John D. Copanos and Sons, Inc. v. FDA

854 F.2d 510 (D.C Cir. 1988)


Copanos manufactures and distributes human and veterinary drugs – including sterile injectable products. The products were approved by the FDA. The FDA produced a notice in the Federal Register stating that the injectable products were to be withdrawn because the methods for producing the drugs were no longer sufficient to ensure their safety. The FDA published a hearing notice and requested a hearing, but before the hearing the agency denied the hearing and subsequently withdrew approval of their injectable products.
The FDA visited petitioner’s production factory on multiple occasions and issued warnings to no avail. Petitioners were then notified of the public hearing in which their right to produce would be revoked. The notice also said that if there were no genuine issues of material fact, there would be no hearing granted and summary judgment could be entered against petitioners. The FDA denied the hearing request and issued a motion for summary judgment, for which this court granted review.


Whether petitioners received adequate notice, “and that the agency did not error in proceeding by summary judgment to withdraw its approvals of Kanasco’s applications.”


The Federal Food Drug and Cosmetic Act provides that “after due notice and opportunity for hearing to the applicant” the FDA can withdraw its prior approval of a product.


Yes, decision upheld. Notice must contain enough information to provide a “genuine opportunity to identify material issues of fact.” Petitioner argues that the notice didn’t provide enough information about what was required to justify a hearing. However, the agency doesn’t need to provide the precise regulation that declares what evidence is needed to justify a hearing to proceed with summary action. “Due notice must depend upon the context of the agency’s action.” Here, the petitioners didn’t receive any sort of ambiguous information regarding what would justify a hearing. When the notice is read in tandem with the agency’s standard requirements, it is obvious that the petitioner should provide evidence related to compliance with the regulatory standard to thwart summary judgment. Moreover, petitioner failed to identify any evidence it would have presented had notice been adequate.

However, the agency in its notice failed “to organize the relevant facts in a way that would show how they met this statutory standard.” The court stops short of ruling that petitioners did not have notice and advises them to correctly organize future notice formatting.

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