FDA Refuses to Apply Catalyst Decision to All Orphan Drugs

Orphan drugmakers’ special rights will apply to the specific uses of the drug approval, and not for every treatment for the same disease, the FDA clarified after a lawsuit threatened to upend the agency’s longstanding interpretation.

The Food and Drug Administration said Monday that it will only apply an Eleventh Circuit order to set aside approval of Jacobus Pharmaceutical Co.’s Ruzurgi to that drug, and not across the board to all rare disease drug approvals.

The FDA announcement that it will stand by its longstanding interpretation of the Orphan Drug Act will keep existing drugs on the market, but it ...