Generic Drug Application Review Fairness Act of 2012

FY 2013 Budget, Implementation of Health Care Reform, Implementation of Generic Biologics, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, drug shortages, prescription drug abuse and generic drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011 H.R. 3839 - Drug Shortage Prevention Act of 2012 H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R. 4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 H.R.6160 - Stop Tampering of Prescription Pills Act of 2012 H.R. 6433 - FDA User Fee Corrections Act of 2012 S. 44 Medicare Prescription Drug Negotiation Act S. 296 and H.R.2245 Preserving Access to Life-Saving Medication Act S. 373 Fair Prescription Drug Competition Act S. 1584 - Drug Safety and Accountability Act of 2011 S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 2295 - Patient Safety and Generic Labeling Improvement Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act S.1855 - Pandemic and All-Hazards Preparedness Act Reauthorization of 2011

Client expense: $487,850 · 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

Patent Reform, Patent Settlements/Reverse Payments/Exclusionary Payments, Patent Term Extensions, Generic Drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3497 - MODDERN Cures Act of 2011 H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R. 4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 S. 27 Preserve Access to Affordable Generics Act S. 373 Fair Prescription Drug Competition Act S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 1882 - The Fair and Immediate Release of Generic Drugs Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act

Client expense: $487,850 · Firm income: Not reported

Approval of the Keystone Pipeline: H.R. 3548 North American Energy Access U.S. Waterway Infrastructure Improvement Legislation: H.R. 4332 WAVE4 Legislation to modernize U.S. essential inland navigation Natural gas subsidies

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

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Funding for FDA offices; S.296. Preserving Access to Life-Saving Medications Act; women's issues relating to healthcare reform law; implementation of biologics provisions of healthcare reform law; prescription drug abuse/diversion proposals; S.1357, Affordable Medicines Utilization Act of 2011; S.1882, Fair & Immediate Release of Generic Drugs Act; H.R.4332, Generic Drug Application Review Fairness Act; FDA Innovation & Safety Act; and S.2295, Patient Safety & Generic Labeling Improvement Act.

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

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

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

Monitored legislation concerning promotion of generic drug use and medicaid Drug Shortages, Forfeiture and FDA regulations H.R. 5651 Food and Drug Administration Reform Act of 2012 H.R. 4332, Generic Drug Application Review Fairness Act of 2012 S.3187, Food and Drug Administration Act

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

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

Monitored legislation concerning promotion of generic drug use and medicaid Drug Shortages, Forfeiture and FDA regulations H.R. 5651 Food and Drug Administration Reform Act of 2012 H.R. 4332, Generic Drug Application Review Fairness Act of 2012 S.3187, Food and Drug Administration Act

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

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

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

Funding for FDA offices; S.296. Preserving Access to Life-Saving Medications Act; women's issues relating to healthcare reform law; implementation of biologics provisions of healthcare reform law; prescription drug abuse/diversion proposals; S.1357, Affordable Medicines Utilization Act of 2011; S.1882, Fair & Immediate Release of Generic Drugs Act; H.R.4332, Generic Drug Application Review Fairness Act; FDA Innovation & Safety Act; and S.2295, Patient Safety & Generic Labeling Improvement Act.

Client expense: $700,000 · Firm income: Not reported

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

H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011; H.R. 2245 & S. 296 - Preserving Access to Life-Saving Medications Act; STAAR Act relating to antimicrobial surveillance; H.R. 4332 - Generic Drug Application Review Fairness Act of 2012; H.R. 5651 & S.2516 & S.3187 - FDA Safety and Innovation Act; P.L. 111-14 - Patient Protection and Affordable Health Care Act provisions relating to biosimilar products; S. 2295 - Patient Safety and Generic Labeling Improvement Act

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

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

Issues relating to REMS and Orange Book patent listing S. 1882 - Fair GeneRxics Act H.R. 4332 - Generic Drug Appliction Review Fairness Act of 2012 H.R. 5651 & S. 2516 & S. 3187 - FDA Safety and Innovation Act

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

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

S. 1882, The Fair and Immediate Release of Generics Act S. 27, the Preserve Access to Affordable Pharmaceuticals Act HR 4332, the Generic Drug Application Review Fairness Act Amending Section 505(j) of the Food, Drug and Cosmetic Act, concerning the ability of generic pharmaceutical manufacturers to file counterclaims seeking the correction of incorrect patent information submitted to FDA's Orange Book by patent owners of New Drug Applications Supreme Court consideration of Novo Nordisk A/S and Novo Nordisk Inc. vs Caraco Pharmaceutical Laboratories Ltd. and Sun Pharmacuetical Industries Ltd. S. 2516, the Food and Drug Innovation and Safety Act: Title VIII, Generating Antibiotic Incentives, Title XI, Other Provisions, Section 1131, Drug Development and Testing HR 5651. the Food and Drug Administration Reform Act: Title VIII, Drug Regulatory Improvements, Subtitle F, Miscellaneous, Section 862, Extension of period for first applicant to obtain tentative approval without forfeiting 180-day exclusivity period, Section 863, Final agency action relating to petitions and civil actions S. 3187.PCS/.ES, the Food and Drug Administration Safety and Innovation Act: Title XI, Other Provisions, Subtitle C, Miscellaneous Provisions, Section 1131, Drug Development and Testing S AMDT 2111 to S. 3187, concerning pharmaceutical market blockages caused by parked 180 day exclusivity periods S. 3187.EAH, the Food and Drug Administration Safety and Innovation Act: Title XI, Other Provisions, Subtitle C, Miscellaneous Provisiosn, Section 1133, Extension of period for first applicant to obtain tentative approval without forfeiting 180 day exclusivity period, Section 1135, Final agency action related to petitions and civil actions Establishment of a federal track and trace system for pharmaceuticals

Client expense: $170,000 · Firm income: Not reported

FY 2013 Budget, Implementation of Health Care Reform, Implementation of Generic Biologics, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, drug shortages, prescription drug abuse and generic drugs H.R.2182 Generating Antibiotic Incentives Now Act of 2011 H.R.3026 - Safeguarding America's Pharmaceuticals Act of 2011 H.R.3839 - Drug Shortage Prevention Act of 2012 H.R.3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R.3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R.4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 S.44 Medicare Prescription Drug Negotiation Act S.296 and H.R.2245 Preserving Access to Life-Saving Medication Act S.373 Fair Prescription Drug Competition Act S.1584 - Drug Safety and Accountability Act of 2011 S.1734 - Generating Antibiotic Incentives Now Act of 2011 S.2295 - Patient Safety and Generic Labeling Improvement Act S.2516 - Food and Drug Administration Safety and Innovation Act S.3187 Food and Drug Administration Safety and Innovation Act

Client expense: $504,925 · Firm income: Not reported

Patent Reform, Patent Settlements/Reverse Payments/Exclusionary Payments, Patent Term Extensions, Generic Drugs H.R.2182 Generating Antibiotic Incentives Now Act of 2011 H.R.3497 - MODDERN Cures Act of 2011 H.R.3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R.3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R.4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 S.27 Preserve Access to Affordable Generics Act S.373 Fair Prescription Drug Competition Act S.1734 - Generating Antibiotic Incentives Now Act of 2011 S. 1882 - The Fair and Immediate Release of Generic Drugs Act S.2516 - Food and Drug Administration Safety and Innovation Act S.3187 Food and Drug Administration Safety and Innovation Act

Client expense: $504,925 · Firm income: Not reported

Funding for FDA Office of Generic Drugs; S.296. Preserving Access to Life-Saving Medications Act; women's issues relating to healthcare reform law; implementation of biologics provisions of healthcare reform law; H.R.5, Help Efficient Accessible Low-Cost Timely Healthcare (HEALTH) Act of 2011; prescription drug abuse/diversion proposals; S.1357, Affordable Medicines Utilization Act of 2011; S.1882, Fair & Immediate Release of Generic Drugs Act; H.R.4332, Generic Drug Application Review Fairness Act

Client expense: $970,000 · 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), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

Patent Reform, Patent Settlements/Reverse Payments/Exclusionary Payments, Patent Term Extensions, Generic Drugs H.R.2182 Generating Antibiotic Incentives Now Act of 2011 H.R.3497 - MODDERN Cures Act of 2011 H.R.3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R.3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R.4332 - Generic Drug Application Review Fairness Act of 2012 S.27 Preserve Access to Affordable Generics Act S.373 Fair Prescription Drug Competition Act S.1734 - Generating Antibiotic Incentives Now Act of 2011 S. 1882 - The Fair and Immediate Release of Generic Drugs Act

Client expense: $480,425 · 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

FY 2013 Budget, Implementation of Health Care Reform, Implementation of Generic Biologics, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, drug shortages, and generic drugs Bills: H.R.2182 Generating Antibiotic Incentives Now Act of 2011 H.R.3026 - Safeguarding America's Pharmaceuticals Act of 2011 H.R.3839 - Drug Shortage Prevention Act of 2012 H.R.3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R.3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R.4332 - Generic Drug Application Review Fairness Act of 2012 S.44 Medicare Prescription Drug Negotiation Act S.296 and H.R.2245 Preserving Access to Life-Saving Medication Act S.373 Fair Prescription Drug Competition Act S.1584 - Drug Safety and Accountability Act of 2011 S.1734 - Generating Antibiotic Incentives Now Act of 2011

Client expense: $480,425 · Firm income: Not reported

S. 1882, the FAIR Generics Act S. 27, the Preserve Access to Affordable Pharmaceuticals Act HR 3995, the Protecting Consumer Access to Generic Drugs Act S. 296, HR 2245, The Preserving Access to Life Savings Medications Act HR 4332, the Generic Drug Application Review Fairness Act HR 3998, Generic Drug and Biosimilar User Fee Act HR 2182, S. 1734, the Generating Antibiotic Incentives Now Act Amending Section 505(j) of the Food, Drug, and Cosmetic Act, concerning the ability of generic pharmaceutical manufacturers to file counterclaims seeking the correction of incorrect information submitted to FDA's Orange Book by patent owners or holders of New Drug Applications Supreme Court consideration of Novo Nordisk A/S and Novo Nordisk Inc. vs Caraco Pharmaceutical Laboratories Ltd. and Sun Pharmaceuticals Industries, Ltd. Prospective legislation establishing a generic drug user fee program Prospective legislation establishing a biosimilar user fee program Establishment of a federal track and trace system for pharmaceuticals The use of Risk Evaluation Mitigation Strategies (REMS) programs by brand drug companies to delay generic competition International Nonproprietary Names for Biosimilars

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

Government targets: Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE