Abbott Labs v. Gardner

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Abbott Labs


Gardner, Secretary of Health


FDA enacted a rule having to do with the printing of labels on prescription drugs. Plaintiff is challenging the regulation on grounds that it exceeded the Commissioner's authority under statute to pass the regulation.


  1. Did the FFDCA forbit pre-enforcement review of this sort of regulation?
  2. Is this controversy "rupe" for judicial resolution?


  1. The APA allows, in 5 USC 704, review of final agency action for which there is no other adequate remedy in a court. The court reiterates that "generous review provisions" must be given "hospitable interpretation." Further, the organic statute states that the remedies in the statute should not substitute other remedies, making it more evident that section 5 USC 701(a) does not kick in.
  2. The court says that for ripeness, "the basic rationale is to prevent the courts, through avoidance of premature adjudication, from entangling themselves into abstract disagreements over administrative policies, and also to protect the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties. The problem is best seen in a twofold aspect, requiring us to evaluate both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration." The court rules that this one is fit for judicial review as it is agreed by both parties that this question is a purely legal one and it is a final agency action as defined by section 10 of the APA. The court considers this decision final because the regulation was "promulgated in a formal manner after announcement in the Federal Register and consideration of comments by interested parties." Furthermore, compliance was expected and the regulation was made effective upon publication. The court also hold that there would be hardship to the parties if there was no court consideration, as companies have to destroy their inventories and make significant investments to comply with the new regulations.