Administrative Law Keyed to Lawson
Syncor International Corp. v. Shalalaa
PET drugs are manufactured by physicians and pharmacists in nuclear pharmacies very close to the place of administration to patients due to the drugs’ short half-life. The 1984 FDA Guidelines specifically stated that PET radiopharmaceuticals were not subject to the Act. However, the 1995 “Notice” issued by the FDA provided that the PET radiopharmaceuticals “should be regulated” under the drug provisions of the Food, Drug, and Cosmetic Act (Act). The FDA indicated that its 1995 publication was to supersede its prior 1984 publication. The FDA characterized its 1995 publication as merely “guidance” (a general statement of policy), and an interpretive rule. The Petitioner claimed that the publication was a substantive regulation, and that the FDA violated the APA’s notice and comment requirements. The district judge granted summary judgment in FDA’s favor.
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