To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.

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

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

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)

Generic Biologics H.R.1038/S.623: Access to Life-Saving Medicine Act S.1695: Biologics Price Competition and Innovation Act of 2007 H.R.5629: Pathway for Biosimiliars Act Citizen Petitions S.1088: Lower PRICED Drugs Act Drug Safety S.484: Enhancing Drug Safety and Innovation Act of 2007 H.R.5839: Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: Food and Drug Import Safety Act of 2007 S. 3409: Drug and Device Accountability Act of 2008 Authorized Generics H.R.806: To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs Generic substitution state come-out laws

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

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

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

Generic Biologics S.623: Access to Life-Saving Medicine Act S.1695: Biologics Price Competition and Innovation Act of 2007 H.R.5629: Pathway for Biosimiliars Act Citizen Petitions S.1088: Lower PRICED Drugs Act Drug Safety S.484: Enhancing Drug Safety and Innovation Act of 2007 H.R.5839: Safeguarding America's Pharmaceuticals Act of 2008 Authorized Generics H.R.806: To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs

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

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

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

Generic Biologics S.623: Access to Life-Saving Medicine Act S.1695: Biologics Price Competition and Innovation Act of 2007 H.R. 5629: Pathway for Biosimilars Act Citizen Petitions S. 1088: Lower PRICED Drugs Act Drug Safety S. 484: Enhancing Drug Safety and Innovation Act of 2007 H.R. 3610: Food and Drug Import Safety Act of 2007 Authorized Generics H.R. 806: To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs User fees

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

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

Work toward implementation of Tax Treaty with Croatia; Development of a biogeneric drug approval framework (S.1695; H.R. 1956); Issues affecting pharmaceuticals, including: Settlements legislation, S.316; patent reform legislation (H.R. 1908 and S.1145); authorized generics (H.R. 806; S.1082); FDA reform and regulation, and the federal drug approval process for generic drugs (S.1082; H.R. 3580); opposition to legislation proposing patent filing deadline extensions, H.R. 1778 and various Senate amendments; potential pharmaceutical offsets for S-CHIP extension; procedures for drug approval harmonizatoin in prospective trade agreements.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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)

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

Development of a biogeneric drug approval framework (S.1695; H.R. 1956); Issues affecting pharmaceuticals, including: Settlements legislation, S.316; patent reform legislation (H.R. 1908 and S.1145); authorized generics (H.R. 806; S.1082); FDA reform and regulation, and the federal drug approval process for generic drugs (S.1082; H.R. 3580); appropriations for the FDA Office of Generic Drug Approval (H.R. 3161; S.1859; H.R. 2764); opposition to legislation proposing patent filing deadline

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

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)

S. 1088: Lower PRICED Drugs Act Drug Safety S. 1082: Food and Drug Administration Revitalization Act S. 484: Enhancing Drug Safety and Innovation Act of 2007 H.R. 3610: Food and Drug Import Safety Act of 2007 Pediatric Exclusivity S. 1082: Food and Drug Administration Revitalization Act H.R. 2900: Food and Drug Administration Amendments Act of 2007 Authorized Generics H.R. 806: To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs User fees S. 1145: Patent Reform Act of 2007 Appropriations Generic Biologics S.623: Access to Life-Saving Medicine Act S.1695: Biologics Price Competition and Innovation Act of 2007 Citizen Positions

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

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

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

authorized generics (H.R. 806; S.1082); patent reform legislation (H.R. 1908 and S.1145); FDA reform and regulation, and the federal drug approval process for generic drugs (S.1082; H.R. 2900); appropriations for the FDA Office of Generic Drug Approval (H.R. 3161; S.1859); procedures for drug approval harmonization in prospective trade agreements. Development of a biogeneric drug approval framework (S.1695; H.R. 1956); Issues affecting pharmaceuticals, including: Settlements legislation, S.316; opposition to legislation proposing patent filing deadline extensions, H.R. 1778 and various Senate amendments;

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

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. 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)