FDA User Fee Protection Act

H.R.2029, Military Construction and Veterans Affairs and Related Agencies Appropriations Act; H.R. 3547, Consolidated Appropriations Act of 2014; Other Labor, Health and Human Services Appropriations (No Bills Introduced); H.R. 1078, Food & Drug Administration Safety Over Sequestration Act; S. 1413, FDA User Fee Protection Act;

Client expense: $1,240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R.2029, Military Construction and Veterans Affairs and Related Agencies Appropriations Act; Other Labor, Health and Human Services Appropriations (No Bills Introduced); H.R. 1078, Food & Drug Administration Safety Over Sequestration Act; S. 1413, FDA User Fee Protection Act; FDAs Changes Being Effected Rule;

Client expense: $930,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Client expense: $2,130,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015

Client expense: $2,130,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

H.R.2029, Military Construction and Veterans Affairs and Related Agencies Appropriations Act; Other Labor, Health and Human Services Appropriations (No Bills Introduced); H.R. 1078, Food & Drug Administration Safety Over Sequestration Act; S. 1413, FDA User Fee Protection Act; FDAs Changes Being Effected Rule;

Client expense: $970,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Patients' Access to Treatment (HR 460) FDA Safety Over Sequestration At (HR 2725/S 1413) Preserving Access to Orphan Drugs Act (S 1128/HR 2315) Medical Foods for Inborn Errors of Metabolism

Client expense: Not reported · Firm income: Not reported

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

PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), Import Safety, Prescription Drug User Fee Act renewal, drug development policy, drug shortages, supply chain integrity, patent settlements, user fee sequester relief

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

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

PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, user fee sequester

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation, biosimilars, 340B, disclosure, comparative effectiveness research H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies

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

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

PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), Drug Safety, Prescription Drug Importation, Import Safety, supply chain integrity, biosimilars, PDUFA and associated policies, patent settlements, accelerated approval, break through therapies, compounding, user fee sequester

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

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

PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation, user fee sequester H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief

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

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

Health care reform, drug importation, 340b, biosimilars PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief H.R. 1281/S. 1417 - Newborn Screening Saves Lives Reauthorization Act ***no specific bills, importation, Prescription Drug User Fee Act Renewal and associated policies, supply chain integrity, user fee sequester

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

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

PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation S. 10, S. 954 - Agriculture Reform, Food, and Jobs Act of 2013 H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), prescription drug importation, import safety, supply chain integrity, Prescription Drug User Fee Act and associated policies, user fee sequester

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

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

PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), 510k reform, imaging policy, medical device user fee reauthorization and all related policies, mobile medical apps, device regulation

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

PL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, user fee sequester

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), Import Safety, Prescription Drug User Fee Act renewal, drug development policy, drug shortages, supply chain integrity, patent settlements, user fee sequester relief

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

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

PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), Drug Safety, Prescription Drug Importation, Import Safety, supply chain integrity, biosimilars, PDUFA and associated policies, patent settlements, accelerated approval, break through therapies, compounding, user fee sequester

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

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

PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation, biosimilars, 340B, disclosure, comparative effectiveness research H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies

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

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

"Accessing Medicare Therapies Act" - H.R.1239 "To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care" - H.R.5214 "The Value-Based Insurance Design (VBID) for Better Care Act of 2014" - H.R.5183 "Patients' Access to Treatment" - H.R.460 "FDA Safety Over Sequestration Act" - H.R.2725/S 1413 "Preserving Access to Orphan Act" - S.1128/H.R. 2315 "Medical Foods for Inborn Errors of Metabolism"

Client expense: Not reported · Firm income: Not reported

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

"Accessing Medicare Therapies Act" - H.R.1239 "To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care" - H.R.5214 "The Value-Based Insurance Design (VBID) for Better Care Act of 2014" - H.R.5183 "Patients' Access to Treatment" - H.R.460 "FDA Safety Over Sequestration Act" - H.R.2725/S 1413 "Preserving Access to Orphan Act" - S.1128/H.R. 2315 "Medical Foods for Inborn Errors of Metabolism"

Client expense: Not reported · Firm income: Not reported

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

H.R. 3204, Drug Quality and Security Act H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413, FDA User Fee Protection Act S. 504, Fair And Immediate Release of Generic Drugs Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), White House Office

Funding for State AIDS Drug Assistance programs under Ryan White Care Act; S. 1281, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2014; H.R. 3547, Consolidated Appropriations Act, 2014; other Labor, Health and Human Services Appropriations; H.R. 2725, Food & Drug Administration Safety Over Sequestration Act of 2013; S. 1413, FDA User Fee Protection Act of 2013; FDAs Changes Being Effected Rule

Client expense: $1,520,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

HR 2375 -Transparency and Accountability in Medicare Bidding Act of 2013 - provisions related to Round One recompete and implications for diabetes products. HR 2810 - The Medicare Patient Access and Quality Improvement Act of 2013 - issues related to reform of the physician fee schedule and the SGR formula.Provided continuing support for Medtronic acquisition of Covidien, which included attention to potential legislation on federal contracting limitations and various tax policy proposals. H.R. 2725 - FDA Safety Over Sequestration Act of 2013, and S. 1413 FDA User Fee Protection Act - provisions related to protecting industry paid user fees from sequestration H.R. 2663 & S. 1422 - The Preventative Health Savings Act - provisions that will permit leaders in Congress to request that CBO estimate the long-term health savings that are possible from preventative health initiatives like abdominal aortic aneurysm, hypertension screenings. H.R. 3077 The TELE-MED Act of 2013 provisions related to telemedicine and remote monitoring that increase access to health care and enhance patient outcomes H.R. 3303 Software Act of 2013 - provisions related to FDA regulation of health information technology and mobile medical applications S. 1932 - Better Care, Lower Cost Act - provisions related to management of chronic disease H.R. - 3890 - Better Care, Lower Cost Act - provisions related to management of chronic disease Issues related to neuroscience research Issues related to the discovery, development and delivery of promising new treatments to patients (21st Century Cures).

Client expense: $950,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum pagePL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief MEDTECH Act, health IT ***, no specific bill(s), 510k reform, imaging policy, medical device user fee reauthorization and all related policies, mobile medical apps, device regulation, 21st Century Cures

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

**see addendum pagePL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation S. 10, S. 954 - Agriculture Reform, Food, and Jobs Act of 2013 H.R. 2186 - Valid Compounding Act H.R. 3204 The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), prescription drug importation, import safety, supply chain integrity, Prescription Drug User Fee Act and associated policies, user fee sequester, 21st Century Cures

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

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

**see addendum pagePL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation, user fee sequester H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief 21st Century Cures

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

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

**see addendum pageHealth care reform, drug importation, 340b, biosimilars PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief H.R. 1281/S. 1417 - Newborn Screening Saves Lives Reauthorization Act ***no specific bills, importation, Prescription Drug User Fee Act Renewal and associated policies, supply chain integrity, user fee sequester, 21st Century Cures

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

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

**see addendum pagePL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), Drug Safety, Prescription Drug Importation, Import Safety, supply chain integrity, biosimilars, PDUFA and associated policies, patent settlements, accelerated approval, break through therapies, compounding, user fee sequester, 21st Century Cures

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

**see addendum pagePL 111-148 The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation, biosimilars, 340B, disclosure, comparative effectiveness research H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, 21st Century Cures, 340B

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

**see addendum pagePL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), Import Safety, Prescription Drug User Fee Act renewal, drug development policy, drug shortages, supply chain integrity, patent settlements, user fee sequester relief, 21st Century Cures

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

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

**see addendum pagePL 111-148 - The Patient Protection and Affordable Care Act, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 2186 - Valid Compounding Act H.R. 3204 - The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief H.R. 3474 - Hire More Heroes Act of 2014, tax extenders, device tax ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, user fee sequester, 21st Century Cures

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

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

Deficit reduction/impact of sequestration on FDA and NIH; FDA Safety Over Sequestration Act of 2013 (HR 2725); FDA User Fee Protection Act (S 1413); FDA and BARDA/CDC appropriations.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

H.R.4800 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 S.2389 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 H.R. 2725 Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413 FDA User Fee Protection Act H.R.83 - FY2015 Omnibus; Consolidated and Further Continuing Appropriations Act Issues related to the regulation of radioactive source materials for medical use and Section 402 of the Senate Energy & Water Appropriations bill

Client expense: $550,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY 2015 FDA Appropriations H.R. 2725 - Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413 - FDA User Fee Protection Act Issues related to lab development testsIssues related to the improving the regulatory system related to the discovery, development and delivery of medical devices (including the 21st Century Cures initiative)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY 2013 and 2014 medical device user fees for the Food and Drug Administration. Food and Drug Administration Safety Over Sequestration Act (H.R. 2725). FDA User Fee Protection Act (S. 1413).

Client expense: $415,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.J. Res 59, Continuing Appropriations Resolution, regarding all biopharmaceutical related provisions. Labor, HHS Appropriations, regarding all biopharmaceutical related provisions. Agriculture appropriations, regarding all biopharmceutical related provisions. H.R. 2725/S. 1413, FDA Safety over Sequestration Act, regarding all biopharmaceutical user-fees. No-bill, educational meetings regarding atrial fibrillation. No bill - regarding FDA regulatory issues and patent incentives related to the 21st Century Cures Initiative. Health Care Reform implementation - regarding essential health benefits coverage and all biopharmaceutical related provisions. H.R. 3723, Viral Hepatitis Testing Act, regarding all provisions.

Client expense: $770,000 · Firm income: Not reported

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

H.J. Res 59, Continuing Appropriations Resolution, regarding all biopharmaceutical related provisions. Labor, HHS Appropriations, regarding all biopharmaceutical related provisions. Agriculture appropriations, regarding all biopharmceutical related provisions. H.R. 2725/S. 1413, FDA Safety over Sequestration Act, regarding all biopharmaceutical user-fees. No-bill, educational meetings regarding atrial fibrillation. No bill - regarding FDA regulatory issues and patent incentives related to the 21st Century Cures Initiative. Health Care Reform implementation - regarding essential health benefits coverage and all biopharmaceutical related provisions. H.R. 3723, Viral Hepatitis Testing Act, regarding all provisions.

Client expense: Not reported · Firm income: $770,000

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

"Accessing Medicare Therapies Act" - H.R.1239 "To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care" - H.R.5214 "The Value-Based Insurance Design (VBID) for Better Care Act of 2014" - H.R.5183 "Patients' Access to Treatment" - H.R.460 "FDA Safety Over Sequestration Act" - H.R.2725/S 1413 "Preserving Access to Orphan Act" - S.1128/H.R. 2315 "Medical Foods for Inborn Errors of Metabolism"

Client expense: Not reported · Firm income: Not reported

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

FY 2013 and 2014 medical device user fees for the Food and Drug Administration. Food and Drug Administration Safety Over Sequestration Act (H.R. 2725). FDA User Fee Protection Act (S. 1413).

Client expense: $375,000 · Firm income: Not reported

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

HR 2375 -Transparency and Accountability in Medicare Bidding Act of 2013 - provisions related to Round One recompete and implications for diabetes products. HR 2810 - The Medicare Patient Access and Quality Improvement Act of 2013 - issues related to reform of the physician fee schedule and the SGR formula.H.R. 2725 - FDA Safety Over Sequestration Act of 2013, and S. 1413 FDA User Fee Protection Act - provisions related to protecting industry paid user fees from sequestration H.R. 2663 & S. 1422 - The Preventative Health Savings Act - provisions that will permit leaders in Congress to request that CBO estimate the long-term health savings that are possible from preventative health initiatives like abdominal aortic aneurysm, hypertension screenings. H.R. 3077 The TELE-MED Act of 2013 provisions related to telemedicine and remote monitoring that increase access to health care and enhance patient outcomes H.R. 3303 Software Act of 2013 - provisions related to FDA regulation of health information technology and mobile medical applications S. 1932 - Better Care, Lower Cost Act - provisions related to management of chronic disease H.R. - 3890 - Better Care, Lower Cost Act - provisions related to management of chronic disease Issues related to neuroscience research Issues related to the discovery, development and delivery of promising new treatments to patients (21st Century Cures).

Client expense: $1,420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Funding for the USDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for FDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for Biomass Crop Assistance Program H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Sequestration of PDUFA Fees S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Biofuels H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015 H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biorefineries Implementation of the Agricultural Act of 2014 H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015

Client expense: $2,090,000 · 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), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Naming Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Vaccine Access/Financing Implementation of Affordable Care Act S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program Implementation of Affordable Care Act Program Implementation & Oversight Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for FDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees S. 1413: FDA User Fee Protection Act Drug Evaluation and Review Compassionate Use/Expanded Access Special Medical Use/Limited Population Drug Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Canadian Policies Sunshine Act Implementation Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations 21st Century Cures InitiativeTransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Transparency Intellectual Property Issues

Client expense: $2,090,000 · 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), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

Deficit reduction/impact of sequestration on FDA and NIH; FDA Safety Over Sequestration Act of 2013 (HR 2725); FDA User Fee Protection Act (S 1413); FDA and BARDA/CDC appropriations.

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE

H.R.4800 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 S.2389 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 H.R. 2725 Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413 FDA User Fee Protection Act

Client expense: $510,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum pagePL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation S. 10, S. 954 - Agriculture Reform, Food, and Jobs Act of 2013 H.R. 2186 - Valid Compounding Act H.R. 3204 The Drug Quality and Security Act, implementation H.R. 2725, S. 1413 - Safety Over Sequester Act, user fee sequester relief ***, no specific bill(s), prescription drug importation, import safety, supply chain integrity, Prescription Drug User Fee Act and associated policies, user fee sequester, 21st Century Cures

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

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