Generating Antibiotic Incentives Now Act of 2011

H.R. 1409: All provisions of the Quality Health Care Coalition Act of 2011; H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733:All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare H.R. 979 - All provisions of the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 605 / S. 312 -All provisions of the Patients Freedom to Choose Act S. 27 - All provisions of the Preserve Access to Affordable Generics Act S. 31 - All provisions of the Prescription Drug and Health Improvement Act of 2011 S. 44 -All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 H.R. 1839 - All provisions of the Community Pharmacy Fairness Act of 2011; H.R. 1946 - All provisions of the Preserving or Hometown Independent Pharmacies Act of 2011; H.R. 1971 / S. 1058 - All provisions of the Pharmacy Competition and Consumer Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H.R. 2672 the Preserving Access to Orphan Drugs Act H.R. 2182 the Generating Antibiotic Incentives Now Act H.R. 3026 the Safeguarding Americas Pharmaceuticals Act H.R. 2746 the Cancer Drug Coverage Parity Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act

Client expense: $559,998 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE

Medical research. Antibiotic resistance issues. H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011. H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3187, Food and Drug Administration Safety and Innovation Act. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. H. J. Res. 117, Continuing Appropriations Resolution.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Antibiotic resistance issues. Pay-for-delay proposals and generic issues. H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011. Prescription Drug User Fee Act reauthorization. H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 2516, Food and Drug Administration Safety and Innnovation Act. S. 3187, Food and Drug Administration Safety and Innovation Act. S. 2292, Patients' FDA Act. S. 2289, Better Pharmaceuticals and Devices for Children Act of 2012. H.R. 6433, FDA User Fee Corrections Act of 2012. H.R. 8, American Taxpayer Relief Act of 2012.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) as enacted in Pub. L. No. 112-144 issues related to the development of antibiotics Issues related to drug safety, supply chain, and facility inspections (No assigned legislation) Issues related to federal purchases under the Trade Agreements Act HR 6611 and related legislative proposals regarding issues surrounding potential drug shortages, including notifications and public reporting Issues related to federal revenues, entitlement reform, and deficit reduction regarding ongoing fiscal talks and sequestration HR 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to healthcare exchanges and essential health benefits

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) as enacted in Pub. L. No. 112-144 issues related to the development of antibiotics S. 27 and related legislative proposals regarding possible restrictions on patent settlements HR 6353 and related legislative proposals regarding possible changes to tax law regarding intellectual property profits H.R. 6621 and related legislative proposals regarding technical fixes in patent reform

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act, issues concerning technical clarifications; issues related to track and trace of pharmaceuticals; issues concerning Patient Centered Outcomes Research Institute grants.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (PREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program S.1855, HR 2405 Pandemic and All-Hazards Preparedness Act Reauthorization of 2011

Client expense: $1,212,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

S. 3187, Food and Drug Administration Safety and Innovation Act; Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act (S. 1734), issues concerning technical clarifications; issues related to track and trace of pharmaceuticals; issues concerning Patient Centered Outcomes Research Institute grants. Implementation of Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Technical changes to Food and Drug Administration Safety and Innovation Act (PL 112-144) Medical research Antibiotic resistance issues H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011 H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013 H.J. Res. 117, Continuing Appropriations Resolution

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Antibiotic resistance issues in the following bills Pay-for-delay proposals and generic issues H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011 Prescription Drug User Fee Act Reauthorization H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 2516, Food and Drug Administration Safety and Innovation Act S. 3187, Food and Drug Administration Safety and Innovation Act S. 2292, Patients' FDA Act S. 2289, Better Pharmaceuticals and Devices for Children Act of 2012 H.R. 6433, FDA User Fee Corrections Act of 2012 H.R. 8, American Taxpayer Relief Act of 2012

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; and community-based public health interventions. 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Middle Class Tax Relief and Job Promotion Act (H.R. 3630) 3.To Repeal the Prevention and Public Health Fund (H.R. 1217) 4.Establishing the budget for the United States Government for fiscal year 2013 and setting forth appropriate budgetary levels for fiscal years 2014 through 2022 (H. Con. Res. 34) 5.FIT Kids Act (S. 576/H.R. 1057) 6.Safe Routes to School Act (S. 800) 7.Healthy Lifestyles and Prevention America Act (S. 174) 8.Energy Tax Prevention Act of 2011 (S.482/H.R. 910) 9.SBIR/STTR Reauthorization Act of 2011 (S. 493) and proposed amendments 10.EPA Stationary Source Regulations Suspension Act (S. 231) 11.S. Res. 97, affirming the importance of exercise and physical activity as key components of a healthy lifestyle, including in combating obesity, reducing chronic disease, and lowering health care costs. 12.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 13.Implementation of Pandemic and All-Hazards Preparedness Act (Public Law 109-417) 14.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 15.Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012 (H.R. 5973/S. 2375) 16.Safe and Complete Streets Act of 2011 (H.R. 1780/S. 1056) 17.SBIR/STTR Reauthorization Act of 2011 and offered amendments related to the Environmental Protection Agency and the Clean Air Act, including amendments 183, 215, 236, and 277. 18.A resolution recognizing past, present, and future public health and economic benefits of cleaner air due to the successful implementation of the Clean Air Act (S.Res.119). 19.Healthy Children Through School Nutrition Education Act (H.R. 576) 20.Department of the Interior, Environment, and Related Agencies Appropriations Act, 2012 (H.R. 2584) 21.Healthy Families Act (H.R. 1876/S. 984) 22.Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 (H.R. 2405, S. 1855/H.R. 6672) 23.Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013 (S. 3295) 24.Department of Homeland Security Appropriations Bill, 2013 (H.R. 5855/S. 3216) 25.Transparency in Regulatory Analysis of Impacts on the Nation Act of 2011 (H.R. 2401) 26.Budget Control Act of 2011 (Public Law 112-25) 27.Surface and Air Transportation Programs Extension Act of 2011 (Public Law 112-30) 28.Health Equity and Accountability Act (HEAA) of 2011 (H.R. 2954) 29.Health Equity and Accountability Act (HEAA) of 2012 (S. 2474) 30.Preservation of Antibiotics for Medical Treatment Act (H.R. 965/S. 1211) 31.Generating Antibiotic Incentives Now Act (H.R. 2182/S. 1734) 32.Regulatory Accountability Act (S. 1606/H.R. 3010) 33.Regulations from the Executive in Need of Scrutiny Act (H.R. 10/S. 299) 34.Consolidated Appropriations Act, 2012 (Public Law 112-74) 35.Temporary Payroll Tax Cut Continuation Act of 2011 (Public Law 112-78) 36.Climate Change Health Protection and Promotion Act (H.R. 3314) 37.S. J. Res 27, a joint resolution disapproving a rule submitted by the Environmental Protection Agency relating to the mitigation by States of cross-border air pollution under the Clean Air Act. 38.MAP-21 (S. 1813) 39.FDA Safety and Innovation Act (S. 3187) 40.Student Success Act (H.R.3989) 41.Encouraging Innovation and Effective Teachers Act (H.R. 3990) 42.American Energy and Infrastructure Jobs Act of 2012 (H.R. 7) 43.Healthy Kids from Day One Act (S. 2119) 44.A joint resolution to disapprove a rule promulgated by the Administrator of the Environmental Protection Agency relating to emission standards for certain steam generating units (S.J.Res37) 45.National Surface Transportation and Freight Policy Act (S. 1950) 46.Repeal of Obamacare Act (H.R. 6079) 47.Commuter Savings Act of 2012 (H.R. 6066) 48.Immunization Improvements Act (S. 3344)The Federal Agriculture Reform and Risk Management Act of 2012 (H.R. 6083) 49.Gasoline Regulations Act of 2012 (H.R. 4471) 50.MAP-21 (Public Law 112-141) 51.Interest Rate Reduction Act (H.R. 4628) 52.Stop the Student Loan Interest Rate Hike Act of 2012 (S. 2343) 53.Elementary and Secondary Education Reauthorization Act of 2011 (S. 3578) 54.Help Obesity Prevention Efforts (HOPE) (H.R. 6143) 55.Measures to Prevent Childhood Obesity Act of 2012 (H.R. 6461 56.Agriculture Reform, Food and Jobs Act of 2012 (S. 3240) 57.Medicare Better Health Rewards Program Act (H.R. 6232/S.2243) 58.Medicaid Information Technology to Enhance Community Health Act (S. 3539) 59.Stop the War on Coal Act (H.R. 3409) 60.Common Sense Nutrition Disclosure Act (H.R. 6174) 61.Red Tape Reduction and Small Business Job Creation Act (H.R. 4078) 62.Lead Exposure Reduction Amendments Act (S. 2148) 63.Immunization Improvements Act of 2012 (S. 3344) 64.Spending Reduction Act of 2012 (H.R. 6684) 65.Supplemental Appropriations for Disaster Assistance (H.R. 1) 66.To extend certain tax relief provisions enacted in 2001 and 2003, and to provide for expedited consideration of a bill providing for comprehensive tax reform, and for other purposes (H.R. 8) 67.The Preventative Health Savings Act of 2012, H.R. 6482

Client expense: $35,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT)

**see addendum page Prescription drug importation S. 319 Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 147 - Prescription Drug Affordability Act H.R. 2182/S. 1734 - Generating Antibiotics Incentives Now Act PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation ***, no specific bill(s), Import Safety, Prescription Drug User Fee Act renewal, drug development policy, drug shortages, supply chain integrity, patent settlements

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

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

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: $486,262 · 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 2014 Budget, 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 H.R.6584 - Verifying Authority and Legality In Drug Compounding Act of 2012 H.R.6611 - Patient Access to Drugs in Shortage Act of 2012 H.R.6638 - S.A.F.E. Compounded Drugs 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: $486,262 · 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

See page three Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

See page 7 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

See page five Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S.1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

H.R. 2182/S. 1734 - Generating Antibiotic Incentives Now Act . Supporting work to increase innovation and development of new antibiotics. S. 1584 - Drug Safety and Accountability Act- Supporting legislation and related Congressional activity regarding upstream supply stream safety. H.R. 3026- Safeguarding America's Pharmaceuticals Act. Supporting legislation and congressional activity regarding downstream supply chain safety. S. 3187 - The FDA Safety and Innovation Act- specific work on antibiotic innovation, up and down stream supply chain issues, and medical device policies. Policies related to the growing concerns regarding drug shortage issues in hospitals across the country. Potential language related to Track and Trace provisions regarding downstream supply chain safety being considered by the Senate HELP and House Energy and Commerce Committees. H.R. 6584 The Valid Compounding Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 6638 - S.A.F.E Compounded Drugs Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 8 - The American Taxpayer Relief Act of 2012- Focused on provisions that could have an impact on the nation's public health system.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 2182/S.1734 - The Generating Antibiotic Incentives Now Act. Supporting work to increase innovation in the development of new antibiotics. S. 1584 - The Drug Safety and Accountability Act. Supporting upstream supply chain safety issues. S. 3026 - Safeguarding America's Pharmaceuticals Act Supporting downstream supply chain issues. Implementation and rulemaking related to the Physician Payment Sunshine Act - A Medicare-related provision in the Health Reform Law focused on increasing systemic transparency. S. 3295- The Department of Labor, Health and Human Services, Education and Related Agencies Appropriations Act of 2013. Supporting report language clarifying congressional intent for the funding of the Physician Payment Sunshine Act. Improvement of safety and efficacy of medical devices. Work related to treatment of medical devices in the upcoming FDA user fee arena. S. 3187 - The FDA Safety and Innovation Act- specific work on antibiotic innovation, up and down stream supply chain issues, and medical device policies. H.R. 6584 The Valid Compounding Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 6638 - S.A.F.E Compounded Drugs Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 8 - The American Taxpayer Relief Act of 2012- Focused on provisions that could have an impact on the nation's public health system.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 1409: All provisions of the Quality Health Care Coalition Act of 2011; H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733:All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; H.R. 979 - All provisions of the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 605 / S. 312 -All provisions of the Patients Freedom to Choose Act S. 27 - All provisions of the Preserve Access to Affordable Generics Act S. 31 - All provisions of the Prescription Drug and Health Improvement Act of 2011 S. 44 -All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 H.R. 1839 - All provisions of the Community Pharmacy Fairness Act of 2011; H.R. 1946 - All provisions of the Preserving or Hometown Independent Pharmacies Act of 2011; H.R. 1971 / S. 1058 - All provisions of the Pharmacy Competition and Consumer Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H.R. 2672 the Preserving Access to Orphan Drugs Act H.R. 2182 the Generating Antibiotic Incentives Now Act H.R. 3026 the Safeguarding Americas Pharmaceuticals Act H.R. 2746 the Cancer Drug Coverage Parity Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act

Client expense: $518,430 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE

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

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

H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) issues related to the development of antibiotics Issues related to US position on intellectual property matters in Canada

Client expense: $370,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) issues related to the development of antibiotics H.R. 3026, S. 1882 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer HR 1483 - issues related to drug safety, supply chain, and facility inspections H.R. 2245, S.296, H.R. 3839 (Prescribing Access to Lifesaving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages, including notifications and public reporting H.R. 3668 issues related to increased penalties for counterfeiting drugs S. Amend. t.2107 and related legislative proposals regarding prescription drug importation

Client expense: $370,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

HR 2182, S1734, and S2187 (as passed in Pub. L. No. 112-144) issues related to the development of antibiotics H.R. 3026, S. 1882 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer HR 1483 - issues related to drug safety, supply chain, and facility inspections H.R. 2245, S.296, H.R. 3839 (Prescribing Access to Lifesaving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages, including notifications and public reporting H.R. 3668 issues related to increased penalties for counterfeiting drugs HR 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to 340B program amendments and implementation of statutory changes. HR 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to definition of essential health benefits and health insurance exchanges. HR 6160 - issues related to drug safety issues, including tamper resistent packaging HR 1513 - issues related to animal research HR 6502 - issues related to development of medicines for life-threatening illnesses HR 3497 - issues related to incentives for developing and improving diagnostic tests and related treatments HR 6272 - issues related to the expansion of clinical trial data banks and increase government reporting of same HR 6163 - issues related to incentives for increased research into pediatric treatments

Client expense: $980,000 · Firm income: Not reported

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

HR 2182, S1734, and S2187 (as passed in Pub. L. No. 112-144) issues related to the development of antibiotics H.R. 6353 - issues related to providing intelletual property incentives for manufacturing H.R. 6502 - issues related to the provision on incentives for development of medicines for life-threatening illnesses

Client expense: $980,000 · Firm income: Not reported

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

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 related to the implementation of health care reform (P.L. 111-148, P.L. 111-152) Issues related to the development of new antibiotics (the Generating Antibiotic Incentives Now Act (H.R. 2182) (S.1734)) Issues related to implementation of the Prescription Drug User Fee Act (now Public Law 112-144)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3590 - Patient Protection and Affordable Care Act - implementation of all provisions related to health, coverage, benefits, and Medicaid HR 1852/S958 - Children's Hospital Graduate Medical Education - Acts to reauthorize and establish funding levels for the program 340B - Implementation of 340B drug discount program for orphan drugs provided through children's hospitals HIT - Certification Standards for Meaningful Use - HIT standards and application to children's hospitals and providers H.R. 2245 & S. 296, Preserving Access to Life-Saving Medications Act of 2011 - work to address growing national drug shortages by requiring drug manufacturers to report foreseeable shortages to the Food & Drug Administration (FDA) 6 months in advance. H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act of 2011 - work to address antibiotic resistance by incentivizing research and development of more-effective antibiotics through, e.g., increased Hatch-Waxman exclusivity and expedited FDA review. S. 606, Creating Hope Act of 2011- work on a bill that encourages development of new treatments for rare and neglected diseases that disproportionately affect children. H.R. 2679 & S. 1440, PREEMIE Reauthorization Act - work on a bill that authorizes programmatic and grant funding for research into the causes of preterm birth and promotes the development of evidence-based standards of care for at-risk pregnancies. H.R. 2795, Fit for Life Act - work on a bill that proposes to increase funding available for obesity prevention and treatment programs through the USDA and HHS. Prescription Drug User Fee Act (no bill number) HR 4274 - Best Pharmaceuticals for Children Act and Pediatric Research Equality Act

Client expense: $900,742 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act, issues concerning technical clarifications.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Antibiotic resistance issues. Pay-for-delay proposals and generic issues. H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011. Prescription Drug User Fee Act reauthorization. H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 2516, Food and Drug Administration Safety and Innnovation Act. S. 3187, Food and Drug Administration Safety and Innovation Act. S. 2292, Patients' FDA Act. S. 2289, Better Pharmaceuticals and Devices for Children Act of 2012. H.R. 6433, FDA User Fee Corrections Act of 2012.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical research. Antibiotic resistance issues. H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011. H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3187, Food and Drug Administration Safety and Innovation Act. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. H. J. Res. 117, Continuing Appropriations Resolution.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Care Reform Prescription Drug User Fee Act (PDUFA) Antibiotic Incentives FDA Funding Antimicrobial Resistance Drug Shortages Homeland Security and Agriculture Appropriations Bill on Certified Importer Program Deficit Reduction/Joint Select Committee Issues (Budget Control Act) H.R. 2182, Generating Antibiotic Incentives Now Act of 2011 H.R. 452, Medicare Decisions Accountability Act S. 1734, Generating Antibiotic Incentives Now Act of 2011 S. 3817, Food and Drug Administration Safety and Innovation Act

Client expense: $2,600,000 · 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), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)

HR 3590 - Patient Protection and Affordable Care Act - implementation of all provisions related to health, coverage, benefits, and Medicaid HR 1852/S958 - Children's Hospital Graduate Medical Education - Acts to reauthorize and establish funding levels for the program 340B - Implementation of 340B drug discount program for orphan drugs provided through children's hospitals HIT - Certification Standards for Meaningful Use - HIT standards and application to children's hospitals and providers H.R. 2245 & S. 296, Preserving Access to Life-Saving Medications Act of 2011 - work to address growing national drug shortages by requiring drug manufacturers to report foreseeable shortages to the Food & Drug Administration (FDA) 6 months in advance. H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act of 2011 - work to address antibiotic resistance by incentivizing research and development of more-effective antibiotics through, e.g., increased Hatch-Waxman exclusivity and expedited FDA review. S. 606, Creating Hope Act of 2011- work on a bill that encourages development of new treatments for rare and neglected diseases that disproportionately affect children. H.R. 2679 & S. 1440, PREEMIE Reauthorization Act - work on a bill that authorizes programmatic and grant funding for research into the causes of preterm birth and promotes the development of evidence-based standards of care for at-risk pregnancies. H.R. 2795, Fit for Life Act - work on a bill that proposes to increase funding available for obesity prevention and treatment programs through the USDA and HHS. Prescription Drug User Fee Act (no bill number) HR 4274 - Best Pharmaceuticals for Children Act and Pediatric Research Equality Act

Client expense: $900,742 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

**see addendum page Prescription drug importation S. 319 Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 147 - Prescription Drug Affordability Act H.R. 2182/S. 1734 - Generating Antibiotics Incentives Now Act S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bill(s), Import Safety, Prescription Drug User Fee Act renewal, drug development policy, drug shortages, supply chain integrity, patent settlements

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

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

H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives 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. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 3486, Patent Law Treaties Implementation Act of 2012: Patent law treaties Patents for Humanity Program Improvements Act of 2012: Provisions related to transferability of PTO acceleration certificates [no bill number] Technical changes to America Invents Act [H.R. 1249 and S.23] International intellectual property issues 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. 1734 / H.R. 2182, Generating Antiobiotic Incentives Now Act (GAIN Act) - incentives for development of products to treat antibiotic-resistant infections; S. 3187, Food and Drug Administration Safety and Innovation Act - incentives for development of products to treat antibiotic-resistant infections; H.R. 5651, Food and Drug Administration Reform Act of 2012 - incentives for development of products to treat antibiotic-resistant infections

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1734 / H.R. 2182, Generating Antiobiotic Incentives Now Act (GAIN Act) - incentives for development of products to treat antibiotic-resistant infections; S. 3187, Food and Drug Administration Safety and Innovation Act - incentives for development of products to treat antibiotic-resistant infections; H.R. 5651, Food and Drug Administration Reform Act of 2012 - incentives for development of products to treat antibiotic-resistant infections

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

See page five Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 HR 6446, Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

See page three Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 HR 6446, Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

See page 7 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 HR 6446, Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 S. 1700 The Medical Device Regulatory Improvement Act S. 1865 The Patient Access to Medical Innovation Act S. 1943 Novel Device Regulatory Relief Act of 2011 S. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

S. 3187, Food and Drug Administration Safety and Innovation Act, provisions relating to drug shortages, antibiotic incentives, and combating diversion H.R. 5998, USPSTF Transparency and Accountability Act of 2012, all provisions H.R. 2119, Ryan Creedon Act of 2011, all provisions H.R. 3497, MODDERN Cures Act of 2011, all provisions H.R. 3207, Modernizing Laboratory Test Standards for Patients Act of 2011, all provisions H.R. 866, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2011, all provisions H.R. 2182, Generating Antibiotic Incentives Now Act of 2011, all provisions H.R. 2960, National Diabetes Clinical Care Commission Act, all provisions H.R. 4384, Patient Safety and Drug Labeling Improvement Act, all provisions Clinical Registries ACA Implementation Insurance Exchanges Prescription Drug Abuse Drug diversion/mandatory CME for DEA Registrants/violence prevention Drug shortages Flexible Spending Accounts (FSAs) Delivery and Payment Reform Personalized Medicine Health Information Technology HIPAA Administrative Simplifications Health Insurance Reform Medical Licensing Boards and Scope of Practice

Client expense: $3,680,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Antibiotic resistance issues. Pay-for-delay proposals and generic issues. H.R. 2182/ S. 1734, Generating Antibiotic Incentives Now Act of 2011-incentives for development of products to treat antibiotic-resistant infections Prescription Drug User Fee Act reauthorization. H.R. 5651, Food and Drug Adminitration Reform Act of 2012 - incentives for development of products to treat antibiotic-resistant infections S. 2516, Food and Drug Administration Safety and Innovation Act. S. 3187, Food and Drug Administration Safety and Innovation Act.- incentives for development of products to treat antibiotic-resistant infections S. 2292, Patients' FDA Act S. 2289, Better Pharmaceuticals and Devices for Childrens Act of 2012 H.R. 6433, FDA User Fee Corrections Act of 2012

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1734/H.R. 2182, Generating Antibiotic Incentives Now Act (GAIN Act) - incentives for development of products to treat antibiotic-resistant infections, issues concerning technical clarifications. S. 3187, Food and Drug Adminitration Safety and Innovations Act - incentives for development of products to treat antibiotic-resistant infections H.R. 5651, Food and Drug Administration Reform Act of 2012 - incentives for development of products to treat antibiotic-resistant infections S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. H.J. Res. 117, Continuing Approprations Resolution Medical Research Antibiotic resistance issues Reauthorization of the Prescrition Drug User Fee Act Reauthorization of the Medical Device User Fee Act H.R. 1483, Drug and Safety Enhancement Act of 2011 Implementation of Patient Protaction and Affordable Care Act of 2010 (Pub. L. 111-148) Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152)

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reauthorization of the Prescription Drug User Fee Act (H.R. 5651; S. 3187); incentives for antibiotic research and development (H.R. 2182; H.R. 5651; S. 3187); hepatitis C education (H.R. 3381); improvements to vaccine immunization (no specific bill); 340b (no specific bill).

Client expense: $2,430,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)