Food and Drug Administration Amendments Act of 2007

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)

S. 251, Pharmaceutical Market Access Act of 2007; S. 242/H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007; S. 2029/H.R. 5605, Physician Payment Sunshine Act of 2008; S. 558, Mental Health Parity Act of 2007; H.R. 1424, Paul Wellstone Health and Addiction Equity Act of 2007; S. 2723/H.R. 5549, Deamonte Driver Dental Access Act of 2008; H.R. 3580 - Food and Drug Administration Amendments Act of 2007

Client expense: $733,000 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

HR 3580 Biomaterial Tax Credit Sustainable agriculture capacity building Sub Sahara Africa/West Africa

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

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

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

Medicare Access to Rehabilitation Services Act of 2007 (S. 450/H.R. 748) Medicare Improvements for Patients and Providers Act (S. 3101/H.R. 6331) Preserving Access to Medicare Act (S. 3118) Public Law No: 110-85 (H.R. 3580) Public Law 110-173 (S. 2499) Medically Fragile Children's Act (H.R. 7130/S. 3631)

Client expense: $269,618 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

H.R. 493, to prohibit discrimination on the basis of genetic information with respect to health insurance and employment. H.R. 1443, to treat arbitration clauses which are unilaterally imposed on consumers as an unfair and deceptive trade practice . H.R. 1685, to protect information relating to consumers, to require notice of security breaches, and for other purposes. H.R. 2099, to authorize the secretary of HHS to order a mandatory recall of any product that is regulated by the FDA. H.R. 2124, to strengthen requirements related to security breaches of data involving the disclosure of sensitive personal information. HR 2718, DSHEA Full Implementation and Enforcement Act of 2007. H.R. 3100, to amend the Federal Food, Drug, and Cosmetic Act and the Consumer Product Safety Act to increase the safety of food, toothpaste, and toys. H.R. 3588, to amend the Consumer Product Safety Act to provide the Consumer Product Safety Commission with greater authority to require recalls, mandatory routine product testing, and for other purposes. H.R. 3580, the Food and Drug Administration Amendments Act of 2007. HR 4030, To prohibit the manufacture, sale, or distribution in commerce of certain children's products and child care articles that contain phthalates. H.R. 4040, Consumer Product Safety Modernization Act. H.R. 5636, to establish a comprehensive process to inform American consumers about food and product recalls, and for other purposes; to Energy & Commerce. H.R. 5769, to direct the Federal Trade Commission to revise the Telemarketing Sales Rule to explicitly prohibit the sending of a text message containing an unsolicited advertisement to a cellular telephone number listed on the national do-not-call registry; to Energy & Commerce. S. 358, to prohibit discrimination on the basis of genetic information with respect to health insurance and employment. S. 1082, the Food and Drug Administration Revitalization Act. S. 1178, to strengthen data protection and safeguards, require data breach notification, and further prevent identity theft. S. 1260, to protect information relating to consumers, to require notice of security breaches, and for other purposes. S. 2256, to establish an office of international and domestic product safety and a product safety coordinating council to improve the management, coordination, promotion, and oversight of product safety responsibilities, develop a centralized public database for product recalls, advisories, and alerts, and for other purposes. S. 2275, to prohibit the manufacture, sale, or distribution in commerce of certain children's products and child care articles that contain phthalates, and for other purposes. S. 2663, to reform the Consumer Product Safety Commission to provide greater protection for children's products, to improve the screening of noncompliant consumer products, to improve the effectiveness of consumer product recall programs, and for other purposes; read the first time. S. 2794, to protect older Americans from misleading and fraudulent marketing practices, with the goal of increasing retirement security; to Judiciary. S. 3086, to amend the antitrust laws to ensure competitive market-based fees and terms for merchants' access to electronic payment systems. S. 3425, to make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products, and for other purposes. S. 3475, to amend the Federal Food, Drug, and Cosmetic Act to require manufacturers of bottled water to submit annual reports, and for other purposes. S. 3633, to amend the Federal Food, Drug, and Cosmetic Act to require country of origin labeling on prescription and over-the-counter drugs. S. 2914, to ensure the safety of seafood and seafood products being imported into the United States. S. 3108, to require the president to call a White House conference on food and nutrition. S. 3385, to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. S. 3422, to amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, and for other purposes. S. 3575, to amend the Federal Food, Drug, and Cosmetic Act with respect to nutrition labeling of food offered for sale in food service establishments. H.R. 5827, to amend the Federal Food, Drug, and Cosmetic Act to improve food safety. H.R. 5839, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs. H.R. 5904, to amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements to improve the safety of food, whether produced and distributed domestically or imported into the United States, by providing for improved information technology to identify high-risk imports and for enhanced capacity in the United States and in foreign governments to identify and address food safety issues on a scientific basis, and for other purposes. H.R. 6127, to require the president to call a White House conference on food and nutrition. H.R. 6270, to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. H.R. 7120, to amend the Federal Food, Drug, and Cosmetic Act concerning the distribution and citation of scientific research in connection with foods and dietary supplements, and for other purposes. H.R. 7143, to establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.

Client expense: $110,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 493, to prohibit discrimination on the basis of genetic information with respect to health insurance and employment. H.R. 1443, to treat arbitration clauses which are unilaterally imposed on consumers as an unfair and deceptive trade practice . H.R. 1685, to protect information relating to consumers, to require notice of security breaches, and for other purposes. H.R. 2099, to authorize the secretary of HHS to order a mandatory recall of any product that is regulated by the FDA. H.R. 2124, to strengthen requirements related to security breaches of data involving the disclosure of sensitive personal information. HR 2718, DSHEA Full Implementation and Enforcement Act of 2007. H.R. 3100, to amend the Federal Food, Drug, and Cosmetic Act and the Consumer Product Safety Act to increase the safety of food, toothpaste, and toys. H.R. 3588, to amend the Consumer Product Safety Act to provide the Consumer Product Safety Commission with greater authority to require recalls, mandatory routine product testing, and for other purposes. H.R. 3580, the Food and Drug Administration Amendments Act of 2007. HR 4030, To prohibit the manufacture, sale, or distribution in commerce of certain children's products and child care articles that contain phthalates. H.R. 4040, Consumer Product Safety Modernization Act. H.R. 5636, to establish a comprehensive process to inform American consumers about food and product recalls, and for other purposes; to Energy & Commerce. H.R. 5769, to direct the Federal Trade Commission to revise the Telemarketing Sales Rule to explicitly prohibit the sending of a text message containing an unsolicited advertisement to a cellular telephone number listed on the national do-not-call registry; to Energy & Commerce. S. 358, to prohibit discrimination on the basis of genetic information with respect to health insurance and employment. S. 1082, the Food and Drug Administration Revitalization Act. S. 1178, to strengthen data protection and safeguards, require data breach notification, and further prevent identity theft. S. 1260, to protect information relating to consumers, to require notice of security breaches, and for other purposes. S. 2256, to establish an office of international and domestic product safety and a product safety coordinating council to improve the management, coordination, promotion, and oversight of product safety responsibilities, develop a centralized public database for product recalls, advisories, and alerts, and for other purposes. S. 2275, to prohibit the manufacture, sale, or distribution in commerce of certain children's products and child care articles that contain phthalates, and for other purposes. S. 2663, to reform the Consumer Product Safety Commission to provide greater protection for children's products, to improve the screening of noncompliant consumer products, to improve the effectiveness of consumer product recall programs, and for other purposes; read the first time. S. 2794, to protect older Americans from misleading and fraudulent marketing practices, with the goal of increasing retirement security; to Judiciary. S. 3086, to amend the antitrust laws to ensure competitive market-based fees and terms for merchants' access to electronic payment systems. S. 3425, to make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products, and for other purposes. S. 3475, to amend the Federal Food, Drug, and Cosmetic Act to require manufacturers of bottled water to submit annual reports, and for other purposes. S. 3633, to amend the Federal Food, Drug, and Cosmetic Act to require country of origin labeling on prescription and over-the-counter drugs. S. 2914, to ensure the safety of seafood and seafood products being imported into the United States. S. 3108, to require the president to call a White House conference on food and nutrition. S. 3385, to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. S. 3422, to amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, and for other purposes. S. 3575, to amend the Federal Food, Drug, and Cosmetic Act with respect to nutrition labeling of food offered for sale in food service establishments. H.R. 5827, to amend the Federal Food, Drug, and Cosmetic Act to improve food safety. H.R. 5839, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs. H.R. 5904, to amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements to improve the safety of food, whether produced and distributed domestically or imported into the United States, by providing for improved information technology to identify high-risk imports and for enhanced capacity in the United States and in foreign governments to identify and address food safety issues on a scientific basis, and for other purposes. H.R. 6127, to require the president to call a White House conference on food and nutrition. H.R. 6270, to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. H.R. 7120, to amend the Federal Food, Drug, and Cosmetic Act concerning the distribution and citation of scientific research in connection with foods and dietary supplements, and for other purposes. H.R. 7143, to establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.

Client expense: $110,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

Legislative and regulatory issues affecting pharmacies and retailers, including health care funding, health care programs, and the delivery of prescription drugs. H.R. 971, The Community Pharmacy Fairness Act. H.R. 3700 and S. 1951, The Fair Medicaid Drug Payment Act of 2007. H.R. 3580, Food and Drug Administration Amendments Act of 2007. H.R. 1585, Fiscal 2008 Defense Authorization - TRICARE provisions. S. 980, Ryan Haight Internet Controlled Substances Act. S. 1693, Wired for Health Care Act. H.R. 5539, the Safeguarding America's Pharmaceuticals Act of 2008. H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008. H.R. 6331, the Medicare Patients and Providers Protection Act of 2008. H.R. 6357, Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008. H.R. 6898, Health-e Information Technology Act of 2008.

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

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

Potential impact of H.R. 3580 (P.L. 110-085), the drug labeling and preemption provisions of the Food and Drug Administration Amendments Act General background on drug labeling rules and preemption S. 3398/H.R. 6381, the Medical Device Safety Act of 2008

Client expense: $9,600,000 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

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)

-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

H.R. 3580: "Food and Drug Administration Amendments Act of 2007" - to establish medical device user fees and make improvements in the FDA's 3rd Party Inspection, and Combination Products Program S. 1734: "The PRIME (Prostate Research, Imaging, Men's Education) Act of 2007" - to provide for expanded prostate research FDA - research on legislation to fund a Medicare demonstration program for remote monitoring technology FDA Globalization Act (Discussion draft - no bill number) - medical device inspection fees.

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

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

H.R. 3161, Agriculture Appropriations Bill, Miscellaneous Title, provisions relating to Agriculture Research Studies H.R. 3222, Defense Appropriations Bill, provisions relating to Agriculture Research Studies H.R. 3580, Food and Drug Administration Amendments Act of 2007, provisions related to Agriculture Research Studies H.R. 2419, Farm Bill, provisions related to Agriculture Research Studies

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

Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE

Prescription drug abuse, misuse, and diversion Development of abuse-deterrent drug formulations Implementation of P.L. 110-85/HR 3580, Food and Drug Administration Amendments Act of 2007 (section on post-market drug safety)

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

Government targets: HOUSE OF REPRESENTATIVES

Drug and biological product pricing and reimbursement; Medical product safety; Prescription drug pedigree and anti-counterfeiting policy; Drug and device marketing and promotion; Healthcare-acquired infections; H.R. 5629, Pathway for Biosimilars Act; Implementation of P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007; Comparative effectiveness research, Renal education.

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

Government targets: SENATE

S.3289, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2009, FDA and USDA funding initiatives. Implementation of Prescription Drug User Fee Amendments, 2007 (Public Law 110-85), Drug safety related issues. H.R. 3580, Food and Drug Administration Amendments Act of 2007, Drug safety and science related issues.

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

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

S 654 - Safe Food Consumption Act of 2007 S 2245 - Food Safety Modernization Act of 2007 S 1776 - Imported Food Safety Act of 2007 HR 3927 - Food Import Safety Act of 2007 HR 3624 - Consumer Food Safety Act of 2007 HR 3610 - Food & Drug Import Safety Act of 2007 HR 3580 - FDA Amendments Act of 2007 HR 5904 - The Safe FEAST Act S 3385 - FDA Food Modernization Act

Client expense: Not reported · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commodity Futures Trading Commission (CFTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, White House Office

Food Safety in Meat and Poultry; Food Safety Research; Mandatory Country of Origin Labeling; Food Packaging; Interstate Shipment of State Inspected Meat and Poultry; Farm Bill 2008 [H.R.5904] [H.R.6124] [H.R.2419] [H.R.3580] [H.R.3610] [H.R.1148] [H.R.2108] [H.R.3115] [H.R.3161] [H.R.3937] [H.R.5762] [S.2770] [S.654] [S.1274] [S1776] [S.2245]

Client expense: $23,000 · Firm income: Not reported

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

Generic Biologics, including but not limited to: S.623, S.1505, S.1695, H.R.1038, H.R.1956, and H.R.5629 Prescription Drug Safety Food and Drug Administration Act of 2007 (H.R.3580): any parts relating to access to generic drugs and the impact and marketing of prescription drugs Citizen Petitions, including but not limited to: S.25 and S.1088 Counterfeit Drugs/Import Safety/Pedigree including but not limited to: S.3409 and H.R.5839 Electronic Prescribing Authorized Generics including but not limited to: S.2408 and H.R.4296 Prescription Drug Importation/Re-Importation Any other matters that relate to access to generic drugs

Client expense: $539,634 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

FDA Model Food Care; Food Safety; H.R.3580, Food and Drug Administration Amendment Act

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, State, Dept of (DOS)

FDA Sentinel Initiative (post market surveillance); H.R. 3580; FDA Guidance Documents; H.R. 3160 - Import Safety; Federal Preemption (S.3398 and H.R. 6381); Direct to Consumer Ads (H.R. 6151)

Client expense: $16,115 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

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

H.R. 6381- Medical Device Safety Act of 2008 H.R.5839 - Safeguarding America's Pharmaceuticals Act of 2008 S.3385 - FDA Food Safety Modernization Act Health Care Reform S.2731/H.R. 5501 Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 H.R. 3580, the Food and Drug Administration Amendments Act of 2007 - issues related to implementation of the Prescription Drug User Fee Act. S.1695, Biologics Price Competition and Innovation Act of 2007 S.623/H.R. 1038 Access to Life-Saving Medicine Act H.R.5629 Pathway for Biosimilars Act H.R.1956 Patient Protection and Innovative Biologic Medicines Act of 2007

Client expense: $1,780,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Medicare Access to Rehabilitation Services Act of 2007 (S. 450/H.R. 748) Medicare Improvements for Patients and Providers Act (S. 3101/H.R. 6331) Preserving Access to Medicare Act (S. 3118) Public Law No: 110-85 (H.R. 3580) Public Law 110-173 (S. 2499) Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY2009 (CMS-1403-P) National Coverage Analysis of Pharmacogenomic Testing for Warfarin Response (CAG-00400N)

Client expense: $411,823 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

FDA Model Food Code USDA & Listeria Risk Assessment Food and Drug Import Safety Act of 2007- H.R. 3610 Farm Bill, H.R. 2419, S. 2302 The FDA Globalization Act of 2008 (House discussion draft) Safe FEAST Act of 2008- H. R. 5904 Food and Drug Administration Amendments Act- H.R. 3580 Consumer Food Safety Act- H.R. 3624 EAT SAFE- S. 2418 Fresh Produce Safety Act- S. 2077 Help America Act- S. 1342, H.R. 2633-Title IV MEAL Act- H.R. 3895, S. 2784 National Food Uniformity Act Foodbourne Illness outbreaks Avian Influenza Trans Fatty acids Mandatory Recall Authority- S. 1274, H. R. 2108 Safe Food Act- S. 654. H.R. 1148 Mandatory Menu Labeling- Labeling Education and Nutrition Act- H.R. 7187, S. 3575 The FDA Food Safety Modernization Act- S. 3385 Improving Food-borne Illness Surveillance and Response Act of 2008- S. 3358 Food Allergy and Anaphylaxis Management Act of 2007- S. 1282

Client expense: $850,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, White House Office

H.R. 3580: "Food and Drug Administration Amendments Act of 2007" - to establish medical device user fees and make improvements in the FDA's 3rd Party Inspection, and Combination Products Program S. 1734: "The PRIME (Prostate Research, Imaging, Men's Education) Act of 2007" - to provide for expanded prostate research FDA - research on legislation to fund a Medicare demonstration program for remote monitoring technology FDA Globalization Act (Discussion draft - no bill number) - medical device inspection fees.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 493, to prohibit discrimination on the basis of genetic information with respect to health insurance and employment. H.R. 1443, to treat arbitration clauses which are unilaterally imposed on consumers as an unfair and deceptive trade practice . H.R. 1685, to protect information relating to consumers, to require notice of security breaches, and for other purposes. H.R. 2099, to authorize the secretary of HHS to order a mandatory recall of any product that is regulated by the FDA. H.R. 2124, to strengthen requirements related to security breaches of data involving the disclosure of sensitive personal information. HR 2718, DSHEA Full Implementation and Enforcement Act of 2007. H.R. 3100, to amend the Federal Food, Drug, and Cosmetic Act and the Consumer Product Safety Act to increase the safety of food, toothpaste, and toys. H.R. 3588, to amend the Consumer Product Safety Act to provide the Consumer Product Safety Commission with greater authority to require recalls, mandatory routine product testing, and for other purposes. H.R. 3580, the Food and Drug Administration Amendments Act of 2007. HR 4030, To prohibit the manufacture, sale, or distribution in commerce of certain children's products and child care articles that contain phthalates. H.R. 4040, Consumer Product Safety Modernization Act. H.R. 5636, to establish a comprehensive process to inform American consumers about food and product recalls, and for other purposes; to Energy & Commerce. H.R. 5769, to direct the Federal Trade Commission to revise the Telemarketing Sales Rule to explicitly prohibit the sending of a text message containing an unsolicited advertisement to a cellular telephone number listed on the national do-not-call registry; to Energy & Commerce. S. 358, to prohibit discrimination on the basis of genetic information with respect to health insurance and employment. S. 1082, the Food and Drug Administration Revitalization Act. S. 1178, to strengthen data protection and safeguards, require data breach notification, and further prevent identity theft. S. 1260, to protect information relating to consumers, to require notice of security breaches, and for other purposes. S. 2256, to establish an office of international and domestic product safety and a product safety coordinating council to improve the management, coordination, promotion, and oversight of product safety responsibilities, develop a centralized public database for product recalls, advisories, and alerts, and for other purposes. S. 2275, to prohibit the manufacture, sale, or distribution in commerce of certain children's products and child care articles that contain phthalates, and for other purposes. S. 2663, to reform the Consumer Product Safety Commission to provide greater protection for children's products, to improve the screening of noncompliant consumer products, to improve the effectiveness of consumer product recall programs, and for other purposes; read the first time. S. 2794, to protect older Americans from misleading and fraudulent marketing practices, with the goal of increasing retirement security; to Judiciary. S. 3086, to amend the antitrust laws to ensure competitive market-based fees and terms for merchants' access to electronic payment systems. S. 3425, to make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products, and for other purposes. S. 3475, to amend the Federal Food, Drug, and Cosmetic Act to require manufacturers of bottled water to submit annual reports, and for other purposes. S. 3633, to amend the Federal Food, Drug, and Cosmetic Act to require country of origin labeling on prescription and over-the-counter drugs. S. 2914, to ensure the safety of seafood and seafood products being imported into the United States. S. 3108, to require the president to call a White House conference on food and nutrition. S. 3385, to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. S. 3422, to amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, and for other purposes. S. 3575, to amend the Federal Food, Drug, and Cosmetic Act with respect to nutrition labeling of food offered for sale in food service establishments. H.R. 5827, to amend the Federal Food, Drug, and Cosmetic Act to improve food safety. H.R. 5839, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs. H.R. 5904, to amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements to improve the safety of food, whether produced and distributed domestically or imported into the United States, by providing for improved information technology to identify high-risk imports and for enhanced capacity in the United States and in foreign governments to identify and address food safety issues on a scientific basis, and for other purposes. H.R. 6127, to require the president to call a White House conference on food and nutrition. H.R. 6270, to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. H.R. 7120, to amend the Federal Food, Drug, and Cosmetic Act concerning the distribution and citation of scientific research in connection with foods and dietary supplements, and for other purposes. H.R. 7143, to establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.

Client expense: $110,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 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: $720,000 · 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)

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) Citizens Petitions, including but not limited to S. 25 and S. 1080 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) Citizens Petitions, including but not limited to S. 25 and S. 1080 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

-H.R.1165, "Swift Approval, Full Evaluation Drug Act or the 'SAFE Drug Act," regarding amending the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs and to establish whistleblower protections for certain individuals; -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. 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;

Client expense: $1,500,000 · Firm income: Not reported

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

H.R. 6331, Medicare Act of 2008 H.R. 1424, Mental Health and Addiction Equity Act of 2007 S. 558, Mental Health Parity Act of 2008 H.R. 6357, PRO(TECH)T Act of 2008 S. 1693, Wired for Health Care Quality Act S. 3101, Medicare Act of 2008, provisions on Electronic Prescribing, Medicare, Medicare Advantage and inclusion of care coordination projects, H.R. 5719, Taxpayer Assistance and Simplification Act of 2008 S. 2818, the Small Business Health Plans Act of 2008 H.R. 6288, Retiree Health Accounts Act H. Con. Res. 405, Workplace Wellness resolution H.R. 2851, Michelle's Law S. 555, SIMPLE Cafeteria Plan Act 2007 H Con Res 405, Recognizing the first full week of April as `National Workplace Wellness Week'. (Introduced in House) H.R. 5884/S.2449, Sunshine in Litigation Act of 2008 H.R. 4854/S.2041, To Amend the False Claims Act H.R. 3800, To amend the Public Health Service Act to promote the adoption of health information technology, and for other purposes H.R. 6049, Energy and Tax Extenders Act of 2008 H.R. 6983, Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 H.R. 6288, Retiree Health Account Act of 2008 H.R. 1494, Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 493/S. 358, Genetic Information Nondiscrimination Act of 2007 H.R. 4296/S. 2480, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 H.R. 6898, Health-e Information Technology Act of 2008 H.R. 2639, Promoting Health for Future Generations Act of 2007 S. 3234, Promoting Health for Future Generations Act of 2007 H.R. 2497, Fair and Reliable Medical Justice Act S.1481, Fair and Reliable Medical Justice Act H.R. 2499, Medicaid, and SCHIP Extension Act of 2007 S. 1544, Medicare Quality Enhancement Act of 2007 H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007 S. 1951, Fair Medicaid Drug Payment Act of 2007 H.R. 3140, Saving Our Community Pharmacies Act of 2007 H.R.241, Small Business Health Fairness Act of 2007 H.R.1666, Health Care Price Transparency Promotion Act H.R. 3717, Healthy Workforce Act of 2007 H.R. 853, Wellness and Prevention Act of 2007 H.R. 6357, Health Information Technology Act H.R. 6852, Small Business Cooperatives for Healthcare Options to Improve Coverage for Employees Act of 2008 (CHOICE) S. 1753, Healthy Workforce Act of 2007 S. 2795, Small Business Health Options Program Act of 2008 H.R. 3947, To amend the Internal Revenue Code of 1986 to provide for a carryforward of unused benefits in health flexible spending arrangements H.R. 3580, Food and Drug Administration Amendments Act of 2007 S. 3118, A bill to amend title XVIII of the Social Security Act to improve access to health care under the Medicare program for beneficiaries residing in rural areas. Implementation of Medicare Modernization Act of 2003 (Health Savings Accounts provisions)

Client expense: $20,600,000 · Firm income: Not reported

Government targets: Bureau of Land Management (BLM), Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Minerals Management Service, Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Generic Biologics, including but not limited to: S.623, S.1505, S.1695, H.R.1038, H.R.1956, and H.R.5629 Prescription Drug Safety Food and Drug Administration Act of 2007 (H.R.3580): any parts relating to access to generic drugs and the impact and marketing of prescription drugs Citizen Petitions, including but not limited to: S.25 and S.1088 Counterfeit Drugs/Import Safety/Pedigree including but not limited to: S.3409 and H.R.5839 Electronic Prescribing (E-Prescribing) Authorized Generics including but not limited to: S.2408 and H.R.4296 Prescription Drug Importation/Re-Importation Any other matters that relate to access to generic drugs

Client expense: $506,976 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 3580 (P.L. 110-085), the drug labeling and preemption provisions of the Food and Drug Administration Amendments Act General Background on Drug Labeling Rules and Preemption S. 3398/H.R. 6381, the Medical Device Safety Act of 2008

Client expense: $9,010,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

Legislative and regulatory issues affecting pharmacies and retailers, including health care funding, health care programs, and the delivery of prescription drugs. H.R. 971, The Community Pharmacy Fairness Act. H.R. 3700 and S. 1951, The Fair Medicaid Drug Payment Act of 2007. H.R. 3580, Food and Drug Administration Amendments Act of 2007. H.R. 1585, Fiscal 2008 Defense Authorization - TRICARE provisions. S. 980, Ryan Haight Internet Controlled Substances Act. S. 1693, Wired for Health Care Act. H.R. 5539, the Safeguarding America's Pharmaceuticals Act of 2008. H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008. H.R. 6331, the Medicare Patients and Providers Protection Act of 2008. H.R. 6357, Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008. H.R. 6898, Health-e Information Technology Act of 2008.

Client expense: $110,000 · Firm income: Not reported

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

FDA Model Food Care; Food Safety; H.R.3580, Food and Drug Administration Amendment Act

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, State, Dept of (DOS)

Drug and biological product pricing and reimbursement; Medical product safety; Prescription drug pedigree and anti-counterfeiting policy; Drug and device marketing and promotion; Healthcare-acquired infections; H.R. 5629, Pathway for Biosimilars Act; Implementation of P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007; Comparative effectiveness research.

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

Drug and biological product pricing and reimbursement; Medical product safety; Prescription drug pedigree and anti-counterfeiting policy; Drug and device marketing and promotion; Healthcare-acquired infections; H.R. 5629, Pathway for Biosimilars Act; Implementation of P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007; Comparative effectiveness research.

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

Prescription drug abuse, misuse, and diversion Development of abuse-deterrent drug formulations Implementation of P.L. 110-85/HR 3580, Food and Drug Administration Amendments Act of 2007 (section on post-market drug safety)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.3289/H.R. TBD, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2009, FDA and USDA funding initiatives. Implementation of Prescription Drug User Fee Amendments, 2007 (Public Law 110-85), Drug safety related issues. H.R. 3580, Food and Drug Administration Amendments Act of 2007, Drug safety and science related issues.

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

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

Food Safety in Meat and Poultry; Food Safety Research; Mandatory Country of Origin Labeling; Food Packaging; Interstate Shipment of State Inspected Meat and Poultry; Farm Bill 2008 [H.R.5904] [H.R.6124] [H.R.2419] [H.R.3580] [H.R.3610] [H.R.1148] [H.R.2108] [H.R.3115] [H.R.3161] [H.R.3937] [H.R.5762] [S.2770] [S.654] [S.1274] [S.1776] [S.2245]

Client expense: $96,000 · Firm income: Not reported

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

S 654 - Safe Food Consumption Act of 2007 S 2245 - Food Safety Modernization Act S 1776 - Imported Food Safety Act of 2007 HR 3927 Food Import Safety Act of 2007 HR 3624 - Consumer Food Safety Act of 2007 HR 3610 - Food & Drug Import Safety Act of 2007 HR 3580 - FDA Amendments Act of 2007 HR 5904 - The Safe FEAST Act S 3385 - FDA Food Safety Modernization Act

Client expense: $8,231 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commodity Futures Trading Commission (CFTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, White House Office

MDUFMA Digital Mammography FDA Ammendment Act of 2007; H.R. 6357: PRO(TECH)T Act of 2008; H.R. 3580: Food and Drug Administration Amendments Act of 2007

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE