TRAVERE THERAPEUTICS

Legislation impacting products approved under the Accelerated Approval pathway, including the Accelerating Clinical Evidence demonstration project. Regulations regarding transparency, reimbursement and care, particularly regarding rare disease. Legislation regarding implementation of the Food and Drug Omnibus Reform Act of 2022.

Legislation regarding FDA and clinical research, particularly with respect to rare disease and orphan drug development and the accelerated approval pathway, and related legislation regarding FY 2024 Appropriations. FY 2025 appropriations for CDC newborn screening programs. HR 7384/S. 4583, Creating Hope Reauthorization Act to renew PRV program.

Legislation regarding drug pricing, value, and reimbursement including implementation of the Inflation Reduction Act of 2022. The Safe Step Act, H.R. 2630/S. 652. The HELP Copays Act, H.R. 830/S. 1375. H.R. 5339/S 3131, the Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act).

Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. HR 6790, the New Era of Preventing End-Stage Kidney Disease Act

Legislation regarding the Orphan Drug Tax Credit. H.R. 1350, Cameron's Law. H.R. 1805, Leo's Law.