FAST Act

S. 606, Creating Hope Act of 2011, S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act, The Food and Drug Administration Safety and Innovation Act (PL 112-144) and amendments considered, including the Faster Access to Specialized Treatments Act (H.R. 4132) and the Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act (S. 2113). Assess potential impact of sequestration on public health/food and drug programs (HR 8/PL 112-240).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Innovation in biotechnology; patient access to treatments; FDA accelerated approval process; orphan drugs for rare diseases, health disparities, drug shortages. HR 4132 Faster Access to Specialized Treatments (FAST) Act; S.2113 Transforming the Regulatory Environment to Accellerate Access to Treatments (TREAT) Act; HR 2245/S.296: Preserving Access to Lifesaving Medications Act; S.3187, Food and Drug Administration Safety and Innovation Act

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

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

Innovation in biotechnology; patient access to treatments; FDA accelerated approval process; orphan drugs for rare diseases, health disparities, drug shortages. HR 4132 Faster Access to Specialized Treatments (FAST) Act; S.2113 Transforming the Regulatory Environment to Accellerate Access to Treatments (TREAT) Act; HR 2245/S.296: Preserving Access to Lifesaving Medications Act; S.3187, Food and Drug Administration Safety and Innovation Act

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

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

Innovation in biotechnology; patient access to treatments; FDA accelerated approval process; orphan drugs for rare diseases, health disparities, drug shortages. HR 4132 Faster Access to Specialized Treatments (FAST) Act; S.2113 Transforming the Regulatory Environment to Accellerate Access to Treatments (TREAT) Act; HR 2245/S.296: Preserving Access to Lifesaving Medications Act; No Bill #: Prescription Drug User Fee Act reauthorization

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

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

Innovation in biotechnology; patient access to treatments; FDA accelerated approval process; orphan drugs for rare diseases, health disparities, drug shortages. HR 4132 Faster Access to Specialized Treatments (FAST) Act; S.2113 Transforming the Regulatory Environment to Accellerate Access to Treatments (TREAT) Act; HR 2245/S.296: Preserving Access to Lifesaving Medications Act; No Bill #: Prescription Drug User Fee Act reauthorization

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

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

H.R. 3590 - Patient Protection and Affordable Care Act / Public Law 111-148; track and monitor implementation; S. 3187 - Food & Drug Administration Safety and Innovation Act; track and monitor. H.R. 5651 - Food & Drug Administration Reform Act of 2012; track and monitor; and H.R. 4132 - Faster Access to Specialized Treatments Act; track and monitor.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.606/H.R. 3059 - Creating Hope Act of 2011 Food and Drug Administration Safety and Innovation Act Implementation S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act H.R. 1483, Drug Safety Enhancement Act H.R. 3737, ULTRA (Unlocking Lifesaving Treatments for Rare Diseases) Act H.R. 4132, FAST (Faster Access to Specialized Treatments) Act Amendments to FDA Accelerated Approval Requirements H.R. 4156, EXPERRT (Expanding and Promoting Expertise in Review of Rare Treatments) Act H.R. 2182, GAIN (Generating Antibiotic Incentives Now) Act S. 1734, Generating Antibiotic Incentives Now Act Biosimilars User Fees Biosimilars Exclusivity Period in Administration's Budget Proposals Report on Innovation/FDA by President's Council of Advisors on Science and Technology (CPAST)

Client expense: $400,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues pertaining to accelerating the drug approval process for ultra rare diseases [Unlocking Lifesaving Treatments for Rare-Diseases Act (H.R. 3737); Faster Access to Specialized Treatments (H.R. 4132); Food and Drug Administration Safety and Innovation Act (S. 3187); Food and Drug Administration Reform Act of 2012 (H.R. 5661)]

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care issues related to neuromuscular disease, including transitional health care issues. S. 3187/H.R. 5651 (P.L. 112-144), FDA Safety and Innovation Act - including S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments Act; H.R. 4132, Faster Access to Specialized Treatments Act; S. 606/H.R. 3059, Creating Hope Act; and H.R. 4156/S. 2281, Expanding & Promoting Expertise in Review of Rare Treatments Act. H.R. 6163/S. 3461, National Pediatric Research Network Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues. Rare Disease Congressional Caucus. Provisions contained in S. 3187/H.R. 5651 (which became Public Law 112-144), the Food and Drug Administration Safety and Innovation Act, relating to the drug approval process and including the Best Pharmaceuticals for Children and Pediatric Research Equity Acts; S. 606/H.R. 3059, the Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments Act; H.R. 4132, Faster Access to Specialized Treatments Act; and H.R. 4156/S. 2281, Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012. H.R. 6163/S. 3461, the National Pediatric Research Network Act of 2012.

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

Government targets: 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. 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

Client expense: $4,140,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

S. 606, Creating Hope Act of 2011, S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act, The Food and Drug Administration Safety and Innovation Act (PL 112-144) and amendments considered, including the Faster Access to Specialized Treatments Act (H.R. 4132) and the Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act (S. 2113). Assess potential impact of sequestration on public health/food and drug programs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending 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 H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.

Client expense: $890,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. S. 3187, the "Food and Drug Administration Safety and Innovation Act - Lobbied for passage of PDUFA legislation. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation. Labor, HHS Appropriations. Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program.

Client expense: $520,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

FDA reform: Changes to PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Act) programs. H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act; H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act of 2011; S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 (See continuation page) H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3187, Food and Drug Administration Safety and Innovation Act. (Became Public Law 112-144)

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

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

FDA reform: changes to PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Act) programs. H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act; H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act of 2011; S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 (See continuation page) H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3187, Food and Drug Administration Safety and Innovation Act (Became Public Law 112-144).

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

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues. Rare Disease Congressional Caucus. Provisions contained in S. 3187/H.R. 5651 (which became Public Law 112-144), the Food and Drug Administration Safety and Innovation Act, relating to the drug approval process and including the Best Pharmaceuticals for Children and Pediatric Research Equity Acts; S. 606/H.R. 3059, the Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments Act; H.R. 4132, Faster Access to Specialized Treatments Act; and H.R. 4156/S. 2281, Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program

Client expense: $2,070,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Client expense: $2,070,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

S.1734/HR2182 Gain Act - support incentives for antibiotic development; S2113 Treat Act; HR 4132 - FAST ACT - support expanding accelerated approval pathway

Client expense: $960,101 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office

H.R. 2595/S.425, "The National Neurological Diseases Surveillance System Act" all sections; "Department of Labor, Health and Human Services, Education and Related Agencies Appropriations," all sections relating to the National Institutes of Health (NIH); "Department of Defense Appropriations," section related to the Neurotoxin Exposure Treatment Parkinson's Research (NETPR) program; H.R. 1546/S.829, "The Medicare Access to Rehabilitation Services Act of 2011" all sections; H.R. 4132, "The Faster Access to Specialized Treatments Act of 2011" all sections; S. 2113 "The Transforming the Regulatory Environment to Accelerate Access to Treatment of 2011" all sections; S. 3187 "The Food and Drug Administration Safety and Innovation Act" all sections;

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access; priority vouchers; end stage renal disease Prospective Payment System (ESRD PPS); H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act; S. 3187, Food and Drug Administration Safety and Innovation Act

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

Government targets: Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), SENATE

Issues related to raising awareness of Hepatitis C (no specific bills); Viral Hepatitis Testing Act of 2011 (H.R. 3381, S. 1809), all provisions; Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 (H.R. 2405, S. 1855), all provisions; (cont'd next page) Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 (H.R.4156 , S.2281), all provisions; Transforming the Regulatory Environment to Accelerate Access to Treatments (S.2113), provisions; The Unlocking Lifesaving Treatments for Rare-Diseases Act (H.R.3737), all provisions; The Food and Drug Administration Safety and Innovation Act (S.3187), all provisions; To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies (H.R.5334), all provisions; The FAST Act (H.R.4132), all provisions; The Food and Drug Administration Reform Act of 2012 (H.R.5651), all provisions.

Client expense: $360,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues. Rare Disease Congressional Caucus. Provisions contained in S. 3187/H.R. 5651 (which became Public Law 112-144), the Food and Drug Administration Safety and Innovation Act, relating to the drug approval process and including the Best Pharmaceuticals for Children and Pediatric Research Equity Acts; S. 606/H.R. 3059, the Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments Act; H.R. 4132, Faster Access to Specialized Treatments Act; and H.R. 4156/S. 2281, Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care issues related to neuromuscular disease, including transitional health care issues. S. 3187/H.R. 5651 (P.L. 112-144), Food and Drug Administration Safety and Innovation Act and provisions incorporated - including S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments Act; H.R. 4132, Faster Access to Specialized Treatments Act; S. 606/H.R. 3059, Creating Hope Act; and H.R. 4156/S. 2281, Expanding & Promoting Expertise in Review of Rare Treatments Act.

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

Government targets: 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

Client expense: $4,840,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

S. 2236: Advancing Breakthrough Therapies for Patients Act. H.R. 5651: Food and Drug Administration Reform Act of 2012. S. 3187: Food and Drug Administration Safety and Innovation Act of 2012. H.R. 4132: Faster Access to Specialized Treatments Act. Federal legislative efforts to enhance the security and integrity of the domestic pharmaceutical distribution system.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues pertaining to accelerating the drug approval process for ultra rare diseases [Unlocking Lifesaving Treatments for Rare-Diseases Act (H.R. 3737); Faster Access to Specialized Treatments (H.R. 4132); Food and Drug Administration Safety and Innovation Act (S. 3187); Food and Drug Administration Reform Act of 2012 (H.R. 5661)]

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.606/H.R. 3059 - Creating Hope Act of 2011 Prescription Drug User Fee Act Reauthorization S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act H.R. 1483, Drug Safety Enhancement Act H.R. 3737, ULTRA (Unlocking Lifesaving Treatments for Rare Diseases) Act H.R. 4132, FAST (Faster Access to Specialized Treatments) Act Amendments to FDA Accelerated Approval Requirements H.R. 4156, EXPERRT (Expanding and Promoting Expertise in Review of Rare Treatments) Act H.R. 2182, GAIN (Generating Antibiotic Incentives Now) Act S. 1734, Generating Antibiotic Incentives Now Act Biosimilars User Fees Biosimilars Exclusivity Period in Administration's Budget Proposals

Client expense: $360,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending 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 HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.

Client expense: $1,440,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending 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 H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases 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. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.

Client expense: $1,220,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R. 5651: Food and Drug Administration Reform Act of 2012. S. 3187: Food and Drug Administration Safety and Innovation Act of 2012. H.R. 4132: Faster Access to Specialized Treatments Act.

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

Government targets: HOUSE OF REPRESENTATIVES

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. NO BILL, Reauthorization of the Prescription Drug User Fee Act - Lobbied for passage of clean PDUFA legislation. Labor, HHS Appropriations - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation.

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. S. 3187, the "Food and Drug Administration Safety and Innovation Act - Lobbied for passage of PDUFA legislation. Labor, HHS Appropriations - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation.

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

Government targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. NO BILL, Reauthorization of the Prescription Drug User Fee Act - Lobbied for passage of clean PDUFA legislation. Labor, HHS Appropriations - Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation.

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

S. 606, Creating Hope Act of 2011, S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act Reauthorization of the Prescription Drug User Fee Act (H.R. 5651/S. 3187) H.R. 4132, Faster Access to Specialized Treatments Act/S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Innovation in biotechnology; patient access to treatments; FDA accelerated approval process; orphan drugs for rare diseases, health disparities, drug shortages. HR 4132 Faster Access to Specialized Treatments (FAST) Act; S.2113 Transforming the Regulatory Environment to Accellerate Access to Treatments (TREAT) Act; HR 2245/S.296: Preserving Access to Lifesaving Medications Act; S.3187, Food and Drug Administration Safety and Innovation Act

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

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

Innovation in biotechnology; patient access to treatments; FDA accelerated approval process; orphan drugs for rare diseases, health disparities, drug shortages. HR 4132 Faster Access to Specialized Treatments (FAST) Act; S.2113 Transforming the Regulatory Environment to Accellerate Access to Treatments (TREAT) Act; HR 2245/S.296: Preserving Access to Lifesaving Medications Act; S.3187, Food and Drug Administration Safety and Innovation Act

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

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

FDA reform: changes to PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Act) programs. H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act; H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act of 2011; S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 (See continuation page) H.R. 5651, Food and Drug Administratioin Reform Act of 2012. S. 3187, Food and Drug Administration Safety and Innovation Act.

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

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

FDA reform: Changes to PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Act) programs. H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act; H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act of 2011; S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 (See continuation page) H.R. 5651, Food and Drug Administratioin Reform Act of 2012. S. 3187, Food and Drug Administration Safety and Innovation Act.

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

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

Reauthorization of the Prescription Drug User Fee & Medical Device User Fee Acts Patient Access to Medical Innovtion Act Faster Access to Specialized Treatments Act HR 4132 Transforming the Regulatory Environment to Accelerate Access to Treatments Act S 2113

Client expense: Not reported · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Social Security Administration (SSA)

S. 606, Creating Hope Act of 2011, S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act Reauthorization of the Prescription Drug User Fee Act and possible amendments thereto (no legislation yet) H.R. 4132, Faster Access to Specialized Treatments Act/S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S1734/HR2182 Gain Act - support incentives for antibiotic development; S2113 Treat Act; HR 4132 - FAST Act - support expanding accelerated approval pathway

Client expense: $221,006 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office