American Cures Act

FY 2017 Appropriations related to the National Institutes of Health, National Cancer Institute, and Food & Drug Administration, including Continuing Resolution S 318/HR 531 Accelerating Biomedical Research Act S 289/HR 2104 American Cures Act

Client expense: $65,519 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Presidents Budget, FY 2017 S. 3040/H.R. 5916 Labor, HHS, Education and Related Agencies Act, 2017, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), Hospital Preparedness Program, and biodefense and public health preparedness programs. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose rescissions from the Center for Medicare and Medicaid Innovation and Patient Centered Outcomes Research Trust Fund. Oppose additional continuing resolutions. President's Budget, FY 2017 Issues: Oppose proposed reductions in Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments; oppose use of Medicare GME funding for creation of new GME grant program. Oppose Independent Payment Advisory Panel (IPAB) and site-neutral payment policy. President's Budget, FY 2017 P.L. 114-223 Continuing Appropriations and Military Construction, Veterans Affairs, and Related Appropriations Act, 2017, and Zika Preparedness Act Issues: Support funding for Veterans Affairs medical research, research infrastructure, and community care. S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health (NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. S. 2624, National Biomedical Research Act. Issue: Support establishment of a Biomedical Innovation Fund to support the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Issue: Oppose Medicare payment reductions as offsets for non-Medicare spending. P.L. 114-74, H.R. 1314, Bipartisan Budget Act of 2015 Issue: Oppose Medicare site-neutral payment policy. Oppose extension of Medicare sequester Issue: Support mandatory funding for the National Health Service Corps (NHSC) authorized under P.L. 114-10, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) P.L. 114-223 Continuing Appropriations and Military Construction, Veterans Affairs, and Related Appropriations Act, 2017, and Zika Preparedness Act Issue: Support supplemental funding to prevent and combat Zika virus; Oppose use of other health funding to offset Zika investments

Client expense: $687,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

Issues related to the prevention and treatment of lung disease including the following legislation: H.R.6 21st Century Cures Act; H.R.531, Accelerating Biomedical Research Act; S.289, American Cures Act; S.318, Accelerating Biomedical Research Act; S 3040 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.5926 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.3520 Pulmonary Hypertension Research and Diagnosis Act of 2015; S.1177 Every Child Achieves Act of 2015;HR 4662 School-Based Asthma Management Program Act; S. 2624 National Biomedical Research Act; S. 2689 REGROW Act; HR 2028 Further Continuing and Security Assistance Appropriations Act, 2017; Issues related to research at the National Institutes of Health; Issues related to Moonshot Initiative; Issues related to the President's Budget; Issues related to the Budget Control Act;

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), Navy, Dept of, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Issues related to the prevention and treatment of lung disease including the following legislation: H.R.6 21st Century Cures; H.R.531, Accelerating Biomedical Research Act; S.289, American Cures Act; S.318, Accelerating Biomedical Research Act; HR 1190 Protecting Seniors Access to Medicare Act of 2015; S. 1177 Every Child Achieves Act; S.1065 School Asthma Management Plan Act; S. 1064 Family Asthma Act; HR 2101 Research for All Act of 2015; S 2956 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; HR 5054 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; S 3040 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.5926 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; S 3000 Department of Defense Appropriations Act, 2017; HR 5293 Department of Defense Appropriations Act, 2017; S. 3117 Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017; H.R.5912 Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017; S 2837 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017; HR 5393 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017; S. 3068, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2017; H.R.5538, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2017; H.R.5394 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2017; S. 2844 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2017 HR 3762 Restoring Americans Healthcare Freedom Reconciliation Act of 2015; HR 3520 Pulmonary Hypertension Research and Diagnosis Act; HR 4662, School-Based Asthma Management Program Act; HR 5263, Women and Lung Cancer Research and Preventive Services Act of 2016; S.2941 - Women and Lung Cancer Research and Preventive Services Act of 2016;; HR 4662 School-Based Asthma Management Program Act; H.R. 4768, the Separation of Powers Restoration Act of 2016; HR 5263 Women and Lung Cancer Research and Preventive Services Act of 2016; S. 2624 National Biomedical Research Act; S. 2689 REGROW Act; HR 2028 Further Continuing and Security Assistance Appropriations Act, 2017; Issues related to Medicare and Medicaid reform; Issues related to Moonshot Initiative; Issues related to the Affordable Care Act; Issues related to Asthma, COPD, Influenza, Lung Cancer, Pneumonia, Tuberculosis and other lung diseases; Issues related to the President's Budget; Issues related to the Budget Control Act;

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), Navy, Dept of, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Accelerating Biomedical Research Act(S.318/ H.R.531) American Cures Act (S.289/ H.R.2104) FY2017 Agriculture Appropriations (H.R.5054/S.2956) FY2017 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ, NIH,and Education(S.3040/H.R.5926) FY2017 Milcon-VA Appropriations-telestroke(S.2806/H.R.2577) FY2017 Transportation/HUD Approps (air ambulance amendment) House Energy and Commerce Committee Budget Reconciliation Instructions House/Senate Health Care Budget Reconciliation (H.R.3762) National Biomedical Research Act (S.2624) National Defense Authorization Act for FY 2017(S.2943) Research for All Act(H.R.2101) Senate Innovations Bill Continuing Resolution (H.R.2028)(P.L.114-254)

Client expense: $175,017 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act. S. 289, the American Cures Act. NIH funding. S. 524/H.R. 953, Comprehensive Addiction and Recovery Act (CARA). Labor HHS appropriations bills FY 2017. General opioid funding issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

No specific provisions lobbied - General Support of passage for S. 3084 - American Innovation and Competitiveness Act, S. 289 - The American Cures Act and H.R. 6 - The 21st Century Cure Act Education about Marathon Pharmaceuticals future products (if approved by FDA). Education about Marathon Pharmaceuticals initiatives, role in rare diseases, precision medicine and sale of legacy products.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 289, America Cures Act H.R. 6, .R. 34, P.L. 114-255, 21st Century Cures Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 34: 21st Century Cures Act and Senate Companion Legislation Legislation to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes (funding for NIH and FDA research). H.R. 1030: Secret Science Reform Act of 2015 A bill to prohibit the Environmental protection Agency from proposing, finalizing, or disseminating regulations or assessments based upon science that is not transparent or reproducible (ALL). H.R. 962 and S. 181: Startup Act 3.0 A bill to jump-start the economic recovery through the formation and growth of new businesses, and for other purposes (ALL). H.R. 1398 and S. 747: American Innovation Act A bill to prioritize funding for an expanded and sustained national investment in basic science research (ALL). H.R. 2104 and S. 289: American Cures Act A bill to prioritize funding for an expanded and sustained national investment in biomedical research (ALL). H.R. 1441 and S. 771: Manufacturing Universities Act of 2015 A bill to emphasize manufacturing in engineering programs by directing the National Institute of Standards and Technology, in coordination with other appropriate Federal agencies including the Department of Defense, Department of Energy, and National Science Foundation, to designate United States manufacturing universities (ALL). H.R. 1426: Public Access to Public Science Act A bill to ensure public access to published materials concerning scientific research and development activities funded by Federal science agencies (ALL). H.R. 1477 and S. 779: Fair Access to Science and Technology Research Act of 2015 A bill to provide for Federal agencies to develop public access policies relating to research conducted by employees of that agency of from funds administered by that agency (ALL). S. 2972: Grant Reform and New Transparency (GRANT) Act A bill to amend title 31, United States Code, to provide transparency and require certain standards in the award of Federal grants, and for other purposes (ALL). S. 2012: Energy Policy Modernization Act An original bill to provide for the modernization of the energy policy of the United States, and for other purposes (specifically authorization of the Department of Energy's Office of Science and ARPA-E). S. 3084: American Innovation and Competitiveness Act A bill to invest in innovation through research and development, and to improve the competitiveness of the United States. S. 3346: National Aeronautics and Space Administration Transition Authorization Act of 2016 A bill to reauthorize the National Aeronautics and Space Administration (Titles V and VI pertaining to NASA research). H.R. 1119: Research and Development Efficiency Act Legislation to improve the efficiency of federal research and development, and for other purposes (ALL). H.R. 5583: University Regulation Streamlining and Harmonization Act Legislation to streamline and harmonize federal research regulations on institutions of higher education, and for other purposes (ALL).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 289/H.R. 2104 American Cures Act, entire bill. S. 318/H.R. 531 Accelerating Biomedical Research Act, entire bill. H.R. 6, 21st Century Cures Act, Title I and II. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act, entire bill. S. 2713, Advancing Precision Medicine Act of 2016, entire bill. H.R. 34, 21st Century Cures Act.

Client expense: $147,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 289/H.R. 2104 American Cures Act, entire bill. S. 318/H.R. 531 Accelerating Biomedical Research Act, entire bill. H.R. 6, 21st Century Cures Act, Title I and II. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act, entire bill. S. 2713, Advancing Precision Medicine Act of 2016, entire bill. H.R. 34, 21st Century Cures Act.

Client expense: $168,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 289/H.R. 2104 American Cures Act, entire bill. S. 318/H.R. 531 Accelerating Biomedical Research Act, entire bill. H.R. 6, 21st Century Cures Act, Title I and II. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act, entire bill. S. 2713, Advancing Precision Medicine Act of 2016, entire bill. H.R. 34, 21st Century Cures Act.

Client expense: $168,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Labor - HHS Appropriations FY'17 - NIH Financial Aid, Department of Education, Commerce, Justice, Science Appropriations FY'17 - NSF Funds, NASA Funding S289 American Cures Act S318; HR531 Accelerating Biomedical Research Act American Innovation Act H.J. Res59 Bipartisan Budget Act of 2013 Budget Control Act of 2011 - Sequestration Provisions FY'17 Continuing Resolution Energy and Water Appropriations FY'17 - DOE Science Funding Defense Appropriations FY'17 - DOD Research Foreign Operations Appropriations - FY'17

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

Government targets: Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE

FY 2017 Appropriations related to the National Institutes of Health, National Cancer Institute, and Food & Drug Administration, including Continuing Resolution S 318/HR 531 Accelerating Biomedical Research Act S 289/HR 2104 American Cures Act

Client expense: $169,982 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act S. 1878, Advancing Hope Act of 2016

Client expense: $270,000 · Firm income: Not reported

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

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S.2055: Medical Countermeasure Innovation Act of 2015 S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Other: - Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program - Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) reauthorization - Biosimilar User Fee Act (BsUFA) reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Biomarker policy issues - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial size policy issues - House Republican Health Proposal (A Better Way) - OTC Monograph Reform - Expanded access policy issues - Patient assistance program policy issues

Client expense: $640,000 · 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), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.

Issues related to the prevention and treatment of lung disease including the following legislation: H.R.6 21st Century Cures Act; H.R.531, Accelerating Biomedical Research Act; S.289, American Cures Act; S.318, Accelerating Biomedical Research Act; S 3040 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.5926 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.3520 Pulmonary Hypertension Research and Diagnosis Act of 2015; S.1177 Every Child Achieves Act of 2015;HR 4662 School-Based Asthma Management Program Act; S. 2624 National Biomedical Research Act; S. 2689 REGROW Act; Issues related to research at the National Institutes of Health; Issues related to Moonshot Initiative; Issues related to the President's Budget; Issues related to the Budget Control Act;

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), Navy, Dept of, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Issues related to the prevention and treatment of lung disease including the following legislation: H.R.6 21st Century Cures; H.R.531, Accelerating Biomedical Research Act; S.289, American Cures Act; S.318, Accelerating Biomedical Research Act; HR 1190 Protecting Seniors Access to Medicare Act of 2015; S. 1177 Every Child Achieves Act; S.1065 School Asthma Management Plan Act; S. 1064 Family Asthma Act; HR 2101 Research for All Act of 2015; S 2956 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; HR 5054 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; S 3040 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.5926 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; S 3000 Department of Defense Appropriations Act, 2017; HR 5293 Department of Defense Appropriations Act, 2017; S. 3117 Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017; H.R.5912 Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017; S 2837 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017; HR 5393 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017; HR 2577 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017; HR 4974 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017; S 2806 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017; S. 3068, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2017; H.R.5538, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2017; H.R.5394 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2017; S. 2844 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2017 HR 3762 Restoring Americans Healthcare Freedom Reconciliation Act of 2015; HR 3520 Pulmonary Hypertension Research and Diagnosis Act; HR 4662, School-Based Asthma Management Program Act; HR 5263, Women and Lung Cancer Research and Preventive Services Act of 2016; S.2941 - Women and Lung Cancer Research and Preventive Services Act of 2016; H.R.5325 Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act; HR 4662 School-Based Asthma Management Program Act; H.R. 4768, the Separation of Powers Restoration Act of 2016; HR 5263 Women and Lung Cancer Research and Preventive Services Act of 2016; S. 2624 National Biomedical Research Act; S. 2689 REGROW Act Issues related to Medicare and Medicaid reform; Issues related to Moonshot Initiative; Issues related to the Affordable Care Act; Issues related to Asthma, COPD, Influenza, Lung Cancer, Pneumonia, Tuberculosis and other lung diseases; Issues related to the President's Budget; Issues related to the Budget Control Act;

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), Navy, Dept of, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

S.289/ H.R.2104 - American Cures Act H.R. 6 - 21st Century Cures Act S.2624 - National Biomedical Research Act S. 318/H.R. 531 - Accelerating Biomedical Research Act S. 747/H.R. 1398 - American Innovation Act General National Institutes of Health, National Science Foundation, and BRAIN Initiative FY17 budget and appropriation levels, including continuing resolution and omnibus appropriations.

Client expense: $52,899 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Management & Budget (OMB), 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; community-based public health interventions and prescription drug abuse. Specific Legislation: 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Implementation of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 7.Implementation of the Drug Quality and Security Act of 2013 (Public Law 113-54) 8.Implementation of Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 9.Implementation of Child Care and Development Block Grant Act of 2014 (Public Law 113-186) 10.Promoting Health as Youth Skills in Classrooms and Life Act (S. 418) 11.National Diabetes Clinical Care Commission Act (H.R. 1192/S. 586) 12.Energy Consumers Relief Act (S. 156) 13.FIT Kids Act (S. 1075/H.R. 2013) 14.Climate Change Health Protection and Promotion Act (H.R. 1275) 15.Treat and Reduce Obesity Act (S. 1509/H.R. 2404) 16.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (H.R. 3660) 17.Developing a Reliable and Innovation Vision for the Economy (DRIVE) Act (S. 1647) 18.Summer Meals Act of 2014 (S. 613/H.R. 1728) 19.Long-Term SCORE Act (H.R. 282/S. 2260) 20.American Cures Act (S. 289) 21.School Food Modernization Act (S. 540) 22.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 430/H.R. 478) 23.Bicycle and Pedestrian Infrastructure Improvement Act of 2015 (H.R. 199) 24.Waters of the United States Regulatory Overreach Protection Act of 2014 (H.R. 594) 25.Promise for Antibiotics and Therapeutics for Health Act (PATH Act, S. 185) 26.Helping Effective Antibiotics Last (HEAL) Act (H.R. 931) 27.Safe Food Act of 2015 (H.R. 609/S. 287) 28.21st Century Cures Act (H.R. 6) 29.Preservation of Antibiotics for Medical Treatment Act (H.R. 1552) 30.Preventing Antibiotic Resistance Act (S. 621) 31.Healthy Families Act (H.R. 932/S. 497) 32.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act (H.R. 512) 33.Antibiotic Development to Advance Patient Treatment Act (not yet introduced) 34.Recognizing the importance of vaccinations and immunizations in the United States (H.Res. 117) 35.Good Samaritan Health Professionals Act (H.R. 865/S. 3101) 36.Head Start on Vaccinations Act (H.R. 933/S. 486) 37.Opioid Overdose Reduction Act (S. 707/H.R. 1821) 38.Comprehensive Addiction and Recovery Act (S. 524/H.R. 953) 39.CHIP Extension and Improvement Act of 2015 (S. 522/H.R. 919) 40.Secret Science Reform Act of 2015 (S. 544/H.R. 1030) 41.EPA Science Advisory Board Reform Act of 2015 (S. 543/H.R. 1029) 42.Medicare Access and CHIP Reauthorization Act of 2015 (H.R. 2) 43.Student Success Act (H.R. 5) 44.Every Child Achieves Act (S. 1177) 45.Sugar-Sweetened Beverages Tax (SWEET) Act (H.R. 1687) 46.Transportation Alternatives Program Improvement Act (S. 705) 47.Jason Simcakoski Memorial Opioid Safety Act (S. 1641/H.R. 4063) 48.Recovery Enhancement for Treatment (TREAT) Act (S. 1455/H.R. 2536) 49.FDA Deeming Authority Clarification Act (H.R. 2058) 50.Pathogen Reduction and Testing Reform Act (H.R. 2303) 51.Medicare Diabetes Prevention Act (S. 1131/H.R. 2102) 52.Ratepayer Protection Act (H.R. 2042) 53.Affordable Reliable Electricity Now Act (S. 1324) 54.Protecting Seniors Access to Medicare Act (H.R. 1190/S. 141) 55.Family Asthma Act (S. 1064) 56.School Asthma Management Plan Act (S. 1065) 57.Healthy Relationships Act (H.R. 453/S. 923) 58.Healthy School Meals Flexibility Act (S. 1146/H.R. 2508) 59.Reducing Federal Mandates on School Lunch Act (H.R. 1504) 60.Safe Streets Act (H.R. 2071) 61.Healthy Kids Outdoors (S. 1078/H.R. 2014) 62.Highway and Transportation Funding Act (H.R. 2353) 63.Federal Water Quality Protection Act (S. 1140) 64.Friendly Airports for Mothers Act (H.R. 2530) 65.Overdose Prevention Act (S. 2092/H.R. 4288) 66.Stop Overdose Stat Act (H.R. 2850) 67.Stop Child Summer Hunger Act (S. 1539/H.R. 2715) 68.Promoting Physical Activity for Americans Act (S. 1793/H.R. 1499) 69.Defund Planned Parenthood Act of 2015 (H.R. 3134) 70.Continuing Appropriations Act, 2016 (H.R. 719) 71.Strengthening Public Health Emergency Response Act (H.R. 3299) 72.Consolidated Appropriations Act, 2016 (Public Law 114-113) 73.Restoring Americans Healthcare Freedom Reconciliation Act of 2015 (H.R. 3762/Senate Amendment) 74.A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Corps of Engineers and the Environmental Protection Agency relating to the definition of "waters of the United States" under the Federal Water Pollution Control Act (S.J. Res 22) 75.A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of a rule submitted by the Environmental Protection Agency relating to "Standards of Performance for Greenhouse Gas Emissions from New, Modified, and Reconstructed Stationary Sources: Electric Utility Generating Units" (S.J.Res. 23) 76.On the Joint Resolution: S.J.Res. 24; A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of a rule submitted by the Environmental Protection Agency relating to "Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units" (S.J.Res 24) 77.Common Sense Nutrition Disclosure Act (H.R. 2017/S. 2217) 78.Food Labeling Modernization Act (H.R. 4061/S. 2301) 79.Fixing Americas Surface Transportation Act (Public Law 114-93) 80.Every Student Succeeds Act (Public Law 114-95) 81.Puerto Rico Assistance Act, 2015 (S. 2381) 82.Full-Service Community Schools Act, 2015 (S. 1787) 83.FY2017 Commerce, Justice, State Appropriations Act (no bill number) 84.FY2017 Financial Services and General Government Appropriations Act (no bill number) 85.Energy Policy Modernization Act of 2015 (S. 2012) 86.Hallways to Health Act (S. 2590/H.R. 4621) 87.GET THE LEAD OUT Act of 2016 (S. 2588) 88.CLEAR Act (S. 2587) 89.TEST KIDS Act (S. 2586) 90.FUND Water Act (S. 2583) 91.NURSE Act (S. 2572) 92.A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Corps of Engineers and the Environmental Protection Agency relating to the definition of "waters of the United States" under the Federal Water Pollution Control Act. (S.J.Res.22) 93.The Ozone Standards Implementation Act of 2016 (H.R. 4775) 94.Ozone National Ambient Air Quality Standard Deadline Harmonization Act of 2015 (H.R. 4000) 95.To repeal the Prevention and Public Health Fund (H.R. 1085) 96.Common Sense Savings Act of 2016 (H.R. 4725) 97.Establishing the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (H.Con.Res. 125) 98.Improving Child Nutrition Integrity and Access Act of 2016 (S. 3136) 99.Promoting Biomedical Research and Public Health for Patients Act (S. 2742) 100.Preventing Superbugs and Protecting Patients Act (S. 2503) 101.The Medical Countermeasures Innovation Act (S. 2055) 102.FY2016 emergency supplemental appropriations request for Zika preparedness and response (no bill number) 103.FY2016 Labor, Health and Human Services, and Education Appropriations Act (S. 1695/H.R. 3020) 104.FY2016 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (S. 1800/H.R. 3049/S. 2129) 105.FY 2016 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (H.R. 2995/S. 1910/S. 2132) 106.FY2016 Congressional Budget Resolution (S.Con.Res. 11/H.Con.Res 27) 107.FY2016 Homeland Security Appropriations Act (S. 1619/H.R. 3128/S.2131) 108.FY2017 Military Construction-VA Appropriations and Zika Supplemental (H.R. 2577) 109.Public Health Emergency Preparedness Act (H.R. 4525) 110.PREPARE Act (H.R. 3583) 111.Zika Response Appropriations Act (H.R. 5243) 112.Making Supplemental Appropriations for fiscal year 2016 to respond to Zika virus (H.R. 5044) 113.A bill to provide emergency supplemental appropriations to address the Zika crisis (S. 2843) 114.FY 2017 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act (S. 3040) 115.FY 2017 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (S. 2956/H.R. 5054) 116.Health Equity and Accountability Act of 2016 (H.R. 5475) 117.SMASH Act (S. 3039) 118.Improving Child Nutrition and Education Act (H.R. 5003) 119.Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act (H.R. 5325) 120.Interior, Environment and Related Agencies Appropriations Bill, 2017 121.Ozone Standards Implementation Act (S. 2882) 122.National Defense Authorization Act for Fiscal Year 2017 (S. 2943) 123.Environmental Health Workforce Act of 2016 (H.R. 5543)

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

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), 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, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)

Client expense: $4,550,000 · 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), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Presidents Budget, FY 2017 S. 3040/H.R. 5916 Labor, HHS, Education and Related Agencies Act, 2017, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), Hospital Preparedness Program, and biodefense and public health preparedness programs. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose rescissions from the Center for Medicare and Medicaid Innovation and Patient Centered Outcomes Research Trust Fund. President's Budget, FY 2017 Issues: Oppose proposed reductions in Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments; oppose use of Medicare GME funding for creation of new GME grant program. Oppose Independent Payment Advisory Panel (IPAB) and site-neutral payment policy. President's Budget, FY 2017 P.L. 114-223 Continuing Appropriations and Military Construction, Veterans Affairs, and Related Appropriations Act, 2017, and Zika Preparedness Act Issues: Support funding for Veterans Affairs medical research, research infrastructure, and community care. S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health (NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. S. 2624, National Biomedical Research Act. Issue: Support establishment of a Biomedical Innovation Fund to support the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Issue: Oppose Medicare payment reductions as offsets for non-Medicare spending. P.L. 114-74, H.R. 1314, Bipartisan Budget Act of 2015 Issue: Oppose Medicare site-neutral payment policy. Oppose extension of Medicare sequester Issue: Support mandatory funding for the National Health Service Corps (NHSC) authorized under P.L. 114-10, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) P.L. 114-223 Continuing Appropriations and Military Construction, Veterans Affairs, and Related Appropriations Act, 2017, and Zika Preparedness Act Issue: Support supplemental funding to prevent and combat Zika virus; Oppose use of other health funding to offset Zika investments

Client expense: $595,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues

Client expense: $4,130,000 · 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), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Accelerating Biomedical Research Act(S.318/ H.R.531) American Cures Act (S.289/ H.R.2104) FY2016 Agriculture Appropriations (S.1800/ H.R.3049) FY2017 Agriculture Appropriations (H.R.5054/S.2956) FY2017 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ, NIH,and Education(S.3040/H.R.5926) FY2017 Milcon-VA Appropriations-telestroke(S.2806/H.R.2577) FY2017 Transportation/HUD Approps (air ambulance amendment) House Energy and Commerce Committee Budget Reconciliation Instructions House/Senate Health Care Budget Reconciliation (H.R.3762) National Biomedical Research Act (S.2624) National Defense Authorization Act for FY 2017(S.2943) Research for All Act(H.R.2101) Senate Innovations Bill

Client expense: $166,728 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act. S. 289, the American Cures Act. Ebola funding. NIH funding. S. 524/H.R. 953, Comprehensive Addiction and Recovery Act (CARA). Funding for Zika Prevention and Response conference report. Labor HHS appropriations bills FY 2017. General opioid funding issues.

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

No specific provisions lobbied - General Support of passage for S. 3084 - American Innovation and Competitiveness Act, S. 289 - The American Cures Act and H.R. 6 - The 21st Century Cure Act Education about Marathon Pharmaceuticals future products (if approved by FDA). Education about Marathon Pharmaceuticals initiatives, role in rare diseases, precision medicine and sale of legacy products.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6: 21st Century Cures Act and Senate Companion Legislation Legislation to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes (funding for NIH and FDA research). H.R. 1030: Secret Science Reform Act of 2015 A bill to prohibit the Environmental protection Agency from proposing, finalizing, or disseminating regulations or assessments based upon science that is not transparent or reproducible (ALL). H.R. 962 and S. 181: Startup Act 3.0 A bill to jump-start the economic recovery through the formation and growth of new businesses, and for other purposes (ALL). H.R. 1398 and S. 747: American Innovation Act A bill to prioritize funding for an expanded and sustained national investment in basic science research (ALL). H.R. 2104 and S. 289: American Cures Act A bill to prioritize funding for an expanded and sustained national investment in biomedical research (ALL). H.R. 1806: America COMPETES Reauthorization Act of 2015 A bill to provide for technological innovation through the prioritization of Federal investment in basic research, fundamental scientific discovery, and development to improve the competitiveness of the United States, and for other purposes (ALL). H.R. 1441 and S. 771: Manufacturing Universities Act of 2015 A bill to emphasize manufacturing in engineering programs by directing the National Institute of Standards and Technology, in coordination with other appropriate Federal agencies including the Department of Defense, Department of Energy, and National Science Foundation, to designate United States manufacturing universities (ALL). H.R. 1426: Public Access to Public Science Act A bill to ensure public access to published materials concerning scientific research and development activities funded by Federal science agencies (ALL). H.R. 1477 and S. 779: Fair Access to Science and Technology Research Act of 2015 A bill to provide for Federal agencies to develop public access policies relating to research conducted by employees of that agency of from funds administered by that agency (ALL). S. 2972: Grant Reform and New Transparency (GRANT) Act A bill to amend title 31, United States Code, to provide transparency and require certain standards in the award of Federal grants, and for other purposes (ALL). S. 2012: Energy Policy Modernization Act An original bill to provide for the modernization of the energy policy of the United States, and for other purposes (specifically authorization of the Department of Energy's Office of Science and ARPA-E). S. 3084: American Innovation and Competitiveness Act A bill to invest in innovation through research and development, and to improve the competitiveness of the United States. S. 3346: National Aeronautics and Space Administration Transition Authorization Act of 2016 A bill to reauthorize the National Aeronautics and Space Administration (Titles V and VI pertaining to NASA research).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 289, America Cures Act H.R. 6, 21st Century Cures Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Labor - HHS Appropriations FY'17 - NIH Financial Aid, Department of Education, Commerce, Justice, Science Appropriations FY'17 - NSF Funds, NASA Funding S289 American Cures Act S318; HR531 Accelerating Biomedical Research Act American Innovation Act H.J. Res59 Bipartisan Budget Act of 2013 Budget Control Act of 2011 - Sequestration Provisions FY'17 Continuing Resolution Energy and Water Appropriations FY'17 - DOE Science Funding Defense Appropriations FY'17 - DOD Research Foreign Operations Appropriations - FY'17

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

Government targets: Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE

S. 289/H.R. 2104 American Cures Act, entire bill. S. 318/H.R. 531 Accelerating Biomedical Research Act, entire bill. H.R. 6, 21st Century Cures Act, Title I and II. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act, entire bill. S. 2713, Advancing Precision Medicine Act of 2016, entire bill.

Client expense: $177,513 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 289/H.R. 2104 American Cures Act, entire bill. S. 318/H.R. 531 Accelerating Biomedical Research Act, entire bill. H.R. 6, 21st Century Cures Act, Title I and II. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act, entire bill. S. 2713, Advancing Precision Medicine Act of 2016, entire bill.

Client expense: $176,233 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act

Client expense: $280,000 · Firm income: Not reported

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

Lobbying Issues Description: 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; community-based public health interventions and prescription drug abuse. Specific Legislation: 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Implementation of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 7.Implementation of the Drug Quality and Security Act of 2013 (Public Law 113-54) 8.Implementation of Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 9.Implementation of Child Care and Development Block Grant Act of 2014 (Public Law 113-186) 10.Promoting Health as Youth Skills in Classrooms and Life Act (S. 418) 11.National Diabetes Clinical Care Commission Act (H.R. 1192/S. 586) 12.Energy Consumers Relief Act (S. 156) 13.FIT Kids Act (S. 1075/H.R. 2013) 14.Climate Change Health Protection and Promotion Act (H.R. 1275) 15.Treat and Reduce Obesity Act (S. 1509/H.R. 2404) 16.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (H.R. 3660) 17.Developing a Reliable and Innovation Vision for the Economy (DRIVE) Act (S. 1647) 18.Summer Meals Act of 2014 (S. 613/H.R. 1728) 19.Long-Term SCORE Act (H.R. 282/S. 2260) 20.American Cures Act (S. 289) 21.School Food Modernization Act (S. 540) 22.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 430/H.R. 478) 23.Bicycle and Pedestrian Infrastructure Improvement Act of 2015 (H.R. 199) 24.Waters of the United States Regulatory Overreach Protection Act of 2014 (H.R. 594) 25.Promise for Antibiotics and Therapeutics for Health Act (PATH Act, S. 185) 26.Helping Effective Antibiotics Last (HEAL) Act (H.R. 931) 27.Safe Food Act of 2015 (H.R. 609/S. 287) 28.21st Century Cures Act (H.R. 6) 29.Preservation of Antibiotics for Medical Treatment Act (H.R. 1552) 30.Preventing Antibiotic Resistance Act (S. 621) 31.Healthy Families Act (H.R. 932/S. 497) 32.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act (H.R. 512) 33.Antibiotic Development to Advance Patient Treatment Act (not yet introduced) 34.Recognizing the importance of vaccinations and immunizations in the United States (H.Res. 117) 35.Good Samaritan Health Professionals Act (H.R. 865/S. 3101) 36.Head Start on Vaccinations Act (H.R. 933/S. 486) 37.Opioid Overdose Reduction Act (S. 707/H.R. 1821) 38.Comprehensive Addiction and Recovery Act (S. 524/H.R. 953) 39.CHIP Extension and Improvement Act of 2015 (S. 522/H.R. 919) 40.Secret Science Reform Act of 2015 (S. 544/H.R. 1030) 41.EPA Science Advisory Board Reform Act of 2015 (S. 543/H.R. 1029) 42.Medicare Access and CHIP Reauthorization Act of 2015 (H.R. 2) 43.Student Success Act (H.R. 5) 44.Every Child Achieves Act (S. 1177) 45.Sugar-Sweetened Beverages Tax (SWEET) Act (H.R. 1687) 46.Transportation Alternatives Program Improvement Act (S. 705) 47.Jason Simcakoski Memorial Opioid Safety Act (S. 1641/H.R. 4063) 48.Recovery Enhancement for Treatment (TREAT) Act (S. 1455/H.R. 2536) 49.FDA Deeming Authority Clarification Act (H.R. 2058) 50.Pathogen Reduction and Testing Reform Act (H.R. 2303) 51.Medicare Diabetes Prevention Act (S. 1131/H.R. 2102) 52.Ratepayer Protection Act (H.R. 2042) 53.Affordable Reliable Electricity Now Act (S. 1324) 54.Protecting Seniors Access to Medicare Act (H.R. 1190/S. 141) 55.Family Asthma Act (S. 1064) 56.School Asthma Management Plan Act (S. 1065) 57.Healthy Relationships Act (H.R. 453/S. 923) 58.Healthy School Meals Flexibility Act (S. 1146/H.R. 2508) 59.Reducing Federal Mandates on School Lunch Act (H.R. 1504) 60.Safe Streets Act (H.R. 2071) 61.Healthy Kids Outdoors (S. 1078/H.R. 2014) 62.Highway and Transportation Funding Act (H.R. 2353) 63.Federal Water Quality Protection Act (S. 1140) 64.Friendly Airports for Mothers Act (H.R. 2530) 65.Overdose Prevention Act (S. 2092/H.R. 4288) 66.Stop Overdose Stat Act (H.R. 2850) 67.Stop Child Summer Hunger Act (S. 1539/H.R. 2715) 68.Promoting Physical Activity for Americans Act (S. 1793/H.R. 1499) 69.Defund Planned Parenthood Act of 2015 (H.R. 3134) 70.Continuing Appropriations Act, 2016 (H.R. 719) 71.Strengthening Public Health Emergency Response Act (H.R. 3299) 72.Consolidated Appropriations Act, 2016 (Public Law 114-113) 73.Restoring Americans Healthcare Freedom Reconciliation Act of 2015 (H.R. 3762/Senate Amendment) 74.A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Corps of Engineers and the Environmental Protection Agency relating to the definition of "waters of the United States" under the Federal Water Pollution Control Act (S.J. Res 22) 75.A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of a rule submitted by the Environmental Protection Agency relating to "Standards of Performance for Greenhouse Gas Emissions from New, Modified, and Reconstructed Stationary Sources: Electric Utility Generating Units" (S.J.Res. 23) 76.On the Joint Resolution: S.J.Res. 24; A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of a rule submitted by the Environmental Protection Agency relating to "Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units" (S.J.Res 24) 77.Common Sense Nutrition Disclosure Act (H.R. 2017/S. 2217) 78.Food Labeling Modernization Act (H.R. 4061/S. 2301) 79.Fixing Americas Surface Transportation Act (Public Law 114-93) 80.Every Student Succeeds Act (Public Law 114-95) 81.Puerto Rico Assistance Act, 2015 (S. 2381) 82.Full-Service Community Schools Act, 2015 (S. 1787) 83.FY2017 Commerce, Justice, State Appropriations Act (no bill number) 84.FY2017 Financial Services and General Government Appropriations Act (no bill number) 85.Energy Policy Modernization Act of 2015 (S. 2012) 86.Hallways to Health Act (S. 2590/H.R. 4621) 87.GET THE LEAD OUT Act of 2016 (S. 2588) 88.CLEAR Act (S. 2587) 89.TEST KIDS Act (S. 2586) 90.FUND Water Act (S. 2583) 91.NURSE Act (S. 2572) 92.A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Corps of Engineers and the Environmental Protection Agency relating to the definition of "waters of the United States" under the Federal Water Pollution Control Act. (S.J.Res.22) 93.The Ozone Standards Implementation Act of 2016 (H.R. 4775) 94.Ozone National Ambient Air Quality Standard Deadline Harmonization Act of 2015 (H.R. 4000) 95.To repeal the Prevention and Public Health Fund (H.R. 1085) 96.Common Sense Savings Act of 2016 (H.R. 4725) 97.Establishing the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (H.Con.Res. 125) 98.Improving Child Nutrition Integrity and Access Act of 2016 (S. 3136) 99.Promoting Biomedical Research and Public Health for Patients Act (S. 2742) 100.Preventing Superbugs and Protecting Patients Act (S. 2503) 101.The Medical Countermeasures Innovation Act (S. 2055) 102.FY2016 emergency supplemental appropriations request for Zika preparedness and response (no bill number) 103.FY2016 Labor, Health and Human Services, and Education Appropriations Act (S. 1695/H.R. 3020) 104.FY2016 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (S. 1800/H.R. 3049/S. 2129) 105.FY 2016 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (H.R. 2995/S. 1910/S. 2132) 106.FY2016 Congressional Budget Resolution (S.Con.Res. 11/H.Con.Res 27) 107.FY2016 Homeland Security Appropriations Act (S. 1619/H.R. 3128/S.2131) 108.FY2017 Military Construction-VA Appropriations and Zika Supplemental (H.R. 2577) 109.Public Health Emergency Preparedness Act (H.R. 4525) 110.PREPARE Act (H.R. 3583) 111.Zika Response Appropriations Act (H.R. 5243) 112.Making Supplemental Appropriations for fiscal year 2016 to respond to Zika virus (H.R. 5044) 113.A bill to provide emergency supplemental appropriations to address the Zika crisis (S. 2843) 114.FY 2017 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act (S. 3040) 115.FY 2017 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (S. 2956/H.R. 5054) 116.Health Equity and Accountability Act of 2016 (H.R. 5475) 117.SMASH Act (S. 3039) 118.Improving Child Nutrition and Education Act (H.R. 5003)

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

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), 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, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

Support H.R. 6, the 21st Century Cures Act to strengthen and improve the discovery, development and delivery of treatments and cures Advocate for NIH and FDA reforms in the Innovation for Healthier Americans initiative. Advocate for medical research, education and prevention funding at the National Institutes of Health, National Cancer Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality under the Labor, Health and Human Services, and Education Appropriations legislation (S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017) Advocate for maintain funding as well as application processes in the Department of Defense medical research programs. Support legislation to adjust discretionary spending caps for biomedical research (S. 318/H.R. 531, Accelerating Biomedical Research Act; S. 289, American Cures Act).

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

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

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 2055 - the Medical Countermeasure Innovation Act of 2015 S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Other: - Kids Innovative Drugs Act (draft) - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances - Drug Supply Chain Security Act policy issues - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial sizes policy issues - House Republican Health Proposal (A Better Way)

Client expense: $1,070,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), 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)

Accelerating Biomedical Research Act(S.318/ H.R.531) American Cures Act (S.289/ H.R.2104) FY2016 Agriculture Appropriations (S.1800/ H.R.3049) FY2017 Agriculture Appropriations (H.R.5054/S.2956) FY2017 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ, NIH,and Education(S.3040) FY2017 Milcon-VA Appropriations (telestroke) FY2017 Transportation/HUD Approps (air ambulance amendment) House Energy and Commerce Committee Budget Reconciliation Instructions House/Senate Health Care Budget Reconciliation (H.R.3762) National Biomedical Research Act (S.2624) National Defense Authorization Act for FY 2017(S.2943) Research for All Act(H.R.2101) Senate Innovations Bill

Client expense: $159,620 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Issues related to the prevention and treatment of lung disease including the following legislation: H.R.6 21st Century Cures; H.R.531, Accelerating Biomedical Research Act; S.289, American Cures Act; S.318, Accelerating Biomedical Research Act; HR 1190 Protecting Seniors Access to Medicare Act of 2015; S. 1177 Every Child Achieves Act; S.1065 School Asthma Management Plan Act; S. 1064 Family Asthma Act; HR 2101 Research for All Act of 2015; S 2956 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; HR 5054 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017; S 3040 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; Issues related to the House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; S 3000 Department of Defense Appropriations Act, 2017; HR 5293 Department of Defense Appropriations Act, 2017; S. 3117 Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017; Issues related to the House Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017; S 2837 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017; HR 5393 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017; HR 2577 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017; HR 4974 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017; S 2806 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017; S. 3068, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2017; H.R.5538, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2017; H.R.5394 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2017; S. 2844 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2017 HR 3762 Restoring Americans Healthcare Freedom Reconciliation Act of 2015; HR 3520 Pulmonary Hypertension Research and Diagnosis Act; HR 4662, School-Based Asthma Management Program Act; HR 5263, Women and Lung Cancer Research and Preventive Services Act of 2016; S.2941 - Women and Lung Cancer Research and Preventive Services Act of 2016; H. Res. 717 National Cancer Research Month; S. Res. 459, National Cancer Research Month; Issues related to Medicare and Medicaid reform; Issues related to Moonshot Initiative; Issues related to the Affordable Care Act; Issues related to Asthma, COPD, Influenza, Lung Cancer, Pneumonia, Tuberculosis and other lung diseases; Issues related to the President's Budget; Issues related to the Budget Control Act;

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), Navy, Dept of, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Issues related to the prevention and treatment of lung disease including the following legislation: H.R.6 21st Century Cures Act; H.R.531, Accelerating Biomedical Research Act; S.289, American Cures Act; S.318, Accelerating Biomedical Research Act; S 3040 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; Issues related to the House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017; H.R.3520 Pulmonary Hypertension Research and Diagnosis Act of 2015; S.1177 Every Child Achieves Act of 2015;Issues related to research at the National Institutes of Health; Issues related to the President's Budget; Issues related to the Budget Control Act;

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), Navy, Dept of, Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

S. 289/H.R. 2104 American Cures Act, entire bill. S. 318/H.R. 531 Accelerating Biomedical Research Act, entire bill. H.R. 6, 21st Century Cures Act, Title I and II. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act, entire bill. S. 2713, Advancing Precision Medicine Act of 2016, entire bill.

Client expense: $157,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1030: Secret Science Reform Act of 2015 A bill to prohibit the Environmental protection Agency from proposing, finalizing, or disseminating regulations or assessments based upon science that is not transparent or reproducible (ALL). H.R. 962 and S. 181: Startup Act 3.0 A bill to jump-start the economic recovery through the formation and growth of new businesses, and for other purposes (ALL). H.R. 1398 and S. 747: American Innovation Act A bill to prioritize funding for an expanded and sustained national investment in basic science research (ALL). H.R. 2104 and S. 289: American Cures Act A bill to prioritize funding for an expanded and sustained national investment in biomedical research (ALL). H.R. 1806: America COMPETES Reauthorization Act of 2015 A bill to provide for technological innovation through the prioritization of Federal investment in basic research, fundamental scientific discovery, and development to improve the competitiveness of the United States, and for other purposes (ALL). H.R. 1441 and S. 771: Manufacturing Universities Act of 2015 A bill to emphasize manufacturing in engineering programs by directing the National Institute of Standards and Technology, in coordination with other appropriate Federal agencies including the Department of Defense, Department of Energy, and National Science Foundation, to designate United States manufacturing universities (ALL). H.R. 1426: Public Access to Public Science Act A bill to ensure public access to published materials concerning scientific research and development activities funded by Federal science agencies (ALL). H.R. 1477 and S. 779: Fair Access to Science and Technology Research Act of 2015 A bill to provide for Federal agencies to develop public access policies relating to research conducted by employees of that agency of from funds administered by that agency (ALL). S. 2972: Grant Reform and New Transparency (GRANT) Act A bill to amend title 31, United States Code, to provide transparency and require certain standards in the award of Federal grants, and for other purposes (ALL). S. 2012: Energy Policy Modernization Act An original bill to provide for the modernization of the energy policy of the United States, and for other purposes (specifically authorization of the Department of Energy's Office of Science and ARPA-E). S. 3084: American Innovation and Competitiveness Act A bill to invest in innovation through research and development, and to improve the competitiveness of the United States.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY 2017 Appropriations related to the National Institutes of Health, National Cancer Institute, and Food & Drug Administration S 318/HR 531 Accelerating Biomedical Research Act S 289/HR 2104 American Cures Act

Client expense: $92,141 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Presidents Budget, FY 2017 S.3040/draft House Labor, HHS, Education and Related Agencies Act, 2017, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), Hospital Preparedness Program, and biodefense and public health preparedness programs. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose rescissions from the Center for Medicare and Medicaid Innovation and Patient Centered Outcomes Research Trust Fund. President's Budget, FY 2017 Issues: Oppose proposed reductions in Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments; oppose use of Medicare GME funding for creation of new GME grant program. Oppose Independent Payment Advisory Panel (IPAB) and site-neutral payment policy. President's Budget, FY 2017 H.R. 2577/H.R. 4974/S. 2806 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2017 Issues: Support funding for Veterans Affairs medical research, research infrastructure, and community care. S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health (NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. S. 2624, National Biomedical Research Act. Issue: Support establishment of a Biomedical Innovation Fund to support the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Issue: Oppose Medicare payment reductions as offsets for non-Medicare spending. P.L. 114-74, H.R. 1314, Bipartisan Budget Act of 2015 Issue: Oppose Medicare site-neutral payment policy. Oppose extension of Medicare sequester Issue: Support mandatory funding for the National Health Service Corps (NHSC) authorized under P.L. 114-10, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Issue: Support supplemental funding to prevent and combat Zika virus; Oppose use of other health funding to offset Zika investments

Client expense: $736,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

No specific provisions lobbied - General Support of passage for S. 3084 - American Innovation and Competitiveness Act, S. 289 - The American Cures Act and H.R. 6 - The 21st Century Cure Act Education about Marathon Pharmaceuticals future products (if approved by FDA). Education about Marathon Pharmaceuticals initiatives, role in rare diseases, precision medicine and sale of legacy products.

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act. S. 289, the American Cures Act. Ebola funding. NIH funding. S. 524/H.R. 953, Comprehensive Addiction and Recovery Act (CARA). Funding for Zika Prevention and Response conference report. Labor HHS appropriations bills FY 2017.

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), SENATE

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)

Client expense: $5,820,000 · 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), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)