John D. Copanos and Sons, Inc. v. Food and Drug Administration
United States Court of Appeals for the District of Columbia Circuit
854 F.2d 510 (1988)
John D. Copanos & Sons, Inc. and its affiliate Kanasco, Ltd. (collectively, Kanasco) (defendant) manufactured sterile injectable drugs under FDA-approved New Drug and New Animal Drug Applications, but repeated FDA inspections over three years found numerous violations of Current Good Manufacturing Practice regulations, which Kanasco failed to remedy despite promises to comply, violated agreements not to distribute noncompliant products, and covered up with falsified records. The FDA published a detailed Notice of Opportunity for a Hearing proposing to withdraw Kanasco's approvals, specifying that Kanasco needed to present facts showing a genuine, substantial factual dispute to obtain a hearing or risk summary judgment; Kanasco requested a hearing with supporting declarations, but the FDA denied the request and summarily withdrew its approvals, and Kanasco petitioned for review.
Whether the FDA provides an NDA applicant with due notice and opportunity to respond to withdrawal of approval when it publishes a notice specifying the information needed to warrant a hearing and detailing the facts underlying the proposed withdrawal.