RACE for Children Act

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety

Client expense: $2,330,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)

Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition of essential health benefits and provider network adequacy Health information technology and electronic health records Telehealth provisions of draft medical innovation legislation Mental health services and violence prevention Lead contamination of drinking water H.R. 6/H.R. 34 - 21st Century Cures Act H.R. 30 - Save American Workers Act H.R. 248/S. 305 - American Job Protection Act H.R. 512 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 596 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 609/S. 287 - Safe Food Act H.R. 879 - Ax the Tax on Middle Class Americans' Health Plans Act H.R. 897 - Zika Vector Control Act H.R. 931 - Helping Effective Antibiotics Last (HEAL) Act H.R. 932/S. 497 - Healthy Families Act H.R. 933/S. 486 - Head Start on Vaccinations Act H.R. 1151 - USPSTF Transparency and Accountability Act of 2015 H.R 1189/S. 620 - Preserving Employee Wellness Programs Act H.R. 1209/S. 628 - Improving Access to Maternity Care Act H.R. 1372 - Home Visiting Extension Act H.R. 1462/S. 799 - Protecting Our Infants Act H.R 1517 - Stop Selling and Marketing to Our Kids E-Cigarettes (SMOKE) Act H.R. 1552 - Preservation of Antibiotics for Medical Treatment Act H.R. 1599 - Safe and Accurate Food Labeling Act H.R 1624 - Protecting Affordable Coverage for Employees (PACE) Act H.R. 2017/S. 2217 - Common Sense Nutrition Disclosure Act H.R. 2300/S. 2519 - Empowering Patients First Act of 2015 H.R. 2646 - Helping Families in Mental Health Crisis Act H.R. 2653 - American Health Care Reform Act H.R. 2690 - Including Families in Mental Health Recovery Act H.R. 2713 - Title VIII Nursing Workforce Reauthorization Act H.R. 2948 - Medicare Telehealth Parity Act H.R. 3081/S. 1778 - Telemedicine for Medicare (TELE-MED) Act H.R. 3299 - Strengthening Public Health Emergency Response Act of 2015 H.R. 3379 - Airplane Kits Act H.R. 3463 - Aligning Childrens Dental Coverage Act H.R. 3495 - Women's Public Health and Safety Act H.R. 3660 - Preventive Health Savings Act H.R. 3659 - Exchange Inclusion for a Healthy America Act H.R. 3762 - Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3865/S. 2542 - Cradle Act H.R. 4276 - Behavioral Health Coverage Transparency Act H.R. 4400/S. 2512 - Adding Zika Virus to the FDA Priority Review Voucher Program Act H.R. 4479 - Families of Flint Act H.R. 4723 - Protecting Taxpayers by Recovering Improper Obamacare Subsidy Overpayments Act H.R. 4724 - Reducing Duplicative and Ineffective Federal Funding Act H.R. 4771 - Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R. 5001/S. 2822 - Flexibility in Health IT Reporting (Flex-IT) Act H.R. 5003 - Improving Child Nutrition and Education Act of 2016 H.R. 5065/S. 3299 - Bottles and Breastfeeding Equipment Screening (BABES) Act H.R. 5284 - Worlds Greatest Healthcare Plan Act of 2016 H.R. 5456/S. 3065 - Family First Prevention Services Act S. 30 - Forty Hours Is Full Time Act S. 142/H.R. 1375/H.R. 3242 - Child Nicotine Poisoning Prevention Act S. 185 - Promise for Antibiotics and Therapeutics for Health (PATH) Act S. 203 - American Liberty Restoration Act S. 339 - ObamaCare Repeal Act S. 481 - Improving Regulatory Transparency for New Medical Therapies Act S. 522 - Protecting & Retaining Our Children's Health Insurance Program (PRO-CHIP) Act S. 612 - Water Infrastructure Improvements for the Nation Act S. 621 - Prevention of Antibiotic Resistance Act S. 673 - Winding Down Obamacare Act S. 674 - 21st Century Womens Health Act S. 764 - National Bioengineered Food Disclosure Standard S. 971 - Medicare Independence at Home Medical Practice Demonstration Improvement Act S. 993/H.R. 1854 - Comprehensive Justice and Mental Health Act S. 1014 - Personal Care Products Safety Act S. 1016 - Preserving Freedom and Choice in Health Care Act S. 1456 - Rural ACO Improvement Act S. 1549 - Care Planning Act S. 1793 - Promoting Physical Activity for Americans Act S. 1893 - Mental Health Awareness and Improvement Act S. 1945 - Mental Health Reform Act S. 2002/H.R. 3722 - Mental Health and Safe Communities Act S. 2045/H.R. 2050 - Middle Class Health Benefits Tax Repeal Act S. 2075 - American Worker Health Care Tax Relief Act S. 2100 - Tobacco to 21 Act S. 2153 - Provider Payment Sunshine Act S. 2173/H.R. 3712 - Improving Access to Mental Health Act S. 2218/H.R. 1218 - Personal Health Investment (PHIT) Act S. 2259 - ACO Assignment Improvement Act S. 2261 - Rural ACO Provider Equity Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act S. 2380 - Public Health Emergency Response and Accountability Act S. 2408/H.R. 4266 - Nurse and Health Care Worker Protection Act S. 2484 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act S. 2525/H.R. 4567 - Expand Excellence in Mental Health Act of 2016 S. 2609 - An original bill to amend the Agricultural Marketing Act of 1946 to require the Secretary of Agriculture to establish a national voluntary labeling standard for bioengineered foods S. 2680 - Mental Health Reform Act of 2016 S. 2687 - Plan of Safe Care Improvement Act S. 2821 - Testing, Removal, and Updated Evaluations of Lead Everywhere in America for Dramatic Enhancements that Restore Safety to Homes, Infrastructure, and Pipes (True LEADership) Act of 2016 S. 2848/H.R. 5303 - Water Resources Development Act of 2016 S. 2873/H.R. 5395 - Expanding Capacity for Health Outcomes (ECHO) Act S. 3136 - Improving Child Nutrition Integrity and Access Act of 2016 S. 3190 - Strengthening Our Rural Health Workforce Act of 2016 S. 3239 - Research to Accelerate Cures and Equity (RACE) for Children Act S. 3245 - Nursing Workforce Reauthorization Act of 2016 S. 3504 - Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act

H.R. 6, H.R. 34 & Public Law 114-255, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; H.R. 3381, Childhood Cancer STAR Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; Public Law 111-148, The Patient Protection and Affordable Care Act; Public Law 111-152, The Health Care and Education Reconciliation Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; S.3239, RACE for Children Act; Expanded Access (legislation not introduced) H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act; S. 2023, Prescription Drug Affordability Act of 2015; H.R. 6501, Prescription Drug and Medical Device Price Review Board Act of 2016; S.3455, Pharmaceutical Supply and Value Enhancement Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act (no legislation introduced);

Client expense: $1,040,000 · Firm income: Not reported

Prevention & Public Health Fund (PPHF) - support for funding/implementation of the ACA, including NECELC; support for S. 2713, the Advancing Precision Medicine Act of 2016; support for maintaining child nutrition reauthorization, specifically CACFP, school lunch and breakfast programs; support for S. 2680, the Mental Health Reform Act of 2016; support for Reducing Obesity in Youth Act S.3194; support for H.R. 4524, the Children's CARE Act; and discussions on S.298/HR 546 ACE Kids Act; S. 2821 True LEADership Act of 2016; S.689 Sports Medicine licensing; CHIPRA (no bill #); Race for Kids Act S.3239, H.R. 5858;Stabilize Medicaid and CHIP Coverage Act of 2015 (SMCA) - H.R.700/ S.428; P.L. 114-255 21st Century Cures Act (biomedical research and mental health provisions for children)

Client expense: $86,077 · Firm income: Not reported

H.R. 34 - The 21st Century Cures Act H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 3731 -RaD Fund Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act S. 1421 - OPEN Act H.R. 3742 - Access to Marketplace Insurance Act S. 1597 - Patient-Focused Impact Assessment Act of 2016 S. 1767 - Combination Product Regulatory Fairness Act of 2016 FDA Appropriations S. 2700 - FDA and NIH Workforce Authorities Modernization Act H.R. 4909 - Fiscal 2017 National Defense Authorization Act (NDAA) H.R. 3012 - Right to Try S. 2689 - REGROW Act H.R. 546/S. 298 - ACE Kids Act S. 3239 - RACE for Children Act Orphan Drug Tax Credit NIH Funding PDUFA MDUFA

Client expense: Not reported · Firm income: Not reported

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

H.R. 34, 21st Century Cures Act; Innovation for Healthier Americans (Senate HELP Committee); Drug safety and drug counterfeiting; Drug importation; Authorized generics; Drug company patent settlements; Prescription drug advertising; Federal preemption for prescription drugs; S. 2041 and H.R. 5182; The Promoting Life Saving New Therapies for Neonates Act of 2015; Implementation of Precision Medicine Initiative; Senate Finance Committee Chronic Care Initiative; White House Cancer Moonshot; H.R. 5858 and S. 3239, RACE for Children Act.

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

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

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

H.R. 6, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; H.R. 6174, Closing Loopholes for Orphan Drugs Act; S.3239, RACE for Children Act; Expanded Access (legislation not introduced); H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act;

Client expense: $1,920,000 · Firm income: Not reported

H.R. 6 - The 21st Century Cures Act H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 3731 -RaD Fund Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act S. 1421 - OPEN Act H.R. 3742 - Access to Marketplace Insurance Act S. 1597 - Patient-Focused Impact Assessment Act of 2016 S. 1767 - Combination Product Regulatory Fairness Act of 2016 FDA Appropriations S. 2700 - FDA and NIH Workforce Authorities Modernization Act H.R. 4909 - Fiscal 2017 National Defense Authorization Act (NDAA) Funding for Pediatric Device Consortia Grant Program H.R. 3012 - Right to Try S. 2689 - REGROW Act H.R. 546/S. 298 - ACE Kids Act S. 3239 - RACE for Children Act Orphan Drug Tax Credit Zika Funding CMS Medicare Part B Demonstration NIH Funding PDUFA

Client expense: Not reported · Firm income: Not reported

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

Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition of essential health benefits and provider network adequacy Health information technology and electronic health records Telehealth provisions of draft medical innovation legislation Mental health services and violence prevention Lead contamination of drinking water H.R. 6 - 21st Century Cures Act H.R. 30 - Save American Workers Act H.R. 248/S. 305 - American Job Protection Act H.R. 512 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 596 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 H.R. 609/S. 287 - Safe Food Act H.R. 879 - Ax the Tax on Middle Class Americans' Health Plans Act H.R. 897 - Zika Vector Control Act H.R. 931 - Helping Effective Antibiotics Last (HEAL) Act H.R. 932/S. 497 - Healthy Families Act H.R. 933/S. 486 - Head Start on Vaccinations Act H.R 1189/S. 620 - Preserving Employee Wellness Programs Act H.R. 1209/S. 628 - Improving Access to Maternity Care Act H.R. 1372 - Home Visiting Extension Act H.R. 1462/S. 799 - Protecting Our Infants Act H.R 1517 - Stop Selling and Marketing to Our Kids E-Cigarettes (SMOKE) Act H.R. 1552 - Preservation of Antibiotics for Medical Treatment Act H.R. 1599 - Safe and Accurate Food Labeling Act H.R 1624 - Protecting Affordable Coverage for Employees (PACE) Act H.R. 2017/S. 2217 - Common Sense Nutrition Disclosure Act H.R. 2300/S. 2519 - Empowering Patients First Act of 2015 H.R. 2646 - Helping Families in Mental Health Crisis Act H.R. 2653 - American Health Care Reform Act H.R. 2690 - Including Families in Mental Health Recovery Act H.R. 2713 - Title VIII Nursing Workforce Reauthorization Act H.R. 2948 - Medicare Telehealth Parity Act H.R. 3081/S. 1778 - Telemedicine for Medicare (TELE-MED) Act H.R. 3299 - Strengthening Public Health Emergency Response Act of 2015 H.R. 3379 - Airplane Kits Act H.R. 3463 - Aligning Childrens Dental Coverage Act H.R. 3495 - Women's Public Health and Safety Act H.R. 3660 - Preventive Health Savings Act H.R. 3659 - Exchange Inclusion for a Healthy America Act H.R. 3762 - Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3865/S. 2542 - Cradle Act H.R. 4276 - Behavioral Health Coverage Transparency Act H.R. 4400/S. 2512 - Adding Zika Virus to the FDA Priority Review Voucher Program Act H.R. 4479 - Families of Flint Act H.R. 4723 - Protecting Taxpayers by Recovering Improper Obamacare Subsidy Overpayments Act H.R. 4724 - Reducing Duplicative and Ineffective Federal Funding Act H.R. 4771 - Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R. 5001/S. 2822 - Flexibility in Health IT Reporting (Flex-IT) Act H.R. 5003 - Improving Child Nutrition and Education Act of 2016 H.R. 5284 - Worlds Greatest Healthcare Plan Act of 2016 H.R. 5456/S. 3065 - Family First Prevention Services Act S. 30 - Forty Hours Is Full Time Act S. 142/H.R. 1375/H.R. 3242 - Child Nicotine Poisoning Prevention Act S. 185 - Promise for Antibiotics and Therapeutics for Health (PATH) Act S. 203 - American Liberty Restoration Act S. 339 - ObamaCare Repeal Act S. 481 - Improving Regulatory Transparency for New Medical Therapies Act S. 522 - Protecting & Retaining Our Children's Health Insurance Program (PRO-CHIP) Act S. 621 - Prevention of Antibiotic Resistance Act S. 673 - Winding Down Obamacare Act S. 674 - 21st Century Womens Health Act S. 764 - National Bioengineered Food Disclosure Standard S. 971 - Medicare Independence at Home Medical Practice Demonstration Improvement Act S. 993/H.R. 1854 - Comprehensive Justice and Mental Health Act S. 1014 - Personal Care Products Safety Act S. 1016 - Preserving Freedom and Choice in Health Care Act S. 1456 - Rural ACO Improvement Act S. 1549 - Care Planning Act S. 1793 - Promoting Physical Activity for Americans Act S. 1893 - Mental Health Awareness and Improvement Act S. 1945 - Mental Health Reform Act S. 2002/H.R. 3722 - Mental Health and Safe Communities Act S. 2045/H.R. 2050 - Middle Class Health Benefits Tax Repeal Act S. 2075 - American Worker Health Care Tax Relief Act S. 2100 - Tobacco to 21 Act S. 2153 - Provider Payment Sunshine Act S. 2173/H.R. 3712 - Improving Access to Mental Health Act S. 2218/H.R. 1218 - Personal Health Investment (PHIT) Act S. 2259 - ACO Assignment Improvement Act S. 2261 - Rural ACO Provider Equity Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act S. 2380 - Public Health Emergency Response and Accountability Act S. 2408/H.R. 4266 - Nurse and Health Care Worker Protection Act S. 2484 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act S. 2525/H.R. 4567 - Expand Excellence in Mental Health Act of 2016 S. 2609 - An original bill to amend the Agricultural Marketing Act of 1946 to require the Secretary of Agriculture to establish a national voluntary labeling standard for bioengineered foods S. 2680 - Mental Health Reform Act of 2016 S. 2687 - Plan of Safe Care Improvement Act S. 2821 - Testing, Removal, and Updated Evaluations of Lead Everywhere in America for Dramatic Enhancements that Restore Safety to Homes, Infrastructure, and Pipes (True LEADership) Act of 2016 S. 2848/H.R. 5303 - Water Resources Development Act of 2016 S. 3190 - Strengthening Our Rural Health Workforce Act of 2016 S. 3239 - Research to Accelerate Cures and Equity (RACE) for Children Act S. 3245 - Nursing Workforce Reauthorization Act of 2016

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

Prevention & Public Health Fund (PPHF) - support for funding/implementation of the ACA, including NECELC; support for S. 2713, the Advancing Precision Medicine Act of 2016; support for maintaining child nutrition reauthorization, specifically CACFP, school lunch and breakfast programs; support for S. 2680, the Mental Health Reform Act of 2016; support for Reducing Obesity in Youth Act S.3194; support for H.R. 4524, the Children's CARE Act; and discussions on S.298/HR 546 ACE Kids Act; S. 2821 True LEADership Act of 2016; S.689 Sports Medicine licensing; CHIPRA (no bill #); Race for Kids Act S.3239, H.R. 5858;Stabilize Medicaid and CHIP Coverage Act of 2015 (SMCA) - H.R.700/ S.428;

Client expense: $15,024 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE

21st Century Cures legislation; Innovation for Healthier Americans (Senate HELP Committee); Drug safety and drug counterfeiting; Drug importation; Authorized generics; Drug company patent settlements; Prescription drug advertising; Federal preemption for prescription drugs; S. 2041 and H.R. 5182; The Promoting Life Saving New Therapies for Neonates Act of 2015; Implementation of Precision Medicine Initiative; Senate Finance Committee Chronic Care Initiative; White House Cancer Moonshot; H.R. 5858 and S. 3239, RACE for Children Act and H.R. 5182.

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

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

To adopt a national standard for hen layers; H.R. 3798, Egg Products Inspection Act Amendment of 2012; S. 3239, Egg Products Inspection Act Amendment of 2012; S. 3240, Agriculture Reform, Food and Jobs Act of 2012; H.R. 6083, Federal Agriculture Reform and Risk Management Act; H.R. 1731, the Egg Products Inspection Act. Amendment 166 to H.R. 1947.

Client expense: Not reported · Firm income: $10,000

Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE