Opinion ID: 425939
Heading Depth: 1
Heading Rank: 3

Heading: enforcement discretion

Text: 27 Of course, FDA determined that even if it had jurisdiction it would choose, in its inherent enforcement discretion, not to investigate or to take any regulatory action. Letter from the Commissioner at 3, JA 88. The District Court held both that FDA's decision to refrain from investigation and enforcement was unreviewable and that, in any event, the decision did not amount to a complete abdication of statutory responsibility. Dist.Ct.Op. at 10-15, JA 224-229. We find that the District Court misunderstood and misapplied its review authority. 28
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
38 When reviewing informal agency action of this type a court must conduct a searching and careful review of the whole record to determine if the agency has been arbitrary or capricious. See 5 U.S.C. Sec. 706(2)(A) (1976); FPC v. Transcontinental Gas Pipe Line Corp., 423 U.S. 326, 331, 96 S.Ct. 579, 582, 46 L.Ed.2d 533 (1976) (per curiam ); Citizens to Preserve Overton Park, Inc. v. Volpe, supra, 401 U.S. at 416, 91 S.Ct. at 823. The court must, therefore, make a searching and careful review of both the administrative record, particularly the uncontroverted evidence submitted by appellant, and the agency's stated reasons for its action. If upon examination the agency record does not satisfy the appropriate standard of judicial review, its action must be vacated. If FDA's inaction in this case was arbitrary, capricious, and without authority of law, 38 and our own analysis of the record leads us to believe it was, 39 we must remand this case for appropriate action. 39 First, the Commissioner stated that the scope of his legal authority to regulate lethal injections in state capital punishment systems is highly uncertain. Brief for appellee at 14. But this argument simply repeats his meritless contention that FDA did not have jurisdiction in the first place. 40 Moreover, it directly contradicts FDA's own policy statement, issued in 1972 and still in effect, which declares that FDA will investigate and take all necessary action to prevent the unapproved use of approved drugs. Policy Statement, 37 Fed.Reg. at 16504. The policy statement makes no exception for state-mandated activity, and the Commissioner must provide an acceptable explanation of why his refusal to act in this case is not in contravention of that 1972 statement. 41 So far he has not. A good faith uncertainty about legal authority may be sound reason to decline to bring enforcement proceedings, see brief for appellee at 15, but willful indifference is not. We do not understand how the Commissioner can assert legal authority to regulate drugs used in both state-licensed clinical investigations and state-licensed veterinary practices and not assert, with equal confidence, authority to regulate drugs used in state-licensed capital punishment practices. 42 It is simply irrational--and thus arbitrary and capricious--to believe that the agency has jurisdiction over the unapproved use of drugs in the former two practices but not in the latter practice. 40 Second, the Commissioner asserts that the use of drugs in lethal injections does not pose a serious danger to the public health. Brief for appellee at 15. But he cites no evidence to support this proposition. Rather, he irrebuttably presumes that duly authorized statutory enactments    [which further] proper State functions cannot, as a matter of law, pose such a danger to the public. Letter from the Commissioner at 3, JA 88. This claim is remarkable in light of the uncontroverted evidence appellants submitted to FDA, which shows that drugs used in lethal injections pose a substantial threat of torturous pain to persons being executed. ROYAL COMMISSION ON CAPITAL PUNISHMENT, 1949-1953 REPORT (1953), Exhibit 1 to Letter to the Secretary, JA 34-40. Furthermore, this claim flies in the face of the Commissioner's admission that FDA has jurisdiction over all state laws that purport[ ] to legitimize the lawful shipment of an unapproved new drug in interstate commerce or that purport[ ] to permit its misbranding after shipment   . Brief for appellee at 20 n. 21. If some state laws can pose a serious danger to the public health, no state law can be presumed, in the face of substantial evidence to the contrary, not to do so. Rather, FDA can rationally distinguish between laws that do endanger the public health and laws that do not only upon the basis of available evidence. In this case all the evidence shows that lethal injection laws do endanger users of drugs, and thus the public health. 43 Finally, this claim rationally cannot stand next to FDA's earlier assertions that prisoners in clinical investigations and dogs in veterinary clinics were in serious danger from the unapproved use of approved drugs. If drugs used in these contexts pose a serious threat to the public health, then certainly drugs used to kill human beings pose such a threat. 44 In short, the Commissioner presents no rational basis for concluding that lethal injections do not pose a serious health threat. Thus we must conclude that he has acted arbitrarily, capriciously, and without authority of law. 45 III. CONCLUSION 41 Judge Tamm, writing for this court over a decade ago, once noted that assertions of discretion inevitably raise questions of degree which must be appraised in the context of the relevant provisions of law and the nature of the particular action sought to be reviewed: '[T]he question is not whether agency action is by law committed to agency discretion but to what extent agency action is so committed.'  Medical Committee for Human Rights v. SEC, supra, 432 F.2d at 673 (quoting 4 K. DAVIS, ADMINISTRATIVE LAW TREATISE 33 (1958) (emphasis by Judge Tamm). Agency enforcement decisions are inevitably based, in large measure, on factors not particularly suitable to judicial resolution, and thus courts give these decisions a great degree of deference. But courts are also responsible for ensuring that government officials do not negate or frustrate congressional enactments through bureaucratic arbitrariness. Courts must assure the public that the vast powers agencies exercise are subject to decent and civilized restraints. 46 In this case, despite expert testimony concerning the dangerousness of using barbiturates and paralytics to execute human beings, the Commissioner of FDA refused to take any investigatory or regulatory action. He provided a glib statement of reasons for the agency's inaction that cannot withstand judicial review. Hence, we must vacate the District Court's judgment in this case with instructions to order the agency to fulfill its statutory function. Both this court and the District Court must be mindful that endless litigation, particularly in this case, concerning the sufficiency of the agency's reasons would be inconsistent with the statute's goal of expeditiously protecting consumers from the alleged hazards. We must be prepared to compel FDA to take action with respect to the prayer for relief where an acceptable explanation of its inaction is not promptly forthcoming. 47 42 Appellants have presented substantial and uncontroverted evidence to support their claim that execution by lethal injection poses a serious risk of cruel, protracted death. See ROYAL COMMISSION ON CAPITAL PUNISHMENT, 1949-1953 REPORT (1953), Exhibit 1 to Letter to the Secretary, supra, JA 34-40. Even a slight error in dosage or administration can leave a prisoner conscious but paralyzed while dying, a sentient witness of his or her own slow, lingering asphyxiation. See brief for appellants at 10-11. In light of these risks, FDA's impermissible refusal to exercise enforcement discretion over the use of drugs for lethal injection--a use well within the jurisdictional ambit of the FDCA, see Part II supra --may also implicate the Eighth Amendment's prohibition of cruel and unusual punishment. 43 In a civilized society, if we assume as we must that the state may take the life of a person as punishment, decency demands that the life be taken without cruelty. The Eighth Amendment embodies society's requirement that the means of punishment not be barbarous or torturous, see Gregg v. Georgia, 428 U.S. 153, 167-171, 96 S.Ct. 2909, 2922-2924, 49 L.Ed.2d 859 (1976); In re Kemmler, 136 U.S. 436, 447, 10 S.Ct. 930, 933, 34 L.Ed. 519 (1890) (punishments are cruel when they involve torture or lingering death), and the Amendment gives even to those on death row the right to a punishment that is not cruel. In this case FDA is clearly refusing to exercise enforcement discretion because it does not wish to become embroiled in an issue so morally and constitutionally troubling as the death penalty. Yet this action amounts to an abnegation of statutory responsibility by the very agency that Congress has charged with the task of ensuring that our people do not suffer harm from misbranded drugs. See Part III-B supra. 44 Though this failure to meet statutory responsibilities is alone sufficient to invalidate the FDA's inaction in this case, we note that by failing to exercise its statutory responsibilities FDA also places serious burdens on appellants' right to a death that is not cruel. As a result of the FDA's inaction, appellants face the risk of a cruel execution and are deprived of the FDA's expert judgment as to the effectiveness of the drugs used for lethal injection, the latter fact making any direct challenge they might bring to this method of execution more difficult. Thus, even though FDA is not responsible for the execution of these prisoners, its failure to meet its statutory responsibility may well place constitutionally impermissible burdens on the Eighth Amendment rights of appellants. 45 Vacated and remanded.