REGROW Act

H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing ____________________________________ Titles: S.2689 - 114th Congress (2015-2016) Short Titles: Short Titles - Senate Short Titles as Introduced: REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Official Titles: Official Titles - Senate Official Titles as Introduced: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies.

Client expense: $350,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

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

HR 4441 - Aviation Innovation, Reform, and Reauthorization Act of 2016 S 2658 - Federal Aviation Administration Reauthorization Act of 2016 S 3117 - State and Foreign Operations Appropriations Act HR 5055 - Energy and Water Development Appropriations Act S 2084 - Energy and Water Development Appropriations Act S 2943 - National Defense Authorization Act Hospital Payment Reform HR 4669 - Advancing Standards in Regenerative Medicine Act HR 4762 - REGROW Act S 2443 - Advancing Standards in Regenerative Medicine Act S 2511 - Improving Health Information Technology Act S 2689 - REGROW Act

Client expense: $1,210,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)

Hospital Payment Reform HR 4669 - Advancing Standards in Regenerative Medicine Act HR 4762 - REGROW Act S 1600 - Judicial Redress Act of 2015 S 2443 - Advancing Standards in Regenerative Medicine Act S 2511 - Improving Health Information Technology Act S 2689 - REGROW Act State and Foreign Operations Appropriations Veterans Affairs and Military Construction Appropriations

Client expense: $2,390,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)

Hospital Payment Reform HR 4669 - Advancing Standards in Regenerative Medicine Act HR 4762 - REGROW Act Medical Device Tax S 2443 - Advancing Standards in Regenerative Medicine Act S 2511 - Improving Health Information Technology Act S 2689 - REGROW Act Veterans Health Administration Procurement

Client expense: $1,430,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R. 6, the 21st Century Cures Act; S. 2689, the REGROW Act; implementation of the Affordable Care Act, implementation of the reauthorization of the CW Bill Young Cell Transplantation Program, the REGROW Act.

Client expense: Not reported · Firm income: $69,000

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

Signed letter to Senate members urging the passing of Senate Resolution 703 designation of November 2016 as National Bladder Health Month in the United States. Sent letter to members of House Energy and Commerce Subcommittee on Health and Senate HELP committee voicing opposition to delays by FDA on key patient safety guidance on biosimilars. Advocated on H.R.6/H.R. 34 - 21st Century Cures Act including: supporting S.849, Advancing Research for Neurological Diseases Act of 2015 that would create a centralized data collection system and the Centers for Disease Control and Prevention to track and collect data on the epidemiology of neurological diseases. Supports S. 800 / H.R. 1631, Enhancing the Stature and Visibility of Medical Rehabilitation. Research at the NIH Act. Discussed quality measures for the SCI/D community and those living with Parkinson's, spina bifida, multiple sclerosis. Supports S.3252 / H.R. 5779 Automatic Voter Registration Act of 2016. Discussed some concerns with S. 2689 - REGROW Act.

Client expense: Not reported · Firm income: $75,000

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Social Security Administration (SSA), Transportation, Dept of (DOT), White House Office

-H.R. 292/S. 849, support passage of the Advancing Research for Neurological Diseases Act. -H.R. 6, 21st Century Cures Act, support inclusion of H.R. 292/S. 849, support increased funding for the National Institutes of Health and support other provisions that speed the development of effective treatments for people with multiple sclerosis. -H.R. 34, 21st Century Cures Act, support inclusion of H.R. 292/S. 849, support increased funding for the National Institutes of Health and support other provisions that speed the development of effective treatments for people with multiple sclerosis. -H.R. 4762/S. 2689, REGROW Act, express concerns about patient safety and oppose inclusion of current version of bill in the Senate Innovations package. - H.R. 34, 21st Century Cures Act, oppose language that would weaken FDA safety/efficacy standards and support language that maintain FDA safety/efficacy standards and providing a clear pathway to market for cellular products.

Client expense: $105,020 · Firm income: Not reported

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

Issues related to S. 2689 Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act Issues related to S. 185 Promise for Antibiotics and Therapeutics for Health (PATH) Act Issues related to H.R. 6463 Patient Safety Toxicology Modernization Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Food and Drug Administration policy on chronic wound healing products H.R. 6 and H.R. 34 (21st Century Cures Act), all provisions, and Senate companion legislation generally S. 2689 (REGROW Act), all provisions

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues Related to the ACA & General Healthcare Reform Issues and Draft Proposals Related to Hospital Reimbursement and Payment Reforms S.2689 - REGROW Act H.R.921 - Sports Medicine Licensure Clarity Act of 2015

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

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

Issues Related to the 21st Century Cures Initiative Issues Related to FDA Reform S.2689 - REGROW Act

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues Related to the 21st Century Cures Initiative Issues Related to FDA Reform S.2689 - REGROW Act

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitored issues related to Pediatric Review Vouchers; S. 2689 the REGROW Act and H.R. 34, The 21st Century Cures Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocate for creation of national strategy for regenerative medicine; lobbied regarding regenerative medicine provisions in S.2689, The REGROW Act; S.2443 & H.R. 4669, Advancing Standards in Regenerative Medicine Act; Senate Innovation for Healthier Americans; H.R. 34, the 21st Century Cures Act; S.2837, Commerce, Justice, Science and Related Appropriations Act.

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

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

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. 292/S. 849, support passage of the Advancing Research for Neurological Diseases Act. -H.R. 6, 21st Century Cures Act, support inclusion of H.R. 292/S. 849, support increased funding for the National Institutes of Health and support other provisions that speed the development of effective treatments for people with multiple sclerosis. -H.R. 4762/S. 2689, express concerns about patient safety and oppose inclusion of current version of bill in the Senate Innovations package

Client expense: $90,717 · Firm income: Not reported

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

H.R. 6, the 21st Century Cures Act; S. 2689, the REGROW Act; implementation of the Affordable Care Act, implementation of the reauthorization of the CW Bill Young Cell Transplantation Program, the REGROW Act.

Client expense: Not reported · Firm income: $69,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), 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.

Interoperability and Regulation of Health IT, including the SOFTWARE Act (H.R. 2396), MEDTECH Act (S. 1101), Improving Heath Information Technology Act (S. 3511), and 21st Century Cures Act (H.R. 6). Food and Drug Administration: drug, medical device, and agency reforms including improving scientific capacity at FDA and use of public-private partnerships (FDA and NIH Workforce Authorities Modernization Act, S. 2700); use of real-world evidence and drug development tools such as biomarkers and patient-reported outcomes (21st Century Cures Act, H.R. 6); and the approval process for certain items such as antibiotics (e.g., PATH Act, S. 185), treatments for unmet needs (e.g., Dormant Therapies Act of 2014, S. 3004, 113th Congress), combination products (e.g., S. 1767), and regenerative medicine/cellular therapies (REGROW Act, S. 2689/H.R. 4762). Medicare, including chronic care coordination, prevention, and health care delivery and payment reform Long-term care financing and Medicaid Money Follows the Person Rebalancing Demonstration program reauthorization Beneficiaries dually eligible for Medicare and Medicaid

Client expense: $260,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Hospital Payment Reform HR 4669 - Advancing Standards in Regenerative Medicine Act HR 4762 - REGROW Act S 2443 - Advancing Standards in Regenerative Medicine Act S 2511 - Improving Health Information Technology Act S 2689 - REGROW Act S 3117 - State and Foreign Operations Appropriations Act

Client expense: $1,310,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), U.S. Trade Representative (USTR)

H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars Gene Therapy Drug Pricing ____________________________________ Titles: S.2689 - 114th Congress (2015-2016) Short Titles: Short Titles - Senate Short Titles as Introduced: REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Official Titles: Official Titles - Senate Official Titles as Introduced: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies.

Client expense: $570,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Issues Related to the 21st Century Cures Initiative Issues Related to FDA Reform S.2689 - REGROW Act

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues Related to the 21st Century Cures Initiative Issues Related to FDA Reform S.2689 - REGROW Act

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 9, Innovation Act (Goodlatte) - changes to inter partes review process H.R. 1600, Patients' Access to Treatments Act (McKinley-Capps) - specialty drug tiers H.R. 4599, Reducing Unused Medications Act (Clark) - partial fillings of prescriptions H.R. 4784, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug issues H.R. 5122, Medicare Part B Prescription Drug Demonstration (Bucshon) H.R. 5951, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - Medicare Part D pharmacy payments H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act (Schakowsky) - reporting requirements for prescription drug price increases S. 1137, PATENT Act (Grassley) - changes to inter partes review process S. 2019, Preserve Access to Affordable Generics Act (Klobuchar-Grassley) - pay-for-delay settlements S. 2023, Prescription Drug Affordability Act (Sanders) - pharmaceutical issues S. 2578, Reducing Unused Medications Act (Warren) - partial fillings of prescriptions S. 2615, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug issues S. 2689, REGROW Act (Kirk) - stem cell /regenerative medicines S. 3056, CREATES Act (Leahy) - challenging anti-competitive practices of brand name drug manufacturers S. 3308, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - Medicare Part D pharmacy payments S. 3335, Fair Accountability and Innovative Research Drug Pricing Act (Baldwin) - reporting requirements for prescription drug price increases Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,710,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

Issues Related to the ACA & General Healthcare Reform Issues and Draft Proposals Related to Hospital Reimbursement and Payment Reforms S.2689 - REGROW Act H.R.921 - Sports Medicine Licensure Clarity Act of 2015

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

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

Issues Related to the 21st Century Cures Initiative Issues Related to FDA Reform S.2689 - REGROW Act

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues Related to the 21st Century Cures Initiative Issues Related to FDA Reform S.2689 - REGROW Act

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues Related to the 21st Century Cures Initiative Issues Related to FDA Reform S.2689 - REGROW Act

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues Related to the 21st Century Cures Initiative Issues Related to FDA Reform S.2689 - REGROW Act

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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)

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)

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)

Monitored issues related to Pediatric Review Vouchers; 21cc & Innovation Initiative; and S. 2689 the REGROW Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Graduate medical education, NIH funding (continuing resolution/appropriations - H.R. 5325), Medicare/Recovery Audit Issues (S.2368), MACRA Implementation (HHS/CMS), Hospital Outpatient Payment System Updates (HHS/CMS), REGROW Act (S. 2689), Lab Developed Tests (draft legislation; Senate HELP Committee), Comprehensive Addiction and Recovery Act (S. 524), the FY2017 Labor, Health and Human Services, and Education and Related Agencies Appropriations Bills (S.3040/H.R. 5926)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), SENATE, Transportation, Dept of (DOT)

Issues related to S. 2689 Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act Issues related to S. 185 Promise for Antibiotics and Therapeutics for Health (PATH) Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Food and Drug Administration policy on chronic wound healing products H.R. 6 (21st Century Cures Act), all provisions, and Senate companion legislation generally S. 2689 (REGROW Act), all provisions S. 2700 (FDA and NIH Workforce Authorities Modernization Act), Section 16, regarding FDA guidances

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocate for creation of national strategy for regenerative medicine; lobbied regarding regenerative medicine provisions in FDA reform legislation; S. 2689, The REGROW Act; S.2443 & H.R. 4669, Advancing Standards in Regenerative Medicine Act; Senate Innovation for Healthier Americans.

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

Government targets: Food & Drug Administration (FDA), 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

Interoperability and Regulation of Health IT, including the SOFTWARE Act (H.R. 2396), MEDTECH Act (S. 1101), and 21st Century Cures Act (H.R. 6). Food and Drug Administration: drug, medical device, and agency reforms including improving scientific capacity at FDA and use of public-private partnerships (FDA and NIH Workforce Authorities Modernization Act, S. 2700); use of real-world evidence and drug development tools such as biomarkers and patient-reported outcomes (21st Century Cures Act, H.R. 6); and the approval process for certain items such as antibiotics (e.g., PATH Act, S. 185), treatments for unmet needs (e.g., Dormant Therapies Act of 2014, S. 3004, 113th Congress), combination products (e.g., S. 1767), and regenerative medicine/cellular therapies (REGROW Act, S. 2689/H.R. 4762). Medicare, including chronic care coordination, prevention, and health care delivery and payment reform Long-term care financing Beneficiaries dually eligible for Medicare and Medicaid

Client expense: $351,424 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars Gene Therapy Drug Pricing ____________________________________ Titles: S.2689 - 114th Congress (2015-2016) Short Titles: Short Titles - Senate Short Titles as Introduced: REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Official Titles: Official Titles - Senate Official Titles as Introduced: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies.

Client expense: $320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE