Syncor International Corp. v. Shalala
By: LN on May 02, 2012 09:46:40 AM

Citation:  127 F.3d 90 (1997)

Summary:  Appellee, FDA came out with a publication in 1995 subjecting all the Pet drugs to be regulated under the Federal Food Drug and Cosmetic Act and also required the drug establishments to register. Appellant claimed that appellee violated the Administrative Procedure Act by not issuing Notice or receiving comments on the rule.

Facts:  In 1995 Appellee, FDA announced that Pet radiopharmaceutical have to be regulated under the drug provisions of the Federal Food, Drug and Cosmetic Act. In the publication issued by appellee it labeled as Notice and referred it alternatively as guidance and a policy statement. Appellee said that the 1995 publications were to supersede its previous publication in 1984. It also directed all drug establishments to register as drug establishment and laid down criteria for determining them. In 1984 guidelines it had stated that the nuclear pharmacists who had an accelerator for producing radioactive drugs to be dispensed with a prescription were not subjected to the act. Appellant claimed that appellee had violated the Administrative Procedure Act which required Notice to be issued and comments to be received.

Issue:  Whether the district court was correct in holding that appellee's rule was a non substantive rule which was not subjected to Notice and Comment?

Holding:  No, the district court was not correct in holding that appellee's rule was a non substantive rule which was not subjected to Notice and Comment.

Procedure:  Judgment of the district court was reversed by the Appellate Court.

Rule:  Enforcement discretion is relevant while determining whether an agency had an intention of binding itself and while determining whether a pronouncement was a legislative rule or a general statement of policy but it does not tell whether a rule is interpretive.

Rationale:  The 1995 publication was far from a policy statement as it was an interpretive rule; the agency itself by the publication drew the boundary to the agency's regulatory reach. The reasons appellee has given for the rule such as unique nature of Pet radiopharmaceuticals, advancement in PET technology, expansion of procedures in which PET is used are the sort of changes under which Notice and Comment are meant to inform to the public.


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Michael Mordechai YadegariReviewsout of 83 reviews