Catalyst Pharmaceuticals, Inc. v. Becerra, No. 20-13922 (11th Cir. 2021)
Annotate this CaseThe Eleventh Circuit held that the statutory phrase "same disease or condition" contained in the Orphan Drug Act is not ambiguous. This case arose from Catalyst's lawsuit against the FDA alleging multiple violations of the Administrative Procedure Act related to its approval of Ruzurgi, which Catalyst claims violated the company's exclusivity of its own drug, Firdapse, to treat Lambert-Eaton Myasthenic Syndrome. Jacobus intervened shortly afterwards. The court concluded that the district court erred by finding this statutory phrase ambiguous and then deferring to the FDA's interpretation of it. Accordingly, the court reversed the district court's grant of summary judgment in favor of defendants and Jacobus and remanded with instructions to grant summary judgment in favor of Catalyst.
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