Orphan Exclusivity Dilemma: Without Legislative Fix, US FDA May Seek New Regulation
FDA didn’t get policy rider it wanted which would have reversed the Catalyst court ruling that the agency cannot limit a drug’s orphan exclusivity to its approved indication. One attorney says the clearest path forward is for FDA to issue new rulemaking and face additional litigation.
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More sponsors are submitting applications around the same time requiring the agency to make complicated decisions about exclusivity and whether approval of subsequent applications is barred, FDA attorney says.
Jazz Disputes FDA’s Approval Of Lumryz Over Xywav’s Orphan Exclusivity, Citing Lack Of Comparative Study
Lawsuit argues FDA wrongly determined that Avadel’s Lumryz is ‘clinically superior’ to Xywav because of once-nightly dosing. FDA’s Division of Neurology revised its initial opinion based on views of CDHR’s sleep team and additional input from the agency’s orphan drug office.
A better description of the US FDA’s regulatory flexibility may be necessary, but tinkering with the foundational law for rare disease drug development could open the door for more substantial and unwanted changes.