Food and Drug Administration Amendments Act of 2007

FY 2009 Ag Approp. Bill, Country of Origin Labeling, Animal Welfare, Antibiotics in Animal Agriculture, Animal Identification, Farm Bill, Antitrust Issues, Ban of Packer ownership of livestock, Interstate Meat shipment, HR 2900 Food & Drug Administration Amendments Act, Captive Supply Ban

Client expense: $310,218 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

FY 2009 Ag Appropriations Bill, Country of Origin Labeling, Animal Welfare, Antibiotics in Animal Agriculture, Animal Identification, Farm Bill, Antitrust Issues, Ban of Packer ownership of livestock, Interstate Meat shipment, H.R. 2900 Food & Drug Administration Amendments Act, Captive Supply Ban

Client expense: $318,988 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

S 234, Wireless Innovation Act HR 1597, Wireless Innovation Act S 337, White Spaces Act of 2007 S 602 Child Safe Viewing Act HR 2102, Free Flow Information Act of 2007 S 215, Internet Freedom Preservation Act HR 2738, Family and Consumer Choice Act HR 2821, Television Freedom Act of 2007 HR 2566, National Digital Television Consumer Education Act HR 2905, Broadcast Freedom Act of 2007 HR 608 Digital Television Consumer Education Act of 2007 HR 1320, Interference Protection for Existing Television Band Devices S 1780, Protecting Children from Indecent Programming Act HR 2900, Food and Drug Administration Act Amendments of 2007 S 1082, Food and Drug Administration Act Amendments of 2007 HR 2331 First Responders Act S 1223, First Responders Act China Market Access S2035 Free Flow Information Act HR 2566 Media Ownership Act S 2332 Media Ownership Act HR 3559 Protecting Children from Indecent Programming S1267, Free Flow Information Act of 2007 S2831, FTC Reauthorization Act S1170, "Connect the Nation Act" HR 3627, "Connect the Nation Act" HR 3862, Preparing America's Seniors for Digital Transition HR 5435, DTV Border Fix S 2507, DTV Border Fix Retransmission consent Product Placement a la carte HR 2905, Fairness Doctrine Fiscal Year 2009 Appropriations Mark HR 6209, Commercial Ads Loudness Mitigation Act S 3154, Commercial Ads Loudness Mitigation Act S 3156, Commercial Ads Loudness Mitigation Act DOJ to adopt new rules governing access under ADA for close captioning/video description in movies HR 6320, On Line Captioning HR 2320, National Amusement Park Ride Safety Act Broadband deployment provisions of Stimulus II HR 6151 Responsibility in Drug and Device Advertising Act of 2008 HR 4083 Non Prescription Drug Modernization Act S 3446 Bill to Create Minority Tax Credits HR 7013 Short Term Analog Flash and Emergency Readiness Act S 3663 Short Term Analog Flash and Emergency Readiness Act

Client expense: $4,260,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Natl Aeronautics & Space Administration (NASA), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

HR 971, the "Community Pharmacy Fairness Act of 2007"; S. 2161, the "Community Pharmacy Fairness Act of 2007"; HR 2900, provision related to pedigree requirements; HR 4 and S.3, the "Medicare Prescription Drug Price Negotiation Act of 2007"; HR 1474, the "Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; potential legislation related to Medicare DMEPOS accreditation and surety bond requirements; Sec. 913 of FDAAA of 2007, relating to development of a standard numerical drug identifier; HR 5839, the "Safeguarding America's Pharmaceuticals Act of 2008," provisions relating to pedigree and track and trace requirements; HR 6852, the "Small Business Cooperative for Health Care Options to Improve Coverage for Employees (CHOICE) Act of 2008; potential amendments to S. 1693, the "Wired for Health Care Quality Act," re privacy issues; S. 980, the "Ryan Haight Online Pharmacy Consumer Protection Act of 2008"; HR 3140, "Saving Our Community Pharmacies Act of 2007"; S. 1951, the "Fair Medicaid Drug Payment Act of 2007"; S. 1954, the "Pharmacy Access Improvement (PhAIm) Act of 2007"; HR 3700, the "Fair Medicaid Drug Payment Act of 2007"; HR 6357, the "PRO(TECH)T Act of 2008", provisions impacting health technology requirements for pharmacies; HR 6331, the "Medicare Improvements for Patients and Providers Act of 2008," Sec. 154 related to Medicare DMEPOS competitive acquisition program, Sec. 171 related to prompt payment of Part D reimbursements to pharmacies, Sec. 203, related to pharmacy reimbursement under Medicaid.

Client expense: $140,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE

HR 1322 Emergency Retiree Health Benefits Protection Act of 2007 - oppose provisions that would not allow companies to reduce retiree health benefits under ERISA covered group health plans. HR 1322 Emergency Retiree Health Benefits Protection Act of 2007 - oppose provisions that would not allow companies to reduce retiree health benefits under ERISA covered group health plans. HR 2900 Food and Drug Administration Amendments Act of 2007 - Support FDA authority to approve biogeneric drugs. HR 4296 Medicare Electronic Medication and Safety Protection Act of 2007 - Support the bill because it would reduce costly prescription medication errors. HR 6143 Pension Protection Act ERISA Amendments Act of 2008 - Concerning section 105, which prohibits changes, reductions or termination of retiree health benefits once an employee has retired. HR 6331 Medicare Impremovements for Patients and Providers Act of 2008 - Concerning Section 231 as it relates to "e-prescribing," which would reduce costly medical errors. HR 6357 The PRO(TECH) Act of 2008 - Support health information technology because it creates a more transparent consumer friendly health marketplace. S 334 Health Americans Act - Concerning core provisions of the bill that would harm ERISA health plans by proposing a state-by-state approach to comprehensive health care reform. S 1455 National Health Information Technology and Privacy Advancement Act of 2007- Concerning establishment of a health information technology and privacy system. S 1544 Medicare Quality Enhancement Act of 2007 - Support provisions to assist employees in obtaining information on health care services and providers. S 1693 Wired for Health Care Quality Act - Support the benefits of electronic records in reducing errors. S 1695 Biologics Price Competition and Innovation Act of 2007 - To support FDA authority to approve biotech drug products and their "generic follow-on versions." S 2408 Medicare Electronic Medication and Safety Protection Act of 2007 - To support efforts to reduce costly prescription medication errors and improve quality for patients/employees.

Client expense: $3,378,638 · Firm income: Not reported

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

H.R.1585, National Defense Authorization Act for Fiscal Year 2008; H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.2900, Food and Drug Administration Amendments Act of 2007; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; H.R.4083, Non-prescription Drug Modernization Act od 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.2331, Non-prescription Drug Modernization Act of 2007; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legisaltive proposals to extend federal contract prices to the retail section in the TRICARE program: H.R.1585, National Defense Authorization Act for Fiscal Year 2008; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legilsative proposals permitting importation of prescription drugs from overseas: H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.1082, Food and Drug Administration Revitalization Act; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legislative proposals regarding drug safety, clinical trial registries, DTC adverstising, and reauthorization of the Prescription Drug User Fee Act, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act: H.R.2900, Food and Drug Administration Amendments Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legislative proposals regarding FDA funding: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative proposals to ensure access to meth-safe alternative medicines: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development , Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative propsals to reform the OTC monograph system: H.R.4083, Non-prescription Drug Modernization Act of 2007; S.2331, Non-prescription Drug Modernization Act of 2007. Response to congressional investigation regarding ENHANCE study.

Client expense: $520,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 84, "Professional Boxing Amendments Act of 2007" S. 124, "Satellite and Cable Access Act of 2007" S. 234, "Wireless Innovation Act of 2007" S. 337, "White Spaces Act of 2007" S. 234, "Wireless Innovation Act of 2007" S. 431, "KIDS Act of 2007" S. 567, "National Defense Authorization Act for Fiscal Year 2008" S. 602, "The Child Safe Viewing Act" S. 760, "Four Corners Television Access Act of 2007" S. 1082, "Prescription Drug User Fee Amendments of 2007" S. 1082, "Food and Drug Administration Revitalization Act" S. 1086, "Cyber Safety for Kids Act of 2007" S. 1224, "First Response Broadcasters Act of 2007" S. 1267, "Free Flow of Information Act of 2007" S. 1285, "Fair Elections Now Act" S. 1453, "ITFA Extension Act of 2007" S. 1742, "Broadcaster Freedom Act of 2007" S. 1748, "Broadcaster Freedom Act of 2007" S. 1780, "Protecting Children from Indecent Programming Act" S. 2035, Free Flow of Information Act of 2007 S. 2125, "Preparing America's Seniors for the Digital Television Transition of Act of 2007" H.R. 600, "Telecommunications Ownership Diversification Act of 2007" H.R. 608, "Digital Television Consumer Education Act of 2007" H.R. 719, " KIDS Act of 2007" H.R. 1077, "Internet Consumer Protection Act of 2007" H.R. 1120, " Deleting Online Predators Act of 2007" H.R. 1320, "Interference Protection for Existing Television Band Devices Act of 2007" H.R. 1597, "Wireless Innovation Act of 2007" H.R. 2102, "Free Flow of Information Act of 2007" H.R. 2566, "National Digital Television Consumer Education Act" H.R. 2738, "Family and Consumer Choice Act of 2007" H.R. 2821, "Television Freedom Act of 2007" H.R. 2829, "Financial Services and General Government Appropriations Act, 2008" H.R. 2900, "Food and Drug Administration Amendments Act of 2007" H.R. 2905, "Broadcaster Freedom Act of 2007" H.R. 2917, "Transition Education Accountability Report Act of 2007" H.R. 3461, "Safeguarding America's Families by Enhancing and Reorganizing New and Efficient Technologies Act of 2007" H.R. 3559, "Protecting Children from Indecent Programming Act" H.R. 3676, "Family Friendly Flights Act of 2007" H.R. 4167, "Broadcast Ownership for the 21st Century Act" H.R. 4221, "Satellite Consumers' Access to Public Television Digital Programming Act of 2007" H.R. 4882, "Broadcast Licensing in the Public Interest Act" H.R. 5140, Recovery Rebates and Economic Stimulus for the American People Act of 2008 H.R. 5470, To amend the Communications Act of 1934 to require the carriage of all local television signals by satellite carriers in all local markets H.R. 6320, Twenty-first Century Communications and Video Accessibility Act of 2008 (Markey) H.Res. 1, "Implementing Recommendations of the 9/11 Commission Act of 2007" S.J. Res. 28, A joint resolution disapproving the rule submitted by the Federal Communications Commission with respect to broadcast media ownership H.J. Res. 79, Disapproving the rule submitted by the Federal Communications Commission with respect to broadcast media ownership General Issues: 1) Content Regulation Issues, eg, Broadcast Indecency and Television Violence 2) Media Ownership Issues 3) Cable A La Carte Issues 4) Retransmission Consent Issues 5) Spectrum Issues 6) Federal Shield Law Issues 7) DTV Transition Issues 8) Direct-to-Consumer Drug Advertising Issues 9) DirecTV-Liberty Media Transaction 10) Online Advertising Issues 11) Broadcast Localism Issues 12) White Spaces Spectrum Issues 13) Libel Tourism 14) Network Neutrality 15) WWOR License Renewal 16) Enhanced Disclosure by Broadcasters 17) Funding for the United States Telecommunications Training Institute 18) Section 2257 Department of Justice Regulations

Client expense: $1,080,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, Smithsonian Institution, State, Dept of (DOS), Treasury, Dept of, U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

HR.380, Pharmaceutical Market Access and Drug Safety Act of 2007 S.242, Pharmaceutical Market Access and Drug Safety Act of 2007 HR.2900, Food and Drug Administration Amendments Act of 2007 Diabetes treatment Comparative effectiveness Pharmaceutical import safety legislation Health care reform

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 234, Wireless Innovation Act HR 1597, Wireless Innovation Act S 337, White Spaces Act of 2007 S 602 Child Safe Viewing Act HR 2102, Free Flow Information Act of 2007 S 215, Internet Freedom Preservation Act HR 2738, Family and Consumer Choice Act HR 2821, Television Freedom Act of 2007 HR 2566, National Digital Television Consumer Education Act HR 2905, Broadcast Freedom Act of 2007 HR 608 Digital Television Consumer Education Act of 2007 HR 1320, Interference Protection for Existing Television Band Devices S 1780, Protecting Children from Indecent Programming Act HR 2900, Food and Drug Administration Act Amendments of 2007 S 1082, Food and Drug Administration Act Amendments of 2007 HR 2331 First Responders Act S 1223, First Responders Act China Market Access S2035 Free Flow Information Act HR 2566 Media Ownership Act S 2332 Media Ownership Act HR 3559 Protecting Children from Indecent Programming S1267, Free Flow Information Act of 2007 S2831, FTC Reauthorization Act S1170, "Connect the Nation Act" HR 3627, "Connect the Nation Act" HR 3862, Preparing America's Seniors for Digital Transition HR 5435, DTV Border Fix S 2507, DTV Border Fix Retransmission consent Product Placement a la carte HR 2905, Fairness Doctrine Fiscal Year 2009 Appropriations Mark HR 6209, Commercial Ads Loudness Mitigation Act S 3154, Commercial Ads Loudness Mitigation Act S 3156, Commercial Ads Loudness Mitigation Act DOJ to adopt new rules governing access under ADA for close captioning/video description in movies HR 6320, On Line Captioning HR 2320, National Amusement Park Ride Safety Act Broadband deployment provisions of Stimulus II HR 6151 Responsibility in Drug and Device Advertising Act of 2008 HR 4083 Non Prescription Drug Modernization Act S 3446 Bill to Create Minority Tax Credits HR 7013 Short Term Analog Flash and Emergency Readiness Act S 3663 Short Term Analog Flash and Emergency Readiness Act

Client expense: $4,260,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Natl Aeronautics & Space Administration (NASA), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S.1951/H.R. 3700 Fair Medicaid Drug Payment Act of 2007 regarding Medicaid reimbursement for generic drugs as related to average manufacturers price (AMP) and federal upper limits (FULs); H.R. 3140 Saving Our Community Pharmacies Act of 2007 regarding Medicaid reimbursement of generic drugs as related to AMP and FULs; S. 334 Healthy Americans Act regarding the role of pharmacy in healthcare and Title VI regarding shared responsibilities; S.980/H.R. 6353 Online Pharmacy Consumer Protection Act of 2007 regarding amendments to the Control Substances Act relating to the delivery of control substances over the internet; S.3101/H.R. 6331 Medicare Improvements for Patients and Providers Act of 2008 Sec. 132 regarding incentives for electronic prescribing, Sec. 171 regarding prompt pay by PDPs and MA-PDs for prescriptions dispensed in Medicare Part D, Sec. 203 regarding reimbursement for generic drugs dispensed in the Medicaid program; S. 2408 "E-Meds Act of 2007 regarding amendments to the Social Security Act requiring physicians to utilize electronic prescribing for Medicare prescriptions; H.R. 2900 Food and Drug Amendments Act of 2007 Sec. 910 regarding pharmaceutical safety; H.R. 5839 Safeguarding Americas Pharmaceuticals Act of 2008 regarding amending the Food, Drug & Cosmetics Act to improve the safety of drugs; Electronic Prescribing of Controlled Substances regarding the need for the DEA to publish rules that would allow for electronic prescribing of controlled substances no specific legislation; S. 3001/ H.R. 5658 National Defense Authorization Act for Fiscal Year 2009 Sec. 702 regarding a freeze on current copays at retail pharmacies for medications dispensed in the TRICARE pharmacy program; MedGuides regarding improvements needed to the Medication Guide program no specific legislation; S. 1693 Wired for Healthcare Quality Act of 2007- Title IV Sec 401 Privacy and Security regarding changes in the definition of marketing under HIPAA and breach notification; H.R. 6357 PRO(TECH)T Act of 2008 - Title III regarding impact of privacy and security provisions on pharnacies, H.R. 6898 Health-e Information Technology Act of 2008 - Title IV regarding impact of privacy and security provisions on pharmacies.

Client expense: $470,000 · Firm income: Not reported

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

HR 780, Counterfeit Drug Prevention Act, pharmaceutical counterfeiting S 2699, Neglected Diseases Elimination Act, promote R&D S 484, Enhancing Drug Safety and Innovation Act 2006 S 1082, FDA Revitalization Act 3/07 HR 2900, FDA Amendments Act 2007 S. 242, Pharmaceutical Market Access and Drug Safety Act 3/07 HR. 380, Pharmaceutical Market Access and Drug Safety Act 2/07

Client expense: $3,250,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

S. 45/H.R. 896, to lift the patient limitation on prescribing drug addiction treatments by medical practitioners in group practices, S. 1082, Prescription Drug User Fee Amendments of 2007 H.R. 2900, The FDA Amendments Act Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored, Executive Order; 2006 S. 2408/H.R. 4296, E-MEDS Act of 2007

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Justice, Dept of (DOJ), Natl Institute of Mental Health (NIMH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA), White House Office

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 S. 3408, Comparative Effectiveness Research Act of 2008 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

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

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

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

FDA Reform Bills - S 1082, HR 2900

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Follow-on Biologics legislation - S 623, HR 1038, HR 1956, S 1695 Food and Drug legislation - S 1082, HR 2900 Safe-guarding America's Pharmaceutical Act - HR 5839

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Prescription Drug User Fee Amendments 2007 (Public Law 110-85), Drug safety related issues. H.R. 2900, Food and Drug Administration Amendments Act of 2007, Drug safety related issues. S.3289/H.R. TBD, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2009, FDA salaries and expenses; and extramural research related issues.

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

Government targets: Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Small Business Administration (SBA)

H.R. 3161, S. 1859, Funding for the Office of Generic Drugs, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act. H.R. 2900, S. 1082, Food and Drug Administration Reform.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY2009 Ag Appropriations Bill; Country of Origin Labeling; Animal WelfareAntibiotics in Animal Ag; Animal Identification; Farm Bill; H.R. 2900 FGS Amendments Act; H.R. 2419 Farm, Nutrition, Bio Act of 2008; H.R. 3697/S. 2313 Strategies to Address Antimicrobial Resistance Act; H.R. 162/S. 549 Presentation of Antibiotics for Medical Treatment Act

Client expense: $288,857 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

-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

S 1408, Health Information Technology Act of 2007, Sections requiring the Department of Health and Human Services to establish a program to utilize health Information electronic technology to improve delivery and care to patients S 1693, Wired for Health Care Quality Act, Sections requiring the Department of Health and Human Services to establish a program to utilize health Information electronic technology to improve delivery and care to patients S 1695, Biologics Price Competition and Innovation Act of 2007, Sections regarding interchangeability, patent and exclusivity issues related to Food and Drug Administration approval of biogeneric drugs. S 691/ HR 1193, Kidney Care Quality and Educations Act of 2007, Section regarding increased costs to employers health plans. HR 5629, The Pathway for Biosimilars Act, Sections regarding interchangeability, patent and exclusivity issues related to Food and Drug Administration approval of biogeneric drugs. S 1082, Food and Drug Administration Revitalization Act, Provisions related to generic pharmaceuticals HR 2900, Food and Drug Administration Amendments Act of 2007, Provisions related to generic pharmaceuticals HR1 of 2003, Medicare Modernization Act, Employee Medicare Prescription Drug Subsidy

Client expense: $1,925,000 · Firm income: Not reported

Government targets: Energy, Dept of, Environmental Protection Agency (EPA), Export-Import Bank of the United States (EXIM Bank), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT), Treasury, Dept of, White House Office

S 1695, Biologics Price Competition and Innovation Act of 2007, Sections regarding interchangeability, patent and exclusivity issues related to Food and Drug Administration approval of biogeneric drugs. S 691/ HR 1193, Kidney Care Quality and Educations Act of 2007, Section regarding increased costs to employers health plans. HR 5629, The Pathway for Biosimilars Act, Sections regarding interchangeability, patent and exclusivity issues related to Food and Drug Administration approval of biogeneric drugs. S 1082, Food and Drug Administration Revitalization Act, Provisions related to generic pharmaceuticals HR 2900, Food and Drug Administration Amendments Act of 2007, Provisions related to generic pharmaceuticals

Client expense: $1,925,000 · Firm income: Not reported

Government targets: Energy, Dept of, Environmental Protection Agency (EPA), Export-Import Bank of the United States (EXIM Bank), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT), Treasury, Dept of, White House Office

Support efforts to ensure appropriate access to vaccines and preventive care. Issues related to Medicare, Medicaid, and State Children's Health Insurance Program Coverage. Issues related to The implementation of the FDAAA of 2007. Issues relating to importation of prescription drugs. Issues relating to Medicare and Medicaid coverage to treat and prevent diseases related to obesity. S.1082, Food and Drug Administration Revitalization Act H.R. 2900, Food and Drug Administration Amendment Act of 2007 S.3101, Medicare Improvements for Patients and Providers act of 2008 S.3118, Preserving Access to Medicare Act of 2008 H.R.6331, Medicare Improvements for Patients and Providers act of 2008 S.2029, Physician Payments Sunshine Act of 2007

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

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

Support efforts to ensure appropriate access to vaccines and preventive care. Issues related to Medicare, Medicaid, and State Children's Health Insurance Program Coverage. Issues related to The implementation of the FDAAA of 2007. Issues relating to importation of prescription drugs. Issues relating to Medicare and Medicaid coverage to treat and prevent diseases related to obesity. S. 1082, Food and Drug Administration Revitalization Act H.R. 2900, Food and Drug Administration Amendment Act of 2007 S. 3101, Medicare Improvements for Patients and Providers act of 2008 S 3118, Preserving Access to Medicare Act of 2008 H.R. 6331, Medicare Improvements for Patients and Providers act of 2008 S. 2029, Physician Payments Sunshine Act of 2007

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

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

Support efforts to ensure appropriate access to vaccines and preventive care. Issues related to Medicare, Medicaid, and State Children's Health Insurance Program Coverage. Issues related to The implementation of the FDAAA of 2007. Issues relating to importation of prescription drugs. Issues relating to Medicare and Medicaid coverage to treat and prevent diseases related to obesity. S. 1082, Food and Drug Administration Revitalization Act H.R. 2900, Food and Drug Administration Amendment Act of 2007 S. 3101, Medicare Improvements for Patients and Providers Act of 2008 S 3118, Preserving Access to Medicare Act of 2008 H.R. 6331, Medicare Improvements for Patients and Providers act of 2008 S. 2029, Physician Payments Sunshine Act of 2007

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

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

Import safety legislation Implementation of HR 2900 H.R. 3970, Tax Reduction and Reform Act of 2007

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2900, Food and Drug Administration Amendments Act of 2007, provisions dealing with drugs and biologicals S. 1082, Prescription Drug User Fee Amendment Act of 2007, provisions relating to drugs and biologicals

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

- Food and Drug Administration Globalization Act of 2008, a bill to increase FDA inspection of manufacturers in the US and abroad. - HR 6381Medical Device Safety Act of 2008, a bill that would remove federal preemption protection for certain medical devices. - HR 2900 Implementation of Food and Drug Administration Amendments Act of 2007, a bill to revise and extend the user-fee programs for prescription drugs and for medical devices. - HR 3014 Health Disparities, a bill to address disparities in the delivery of health care, specifically as it relates to cardiovascular care. - S. 3398 Medical Device Safety Act of 2008, a bill that would remove federal preemption protection for certain medical devices. - HR 6432 Animal Drug User Fee Act, a provision to make technical corrections to device user fee program.

Client expense: $390,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Intl Trade Administration (ITA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Implementation of Prescription Drug User Fee Amendments, 2007 (PL 110-85), Drug safety related issues. H.R. 2900, Food and Drug Administration Amendments Act of 2007, drug safety related issues. S.3289, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2009, FDA salaries and expenses; and extramural research related issues.

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

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

Drug safety issues. Implementation of Prescription Drug User Fee Amendments 2007 (Public Law 110-85), drug manufacturing issues. Department of Defense Appropriations Act, FY2009, Army RDT&E. Public Law 110-329, Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, FY2009, Army RDT&E. S.3230, Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act, FY2009, health research funding. S.3258/H.R.7324, Energy and Water Development Appropriations Act, FY2009, DOE Research funding. S.3001/H.R.5658, National Defense Authorization Act, FY2009, Army RDT&E. H.R. 2900, Food and Drug Administration Amendments Act of 2007, drug manufacturing issues. Medicaid reimbursement. H.R.6331/S.3101, Medicare improvements for Patients and Providers Act of 2008, Medicare reimbursement. S.3067, Dental Health Improvement Act, Dental Health professional shortage issues.

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

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

Implementation of Prescription Drug User Fee Amendments 2007 (Public Law 110-85), Drug safety related issues. H.R.2900, Food and Drug Administration Amendemtns Act of 2007, Drug safety related issues. S.3289, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2009, FDA salaries and expenses; and extramural research related issues.

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

Government targets: Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Small Business Administration (SBA)

H.R. 2900, Food and Drug Adminsitration Amendments Act, sections dealing with Direct to Consumer Advertising, S. 1082, Prescription Drug User Fee Amendments, sections dealing with Direct to Consumer Advertising.

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, White House Office

Followed progress on all potential Direct to Consumer advertising amendments in the House and Senate, in particular H.R. 2900, Food and Drug Administration Amendments Act of 2007; H.R. 2823, Fair Balance Prescription Drug Advertisement Act of 2007; and S. 1082, FDA Authorization Revitalization Act.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1038 & S. 623, Access to Life-Saving Medicine Act; H.R. 1956, Patient Protection & Innovative Biologic Medicines Act; H.R. 5629, Pathway for Biosimilars Act; S. 316, Preserve Access to Affordable Generics Act; H.R. 1902, Protecting Consumer Access to Generic Drugs Act; Development of "Pedigree" or National Drug Trafficking System; H.R. 2900, Food & Drug Administration Amendments Act; H.R. 1980 & S. 1145, Patent Reform Act; FDA Globalization Act; Tax Incentives/Extensions (R&D Tax Credit)

Client expense: $1,560,000 · Firm income: Not reported

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

S. 28 - To amend title XVIII of the Social Security Act to require the use of generic drugs under the Medicare part D prescription drug program when available unless the brand name drug is determined to be medically necessary. S. 1505 - Affordable Biologics for Consumers Act. S. 1695 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences, and for other purposes. S. 242 - Pharmaceutical Market Access and Drug Safety Act of 2007. S. 251 - Pharmaceutical Market Access Act of 2007. S. 1082 - Prescription Drug User Fee Amendments of 2007. H.R. 2900 - Food and Drug Administration Amendments Act of 2007. H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act. H.R. 1038 - Access to Life-Saving Medicine Act. H.R. 5629 - Pathway for Biosimilars Act H.R. 3610 - Food and Drug Import Safety Act of 2007 H.R. 3624 - Consumer Food Safety Act of 2007

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor food labeling issues that pertain to the client including country of origin food labeling, allergens, tort reform, and agriculture issues, including Consumer Food Safety Act of 2007 (H.R.3624), Bill to amend the Internal Revenue Code of 1986 to exclude from gross income amounts awarded to quitam plaintiffs (H.R. 1274), Human and Pet Food Safety Act of 2007 (H.R.2108), Food and Drug Administration Revitalization Act. (S.1082). Food and Drug Administration Amendments Act of 2007 (H.R. 2900), Food and Drug Administration Amendments Act of 2007 (H.R.3580), Ending Agricultural Threats: Safeguarding America's Food for Everyone (EAT SAFE) Act of 2007 (S.2418), Agriculture Appropriations Bill, Farm Bill. Safe FEAST Act of 2008 (H.R. 5904), FY 2009 Labor, Health and Education Appropriations (FDA Appropriations - seeking increased funding for FDA), working to amend Ethanol mandates, Food and Drug Administration Globalization Act (Discussion Draft), Food and Drug Import Safety Act of 2007 (H.R. 3610), and pending Food Safety Legislation. Fiscal 2009 Continuing Resolution (H.R. 2638), Tax Extenders Bills (H.R. 6049) & (H.R. 7060), TRACE Act of 2007 (HR 3485), FDA Food Safety Modernization Act (S. 3385), Food Tracking Improvement Act (S. 3422), Safe Food Enforcement, Assessment, Standards and Targeting Act of 2008 (H.R. 5905) and EPA's Renewable Fuel Standard.

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

Government targets: Council on Environmental Quality (CEQ), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Monitor food labeling issues that pertain to the client including country of origin food labeling, allergens, tort reform, and agriculture issues, including Consumer Food Safety Act of 2007 (H.R.3624), Bill to amend the Internal Revenue Code of 1986 to exclude from gross income amounts awarded to quitam plaintiffs H.R. 1274), Human and Pet Food Safety Act of 2007 (H.R.2108), Food and Drug Administration Revitalization Act. (S. 1082). Food and Drug Administration Amendments Act of 2007 (H.R. 2900), Food and Drug Administration Amendments Act of 2007 (H.R. 3580), Ending Agricultural Threats: Safeguarding America's Food for Everyone (EAT SAFE) Act of 2007 (S. 2418), Agriculture Appropriations Bill, Farm Bill. Safe FEAST Act of 2008 (H.R. 5904), FY 2009 Labor, Health and Education Appropriations (FDA Appropriations - seeking increased funding for FDA), working to amend Ethanol mandates, Food and Drug Administration Globalization Act (Discussion Draft), Food and Drug Import Safety Act of 2007 (H.R. 3610), and pending Food Safety Legislation. Fiscal 2009 Continuing Resolution (H.R. 2638), Tax Extenders Bills (H.R. 6049) & (H.R. 7060), TRACE Act of 2007 (H.R. 3485), FDA Food Safety Modernization Act (S. 3385), Food Tracking Improvement Act (S. 3422), Safe Food Enforcement, Assessment, Standards and Targeting Act of 2008 (H.R. 5905) and EPA's Renewable Fuel Standard.

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

Government targets: Council on Environmental Quality (CEQ), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

HR 780, Counterfeit Drug Prevention Act, pharmaceutical counterfeiting S 2699, Neglected Diseases Elimination Act, promote R&D S 484, Enhancing Drug Safety and Innovation Act 2006 S 1082, FDA Revitalization Act 3/07 HR 2900, FDA Amendments Act 2007 S. 242, Pharmaceutical Market Access and Drug Safety Act 3/07 HR. 380, Pharmaceutical Market Access and Drug Safety Act 2/07

Client expense: $3,070,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

H.R.1585, National Defense Authorization Act for Fiscal Year 2008; H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.2900, Food and Drug Administration Amendments Act of 2007; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; H.R.4083, Non-prescription Drug Modernization Act od 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.2331, Non-prescription Drug Modernization Act of 2007; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legisaltive proposals to extend federal contract prices to the retail section in the TRICARE program: H.R.1585, National Defense Authorization Act for Fiscal Year 2008; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legilsative proposals permitting importation of prescription drugs from overseas: H.R.2638, Department of Homeland Security Appropriations Act, 2008; H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; H.R.3162, Children's Health and Medicare Protection Act of 2007; S.242, Pharmaceutical Market Access and Drug Safety Act of 2007; S.1082, Food and Drug Administration Revitalization Act; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; SConRes.21, Concurrent resolution setting forth the congressional budget for the United States. Legislative proposals regarding drug safety, clinical trial registries, DTC adverstising, and reauthorization of the Prescription Drug User Fee Act, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act: H.R.2900, Food and Drug Administration Amendments Act of 2007; S.468, Food and Drug Administration Safety Act of 2007; S.484, Enhancing Drug Safety and Innovation Act of 2007; S.830, Pediatric Medical Device Safety and Improvement Act of 2007; S.993, Pediatric Research Improvement Act; S.1082, Food and Drug Administration Revitalization Act; S.1547, National Defense Authorization Act for Fiscal Year 2008. Legislative proposals regarding FDA funding: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative proposals to ensure access to meth-safe alternative medicines: H.R.3161, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008; S.1859, Agriculture, Rural Development , Food and Drug Administration, and Related Agencies Appropriations Act, 2008. Legislative propsals to reform the OTC monograph system: H.R.4083, Non-prescription Drug Modernization Act of 2007; S.2331, Non-prescription Drug Modernization Act of 2007. Response to congressional investigation regarding ENHANCE study.

Client expense: $500,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 84, "Professional Boxing Amendments Act of 2007" S. 124, "Satellite and Cable Access Act of 2007" S. 234, "Wireless Innovation Act of 2007" S. 337, "White Spaces Act of 2007" S. 234, "Wireless Innovation Act of 2007" S. 431, "KIDS Act of 2007" S. 567, "National Defense Authorization Act for Fiscal Year 2008" S. 602, "The Child Safe Viewing Act" S. 760, "Four Corners Television Access Act of 2007" S. 1082, "Prescription Drug User Fee Amendments of 2007" S. 1082, "Food and Drug Administration Revitalization Act" S. 1086, "Cyber Safety for Kids Act of 2007" S. 1224, "First Response Broadcasters Act of 2007" S. 1267, "Free Flow of Information Act of 2007" S. 1285, "Fair Elections Now Act" S. 1453, "ITFA Extension Act of 2007" S. 1742, "Broadcaster Freedom Act of 2007" S. 1748, "Broadcaster Freedom Act of 2007" S. 1780, "Protecting Children from Indecent Programming Act" S. 2035, Free Flow of Information Act of 2007 S. 2125, "Preparing America's Seniors for the Digital Television Transition of Act of 2007" H.R. 600, "Telecommunications Ownership Diversification Act of 2007" H.R. 608, "Digital Television Consumer Education Act of 2007" H.R. 719, " KIDS Act of 2007" H.R. 1077, "Internet Consumer Protection Act of 2007" H.R. 1120, " Deleting Online Predators Act of 2007" H.R. 1320, "Interference Protection for Existing Television Band Devices Act of 2007" H.R. 1597, "Wireless Innovation Act of 2007" H.R. 2102, "Free Flow of Information Act of 2007" H.R. 2566, "National Digital Television Consumer Education Act" H.R. 2738, "Family and Consumer Choice Act of 2007" H.R. 2821, "Television Freedom Act of 2007" H.R. 2829, "Financial Services and General Government Appropriations Act, 2008" H.R. 2900, "Food and Drug Administration Amendments Act of 2007" H.R. 2905, "Broadcaster Freedom Act of 2007" H.R. 2917, "Transition Education Accountability Report Act of 2007" H.R. 3461, "Safeguarding America's Families by Enhancing and Reorganizing New and Efficient Technologies Act of 2007" H.R. 3559, "Protecting Children from Indecent Programming Act" H.R. 3676, "Family Friendly Flights Act of 2007" H.R. 4167, "Broadcast Ownership for the 21st Century Act" H.R. 4221, "Satellite Consumers' Access to Public Television Digital Programming Act of 2007" H.R. 4882, "Broadcast Licensing in the Public Interest Act" H.R. 5140, Recovery Rebates and Economic Stimulus for the American People Act of 2008 H.R. 5470, To amend the Communications Act of 1934 to require the carriage of all local television signals by satellite carriers in all local markets H.R. 6320, Twenty-first Century Communications and Video Accessibility Act of 2008 (Markey) H.Res. 1, "Implementing Recommendations of the 9/11 Commission Act of 2007" S.J. Res. 28, A joint resolution disapproving the rule submitted by the Federal Communications Commission with respect to broadcast media ownership H.J. Res. 79, Disapproving the rule submitted by the Federal Communications Commission with respect to broadcast media ownership General Issues: 1) Content Regulation Issues, eg, Broadcast Indecency and Television Violence 2) Media Ownership Issues 3) Cable A La Carte Issues 4) Retransmission Consent Issues 5) Spectrum Issues 6) Federal Shield Law Issues 7) DTV Transition Issues 8) Direct-to-Consumer Drug Advertising Issues 9) DirecTV-Liberty Media Transaction 10) Online Advertising Issues 11) Broadcast Localism Issues 12) White Spaces Spectrum Issues 13) Libel Tourism 14) Network Neutrality 15) WWOR License Renewal 16) Enhanced Disclosure by Broadcasters 17) Funding for the United States Telecommunications Training Institute 18) Section 2257 Department of Justice Regulations

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, Smithsonian Institution, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

S 1695, Biologics Price Competition and Innovation Act of 2007, Sections regarding interchangeability, patent and exclusivity issues related to Food and Drug Administration approval of biogeneric drugs. S 691/ HR 1193, Kidney Care Quality and Educations Act of 2007, Section regarding increased costs to employers health plans. HR 5629, The Pathway for Biosimilars Act, Sections regarding interchangeability, patent and exclusivity issues related to Food and Drug Administration approval of biogeneric drugs. S 1082, Food and Drug Administration Revitalization Act, Provisions related to generic pharmaceuticals HR 2900, Food and Drug Administration Amendments Act of 2007, Provisions related to generic pharmaceuticals

Client expense: $1,925,000 · Firm income: Not reported

Government targets: Energy, Dept of, HOUSE OF REPRESENTATIVES, SENATE

S 1218/ HR 2034, Medicare for All Act, Amending the Social Security Act to add a new Title (XXII) to expand health care coverage S 1408, Health Information Technology Act of 2007, Sections requiring the Department of Health and Human Services to establish a program to utilize health Information electronic technology to improve delivery and care to patients S 1693, Wired for Health Care Quality Act, Sections requiring the Department of Health and Human Services to establish a program to utilize health Information electronic technology to improve delivery and care to patients S 1695, Biologics Price Competition and Innovation Act of 2007, Sections regarding interchangeability, patent and exclusivity issues related to Food and Drug Administration approval of biogeneric drugs. S 691/ HR 1193, Kidney Care Quality and Educations Act of 2007, Section regarding increased costs to employers health plans. HR 5629, The Pathway for Biosimilars Act, Sections regarding interchangeability, patent and exclusivity issues related to Food and Drug Administration approval of biogeneric drugs. S 1082, Food and Drug Administration Revitalization Act, Provisions related to generic pharmaceuticals HR 2900, Food and Drug Administration Amendments Act of 2007, Provisions related to generic pharmaceuticals HR1 of 2003, Medicare Modernization Act, Employee Medicare Prescription Drug Subsidy

Client expense: $1,925,000 · Firm income: Not reported

Government targets: Energy, Dept of, HOUSE OF REPRESENTATIVES, SENATE

S 234, Wireless Innovation Act HR 1597, Wireless Innovation Act S 337, White Spaces Act of 2007 S 602 Child Safe Viewing Act HR 2102, Free Flow Information Act of 2007 S 215, Internet Freedom Preservation Act HR 2738, Family and Consumer Choice Act HR 2821, Television Freedom Act of 2007 HR 2566, National Digital Television Consumer Education Act HR 2905, Broadcast Freedom Act of 2007 HR 608 Digital Television Consumer Education Act of 2007 HR 1320, Interference Protection for Existing Television Band Devices S 1780, Protecting Children from Indecent Programming Act HR 2900, Food and Drug Administration Act Amendments of 2007 S 1082, Food and Drug Administration Act Amendments of 2007 HR 2331 First Responders Act S 1223, First Responders Act S 124, Satellite and Cable Access Act of 2007 China Market Access Mexico Market Access S2035 Free Flow Information Act HR 2566 Media Ownership Act S 2332 Media Ownership Act HR 3559 Protecting Children from Indecent Programming S1267, Free Flow Information Act of 2007 S2831, FTC Reauthorization Act S1170, "Connect the Nation Act" HR 3627, "Connect the Nation Act" HR 3862, Preparing America's Seniors for Digital Transition HR 5435, DTV Border Fix S 2507, DTV Border Fix Retransmission consent Product Placement a la carte HR 2905, Fairness Doctrine Fiscal Year 2009 Appropriations Mark SJR 28 - Media Ownership HR 6209, Commercial Ads Loudness Mitigation Act S 3154, Commercial Ads Loudness Mitigation Act S 3156, Commercial Ads Loudness Mitigation Act DOJ to adopt new rules governing access under ADA for close captioning/video description in movies HR 6320, On Line Captioning HR 2320, National Amusement Park Ride Safety Act

Client expense: $4,800,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Natl Aeronautics & Space Administration (NASA), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

FDA Reform Bills - S 1082, HR 2900

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE