Orphan Exclusivity: Rarely Used, But Well-Known, Loophole Would Be Closed By House Legislation
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.
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US FDA-related legislation among the bills moving during the lame duck session of Congress.
Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.
Restricting orphan drug approvals could save the US billions of dollars, study from University of California’s Center for Health Policy and Economics suggests.