EDWARD BUCKLEY

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)

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

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)

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)

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

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

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)

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)

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

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)

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)

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

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)

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)

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)

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

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)

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

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

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)

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)

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

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

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)

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)

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)

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

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

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, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers

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

Medicaid rare disease patient access to therapy; Medicaid line extension rebates; Expanded access - H.R. 909, the Andrea Sloan Compassionate Use Reform and Enhancement Act; Patent Reform - H.R. 9, Innovation Act; S. 632, STRONG Patents Act; Rare Pediatric Disease Priority Review Vouchers - H.R. 1537, Advancing Hope Act of 2015; DEA processes and re-exportation; FDA funding; Orphan Drug Tax Credit; Newborn Screening; Binge Eating Disorder awareness; ADHD awareness; Rare diseases awareness; FDA policies regarding wound care healing

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

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

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

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

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

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, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers

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

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

Medicaid rare disease patient access to therapy; Medicaid line extension rebates; Expanded access - H.R. 909, the Andrea Sloan Compassionate Use Reform and Enhancement Act; Patent Reform - H.R. 9, Innovation Act; S. 632, STRONG Patents Act; Rare Pediatric Disease Priority Review Vouchers - H.R. 1537, Advancing Hope Act of 2015; DEA processes and re-exportation; FDA funding; Orphan Drug Tax Credit; Newborn Screening; Binge Eating Disorder awareness; ADHD awareness; Rare diseases awareness; FDA policies regarding wound care healing

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

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, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers

Medicaid rare disease patient access to therapy; Medicaid line extension rebates; Expanded access - H.R. 909, the Andrea Sloan Compassionate Use Reform and Enhancement Act; Patent Reform - H.R. 9, Innovation Act; S. 632, STRONG Patents Act; Rare Pediatric Disease Priority Review Vouchers - H.R. 1537, Advancing Hope Act of 2015; DEA processes and re-exportation; FDA funding; Orphan Drug Tax Credit; Newborn Screening; Binge Eating Disorder awareness; ADHD awareness; Rare diseases awareness; FDA policies regarding wound care healing

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, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Medicaid rare disease patient access to therapy; Medicaid line extension rebates; Expanded access - H.R. 909, the Andrea Sloan Compassionate Use Reform and Enhancement Act; Patent Reform - H.R. 9, Innovation Act; S. 632, STRONG Patents Act; Rare Pediatric Disease Priority Review Vouchers - H.R. 1537, Advancing Hope Act of 2015; DEA processes and re-exportation; FDA funding; Orphan Drug Tax Credit; Newborn Screening; Binge Eating Disorder awareness; ADHD awareness; Rare diseases awareness; FDA policies regarding wound care healing

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

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, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers

issues surrounding ADHD, including economic and social impact; binge eating disorder; drug shortages; DEA processes; FDA funding and sequester; specialty tiers; track and trace; step therapy; drug development; patent issues; H.R. 5805, Andrea Sloan Compassionate Use Reform and Enhancement Act, relating to expanded access; H.R. 1281, Newborn Screening Saves Lives Reauthorization Act of 2014; Priority Review Vouchers; FDASIA implementation; ACA implementation; bundling rules for the Hospital Outpatient Prospective Payment System; CMS coding coverage; line extension rebates; Medicare Part D rebates; H.J. Res. 59, Continuing Appropriations Resolution, 2014 and possible drug industry issues; tax reform; orphan drug tax credit; R&D tax credits

issues surrounding ADHD, including economic and social impact; binge eating disorder; drug shortages; DEA processes; FDA funding and sequester; specialty tiers; track and trace; step therapy; drug development; patent issues; H.R. 5805, Andrea Sloan Compassionate Use Reform and Enhancement Act, relating to expanded access; H.R. 1281, Newborn Screening Saves Lives Reauthorization Act of 2014; Priority Review Vouchers; FDASIA implementation; ACA implementation; bundling rules for the Hospital Outpatient Prospective Payment System; CMS coding coverage; line extension rebates; Medicare Part D rebates; H.J. Res. 59, Continuing Appropriations Resolution, 2014 and possible drug industry issues; tax reform; orphan drug tax credit; R&D tax credits

issues surrounding ADHD, including economic and social impact; binge eating disorder; drug shortages; DEA processes; FDA funding and sequester; specialty tiers; track and trace; step therapy; drug development; patent issues; H.R. 5805, Andrea Sloan Compassionate Use Reform and Enhancement Act, relating to expanded access; H.R. 1281, Newborn Screening Saves Lives Reauthorization Act of 2014; Priority Review Vouchers; FDASIA implementation; ACA implementation; bundling rules for the Hospital Outpatient Prospective Payment System; CMS coding coverage; line extension rebates; Medicare Part D rebates; H.J. Res. 59, Continuing Appropriations Resolution, 2014 and possible drug industry issues; tax reform; orphan drug tax credit; R&D tax credits

Issues relating to R&D funding for rare disease products; drug shortages; DEA quotas for controlled substances; manufacturing, distribution and dispensing process for ADHD medication; extension of enantiomer exclusivity program; fast track and accelerated approvals; voucher program to incentivize development of products for rate pediatric cancer; end stage renal disease Prospective Payment System (ESRD PPS); drug importation; tax reform; prescription drug user fees; H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 3187, Food and Drug Administration Safety and Innovation Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access; priority vouchers; end stage renal disease Prospective Payment System (ESRD PPS); H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act; S. 3187, Food and Drug Administration Safety and Innovation Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

Health care reform implementation, generally; Food and Drug Administration Safety and Innovation Act (PL 112-144) implementation; sequestration; drug shortages; DEA quotas for controlled substances; ADHD medication; exclusivity periods; fast track and accelerated approvals; priority vouchers; end stage renal disease Prospective Payment System (ESRD PPS); drug importation; orphan drugs; drug compounding; drug innovation and patient access; H.R. 2672, Preserving Access to Orphan Drugs Act of 2011, annual fees on orphan drugs; S. 1423, Preserving Access to Orphan Drugs Act of 2011, annual fees on orphan drugs; H.R. 8, American Taxpayer Relief Act of 2012, orphan drug tax credit; S. 481, the Federal Response to Eliminate Eating Disorders Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access; priority vouchers; end stage renal disease Prospective Payment System (ESRD PPS); H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act; S. 3187, Food and Drug Administration Safety and Innovation Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access; priority vouchers; end stage renal disease Prospective Payment System (ESRD PPS); H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act; S. 3187, Food and Drug Administration Safety and Innovation Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

Issues relating to R&D funding for rare disease products; drug shortages; DEA quotas for controlled substances; manufacturing, distribution and dispensing process for ADHD medication; extension of enantiomer exclusivity program; fast track and accelerated approvals; voucher program to incentivize development of products for rate pediatric cancer; end stage renal disease Prospective Payment System (ESRD PPS); drug importation; tax reform; prescription drug user fees; H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 3187, Food and Drug Administration Safety and Innovation Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access; priority vouchers; end stage renal disease Prospective Payment System (ESRD PPS); H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act; S. 3187, Food and Drug Administration Safety and Innovation Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act

Issues relating to R&D funding for rare disease products, biosimilars and other products; drug shortages; Prescription Drug User Fee Act (PDUFA) reauthorization; exclusivity periods; orphan drugs; fast track and accelerated approvals; health care reform implementation; drug innovation and patient access; priority vouchers; end stage renal disease Prospective Payment System (ESRD PPS); H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); H.R. 4132, Faster Access to Specialized Treatments (FAST) Act; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 606, Creating Hope Act; S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act; S. 3187, Food and Drug Administration Safety and Innovation Act

Issues relating to R&D funding for rare disease products; drug shortages; DEA quotas for controlled substances; manufacturing, distribution and dispensing process for ADHD medication; extension of enantiomer exclusivity program; fast track and accelerated approvals; voucher program to incentivize development of products for rate pediatric cancer; end stage renal disease Prospective Payment System (ESRD PPS); drug importation; tax reform; prescription drug user fees; H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 3187, Food and Drug Administration Safety and Innovation Act

Health care reform implementation, generally; Food and Drug Administration Safety and Innovation Act (PL 112-144) implementation; sequestration; drug shortages; DEA quotas for controlled substances; ADHD medication; exclusivity periods; fast track and accelerated approvals; priority vouchers; end stage renal disease Prospective Payment System (ESRD PPS); drug importation; orphan drugs; drug compounding; drug innovation and patient access; H.R. 2672, Preserving Access to Orphan Drugs Act of 2011, annual fees on orphan drugs; S. 1423, Preserving Access to Orphan Drugs Act of 2011, annual fees on orphan drugs; H.R. 8, American Taxpayer Relief Act of 2012, orphan drug tax credit; S. 481, the Federal Response to Eliminate Eating Disorders Act

S. 296, Preserving Access to Life Saving Medicines Act; H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA); Life Sciences Investment Act Issues relating to R&D funding for rare disease products, biosimilars and other products; end stage renal disease (ESRD) orphan drugs; reimbursements; drug shortages; DEA quotas; prescription drug user fees; exclusivity periods