Citizen Petition Fairness and Accuracy Act of 2007

Patent Reform Act of 2008 (S. 3600), Patent Reform Act of 2007 (H.R. 1908 & S. 1145) Preserve Access to Affordable Generics Act (H.R. 1432 & S. 316), Protecting Consumer Access to Generic Drugs Act (H.R 1902), To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes (S. 25).

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)

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

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. 1432 - Preserve Access to Affordable Generics Act S. 316 - Preserve Access to Affordable Generics Act H.R. 1908 - Patent Reform Act of 2007 S. 1145 - Patent Reform Act of 2007 H.R. 1902 - Protecting Consumer Access to Generic Drugs Act S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 3600 - Patent Reform Act of 2008

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

S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 1145 - Patent Reform Act of 2007 H.R. 1908 - Patent Reform Act of 2007 H.R. 1432 - Preserve Access to Affordable Generics Act S. 3600 - Patent Reform Act of 2008

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

H.R. 1432 - Preserve Access to Affordable Generics Act S. 316 - Preserve Access to Affordable Generics Act H.R. 1908 - Patent Reform Act of 2007 S. 1145 - Patent Reform Act of 2007 H.R. 1902 - Protecting Consumer Access to Generic Drugs Act S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes.

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, 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 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 relates to access to generic drugs

Client expense: $459,139 · 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. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 1145 - Patent Reform Act of 2007 H.R. 1908 - Patent Reform Act of 2007 H.R. 1432 - Preserve Access to Affordable Generics Act.

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

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. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 1145 - Patent Reform Act of 2007 H.R. 1908 - Patent Reform Act of 2007 H.R. 1432 - Preserve Access to Affordable Generics Act.

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

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

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)

S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 1145 - Patent Reform Act of 2007 H.R. 1908 - Patent Reform Act of 2007

Client expense: Not reported · Firm income: $200,000

S 1082/HR 2900--FDA reauthorization (follow on biologics, citizens petition reform, pediatric exclusivity reform, pedigree) S. 623/HR 1038/HR 1956/S. 1695--Regulatory pathway for generic biologics S 1088/S 25/S 28/S 316/ HR 1902--Issues relating to bringing generics to market in a timely fashion S 1376/HR 2606--expansion of 340b pricing

Client expense: $490,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office

S 1082/HR 2900--FDA reauthorization (follow on biologics, citizens petition reform, pediatric exclusivity reform, pedigree) S. 623/HR 1038/HR 1956--Regulatory pathway for generic biologics S 1088/S 25/S 28/S 316/ HR 1902--Issues relating to bringing generics to market in a timely fashion S 1376/HR 2606--expansion of 340b pricing

Client expense: $490,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office

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)

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)

S 1082/HR 2900--FDA reauthorization (follow on biologics, citizens petition reform, pediatric exclusivity reform, pedigree) S. 623/HR 1038/HR 1956--Regulatory pathway for generic biologics S 1088/S 25/S 28/S 316/ HR 1902--Issues relating to bringing generics to market in a timely fashion S 1376/HR 2606--expansion of 340b pricing

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office

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)

S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 1145 - Patent Reform Act of 2007 H.R. 1908 - Patent Reform Act of 2007

Client expense: Not reported · Firm income: $200,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE