Patient Protection and Innovative Biologic Medicines Act of 2007

Monitor Affordable Biologics for Consumers Act and Biologics Price Competition and Innovation Act of 2007, support enactment and follow-on Biologics legislation with amendments that strengthen FDA pathway and provide data exclusivity. H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2 Children's Health Insurance Program Reauthorization Act 2009. S301 Physician Payments Sunshine Act 2009. HR380, S623, Access to Life-Saving Medicine Act; Follow-on biologics, importation, HR3610 Food and Drug Safety Act of 2007: Import safety; HR5839, Safeguard Americans Pharmaceuticals Act; S2029, Physician's Payment Sunshine Act; Reporting periodicity, pre-emption. HR1427 and HR1038, Access to Life-Saving Medicine Act; follow-on biologics; HR1956, Patient Protection and Innovative Biologic Medicines Act of 2007; follow-on biologics; HR3610, 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

Issues regarding follow on biologics, HR 5629 Pathway for Biosimilar Act; S 1695 Biologics, Price Competition and Innovation Act of 2007, HR 1956 - provide for approval of similar biological products, HR 5629 - establish a pathway for the licensure of biosimilar biological products, HR 1038 - provide for licensing of comparable and interchangeable biological products.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues regarding follow on biologics, HR 5629 Pathway for Biosimilar Act; S 1695 Biologics, Price Competition and Innovation Act of 2007, HR 1956 - provide for approval of similar biological products, HR 5629 - establish a pathway for the licensure of biosimilar biological products, HR 1038 - provide for licensing of comparable and interchangeable biological products.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor Affordable Biologics for Consumers Act and Biologics Price Competition and Innovation Act of 2007, support enactment and follow-on Biologics legislation with amendments that strengthen FDA pathway and provide data exclusivity. H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 4703, S 2467, HR 4991 - Vaccine Shortage preparedness Act of 2008 S 2464, HR 4992, HR 4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare Part B S 2465 - Vaccines for Children Access Act of 2008 HR 2 - Children's Health Insurance Program Reauthorization Act of 2009 S 75 - Generics First Act 2009 S 80 - Importation of Prescription Drugs S 301 - Physician Payments Sunshine Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 5839 - Safeguarding America's Pharmaceuticals Act of 2008 S 3408 - Comparative Effectiveness Research Act of 2008 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 S 2467 - Vaccine shortage preparedness Act of 2008 S 3678 - /PL 109-417 All pandemic and all-hazards act - Section 317 program issues HR 970 and S 1378 - Dextromethorphan Distribution Act of 2007 S 103 - Combat Meth Act of 2005 HR 2207 - Agricultural Disaster Assistance and Western States Emergency - Unfinished business Appropriations Act of 2007 HR 1908 and S 1710 Patent Reform Act of 2007 HR 1 - Implementing the 9/11 Commission recommendations Act of 2007 HR 3162 - Children's Health and Medicare Protection Act of 2007 S 1505 - Affordable Biologics for Consumers Act S 1695 - Biologics Price Competition and Innovation Act of 2007 HR 1956 - Patent Protection and Innovative Biologic Medicines Act of 2007 HR 1038, S623 - Access to Life-Saving Medicine Act HR 4083 - Non-prescription Drug Modernization Act of 2007 HR 1308 - Legal Immigrant Children's Health Improvement Act of 2007 HR 5629 - Pathway for Biosimilars Act HR 1427 - To amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes S 726 - A bill to amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes Comparative Effectiveness Research Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension

Client expense: $1,347,134 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)

H.R. 1956, Patent Protection and Innovative Biologic Medicines Act of 2007, S.1695, Biologics Price Competition and Innovation Act of 2007, H.R. 1038, S.623, Access to Life-Saving Medicine Act, H.R. 1908, S.1145, Patent Reform Act of 2007

Client expense: Not reported · Firm income: $6,500

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

Follow-on Biologics - S 1695, HR 1038, HR 1956

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.1082/H.R. 2900 - Food and Drug Revitalization Act: to provide for reasonable limits for conflicts of interest on FDA advisory committees and to stimulate pediatric device development. Also, to include unique device identification systems for medical devices. H.R. 2900/S.1082 - Food and Drug Amendments Act of 2007: to provide for reasonable limits for conflicts of interest on FDA advisory committees and to stimulate pediatric device development. Also, to provide unique identification systems for medical devices. S.830/H.R. 1494 - Pediatric Medical Devices Safety and Improvement Act: to stimulate development of necessary medical devices for the pediatric population. H.R. 1956/H.R. 5629/H.R. 1038/S.623 - Regulation Devices Biologics and Combination Products by the FDA: to provide a pathway for follow-on biologics that would not allow for interchangeability without express physician approval. The Food and Drug Administration Globalization Act of 2008: to provide for the safety of medical devices manufactured in foreign countries. H.R. 6381 - Medical Device Safety Act of 2008: to amend the Food, Drug and Cosmetic Act with respect to liability under state and local requirements for medical devices.

Client expense: $365,000 · Firm income: Not reported

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

Medicare (HR 6331), Follow-on Biologics (HR 5629, HR 1956, S 623, S 1695, S 1505, HR 1038)

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

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

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

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

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

Follow-on Biologics (HR 5629, HR 1956, S 623, S 1695, S 1505, HR 1038), Patent Reform (HR 1908, S 1145)

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

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

Access for uninsured (S 1886 & S 1975), Biosimilares (S 1695 & HR 5629), health care reform, United Kingdom (pricing reform), Italy (health care reform & pricing), Germany (health care reform & pricing), France (health care reform & pricing), funding to fight tuberculosis (HR 5501, S 2731), Follow-on Biologics (S 623 & HR 1956), FDA Reauthorization (HR 3580), Medicare Reimbursement (HR 6331), Patent Reform (HR 1908, S 1145)

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

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

Pending draft oncology, Follow-on biologics (HR 5629, HR 1956, S 623, S 1695, S 1505, HR 1038), Patent Reform (HR 1908, S 1145)

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

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

Pending draft oncology, Follow-on biologics (HR 5629, HR 1956, S 623, S 1695, S 1505, HR 1038), Patent Reform (HR 1908, S 1145)

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

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

Medicare (HR 6331), Follow-on Biologics (HR 5629, HR 1956, S 623, S 1695, S 1505, HR 1038)

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

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

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

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

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

Access for uninsured (S 1886 & S 1975), Biosimilares (S 1695 & HR 5629), health care reform, United Kingdom (pricing reform), Italy (health care reform & pricing), Germany (health care reform & pricing), France (health care reform & pricing), funding to fight tuberculosis (HR 5501, S 2731), Follow-on Biologics (S 623 & HR 1956), FDA Reauthorization (HR 3580), Medicare Reimbursement (HR 6331), Patent Reform (HR 1908, S 1145)

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

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

Follow-on Biologics (HR 5629, HR 1956, S 623, S 1695, S 1505, HR 1038), Patent Reform (HR 1908, S 1145)

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

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

S. 877, Controlling the Abuse of Prescriptions Act of 2007 Drug 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. 5629, Pathway for Biosimilars Act S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 2029, Physician Payments Sunshine Act of 2007 S. 623, Access to Life-Saving Medicine Act, follow-on biologics

Client expense: Not reported · Firm income: $50,000

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), Patent & Trademark Office (PTO), SENATE

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination Counterfeit Drugs FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 H.R. 4911 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Vaccines for Children Program National Vaccine Advisory Committee Draft Recommendations Influenza Vaccine Supply and Immunization Recommendations Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Patient Services S. 3101: Medicare Improvements for Patients and Providers Act of 2008 In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Alliance for Healthcare Competitiveness Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) FY 2008 Supplemental Appropriations Bill (H.R. 2642) Access to Investigation Drugs for Seriously Ill Patents The Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (S.1956) Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act 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 Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Issues regarding follow on biologics, HR 5629 Pathway for Biosimilars Act; S 1695 Biologics, Price Competition and Innovation Act of 2007, HR 1956 - provide for approval of similar biological products, HR 5629 - establish a pathway for the licensure of biosimilar biological products, HR 1038 - provide for licensing of comparable and interchangeable biological products

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.1908, S.1145 Patent Reform Act of 2007 H.R.806 To Amend the FD&C Act to Prohibit the Marketing of Authorized Generics S.438 Fair Prescription Drug Competition Act H.R.1038, S.623 Access to Life Saving Medicines Act H.R.1956 Patient Protection and Innovative Biologic Medicines Act of 2007 H.R.5629 Pathway for Biosimilars Act H.R.1902 Protecting Consumers Access to Generic Drugs Act of 2007 S.316 Preserve Access to Affordable Generics Act

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

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

S. 623 Access to Lifesaving Medicine Act H.R. 1038 Access to Lifesaving Medicine Act H.R. 1956 Patient Protection and Innovative Biologic Medicine Act of 2007 S. 1695 Biologics Price Competition and Innovation Act of 2007 S. 1505 Affordable Biologics for Consumer Act H.R. 5629 Pathway for Biosimilars Act

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

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

S. 623 Access to Lifesaving Medicine Act H.R. 1038 Access to Lifesaving Medicine Act H.R. 1956 Patient Protection and Innovative Biologic Medicine Act of 2007 S. 1695 Biologics Price Competition and Innovation Act of 2007 S. 1505 Affordable Biologics for Consumer Act H.R. 5629 Pathway for Biosimilars Act

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

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

Access for uninsured (S 1886 & S 1975), Biosimilars (S 1695 & HR 5629), healthcare reform, United Kingdom (pricing reform), Italy (healthcare reform & pricing), Germany (healthcare reform & pricing), France (healthcare reform & pricing), funding to fight tuberculosis (HR 5501, S 2731, S 968, HR 1567), Follow-on biologics (S 623 & HR 1956)

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

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

Health care reform: Federal Food, Drug and Cosmetic Act Issues, including drug safety and comparative effectiveness, follow-on biologics and related provisions in HR1956, Patient Protection and Innovative Biologic Medicines Act, HR 5629, Pathway for Biosimilars Act, and S. 1695, Biologics Price Competition and Innovation Act, and cardiovascular issues, including provisions in HR1014 and S.573, bills 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; and women's cancer issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocates for the increased appropriations for the Center for Disease Control & Prevention and the National Institues of Health Supported the following bills: H.R. 2638 S. 3230 Patient Protection and Innovative Biologic Medicines Act (H.R. 1956) Pathway for Biosimilars Act (H.R. 5629) Access to Life-Saving Medicine Act (H.R. 1038) Biologics Price Competition and Innovation (S. 1695) Support for and passage of the Arthritis Prevention, Control & Cure Act (S.626/H.R. 1283)

Client expense: $100,045 · Firm income: Not reported

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

Advocate for cost containment policies, including generic access and the removal of barriers to greater competition in the pharmaceutical marketplace (including but not limited to H.R. 1038, S. 623, H.R. 5629, H.R. 1956, S. 1505, S. 1695). Food and Drug Administration Amendents Act of 2007 (H.R. 3580) Counterfeit Drugs/Import safety/Pedigree Electronic prescribing (including H.R. 6331, S. 2408, and H.R. 4296) Prescription drug importation/re-importation Average Manufacturers Price/AMP

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Advocate for cost containment policies, including generic access and the removal of barriers to greater competition in the pharmaceutical marketplace (including but not limited to H.R. 1038, S. 623, H.R. 5629, H.R. 1956, S. 1505, S. 1695). Food and Drug Administration Amendents Act of 2007 (H.R. 3580) Counterfeit Drugs/Import safety/Pedigree Electronic prescribing (including H.R. 6331, S. 2408, and H.R. 4296) Prescription drug importation/re-importation Average Manufacturers Price/AMP

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

-Advocated for cost containment policies including generic access, e-prescribing, and comparative effectiveness (including H.R. 1038 and S. 623) and policies that promote competition in the pharmaceutical marketplace (including but not limited to HR 5629, HR 1956, S 1505, and S. 1695).

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

-Advocated for cost containment policies including generic access, e-prescribing, and comparative effectiveness (including H.R. 1038 and S. 623) and policies that promote competition in the pharmaceutical marketplace (including but not limited to HR 5629, HR 1956, S 1505, and S. 1695).

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

-Advocated for cost containment policies including generic access, e-prescribing, and comparative effectiveness (including H.R. 1038 and S. 623) and policies that promote competition in the pharmaceutical marketplace (including but not limited to HR 5629, HR 1956, S 1505, and S. 1695).

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Advocate for the creation of a regulatory pathway for generic biologic medications and policies that promote competition in the pharmaceutical marketplace, including but not limited to H.R. 1038, S. 623, H.R. 5629, H.R. 1956, S. 1505, S. 1695; advocate for cost containment policies related to electronic prescriptions including but not limited H.R. 6631, S. 2408, H.R. 4296.

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Advocate for the creation of a regulatory pathway for generic biologic medications and policies that promote competition in the pharmaceutical marketplace, including but not limited to H.R. 1038, S. 623, H.R. 5629, H.R. 1956, S. 1505, S. 1695; advocate for cost containment policies related to electronic prescriptions including but not limited H.R. 6631, S. 2408, H.R. 4296.

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Advocate for cost containment policies related to electronic prescriptions, comparative effectiveness, and advocate for policies on broader health care reform initiatives (including but not limited to H.R. 6631, S. 2408, H.R. 4296, S. 334). Advocate for cost containment policies related to the creation of a regulatory pathway for generic biologic medications (including but not limited to H.R. 1038, S. 623, H.R. 5629, H.R. 1956, S. 1505, S. 1695).

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

-Advocate for cost containment policies related to the creation of a regulatory pathway for generic biologic medications (including but not limited to H.R. 1038, S. 623, H.R. 5629, H.R. 1956, S. 1505, S. 1695).

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Advocate for initiatives designed to improve safety, enhance quality and constrain costs through generic utilization and the use of electronic prescribing (including but not limited to H.R. 1038, S. 623, H.R. 5629, H.R. 1956, S. 1505, S. 1695, H.R. 6631, S. 2408, and H.R. 4296)

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Advocate for initiatives designed to improve safety, enhance quality and constrain costs through generic utilization and the use of electronic prescribing (including but not limited to H.R. 1038, S. 623, H.R. 5629, H.R. 1956, S. 1505, S. 1695, H.R. 6631, S. 2408, and H.R. 4296)

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Advocate for initiatives designed to improve safety, enhance quality and constrain costs through generic utilization and the use of electronic prescribing (including but not limited to H.R. 1038, S. 623, H.R. 5629, H.R. 1956, S. 1505, S. 1695, H.R. 6631, S. 2408, and H.R. 4296)

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, 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)

Issues regarding follow on biologics, HR 5629 Pathway for Biosimilars Act; S 1695 Biologics, Price Competition and Innovation Act of 2007, HR 1956 - provide for approval of similar biological products, HR 5629 - establish a pathway for the licensure of biosimilar biological products, HR 1038 - provide for licensing of comparable and interchangeable biological products.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE