Fair Prescription Drug Competition Act

Veterans Healthcare issues Electronic Prescribing Comparative Effectiveness Research S. 2408, Medicare Electronic Medication and Safety Protection Act 2007 HR. 4296, Medicare Electronic Medication and Safety Protection Act 12/07 HR. 3800, Promoting Health Information Technology Act 10/07 HR. 2406, (no title) authorize the NIST to increase its efforts in support of the integration of the healthcare information enterprise in the United States 11/07 S. 1693, The Wired for Health Care Quality Act 10/07 S. 438, Fair Prescription Drug Competition Act 1/07 S. 1082, Food and Drug Administration Revitalization Act 5/07 HR. 806 2/07 S. 1432, Preserve Access to Affordable Generics Act 5/07 S. 316, Preserve Access to Affordable Generics Act 3/07 S. 2029 Physician Payments Sunshine Act HR 5605 Physician Payments Sunshine Act HR 962 Preservation of Antibioties for Medical Treatment Act S. 349 Preservation of Antibioties for Medical Treatment Act S. 2313 Strategies to Address Antimicrobial Resistance HR 3697 Strategies to Address Antimicrobial Resistance HR 1424. The Paul Wellstone Mental Health and Addiction Equity Act H.R. 6331 Medicare Improvements for Patients & Providers Act H.R. 6376 and H.R. 6378 - Strengthening FDA Integrity Act (6/08) S. 877 - Stop Abuse of Growth Hormone Act (3/07) H.R. 4911 - Human Growth Hormone Restriction Act (12/07) H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or The Pro(TECH)T Act of 2008 H.R. 6898 - the Health-e Information Technology Act of 2008 S. 3396 - Independent Drug Education and Outreach Act of 2008

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)

HR. 1432, Preserve Access to Affordable Generics Act (settlements) 3/07 S. 316, Preserve Access to Affordable Generics Act (settlements) 3/07 HR 1902, Protecting Consumer Access to Generic Drugs Act (4/07) S 2300, Lower PRICED Drugs Act, legislation pediatric exclusivity, citizens petitions HR 6022, Lower PRICED Drugs Act, legislation on pediatric exclusivity, citizens petitions S 3695, To Amend the Federal Food, Drug & Cosmetic Act to prohibit the marketing of authorized generic drugs, authorized generics HR 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs HR 5120, To Amend Title 35, United States Code, to confirm certain filing provisions within the Patent and Trademark Office. HR 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges S 438, Fair Prescription Drug Competition Act (ban authorized generics) 1/07 HR 780, Counterfeit Drug Prevention Act of 2007 3/07 HR 1908, Patent Reform Act of 2007 S 1145, Patent Reform Act of 2007 S 623, Access to Life-Saving Medication Act (FOBS) 2/07 HR 1038, Access to Life-Saving Medication Act HR 5629, Pathway For Biosimilars Act S. 1145, Patent Reform Act (4/07) HR 1908, Patent Reform Act S. 3325, PL-110-403 (10/13/08) Intellectual Property Enforcement Act

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

Access to Life-Saving Medicine Act (H.R. 1038 & S. 623), Affordable Biologics for Consumers Act (S. 1505), Biologics Price Competition and Innovation Act of 2007 (S. 1695), Consumer Food Safety Act of 2008 (H.R. 3624), Fair Prescription Drug Competition Act (H.R. 806 & S. 438), Food and Drug Import Safety Act of 2007 (H.R. 3610, The Pathway for Biologics Act (H.R. 5629), The Patient Protection and Innovative Biologic Medicines Act (H.R. 1956).

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

Government targets: Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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.

S. 623 - Access to Life-Saving Medicine Act S. 438 - Fair Prescription Drug Competition Act H.R. 806 - Fair Prescription Drug Competition Act H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 5629 - The Pathway for Biologics Act H.R. 1038 - Access to Life-Saving Medicine Act S. 1505 - Affordable Biologics for Consumers Act S. 1695 - Biologics Price Competition and Innovation Act of 2007 H.R. 3610 - Food and Drug Import Safety Act of 2007 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. H.R. 3624 - Consumer Food Safety Act of 2007

Client expense: $510,000 · 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), SENATE

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

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

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

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

Client expense: Not reported · Firm income: Not reported

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

Veterans Healthcare issues Electronic Prescribing Comparative Effectiveness Research Genetic Information Non-Discrimination S. 2408, Medicare Electronic Medication and Safety Protection Act 2007 HR. 4296, Medicare Electronic Medication and Safety Protection Act 12/07 HR. 3800, Promoting Health Information Technology Act 10/07 HR. 2406, (no title) authorize the NIST to increase its efforts in support of the integration of the healthcare information enterprise in the United States 11/07 S. 1693, The Wired for Health Care Quality Act 10/07 S. 438, Fair Prescription Drug Competition Act 1/07 S. 1082, Food and Drug Administration Revitalization Act 5/07 HR. 806 2/07 S. 358, Genetic Information Nondiscrimination Act 4/07 S. 1432, Preserve Access to Affordable Generics Act 5/07 S. 316, Preserve Access to Affordable Generics Act 3/07 S. 2029 Physician Payments Sunshine Act HR 5605 Physician Payments Sunshine Act HR 962 Preservation of Antibioties for Medical Treatment Act S. 349 Preservation of Antibioties for Medical Treatment Act S. 2313 Strategies to Address Antimicrobial Resistance HR 3697 Strategies to Address Antimicrobial Resistance HR 1424. The Paul Wellstone Mental Health and Addiction Equity Act S 2731, The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIVAIDS, Tuberculosis, and Malaria Reauthorization Act (Also HR 5501) H.R. 6331 Medicare Improvements for Patients & Providers Act H.R. 6376 and H.R. 6378 - Strengthening FDA Integrity Act (6/08) S. 877 - Stop Abuse of Growth Hormone Act (3/07) H.R. 4911 - Human Growth Hormone Restriction Act (12/07) H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or The Pro(TECH)T Act of 2008 H.R. 6898 - the Health-e Information Technology Act of 2008 S. 3396 - Independent Drug Education and Outreach Act of 2008

HR. 1432, Preserve Access to Affordable Generics Act (settlements) 3/07 S. 316, Preserve Access to Affordable Generics Act (settlements) 3/07 HR 1902, Protecting Consumer Access to Generic Drugs Act (4/07) S 2300, Lower PRICED Drugs Act, legislation pediatric exclusivity, citizens petitions HR 6022, Lower PRICED Drugs Act, legislation on pediatric exclusivity, citizens petitions S 3695, To Amend the Federal Food, Drug & Cosmetic Act to prohibit the marketing of authorized generic drugs, authorized generics HR 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs HR 5120, To Amend Title 35, United States Code, to confirm certain filing provisions within the Patent and Trademark Office. HR 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges S 438, Fair Prescription Drug Competition Act (ban authorized generics) 1/07 HR 780, Counterfeit Drug Prevention Act of 2007 3/07 HR 1908, Patent Reform Act of 2007 S 1145, Patent Reform Act of 2007 S 623, Access to Life-Saving Medication Act (FOBS) 2/07 HR 1038, Access to Life-Saving Medication Act HR 5629, Pathway For Biosimilars Act S. 1145, Patent Reform Act (4/07) HR 1908, Patent Reform Act

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

Veterans Healthcare issues Electronic Prescribing Comparative Effectiveness Research Genetic Information Non-Discrimination S. 2408, Medicare Electronic Medication and Safety Protection Act 2007 HR. 4296, Medicare Electronic Medication and Safety Protection Act 12/07 HR. 3800, Promoting Health Information Technology Act 10/07 HR. 2406, (no title) authorize the NIST to increase its efforts in support of the integration of the healthcare information enterprise in the United States 11/07 S. 1693, The Wired for Health Care Quality Act 10/07 S. 438, Fair Prescription Drug Competition Act 1/07 S. 1082, Food and Drug Administration Revitalization Act 5/07 HR. 806 2/07 S. 358, Genetic Information Nondiscrimination Act 4/07 S. 1432, Preserve Access to Affordable Generics Act 5/07 S. 316, Preserve Access to Affordable Generics Act 3/07 S. 2029 Physician Payments Sunshine Act HR 5605 Physician Payments Sunshine Act HR 962 Preservation of Antibioties for Medical Treatment Act S. 349 Preservation of Antibioties for Medical Treatment Act S. 2313 Strategies to Address Antimicrobial Resistance HR 3697 Strategies to Address Antimicrobial Resistance HR 1424. The Paul Wellstone Mental Health and Addiction Equity Act S 2731, The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIVAIDS, Tuberculosis, and Malaria Reauthorization Act (Also HR 5501) H.R. 6331 Medicare Improvements for Patients & Providers Act H.R. 6376 and H.R. 6378 - Strengthening FDA Integrity Act (6/08) S. 877 - Stop Abuse of Growth Hormone Act (3/07) H.R. 4911 - Human Growth Hormone Restriction Act (12/07) H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or The Pro(TECH)T Act of 2008 H.R. 6898 - the Health-e Information Technology Act of 2008 S. 3396 - Independent Drug Education and Outreach Act of 2008

HR. 1432, Preserve Access to Affordable Generics Act (settlements) 3/07 S. 316, Preserve Access to Affordable Generics Act (settlements) 3/07 HR 1902, Protecting Consumer Access to Generic Drugs Act (4/07) S 2300, Lower PRICED Drugs Act, legislation pediatric exclusivity, citizens petitions HR 6022, Lower PRICED Drugs Act, legislation on pediatric exclusivity, citizens petitions S 3695, To Amend the Federal Food, Drug & Cosmetic Act to prohibit the marketing of authorized generic drugs, authorized generics HR 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs HR 5120, To Amend Title 35, United States Code, to confirm certain filing provisions within the Patent and Trademark Office. HR 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges S 438, Fair Prescription Drug Competition Act (ban authorized generics) 1/07 HR 780, Counterfeit Drug Prevention Act of 2007 3/07 HR 1908, Patent Reform Act of 2007 S 1145, Patent Reform Act of 2007 S 623, Access to Life-Saving Medication Act (FOBS) 2/07 HR 1038, Access to Life-Saving Medication Act HR 5629, Pathway For Biosimilars Act S. 1145, Patent Reform Act (4/07) HR 1908, Patent Reform Act

Client expense: $3,060,000 · Firm income: Not reported

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

Client expense: $155,000 · Firm income: Not reported

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

Access to Life-Saving Medicine Act (H.R. 1038 & S. 623), Affordable Biologics for Consumers Act (S. 1505), Biologics Price Competition and Innovation Act of 2007 (S. 1695), Consumer Food Safety Act of 2008 (H.R. 3624), Fair Prescription Drug Competition Act (H.R. 806 & S. 438), Food and Drug Import Safety Act of 2007 (H.R. 3610, The Pathway for Biologics Act (H.R. 5629), The Patient Protection and Innovative Biologic Medicines Act (H.R. 1956).

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

Government targets: Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

-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;

S. 623 - Access to Life-Saving Medicines Act S. 438 - Fair Prescription Drug Competition Act H.R. 806 - Fair Prescription Drug Competition Act H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 5629 - The Pathway for Biologics Act H.R. 1038 - Access to Life-Saving Medicine Act S. 1505 - Affordable Biologics for Consumers Act S. 1695 - Biologics Price Competition and Innovation Act of 2007 H.R. 3610 - Food and Drug Import Safety Act of 2007 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. H.R. 3624 - Consumer Food Safety Act of 2007

Client expense: $570,000 · 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), SENATE

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

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

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

Veterans Healthcare issues Electronic Prescribing Comparative Effectiveness Research Genetic Information Non-Discrimination S. 2408, Medicare Electronic Medication and Safety Protection Act 2007 HR. 4296, Medicare Electronic Medication and Safety Protection Act 12/07 HR. 3800, Promoting Health Information Technology Act 10/07 HR. 2406, (no title) authorize the NIST to increase its efforts in support of the integration of the healthcare information enterprise in the United States 11/07 S. 1693, The Wired for Health Care Quality Act 10/07 S. 438, Fair Prescription Drug Competition Act 1/07 S. 1082, Food and Drug Administration Revitalization Act 5/07 HR. 806 2/07 S. 358, Genetic Information Nondiscrimination Act 4/07 S. 1432, Preserve Access to Affordable Generics Act 5/07 S. 316, Preserve Access to Affordable Generics Act 3/07 S. 2029 Physician Payments Sunshine Act HR 5605 Physician Payments Sunshine Act HR 962 Preservation of Antibioties for Medical Treatment Act S. 349 Preservation of Antibioties for Medical Treatment Act S. 2313 Strategies to Address Antimicrobial Resistance HR 3697 Strategies to Address Antimicrobial Resistance HR 1424. The Paul Wellstone Mental Health and Addiction Equity Act S 2731, The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIVAIDS, Tuberculosis, and Malaria Reauthorization Act (Also HR 5501) H.R. 6331 Medicare Improvements for Patients & Providers Act H.R. 6376 and H.R. 6378 - Strengthening FDA Integrity Act (6/08) S. 877 - Stop Abuse of Growth Hormone Act (3/07) H.R. 4911 - Human Growth Hormone Restriction Act (12/07) H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or The Pro(TECH)T Act of 2008

Client expense: $3,060,000 · Firm income: Not reported

HR. 1432, Preserve Access to Affordable Generics Act (settlements) 3/07 S. 316, Preserve Access to Affordable Generics Act (settlements) 3/07 HR 1902, Protecting Consumer Access to Generic Drugs Act (4/07) S 2300, Lower PRICED Drugs Act, legislation pediatric exclusivity, citizens petitions HR 6022, Lower PRICED Drugs Act, legislation on pediatric exclusivity, citizens petitions S 3695, To Amend the Federal Food, Drug & Cosmetic Act to prohibit the marketing of authorized generic drugs, authorized generics HR 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs HR 5120, To Amend Title 35, United States Code, to confirm certain filing provisions within the Patent and Trademark Office. HR 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges S 438, Fair Prescription Drug Competition Act (ban authorized generics) 1/07 HR 780, Counterfeit Drug Prevention Act of 2007 3/07 HR 1908, Patent Reform Act of 2007 S 1145, Patent Reform Act of 2007 S 623, Access to Life-Saving Medication Act (FOBS) 2/07 HR 1038, Access to Life-Saving Medication Act HR 5629, Pathway For Biosimilars Act S. 1145, Patent Reform Act (4/07) HR 1908, Patent Reform Act

Client expense: $3,060,000 · Firm income: Not reported

S. 623 - Access to Life-Saving Medicines Act S. 438 - Fair Prescription Drug Competition Act H.R. 806 - Fair Prescription Drug Competition Act H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 5629 - The Pathway for Biologics Act H.R. 1038 - Access to Life-Saving Medicine Act S. 1505 - Affordable Biologics for Consumers Act S. 1695 - Biologics Price Competition and Innovation Act of 2007 H.R. 3610 - Food and Drug Import Safety Act of 2007 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. H.R. 3624 - Consumer Food Safety Act of 2007

Client expense: $490,000 · 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), 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 o mental health and substance-related disorder benefits under group health plans; H.R. 1494 / S. 830, "Pediactric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediactric 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, "To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs", regarding all provisions; S. 334, "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, "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, "A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs", regarding all provisions.

S. 623/Access to Life-Saving Medicine Act, S. 438/Fair Prescription Drug Competition Act, H.R. 806/Fair Prescription Drug Competition Act, H.R. 1956/Patient Protection and Innovative Biologic Medicines Act of 2007, H.R. 5629, H.R. 1038/Access to Life-Saving Medicine Act, S. 1505/Affordable Biologics for Consumers Act, S. 1695/Biologics Act of 2007, HR 3610

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

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

S. 623 - Access to Life-Saving Medicine Act S. 438 - Fair Prescription Drug Competition Act H.R. 806 - Fair Prescription Drug Competition Act H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 5629 - The Pathway for Biologics Act H.R. 1038 - Access to Life-Saving Medicine Act S. 1505 - Affordable Biologics for Consumers Act S. 1695 - Biologics Price Competition and Innovation Act of 2007 H.R. 3610 - Food and Drug Import Safety Act of 2007

Client expense: $640,000 · Firm income: Not reported

H.R. 1908, S. 1145 Patent Reform Act of 2007 H.R. 806 To Amend the Food, Drug, and Cosmetic Act to Prohibit the Marketing of Authorized Generics S. 438 Fair Prescription Drug Competition Act H.R. 1038, S. 623 Access to Life Saving Medicines Act H.R. 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 5629 Pathway for Biosimilars Act

Client expense: $295,390 · Firm income: Not reported

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

HR. 1432, Preserve Access to Affordable Generics Act (settlements) 3/07 S. 316, Preserve Access to Affordable Generics Act (settlements) 3/07 S. 445, Patent Reform Act HR 1908, Patent Reform Act S 2300, Lower PRICED Drugs Act, legislation pediatric exclusivity, citizens petitions HR 6022, Lower PRICED Drugs Act, legislation on pediatric exclusivity, citizens petitions S 3695, To Amend the Federal Food, Drug & Cosmetic Act to prohibit the marketing of authorized generic drugs, authorized generics HR 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs HR 5120, To Amend Title 35, United States Code, to confirm certain filing provisions within the Patent and Trademark Office. HR 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges S 438, Fair Prescription Drug Competition Act (ban authorized generics) 1/07 HR 780, Counterfeit Drug Prevention Act of 2007 3/07 HR 1908, Patent Reform Act of 2007 S 1145, Patent Reform Act of 2007 S 623, Access to Life-Saving Medication Act (FOBS) 2/07 HR 1038, Access to Life-Saving Medication Act HR 5629, Pathway For Biosimilars Act

Client expense: $2,800,000 · Firm income: Not reported

Veterans Healthcare issues Electronic Prescribing Comparative Effectiveness Research S. 2408, Medicare Electronic Medication and Safety Protection Act 2007 HR. 4296, Medicare Electronic Medication and Safety Protection Act 12/07 HR. 3800, Promoting Health Information Technology Act 10/07 HR. 2406, (no title) authorize the NIST to increase its efforts in support of the integration of the healthcare information enterprise in the United States 11/07 S. 1693, The Wired for Health Care Quality Act 10/07 S. 438, Fair Prescription Drug Competition Act 1/07 S. 1082, Food and Drug Administration Revitalization Act 5/07 HR. 806 2/07 S. 358, Genetic Information Nondiscrimination Act 4/07 S. 1432, Preserve Access to Affordable Generics Act 5/07 S. 316, Preserve Access to Affordable Generics Act 3/07 S. 2029 Physician Payments Sunshine Act HR 5605 Physician Payments Sunshine Act HR 962 Preservation of Antibioties for Medical Treatment Act S. 349 Preservation of Antibioties for Medical Treatment Act S. 2313 Strategies to Address Antimicrobial Resistance HR 3697 Strategies to Address Antimicrobial Resistance HR 1424. The Paul Wellstone Mental Health and Addiction Equity Act S 2731, The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIVAIDS, Tuberculosis, and Malaria Reauthorization Act (Also HR 5501) E-Meds Act

Client expense: $2,800,000 · Firm income: Not reported

S. 623 - Access to Life-Saving Medicine Act S. 438 - Fair Prescription Drug Competition Act H.R. 806 - Fair Prescription Drug Competition Act H.R. 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 5629 - The Pathway for Biologics Act H.R. 1038 - Access to Life-Saving Medicine Act S. 1505 - Affordable Biologics for Consumers Act S. 1695 - Biologics Price Competition and Innovation Act of 2007 H.R. 3610 - Food and Drug Import Safety Act of 2007

Client expense: $640,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

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 Amendments 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 Authorized Generics including but not limited to: S.438 and H.R.806 Electronic Prescribing (E-Prescribing), including but not limited to: S.2408 and H.R.4296 Prescription Drug Importation/Re-Importation Any other matter that relates to access to generic drugs

Client expense: $434,495 · 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

S. 623/Access to Life-Saving Medicine Act, S. 438/Fair Prescription Drug Competition Act, H.R. 806/Fair Prescription Drug Competition Act, H.R. 1956/Patient Protection and Innovative Biologic Medicines Act of 2007, H.R. 5629, H.R. 1038/Access to Life-Saving Medicine Act, S. 1505/Affordable Biologics for Consumers Act, S. 1695/Biologics Act of 2007, HR 3610

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

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

S. 1640, the Vessel Hull Design Protection Amendments of 2007. S. 681, the Stop Tax Haven Abuse Act. (Section 303, relating to prohibition on "tax shelter patents.") S. 242 and H.R. 1432, the Pharmaceutical Market Access and Drug Safety Act of 2007. (Provisions relating to reimportation of patents drugs sold abroad.) S. 256, the Platform Equality and Remedies for Rights Holders in Music Act of 2007. S. 438, the Fair Prescription Drug Competition Act. S. 316, the Preserve Access to Affordable Generics Act. S. 522, the Intellectual Property Rights Enforcement Act S. 1145, the Patent Reform Act of 2007. (Patent law reform.) H.R. 1908, the Patent Reform Act of 2007. (Patent law reform.) H.R. 1778, a bill to allow the USPTO to accept unintentionally late filings. H.R. 380, the Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 2365, a bill to limit damages for infringement of patents relating to tax planning methods. S. 2369, a bill to prohibit patents on tax preparation strategies.

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

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Legal Services Corporation, Library of Congress (LOC), Office of Management & Budget (OMB), President of the U.S., SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), State, Dept of (DOS), Transportation, Dept of (DOT), U.S. Commission on Civil Rights, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. Trade Representative (USTR), White House Office

H.R.1908, S 1145 Patent Reform Act of 2007 H.R.806 To Amend the Food, Drug, and Cosmetic Act to Prohibit the Marketing of Authorized Generics S.438 Fair Prescription Drug Competition Act H.R.1038, S.623 Access to Life Saving Medicines Act

Client expense: $420,000 · Firm income: Not reported

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

S.25, Citizen Petition Fairness and Accuracy Act of 2007 S.623 and H.R. 1038, Access to Life Saving Medicine Act S.438 and H.R. 806, Fair Prescription Drug Competition Act S.1082, FDA Revitalization Act S.1088, Lower Priced Drugs Act S.1505, Affordable Biologics Price Competition and Innovation Act S.1695, Patent Protection and Innovative Biologic Medicines Act H.R. 2900, Food and Drug Administration Amendments of 2007 H.R.1432 and S.316, Preserve Access to Affordable Generics Act H.R. 1908 and S.1145, Patent Reform Act of 2007 H.R. 1902, Protecting Consumer Access to Generic Drugs Act

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

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

H.R.1908, S.1145 Patent Reform Act of 2007 H.R.806 To Amend the Food, Drug, and Cosmetic Act to Prohibit the Marketing of Authorized Generics S. 438 Fair Prescription Drug Competiton Act H.R.1038, S.623 Access to Life Saving Medicines Act

Client expense: $420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.25, Citizen Petition Fairness and Accuracy Act of 2007 S.623 and H.R. 1038, Access to Life Saving Medicine Act S. 438 and H.R. 806, Fair Prescription Drug Competition Act S. 1082, FDA Revitalization Act

Client expense: $1,080,000 · 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), SENATE, White House Office

S. 25 - Citizen Petition Fairness and Accuracy Act of 2007 S. 623 - Access to Life-Saving Medicine Act S. 438 - Fair Prescription Drug Competition Act H.R. 806 - Fair Prescription Drug Competition Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), UNDETERMINED

S. 25 Citizen Petition Fairness and Accuracy Act of 2007, S.623/HR 1038 Access to Life-Saving Medicine Act, S. 438/HR 806 Fair Prescription Drug Competition Act, S.1082 Food and Drug Administration Revitalization Act, S. 1088 Lower PRICED Drugs Act, S.1505 Affordable Biologics for Consumers Act, S. 1695 Biologics Price Competition and Innovation Act of 2007, H.R. 1956, H.R. 2900, H.R. 3140, H.R. 2606, HR 3580, HR 3610

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

Generic Biologics - S.623, S.1695, H.R.1038, and H.R.1956 Pediatric Exclusivity - S.1082, H.R.2900, and H.R.3580 Drug Safety - S.484, S.1082, H.R.3580 Authorized Generics - S.438 and H.R.806 Citizen Petitions - S.1088, S.25, and H.R.3580 Import Safety - H.R.3610 Counterfeit Drugs - S.242, S.1082, H.R.780, H.R.2710, H.R.3580, and H.R.3610

Client expense: $398,128 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

HR 2406, (no title) authorize the NIST to increase its efforts in support of the integration the healthcare information enterprise in the United States. S 1693, The Wired for Heath Care Quality Act S. 438, Fair Prescription Drug Competition Act S. 1082, Food and Drug Administration Revitalization Act HR 806 S 358, Genetic Information Nondiscrimination Act S 1693, Wired for Health Quality Act HR 1432, Preserve Access to Affordable Generics Act S 316, Preserve Access to Affordable Generics Act HR 2406 Veterans' Healthcare issues

Client expense: $7,220,000 · Firm income: Not reported

HR 1432, Preserve Access to Affordable Generics Act (settlements) S 316, Preserve Access to Affordable Generics Act (settlements) S 2300, Lower PRICED Drugs Act, legislation pediatric exclusivity, citizens petitions HR 6022, Lower PRICED Drugs Act, legislation on pediatric exclusivity, citizens petitions S 3695, To Amend the Federal Food, Drug & Cosmetic Act to prohibit the marketing of authorized generic drugs, authorized generics HR 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs HR 5120, To Amend Title 35, United States Code, to confirm certain filing provisions within the Patent and Trademark Office. HR 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges S 438, Fair Prescription Drug Competition Act (ban authorized generics) HR 780, Counterfeit Drug Prevention Act of 2007 HR 1908, Patent Reform Act of 2007 S 1145, Patent Reform Act of 2007 S 623, Access to Life-Saving Medication Act (FOBS) HR 1038, Access to Life-Saving Medication Act

Client expense: $7,220,000 · Firm income: Not reported

H.R. 1038 - Access to Life-Saving Medicine Act S. 1082 - Food and Drug Administration Revitalization Act S. 1088 - Lower PRICED Drugs Act S. 1505 - Affordable Biologics for Consumers Act S. 1695 - Biologics Price Competition and Innovation Act of 2007 H.R. 1956 - The Patient Protection and Innovative Biologic Medicines Act H.R. 2900 - Food and Drug Administration Amendments Act of 2007 H.R. 3140 - Saving Our Community Pharmacy Act of 2007 H.R. 2606 - 340B Program Improvement and Integrity Act of 2007 S. 25 - Citizen Petition Fairness and Accuracy Act of 2007 S. 623 - Access to Life-Saving Medicine Act S. 438 - Fair Prescription Drug Competition Act H.R. 806 - Fair Prescription Drug Competition Act]

Client expense: $1,100,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

H.R.1908, S. 1145 Patent Reform Act of 2007 H.R. 806 To Amend the Food Drug and Cosmetic Act to Prohibit the Marketing of Authorized Generics S. 438 Fair Prescription Drug Competiton Act H.R. 1038, S. 623 Access to Life Saving Medicines Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Generic Biologics - S.623, S.1695, H.R. 1038, and H.R. 1956 Pediatric Exclusivity - S.1082 and H.R. 2900 Drug Safety - S.484 and S.1082 Authorized Generics - S.438 and H.R. 806 Citizen Petitions - S.1088 and S.25 Counterfeit Drugs - S.242, S.1082, H.R. 780 and H.R.2710

Client expense: $420,000 · 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, U.S. Trade Representative (USTR)

* H.R. 1908/S. 1145, Patent Reform Act; (Provisions relating to modernize and harmonize the U.S. process for patent review and approvals.) S. 316, Preserve Access to Affordable Generics Act (Provisions relating to patent settlements.) S. 438, Fair Prescription Drug Competition Act of 2007; (Sections relating to authorized generics.) H.R. 1038, Access to Life-Saving Medicine Act (provisions relating to follow-on biologics.) H.R. 780, Counterfeit Drug Prevention Act of 2007 (Provisions relating to prevention of counterfeit drugs.) H.R. 1908/S. 1145, A bill to amend title 35, United States Code to provide for patent reform; (Provisions relating to patent reform.) H.R. 1908/S. 1145, A bill to amend title 35, United States Code, to provide for patent reform; (Provisions relating to patent reform.) 7 16 24

Client expense: $2,082,850 · Firm income: Not reported

* H.R. 1232/S. 746, To establish a competitive grant program to build capacity in veterinary medical education and expand the workforce of veterinarians engaged in public health practice and biomedical research; Section 2. Competitive Grants; (Provisions relating to entire bill.) S. 438, Fair Prescription Drug Competition Act of 2007; (Sections relating to authorized generics.) H.R. Access to Life -Saving Medicine Act; (Relating to follow-on biologics) H.R. 1165, Swift Approval, Full Evaluation Drug Act of the "SAFE Drug Act"; (Provisions relating to drug safety.) S. 21, A bill to provide for homeland security grant coordination and simplification, and for other purposes; (Sections relating to access to women's health therapies.) H.R. 970, Gang Prevention and Effective Deterrence Act of 2005; (Relating to bulk distribution of DXM.) H.R. 780, Counterfeit Drug Prevention Act of 2007; (Relating to prevention of counterfeit drugs.) H.R. 1282, Medigap Access Improvement Act; (Provisions relating to MediGap and hemophilia patients.) S. 1082, Prescription Drug User Fee Amendments of 2007; (Relating to FDA user fees reauthorization.) Full House Energy & Commerce Committee Markup of Committee prints on: PDUFA, MDUFMA, PREA, BPCA, Drug Safety; (Relating to reauthorization fo FDA user fees and safety.) H.R. 4, Prescription Drug Negotiation Act of 2007; (Provisions concerning repealing non-interference in Medicare.) S. 316, the "Preserve Access to Affordable Generics Act"; (Provisions relating to patent settlements.) 15

Client expense: $2,082,850 · Firm income: Not reported

S. 438, the “Fair Prescription Drug Competition Act.” S. 316, the “Preserve Access to Affordable Generics Act.” S. 522, the “Intellectual Property Rights Enforcement Act.” H.R. 34, a bill to establish a pilot program for patent cases in U.S. district courts. S. 1145, the “Patent Reform Act of 2007.” (Patent law reform.) H.R. 1908, the “Patent Reform Act of 2007.” (Patent law reform.) H.R. 1778, a bill to allow the USPTO to accept unintentionally late filings. H.R. 380, the “‘‘Pharmaceutical Market Access and Drug Safety Act of 2007’’. S. 1640, the “Vessel Hull Design Protection Amendments of 2007.” S. 681, the “Stop Tax Haven Abuse Act”. (Section 303, relating to prohibition on “tax shelter patents.”) S. 242 and H.R. 1432, the “Pharmaceutical Market Access and Drug Safety Act of 2007.” S. 256, the “ Platform Equality and Remedies for Rights Holders in Music Act of 2007.”

Client expense: $660,000 · Firm income: Not reported

H.R. 1038 Access to Life-Saving Medicine Act - all provisions S.1082 Food and Drug Administration Revitalization Act - all provisions S. 1088 Lower PRICED Drugs Act- all provisions S.1505 Affordable Biologics for Consumers Act - all provisions S. 1695 Biologics Price Competition and Innovation Act of 2007- all provisions H.R. 1956 The Patient Protection and Innovative Biologic Medicines Act - all provisions H.R. 2900 Food and Drug Administration Amendments Act of 2007 - all provisions S. 25, Citizen Petition Fairness and Accuracy Act of 2007 - all provisions S.623, Access to Life-Saving Medicine Act - all provisions S. 438, Fair Prescription Drug Competition Act - all provisions H.R. 806, Fair Prescription Drug Competition Act - all provisions

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)