Sunday, May 12, 2013

Syncor International Corp. v. Shalala case brief

Syncor International Corp. v. Shalala case brief
127 F.3d 90, 326 U.S. App. D.C. 422 (D.C. Cir. 1997)

CASE SYNOPSIS: Appellant, a radiopharmaceutical manufacturer, challenged the decision of the United States District Court for the District of Columbia, which held that a 1995 notice of respondent Secretary's Food and Drug Administration (FDA), entitled "Regulation of Positron Emission Tomography Radiopharmaceutical Drug Products; Guidance; Public Workshop," was a non-substantive rule not subject to notice and comment rulemaking.

FACTS: The radiopharmaceutical manufacturer manufactured positron emission tomography (PET) drugs, drugs which determined the function or malfunction of various body organs and tissues by measuring the concentration of radioactivity in a targeted area of the body. The FDA announced that the PET drugs should be regulated under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 351 et seq. In the publication, labelled "Notice," the FDA indicated that it would require PET radiopharmaceutical manufacturers to comply with the adulteration provision, the misbranding provision, the new drug provision, and the registration and listing provisions of 21 U.S.C.S. §§ 501(a)(2)(B), 502, 505, and 510. The radiopharmaceutical manufacturer brought suit in the district court challenging the publication, arguing that the FDA lacked jurisdiction over PET drugs, violated U.S. Const. amend. X by regulating pharmacies in an area of state province, and violated the Administrative Procedure Act's (APA) requirement of public notice prior to rulemaking, under 5 U.S.C.S. § 553(b). The district court granted summary judgment for the FDA on all three claims, however, the court reversed on the APA issue alone.

CONCLUSION: The court found that the FDA's publication was not an interpretative rule. It did not purport to construe any language in a relevant statute or regulation. It did not interpret anything; instead, the rule used wording consistent only with the invocation of its general rulemaking authority to extend its regulatory reach. The court reversed the lower court and remanded the case.

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