Opinion ID: 564944
Heading Depth: 1
Heading Rank: 3

Heading: amenability to judicial review

Text: 26 The district court, although it ruled, conditionally, that Doe's complaint lacked legal merit, held, initially, that Doe's claims were not amenable to judicial review. Only the electoral branches--Congress and the President--that court indicated, are competent authorities in matters of military discipline and strategy. With respect to Doe's challenge to the FDA's authority to promulgate Rule 23(d), the district judge noted: 27 Plaintiffs' claim against the Secretary of Health and Human Services regarding the FDA's interim rule arguably does not implicate military discipline and strategy. Whether the fact that the interim rule was adopted at the DOD's request in preparing for possible war insulates it from the ordinary scope of judicial review is not clear. However, Congress delegated rulemaking authority regarding unapproved drugs to the FDA, which is part of the executive branch. 21 U.S.C. Sec. 355(i). The FDA exercised that delegated authority in adopting Sec. 50.23(d). The Supreme Court has cast the principle of judicial deference to the electoral branches in military matters in broad terms. See, e.g., Chappell v. Wallace, 462 U.S. 296, 103 S.Ct. 2362 [76 L.Ed.2d 586] (1983); Gilligan v. Morgan, 413 U.S. 1, 93 S.Ct. 2440 [37 L.Ed.2d 407] (1973). On balance, therefore, the Court believes that [Rule 23(d) ] is not reviewable. 28 Doe v. Sullivan, 756 F.Supp. at 15 n. 2. We agree that deference is owed to the political branches in military matters, but do not agree that judicial review of the matter here at issue is out of order. 29 In contrast to the turbulent background of this litigation, Doe's facial challenge to Rule 23(d) is a straightforward one with a commonplace cast. Doe contends that, in promulgating Rule 23(d), the FDA stepped outside its statutory authority and adopted an exception to its informed consent regulations that is not in accordance with law. Doe therefore seeks a court order setting aside the FDA's action. See 5 U.S.C. Sec. 706(2)(A), (C) (court shall set aside agency action that is not in accordance with law or is in excess of statutory jurisdiction, authority, or limitations). We see no military action bar to the brand of review Doe now requests. 15 30 From the main rule that administrative acts are reviewable in court on the complaint of a person adversely affected within the meaning of a relevant statute (here, principally the informed consent provision in section 505(i) of the FDC Act), the Administrative Procedure Act (APA) excepts, inter alia, military authority exercised in the field in time of war or in occupied territory. 5 U.S.C. Sec. 701(b)(1)(G). The government emphasizes that exception. See Brief for Appellees at 16, 24, 29. We think the military authority exception is not on point. 31 Doe currently does not ask us to review military commands made in combat zones or in preparation for, or in the aftermath of, battle. His claim, as now advanced, entails no judicial interference with the relationship between soldiers and their military superiors. Cf. Chappell v. Wallace, 462 U.S. 296, 300, 103 S.Ct. 2362, 2365, 76 L.Ed.2d 586 (1983) (court will hesitate long before interfering in relationship between military personnel and their superior officers); Gilligan v. Morgan, 413 U.S. 1, 10, 93 S.Ct. 2440, 2445, 37 L.Ed.2d 407 (1973) (court is not well-positioned to interfere in composition, training, equipping, and control of military force). We confront at this time not a dispute over military strategy or discipline, not one between soldiers and their superiors, but one over the scope of the authority Congress has entrusted to the FDA. Homing in on the facial challenge to the FDA's regulation, Doe's counsel explained: 32 Plaintiffs seek review under the Administrative Procedure Act ... of a rule published in the Federal Register by the Secretary of HHS, who is not part of any military chain of command.... [W]hen he adopted the rule, [the Secretary] did not purport to be exercising the President's powers as Commander in Chief. Rather, he relied exclusively on his authority under the Food, Drug, and Cosmetic Act, ... a statute which cannot, by any stretch of the imagination, be construed as a source of authority for military discipline. 33 Reply Brief at 2-3. That explanation accurately portrays Doe's APA claim. 34 The FDA's Rule 23(d), we recognize, unquestionably involves a military matter: it allows the FDA to grant the Department of Defense a waiver of informed consent requirements in certain battlefield or combat-related situations. But the judgment Doe asks the court to make does not entail judicial review of the existence of a military exigency. Rather, Doe's facial attack asks simply whether the law that governs FDA action permits the measure which that non-military agency has taken. The question thus presented is meet for judicial review, 16 and we proceed to its resolution.