Opinion ID: 564944
Heading Depth: 2
Heading Rank: 1

Heading: The FDC Act

Text: 36 We review the FDA's interpretation of the FDC Act under the two-step formulation restated in Chevron U.S.A. v. Natural Resources Defense Council, 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). See, e.g., E.R. Squibb and Sons, Inc. v. Bowen, 870 F.2d 678, 680-81 (D.C.Cir.1989). First, if the intent of Congress is clear, then the court as well as the agency, must give effect to the unambiguously expressed intent of Congress. Chevron, 467 U.S. at 842-43, 104 S.Ct. at 2781-82. Our decisions call this initial step Chevron I  analysis. See Coal Employment Project v. Dole, 889 F.2d 1127, 1131 (D.C.Cir.1989). If, however, the governing legislation is silent or ambiguous with respect to the specific issue, the court generally need ask only whether the agency's interpretation is a permissible construction of the statute. Chevron, 467 U.S. at 843, 104 S.Ct. at 2782. Circuit precedent labels this Chevron II  analysis. See Coal Employment Project, 889 F.2d at 1131. 37 Doe urged in the district court, and maintains on appeal, that Congress spoke plainly in the FDC Act and that the FDA failed to give effect to the unambiguously expressed legislative intent; in other words, Doe contends that the FDA's Rule 23(d) must fail under Chevron I inspection. We now examine that contention. 38 Congress provided, in section 505(i) of the FDC Act, for the use of unapproved investigational drugs only on the informed consent of the human subjects affected, except where [the experts administering the drug] deem [the human subject's consent] not feasible. 21 U.S.C. Sec. 355(i). 17 The words not feasible in this context, Doe insists, focus on the human recipient of the drug: if that individual has the capacity intelligently to give or withhold consent, then the exception cannot apply; if, on the other hand, that individual is unable intelligently to convey a choice, only then is informed consent not feasible so that the decision may be made by the experts administering the drug. 39 Doe observes that, before the FDA adopted Rule 23(d), the agency itself apparently subscribed to Doe's view, i.e., Rule 23 formerly recognized consent as not feasible only where the human subject could not competently make or convey an informed choice. See 21 C.F.R. Sec. 50.23(a), (b), set out supra note 4. Doe additionally cites, as supportive of his position, remarks by legislators pointing to the not feasible language. See 108 Cong.Rec. 22,04 2-43 (remarks of Sen. Kefauver and Sen. Javits). 40 In common with the district court, we do not find the text of FDC Act section 505(i) free from ambiguity. The FDA currently reads not feasible to include impracticable, taking into account particularly urgent circumstances: a combat-zone setting, the safety of military personnel at that location, and the compelling need to promote success of the service members' mission. That reading, as the district court said, is well within the ordinary meaning of the words Congress used. See Doe v. Sullivan, 756 F.Supp. at 16. 41 We note, furthermore, that the statutory section in question emphasizes the professional judgment of the experts responsible for administering the unapproved investigational new drugs to human subjects; the legislative text permits exceptions where [those experts] deem [consent] not feasible. See 21 U.S.C. Sec. 355(i). Correspondingly, Rule 23(d) requires written justification for the conclusions of the drug investigators and physicians responsible for the medical care of the troops involved, as well as the approval of an institutional review board. 42 While it is true that the FDA's prior interpretation of the words not feasible focused on the subject's condition, the agency here has not reversed course. It has simply added a tightly circumscribed set of urgent circumstances in which the main rule of informed consent, with fidelity to the statute's terms, can be displaced. Cf. Rust v. Sullivan, --- U.S. ----, 111 S.Ct. 1759, 1769, 114 L.Ed.2d 233 (1991) (agency's revised interpretation of a statute, if supported by a reasoned analysis, is entitled to deference). As for the legislative history, the Senate floor statements Doe has called to our attention are scarcely helpful. They merely repeat the statutory language, and therefore do not advance our understanding of the legislators' intent. 43 The FDA's Rule 23(d), we thus conclude, reasonably construes a statute that leaves room for interpretation. We therefore defer to the agency's determination. 18