Food and Drug Administration Safety Over Sequestration Act of 2013

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

Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations21st Century Cures Initiative Biomarkers and Regulatory Science Improvements Communication with Healthcare Professionals 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative Biosimilars Biosimilar User Fee Act Implementation Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming Patent Certification Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 340B Drug Pricing Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Implementation of Affordable Care Act Program Implementation & Oversight Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Issues Intellectual Property IssuesReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure Canadian Policies European Policies Sunshine Act Implementation

Client expense: $2,090,000 · 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), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Biomass Crop Assistance Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Energy Basic Research Funding H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Biofuels H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015

Client expense: $2,090,000 · 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), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office

**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

Monitor legislative and administrative action on appropriations and budget. Draft, House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015. Draft, Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015. Draft, House Energy and Water Development and Related Agencies Appropriations Act, 2015. Draft, Senate Energy and Water Development and Related Agencies Appropriations Act, 2015. Draft, House Interior and Environment Appropriations Act, 2015. Draft, Senate Interior and Environment Appropriations Act, 2015. Draft, House Departments of Labor, Health and Human Services and Related Agencies Appropriations Act, 2015. Draft, Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. Draft, House National Defense Authorization Act, 2015. Draft, Senate National Defense Authorization Act, 2015. Monitor the passage of FY2014 omnibus appropriations legislation (P.L. 113-76). H.R. 2217, Department of Homeland Security Appropriations Act, 2014. Funding for national biodefense and agriculture funding. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013.

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

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to Medicare's 2011 guidance on servicing hospital equipment, including medical imaging equipment. Monitor legislative and administrative action related to drug safety and drug counterfeiting (track and trace). Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to federal preemption for prescription drugs. Monitor legislative and administrative action related to point-of-care instruments. Monitor legislative and administrative action related to streamlined pathways to market for breakthrough technologies. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administration action related to Tropical Disease Priority Review Voucher Program. Monitor activities related to House Energy and Commerce Committees 21st Century Cures Initiative. H.R. 1150, Preservation of Antibiotics for Medical Treatment Act of 2013. Title II and general provisions in the bill. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013. H.R. 4302, Protecting Access to Medicare Act. Provisions related to imaging and Sec. 213. S. 1256, Preventing Antibiotic Resistance Act of 2013. S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013. H.R. 4771, Designer Anabolic Steroid Control Act of 2014. S. 2012, Designer Anabolic Steroid Control Act of 2014. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148. H.R. 1295, Medical Device Tax Elimination Act. S. 2917, Adding Ebola to the FDA Priority Review Voucher Program Act. H.R. 3969, Preventing Abuse of Cough Treatments Act of 2014 or the PACT Act. S. 644, Preventing Abuse of Cough Treatments Act of 2013 or the PACT Act.

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

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Issues relating to FDA funding; H.R. 4800 and S. 2389 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015; H.R. 2725 - Food an Drug Administration Safety Over Sequestration Act of 2013; S. 1412 - FDA User Fee Protection Act

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

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

**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

Issues related to access to rare and orphan disease therapeutics under the enactment of ACA (no specific bills); Issues related to FDA regulatory pathways for pharmaceuticals (no specific bills); H.R. 460 The Patients' Access to Treatments Act of 2013 (all provisions); H.R. 2725 FDA Safety Over Sequestration (SOS) Act (all provisions)

Client expense: $210,000 · Firm income: Not reported

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

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to Medicare's 2011 guidance on servicing hospital equipment, including medical imaging equipment. Monitor legislative and administrative action related to drug safety and drug counterfeiting (track and trace). Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to federal preemption for prescription drugs. Monitor legislative and administrative action related to point-of-care instruments. Monitor legislative and administrative action related to streamlined pathways to market for breakthrough technologies. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administration action related to Tropical Disease Priority Review Voucher Program. Monitor activities related to House Energy and Commerce Committees 21st Century Cures Initiative. H.R. 1150, Preservation of Antibiotics for Medical Treatment Act of 2013. Title II and general provisions in the bill. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013. HR 3204, Drug Quality and Security Act. Provisions related to drug distribution. H.R. 4302, Protecting Access to Medicare Act. Provisions related to imaging and Sec. 213. S. 959, Pharmaceutical Quality, Security, and Accountability Act. Provisions related to drug distribution. S. 1256, Preventing Antibiotic Resistance Act of 2013. S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013. H.R. 1528, Veterinary Medicine Mobility Act of 2014. H.R. 4771, Designer Anabolic Steroid Control Act of 2014. S. 2012, Designer Anabolic Steroid Control Act of 2014. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148. H.R. 1295, Medical Device Tax Elimination Act.

Client expense: $1,450,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Monitor legislative and administrative action on appropriations and budget. Draft, House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015. Draft, Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015. Draft, House Energy and Water Development and Related Agencies Appropriations Act, 2015. Draft, Senate Energy and Water Development and Related Agencies Appropriations Act, 2015. Draft, House Interior and Environment Appropriations Act, 2015. Draft, Senate Interior and Environment Appropriations Act, 2015. Draft, House Departments of Labor, Health and Human Services and Related Agencies Appropriations Act, 2015. Draft, Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. Draft, House National Defense Authorization Act, 2015. Draft, Senate National Defense Authorization Act, 2015. Monitor the passage of FY2014 omnibus appropriations legislation (P.L. 113-76). H.R. 2217, Department of Homeland Security Appropriations Act, 2014. Funding for national biodefense and agriculture funding. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013.

Client expense: $1,450,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to sustainable growth rate and SGR repeal. Issues of tranparency on the CMS preventative maintenance directive for medical equipment. Monitor legislative and administrative action related to Medicare's 2011 guidance on servicing hospital equipment, including medical imaging equipment. Monitor legislative and administrative action related to drug safety and drug counterfeiting (track and trace). Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to federal preemption for prescription drugs. H.R. 1150, Preservation of Antibiotics for Medical Treatment Act of 2013. Title II and general provisions in the bill. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013. HR 3204, Drug Quality and Security Act. Provisions related to drug distribution. H.R. 4302, Protecting Access to Medicare Act. Provisions related to imaging and Sec. 213. S. 959, Pharmaceutical Quality, Security, and Accountability Act. Provisions related to drug distribution. S. 1256, Preventing Antibiotic Resistance Act of 2013. S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013. H.R. 1528, Veterinary Medicine Mobility Act of 2014. H.R. 4771, Designer Anabolic Steroid Control Act of 2014. S. 2012, Designer Anabolic Steroid Control Act of 2014. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148. H.R. 1295, Medical Device Tax Elimination Act.

Client expense: $1,360,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Monitor legislative and administrative action on appropriations and budget. Draft, House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015. Draft, Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015. Draft, House Energy and Water Development and Related Agencies Appropriations Act, 2015. Draft, Senate Energy and Water Development and Related Agencies Appropriations Act, 2015. Draft, House Interior and Environment Appropriations Act, 2015. Draft, Senate Interior and Environment Appropriations Act, 2015. Draft, House Departments of Labor, Health and Human Services and Related Agencies Appropriations Act, 2015. Draft, Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. Draft, House National Defense Authorization Act, 2015. Draft, Senate National Defense Authorization Act, 2015. Monitor the passage of FY2014 omnibus appropriations legislation (P.L. 113-76). H.R. 2217, Department of Homeland Security Appropriations Act, 2014. Funding for national biodefense and agriculture funding. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013. H.R. 2217, Department of Homeland Security Appropriations Act, 2014. Funding for national biodefense and agriculture funding.

Client expense: $1,360,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to sustainable growth rate and SGR repeal. Issues of transparency on the CMS preventative maintenance directive for medical equipment. Monitor legislative and administrative action related to Medicare's 2011 guidance on servicing hospital equipment, including medical imaging equipment. Monitor legislative and administrative action related to drug safety and drug counterfeiting (track and trace). Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. oMonitor legislative and administrative action related to federal preemption for prescription drugs. H.R. 1150, Preservation of Antibiotics for Medical Treatment Act of 2013. Title II and general provisions in the bill. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013. HR 3204, Drug Quality and Security Act. Provisions related to drug distribution. H.R. 4302, Protecting Access to Medicare Act. Provisions related to imaging and Sec. 213. S. 959, Pharmaceutical Quality, Security, and Accountability Act. Provisions related to drug distribution. S. 1256, Preventing Antibiotic Resistance Act of 2013. S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148.

Client expense: $2,080,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor legislative and administrative action on appropriations and budget. Draft, House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015. Draft, Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015. Draft, House Energy and Water Development and Related Agencies Appropriations Act, 2015. Draft, Senate Energy and Water Development and Related Agencies Appropriations Act, 2015. Draft, House Interior and Environment Appropriations Act, 2015. Draft, Senate Interior and Environment Appropriations Act, 2015. Draft, House Departments of Labor, Health and Human Services and Related Agencies Appropriations Act, 2015. Draft, Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. Draft, House National Defense Authorization Act, 2015. Draft, Senate National Defense Authorization Act, 2015. Monitor the passage of FY2014 omnibus appropriations legislation (P.L. 113-76). H.R. 2217, Department of Homeland Security Appropriations Act, 2014. Funding for national biodefense and agriculture funding. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013.

Client expense: $2,080,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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: $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