MARGARET M. HECKLER, SECRETARY OF HEALTH AND HUMAN SERVICES, PETITIONER V. LARRY LEON CHANEY, ET AL. No. 84-1878 In the Supreme Court of the United States October Term, 1984 On Writ of Certiorari to the United States Court of Appeals for the District of Columbia Circuit Reply Brief for the Petitioner 1. Respondents' submission depends almost entirely on a "strong presumption" favoring judicial review of "all final agency action" (Resp. Br. 19; see also id. at 19-40, 65-69) -- perhaps in implicit recognition of the weakness of their argument that there is "law to apply" in this case. /1/ However, respondents have not in any way refuted our contention (Pet. Br. 15-25) that no such presumption applies to administrative enforcement decisions and that, if anything, the presumption is precisely the reverse. See Allen v. Wright, No. 81-757 (July 3, 1984), slip op. 23 ("The Constitution, after all, assigns to the Executive Branch, and not to the Judicial Branch, the duty to 'take Care that the Laws be faithfully executed.' U.S. Const., Art. II, Section 3."). Respondents' logic would require that even criminal prosecutorial decisions be reviewed by the courts, and respondents seem to suggest that such decisions are in fact reviewable to determine whether there has been an abuse of prosecutorial discretion (see Resp. Br. 23-24 & n.14). This is a sharp departure from this Court's precedents (see Pet. Br. 18). /2/ Respondents also attempt to distinguish prosecutorial determinations from administrative enforcement decisions on the ground that "(c)riminal prosecutorial decisions are made to protect society as a whole," while administrative enforcement decisions directly affect classes of "individuals whom the statutes were enacted to protect" (Resp. Br. 26). This distinction is specious. Administrative enforcement is often designed primarily to protect the public. Certainly that is the chief purpose of FDA's enforcement actions under the FDCA. And criminal statutes, no less than statutes calling for administrative enforcement, often have the effect of protecting particular groups or individuals. Bank robbery statutes, for example, protect banks and bank employees; criminal statutes in the securities field protect investors. But it has never been held that such private parties may obtain judicial review under the APA of prosecutorial decisions they dislike. Respondents cite a plethora of cases in an effort to show that enforcement decisions are freely reviewable, but respondents cite only one decision of this Court -- Dunlop v. Bachowski, 421 U.S. 560 (1975) -- in which the exercise of enforcement discretion was held to be reviewable under the APA. In our opening brief (at 23-25), we showed that Bachowski is easily distinguishable from the present case. Respondents state (Br. 30) that our characterization of Bachowski is "flatly wrong," but it is respondents who are in error. Respondents suggest (Br. 30-31) that the discussion in this Court's opinion concerned the question whether the Secretary of Labor's decision in that case was a matter "committed to agency discretion by law" and thus exempt from review under 5 U.S.C. 701(a)(2). Contrary to respondents' suggestion, this Court's discussion was limited to the separate question whether the Secretary's decision was exempt from review under 5 U.S.C. 701(a)(1) on the ground that Title IV of the Labor-Management Reporting and Disclosure Act of 1959 (LMRDA), 29 U.S.C. 481 et seq., "preclude(s) review" (5 U.S.C. 701(a)(1)). The very portions of this Court's opinion that respondents quote (Br. 31-32) show that the discussion was restricted to 5 U.S.C. 701(a)(1). This Court did not discuss 5 U.S.C. 701(a)(2) but merely expressed agreement with the court of appeals' treatment of the issue (421 U.S. at 567 n.7). And in our opening brief (at 24-25), we demonstrated that none of the factors found by the court of appeals to support review in Bachowski is present in this case. /3/ Moreover, it is significant that the statutory scheme at issue in Bachowski, unlike the FDCA, did not grant unfettered enforcement discretion to the Secretary of Labor. Under Title IV of the LMRDA, the Secretary may not bring suit to set aside a union election unless a union member exhausts his internal union remedies and files a complaint with the Secretary. See Local 82 v. Crowley, No. 82-432 (June 12, 1984), slip op. 12. In that narrow circumstance, the Court concluded that Congress intended to permit the complaining union member of the general public -- to bring suit pursuant to the APA to challenge the Secretary's exercise of discretion. /4/ Here, by contrast, the FDA's enforcement discretion is not limited by statute, and respondents' submission, if accepted, would allow anyone to seek judicial review of the agency's decision not to bring enforcement proceedings under any portion of the Act. Most of the remaining cases cited by respondents -- and certainly all of the remaining decisions of this Court -- are inapposite. Many do not involve enforecement activity at all, /5/ much less an agency's refusal to take enforcement activity at all, /5/ much less an agency's refusal to take enforcement action in a particular case, which of course is what is at issue here. Still other cases cited by respondents (Br. 27, 28) involve an agency's refusal to promulgate regulations. /6/ But since Congress often specifically intends for agencies to issue implementing regulations, such cases are easily distinguishable from cases involving an agency's refusal to take enforcement action in a particular case -- a matter on which Congress rarely intends to restrict an agency's discretion. See also Pet. App. 45a-46a (Scalia, J., dissenting). Likewise, respondents' reliance on cases involving an agency's refusal to adjudicate disputes between private parties is misplaced. /7/ While there is a stong tradition of prosecutorial and enforcement discretion, adjudicatory bodies do not customarily have the same discretion to decline to entertain cases falling within their jurisdiction. 2. Respondents acknowledge (Br. 40-41), as they must, that the FDA's decision in this case is unreviewable if there is "'no law to apply.'" Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 410 (1971), quoting S. Rep. 752, 79th Cong., 1st Sess. 26 (1945). Respondents have found no law to apply. The bulk of respondents' discussion on this point (Br. 41-48, 58-65) confuses two entirely different concepts: law explaining what the FDCA prohibits and law setting forth standards for the exercise of the FDA's enforcement discretion. Only the latter has a bearing on whether the FDA's exercise of enforcement discretion is reviewable under the APA. Respondents instead rely on "criteria by which noncompliance with the (FDCA) can be determined" (Resp. Br. 41-48) and case law regarding what constitutes a violation of the FDCA (Resp. Br. 58-65). If respondents were correct, all prosecutorial decisions would be judicially reviewable. For example, the bank robbery statute (18 U.S.C. 2113) provides "criteria by which noncompliance with the (statute) can be determined," and there is abundant case law regarding what constitutes a violation of the statute. But that hardly means that a prosecutor's decision not to charge under the bank robbery statute is reviewable. What is critical is that neither the bank robbery statute nor the FDCA provides law to apply in the form of standards restricting the exercise of prosecutorial or administrative enforcement discretion. /8/ Respondents are thus relegated to relying on a few words taken out of context from a preamble to an unadopted regulation (Resp. Br. 45-58). This is a slender reed that cannot possibly bear the weight of respondents' argument. In our opening brief, we showed (at 23-31) that the preamble did not purport to provide standards for the exercise of the FDA's enforcement discretion. Respondents have not attempted to answer this dispositive argument. We also argued (Pet. Br. 31-35) that the preamble did not bind the FDA in this case because the preamble is not a legislative rule and because the FDA's own rules do not regard the preamble as having binding effect in this context. Respondents contend (Br. 57-58 & n.29) that the preamble need not be a legislative rule in order to provide "law to apply." However, respondents have not cited any authority that supports this proposition. /9/ Respondents also disagree with the FDA's interpretation of its rules regarding advisory opinions (Resp. Br. 53-57), but respondents' alternative interpretation -- that advisory opinions always bind the FDA but do not bind adversely affected third parties -- is not supported by the language of the rules or by any cited authority. In any event, the FDA is the best judge of its own regulations. /10/ Respondents have also made virtually no response (see Resp. Br. 66 n.33) to the legislative history of the FDCA, which demonstrates Congress's understanding that the FDA would have no judicially cognizable duty to initiate proceedings to enforce the Act. See Pet. Br. 39-42. Contrary to respondents' characterization, the excerpts we relied on do not refer solely to FDA's "limited 'discretion' under 21 U.S.C. Section 336" (Resp. Br. 66 n.33). The excerpts speak for themselves and show that Congress clearly intended for the FDA to have unreviewable enforcement discretion. 3. Finally, respondents have failed to show that the FDA abused its discretion in not investigating the means used by the states in carrying out capital punishment. First, the FDA lacks jurisdiction over the use of approved drugs by state authorities for capital punishment purposes. It is a sheer contradiction in terms for respondents to contend that the FDA has "abandoned" (Resp. Br. 75) and "jettisoned" (Resp. Br. 76) its original position in this regard, while at the same time arguing that the FDA's present position is "identical" to (Resp. Br. 78) and only "couched in slightly different terms" from (Resp. Br. 76) that original position. /11/ Respondents' reliance on the Supremacy Clause (Resp. Br. 80-81) is also an irrelevant distraction, for while Supremacy Clause provides for the preemptive effect of federal law (Resp. Br. 80-81), the Clause does not assist in construing the extent of jurisdiction provided by a particular federal statute. In our opening brief (at 43-37), we argued that the FDA lacked jurisdiction because the drugs at issue here are not literally "held for sale" when administered to prisoners and because there is not a scintilla of evidence that Congress intended for the FDCA to regulate capital punishment. We noted (Pet. Br. 44) that respondents' contrary interpretation would lead to the absurd result of requiring the FDA to regulate such traditional means of capital punishment as the gas chamber, electric chair and gallows. Respondents' argument that electric chairs and gallows do not fit within the statutory definition of "device," while the drugs used for lethal injections do fit within the statutory definition of "drug" (Resp. Br. 93-95 n.46), is based on a strained reading of the two statutory definitions. See 21 U.S.C. 321(g)(1), 321(h). Each definition contains three categories, any one of which serves to meet the broad statutory requirements: first, articles recognized in an official compendium (21 U.S.C. 321(g)(1)(A), 321(h)(1)), second, articles "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" (21 U.S.C. 321g(1)(B), 321(h)(2)), and third, articles "intended to affect the structure or any function of the body of man or other animals" (21 U.S.C. 321(g)(1)(C), 321(h)(3)). /12/ It is absurd for respondents to suggest that means for carrying out capital punishment are not "intended to affect the structure or any function of the body of man." Such an argument, in addition to ignoring the words of the Act, would eviscerate the FDA's ability to regulate articles that do not fit within the first two categories, thus frustrating congressional intent in providing a third, separate category. Moreover, apart from what Congress may have intended the FDCA to mean, the FDA's uncertainty about how the courts would greet any attempt to assert authority over the state-mandated executions is a fully adequate basis for an agency with limited resources to decline proposed enforcement efforts. See Pet. Br. 47; Pet. App. 85a. Respondents rely repeatedly and extensively upon the FDA's actions regarding drugs used to kill animals (Resp. Br. 61-63, 83, 91, 100-101) and drugs used on human prisoners for research (Resp. Br. 18h, 63-64, 96-97). In these situations, however, the FDA was on much sounder jurisdictional footing than it would have been with regard to the enforcement proceedings sought by respondents. In United States v. Beuthanasia-D Regular, (1979 Transfer Binder) Food Drug Cosm. L. Rep. (CCH Paragraph 38,265 (D. Neb. Aug. 1, 1979), the FDA did not assert authority over the use of drugs to kill animals. That case involved instead a situation in which a manufacturer was marketing a drug for purposes of animal euthanasia. Thus the case was of the type in which FDA normally assumes jurisdiction -- the marketing and promotion by a manufacturer of a drug for a purpose that has not been subject to premarketing approval. /13/ Similarly, unlike its doubtful authority to regulate drugs used for administration of the death penalty, the FDA has clear statutory authority to regulate the use of drugs in a research involving prisoners. The FDA has authority over all research investigations, whether or not involving prisoners, because drugs used in investigations are manufactured and shipped for that purpose. To ship such research drugs without first having obtained FDA approval (21 U.S.C. 351(i)) is a violation of 21 U.S.C. 355(a) and 331(d) because the FDA has explicit statutory authority to regulate the distribution of drugs for research. The regulations referred to by respondents (Resp. Br. 63-64, 96-97) simply implement Section 355(i) and other similar FDA statutory authorizations. See 21 U.S.C. 357(d), (360)(g). Finally, respondents (Resp. Br. 89-95) and amici Public Citizen and American Society of Law and Medicine, et al., argue that the FDA was legally obligated to intervene because lethal injection is a less desirable means of capital punishment than other methods. Whatever the merits of this argument -- and there is surely much to be said on the other side /14/ -- it is an argument that should be addressed to bodies other than the FDA -- to courts, which must review death sentences and may be called upon to determine whether execution by lethal injection satisfies Eighth Amendment standards, and to state legislatures, which in increasing numbers are conducting, after studying the available evidence, that lethal injection is the least painful method of execution. The FDA has no experience or particular expertise in making a comparative assessment of different methods of capital punishment, nor does it have a congressional mandate to venture into this field. The FDA thus properly declined to intervene. For the foregoing reasons and those stated in our opening brief, it is respectfully submitted that the judgment of the court of appeals should be reversed. REX E. LEE Solicitor General THOMAS SCARLETT Chief Counsel Food and Drug Administration NOVEMBER 1984 /1/ Respondents also err in suggesting that FDA enforcement decisions are reviewable absent "'clear and convincing' evidence that Congress intended to prohibit judicial review" (Resp. Br. 65). See Block v. Community Nutrition Institute, No. 83-458 (June 4, 1984), slip op. 10-11. /2/ This Court's suggestion (relied upon at Resp. Br. 25-26) in Marshall v. Jerrico, Inc., 446 U.S. 238, 249-250 (1980), that a personal financial interest on the part of administrative prosecutors "may * * * in some contexts" raise due process concerns does not imply that prosecutorial determinations are presumptively reviewable. Moreover, respondents' reliance on Jerrico evidences the confusion that pervades their brief. Obviously once a law enforcement proceeding has been instituted, judicial review is available to ensure compliance with constitutional and statutory requirements. This case, of course, involves judicial review of a decision not to bring an enforcement proceeding. /3/ Adams v. Richardson, 480 F.2d 1159 (D.C. Cir. 1973), relied upon at Resp. Br. 28, 33-35, 73, involved allegations that the Department of Health, Education, and Welfare had adopted a "general policy" not to utilize specific statutory enforcement provisions contained in Title VI of the Civil Rights Act, with the result that HEW was "actively supplying segregated institutions with federal funds." 480 F.2d at 1162. In contrast, the FDA continues to utilize broadly all of its statutory enforcement provisions: no statutory language is nullified by its refusal to apply its enforcement authority in the particular area of lethal injections. Moreover, the FDA is obviously not engaged in affirmative support of activities contrary to congressional purposes. /4/ Indeed, the Court described the Secretary's role as "lawyer for the complaining union member" (421 U.S. at 572). /5/ E.g., Leedom v. Kyne, 358 U.S. 184 (1958) (Resp. Br. 27, 72) (challenge to NLRB certification of a particular collective bargaining unit); Harmon v. Brucker, 355 U.S. 579 (1958) (Resp. Br. 72) (challenge to less than honorable military discharge); Stark v. Wickard, 321 U.S. 288 (1944) (Resp. Br. 72) (challenge to milk marketing order); Carpet, Linoleum & Resilient Tile Layers v. Brown, 656 F.2d 564 (10th Cir. 1981) (Resp. Br. 27) (challenge to agency refusal to comply with Davis-Bacon Act requirement that contractors pay local prevailing wages); Pennsylvania v. National Association of Flood Insurers, 520 F.2d 11 (3d Cir. 1975) (Resp. Br. 28) (challenge to failure to publicize flood insurance); Davis v. Romney, 490 F.2d 1360 (3d Cir. 1974) (Resp. Br. 28) (challenge to affirmative action of HUD in insuring mortgages on plaintiffs' homes); Goodman v. United States, 424 F.2d 914 (D.C. Cir. 1970) (Resp. Br. 68) (challenge to agency refusal to permit withdrawal of employee's resignation). /6/ E.g., NRDC v. EPA, 683 F.2d 752 (3d Cir. 1982); WWHT, Inc. v. FCC, 656 F.2d 807 (D.C. Cir. 1981); NRDC v. SEC, 606 F.2d 1031 (D.C. Cir. 1979); British Airways Board v. Port Authority, 564 F.2d 1002 (2d Cir. 1977). Rockbridge v. Lincoln, 449 F.2d 567 (9th Cir. 1971). /7/ E.g., Hotel Employees v. Leedom, 358 U.S. 99 (1958) (Resp. Br. 35-36, 72) (review of refusal to adjudicate labor disputes in hotel industry); Office Employees Local No. 11 v. NLRB, 353 U.S. 313 (1957) (Resp. Br. 18g, 27, 70-72, 73) (review of refusal to resolve dispute between labor union and its employees); Medical Committee for Human Rights v. SEC, 432 F.2d 659 (D.C. Cir. 1970), vacated as moot, 404 U.S. 403 (1972) (Resp. Br. 25, 28 68) (review of informal decision not to resolve proxy dispute between management and shareholder); UAW v. NLRB, 427 F.2d 1330 (6th Cir. 1970) (Resp. Br. 28, 72) (review of refusal to decide particular dispute between labor and management). See also Safir v. Gibson, 417 F.2d 972, 977 & n.6 (2d Cir. 1969), cert. denied, 400 U.S. 850 (1979) (Resp. Br. 72). Respondents also rely upon cases permitting review of agency delays in making quasi-judicial determinations. Caswell v. Califano, 583 F.2d 9 (1st Cir. 1978) (Resp. Br. 27, 37); White v. Mathews, 559 F.2d 852 (2d Cir. 1977), cert. denied, 435 U.S. 908 (1978) (Resp. Br. 27, 73). (These decisions, of course, are no longer good law. Heckler v. Day, No. 82-1371 (May 22, 1984).) Such review obviously does not implicate separation of powers concerns. /8/ To the extent that respondents also rely upon statutory provisions that are not merely substantive requirements of the FDCA -- i.e., statutory language that violators "shall" receive specified penalties (Resp. Br. 43-44) and the provision of the FDCA regarding nonreporting of minor violations (21 U.S.C. 336) (Resp. Br. 45-48) -- we have already demonstrated that such reliance is frivolous (see Gov't Br. 26-27 & n.16). /9/ In Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944), on which respondents rely (Br. 58 n.29), the Court did not hold that an informal agency pronouncement furnishes law to apply under the APA (this was of course a pre-APA case) or that such a statement binds the agency in any other way. The Court merely took note of the Wage and Hour Administration's interpretive bulletins in deciding a question of statutory construction under the Fair Labor Standards Act. /10/ United States v. Ewig Bros., 502 F.2d 715, 725 n.34 (7th Cir. 1974), an action brought by the government to enjoin distribution of fish contaiminated by DDT, is inapposite. There, an FDA press release purporting to set tolerance limits for DDT in food was regarded as a legislative rule because the language of the press release suggested that it was intended to have such an effect and because the government had apparently prosecuted the case at trial and on appeal on the theory that the press release was binding. See id. at 724-725 & nn.31-34. No similar circumstances are present here. /11/ Contrary to respondents' assertion (Resp. Br. 18c, 43 n.21), the government does not agree that drugs used for lethal injections are necessarily misbranded. See Pet. Br. 46. /12/ The definition of a drug also contains a fourth category that extends the definition to components of articles specified in the other three categories (21 U.S.C. 321(g)(1)(D)). /13/ Even were this not the case, the agency would still have clearer statutory authority to intervene in a situation involving the unapproved use of animal as opposed to human drugs. 21 U.S.C. 360b(a)(1) specifically provides that without approval a new animal drug "with respect to any particular use or intended use" (emphasis added) is "unsafe" and therefore "adulterated" as a matter of law under 21 U.S.C. 351(a)(5). No comparable provision exists with respect to human drugs. Under 21 U.S.C. 331(k), "adulteration" serves as an alternative to "misbrand(ing)." /14/ For contrary expert opinion, see Kemperman, Medical Involvement in Capital Punishment, The Lancet, Feb. 5, 1983, at 301-302; Death Row and the Medical Model, Hastings Center Rep., Oct. 1979, at 5; Nichols, Lethal Injection Rarely Used Execution Method, Chi. Daily L. Bull., Mar. 19, 1984, at 3; Note, Criminal Procedure -- Capital Punishment -- Texas Statutes Amended to Provide for Executions by Intravenous Injection of a Lethal Substance, 9 St. Mary's L.J. 359, 364-365 (1977). Respondents argue (Br. 10-11) that since doctors are ethically barred from administering lethal injections the chances that something will go wrong are increased. But as the British Royal Commission on Capital Punishment observed more than 30 years ago (1949-1953 Report of the Royal Commission on Capital Punishment 259 (1953)), "it is not only within the profession that the necessary skill is to be found. There are many outside it who are fully competent either to give injections themselves or to train others to do it." See also Bolsen, Strange Bedfellows: Death Penalty and Medicine, 248 J.A.M.A. 518, 518-519 (1982); see Malone, More Humane? First Execution by Injection, 69 A.B.A. J. 143 (1983); N.J. Stat. Ann. Section 2C: 49-2 (West 1984) (specifies use of "execution technicians").