Syncor International Corp. v. Shalala
United States Court of Appeals for the District of Columbia Circuit
127 F.3d 90 (1997)
In a 1984 guideline, the FDA (defendant) stated that the Federal Food, Drugs, and Cosmetics Act (FFDCA) did not apply to positron emission tomography (PET) drugs; in 1995, the FDA issued a new notice reversing that position and stating PET drugs would now need to comply with the FFDCA, characterizing the notice as a nonsubstantive guidance or policy statement exempt from the APA's notice-and-comment requirements. Syncor International Corporation (plaintiff) sued, arguing the 1995 notice was actually a substantive rule requiring notice and comment before issuance; the district court found it was a nonsubstantive interpretive rule not requiring notice and comment, and Syncor appealed.
Whether the Administrative Procedure Act's notice and comment provisions apply to any federal agency rule that modifies or adds to an existing legal requirement.