Yifan Wang


In Catalyst Pharms., Inc. v. Becerra, the court held that the scope of orphan drug exclusivity applies to the disease or conditions for which the drug is designated because the plain language of the 21 U.S.C. § 360cc(a) is clear. The decision is in contrast to the practice of the FDA to narrowly construe the exclusivity to apply only to the uses or indications for which the drug is approved. The court correctly reached its holding using a plain language approach and rejected the FDA’s argument based on legislative history and purpose. The FDA has repeatedly ignored courts interpretations of the orphan drug exclusivity provision, persisting on an interpretation that is an overreach of its statutory authority. The FDA does not have the institutional competence to address complex issues such as orphan drug pricing and affordability. The FDA should not depend on a fractured Congress to codify its overreaching interpretations. Instead, the FDA should implement regulations within its statutory authority and limit the scope of the orphan drug designation based on preliminary evidence.