Law Commons^™

Catalyst Pharms., Inc. V. Becerra: When The Food And Drug Administration Repeatedly Ignores The Plain Language Of The Orphan Drug Act (Oda), Yifan Wang

Journal of Law and Health

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 …