Pika Sharp, Elizabeth Kegler] HR 1014/S. 573 - To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. [Brett Loper, Elizabeth Pika Sharp] * Direct to Consumer advertising of medical devices - No specific bill - [Julie Cohen, Leah Kegler, Brett Loper] * Import Safety - S. 3409/(No Specific House bill) - A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration.[Brett Loper, Elizabeth Pika Sharp]

Client expense: $335,662 · 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), Medicare Payment Advisory Commission (MedPAC), SENATE

S. 2313, Strategies to Address Antimicrobial Resistance Act, Issues relating to HAI/MRSA surveillance and prevention H.R.3697, Strategies to Address Antimicrobial Resistance Act, Issues relating to HAI/MRSA surveillance and prevention S. 2278, Community and Healthcare-Associated Infections Reduction Act of 2007, Issues relating to HAI/MRSA surveillance and prevention H.R. 4214, Community and Healthcare-Associated Infections Reduction Act of 2007, Issues relating to HAI/MRSA surveillance and prevention S. 549, Preservation of Antibiotics for Medical Treatment Act of 2007, Issues relating to HAI/MRSA surveillance and prevention H.R. 962, Preservation of Antibiotics for Medical Treatment Act of 2007, Issues relating to HAI/MRSA surveillance and prevention S. 2525, MRSA Infection Prevention and Patient Protection Act, Issues relating to HAI/MRSA surveillance and prevention S. 2526, Worker Infection Protection Act, Issues relating to HAI/MRSA surveillance and prevention H.R. 4451, MRSA Research and Study Act of 2007, Issues relating to HAI/MRSA surveillance and prevention H.R. 1174, Healthy Hospitals Act of 2007, Issues relating to HAI/MRSA surveillance and prevention S. Res. 454, Designating the month of March 2008 as "MRSA Awareness Month", Issues relating to HAI/MRSA surveillance and prevention H. Res. 988, Designating the month of March 2008 as "MRSA Awareness Month", Issues relating to HAI/MRSA surveillance and prevention S. Res.454, A resolution designating the month of March 2008 as "MRSA Awareness Month" H.R. 6381, Medical Device Safety Act of 2008, Issues relating to pre-emption S. 3398, Medical Device Safety Act of 2008, Issues relating to pre-emption S.3409, Drug and Device Accountability Act of 2008, Issues relating to the FDA regulation of imported medical devices S.2221, Transparency in Medical Device Pricing Act of 2007, Issues relating to cost of care H.R.5839, Safeguarding America's Pharmaceuticals Act of 2008, Issues related to drug pedigree S.3408, A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes, Issues relating to comparative effectiveness

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Import Safety, S. 3409 Consumer Product Safety Improvement Act, H.R. 4040

Client expense: $65,235 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), HOUSE OF REPRESENTATIVES, SENATE

FDA Globalization Act - HR 3610, S 3409; MRSA Awareness Month Resolution - S. 454, H. R. 988; STARR Act - HR 3697, S. 2313; CHAIR Act, HR 4214, S 2278

Client expense: $167,844 · 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, Veterans Affairs, Dept of (VA)

S1695/HR5629/HR1038 Biologics. HR6344 Responsive Government Act. S3409 Foriegn Inspections. HR 5839 Pedigree. Authorized Generics

Client expense: $250,000 · 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)

Health Information Technology - S 1693 FDA Globalization Act - HR 3610, S 3409 Follow-on biologics legislation - S 623, HR 1038, HR 1956, S 1695

Client expense: Not reported · Firm income: $230,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Follow-on Biologics legislation - S 1695, S 623, HR 1038, HR 1956 Food and Drug Globalization Act - S 3409, HR 3610 Physician Payments Sunshine Act - S 2029 Mental health parity legislation - S 558, HR 1424

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA Globalization Act - HR 3610, S 3409; MRSA Awareness Month Resolution - S. 454, H.R. 988; STAAR Act - HR 3697, S 2313; CHAIR Act, HR 4214, S 2278

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulation of laboratory-developed tests S. 736, Labaratory Test Improvement Act. S. 976, Geonomics and Personalized Medicare Act FDA Globalization Act, HR3610, S 3409 Medicare Improvement Patients and Providers Act - HR 6331

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA Globalization Act - HR 3610, S 3409 Follow-on Biologics -- S 1695, HR 1038, HR 1956 Physician Payments Sunshine Act: S 2029

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

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

Safe-guarding America's Pharmaceuticals Act - HR 5839 FDA Globalization Act - HR 3610, S 3409 Medicare Improvement for Patients and Providers Act

Client expense: Not reported · Firm income: $52,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicaid Rebate Issues FDA Globalization Act - HR 3610, S 3409 Medicare Improvement for Patients and Providers Act - HR 6331

Client expense: Not reported · Firm income: $45,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Non-Prescription Drug Modernization Act - HR 4083, S. 2317 FDA Globalization Act - HR 3610, S 3409

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Ryan White AIDS Care Act and federal HIV/AIDS policy FDA Globalization Act- HR 3610, S 3409

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Follow-on Biologics - S 1695, HR 1038, HR 1956 FDA Globalization Act - HR 3610, S 3409

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Follow-on biologics - S 1695 FDA Globalization Act - HR 3610, S 3409 Physician Payments Sunshine Act - S. 2029

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Follow-on biologics legislation - S 1695, HR 1038, HR 1956 Physician Payments Sunshine Act - S. 2029 FDA Globalization Act - HR 3610,S 3409

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA Globalization Act, HR 3610, S 3409 Follow-on biologics - S 1695, HR 1038, HR 1956 Physician Payments Sunshine Act - S 2029

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA Globalization Act, HR 3610, S 3409 Follow-on biologics - S 1695, HR 1038, HR 1956 Physician Payments Sunshine Act - S 2029

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans; -H.R. 1494 / S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediatric medical devices; -H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; -H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; -H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; -H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; -H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; -H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; -S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; -S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; -S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; -S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; -S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; -S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; -H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; -H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; -H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; -S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; -H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; -H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products; -H.R. 5839, "Safeguarding America's Pharmaceuticals Act of 2008", To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, regarding all provisions; -S. 334, "Healthy Americans Act", A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away, regarding all provisions; -H.R. 6381, "Medical Device Safety Act of 2008", To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions; -S. 438, "Fair Prescription Drug Competition Act", A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs, regarding all provisions; -S.2274, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan", and for other purposes, regarding all provisions. -S.3409 "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration", and for other purposes; regarding all provisions. -S.1378 "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan", and for other purposes; regarding all provisions. -S. 3408, "Comparative Effectiveness Research Act of 2008", A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes, regarding all provisions; -S. 1276, "Methamphetamine Production Prevention Act of 2008", A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions. -Proposed Rule (CMS-1403-P), Regarding revisions to Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions; -S.2424, "A bill to ensure that all Americans have basic health literacy skills to function effectively as patients and health care consumers", regarding all provisions.

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

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

**see addendum page S. 2029 - Physician Payments Sunshine Act of 2007, disclosure H.R. 5605 - Physician Payments Sunshine Act of 2008, disclosure S. 1042 - Consistency, Accuracy, Responsibility and Excellence in Imaging Act, to improve imaging S. 2449 - Sunshine in Litigation Act of 2007, settlement disclosure H.Res. 1216 - a resolution to reduce unnecessary radiation exposure through CT scans to children S. 3409 - Drug and Device Accountability Act of 2008, Import Safety ***, no specific bill number, Import Safety

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

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

**see addendum page Import Safety H.R. 3610 - Food and Drug Import Safety Act of 2007 H.R. 5839 - Safeguarding America's Pharmaceuticals Act of 2008 S. 3409 - Drug and Device Accountability Act of 2008 ***, no specific bill(s), Drug Safety, FDAAA Implementation, Prescription Drug Importation, Import Safety

Client expense: Not reported · Firm income: $70,000

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

HR 3610 Food and Drug Import Safety Act of 2007 HR 5839 Safeguarding America's Pharmaceutical Act of 2008 S 3409 Drug and Device Accountability Act of 2008

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

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 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

Regulation of laboratory-developed tests S. 736, Labaratory Test Improvement Act. S. 976, Geonomics and Personalized Medicare Act FDA Globalization Act, HR3610, S 3409 Medicare Improvement Patients and Providers Act - HR 6331

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

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

HR 3610, Food and Drug Import Safety Act of 2007, provision affecting medical isotope import requirements S. 3409, Drug and Device Accountability Act of 2008

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

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

**see addendum page S. 2029 - Physician Payments Sunshine Act of 2007, Disclosure H.R. 5605 - Physician Payments Sunshine Act of 2008, Disclosure S. 3409 - Drug and Device Accountability Act of 2008 - Import Safety ***, no specific bill(s), FDA Globalization Act, Import Safety

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

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

**see addendum page Importation of prescription drugs (H.R. 3161) (S. 1644) (S. 3409) Rx Pedigree (H.R. 5839) Methamphetamine/Pseudoephedrine Regulatioin (S. 2071) Internet Pharmacy (S. 980) (H.R. 6353)

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

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