Congressional Focus Signals Possible Changes for Orphan Drug Approval Process, Clinical Leader

In an article for Clinical Leader, partner Jacqueline Berman and associate Angela Silva report that while many provisions of the US Congress’ FY 2023 Consolidated Appropriations Act (Omnibus) have received attention, one provision has flown under the radar.

In its explanatory statement on the Omnibus, Congress indicated that it’s keeping an eye on how the US Food and Drug Administration (FDA) approves orphan drug products and, more specifically, on the composition of FDA advisory committees reviewing orphan drugs.