Opinion ID: 64717
Heading Depth: 3
Heading Rank: 2

Heading: Eighth Circuit's Garfinkel Opinion

Text: The Eighth Circuit first determined that whether § 355(i) provides sufficient guidance for the issuance of clinical investigator regulations that resulted in criminal penalties presented a (1) statutory issue related to whether § 355(i) authorized the FDA regulations at issue and a (2) constitutional issue related to the nondelegation doctrine. Garfinkel, 29 F.3d at 453-54. The Garfinkel court began its analysis of § 355(i) by interpreting the Ninth Circuit's decision in Smith, and determined that, while not explicitly mentioned, the Smith decision was premised on the Ninth Circuit's determination that § 355(i) violated the nondelegation doctrine. Id. at 454. The Eighth Circuit also noted that the Smith court's initial basis for dismissing the indictment was that § 355(i) lacked sufficient standards for [the] FDA to promulgate regulations imposing criminal penalties upon clinical investigators. Id. The Eighth Circuit then analyzed § 355(i) and held the language of the statute to be ambiguous as it related to the FDA's authority over clinical investigators. Id. at 456. The court engaged in a Chevron doctrine analysis to determine whether the FDA's interpretation of § 355(i) `reflect[ed] a plausible construction of the plain language of the statute and does not otherwise conflict with Congress'[s] expressed intent.' Id. (citation omitted). See also Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). [3] The Garfinkel court reviewed § 355(i)'s legislative history and held that § 355(i) authorized the promulgation of clinical investigator record-keeping regulations. Garfinkel, 29 F.3d at 457. The Eighth Circuit then analyzed § 355(i) under the constitutional issues presented by the nondelegation doctrine. Id. The court examined the language of § 355(i); the purpose of the Food, Drug, and Cosmetic Act, along with its factual background; and the statutory context of the Act's standards. Id. at 458. Ultimately, the court disagreed with what it characterized as the Ninth Circuit's determination that the statute violated the nondelegation doctrine, and held that the standards enunciated by the Act, along with judicial review and the procedural requirements dictated by the [Administrative Procedure Act], impose[d] sufficient restraints upon FDA to satisfy the constitutional concerns underlying the nondelegation doctrine. Id. at 459.