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Orphan Exclusivity: Rarely Used, But Well-Known, Loophole Would Be Closed By House Legislation

 
• By Derrick Gingery

US FDA could revoke orphan designation or exclusivity if cost recovery requirements were not satisfied under bill unanimously passed by the House Energy and Commerce Committee.

Washington DC Capitol dome detail with waving american flag
The adjustment to the orphan drug act was one of 30 bills passed by the House Energy and Commerce Committee 15 July. • Source: Shutterstock

A rare, but now well-known, loophole in the cost recovery pathway to orphan drug exclusivity would be closed under legislation unanimously passed by the House Energy and Commerce Committee.

The Fairness in Orphan Drug Exclusivity Act, sent to the full House of Representatives for consideration on 15 July, would allow the US Food and Drug Administration to revoke or refuse to give seven-year orphan drug exclusivity for larger products if

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