US FDA Orphan Exclusivity Would Revert To Pre-Catalyst Status Under Senate Legislation
Federal court decision said the FDA cannot grant orphan exclusivity for subpopulations of a disease, which agency officials fear could damage pediatric rare disease drug development.
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The cost of rare diseases to patients and society at large is 10 times higher than for many of the biggest mass market diseases combined. With 95% of rare diseases lacking a treatment or cure, there is an economic imperative for policymakers to keep encouraging pharmaceutical companies to develop more orphan drug treatments. In Vivo looks at the US and EU regulatory impetus to keep rare diseases open for innovation.
Orphan Exclusivity, Drug-Device Designation Court Rulings Against FDA Would Be Fixed In User Fee Bill
Draft legislation would undo the Catalyst decision prohibiting FDA from providing separate orphan exclusivity periods for different subpopulations and alter the Genus ruling by requiring FDA to treat contrast agents, radioactive drugs and OTC monograph drugs as drugs.
Legislation in development also could create an option for tentative approval of interchangeable biosimilars.