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Orphan Drug Exclusivity: In Narrow Application Of Catalyst Ruling, FDA Retains Its Existing Regs

 
• By Brenda Sandburg

US FDA will continue to tie orphan exclusivity to uses or indications for which the drug was approved. Attorneys say this buys agency time to sort out complex policy and legal questions and continue to seek legislative fix. Additional litigation is also possible, as happened in Depomed case.

Challenge
FDA to go forward with its current orphan drug exclusivity policy but questions remain • Source: Shutterstock

The US Food and Drug Administration has decided not to adopt the Catalyst court ruling limiting the scope of orphan drug exclusivity and instead will continue to tie exclusivity to the uses or indications for which the drug was approved rather than to the entire disease. The move leaves questions about the agency's policy unresolved and will likely lead to further litigation.

The agency announced in a Federal Register notice scheduled for publication on 24 January that it would set aside its approval of Jacobus Pharmaceutical Co. Inc’s Ruzurgi (amifampridine)...

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