Larry Leon Chaney v. Margaret M. Heckler, as Secretary of Health and Human Services

WRIGHT, J. SKELLY Circuit Judge: Food, Drug, In the Act Cosmetic (FDCA), (1976 21 U.S.C. 301 et & seq. 1981), Supp. Congress required V Health and Secretary of Human Services delegate, her of the Food Commissioner and Drug (FDA),1 Administration to assure drugs” all “new are “safe and effec- pre- tive” for under use conditions scribed, recommended, or suggested on labeling.2 355(a). official Id. § Before can Commissioner allow a “new be drug” to commerce, distributed interstate FDA must the safety assure drug and 355; adequacy branding. Id. §§ see also 21 C.F.R. 201 et A seq. (1983). § Stephen M. Kristovich, D.C., Washington, “misbranded,” drug is impermissibly and whom Kendall, David E. Washington, consumers, available use by for unless its D.C., Berger, Joel and G. Anthony Amster- labeling adequate bears use directions for dam, brief, New York City, were on the for adequate and such warnings against unap- appellants. proved or uses methods of administration as are for the necessary protection of its users. Margaret Halpern, Dept, G. of Jus- Atty., 352(f). U.S.C. Commissioner has § tice, Washington, D.C., with whom Robert interpreted previously FDCA’s labeling Nicholson, B. Atty., Dept, Justice, quirements impose upon “obli- FDA the Washington, D.C., Scarlett, Thomas Chief gat[ion]” investigate and take appropri- Counsel, Food Admin., and Drug Wash- ate against unapproved ap- uses of ington, D.C., and Levine, Arthur N. proved where drugs such use unapproved Rockville, Md., Deputy Counsel, Chief Food widespread becomes endangers pub- Drug and Admin., brief, were on the for lic Legal health. See Status of Approved appellee. Labeling Prescription Drugs; Pre- SCALIA, Before WRIGHT and Circuit Uses scribing Unapproved by the Food WEIGEL,* and Judges, District Senior Administration, and Drug Fed.Reg. Judge. (August 1972) (hereinafter Opinion for the court filed Circuit ).3 Policy Statement J. Judge SKELLY WRIGHT. Dissenting opinion Judge filed In this we by Circuit case review FDA’s decision to SCALIA. take no action —either reg- investigatory or * dence,” the United 355(d). Of States District for the Court as defined at 21 U.S.C. See § California, sitting desig- Rutherford, Northern District of United States v. 549- pursuant 294(d) (Supp. nation to 28 V 550 n. U.S.C. 2473-2474 n. 1981). (1979). obtaining may enforce the statute 3. FDA (1983) (delegating 21 C.F.R. au- 5.10 332(a), injunctions, 21 U.S.C. § court-ordered thority FDA). to the Commissioner of imprisonment, sei- fines and id. § zures, 334(a). may promulgate drug” FDA аlso id. § statute defines 2. The the term “new * * * hearings, regulations “[a]ny and hold conduct exami- generally recog mean * * keep- investigations, require nized, *, record among experts nations and as and effec safe inspections, public reports. ing, prescribed, and issue make for use tive under the conditions recommended, labeling suggested Id. 371-375. §§ in the 321(p)(1) thereof unapproved approved uses of In the area take, Supreme de- interpreted drugs, has indicated that it will Court has case, pending upon “safe and is an “ex- the facts of each effective” when there change, requiring labeling pert following consensus” founded “substantial evi- actions: Background ulatory against the unapproved ap- use I. — proved drugs capital punishment During the last six years at least five systems. Appellants, eight prison inmates states, Oklahoma, Texas including have under sentence of death in Texas and Okla- enacted adopting injection statutes lethal homa,4 claim that FDA arbitrarily means of human execution.7 Prisons in these states house over 200 of the capriciously ap- refused to five prevent the use of 1,100 proximately persons sentenced to proven “safe and effective” as a States, death in the United and at least six means of human execution.5 petition Their (with other states 300 persons on death to FDA asserted that use of barbiturates row) apparently considering adopting paralytics capital punishment de- injection as a means capital pun- vices, prior without FDA approval, violates ishment.8 On December 1982 Texas be- drug” the “new “misbranding” provi- came the first state to actually administer a FDCA, sions of see 21 U.S.C. 355.6 §§ injection lethal to a condemned inmate.9 FDA, in response, asserted that its jurisdic- injection Because the lethal statutes au tion did not extend to the regulation thorize prison officials to unap make state-sanctioned use of lethal injections and proved use of drugs distributed in interstate that, did, would, even if it FDA as a matter commerce, appellants petitioned FDA to en discretion, of its inherent enforcement un- force the Act against the states.10 Their dertake no investigatory regulatory ac- 19, December petition recited the tivity. 7, Letter July dated 1981 from the known evidence concerning injection, lethal Commissioner to appellants’ (here- counsel which strongly indicates that such drugs inafter Letter from the Commissioner), pose a substantial threat of pain torturous Joint Appendix (JA) 86-89. The District Royal persons being executed. Commis granted Court summary judgment against Capital 1949-1953 Re Punishment, sion on appellants’ challenge to FDA’s inaction. port (1953), Exhibit 1 to Letter dated De See Memorandum Opinion filed August 19,1980 cember appellants counsel for 1982 in D.D.C. Civil Action No. 81-2265 to the Secretary of Health and Human (hereinafter Dist.Ct.Op.), JA 215-231. Be- (hereinafter Services Letter to the Secre cause we believe that FDA arbitrarily and tary), JA 34-40. Appellants appended to capriciously refused to exercise its regula- their petition affidavits of leading medical jurisdiction, tory we vacate the District experts and scientific which aver that there judgment Court’s and remand the case to it is no “expert consensus” founded for further action consistent opin- with this “substantial evidence” that these drugs will ion. produce death and quickly pain without and approving use, unapproved restricting Drug Cosm.L.Rep. Transfer Food Binder] distribution, withdrawing channel of (CCH) (D.Neb.1979). at 39129 h Statement, Policy from the market. See Fed.Reg. at supra Secretary, 16504. 6. Letter to the at 18. Originally only Larry Chaney Doyle 4. Leon petition. remaining Skillem were on the See, e.g., 19-2716, 7. Idaho Code § amended appellants joined petition by six letter of Idaho H.B. No. Amendment to Section January 1981. Sess., (2d (March 31, Leg.) 1982); 46th N.M. 31-14-11; 1014; Stat. Okla.Stat. Tit. Tex. § 5. 43.14; Letter dated December 1980 from Crim.Pro. Code § Wash.Rev. Code appellants Secretary, Depart- counsel 10.95.180. (herein- ment of Health and Human Services Secretary) 18-19, after Letter to appellants at JA 31- 8. Brief for at 3. 32. A previ- United States District Court has ously approved appellee FDA’s assertion 9. Brief for at 3 n. 3. used in animal euthanasia must be “safe and approved Filing petition effective” and has the relevant crite- 10. of a citizen’s is authorized making ria for such See Unit- governed by 360g(a) (f) determinations. 21 & and Regular, ed States v. Beuthanasia-D. 21 C.F.R. 10.30 [1979 Secretary 2 to JA 31-32. discomfort. Exhibit Letter Sec Letter to the Indeed, addition, affiants eviden- retary, appellants requested JA 43-83. these any published aware of data or hearing any controlling were not issue of tiary the ef investigations that would establish JA 32.11 Id. fact. injec lethal fectiveness such 1981 the Commissioner July On Id. grounds,

tion. With evidence letter, of the FDA, refused to take any take appellants requested that FDA appellants’ requested petition. actions following actions: 2, JA 87. the Commissioner at Letter from Affix a warning boxed labels claims, investigate appellants’ Rather than in a drugs specified for use jur- asserted that FDA’s Commissioner policies statutes or injection prison regulation extend to did isdiction Texas, Oklahoma, Mexico Idaho and New injections. use of lethal state-sanctioned these drugs approved are not for use Indeed, “duly au- Id. because these were execution, as a means of are not con- fur- statutory thorized enactments [that safe and sidered effective as means of * functions,” the proper State thered] execution, and should not used as a that, it had Commissioner indicated even if of execution[;] means evi- jurisdiction, gather any would not Prepare manufac- send to the Id. dence or enforcement. pursue of the drugs prisons turers and to refusing JA 88. He noted two reasons for Texas, departments corrections case to enforce: investigate * * * Oklahoma, Idaho and New Mexico unapproved law use of other- drugs on the advising specified notices drugs uniform, wise FDA was not approved pris- in those states’ execution or statutes had a policy initiating and FDA of not for policies on use in an execution as well action against unapproved as other drugs ap- or are dan- approved drugs uses of absent “serious execution, for proved use as a means of Id. public health.” Com- ger to the are not considered safe and effective as a “danger” could find missioner no such execution, means and should not be properly capi- where a had a state enacted execution; as a used means of Id. law. punishment tal Place in Drug 3. Bulletin an arti- appellants On 1981 filed September advising cle drugs specified for seeking compel suit in the District Court injection use in lethal by statutes or FDA statutory obligation to fulfill prison policies Texas, Oklahoma, Idaho regulate and to investigate unapproved New and Mexico are not for approved use approved drugs use of human execution execution, as means of are not con- systems. discovery, ap- After limited both safe sidered and effective a means pellants FDA filed for cross-motions execution, and should used not be summary judgment. execution; means of Adopt a policy and for procedure 30, 1982 the Court August On District the seizure and from pris- condemnation granted summary judgment to FDA. ons state departments of corrections of court to decide the jurisdictional declined which drugs are destined or held use issue, on to but went hold that “decisions of execution; means as a to [and] departments agencies executive

5. Recommend frain prosecution instituting investigations manufacturers, wholesalers, proceedings essentially retailers and un- pharmacists who knowingly Dist.Ct.Op. sell reviewable courts.” unapproved injection use of (emphasis original). JA 224 Thus prison knowingly officials who buy, interfering to refrain from FDA’s “decision possess use drugs unapproved capital for the implementation of state use of lethal injections. punishment statutes constitutes a defensi- Hearings may agency’s 10.30(h)(2) (1983). be held in the discre tion. 21 C.F.R.

1179 investiga- ble considerable Act has been exercise held to apply situations [its] ** rеtailers, tive and enforcement discretion Id. where are held United Sullivan, 689, 696-697, States v. JA 216. The District Court noted that U.S. 331, 335-336, (1948), 92 L.Ed. 297 explained the Commissioner had FDA’s rea- wholesalers, States, DeFreese v. United 227, and, sons for not acting, id. (5th Cir.1959), denied, F.2d 730 cert. though the court could not review these 4 L.Ed.2d (1960), reasons for their it rationality,12 therefore bailees, United v. Wiesenfeld States Ware found that FDA completely had not abdi- Co., 559, 563, house cated its statutory responsibilities, id. at (1964), and physicians, Unit JA 229. Evers, (5th ed States Cir. Larry Chaney Leon and the other seven 1981). explained by As the court in United prisoners then filed this appeal. Cartons, v. 10 Labeled in Part States “Hox (W.D.Pa.1957), sey”, F.Supp. II. FDA’s Jurisdiction Over “is holding not the for sale in a technical Injections Lethal legal sense which gives rise to the federal * * * The Commissioner of FDA refused to in- jurisdiction the fact vestigate appellants’ allegations or to assess channels of commerce have been used.” respond they presented. evidence also Eleemosy United States Sene X Instead, he asserted that FDA did not have (S.D.Fla. nary Corp., F.Supp. jurisdiction to interfere with govern- 1979) (“[t]he ‘held for sale’ standard of sec ments’ prescription use of drugs for the tion 301 long has been afforded a liberal purpose of causing by injection. death We reading”). disagree. appeal, On FDA does not focus its ener- In determining whether FDA juris has gies argument unapproved diction over a particular drug or practice, of drugs injection use for lethal is outside the Supreme Court counselled us to general jurisdictional provisions * * * inquire merely “not into statutory Instead, Act. that state-sanc- argues purpose,” but also into the “various sorts of injections tioned use of within lethal comes supervision to goals effectuate the [needed] to the commonly recognized exception * * Ass’n, of the Act *.” Toilet Goods Inc. protective coverage: Act’s broad and Gardner, v. 163-164, 387 U.S. 87 S.Ct. “practiee-of-medicine” FDCA’s exemption. 1520, 1524-1525, (1967). legislative history expresses specific in- Jurisdiction is to be analyzed in terms of prohibit tent regulating phy- “consumer protection, dialectics.” practice According sicians’ of medicine.13 Urbuteit, United States Commissioner, regu- to the FDCA does 357-358, 112, 113-114, 93 L.Ed. 61 physicians practice late in their because (1948). Congress clearly intended that the Let- physicians by are licensed the states. “coverage Act’s be as broad as its literal ter from the Commissioner at JA 88. language indicates United States also licensed prisons by Since Bacto-Unidisk, states, thought that FDA Commissioner 1410, 1418, 22 (1969). Thus the jurisdiction regulate did not have the use practice healing 12. See note 37 infra. with the of the art chiro- practors they and others in the States where pass 13. The first bill to either house of Con- engage practice.” are licensed law to in such gress substantially that was similar to the (1935); S.Rep. Cong., No. 74th 1st Sess. present Act included within its definition of S.Rep. Cong., (1935). No. 74th 1st Sess. 1 “drug” qualification apply that it did not “drug” ultimately While the definition of regulation legalized practice “the of the of the proviso, enacted did not include this see healing Cong., art.” S. 74th 1st Sess. (1976), legislative history 321(g) U.S.C. § 201(b), Cong.Rec. In ex- Congress limit makes clear that did not want to plaining proviso reports the committee em- ability patients. physician’s to treat his phasized that the bill was “not intended as a practices medical act and not interfere [would] Id. drugs capital punishment systems. uses.15 Congress exempted prac- Thus JA 87-88. tice of medicine from the Act so as not to physician’s ability pa- limit a to treat his problem with the Commissioner’s tients.16 analogy starting is his point: prac- tice of medicine is because exempt physi- physicians’ If FDA were correct that cians are licensed states. There is use of not within drugs jurisdic FDA’s legislative scant on the history subject,14 tion simply physicians because are licensed but the few sentences that can be found are states, by the then it would necessarily fol fairly more read as reflecting Congress’ rec- that FDA could have authority low no the states do regulate ognition that regulate drugs physi state-licensed practice of medicine physician and that a cians administer prison exper inmates cannot eligible for the practice-of-medi- imental investigations clinical and no au cine exemption if he has not been so li- thority regulate drugs that state-licensed censed. practice-of-medicine exemp- itself, put veterinarians use to animals to their however, tion cannot be attributed to the states’ death. But licensing physicians. regulated of their FDA has fact prison used in clinical investigations, The better explanation the practice- see 21 C.F.R. (1983), 50.44 and in veteri exemption of-medicine Congress is that did nary practices, see United v. Beau States not want to physicians’ interfere with treat- Regular, thanasia-D. Transfer [1979 Binder] ment patients. of their New uses Food Drug Cosm.L.Rep. (CCH) are often discovered after FDA approves (D.Neb.1979). In both situations FDA has the package inserts explain a drug’s rejected arguments it does not have approved uses. Congress would have creat- authority regulate unapproved ed havoc in the uses of practice of medicine had it required physicians approved drugs.17 to follow Nonmedical use expensive and time-consuming procedure injections of obtaining therefore cannot fall within the FDA approval putting before drugs to new “practice-of-medicine” exemption simply S.Rep. 3, 5; 14. supra ing drugs No. scope practice note is outside the of the S.Rep. supra No. medicine). Indeed, prior interpretation FDA’s of the rele- drug” provisions require The “new of FDCA legislative history vant matches our own. filing drug application, including of a new Throughout leading the debate to enactment reports investigations full respect Act], repeated there were [of statements drug’s safety effectiveness; a full list of the Congress did not intend the Food and components drug; articles used as of the a full Drug Administration to interfere with medi- composition drug; statement of the a full practice cal and references to thе under- description in, of the methods used and the standing purport regu- that the bill did not for, facilities and controls used ing, processing, the manufactur- practice late the of medicine as between the packing drugs; of such physician patient. Congress recog- and the samples drugs of the and the articles used as patient’s right damages nized a to seek civil components; specimens labeling of the in the courts if there should be evidence of proposed 355(b). to be used. 21 U.S.C. An malpractice, any provide leg- and declined to applicant may up have to wait to six months upon profes- islative restrictions the medical participate for hearings. action and in Id. 355(c) (c)(2). Hence, sion. drug” & these “new provisions simply reality do not fit the of the Policy Statement, Fed.Reg. (em- at 16503 clinical situation. phasis added). Subjects; 17. See Protection of Human Prison- 16. The case law under this and related statutes Subjects Research, Fed.Reg. ers Used as in reading legislative consistent with our of the (May 1980) (rejecting argument in history. Evers, See United States v. 643 F.2d drug investigations pris- context of with state (5th Cir.1981) (physician does not oners); in Answer of Defendant D.D.C. Civil drug misbrand when he administers to his own 81-2265, (admitting Action No. JA 91 patients); Moore, see also United States v. H previously position that FDA has taken the drug applications demonstrating safety new the (physician violates related law when he sells put dogs and effectiveness of chemicals used to drugs addicts); illicit lier, United States v. Col- sleep filed). must be (5th Cir.1973) (physician F.2d 268 us- prison because the states license their facili- of the distribution drugs stage at each from process patient. ties.18 manufacturer Ac- Evers, United cord States FDA did suggest cursorily in both its (5th Cir.1981). In first place, the Sec- brief on appeal, brief for appellee at 26 FDCA, 331(b) which prohibits tion n. and its initial Letter from the Commis- commerce,” misbranding in “interstate any sioner, JA the use of drugs for be broad to cover the sufficiently should injections, even if not covered case, prisons of the state in this actions practice-of-medicine exception, falls outside under- given modem constitutional jurisdictional ambit of the FDCA. The standing congressional of the breadth of dissent to this opinion has graciously elabo- power under commerce clause. More- argument; rated FDA’s alternative while over, sale” Congress enacted the “held for acknowledging the inapplicability of the 331(k), provision of on which the Section practice-of-medicine exception, the dissent limit, relies, expand, not to dissent argues “FDA jurisdiction depends of the FDCA. Prior to addition of ambit upon the existence of misbranding under language this the FDCA had been 331(k), which cannot be established under interpretation, to an under more open the facts of case.” Dissent at 1198. reading phrase of the restrictive “interstate prevailing, commerce” then that excluded prohibits any action taken 331(k) Section the Act’s coverage penultimate cosmetic, “food, device, if drug, in the if entity actor distribution chain such act is done while such article is held had neither received nor transmitted mis- (whether sale) for or not the first after sale branded in interstate commerce. Fill- shipment interstate commerce and ing potential gap pro- statute’s in such being sults article adulterated scheme, 331(k). tective enacted Congress misbranded.” 21 The dis- Section U.S.C. § 331(k) misbranding specific sent contends that no could with the stated explicitly the present have occurred in case because protection intent “extend consum- drugs prisons hold for use in lethal law contemplated by ers to the full injections to be cannot deemed “held constitutionally extent H.R. permissible.” under any interpretation sale” “conceivable No. 75th 3d Rep. Cong., Sess. 3 English language.” Dissent at 1199. use states have moved

through com- the channels of interstate merce, of De- Support see Memorandum in This rhetorical flourish masks what fendant’s Motion to Dismiss at is in essence “plain meaning” argument, Congress thus is well within its consti- we do not fulfill our interpretive role powers regulate when we tutional when it seeks to look to the statutory lan guage. into the use to which these Inquiry put. statutory scheme legislative history light Congress’ express intent to exercise the FDCA and subsequent 331(k), amendments powers reveals a these hilt in specific Section congressional intent to prevent impermissible would be both ironic and misbranding 18. FDA’s contention that Congress Act embodies in areas in which not to elected congressional deference to law regulate. Supremacy in “several But Clause respects” other law, is further evidence of mis- preempts Constitution still state like a reading congressional statute, injection intent. FDCA lethal that conflicts with fed- upon power, based the Commerce and the fact eral law. See Arkansas v. Texas Kansas & apply wholly Co., Act 185, 47, 48, the does not 189, intrastate Coal 183 U.S. activity simply Congress’ (1901). reflects the Supreme limits of L.Ed. Arid the Court has powers, not deference to broadly, all state-mandated concluded that FDCA should be read activity. Likewise, doing FDA’s far-reaching claim that “the Act even if so “would result in generally defers to state customary law areas that do inroads control local au- ** directly it,” not appellee conflict with brief traditionally for thorities of local activities 18, way stating Sullivan, 693, a 689, curious the obvious United States v. 332 U.S. proposition may 331, regulate 334, (1948). that a at times L.Ed. 297 reading thwarts the drugs. a this court to construe that section so as to Such 331 of purpose of Section ultimate in this case.19 jurisdiction limit FDA’s consume of those who protection FDCA — the broad apparent recognition of misbrand- potential harm drugs from sale,” for the dis- scope of the term “held of distribution.20 in the chain ing by anyone argue sent must strain to Section not because 331(k) apply nonetheless does jurisdic admits that it has in this case are not the prison officials purport[] all state laws “that tion over penultimate actors at whom this section unap of an shipment lawful legitimize the aimed, ultimate consumers of but rather the commerce, or that proved drug in interstate the strictures of beyond and thus misbranding after permit its purport[] reality. blinks the Act. This view at 20 appellee Brief for shipment not the last person ultimate consumer is injection lethal statutes n. 21. The states’ purchase drug, person but the last pre mandate the use of certain purport drug usually patient, consume the a — listed on drugs purpose for a not scription notes, 643 F.2d at United Evers States v. falls activity their label. The of the states 1049, prisoner in this case the who ambit of jurisdictional within the Section injection. pris- receives the That the FDCA, the practice-of-medi 331 of the might unwilling oner be an consumer does this activ exception cine does not immunize change prisoner the fact that is the of mis ity prohibition from the FDCA’s one who will suffer an if excruciating death juris have branding. FDA therefore must unapproved administration is conducted regulate activity.21 diction to such the ultimate improperly. Styling purchaser III. consumer, Enforcement ultimate dissent would Discretion course, that even if Of FDA determined free from the strictures of the FDCA. choose, jurisdiction it would had use to which the wished to purchaser put Eleemosyna- drugs adequate X instructions. 19. Accord United States v. Sene use the without ry Corp., F.Supp. (S.D.Fla.1979) physician neither “held for sale” to Thus the (“[t]he statutory duty ‘held for sale’ standard of section 301 to whom he owed a the doctors long misbrand, duty pa- been afforded a [29 § 331] nor a not to owed reading”); liberal United States 10v. Cartons he “held for sale.” Under these tients to whom “Hoxsey”, F.Supp. Labeled in facts, Part unique no violation made out. (W.D.Pa.1957) (it holding “is not the for sale in clearly distinguishable Evers is from the legal gives a technical sense which rise to the present persons case. In this case the to whom * * * jurisdiction federal but the fact that statutory duty prisons owe are the same used.”). channels of commerce have been drugs persons prisons whom the hold the for cannot, prisoners. The FDA un- for sale—the Evers, supra 20. United States v. does circumstances, in its claim der these succeed reading “held restrictive of the jurisdiction. that it lacks language for sale” in this case. In Evers the physician court held that did not violate not have 21. FDA’s determination that it does approved drugs when he FDCA held certain injections jurisdiction drugs used in lethal over patients simultaneously treatment of his the most limited deference is entitled program advertised and advocated a treatment longstanding because it is inconsistent with unapproved involved an use of those interpretation Act. FDA and court of the drugs. Although physician held had both Campaign FEC v. Democratic Senatorial Com- unapproved for sale and advocated use 38, 44, mittee, 27, 37, 454 U.S. 102 S.Ct. instructions, proper without (1981); Corp. v. Unit- Zenith Radio court found no unique violation the basis of the States, ed 437 U.S. 98 S.Ct. persons facts of the case. The agen- 57 L.Ed.2d 337 Where an physician drugs— whose benefit the held the express cy’s interpretation contradicts the lan- patients persons his not the to whom —were statute, give guage purpose of a courts physician statutory duty give owed the See, e.g., interpretation little FPC v. deference. adequate practice-of-medi- instructions. The Conway Corp., exception exempted physician cine (1976); Office Consum- duty unapproved not to advocate an use to FERC, 1141— ers’ 655 F.2d Counsel patients. duty physicians his ran to other (D.C.Cir.1980); Elizabethtown Gas Co. might unap- who hear his advertisement of the FERC, (D.C.Cir.1978). 887-889 proved process might treatment and therefore

1183 discretion, subject to in- judicial inherent enforcement action is review unless vestigate any or action. regulatory precluded by to take such review statute or com 3, JA Letter from the at to agency Commissioner mitted law. 5 The held FDA’s 701(aXl) (2).22 District Court both that & This section § U.S.C. es from investigation decision to refrain and a “strong presumption” tablishes of review- that, ‍​‌​​​‌​​‌​​​​‌‌‌​‌‌‌‌​‌‌‌​‌‌​​​​‌‌​​‌​​​​‌‌‌‌​​​‍unreviewable enforcement was and and the ability, exceptions of 5 U.S.C. event, the decision did not amount (2) 701(a)(1) & should therefore be con § complete responsi- of statutory abdication narrowly. Dunlop Bachоwski, strued v. 10-15, bility. at 224-229. Dist.Ct.Op. 1851, 1858 421 567 & n. 95 S.Ct. U.S. We find that District Court misunder- (1975); & n. 44 L.Ed.2d 377 Citizens to stood authority. its review misapplied Park, Overton v. Volpe, Preserve Inc. 401 402, 410, 814, 820, 91 28 U.S. L.Ed.2d

A. Judicial Review of Enforcement Dis- (1971); Gardner, 136 Abbott v. Laboratories cretion 1510-1512, 136, 140-141, 387 87 S.Ct. U.S. Administrative (1967); WWHT, 10 of the L.Ed.2d 681 Section Inc. v. 18 (APA), 701(a) FCC, Procedure (D.C.Cir.1981); Act U.S.C. 656 F.2d § (1982), Council, governs judicial agency review of Natural Resources Inc. Defense action. SEC, all agency Under final 606 F.2d 1043 (D.C.Cir.1979).23 Section “agency page opinion 22. The APA defines action” to include same on the reiterates the rule, order, part “the whole or a of an point respect 701(a)(2), noting to § that it license, relief, sanction, equivalent or the applies “in rare instances.” Id. And on thereof, act," denial or failure to following page opinion articulates a test 551(13) (1982) (emphasis added), gives § deciding whether an action is committed to power “compel agency courts the unlawfully 701(a)(2) discretion under that re- § unreasonably delayed,” withheld quires inquiry an as to “whether the considera- 706(1). id. § Thus the APA authorizes courts * * * nonreviewability tions in favor of are to review ing decisions to refrain from tak sufficiently compelling strong pre- to rebut See, Bachowski, e.g., Dunlop action. sumption of review.” Id. at 1044. Similarly, Gardner, both Abbott Laboratories v. (explicitly approving review of decision Sec 387 U.S. retary of Labor not file suit to invalidate WWHT, FCC, (1967), and Inc. v. F.2d 807 WWHT, election); FCC, union Inc. v. 656 F.2d (D.C.Cir.1981), held, pages on the cited in this (D.C.Cir.1981) (reviewing denial of FCC opinion, strong pre- the APA created a petition rulemaking proceedings); to institute sumption reviewability in the context of a Carpet, Layers, Linoleum & Resilient Tile Local 701(a)(1) 701(a)(2). of both discussion § § Brown, (3d Union No. 419 v. 656 F.2d 1510-1511; at 87 S.Ct. at Cir.1974) (requiring FHA to make reasonable very (citing page 656 F.2d at 809 in Natural efforts to ascertain whether homes with in Council, SEC, supra, Resources Defense Inc. v. mortgages municipal housing sured standards); meet code opinion, 1043); Richardson, cited in 606 F.2d see also Adams v. WWHT, FCC, (D.C.Cir.1973) (en supra, banc) (per curiam) Inc. v. 656 F.2d at 815 (requiring (discussing pro making HEW commence the issue in detail and more ceedings against segregated case). dissent, 701(а)(2) certain dis it is school clear that § systems); tricts moreover, precisely Environmental Defense contradicts itself on Fund, Ruckelshaus, (D.C. Inc. v. 439 F.2d 584 point acknowledges when it later that “Natural Cir.1971) (requiring Secretary Agriculture Resources Defense Council states that the to- registration * issuing cancel of DDT cancella 701(a) tality ‘strong pre- §of creates a notices). tion sumption reviewability,’ 606 F.2d at 1043. Undoubtedly (emphasis so.” Dissent at 1195 cases, 23. The dissent claims that these or at original). cited, portions least do not involve importantly, More the neat demarcation that committed-to-agency-discretion exception of 5 preclud- seeks the dissent to draw between the 701(a)(2), U.S.C. case, which § is at in this issue ed-by-statute committed-to-agency-discre- precluded-by-statute excep- but rather the exceptions muddy tion to review tends to 701(a)(1), tion of which is not. See Dissent analysis in this area. Under claims of flatly 1193. This claim is In inaccurate. disfavored, nonreviewability Council, whatever Natural their Resources Defense Inc. v. SEC, Supreme analysis (D.C.Cir.1979), Judge F.2d 1031 source. Court’s in Ab- Gardner, supra, opinion, page McGowan’s bott Laboratories v. instruc- states 701(a)(1) 701(a)(2) deciding both pre-enforcement and § tive. create whether “strong presumption reviewability.” regulation appropriate, Later view of in rare applicable only and to find it those FDA nor the District Court Neither judicial re- precludes that FDCA claims statute governing where the instances Rather, that FDCA view.24 both assert given terms that in a “drawn in such broad FDA absolute discretion over deci- gives Citizens apply.” is no law to case there and enforce- concerning investigation sions Park, supra, Volpe, Inc. v. Preserve Overton 3, ment, at Letter from the Commissioner 821, quoting 410, at at S.Ct. U.S. 224, 88; 10, thus Dist.Ct.Op. at JA 752, Cong., 79th 1st Sess. 26 S.Rep. No. decisions to agency commits those (1945).25 applies This admonishment some 701(a)(2). Though law. 5 by U.S.C. § enforce agency to review of no less force courts have reluc- traditionally displayed discretion, including agency decisions ment to review exеrcises of enforcement tance action. Dun to refrain from enforcement discretion, Supreme Court has consist- Bachowski, 560, supra, lop 421 U.S. narrowly instructed us to construe ently 1851, L.Ed.2d 377. exception, to agency “committed discretion” spe- survey provisions that noted that “a of our cases shows 24. The statute has detailed Court See, e.g., cifically contemplate judicial judicial review. of a review final 332(a) (jurisdiction courts over aggrieved 5 U.S.C. injunction actions); person § an will not be cut off unless 346a(i) (judicial id. persuasive § there is to believe such was reason regulations view of which establish tolerances purpose Congress,” 387 U.S. at chemicals); (judicial pesticide 348(g) id. § point S.Ct. at went on to out that * * * additives); review for controversies over food embodies “Administrative Procedure Act 355(h) (judicial review of new or- id. § presumption judicial review so basic premark- ders); 360(g) (judicial review of id. § long precludes as no statute such relief or the eting provisions). is not one action discretion,” id., committed law to “only upon and concluded that light importance The dissent makes of the 25. showing convincing of ‘clear and a evidence’ of the resolution of this contro Overton Park to contrary legislative intent should the courts must, versy. Dissent at 1193. Overton Park restrict access to review.” Id. at however, analy occupy place in our a central Cort, (quoting 87 S.Ct. at 1511 367, Rusk v. meaning sis: it defines the of the committed-to- (1962)). One 701(a)(2) agency-discretion exception of § therefore, important question ask, must we power is at issue here. To dilute the of the Congress grant whether FDA unre- intended to 701(a)(2) give command that we § Court’s extremely power viewable in the area. We construction, narrow find no evidence of such an intention in this argues the dissent case. “[ujnless Supreme assumes that the Court one The dissent also seeks to deflect the force of casually setting wildly forth a rule out of principle stated in Natural Resources De- law, prior mean accord with ing case the obvious Council, WWHT, Inc., supra, supra, fense application of ‘narrow construction’ was an argument inappo- with the that these cases are exception limit the to enforcement that would present controversy they site to the because discretion and to few other matters reviewability rulemaking, involved the Supreme Apparently the Dissent enforcement, 1194— Dissent at decisions. See meaning” in 1975 missed this “obvious Court 1195. But it is the dissent that misses page cited the relevant of Over- when Court rely sup- mark. We do not these cases holding Dunlop in ton Park to port proposition rulemaking that because Bachowski, supra 421 U.S. at decisions can be reviewed enforcement deci- Secretary of Labor’s S.Ct at Rather, perforce sions can be reviewed. we of enforcement discretion was review exercise simply follow the consistent construction reading of Park able. The constricted Overton 10 of the APA Re- articulated Natural square also difficult to with the text of Over WWHT, sources Defense Council and Inc. itself; opinion does not even hint ton Park This consistent construction establishes meaning would divine at the that the dissent strong presumption reviewability in cases it, 701(a)(2) excep from but stresses that the under 10. The Resources applied courts Natural “very is to be tion is narrow” and WWHT, Defense Council and in Inc. evaluated 401 U.S. at 91 S.Ct. at “rare instances.” reviewability rulemaking Moreover, sup of the decisions at direct cited as Court light strong presumption. Berger port holding issue in of this Simi- Raoul for its an article larly, cognizance strong pre- specifically approves we take in which he discusses and sumption as we undertake our evaluation of discretion. Ber review of ger, reviewability Arbitrariness and Judicial the exercise of enforcement Administrative Review, present discretion at issue in the case. 65 Colum.L.Rev. frain from enforcement Dunlop scrutiny exercising power The case deserves close held, precisely analogous because it оn facts was reviewable.26 In the present controver- case, agency to those of the that an present more sy appellants nothing seek than what enforcement discre- decision to exercise sought the union official in disappointed In Dunlop tion was reviewable. an unsuc- Dunlop: judicial agency review of an deci- cessful candidate for a union office com- to power. sion not exercise enforcement the the plained Secretary to of Labor that precludes thus a facile resolution Dunlop fraudulent, election was and thus invoked denying review in this case because an ex- of the Labor- provision U.S.C. § ercise of discretion at issue. Management Reporting and Disclosure Act must, Park, We under the test of Overton empowers investigate the to Secretary there is “law to apply” decide whether such complaints bring and to a civil action in FDA’s nonenforcement decision this case. to set aside the election if warranted. The determination of whether 562-563,95 S.Ct. at 1855-1856. The prag there “is law to turns on such apply” Secretary response took no action in judicial matic considerations as whether su complaint in and the unsuccessful Dunlop, plain pervision necessary safeguard union sought candidate review of that deci- interests, judicial tiffs’ whether review will exercising sion to refrain from agency the in effec unnecessarily impede power. Secretary argued that his ac- out as tively carrying congressionally tion was unreviewable under Section 10 of role, signed ap and whether the issues are APA, precluded- and relied on both the propriate judicial review. Natural Re by-statute eommitted-to-agency- Council, SEC, Inc. v. supra, sources Defense exceptions 10 of the Section 606 F.2d at 1043-1044. We conduct 701(a)(1) (2). Finding APA. 5 & U.S.C. § to determine whether the considera inquiry neither exception applicable, U.S. at 567 favoring nonreviewability & n. tions are suffi S.Ct. at 1858 & n. the Court held that discretionary strong pre decision to re- to rebut ciently compelling lеgal against Dunlop explicitly rejected clear agency standards exist which the 26. The Court in measured; Secretary’s claim that the de- action at issue can be in the nonenforcement prose- cision was an unreviewable apply.” Park, exercise is “law to words of Overton there discretion, expressly adopted cutorial accompanying nearly every ‘to include enough “broad is ap- an use of unapproved Where the ” * * make *.’ may agency an statement or widespread becomes new proved NHTSA, 710 F.2d v. Safety for Auto Center health, the Food and public endangers Batterton v. quoting (D.C.Cir.1983), 846 to in- obligated Drug Administration (D.C.Cir.1980). 700 Marshall, F.2d 648 and to take what- vestigate thoroughly it the court con- Safety for Auto Center protect is warranted to ever action ac- statements agency policy that cluded * * * the Food necessary When public. a notice of withdrawal of companying hesi- Administration will not Drug and the defini- rulemaking fell within proposed * * * may take whatever action tate to inter- “clearly they tion of “rule” because harmful use bring possible required indicate statute and the relevant pret under control. approved drug of an the exercise policy regarding NHTSA’s * * * Thus, manufacturer or where a legislative to it granted discretion in the any person or representative, his The FDA 710 F.2d at 846. enactment.” distribution, anything chain of does also inter- quoted above policy statement phy- directly indirectly suggests or and indicates the relevant statute prets patient approved or the that an sician the exercise of regarding policy FDA’s drug may properly unap- statement, be used for along policy discretion.28 The it is neither labeled proved uses which terms of the statute29 precise with the advertised, law,30 provides that action constitutes a case thus growing body nor enough law to with more than punisha- direct violation of the Act and is this court apply” has “law to Where a court accordingly. apply31 ble “ policy goals prefеrred putting 551(4) (a ‘rule’ method of 27. See 5 U.S.C. § part agency whole or a of an state- into effect. means the general particular applicability ment of or * designed implement accompanying supra effect law future 24 29. See notes policy”). agency bind- phrased or An statement that is prohibitions in man- text. FDCA’s ing See, 333(a) a rule. e.g., and that has substantive effect datory 21 terms. Ass’n v. Federal See Guardian Federal S. & L. im- (any person “shall” be who violates 331 (D.C. Corp., minimum, fined); (at L. Ins. 589 F.2d 666-669 prisoned S. & Sec- id. Cir.1978); retary provide Board of Pickus v. United States written notice or must suitable Parole, (D.C.Cir. violations). warning 1112-1113 The statute’s minor 1974). history Congress legislative in- indicates that grant appro- and to tended for courts to review “any priate against on the act or omission relief Policy accompanied 28. That the Statement part Department in the administration unadopted FDA has ad- rule is not decisive. S.Rep. supra note No. the act.” Policy mitted that the statement is an authori- views as to what the tative statement Evers, supra See, e.g., note operates requires. States v. United statute under which it Regular, 16; Support v. Beuthanasia-D. United States Memorandum in of Motion to Dismiss Hoffmann-LaRoche, 5; Inc. Wein 131-132; supra at 4-5 nn. Letter & (D.D.C.1975); F.Supp. Ameri admission, berger, the Commissioner at JA 87. This Veneman, 349 moreover, Ass’n v. argument can Public Health potential eviscerates (D.D.C.1972). F.Supp. 1311 policy guidelines ‍​‌​​​‌​​‌​​​​‌‌‌​‌‌‌‌​‌‌‌​‌‌​​​​‌‌​​‌​​​​‌‌‌‌​​​‍FDA in the renounced the proposed rule statement when it withdrew the accompanied The with- the statement. 31. 2 K. Davis, Law Treatise Administrative Supp.). 7:26-7:28, (2d rejected con- ed. 1979 & drawal indicates not that FDA 28:16 §§ statement, precept can policy courts tents of the It is a well established rules agencies to their for conformance proposed review rule was not a decided that action is not committed to court have never allowed the phrase ‘prose- subject review cutorial discretion’ to be treated as a magi- under the APA. Citizens to Preserve Over- cal automatically pro- incantation whiсh Park, Volpe, ton Inc. v. supra, U.S. vides a shield arbitrariness.” Medical 410, 91 at 820. SEC, Rights Committee for Human (D.C.Cir.1970), vacated as The District Court did not review the L.Ed,2d moot, provisions governing judicial APA’s review Indeed, last (1972).33 in the twenty establishing or discuss the case law years frequently federal courts have forced strong presumption reviewability.. Rath- er, articulating agencies implement cases and enforce their relied on venera- statutes, ble proposition that courts should not un- regulatory explain at least duly prosecutorial interfere discre- their failure do so.34 cases the While tion.32 has never proposition distinguishable But been District Court cited are blindly bar,35 applied: “key decisions from the case the real lies in “[T]he regulations, especially where those rules tional Labor Relations Board has unreviewable are to have substantive Dulles, effect. Service v. discretion to refuse to unfair initiate an labor 363, 1152, practice complaint. 354 U.S. 77 1 S.Ct. L.Ed.2d Sears Roebuck makes (1957); however, clear, 1403 United rel. agency States ex Accardi v. that this discretion was 260, 499, Shaughnessy, 347 74 U.S. 98 explicit preclu- S.Ct. a unreviewable as result of the (1954). L.Ed. 681 statutory 153(d), sive command of 29 U.S.C. 138, 421 U.S. at and not as a result of 10-11, Dist.Ct.Op. judi at JA 224-225. The generalized presumption against review of prosecutorial cial reluctance to interfere with agency Also, enforcement discretion. unre- specific discretion arises from the lack ac only viewable arises enforcement discretion un- review, record, separation tion to the lack of a which, FDCA, der statutes unlike the are not powers principles, prosecuting agency’s individuals, for the benefit for the resources, need to its own control solicitude for country whole. as a See Bachowski v. Bren- accused, voluntary and adverse on effects nan, 26, 11, supra 502 note F.2d at 87 & n. rev’d settlement. But both courts and commentators grounds, approval on other but cited on convincingly have demonstrated that these Bachowski, point, Dunlop supra 22, v. note justify committing agency concerns do en 7, 421 U.S. at 567 n. 95 at 1858 S.Ct. n. 7. completely forcement action to administrative Industries, FTC, 411, Moog 414, Inc. v. U.S. 355 totally judicial precluding discretion or review. 377, 380, (1958), simply 78 2 S.Ct. L.Ed.2d 370 Bachowski, 22, Dunlop supra See v. note 421 held that the Federal Trade Commission’s dis- 571-572, 1859-1860; U.S. at 95 S.Ct. at Adams cretionary prosecute determinations to should Richardson, supra 22, v. 1163; note 480 F.2d at 1161- patent “not be overturned in the absence of a 31, supra 2 K. note §§ 9:1-9:6 at Davis, Tiffany abuse of discretion.” SEC v. Indus- 215-248; Vorenberg, Decent Restraint of Pros tries, Inc., F.Supp. (E.D.Mo.1982), 535 1160 Discretion, 1521, ecutorial 94 Harv.L.Rev. 1545- simply judicial did not involve review of the Note, (1981); 1554 Judicial Review of Adminis propriety agency’s of an exercise enforce- Inaction, 627, trative 83 Colum.L.Rev. States, ment discretion. Newman v. United 658-661 (D.C.Cir.1967), pros- 382 F.2d 479 involved the See, Jerrico, e.g., Inc., Marshall v. 446 U.S. Attorney ecutorial of a discretion United States 238, 249-250, 1610, 1616-1617, 100 S.Ct. 64 matter, in a criminal a that has al- (1980) (reviewing L.Ed.2d 182 claim that ad ways degree judicial received maximum personal outcome); had ministrator interest in deference. Hopkins, 356, 1064, Yick Wo v. 118 6 U.S. S.Ct. SEC, (D.C.Cir. Kixmiller v. 492 F.2d 641 (1886) (reviewing 30 L.Ed. 220 claim that law 1974), assertion, weight will not bear the discriminatorily applied); see also Black made the District echoed in Court and Allison, ledge 76, 63, 1621, v. 431 U.S. 97 S.Ct. opinion, supports dissent to this strong that the case a 1630, (1977) (reversing convic against reviewability. presumption The ground prosecutor tion keep on did not a F.2d, language at 644-645 of 492 which the promise). rely, District and the Court dissent most fairly holding statutorily read as that review supra. 34. See note 22 precluded on facts of Kixmiller. And the Sears, Co., 35. NLRB three cites v. Roebuck 421 authorities Kixmiller for its & U.S. 132, 138, 1510, 1504, 95 S.Ct. 44 overbroad dictum that enforcement dis- L.Ed.2d 29 (1975), unreviewable,” 171, 182, Sipes, “generally and Vaca v. 492 386 U.S. 87 cretion is F.2d at 912, 17 903, hold, 27, (1967), position. S.Ct. both 645 & n. will not such a dicta, first, Goldberg Hoffman, 463, in General 225 Counsel the Na- The v. F.2d 1188 rebut this We must pelling presumption. in transi- recognizing that the law has been * * * subject law

tion the case that FDA’s inaction here conclude [is now] reviewability.” 2 K. strongly on side judicial review.37 9:6, Davis, Law Treatise Administrative (2d 1979).36 at 239-240 ed. Review Scope Judicial B. correctly District Court noted informаl reviewing agen When statutory exemption the “absence of must conduct cy of this court type activity logical for state-mandated does * “searching * * careful” review of suggest ly compel or even if the “whole record” to determine Commissioner has no discretion to refrain 5 “arbitrary capricious.” been investigative initiating requested (1976); FPC v. Trans 706(2)(A) U.S.C. *.” proceedings and/or Corp., Line Pipe Gas 423 U.S. continental 15, origi in Dist.Ct.Op. (emphasis at 582, 46 L.Ed.2d S.Ct. nal). mean that But neither does curiam); Citizens to Preserve (1976) (per en has absolute discretion in Commissioner Park, Volpe, supra, v. Overton Inc. or that these decisions forcement decisions must, at 823. The court 91 S.Ct. judicial review. The are insulated from therefore, review, “searching make a and careful” is in favor of presumption record, nothing sufficiently case is corn- review of both the administrative (1971), (7th Cir.1955), and Abbott involved not discre 28 L.Ed.2d Gardner, pure prosecutorial supra tion but the discretion of a note v. Laboratories Attorney United States a criminal matter. elabo- L.Ed.2d U.S. cases, Sipes, v. 912, second and third Vaca De- in this circuit Natural Resources rated supra, SEC, Council, supra note fense Inc. NLRB, (3d Jacobsen v. Cir. FCC, supra Inc. and WWHT 1941), both the enforcement discretion involved 23, 807, specifically applica- made 656 and of of the General Counsel the NLRB that was Dunlop in v. Ba- to enforcement discretion ble Roebuck, supra, later clarified Sears as be 22, 560, chowski, supra note 421 U.S. 95 S.Ct. review, ing statutorily placed beyond judicial 1851, 377, 44 the dissent’s insistence L.Ed.2d 138, Beyond 421 at these U.S. at 95 S.Ct. 1510. “general- agency is that ly citations, opinion nonsupportive the Kixmiller ring. has an unreviewable” anachronistic provides analysis justify posture no to of all prece- See Dissent 1195-1196. And agency but total deference to enforcement dis places primary re- which the dissent dents on limiting importantly, pre Most cretion. helpful not to Kixmiller has al- liance are it. sumption stated Kixmiller little in retains force seriously ready to be been demonstrated circuit, light subsequent in deсisions of this Laird, supra. v. See 35 flawed. note Curran Council, see Natural Resources Defense Inc. v. (D.C.Cir.1969) banc), (en 122 is whol- 420 F.2d SEC, 30, supra 606 F.2d at and ly inapposite case. involved the to this Curran Supreme Court, Dunlop of the see v. Bachow reviewability by the of a decision Executive ski, 22, 7, supra note 421 U.S. & n. at 567 95 composition Branch about the nation’s S.Ct. at 1858 & 7.n. during war. A ma- fleet the Vietnam reserve Moreover the two FDCA cases the Dis- jority to of the held the be com- court decision cites hold courts trict Court do not cannot de- to discretion because “these mitted official complete investigate review FDA’s to refusal inextricably with and cisions are intertwined regulate drugs. and an entire class In Nat’l by assumptions permeated conclusions of and Harris, Milk Producers Federation v. strategy.” 420 F.2d at 131. national defense (8th Cir.1981), 339 the court reviewed and ac- opinion point to out that the was careful cepted good budgetary FDA’s faith reasons — in the context of Executive decision occurred seeking constraints —for not to enforce certain emergency,” id. at 128. Curran “national regulations. Kennedy, Id. In at 342. v. Cutler remotely anything only resem- to failed F.Supp. (D.D.C.1979), 475 838 the court refused “general bling presumption unreviewa- equity grounds require to FDA to take cer- it, pull bility” from but would the dissent drugs tain off the market. Id. at To question simply nothing had to do with the supports in extent dicta proposition the broader Cutler agency discretion. that certain FDA duties are not mandatory, and FDA’s actions cannot be reviewed, expressly disapprove we it. final, negative, disposi- but 37. Under the APA a agency petition for of an authorized tion light strong presumption favoring judicial subject review. See judicial is final order to review Pre- articulated in Citizens to (1982). 402, 551(6) Park, Volpe, serve v. Overton Inc. 401 U.S. investigate necessary uncontroverted evidence will and take all ac- particularly appellant, agency’s submitted use prevent unapproved ap- tion to for If upon Statement, stated reasons its action. exam- Poliсy proved drugs. Fed. ination the record does not satisfy Reg. policy at 16504. The statement makes review, the appropriate standard of exception no for state-mandated activity, its action be vacated. If FDA’s inac- must an ac- provide the Commissioner must arbitrary, tion in capricious, this case his ceptable refusal explanation why law,38 authority without and our own act in this case is not in contravention of analysis of the record leads us believe it he has that 1972 statement.41 far not. So was39 we must remand this ease for appro- A “good uncertainty legal faith” about au- priate action. to decline to thority may be sound reason see brief proceedings, bring enforcement First, the Commissioner stated that 15, is appellee at willful indifference his “scope legal authority” regu not. We do not understand how Com- late injections capital in state punish legal authority missioner can assert to regu- ment systems uncertain.” Brief “highly late used both state-licensed clini- appellee argument 14. But sim cal and state-licensed veteri- ply repeats investigations his meritless contention that assert, equal jurisdiction nary practices FDA did have and not the first confidence, Moreover, place.40 directly authority regulate contradicts used statement, FDA’s own policy capital punishment prac- issued in 1972 state-licensed effect, and still in which declares that FDA It simply tices.42 irrational —and thus allegations injection 38. The District Court reviewed statement factual that lethal does not only completely to determine whether FDA had “quick painless” cause a death that it statutory responsibilities. abdicated its “poses a substantial threat of torturous and 15, Dist.Ct.Op. 229. This kind of review unnecessary being pain persons executed” applied pursuant action taken 18, Complaint must be assumed to be true. specifically preclude judicial statutes which Digest Ass’n, JA 9. See Wolston Reader’s view. undertake Courts such review 157, Inc., 5, 2701, 443 U.S. 162 n. 99 S.Ct. flagrantly ig- ensure that the does not Wood, (1979); Bishop n. L.Ed.2d specific statutory See, e.g., nore mandates. 426 U.S. 347 n. 2079 n. Kyne, Leedom v. 358 U.S. 79 S.Ct. (1976); 48 L.Ed.2d United States v. (1958); Employees Hotel Local No. Diebold, Inc., Leedom, 255 v. (1958); Employees Office Int’l Un- ion, NLRB, 11 Local No. v. U.S. supra. 40. See Part II (1957). 1 L.Ed.2d 846 contrast, By reviewing when policy a 41. This statement asserted broad re- “arbitrary capricious” test, under and * * * sponsibility “investigate to and to take courts must assure themselves that the “ protect to whatever action public.” warranted discretion, ‘has a exercised reasoned with rea Policy Statement, Fed.Reg. at ignore sons that not do deviate from or ” recognized specifically 16504. It that the Act legislative ascertainable intent.’ Lead Indus regulate practice purport Ass’n, EPA, to “did not tries Inc. v. (D.C.Cir. pa- physician 1980) (quoting and the medicine as between the Greater Boston Televi FCC, Corp. nothing (D.C.Cir.1970), sion tient.” It mentioned F.2d Id. at denied, activity. exempting rt. U.S. about all state-licensed ce (1971)). gain 29 L.Ed.2d 701 Courts such as only by reviewing surance the facts relied asserted, 42. The Commissioner has not upon, record, the other facts in the the relevant point, budgetary pre- that constraints would considered, factors and the available alterna taking appro- investigating vent FDA from EPA, Ethyl Corp. tives considered. priate While no occasion to action. we have (D.C.Cir.) (en banc), denied, cert. hypothetical explanation, address we do this rejected courts it in situa- note that other have not, tell, The District did Court so far we can Congress (or agency) tions where promised has adequately explore agency’s decision to de See, e.g., that action will be taken. engaged termine if it had making. in reasoned decision- Califano, Action Adams v. D.D.C. No. Civil 29, 1977); Hoffmann-LaRoche, (Dec. 70-3095 30; Weinberger, supra 39. The American case was decided on a motion Inc. v. note below summary Therefore, Veneman, supra judgment. appellants’ Public Health Ass’n v. permit to mis- purport[] believe that merce or that capricious arbitrary —to branding shipment after *.” Brief jurisdiction unap- has over the 20 n. 21. If sоme state laws two can use in the former proved drugs appellee practice. health,” the latter but not in practices danger public to the pose a “serious presumed, in the face of no state law can be Second, asserts the Commissioner to contrary, evidence to the not substantial injections in does drugs the use of lethal Rather, rationally can distin- do so. public to the health.” pose danger a “serious that do endanger guish between laws Brief for at 15. But he cites no appellee laws that do not public health and proposition. to this Rath- evidence In available evidence. upon the basis of er, “duly irrebuttably presumes he au- * * * this case all lethal evidence shows statutory thorized enactments [which laws do drugs, injection endanger users cannot, functions” proper State further] public Finally, and thus the health.43 law, a to pose danger a matter of such rationally claim cannot stand next FDA’s public. Letter from the Commissioner at prisoners earlier in clinical assertions light remarkable in 88. This claim is investigations dogs veterinary in clinics appellants the uncontroverted evidence sub- danger” unap- were in “serious from the FDA, mitted to which shows that drugs If proved approved drugs. use of injections pose used in lethal a substantial pose in these contexts a “serious used persons pain being threat torturous Royal Capital health, certainly the public threat” to then executed. Commission on Report pose to kill human such a beings used Punishment, (1953), 1949-1953 Ex- short, threat.44 the Commissioner Secretary, hibit 1 to Letter JA 34-40. concluding Furthermore, presents no rational basis for flies in face claim injections a pose admission that FDA has do serious Commissioner’s jurisdiction Thus we must conclude that pur- over all state laws “that health threat. port has legitimize shipment arbitrarily, capriciously, the lawful he acted ] an unapproved new in interstate com- without of law.45 authority violation, imply gather subject alleged statutory 43. We do not FDA must to this concerning pоtentially danger. evidence the health effects of all more are in over 900 statutory alleged supra. Only accompanying violations to survive a cal text note 8 scrutiny. simply We hold that FDA cannot lous mind would claim that this is not serious irrebuttably presume particular practice danger public particu that a health. The claim is pose public danger larly light regulation does not a “serious irrational of FDA’s practice prisons, practices health” because that is sanctioned clinical where give equally prisoners state law. FDA must rational reasons small number of serve as sub why practice pose presumed jects experiments. can itself See 21 50.1 et C.F.R. danger public deny petition Finally, seq. (1983). no if it is to it is established doctrine that, investigating allegations, particu- Congress specifically without larly unless otherwise petition presents decided, litigation private where the substantial resort to cause contrary. adequate evidence of action is not an to an alternative agency performing its administrative lawful See, e.g., function. Medical Committee for Hu appeal government 44. On counsel contend SEC, 659, (D.C.Cir. Rights injection man v. 432 F.2d 672 403, lethal statutes cannot threaten the moot, 1970), because, public by definition, vacated as 404 U.S. 92 S.Ct. they apply health (1972). Mega 30 L.Ed.2d 560 See also only persons to a small number of convicted of Lewis, pulse, offenses, v. 672 F.2d 970 n. 57 capital Inc. persons and such have exten- 1982) (D.C.Cir. (discussing adequacy of alterna legal protection sive under other laws. See remedies); v. tive Investment Co. Institute appellee preliminary brief for As a at 15-16. System, matter, Reserve 551 Board of Gov’rs Fed. properly we note that courts affirm 1977) (D.C.Cir. (same); reasons, agency’s F.2d 1279-1280 on the basis of Stanley Chesapeake Harris & Land Co. v. subsequent Coal not on rationalizations ‍​‌​​​‌​​‌​​​​‌‌‌​‌‌‌‌​‌‌‌​‌‌​​​​‌‌​​‌​​​​‌‌‌‌​​​‍of coun- Co., (6th Cir.1946) Lines, Ohio R. 453 & Burlington sel. Truck Inc. v. United (same). States, 156, 168-169, 371 U.S. 245-246, But, 9 L.Ed.2d 207 more to point, government compelling particularly the quent even This counsel’s subse- conclusion with rationalizations would not make FDA refused to take action rational since response. persons presently category allegedly pro- regard Over 200 are entire to an

1191 ing III. Conclusion sufficiency agency’s reasons would be inconsistent with statute’s Tamm, Judge for writing this court over goal expeditiously protecting consumers ago, a decade once noted that “assertions of questions alleged discretion from the We be inevitably raise de- hazards. must gree which must be in the con- appraised to prepared compel FDA take to action provisions text the relevant of law and respect prayer for relief where the nature of the particular sought acceptable explanation of inaction is question reviewed: is not ‘[T]he promptly forthcoming.47 not whether agency action is law committed presented Appellants have substantial discretion what extent to support ” uncontroverted evidence agency action so committed.’ Medical their claim that injec- execution SEC, Rights Committee for Human su- v. cruel, tion poses protracted a serious risk of 432 pra, (quoting F.2d 4 K. Davis, Royal Capital death. See Commission on (1958) Administrative Law Treatise Report (1953), 1949-1953 Ex- Punishment, (emphasis Judge Tamm). Agency en- hibit 1 Letter the Secretary, supra, based, forcement decisions are inevitably slight in dosage 34-40. Even error or measure, large not particularly factors prisoner administration can leave a con- resolution, suitable to and thus give courts these scious but while great degree paralyzed dying, decisions a sentient deference. But courts are responsible also slow, witness of his or her lingering own ensuring that government officials do asphyxiation. brief appellants negate congressional not or frustrate enact- risks, light 10-11. In of these FDA’s im- through ments bureaucratic arbitrariness. permissible refusal exercise enforcement public Courts must assure the that the vast over use for lethal powers agencies exercise are subject de- injection jurisdic- use well within the —a cent and civilized case, restraints.46 In this FDCA, tional ambit of the see Part II supra despite expert testimony concerning the —may implicate Eighth also Amend- dangerousness of using barbiturates and ment’s prohibition cruel and unusual paralytics to execute human beings, punishment. Commissioner of FDA refused take any In a society, civilized if we assume we investigatory regulatory He pro- action. must may take the life of glib vided a statement of reasons for the person punishment, decency demands agency’s inaction that cannot ju- withstand life be taken without cruelty. The Hence, dicial review. we must vacate the Eighth Amendment embodies society’s District Court’s judgment in this case with quirement punishment the means of instructions to order the agency to fulfill its statutory torturous, be barbarous see function. v. Gregg Both this court and the District Court Georgia, must be mindful endless U.S. S.Ct. litigation, case, in this particularly 2909, 2922-2924, concern- (1976); activity. especially hibited willing 1163-1164;. Courts Terminal note 480 F.2d at (or recalcitrance) Freight Handling Solien, to review lassitude Co. 444 F.2d 699 Mathews, magnitude. See, e.g., denied, (8th White v. Cir.1971), cert. denied, (2d Cir.1977), 559 F.2d 852 cert. Templeton (1972); L.Ed.2d 465 Co., Printing v. Dixie Color (5th general (challenging delay processing Trailways England, Cir.1971); of New Social Inc. Security disability appeals); CAB, Adams v. Richard (1st Cir.1969). 412 F.2d 926 For other son, supra (challenging inaction, note 22 addressing agency HEW’s see cases pplicy enforcing supra. Rights of not Supreme definitively Title VI of the Civil Act Court 1964). Bachowski, of Dunlop issue, addressed the see supra note 575-576, 421 U.S. at S.Ct. generally Vorenberg, supra See logic presupposes note 32. but its that agency court order can an to take affirmative ample precedent 47. There is enforcement action. See id. affirmatively ordering agency J., District Court in (Rehnquist, concurring in in the result See, e.g., Richardson, supra Adams v. part action. dissenting part). and forth for the reasons set 436, 447, 10 I would affirm Kemmler, 136 re opinion. court’s district are (“punishments 34 L.Ed. 519 lingering or they involve torture cruel when Discretion I. Enforcement gives even to death”), the Amendment and Food, it were correct Even if punish right row the those on death makes the chal Cosmetic Act Drug, and In this case FDA ment is not cruel. dis majority’s lenged drug illegal, use enforcement clearly refusing to exercise supporta not be position would of case it does not wish to be discretion because governing law well established ble under morally an so come embroiled in issue agencies’ of enforcement judicial review the death pen constitutionally troubling enforce speaking, Generally discretion. an Yet amounts to abne alty. this action of this are the business priorities ment not statutory responsibility by of gation whom, Branch, but of the Executive —to charged has Congress very agency courts, con the Constitution not to do people that our ensuring task to “take Care responsibility fides the drugs. misbranded not suffer harm from executed,” U.S. faithfully Laws supra. Part III-B Const, II, Preserving that sound art. Though statutory this failure to meet responsibility one allocation alone to invali- sponsibilities is sufficient primary purposes, perhaps and has been case, we date the FDA’s inaction in this of the Admin application, provision of that failing statutory its exercise excludes Procedure Act which istrative responsibilities places FDA also serious bur- ... “agency from review action right dens on to a death that is appellants’ law.” 5 committed not cruel. As a the FDA’s inac- result of As 701(a)(2) (1976). this court U.S.C. § tion, appellants of a face the risk cruel stated, agency’s decision accurately “[a]n deprived are the FDA’s execution and or enforce investigation an an refrain from as to expert judgment the effectiveness of generally ment unreviewable.” injection, used for lethal the lat- SEC, (D.C. Kixmiller v. 492 F.2d making any challenge they ter fact direct Safety on Cir.1974). See also Action might to this method of execution bring FTC, (D.C.Cir. Health v. Thus, though more difficult. even FDA is 1974). in a explained The reason is well responsible execution these easily that could more Supreme Court case prisoners, failure to its statutory its meet judi regarded appropriate have been well responsibility may place constitutional- policy cial control of enforcement ly impermissible on the Eighth burdens one, non- present than the since involved rights appellants. Amendment companies com against some against bined with enforcement others: Vacated and remanded. within shaping of its remedies [I]n regulatory legislation, the framework of SCALIA, dissenting: Judge, Circuit called exercise designed a law majority converts Thus, specialized, experienced judgment. protect against drugs consumers that are an order the decision as to whether represented unsafe ineffective for their against one firm to cease desist use into permitting a law not price discrimination engaging illegal supervision federal of the man- mandating into before others go should effect implausible ner state executions. This variety prohibited depends similarly by rewriting result is achieved the law with expert peculiarly within the factors regard to and ignor- enforcement discretion understanding the Commission.... ing regard jurisdiction. it with to FDA I empowered alone is Commission [T]he dissent me a best cal- policy from what seems to clear develop belong contemplated intrusion ends upon powers that to Con- culated to achieve the available gress, the to allocate its by Congress Executive Branch and states.

H93 personnel way agree[d] funds such a the Court of Appeals, its economi- policy efficiently execute opinion, reasons stated in its cally. 79, (CA 1974), 86-88 3 that there is no merit in the Secretary’s contention that FTC, 411, 413, Moog Industries v. 355 U.S. his is an decision unreviewable exercise of 377, 379, (1958). 78 2 L.Ed.2d S.Ct. 370 prosecutorial 171, 179, discretion. also v. 386 Sipes, Vaca U.S. 87 903, 911, 17 842 S.Ct. L.Ed.2d 7, Id. at 567 n. 95 at 7 (empha- S.Ct. 1858 n. The view majority opinion gives its of added). sis An examination of the cited enforcement discretion the of appearance pages appellate opinion pro- court’s reality by from Court quoting Supreme duces no language hinting “strong even аt “strong presumption” cases that assert a presumption” of reviewability, but rather reviewability “clear rebuttable the contrary implication in its observation convincing” legislative intent negate refusal every by Government “[n]ot Maj.Op. view. at 1183-1184 n. These statute, official to take action enforce a are excerpts misleading, they since however, unreviewable,” Bachowski, su- taken from or portions cases of cases pra, 502 at (emphasis added). F.2d 87 that do not involve review of enforcement court of appeals necessary finds to care- Indeed, discretion. all but one them fully distinguish type of enforcement come from cases or portions cases do responsibility given the Secretary under the not even deal agen- with the “committed to typical L-MRDA the more case in cy discretion” provision of APA which a decision not to enforce is unreview- (§ 701(a)(2)), but rather with provision Bachowski, able. 502 at supra, F.2d 87-88 that denies review “to the extent .. . Thus, & n. 11. Dunlop princi- reaffirms the preclude statutes review” ple general unreviewability of enforce- (§ 701(a)(1)). The citation to Dunlop Ba- ment decisions. chowski, U.S. n. 95 S.Ct. Supreme The other Court cases cited n. 44 L.Ed.2d (1975), the majority position. also do not illustrative. The of appeals court in that Gardner, Abbott Laboratories v. case, Brennan, Bachowski (3d 502 F.2d 79 (1967), S.Ct. 18 L.Ed.2d 681 Cir.1974), rejected separate considered has even present less to do with the case arguments by the Secretary of Labor that than the portion Dunlop, involving first (1) the Labor-Management Reporting and neither “agency exemption discretion” Act Disclosure 401 et U.S.C. § (5 nor 701(a)(2)) enforce- seq. (1976) (“L-MRDA”), precluded judicial ment Congress action. The Court held that review his failure to institute civil did not to “preclude judicial intend review” set election, aside a tainted union (5 701(a)(1)) of rule-mak- U.S.C. § 84-86, at his decision ing to the prior stage. prosecute was committed to agency discre- U.S. S.Ct. at 1512. tion, Citizens id. at 86-88. Supreme Court ad- Preserve Park v. Volpe, Overton dressed the first аrguments of those in de- tail, Dunlop, supra, 421 U.S. at (1971), at least involved the provi- relevant at 1857-58. In the context of its APA; sion

preclusion it did not involve discussion, the Court established discretion, and therefore the absence an express “[i]n [statu- tory] prohibition,” Court’s dictum to the effect that excep- there “the strong exists tion for presumption Congress action “committed to discre- did mean prohibit judicial review,” tion” all is to be construed does not narrowly id. at It establish what the majority suggests. statement Un- which the here less majority Supreme In re- one assumes Court relies. however, sponse, Secretary’s casually setting wildly second a rule out forth contention, which law, is the prior contention issue accord with case the obvious in the present case, the Court meaning of “narrow construction” was an was not in the case before the court exception the sertion would limit

application regard a oth- to few enforcement “with merely discretion and deficient enforcement strong a tradition of a where either in the course er matters a few school districts of expectation) (and congressional therefore program,” effective enforcement generally exists, see, e.g., Curran abstention judicial express[] and but rather “conscious[] (D.C.Cir.1969) (en Laird, v. which is in a [adoption general policy of] legislative commitment banc), specific or a duty,” statutory of ... effect abdication an evident, v. Ba- Dunlop see to discretion not consisted nonenforcement (3) the chowski, supra, 421 U.S. “affirmatively inaction but of merely of J., concurring in the result (Rehnquist, to de federal funds continuing] channel part).1 in part dissenting in in (emphasis Id. at 1162 schools.” faulting nar- support (The no more of the second original). centrality Cases in this circuit exception rowing “agency the discretion” recent en banc emphasized our point was of a application an by Bell, across-the-board of Adams decision of than do the “presumption reviewability” (D.C.Cir.1983).) 167 & n. 35 have Supreme decisions of the Court.2 We opinions the of this and panel Nor are subject two en banc to consider the on sat by majority courts cited the other circuit case, first Curran v. occasions. the of novel assertion probative the more Laird, we held that the Executive’s supra, of of en- “presumption reviewability” of a from the ships decision not withdraw of them sets forcement decisions. None national reserve fleet fell within defense all of startling proposition, a forth such “span pertaining of executive the actions — circumstances over- display special them establishment, cur- expansion, to the fleet’s presumption of nonre- coming the usual tailment, and use —that maintenance Thus, the viewability. requiring case within the ‘committed discretion’ the the of agency to enforce restrictions meaning 701(a)(2)].” of [5 Resil- (Carpet, Linoleum & Davis-Bacon Act no opinion F.2d at 128. Our made mention Local No. Layers, ient Tile Union “presumption reviewability,” though of a (10th Cir.1981)) Brown, in- 656 F.2d 564 J.) 140. (per Wright, the dissent did. Id. at oper- we volved the third factor that found second en banc consideration of this Our Richardson, supra: ative in Adams v. Richardson, general subject was Adams v. funds to channeling were federal agencies (D.C.Cir.1973), 480 F.2d 1159 which not split The those in violation of the law. “agency exception, involved the discretion” Environ- panel of a of this court in decision to en- precise application considered Fund, Ruckelshaus, Inc. v. mental Defense again forcement discretion. We did (D.C.Cir.1971), relied a 439 F.2d 584 reviewability” any “presumption invoke by agency making very statement decisions, but to the con- enforce- mandatory finding triggered distinguish the trary necessary found it statute; governing ment under the cases prosecutorial on stan- reviewing generalized (1) support “do not and while grounds that those cases discretion,” had estab- claim as- which the proof to absolute dard of above, (footnote dispute 25) explained majority I do not The As asserts Supreme interpreted requires expression provision Court itself Over- clear latter fashion, case ton Park in this since it cited that legislative intent. Dunlop proposition Secretary of Labor’s exercise 23) (footnote majority’s response fash- majority over- discretion was renewable. looks, however, sepa- quite of this dissent’s ions a mixture out Dunlop portion that both the regarding Supreme case Court rate assertions appears portion which the citation hand, law, case law of this the one and the on refers, Park to the citation deal Overton which appeals, the other hand. courts of other possible posed with the bar to review —not assertions, unmingled, and must I stand 701(a)(2), discre- “committed to dialyze majority leave it to reader provision 701(a)(1), tion” which —but opinion. statutory preclusion lates to review. discretion, is, lished for the exercise of its The short matter far from there being “presumption of reviewabili- pointedly court declined to review its find- ty” with regard enforcement determina- ing as to whether that standard had been tions, the well known presumption pre- is (In met. at 439 F.2d 595-96. the instant cisely contrary. the As the author of the case, contrast, the by agency has made a majority opinion dissenting noted in from finding danger that there is no “serious Laird, our en decision banc in Curran v. the public health dr ... blatant scheme to supra: defraud,” Letter from the at Commissioner “presumption This of reviewability” is Jt.App. and it is finding at which often as regarded reversed certain review.) the claims majority power to The types of Executive actions. Actions re- ‍​‌​​​‌​​‌​​​​‌‌‌​‌‌‌‌​‌‌‌​‌‌​​​​‌‌​​‌​​​​‌‌‌‌​​​‍panel of decisions this court in Natural Re- lating foreign to the conduct of or mili- Council, SEC, sources Defense Inc. v. tary normally have not been affairs (D.C.Cir.1979), WWHT, F.2d 1031 Inc. courts, by exceptional viewed absent FCC, (D.C.Cir.1981), are not circumstances.... Thus we would not apposite, they since involved refusal to con- normally review the failure of the Execu- duct rulemaking, rather than enforcement tive grant- to exercise emergency powers discretion in sense of а refusal pro- purpose ed it for meeting of the mili- against ceed law alleged And violators.. tary needs of nation. context, even in that the dicta of these J., 420 F.2d at 141 (Wright, dissenting). cases presumption do not of re- Enforcement decisions are unquestionably viewability in sense here issue. Nat- one of those “certain of types Executive ural Resources Defense Council states that action” to which this analysis properly ap 701(a) the totality (which of § reads “This plies. Even those who general favor review chapter applies, according provisions of decisions not to undertake enforcement thereof, except to the (1) extent stat- that — acknowledge that it will constitute a review; preclude judicial utes agency law, change in the since “reluctance to re action is committed to agency discretion Note, view remains entrenched.” Judicial law”) a “strong presumption creates of re- Inaction, Review of Administrative 83 Col. viewability,” 606 F.2d at 1043. Undoubted- (1983). majority seeks L.Rev. ly so. But does suggest that that the citing dismiss established law by Profes presumption applicable to the totality of sor Davis for the proposition that “the real applicable action is to the narrow ‘key lies in the law recognizing has category of action of consisting refusal been in case transition and that the law adopt rules. To the contrary, the opinion strongly on the side review- [is now] ” makes it respect clear that with to that ability.’ Maj.Op. at quoting category “the relevant factors incline Davis, from 2 K. Law Administrative Trea against reviewability,” id. at 1047. As for (2d 1979). 9.6 at 239-40 ed. This also tise WWHT, (which its dicta again are applica- is misleading. quoted statement was ble only to the weaker case refusal to made in the context of a dealing discussion adopt rules) upon are based a terminology largely with the discretion which problems resolves the at issue here prosecutors, criminal which had previously under the of “scope rubric of review” rather been (as asserted to be not merely cases than “reviewability.”3 regard establish with to the enforcement particular opinion When action can be set at 809. I have used the former only category aside prefer the courts for a narrow formulation —not I it but because (e.g., complete alleged used, infractions majority abdication because what is responsibility, see Adams evident from the fact that all of the issues Richardson, supra) possible portion it is to describe here discussed are addressed in that by saying either opinion situation entitled “Judicial Review of En- Discretion,” generally Maj.Op. action is not reviewable or that it is rather forcement scope very portion “Scope reviewable but “the of review than entitled Judicial [is] narrow,” WWHT, FCC, supra, Review,” Inc. v. Maj.Op. meaning phrase public”; tect the agencies) gen- of administrative unreviewable, Ap- entirely necessary.” Legal so. As a Status of “when

erally Prescription Drugs; bald whether proposition, Labeling refutation of that proved en- or administrative applied to criminal Unapproved for Uses Prescribing ac- forcement, entirely statement Administration, Davis’s Fed.Reg. Drug Food and statement, nor the curate. But neither the Moreover, last cases, relies, support gen- which excerpt, which quoted paragraph reviewability presumption eral give precise more apparently intended sense at issue here. suggests paragraph, content first then, premise Proceeding, actions, discretionary intended fortiori) or (a exercise nonexer- agency’s an are, be taken where only are to they is gener- cise of its discretion ... “any in the chain of distribution person unreviewable, must ally one consider indirectly or directly does anything circumstances special whether there to the physician patient suggests general from that rule justifying departure be may properly approved drug that an none, I aware of present in the case. am applies, uses.” Id. It unapproved used for opinion assuredly and the has majority words, has oc- misbranding in where other (footnote 29) suggested any. Its reliance in the (as be discussed curred —which will the upon mandatory the terms of statute next is not here. the ease part) person be (“any who violates ‘shall’ § however, fundamentally, quoted More the fined,” citing imprisoned rule, and is agency statement is not an half-hearted, 333(a) (1976)) proper- is § policy not even an authoritative indeed ly so. Most of the criminal code is cast in it opinion majority’s gives statement. The terms, mandatory yet prosecutors’ such (which the it never “Policy title Statement” indict archetype discretion not to is the of bore), at 1176 Maj.Op. see & n. and uses unreviewable enforcement discretion. Be- conclusory designation throughout. Department, it is the sides which Justice fact, however, the part statement was FDA, rather the than executes Notice justification the set forth in a policy 333(a). 21 U.S.C. 335. with to a Proposed Rulemaking, respect opinion The places major upon reliance proposal adopted. that was never Statement,” what it FDA’s “Policy calls the quoted the id. paragraphs majority, the portion relevant which is set forth at them, the first of particularly page 1186. Even if agency’s an failure to that are more principles specifically recite follow its rules regarding poli- in the recited text subsequently embodied cy (which case, is reviewable may not the C.F.R., to 21 proposed the amendment e.g., Snell, see United States v. 592 F.2d is Fed.Reg. see 37 at 16504. It remarkable (9th Cir.1979)); if the and even state- that, the the suggest although to text of ment in question an agency constituted rule rejected, rule substance of that was the not, (which it did as will be discussed be- adopted by text was the authoritatively low); it impossible is see how that “rule” Proposed mere recital of it in the Notice of has been violated here. statement Rulemaking. (as if one is to I accept Even terms, full of precise flexible applica- to) am expansive not inclined dictum be, tion of which was intended obviously two majority of our cases referred to be, properly and could left to ‘to enough the term “rule” is “broad of the agency example, whether an —for statement unapproved “widespread”; nearly every use has include an become ” health”; make,’ whether Auto “endangers may Safety public Center particular NHTSA, (D.C.Cir.1983), what action “is warranted to 710 F.2d pro- interesting instances) (availability It is it is note that Professor Davis’s of review in some applied “prosecutors’ statement not to discussed text to de- not prosecute,” decisions extended prosecute. cisions to Even in the limited sense as to which “the law is still some- supra, which that to be 9.6 at statement understood what unclear.” K. Davis Marshall, legal with quoting nothing Batterton v. That status has to do (D.C.Cir.1980), surely exceptions rigid obligations detailed enforcement must least princi opinion suggests include statements of which the has ples thinking adopting that the imposed itself. It is ultimately adopt. decides not Thus, ultimately there is no factor special irrationality height equate extraordinary assertion of rejected (what of a rule with

prologue authority to enforce- agency’s control involved in Center for Auto Safety) the present ment discretion in case—noth- its rea agency’s authoritative statement of disagreement ing, except majority’s son notice withdrawing proposed agency’s determination no observed, rule. Center Safety As for Auto public health exists. danger serious Sys quoting Broadcasting from Columbia only public But we are not the officials tem, States, 407, 416, Inc. v. United intelligence worthy endowed with (1942): L.Ed. trust, system and our of laws has commit- what [agency] is the substance of [I]t health public ted relative evaluation purported to do and has done which is Moreover, concerns to even if the others. decisive. clear of an reason agency’s erroneousness Here, at 846. what the for not conducting activities purported to do its proposal and did and were a for proper basis our intervention nonadoption was was to nothing it (which not), —unless it is there is no clear error here. the disapprove principles which the proposal the humane concerns as- belittling Without prologue and its contain. sociated with the it must present complaint,

The opinion remedy acknowledged public seeks to this be that the health in- patent that the still at deficiency observing widespread “FDA terest issue is not death or Policy (at most) considers so-called but a risk permanent disability, of [the Statement] effect,” binding and to have num- temporary pain relatively substantive to a small 1186. Maj.Op. at That is not The (200, majority so. ber of individuals which the majority’s 1,100 citation to that to by including prisoners conclu- swells under portion sion is to Memo- of states that have not agency’s sentence death in randum in Support statutes). of the Defendant’s Mo- lethal More- adopted injection Dismiss, tion (in referring over, which turn to it is pain not a matter of versus no the response Commissioner’s letter the of pain, pain but rather one sort substituted Appellants’ request) concedes the pain that for of another —and in all likelihood forth agency’s position Notice sets the pain, substitution of a lesser since “the status legal labeling injection for of approved principal purpose the the lethal statutes,5 circumstances, prescription drugs.” Jt.App. at 131 n. these Gimlin, Administering Penalty, years 5. See the Death for could have added that veterinarians injection Rep., Weekly have considered the lethal most Editorial Research Ser- Reminder way putting hopelessly crippled vice, “humane” August 1977: misery. diseased animals out of their public hanging, with The atmo- circus Report majority, repeatedly by The cited sphere, disappeared early in America in this Royal Capital Punishment, 1949- Commission on chair, century. But then the electric installed (1953), said that “intravenous Report in- snuffing as a more humane device for out jection, practicаble, if would fulfill our three life, produced grim host stories humanity, requisites certainty decency] [of gas witnesses the death scene. The cham- better than other method.” Id. ber, usually regarded by penal as an officials doubted, however, Report the method’s improvement chair, requires over the electric practicability, basis of knowl- on the medical strapped-in a sealed room and a victim .... thirty years edge technique ago, and there- Oklahoma and have Texas since moved rejected being, fore it for the time but recom- direction, providing a new for execution mended, “unanimously emphatically, injection. hope lethal “I think and I this will examined, periodically question should provide death,” dignity some Texas light progress especially made in in the Dolph May anaesthetics, Gov. Briscoe said last he when with a view to a science signed injection law, being into change system proposed bill Briscoe ... to Parliament authority the existence of FDA lethal establish hardly clear error determine The majority requested take the action. do a “serious injection pose statutes not It point this as well. health,” opinion carry fails danger justifying public agency’s reliance demolishes properly FDA resources diversion of action, see Maj.Op. at 1179- upon state Indeed, it seems to me projects. from other not the more serious does address pose do a serious they the conclusion jurisdiction depends upon obstacle: danger fanciful.6 under misbranding existence ring” which the As the “anachronistic established under 331(k), which cannot be majority hears in all (Maj.Op. at 1188 the facts of case. court, 36): n. If clear of this statements opinion concludes and sum- majority Safety see Kixmiller Action on jurisdictional its discussion on marizes Health, supra, downright become anachron- point as follows: years, perhaps stop isms in nine we should pur- injection statutes however, The states’ opinions. our I publishing fancy, pre- use of certain port to mandаte the which majority sound heard not listed on scription purpose for a all, ring was not an anachronistic but the FDA therefore must their label.... decisis, or cry stifled of smothered stare regulate such activi- jurisdiction have perhaps the far-off of well estab- shattering ty- separating proper lished barriers busi-

ness the executive and branches. at 1182 Maj.Op. (emphasis added). This progression does thought follow

II. Jurisdiction opinion unless the establishes intermedi- If, however, “using prescription issue is found ate proposition FDA, listed on their label against purpose it becomes necessary only by presented soon of the that these as it can be shown that there are no virtue fact written, however, longer any grounds for now the ex- the doubts that state laws. As were recommending cerpt specific us deter from it.” Id. at 261. the nature of these laws refers to Report’s concerning (“lethal injection laws”) verdict the alternative therefore does —and prisoners means of execution that these 200 will good not calculus exclude the Commissioner’s undergo drugs descriptive if lethal not are used is a text. The factors discussed in qualified: authorized, etc.,” phrase, duly less cannot deal recom- “[W]e are “which gas-cham- mend that either electrocution or the important in the Commission- flects an element replace hanging ber necessarily should as the method of analysis, dis- er’s but not country. execution the at- positive interpret an one. To the statement as ‘humanity’ tributes have called we ‘certain- provided by that assertion whatever lies, balance, ty’ advantage hang- challenged law the FDA would will not be ing.” at 256. Id. quite incompatible with it the Commis- render paragraph preceding in the sioner’s statement majority opinion preclude 6. The con- seeks course, provi- say, not that do that “[w]e sideration of the the matter realities of as- contrary of State law that are sions serting “irrebuttably that the Commissioner Food, Drug, Act are law- Federal and Cosmetic рresume[d] ‘duly statutory authorized en- ful.” Id. * proper actments State [which further] majority’s authority for the asser- There is no cannot, law, pose functions’ as a matter such statement of “no tion that Commissioner’s danger public.” Maj.Op. at 1190. danger public health” is not serious enough, That so. What not the Commissioner wrote “give rea- but that must rational he was that cannot conclude that those dan- “[w]e why Maj.Op. that is sons” so. at 1190 n. 43. gers public a serious risk to the or a [of health Indeed, authority proposi- I for the know no present blatant scheme to under defraud] ground provide any tion that an must injection laws, duly State lethal which are au- comply request with a for its refusal to statutory thorized enactments in furtherance discretion, of its enforcement much exercise less ing proper State functions.” Letter the Com- analysis underly- provide it must 3, Jt.App. added). (emphasis missioner at If, at 88 ground. seems to me one of those This excerpt, phrase injection” in that “lethal procedural requirements we have been novel omitted, were placed word “which” were re- Nuclear told not to invent. Vermont Yankee they,” with the words “since it be would NRDC, Corp. Power possible to assert that the Commissioner was maintaining that no serious health hazard was utory language sale,” unlawful under the FDCA.” It makes no “held for it is clear attempt proposition prin- to establish that that when the House Report, quoted by the — think, I cipally because it is impossible do 1181), majority (p. said that intent so. The FDCA is directed at the sale and the 1938 amendment was to “extend the distribution of rather their than use. protection of consumers contemplated by The only provision that could remotely ap- the law to the full extent constitutionally ply prohibition against here is the “the do- permissible,” it using the word “con- ing of any respect ... act with to ... sumer” in the “purchaser” sense of rather drug ... ... results in such article [which] than “ingester” just as “consumer protec- — misbranded,” being ... 331(k). 21 U.S.C. § tion” shoppers refers to rather than gour- adopts Even if one the extraоrdinary notion mets, price and the consumer pur- index to a person causes an article to be mis- Thus, chasers rather than eaters. in the branded simply using for a purpose statute, context of discussion of this label, 331(k) stated on the would still notion majority’s “unwilling consum- apply, since—in accordance with the er,” Maj.Op. does not compute. Act’s focus sale and distribution rath- None of the cases upon by relied er drug than use —it requires that the mis- majority the principle of expan- branding occur “while such article is held sive interpretation involves an expansive- (whether for sale sale) or not the first after ness beyond field of actual sale. United shipment in interstate commerce.” Id. States v. Sene X Eleemosynary Corp., 479 Here are in possession F.Supp. (S.D.Fla.1979), involved the is- penal states’ authorities. Under no conceiv- sue of whether the able was “held for sale” interpretation of the English language when it was compounded could with another they be deemed sub- “held for sale.” sale; stance for United States 10 Cartons The majority opinion out, points quite Labeled, Part, “Hoxsey”, 152 F.Supp. 360 331(k) correctly, was added to the (W.D.Pa.1957), held (erroneously, as later Act with the intent of expanding its appli- case established) law has physician cation. Given the fact that pri- Act’s it, can misbrand a drug by using part mary application was to commercial trans- a paid-for therapy, for an unapproved use. actions, it was a vast expansion to extend it Even those sharing majority’s apparent to sales within a state after the first sale disdain plain for the meaning statutory following shipment in interstate commerce. language pressed explain would hard Nonetheless, that expansion was still limit- why, express to the of concept any trans- ed to misbranding which occurs “while such mission ingester (as to the ultimate opposed article is held for sale.” This is a statute purchaser) ultimate of the drug, Con- that bears penalties, criminal and it is sim- gress should choose the peculiarly inapt ply possible disregard to qualifica- phrase “held for sale.” And the conse- tion entirely, as the majority would do. It quences that ensue are as as the implausible is sometimes improper to “look only to the statutory language,” interpretation produces them: It Maj.Op. 1181; can- but not seriously thought that the it is household- always improper opens the gates —and er who drug much administers a to his child for widely more to ig- abuse —to use, nore an unapproved places or who it in an statutory intentional language entire- Thus, ly. I unmarked bottle on his medicine shelf would acknowledge that the use, expansive approved administer later for an vio- intent of the amendment bemay Food, invoked to lates the provisions extend the criminal of the statutory text to all “holding” Drug, short, drug occurs while the and Cosmetic Act. In even the stream of giving phrase commerce from the for sale” the mini- manufacturer “held consumer, to ultimate see United mum content it can contain with- possibly States v. Co., Wiesenfeld Warehouse reading out it out of statute entirely, the it 11 L.Ed.2d 536 (1964). does not cover the a state for holding by But not beyond that point. Given the stat- purposes of coerced of the administration pertain- as alluded to pun- of sions such above capital a sentence drug to execute use, context, is as investigative drug the to clinical or ing ishment. as drug the ultimate consumer of giving much in the statute nothing there rejected arguments that portions cy out of tigations the first of these situations the Commission curred in examination under its authority bullets. again executed oner it was of “consumer” asserts approved drugs.” Maj.Op. at 1180. But same proceeding executed unsuccessfully, majority specific authority purpose; Thus, misbranding the present its “[i]n firing squad veterinary practices] regulate electricity own mouth. The not under statute both opinion attempts, injection citations to condemn the case. [prison unapproved than is the previously condemned consumer issue does regulate shows that clinical more no more has not here, not have majority used prisoner uses of general inves- agen- clini- pris- once oc- preventing permit proved refuse to tion come embroiled in listed assuring clearly refusing to discussed supported constitutionally with Commission alty.” are to be enforcing in a cause that has less to do majority its use of Maj.Op. at 1192. I safe act. above, powers because it does not wish reasons for the states’ “authority and effective approved indulged sk If troubling discerns there speculations was an issue so ^[*] exercise enforcement being wrongfully properly constitutionally were in, drugs.” that “the FDA is laws it is I ^[*] doubt that. As regulate Commission plenty would morally refusing death to motiva- than with charged suggest of well to be- unap- pen- per- en- imposition capital punishment. missible testing 355(i), see 21 drugs, cal §§ It is court have done the same. 357(d); 21 This should (1982); C.F.R. 50.44 and that embroilment, FDA’s the second situation involved our rather than the assertion use, abstention, authority to regulate but of authori- that is remarkable. ty require proper labeling sold opinion I affirm on the basis would particular for a use. See United States below. Beuthanasia-D. Regular, Transfer [1979 (CCH) Food Drug Cosm.L.Rep. Binder] (D.Neb.1979). Of course even if the

1f

FDA had- acknowledged opinion what

suggests, we are not in habit of permit-

ting agency, expand authority by

simply acknowledging the legitimacy expansion.

such Except for special provi- See notes & 28 text infra. reasoning point. of the lower court on this precedential To blunt the force of Bachowski U.S. at 567 n. 1858 n. 7. The Brennan, mischaracterizes dissent Court, Brennan, Circuit in Bachowski v. one, holding exceedingly as an narrow based (3d Cir.1974), F.2d 79 had advanced two ration- extraordinary justified circumstances that holding Secretary’s ales for that the decision departure disfavoring from the usual rule prosecu- should be viewed as unreviewable necessary appeals “The court finds it view: First, prose- torial discretion. “the doctrine of carefully distinguish type of enforcement cutorial discretion should be limited to those Secretary responsibility given the under the which, prosecutions, civil cases like criminal typical L-MRDA the more case in which govern- involve vindication of societal or a decision not to is unreviewable. enforce interest, protection mental rather than the Dunlop principle general Thus reaffirms the rights.” Second, individual 502 F.2d at 87. unreviewability of enforcement decisions.” appropriate legal against standards existed Appeals in Ba- Dissent at 1193. The Court Secretary’s which the conduct could be meas- chowski, course, just opposite. intended ured. Id at 88. opinion pains applicabili- takes to limit apply equal These force considerations ty prosecutorial of notions of deference to dis- controversy. provi- present The FDCA cretion in the area of review of enforce- protect gen- sions are intended not language opinion ment decisions. No in the welfare, specifically protect eral but also the case be- even hints that the court viewed individuals on whom Since are used. way. atypical extraordinary fore it as appellants involuntary in this case are users of any language opinion Nor does in the drugs, they analogous position stand in a imply acknowledged gen- even that the court the unsuccessful union official in Brennan; Bachowski review; only presumption against with the eral act, appel- if the refuses to language quoted in addition of italics does the unprotected. lants are left 502 F.2d at 87-88. begin the dissent even to hint at such a mean- “Absolute discretion in this situation seems ing. See Dissent at 1193. Moreover, particularly inappropriate.” Id Statement, at 16504. Fed.Reg. Policy In this Id. review. sumption FDA still con- which statement policy This delve into a however, need not case, we ef- and to have substantive binding siders nonreviewability be- analysis detailed of Motion fect, Support Memorandum see conducted already cause the nn. at 4-5 & to Dismiss FDA, policy in an earlier for us. inquiry of a APA’s definition within the comes statement, govern guide made law consistently ‍​‌​​​‌​​‌​​​​‌‌‌​‌‌‌‌​‌‌‌​‌‌​​​​‌‌​​‌​​​​‌‌‌‌​​​‍has been rule27 as that term unapproved regulating its discretion term “rule” circuit. The in this interpreted drugs: approved use of

Case Details

Case Name: Larry Leon Chaney v. Margaret M. Heckler, as Secretary of Health and Human Services

Court Name: Court of Appeals for the D.C. Circuit

Date Published: Jan 17, 1984

Citation: 718 F.2d 1174

Docket Number: 82-2321

Court Abbreviation: D.C. Cir.