Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 2615, Increasing Competition in Pharmaceuticals Act; Proposals/Initiatives related to international intellectual property protection;

Client expense: $2,610,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

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

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

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

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

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; S. 1878, Advancing Hope Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; H.R. 5573 & S. 3094, Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act; S. 3056, CREATES Act of 2016; Proposals/Initiatives related to international intellectual property protection;

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 971 & S. 1421) -- all provisions; 21st Century Cures Act (H.R. 6)]

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act and S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

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

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 2615, Increasing Competition in Pharmaceuticals Act; Proposals/Initiatives related to international intellectual property protection;

Client expense: $2,600,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 2615, Increasing Competition in Pharmaceuticals Act; Proposals/Initiatives related to international intellectual property protection;

Client expense: $26,000,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; H.R. 5573 & S. 3094, Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act; S. 3056, CREATES Act of 2016; Proposals/Initatives related to international intellectual property protection; H.R. 1806, America COMPETES Reauthorization Act of 2015;

Client expense: $1,700,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 971 & S. 1421) -- all provisions; 21st Century Cures Act (H.R. 6)]

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

ADHD awareness Binge Eating Disorder awareness Newborn Screening DEA processes and re-exportation FDA funding Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act Advancing Hope Act of 2015 (S. 1878, H.R. 1537); related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 Issues surrounding mergers & acquisitions, including taxes

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

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 2615, Increasing Competition in Pharmaceuticals Act; Proposals/Initiatives related to international intellectual property protection;

Client expense: $2,570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 2615, Increasing Competition in Pharmaceuticals Act; Proposals/Initiatives related to international intellectual property protection;

Client expense: $2,630,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 971 & S. 1421) -- all provisions; 21st Century Cures Act (H.R. 6)]

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 1890: Defend Trade Secrets Act of 2015 - Provisions related to improving trade secret protection S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues

Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Innovation for Healthier Americans Initiative, Prescription Drug Cost, H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act, S. 1421 Orphan Product Extensions Now Accelerating Cures and Treatments Act, H.R. 2841 FAST Generics Act, Dormant Therapies Act, H.R. 3513 Prescription Drug Affordability Act, S. 2023 Prescription Drug Affordability Act, The Bipartisan Budget Act of 2015, Importation

Client expense: $940,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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 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 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

ADHD awareness Binge Eating Disorder awareness Rare diseases awareness Newborn Screening DEA processes and re-exportation FDA funding FDA policies regarding wound care healing Medicare Chronic Care Reform Medicaid line extension rebates Medicaid rare disease patient access to therapy orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Anna Westin Act of 2015 (H.R. 2515, S. 1865) S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421) Combination Product Regulatory Fairness Act of 2015 (S. 1767) Promoting Life-Saving New Therapies for Neonates Act of 2015 (S. 2041) S. 275 and H.R. 605, Medicare Home Infusion Site of Care Act of 2015 H.R. 3742, Access to Marketplace Insurance Act Issues surrounding mergers & acquisitions, including taxes

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

HR 6: 21ST CENTURY CURES ACT; PROVISIONS RELATED TO RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER PROGRAM AND PRECISION MEDICINE HR 546: ADVANCING CARE FOR EXCEPTIONAL KIDS(ACE)ACT OF 2015; ALL PROVISIONS OF THE BILL HR 971: ORPHAN PRODUCT EXTENSIONS NOW ACCELERATING CURES AND TREATMENTS ACT OF 2015; PROVISIONS RELATED TO ORPHAN DRUG TAX CREDIT EXCLUSIVITY S 320: MEDICAL INNOVATION ACT OF 2015; PROVISIONS RELATED TO PLATFORM TECHNOLOGIES AND RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER PROGRAM S 1421: ORPHAN PRODUCT EXTENSIONS NOW ACCELERATING CURES AND TREATMENTS ACT OF 2015; PROVISIONS RELATED TO ORPHAN DRUG TAX CREDIT EXCLUSIVITY S 1878: ADVANCING HOPE ACT OF 2015; ALL PROVISIONS OF THE BILL S 2030: ADVANCING TARGETED THERAPIES FOR RARE DISEASES ACT OF 2015; ALL PROVISIONS OF THE BILL

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 1890: Defend Trade Secrets Act of 2015 - Provisions related to improving trade secret protection S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues

H.R. 3116, MODDERN Cures Act of 2013; S. 3004, Dormant Therapies Act of 2014; H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 1720, Patent Transparency and Improvements Act of 2013; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; Proposals/Initiatives related to international intellectual property protection;

Client expense: $1,180,000 · 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), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 971 & S. 1421) -- all provisions; 21st Century Cures Act (H.R. 6)]

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, H.R. 6 21st Century Cures Act, Innovation for Healthier Americans Initiative, Prescription Drug Pricing, H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act, S. 1421 Orphan Product Extensions Now Accelerating Cures and Treatments Act, H.R. 2841 FAST Generics Act, Dormant Therapies Act, H.R. 3513 Prescription Drug Affordability Act, S. 2023 Prescription Drug Affordability Act

Client expense: $870,000 · Firm income: Not reported

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

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B Issues and Legislative Reform Proposals Drug Shortage Issues 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 Initiative including H.R.6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative 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. Implementation of Orphan Drug Act and Orphan Drug Development S. 122, Safe and Affordable Drugs from Canada Act of 2015 S. 320, Medical Innovation Act H.R. 744, Medical Innovation 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 Biosimilars Exclusivity Period Biosimilars FDA Guidance FDA Oversight and Management Expanded Access Programs Patient Involvement with FDA Decision Making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to 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

H.R. 1101: Viral Hepatitis Testing Act. Increased appropriations for Viral Hepatitis Testing for CDC and VA. Implementation of Affordable Care Act as it relates to a regulatory pathway for biosimilars, including patent dispute resolution. H.R. 6: 21st Century Cures Act, including inclusion of H.R. 971: OPEN Act. Education about the value of innovative new medicines. Education about the 340(b) program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1101: Viral Hepatitis Testing Act. Increased appropriations for Viral Hepatitis Testing for CDC and VA. Implementation of Affordable Care Act as it relates to a regulatory pathway for biosimilars, including patent dispute resolution. H.R. 6: 21st Century Cures Act, including inclusion of H.R. 971: OPEN Act. Education about the value of innovative new medicines. Education about the 340(b) program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the development and delivery of rare disease medicines and other pharmaceuticals, including: ADHD awareness; Binge Eating Disorder awareness; Rare diseases awareness; Newborn Screening; DEA processes and re-exportation; FDA funding; FDA policies regarding wound care healing; Medicare Chronic Care Reform; Medicaid line extension rebates; Medicaid rare disease patient access to therapy; orphan drug tax credit; Orphan Drug Act regulations; H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations H.R. 9, Innovation Act, S. 632, STRONG Patents Act, related to patent reform; H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act, related to expanded access H.R. 1537, S. 1878, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers; H.R. 2515, S. 1865, Anna Westin Act of 2015; S. 481, Improving Regulatory Transparency for New Medical Therapies Act; provisions relating to DEA re-exports; H.R. 971, S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 1767, Combination Product Regulatory Fairness Act of 2015; S. 2041, Promoting Life-Saving New Therapies for Neonates Act of 2015

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

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues

H.R. 3116, MODDERN Cures Act of 2013; S. 3004, Dormant Therapies Act of 2014; H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; Proposals/Initiatives related to international intellectual property protection;

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

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

H.R. 3116, MODDERN Cures Act of 2013; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 1137, Protecting American Talent and Entrepreneurship Act of 2015; Proposals/Initiatives related to international intellectual property protection;

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

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

H.R. 3116, MODDERN Cures Act of 2013; H.R. 971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; Proposals/Initiatives related to international intellectual property protection; S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; S. 320, Medical Innovation Act of 2015;

Client expense: $1,870,000 · Firm income: Not reported

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

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues

Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 971 & S. 1421) -- all provisions; 21st Century Cures Act (H.R. 6)]

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B Issues and Legislative Reform Proposals Drug Shortage Issues 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 Initiative including H.R.6, 21st Century Cures 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. Implementation of Orphan Drug Act and Orphan Drug Development S. 122, Safe and Affordable Drugs from Canada Act of 2015 S. 320, Medical Innovation Act H.R. 744, Medical Innovation 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, Advancing Hope Act of 2015 Implementation of Newborn Screening Programs Biosimilars Exclusivity Period Biosimilars FDA Guidance FDA Oversight and Management Expanded Access Programs Patient Involvement with FDA Decision Making S. 289 and H.R. 2104, American Cures Act

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

HR 6: 21ST CENTURY CURES ACT; PROVISIONS RELATED TO PEDIATRIC RARE DISEASE PRIORITY REVIEW VOUCHER REVIEW/APPROVAL PROTOCOLS HR 971: ORPHAN PRODUCT EXTENSIONS NOW ACCELERATING CURES AND TREATMENTS ACT OF 2015; PROVISIONS RELATED TO ORPHAN DRUG TAX CREDIT EXCLUSIVITY S 1421: ORPHAN PRODUCT EXTENSIONS NOW ACCELERATING CURES AND TREATMENTS ACT OF 2015; PROVISIONS RELATED TO ORPHAN DRUG TAX CREDIT EXCLUSIVITY S 1597: PATIENT-FOCUSED IMPACT ASSESSMENT ACT OF 2015; PROVISIONS RELATED TO PATIENT-FOCUSED DRUG DEVELOPMENT TOOLS

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3116, MODDERN Cures Act of 2013; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 1137, Protecting American Talent and Entrepreneurship Act of 2015; Proposals/Initiatives related to international intellectual property protection;

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

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

Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, H.R. 6 21st Century Cures Act, Innovation for Healthier Americans Initiative, Prescription Drug Pricing, Abuse-Deterrent Prescription Drug Formulations,H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act, S. 1421 Orphan Product Extensions Now Accelerating Cures and Treatments Act,H.R. 2841 FAST Generics Act

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

H.R. 1101: Viral Hepatitis Testing Act. Increased appropriations for Viral Hepatitis Testing for CDC and VA. Implementation of Affordable Care Act as it relates to a regulatory pathway for biosimilars, including patent dispute resolution. H.R. 6: 21st Century Cures Act, including inclusion of H.R. 971: OPEN Act. Education about the value of innovative new medicines. Education about the 340(b) program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues

Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).

Client expense: Not reported · Firm income: Not reported

Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).

Client expense: Not reported · Firm income: Not reported

Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).

Client expense: Not reported · Firm income: Not reported

Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).

Client expense: Not reported · Firm income: Not reported

Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).

Client expense: Not reported · Firm income: Not reported