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Orphan Exclusivity, Drug-Device Designation Court Rulings Against FDA Would Be Fixed In User Fee Bill

 
• By Brenda Sandburg

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.

US Capitol
FDA user fee legislation would fix court rulings against FDA • Source: Shutterstock

House legislation to renew the US Food and Drug Administration’s user fee programs would undo negative court rulings against the agency and reinstate its policies on orphan drug exclusivity and the designation of contrast agents as drugs.

The House user fee bill released by the Democratic and Republican leadership of the House Energy and Commerce Committee on 4 May includes provisions providing legislative fixes to cases that...

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