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Reported covered position: Legal Fellow, Counsel, S. Committee on Judiciary
How to read the money
Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Advancing Hope Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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)
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2016 · second_quarter · Q2
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)
Source: Senate LDA
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)
Medicare Home Infusion Site of Care Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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. 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)
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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)
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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)
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Advancing Hope Act of 2016
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Advancing Hope Act of 2016
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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)
Promoting Life-Saving New Therapies for Neonates Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Medicare Home Infusion Site of Care Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Trickett Wendler Right to Try Act of 2016
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Advancing Hope Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Advancing Hope Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Advancing Hope Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Advancing Hope Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Access to Marketplace Insurance Act
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
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
Medicare Home Infusion Site of Care Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
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
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
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
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
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Combination Product Regulatory Fairness Act of 2016
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Combination Product Regulatory Fairness Act of 2016
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Advancing Hope Act of 2016
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Advancing Hope Act of 2016
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Promoting Life-Saving New Therapies for Neonates Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Promoting Life-Saving New Therapies for Neonates Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Medicare Home Infusion Site of Care Act of 2015
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Improving Regulatory Transparency for New Medical Therapies Act
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Improving Regulatory Transparency for New Medical Therapies Act
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
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, Advancing Hope Act of 2015; related to rare pediatric disease priority review vouchers
Newborn Screening Saves Lives Reauthorization Act of 2014
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Proposing an amendment to the Constitution of the United States to protect the rights of crime victims.
Client: SHIRE PHARMACEUTICALS LLC · Firm: SHIRE PHARMACEUTICALS LLC
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2016 · first_quarter · Q1
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
Filing targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, SENATE
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2015 · fourth_quarter · Q4
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2015 · third_quarter · Q3
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2015 · second_quarter · Q2
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2015 · first_quarter · Q1
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
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2014 · fourth_quarter · Q4
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2014 · first_quarter · 1A
orphan drug tax credt; issues surrounding ADHD, including economic and social impact; binge eating disorder; drug shortages;DEA processes; FDA funding and sequester; specialty tiers; track and trace; bundling rules for the Hospital Outpatient Prospective Payment System; compassionate use; step therapy; line extension rebates
Filing targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2014 · third_quarter · Q3
orphan drug tax credit; issues surrounding ADHD, including economic and social impact; binge eating disorder; drug shortages; DEA processes; FDA funding and sequester; specialty tiers; track and trace; bundling rules for the Hospital Outpatient Prospective Payment System; compassionate use; step therapy; line extension rebates; drug development; patent issues; CMS coding coverage; Medicare Part D rebates; tax reform; R&D tax credits; Priority Review Vouchers; FDASIA implementation
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2014 · second_quarter · Q2
orphan drug tax credit; issues surrounding ADHD, including economic and social impact; binge eating disorder; drug shortages;DEA processes; FDA funding and sequester; specialty tiers; track and trace; bundling rules for the Hospital Outpatient Prospective Payment System; compassionate use; step therapy; line extension rebates; drug development; patent issues; CMS coding coverage; Medicare Part D rebates; tax reform; R&D tax credits
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
SHIRE PHARMACEUTICALS LLC via SHIRE PHARMACEUTICALS LLC
2014 · first_quarter · Q1
orphan drug tax credt; issues surrounding ADHD, including economic and social impact; binge eating disorder; drug shortages;DEA processes; FDA funding and sequester; specialty tiers; track and trace; bundling rules for the Hospital Outpatient Prospective Payment System; compassionate use; step therapy; line extension rebates
Filing targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE