Opinion ID: 425939
Heading Depth: 2
Heading Rank: 1

Heading: Judicial Review of Enforcement Discretion

Text: 29 Section 10 of the Administrative Procedure Act (APA), 5 U.S.C. Sec. 701(a) (1982), governs judicial review of agency action. Under Section 10, all final agency action is subject to judicial review unless such review is precluded by statute or committed to agency discretion by law. 5 U.S.C. Sec. 701(a)(1) & (2). 22 This section establishes a strong presumption of reviewability, and the exceptions of 5 U.S.C. Sec. 701(a)(1) & (2) should therefore be construed narrowly. See Dunlop v. Bachowski, 421 U.S. 560, 567 & n. 7, 95 S.Ct. 1851, 1858 & n. 7, 44 L.Ed.2d 377 (1975); Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 410, 91 S.Ct. 814, 820, 28 L.Ed.2d 136 (1971); Abbott Laboratories v. Gardner, 387 U.S. 136, 140-141, 87 S.Ct. 1507, 1510-1512, 18 L.Ed.2d 681 (1967); WWHT, Inc. v. FCC, 656 F.2d 807, 809, 815 (D.C.Cir.1981); Natural Resources Defense Council, Inc. v. SEC, 606 F.2d 1031, 1043 (D.C.Cir.1979). 23 30 Neither FDA nor the District Court claims that FDCA precludes judicial review. 24 Rather, both assert that FDCA gives FDA absolute discretion over decisions concerning investigation and enforcement, Letter from the Commissioner at 3, JA 88; Dist.Ct.Op. at 10, JA 224, and thus commits those decisions to agency discretion by law. 5 U.S.C. Sec. 701(a)(2). Though some courts have traditionally displayed reluctance to review exercises of enforcement discretion, the Supreme Court has consistently instructed us to construe narrowly the committed to agency discretion exception, and to find it applicable only in those rare instances where the governing statute is drawn in such broad terms that in a given case there is no law to apply. Citizens to Preserve Overton Park, Inc. v. Volpe, supra, 401 U.S. at 410, 91 S.Ct. at 821, quoting S.Rep. No. 752, 79th Cong., 1st Sess. 26 (1945). 25 This admonishment applies with no less force to review of agency enforcement discretion, including agency decisions to refrain from enforcement action. Dunlop v. Bachowski, supra, 421 U.S. 560, 95 S.Ct. 1851, 44 L.Ed.2d 377. 31 The Dunlop case deserves close scrutiny because it held, on facts precisely analogous to those of the present case, that an agency decision not to exercise enforcement discretion was reviewable. In Dunlop an unsuccessful candidate for a union office complained to the Secretary of Labor that the election was fraudulent, and thus invoked 29 U.S.C. Sec. 482, a provision of the Labor-Management Reporting and Disclosure Act that empowers the Secretary to investigate such complaints and to bring a civil action to set aside the election if warranted. 421 U.S. at 562-563, 95 S.Ct. at 1855-1856. The Secretary took no action in response to the complaint in Dunlop, and the unsuccessful union candidate sought review of that decision to refrain from exercising enforcement power. The Secretary argued that his action was unreviewable under Section 10 of the APA, and relied on both the precluded-by-statute and the committed-to-agency-discretion exceptions of Section 10 of the APA. 5 U.S.C. Sec. 701(a)(1) & (2). Finding neither exception applicable, 421 U.S. at 567 & n. 7, 95 S.Ct. at 1858 & n. 7, the Court held that this discretionary decision to refrain from exercising enforcement power was reviewable. 26 In the present controversy appellants seek nothing more than what the disappointed union official sought in Dunlop : judicial review of an agency decision not to exercise enforcement power. Dunlop thus precludes a facile resolution denying review in this case because an exercise of enforcement discretion is at issue. We must, under the test of Overton Park, decide whether there is law to apply to FDA's nonenforcement decision in this case. 32 The determination of whether there is law to apply turns on such pragmatic considerations as whether judicial supervision is necessary to safeguard plaintiffs' interests, whether judicial review will unnecessarily impede the agency in effectively carrying out its congressionally assigned role, and whether the issues are appropriate for judicial review. Natural Resources Defense Council, Inc. v. SEC, supra, 606 F.2d at 1043-1044. We conduct this inquiry to determine whether the considerations favoring nonreviewability are sufficiently compelling to rebut the strong presumption of judicial review. Id. In this case, however, we need not delve into a detailed analysis of nonreviewability because the agency has already conducted the inquiry for us. FDA, in an earlier policy statement, made law to govern and guide its discretion in regulating the unapproved use of approved drugs: 33 Where the unapproved use of an approved new drug becomes widespread or endangers the public health, the Food and Drug Administration is obligated to investigate it thoroughly and to take whatever action is warranted to protect the public.    When necessary the Food and Drug Administration will not hesitate to take whatever action    may be required to bring possible harmful use of an approved drug under control. 34    Thus, where a manufacturer or his representative, or any person in the chain of distribution, does anything that directly or indirectly suggests to the physician or the patient that an approved drug may properly be used for unapproved uses for which it is neither labeled nor advertised, that action constitutes a direct violation of the Act and is punishable accordingly. 35 Policy Statement, 37 Fed.Reg. at 16504. This policy statement which FDA still considers binding and to have substantive effect, see Memorandum in Support of Motion to Dismiss at 4-5 & nn. 10, 12, JA 131-132, comes within the APA's definition of a rule 27 as that term has been consistently interpreted in this circuit. The term rule is broad enough 'to include nearly every statement an agency may make   .'  Center for Auto Safety v. NHTSA, 710 F.2d 842, 846 (D.C.Cir.1983), quoting Batterton v. Marshall, 648 F.2d 694, 700 (D.C.Cir.1980). In Center for Auto Safety the court concluded that agency policy statements accompanying the withdrawal of a notice of proposed rulemaking fell within the definition of rule because they clearly interpret the relevant statute and indicate NHTSA's policy regarding the exercise of discretion granted to it by that legislative enactment. 710 F.2d at 846. The FDA policy statement quoted above also interprets the relevant statute and indicates FDA's policy regarding the exercise of its discretion. 28 The policy statement, along with the precise terms of the statute 29 and a growing body of case law, 30 thus provides this court with more than enough law to apply. 31 Where a court has law to apply agency action is not committed to agency discretion and is subject to judicial review under the APA. Citizens to Preserve Overton Park, Inc. v. Volpe, supra, 401 U.S. at 410, 91 S.Ct. at 820. 36 The District Court did not review the APA's provisions governing judicial review or discuss the case law establishing the strong presumption of reviewability. Rather, it relied on cases articulating the venerable proposition that courts should not unduly interfere with prosecutorial discretion. 32 But this proposition has never been blindly applied: [T]he decisions of this court have never allowed the phrase 'prosecutorial discretion' to be treated as a magical incantation which automatically provides a shield for arbitrariness. Medical Committee for Human Rights v. SEC, 432 F.2d 659, 673 (D.C.Cir.1970), vacated as moot, 404 U.S. 403, 92 S.Ct. 577, 30 L.Ed.2d 560 (1972). 33 Indeed, in the last twenty years federal courts have frequently forced agencies to implement and enforce their regulatory statutes, or at least to explain their failure to do so. 34 While the cases the District Court cited are distinguishable from the case at bar, 35 the real key lies in recognizing that the law has been in transition and that the case law    [is now] strongly on the side of reviewability. 2 K. DAVIS, ADMINISTRATIVE LAW TREATISE Sec. 9:6, at 239-240 (2d ed. 1979). 36 37 The District Court correctly noted that the absence of a statutory exemption for state-mandated activity does not logically compel or even suggest    that the Commissioner has no discretion to refrain from initiating requested investigative and/or enforcement proceedings   . Dist.Ct.Op. at 15, JA 229 (emphasis in original). But neither does it mean that the Commissioner has absolute discretion in enforcement decisions or that these decisions are insulated from judicial review. The presumption is in favor of judicial review, and nothing in this case is sufficiently compelling to rebut this presumption. We must conclude that FDA's inaction here is subject to judicial review. 37