Sunday, October 27, 2013

John D. Copanos and Sons, Inc. v. Food and Drug Administration case brief

John D. Copanos and Sons, Inc. v. Food and Drug Administration case brief summary
854 F.2d 510 (1988)

CASE SYNOPSIS
Petitioner human and veterinary drug company, which both manufactured and distributed the drugs, sought review of an order of respondent United States Food and Drug Administration (FDA), which denied the drug company a hearing and summarily withdrew its approval of the drug company's applications for sterile injectable products.

CASE FACTS
The FDA withdrew the drug company's New Drug Applications and New Animal Drug Applications on the grounds that the methods, facilities, and controls used to produce the sterile injectable products were inadequate to assure their identity, strength, quality, and purity. The drug company sought a petition for review, claiming that it was denied an opportunity for hearing and due notice because the FDA failed to give it notice of the type of information that was required to have been submitted to justify a hearing.

DISCUSSION
  • On appeal, the court denied the petition for review. 
  • The court held that it was rejecting the drug company's claim that it had a right to any more specific notice than it received because the drug company had failed to identify any evidence, or type of evidence, that it might have presented but for lack of notice as to its relevance. 
  • The court further held that the FDA was entitled to withdraw the drug company's applications without holding a hearing because the record demonstrated that in several respects the methods, facilities, and controls were inadequate and were not made adequate within a reasonable time after receipt of written notice.
OUTCOME

The court denied the drug company's petition for review of the FDA's summary withdrawal of its approval of the drug company's applications for sterile injectable products.

Recommended Supplements for Administrative Law Examples & Explanations: Administrative Law, Fourth Edition
Administrative Law and Process: In a Nutshell (Nutshell Series)

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