Abigail Alliance for Better Access to Developmental Drugs & Washington Legal Foundation v. Von Eschenbach

III. BETTER FOR ABIGAIL ALLIANCE reasons, affirm the foregoing we For the ACCESS TO DEVELOPMENTAL of John Doe’s dismissal court’s district LEGAL AND WASHINGTON DRUGS Rule of Civil to Federal pursuant claim FOUNDATION, Appellants 12(b)(6) prejudice. and with Procedure four Jane dismissal reverse the

We ESCHENBACH, M.D., Andrew C. VON pro- further and remand for Does’ claims Acting capacity Com in his official as opinion. this consistent with ceedings missioner, Drug Administra Food Leavitt, in his and Michael O. ordered. tion So Secretary, capacity official Services, Dept. of Health and Human Appellees.

No. 04-5350. of Appeals, States Court United District of Columbia Circuit. Argued Oct. 2005. 2,May Decided that, deficient, probable objectively regard constitutionally cause without reason even if "[sjubjective play governing intentions no ably misapprehends [which] law confronted.”) ordinary, probable-cause (citing role in Fourth Sau circumstances she Katz, 194, 206, Although analysis.” the civil of- Amendment cier v. 533 U.S. 121 S.Ct. did (2001)). fense for which Bookhardt was arrested We L.Ed.2d 272 leave the arrest, issue, others, the offense for which not authorize' of this to the resolution probable cause to believe he had do, however, there was court on remand. We district was therefore committed did so and his arrest briefly holdings. on one of our comment Bookhardt, & 11 lawful. 277 F.3d n. Bookhardt, 277 In United States v. F.3d Sullivan). (citing Although the Whren and (D.C.Cir.2002), we held that an arrest "where dic- District labels the Bookhardt discussion actually charged the crime was not crime” government's concession tum because of the Bookhardt, Id. at 565 n. 9. In is invalid. there, we are not so sure. Whether the of- government conceded that the offense fense for which one is arrested is not in fact police initially which a officer had arrested or the offense in fact a crime but the crime is (driving expired Bookhardt with a license probable arresting cause to be- officer lacks days) was civil in nature under fewer than committed, lieve the crime has been "an ar- did authorize an D.C. law and therefore equally invalid rest in either circumstance however, argued, arresting arrest. It that the only question precedents and the under our probable had cause to believe that officer another, ground valid for arrest ex- whether driving recklessly, a Bookhardt had been Bookhardt, 9; ists.” 277 F.3d 565 n. he be arrest- Portland, criminal offense for which could City also Allen v. 73 F.3d applied ed. We the rule established in Whren (9th 1995) (“probable cause can exist Cir. States, conduct”); v. United to criminal Peterson v. in relation (1996), expanded (8th 135 L.Ed.2d 89 City Plymouth, 60 Cir. F.3d Sullivan, 1995) (arrest probable in Arkansas v. lacked cause because intent); (ap- 149 L.Ed.2d 994 lacked criminal Moore v. arrestee Rest., (7th objective probable Marketplace rule F.2d 1336 Cir. plying Whren cause remand, however, arrest), 1985) (same). stop Because we for civil traffic to criminal which we not decide the issue. requires the court to determine the existence need Ballenger argued

James S. the cause for appellants. himWith on the briefs were Popeo Daniel J. and David Price. Richard A. Samp appearance. entered an Fields, Rhonda C. Assistant U.S. Attor- ney, argued appellee. the cause for With her on the brief were Kenneth L. Wain- stein, Attorney, Ryan, U.S. Michael J. As- Attorney, Blumberg, sistant U.S. Eric M. Counsel, Deputy Department Chief Services, Health and Human and Karen E. Schifter, Associate R. Chief Counsel. Lawrence, Craig Attorney, Assistant U.S. appearance. entered an GINSBURG, Judge, Before: Chief GRIFFITH, Judges. ROGERS Circuit Opinion for the Court filed Circuit Judge ROGERS.

Dissenting opinion filed Circuit Judge GRIFFITH.

ROGERS, Judge. Circuit Abigail for Better Alliance Access (“the Alliance”) Developmental Drugs access to has not blocked government Admin- Drug Food and enjoin the seeks greater part drugs throughout (“FDA”) continuing to en- new istration years history. Only in recent Nation’s of new our barring the sale policy force injected into determined, itself government has the after FDA has drugs that the of the effectiveness of consideration beings, are suffi- on human Phase I trials Third, Supreme precedent Court drugs. testing human expanded for ciently safe claimed liberty right that the indicates (hereafter investigational I “post-Phase from the can be inferred Alli- the Alliance specifically, the More drugs”). new Director, v. conclusion Cruzan life-saving Court’s potentially ance seeks Health, 497 U.S. Department Missouri drugs on investigational I new post-Phase 278, 2841, 224 261, 111 L.Ed.2d ill terminally mentally competent, behalf of (1990), process that an individual has due gov- have no alternative patients who adult life-sustaining medical right to refuse options ernment-approved treatment 279, treatment, 110 id. at S.Ct. (hereafter “terminally patients”). ill Here, implicates the claim similar policy Alliance contends FDA’s life- right potentially to access process due violates substantive —the there are no sustaining medication where terminally liberty, and life of its privacy, treat- government-approved alternative presents the complaint ill members. instances, key options. ment both Due Process of whether question to make the decision patient’s right is the protects the Clause inter- decide, government about her life free from FDA interfer- without ence, using ference. whether to assume the risks investigational new

potentially life-saving whether question Because the remains yet approve FDA for drugs that the has challenged policy FDA’s has violated that the FDA marketing but commercial right, we reverse the dismissal determined, I hu- after Phase clinical and remand the case complaint Alliance’s trials, further enough are safe man court to determine whether to the district human a substantial number of testing on narrowly tailored to policy the FDA’s “is beings. inter- compelling [governmental] serve Court’s test Upon applying the 117 Glucksberg, 521 est.” U.S. addressing process Flores, due substantive (quoting Reno S.Ct. Washington forth in v. Glucks- claims set 123 L.Ed.2d U.S. 702, 710, 117 berg, (1993)). (1997), we hold that the dis- L.Ed.2d I, background In Part we set forth the dismissing the Alli- trict court erred II, appeal. In Part we examine to this pursuant to Federal Rule complaint ance’s precedent indicating how Supreme Court 12(b)(6) Procedure for failure to of Civil rights are to be substantive due issue, First, a claim. state consider, in Part guided, discerned. So we described, carefully is the of men- III, claimed whether Alliance’s tally competent, adult protection under the Due Pro- warrants life-saving post-Phase potentially

to access cess Clause. a doc- investigational drugs, upon advice, that medication tor’s even where I. Second, we patient. for the carries risks A. find, history, examining “our Nation’s Food, Act traditions, Drug, and Cosmetic legal practices,” Glucks- 1-902, (“FDCA”), §§ No. Pub.L. berg, 521 (1938) (codified as amended Oct. 2005 at 15:57-15:59. II Phase 52 Stat. (2000)), seq. prohibits § et targeted, at 21 U.S.C. involves controlled clinical stud- any introducing manufacturers from up ies of to several hundred human sub- until drug” “new into interstate commerce jects “to evaluate the effectiveness of the for, applied and re manufacturers have I investigational drug ... and [Phase new] 355(a). ceived, § approval. U.S.C. to determine the common short-term side any covered drug” A “new substance effects and risks associated with the drug.” “generally recognized, the FDCA 312.21(b). § 21 C.F.R. III expand- Phase among experts ... as safe and effective trials, ed which can include several thou- prescribed for use under the conditions subjects, sand human “performed are after labeling.” 21 U.S.C. preliminary suggesting evidence effective- § 321(p)(l); see also United States v. 50 obtained, drug ness of the has been (1st Less, Boxes More or 909 F.2d gather are intended to the additional infor- Cir.1990). drug eligible Before new mation about safety effectiveness and that marketing, full approval for the Secre is needed to evaluate the overall benefit- ” tary Department of the of Health and relationship risk of the .... drug Id. Human must find ev Services “substantial 312.21(c). § exceptions, With narrow idence that the will have the effect it regulations FDA require informed consent represented or is to purports have.” to be partici- obtained from clinical trial 355(d). § Exempted gen from this U.S.C. pants. §§ Id. 50.1-50.27. drugs solely eral ban are new “intended investigational by experts for use . . . .” Id. B. 355(i)(l). § January On the Alliance sub- Secretary pro- The FDCA directs the to a proposal mitted to the FDA for new regulations mulgate testing drugs. for new regulations post-Phase to render I investi- authority, Id. Pursuant to this the FDA gational drugs terminally new available promulgated regulations require patients ill who were not admitted to the phases government testing three on hu- rejected FDA’s clinical trials. FDA investigational drugs mans before new can proposal by April letter dated FDA approval receive and enter the com- outlining policy. the FDA’s On June I, marketplace. mercial Phase new Petition, pur- Alliance filed a Citizen drugs are tested on 20 to 80 human sub- 10.30, § challenging suant to C.F.R. jects to determine “the side effects associ- policy barring investiga- FDA’s the sale of doses, and, increasing if possible, ated with drugs successfully tional new that have gain early evidence on effectiveness.” I completed Phase trials to 312.21(a). § It approxi- C.F.R. takes patients not selected for clinical trials. mately year I one to conduct Phase test- The FDA acknowledged receipt of the Cit- FDA ing.1 acknowledged counsel at oral izen Petition not respond but otherwise did argument that drugs that survive this days, thereby entitling within 180 the Alli- phase “sufficiently deemed been safe judicial ance to of the chal- seek review testing, human for substantial but [are] 10.30(e)(2). § lenged policy. id. yet proven to be safe effective to the FDA against satisfaction of the be commercial- The Alliance filed suit the FDA [to ly Argument Tape Secretary Oral marketed].” Commissioner and the Wealth, McCabe, Industry 1. See Alison R. A Precarious Balanc- Public Health and 36 Suffolk ing Role Act—The the FDA as Protector U.L. Rev. 790 n. 26 I in- post-Phase to use patients and Human Ser- choice Department of Health vices, seeking enjoin despite pa- the FDA from drugs vestigational new barring the policy sale enforcing willingness tients’ “to assume risks drugs new post-Phase investigational treat- physicians their advise them that a not in II clin- Phase their may prolong ment save or lives FDA Noting that the has ad- ical trials. options.” if they have no other viable discretion to define several ministrative ¶¶ 16, discovery, 18. Prior to Compl. stages testing human of new for complaint, FDA moved dismiss conducted, testing after has been animal and, alternatively, summary judgment. for takes, alleges it av- complaint oppo- responded filing Alliance for erage, just years under seven investi- summary motion for sition and own three gational complete judgment. phases of clinical human trials and receive marketing for approval commercial district court dismissed the com- eligible purchase and thus become 12(b)(6) failure plaint pursuant to Rule in FDA clinical trials. persons not rejected a claim. The court state ¶ Compl. complaint alleges 12.2 The also argument sought it no Alliance’s provide options that non-commercial relief only recognition “new” but and en- terminally only very small number of to explic- of the to life forcement that spaces ill as in clinical trials are patients itly guaranteed by Due Process ... to “very limited in relation the need.” Clause, that no court decision observing ¶ Compl. 15. Alliance asserts that “extended the Due Process to has Clause human are limited in num- clinical trials ill to patient’s right cover a type of qualifies. ber and who Op. of receive medical treatment.” Mem. Further, “compassionate the FDA’s use” 30, 2004, 18, 2004 Aug. at WL programs, permit drug companies which deleted). Although acknowl- (emphasis voluntarily provide at cost new longstanding legal “the Nation’s edging pre-approval during period, are avail- life,” preserve ... attempt tradition desper- able to “a of those in fraction id., the district court that stated may ate Although Id. the FDA need.” Glucksberg, the Court Supreme had distin- permit unapproved “treatment use” guished some from “personal” decisions (1999), § drugs, new 312.34 C.F.R. others, 521 U.S. at groups allowed for limited “possibl[y] and that the Alliance could not AIDS,3 persons the FDA has re- specific right claim that the claimed has a fused general as a matter allow termi- long-standing Op. tradition.” Mem. at 18. nally ill have access to investi- rejected Alli- The district court also successfully gational that have argument ance’s Court’s I completed Consequently, Phase trials. recognition Cruzan alleges, the effect of the complaint by refusing treat- choose death medical as policy, illustrated the exam- implied complementary right ment ples terminally ill of the deaths of four patients, deny terminally by obtaining potentially life life- has been to choose AIDS, Christopher Greenberg, Experi- P. Adams V. 3. Michael See also & Van See D. Brantner, Drug Development: Estimating Drug Drug New Approval, mental FDA New Legis. (July Entry Human Clinical Trials 9 Process, Screening J. & Pub. 3 N.Y.U. from 2003), http://www.ftc. Pol’y available (1999-2000). 315-20 gov/be/workpapers Avp262.pdf. treating In the district court’s de novo saving complaint’s medication. while fac- view, sought recognition of allegations the Alliance tual as true and granting the entirely plaintiff “an different sort the benefit of all [from reasonable infer- recognized Cruzan freedom from alleged. Conley, ] ences the facts See —not 45-46, government imposition, 99; but an affir- Sparrow 78 S.Ct. v. Lines, Inc., mative of access to medical treat- United Air 216 F.3d (D.C.Cir.2000). ment.” at 19. In the absence of due Id. protection pa-

process II. seeking potentially tients access to life saving post-Phase drugs, the district The Due Process Clause of the Fifth challenged court concluded that the FDA Amendment to the United States Constitu policy rationally legitimate related to a provides person tion shall ... “[n]o governmental interest. life, deprived liberty, or property, with process out due of law.” U.S. Const. appeals, The Alliance and our re The Supreme V. Court has held Amend. Cicippio-Puleo view is de novo4 See that the “guarantees Clause more than fair Iran, Republic Islamic 353 F.3d process” and accords protec substantive (D.C.Cir.2004). 1031-32 We treat the dis guarantees. tion to the it See Trox complaint occurring pursu missal of the Granville, el v. 12(b)(6), notwithstanding ant to Rule 2054, 147 L.Ed.2d (plurality opin district court’s consideration of the FDA’s ion); 719, 117 Glucksberg, 521 atU.S. April 2003 letter because the letter’s 2258; Flores, alleged conclusion complaint was 1439. Substantive due claims can dispute and the FDA does not contents. present difficulties courts. See Mi Gryl Group ex rel. Pharms. Shire D., 110, 121, chael H. v. 491 Gerald U.S. PLC, v. Group PLC Shire Pharms. 298 2333, 109 S.Ct. 105 (plu L.Ed.2d 91 (2d 136, Cir.2002); Pryor F.3d 140 v. Nat’l rality opinion); City Moore v. East of Ass’n, 548, Collegiate Athletic 560 288 F.3d Cleveland, 494, 502, 1932, 431 97 U.S. S.Ct. (3d Cir.2002) (citing 62 Fed. Proc. L.Ed. (1977). 52 L.Ed.2d 531 In a case first 62:508). § Settles v. United States Pa Cf. impression may rights where fundamental Comm’n, 1098, role 429 F.3d 1107 stake, determining be at the limits of the (D.C.Cir.2005). government’s authority over an individual’s A court should not personal dismiss freedom to make certain deci 12(b)(6) complaint pursuant unavoidably pos to Rule sions entails a careful and sibly failure to state a claim “unless it appears personal arduous assessment of beyond plaintiff objective doubt that the can prove decision’s characteristics order in support protec no set facts of his claim to determine whether it warrants him to tion Conley which would entitle relief.” under the Due Process Clause. Cf. Gibson, 41, 99, 609, 620, Jaycees, v. 355 U.S. 78 S.Ct. 2 Roberts v. U.S. 468 U.S. (1957); 3244, L.Ed.2d 80 v. District 104 82 L.Ed.2d 462 Warren S.Ct. (D.C.Cir.2004). Columbia, 36, Nonetheless, appears 353 37 the district court F.3d In determining sufficiency unduly the of the com have viewed its role as constrained. plaint, questions Pointing advisory cautioning this court reviews of law to an Dro- Washington Legal standing. 4. The Foundation is also a ment that it lacked Article III appellant, argu- named but conceded at oral 476 Baird, 1388, 438, Zech, through v. 405 U.S. 741 1396 Eisenstadt

nenburg v. F.2d (1972), 1029, (D.C.Cir.1984), 92 S.Ct. 31 L.Ed.2d 349 Roe lower courts “should Wade, 113, 705, 35 freely create new constitutional v. 93 S.Ct. [not] (1973), Casey, and 505 “guidance from the Consti- L.Ed.2d 147 U.S. rights” without 833, 2791, 112 first Supreme ap S.Ct. follow the tution or ... from articulated heavy on proach the district court focused with their reliance the principle,” Court rights binding precedent recog- concepts autonomy of individual absence self-determination, in their unwill process right and and nizing substantive due intrusion ingness Alliance. Dronen- countenance state into claimed Since provided protected Court certain domains such as the bed burg, Supreme has room, clinic, This ap a court to assess the and womb. guideposts enable Casey’s Alliance’s proach succinctly captured by merits claim.5 process characterization of substantive due Although Supreme has never Court rights as “the most inti those involve so, explicitly and we need not decide said personal person may mate and choices here, appears matter it lifetime, per make in a choices central ap- employed has two distinct Court dignity autonomy.” Casey, sonal and 505 faced with claim to proaches when 851, 112 U.S. S.Ct. 2791. cases, In right. fundamental some approach determining the existence of fun- The other Court discerned rights by probing “personal a claimed substan- damental what whether warrants autonomy” dignity appears demand. tive due protection, See which restrictive,7 Planned Parenthood Southeastern Pa. to be more has two “features.” Casey, 720, Glucksberg, v. 521 U.S. at U:S. S.Ct. omitted). (1992) (citations Glucksberg, L.Ed.2d 2258. Under courts must in- cases, quire other the Court has derived fun- whether the fundamental as- “objectively, ‘deeply damental reference to Na- serted is rooted this ” see, tradition, tradition,’ history legal e.g., tion’s Nation’s id. Glucksberg, Moore, (quoting 2258.6 117 S.Ct. S.Ct. 2258 431 U.S. at 1932; Snyder line of beginning cases with Griswold v. Massachu- setts, Connecticut, U.S. 78 L.Ed. (1965), (1934)),8 “implicit concept 14 L.Ed.2d 510 continuing in the dissent, (2003), presupposes "emerging 5. The to the extent it 156 L.Ed.2d 508 only protected by regarding liberty engage awareness" to in liberties the Constitution recognized explicitly homosexual conduct does not limit the are those that have been swath Court, surveyed Gluclcsberg Supreme analy- of time in a at 493 & Dissent n. 3, history sis of and tradition. The reference error. past century” "laws and tradition in the half Post, Court, appears support of the Supreme Court's decision to 6. See Robert C. 2002 depart Legal from stare decisis overrule Fashioning the Bowers Term—Foreword: Con- 186, Hardwick, 2841, Culture, Courts, Law, v. U.S. 478 106 S.Ct. 92 stitution: 117 Harv (1986). Discrediting L.Ed.2d 140 L. Rev. Bowers's (2003). 4, 89 "sweeping history references” thus had a Post, 6, 91-93; supra purpose 7. at Laurence in addition that addressed note H. Tribe, Glucksberg analysis: v. Texas: it is intended to Lawrence The "Fundamental show Name, Right” Speak that not the Court That Dare Not 117 had in Bowers misread 1893, history ignored L. but that it also had modern 1921-23 Harv. Rev. giving protection trends to conduct that had Supreme long proscription 8. The Court's in Lawrence criminal mention avoided Texas, 2472, Lawrence, 568, 123 S.Ct. states. See 539 U.S. at 123

477 liberty, liberty marketing such that neither but ordered the FDA has deter- mined, trials, justice nor would exist were sacri- after Phase clinical human [it] 721, ficed,” are Glucksberg, enough 521 U.S. at safe for further testing on a Connecticut, (quoting S.Ct. 2302 Palko v. substantial number of human beings. The 325-26, 149, Clause, 58 S.Ct. 82 Due Process Glucksberg as makes (1937)) (internal clear, quotation protects L.Ed. “deeply those liberties root- omitted). Additionally, in order ed in history marks this Nation’s and tradition.” (citation multiply rights ensure courts do U.S. 117 S.Ct. 2258 omitted). boundaries, principled Supreme without courts must Court has vari- ously provide description rights “careful the funda- referred to these principles as liberty Id. mental interest.” “so rooted the traditions and conscience If a our people S.Ct. 2302. court concludes that as to be ranked as funda- mental,” right Snyder, right claimed fundamental 291 U.S. at protection under “implicit entitled the Due Pro- and as immunities in the Clause, Palko, concept liberty,” cess then the burden shifts to the of ordered Thus, government to show that its encroachment U.S. at S.Ct. a court’s right narrowly “is tailored to examination of our Nation’s compelling [governmental] serve a inter- tradition cannot be specific based on so (quoting description est.” Id. at the claimed as would 1439). Flores, 507 U.S. at undercut protected by interests Due Process Clause. conclude, upon applying Because we seemingly analysis more restrictive A.

Glucksberg, the claimed war- protection rants under the Due Process Glucksberg analysis One feature of the Clause, need not we decide whether the requires compose courts to a “careful de- line of construing concept cases scription” of the asserted fundamental lib- “personal dignity autonomy” would erty extending interest before due protection right. also lend to the claimed protection to it. 521 U.S. at 2258. The Court has not settled

III. precisely how formulated the question presented by the Alliance’s must Two Justices interpreted be. complaint is whether description” requirement the Due Process the “careful protects Clause indicating identify that courts should fun- to make informed decision that damental specific the “most level life, may prolong specifically by use of at which a protecting, relevant tradition potentially life-saving to, denying protection that the the asserted H., yet approve FDA has for commercial can be identified.” Michael Dist., (9th Cir.2005); Reading narrowing S.Ct. 2472. Lawrence as 427 F.3d 1197 Fields v. (9th Glucksberg inquiry Legacy System, historical to the last Health 413 F.3d 943 Cir. 2005); Ind., century gut purpose City Lafayette, half would of the Doe v. 377 F.3d test, (7th Cir.2004), Glucksberg prevent which is to the cre- 768 or viewed Lawrence not, process rights by properly speaking, ation of substantive due as due substantive decision, forcing process protec- Sec’y process Dep’t courts to accord due see v. Lofton Servs., only rights strong Family tion to those with a founda- Children and 358 F.3d Frank, (11th Cir.2004); tion in tradition. Other circuits have either 815-16 Muth v. 412 (7th Cir.2005). analysis Glucksberg controlling treated the F.3d 818 No court has Lawrence, cabining Glucksberg. regarded after v. Fields Palmdale School Lawrence as 478 (1989) (Scalia, process due examining care in substantive 109 S.Ct.

at 127 n. C.J., id. at 538. concurring). Two claims. See J., Rehnquist, with indicated that asserted other Justices complaint contains The Alliance’s “ specific ‘the most expressed at rights not seek, allowing this description careful we can none- available” generality] [of level’ challenged whether the court to consider Id. at recognized. theless be more of impinges upon one or policy (O’Connor JJ., Kennedy, S.Ct. Pro- protected by the Due the interests description” “careful re- concurring). The FDA characterizes the cess Clause. The by the Court was first invoked quirement broadly stat- claimed as a Alliance’s Flores, at 113 S.Ct. 507 U.S. I in- post-Phase prerogative ed (1993), City v. relied Collins which and to receive new vestigational 115, 125, 112 Heights, 503 U.S. Harker treatment, the Alliance has defined but (1992), L.Ed.2d 261 where narrowly. Alliance right more description was ex- the notion of careful right of ac- neither an unfettered claims requirement. pressed pleading as a Since investigational to all new or cess applied this re- Glucksberg, the Court to receive treatment drugs nor elaboration. See quirement once without at government government from the Martinez, 760, 775-76, Chavez v. claim does The Alliance’s also expense. 1994, 155 L.Ed.2d 984 challenge the Controlled Substances Columbia, Act, seq., gov- §§ et or the U.S.C. In Hutchins v. District of (D.C.Cir.1999), authority regulate the en banc ernment’s substances 188 F.3d 531 health, safety, public harmful to description re- deemed applied court the careful Rather, the Alliance con- process due and welfare. quirement its substantive de- tends that the fundamental due analysis. The court viewed the careful rights privacy, liberty, and life include requirement as a means of con- scription patients, acting inadvertent creation of straining the advice, potentially to obtain scope loosely fall on a doctor’s that could within life-saving medication when no alternative and thus threaten the descriptions worded government approved at 542-45. treatment separation powers. See id. that the effective- Recognizing conclusions available. Despite reaching different investigational in ness and side effects of the appropriate generality level of about after drugs may question id. new still be describing right, compare the claimed H., completed, at 127 Phase I trials have been (citing Michael 2333) (Scalia, J., Alliance asks that the decision to n. with Rehn- C.J., assume these known or unknown risks be quist, concurring), with id. 555-57 Moore, J., and not to dissenting) (citing 431 left to the (Rogers, 1932), description FDA. This of the claimed the court un- conforms to the demands of even the animating principle concluded that the interpretation Glucksberg of the derlying description require- the careful narrowest requirement.9 description” “careful proceed ment is that courts should especially given explicitly de- light dissenting opinion, that these cases it bears that, first, challenges. presented to address constitutional emphasizing the court is clined - 493, (relying on challenge policy Compare at 492 with a constitutional Dissent Buyers’ statutory Cannabis Co- adopted by pursuant to a United States Oakland the FDA 1711, 483, authority. op., 532 U.S. delegation of The dissent therefore Raich, and support misplaced reli- L.Ed.2d can derive no from its Gonzales 1, 2195, 162 L.Ed.2d 1 raising statutory challenges, ance on cases B. Due Process Clause Supreme and Court precedent construing the Clause. See in- Glucksberg The other feature of the Cruzan, at 110 S.Ct. 2841. quiry requires courts determine wheth- Although it is relevant to the substantive long-standing er there exists a tradition process analysis due government protect our Nation that would individual conduct, proscribed has never the desired potentially life-saving access medi- this is not dispositive. The absence discerning cation. Courts must focus on regulation could be attributable to a liber- constitutionally protected those interests ty deeply interest rooted in this tradition, whose existence can be inferred from the Nation’s and there- (2005)), Buyers' potentially life-saving with Oakland Cannabis Co- medication (“We op., 532 U.S. at that has cleared FDA Phase I trials are nar- decide, however, necessity need not whether rowly govern- compelling tailored to serve a can ever be a defense when the federal statute Opinion mental interest. See at 486. At that it.”), expressly provide does not for id. at time, governmental interests will be iden- ("Nor 121 S.Ct. 1711 do we consider the by tified the FDA. The dissent oscillates be- underlying constitutional due [substantive ignoring tween that this issue remains to be Gonzales, process] today.”), issues resolved, asserting see Dissent ("[W]e ques- do not address the resolution, incapable that the issue is see id. judicial tion whether relief is available to re- Performing scrutiny at 499. strict is not a spondents” process on their "substantive due task that historically Article III courts have necessity claim and ... medical de- [their] regarded "impossible.” But see Dissent at fense.”). helpful No more are the other cases - cited, see Dissent at 497 & n. because Third, suggests the dissent that the court right in these cases either no fundamental paves way marijuana. for medicinal use of - issue, Opinion was at at 485 or else See Dissent 499. There is no the fundamental that was asserted was slippery slope finding of access scope far broader in than the asserted potentially life-saving investigational here. Had these courts addressed the sub- drugs that have cleared FDA Phase trials for by stantive due claim asserted safety finding illegal of access to Alliance, they no less than this court could not Marijuana narcotics. is listed as a Schedule I ignore Court's due substantive substance under the Controlled Substances process precedents that discern fundamental Act. A is included in Schedule I if it "has liberty long-standing interests in common law abuse,” high potential currently "has no protections. Opinion and constitutional accepted medical use in treatment in the at 481 n. 12. States,” accepted United “a has lack of Second, contrary argument, to the dissent's safety supervision." . . . for use under medical - 498, see Dissent at 497 the court does not 812(b)(l)(A)-(C). investiga §§ 21 U.S.C. analysis addressing undertake scientific tional new that have cleared FDA Phase potentially life-saving Alliance's claim to med- possess I trials do not these attributes or the ication. The science has been decided permitting FDA would not be their medical FDA, acknowledges. as the Alliance The FDA treatment, supervision, use in medical under determined, upon analysis scientific participants. Nothing Phase II trial in the evaluation, investigation- that certain Phase I holding supports court's the .dissent's infer sufficiently expand- al new are safe marijuana, any ence that other Schedule I testing ed human in Phase II trials. The substance, tested, qualify would for Phase I piggyback Alliance seeks on the FDA's potentially life-saving. By clearance and be Also, contrary scientific determination. token, - imply the same does not claims, record the dissent’s see Dissent at “federally- that a of access exists to engaged balancing the court has in no funded stem cell research and treatment.” interests and has not evaluated whether the Dissent at 499. That issue not before narrowly FDA's restrictions are tailored. It court and the considerations that would be remains for the district court on remand to Gluclcsberg obviously determine in the relevant under are not first instance whether FDA patient's right on a restrictions similar. See n. 26. infra law, person a history and when liberty American by of characterized

fore death, necessity often war- interference, but there is faced with governmental from not other- extraordinary measures For exam- rants explanation. may another be holds justified. principle Indeed the might indicate wise regulation ple, a lack of impinges upon did yesteryear of that action technology even when only that the See, v. Put- e.g., it. of others. not warrant Ploof (1908) nam, 71 A. 188 81 Vt. of of the merits FDA’s discussion (“This necessity applies with doctrine of single sentence: consists of question this of human preservation force to the special authority to statutory FDA has had “[The] life____ personal may sacrifice One century, and for almost a regulate drugs save his life or the property of another to firmly ingrained authority is now fellows.”) (internal citation of his lives role understanding appropriate our Case, omitted); Eng. Rep. Mouse’s Br. at 19.10 Appellee’s government.” of (K.B.1609) (deciding that it is observations, mind- following We offer of an property to throw overboard lawful complain- fact that the Alliance is ful of the passengers); safety of lives of other I inves- post-Phase of obstacles ing § 197 (First) of Torts Restatement by erected tigational new Christie, (1934); George C. generally by erected might not obstacles Necessity Considered protection or other laws.11 from state consumer Defense View, Moral Points Legal body control over one’s right A (1996). Queen But see The Duke L.J. in the common law. The vener- deep roots Q.B.D. Stephens, 14 Dudley v. on the common law Wil- able commentator of necessi (holding that the defense wrote that liam Blackstone life). justify taking of innocent ty did “a security” person’s includes “personal from the Barring a enjoyment of his legal uninterrupted life-saving treatment potentially of a use health,” limbs, life, body, his [and] his his self-preservation. on this impinges preservation “the of a man’s well as as FDA in the puts a bar also Such practices may preju- such health interfering efforts that position with annoy it.” dice Blackstone, William patient’s life. in- could save a *130. This *125, Commentaries imposes gen- the common law no .right Although and the cluded the self-defense life, it duty preserve eral to rescue or self-preservation. “For whatever man, liability interfering create either life or does is done to save Restate- member, such efforts. Section 326 upon is looked as done (First) Torts, published first necessity Id. at ment highest compulsion.” 1934, explained that throughout Anglo- recognized *127. As fully why argues There is no reason in its brief that the Alli- court is briefed. The FDA argued analysis proceed. in the district court that ance never cannot unregulated Na- drugs were for most of our argu- history, and thus cannot raise this tion’s regulate doctors in 11. The FDCA does not fact, appeal. ment for the first time on medicine; they practice of are licensed their argued Alliance in district court that Glucks- Heckler, Chaney v. 718 F.2d the states. See claim, berg supported see Pis.' its due (D.C.Cir.1983), rev’d on other court re- Cross-Mot. at and the district Chaney, grounds, v. Heckler analysis dismissing Glucksberg lied on the (1985). See also 84 L.Ed.2d 714 brief, complaint. As the FDA states in -, Oregon, -U.S. Gonzales a funda- whether the Alliance has asserted 904, 922-23, 163 L.Ed.2d 748 legal on which this is a issue mental

481 who, (“1906 so, privilege Act”), without a to do the Pure Food and Drug [o]ne Act intentionally a third prevents person 59-384, Pub.L. No. (repealed 34 Stat. 768 necessary from to another giving aid 1938), prohibited which misbranded and bodily security, bodily his is liable for adulterated foods or drugs from entering harm caused to the other the absence commerce, 768, interstate 34 Stat. at and he has prevented of aid which the third prohibited false and misleading labeling, from person giving. id. at 770. For a small particu- number of invoked, infrequently larly While this common dangerous drugs, the 1906 Act re- id.; of vintage. law rule is venerable quired identify the labels to drug’s O’Daniels, see also Soldano v. 141 Cal. ingredients quantities. Id. The stat- 443, 310, 313, App.3d Cal.Rptr. 316-18 ute also authorized the Bureau of Chemis- (1983); Miller v. Arnal 129 Ariz. Corp., try, FDA, a predecessor of the to seize 484, 987, (App.1981).12 632 P.2d nonconforming goods and to recommend prosecution federal of

In those who violated principles, contrast these ancient § the 1906 Act. Id. at 769 4. regulation of access to new has a The 1906 Act not, however, did history country in this is of limit individual recent access to 1906, origin. regulate Prior to there new or therapeutic was essential- claims ly drug regulation by drug no in the United manufacturers. United States Cf. Johnson, year 488, In that Congress 627, States.13 enacted v. 221 U.S. notes, (1995); 12. As the fundamental 69 S. Cal. L. dissent see also Rev. Raich, may simply [be] "not deduced from abstract Gonzales concepts personal autonomy.” 2202-03, of (2005). Dissent at 162 L.Ed.2d 1 The FDA (quoting Glucksberg, 521 U.S. at prior Historian Wallace F. Janssen writes that 2258). impermissible Were it to draw "heyday 'patent to 1906 was the medi- ” any inferences from broader to a nar cines,’ "[a]nyone, a time when no matter however, right, nearly rower all of the Su ignorant unqualified, go how could into the preme Court’s due substantive case drug manufacturing business” and when See, e.g., law would be out of bounds. Gris ... were without "[m]edicines sold restriction wold, (in 381 U.S. at 85 S.Ct. 1678 every at almost crossroads store.” Wallace F. ferring specific right contraception to use Janssen, History Drug Outline general right from to be free from intrusion Drug Regulation Labeling, 36 Food Cosm. bedrooms”); precincts into "sacred of marital (1981) ("Outline L.J. the Histo- Roe, (identifying 93 S.Ct. 705 ”). ry He further recounts that in "colonial specific right pregnancy to terminate a afterward, days, long consumers ... were Moore, privacy); broader 431 U.S. at drug inspectors,” their own food and "there (extrapolating 97 S.Ct. 1932 from broad striking dealing was a absence of statutes protection sanctity er constitutional for "the and, drugs,” although there were food family” specific right to determine inspection weights laws and standards for family living arrangements). any extended measures, 423, 425, "drug see id. laws event, holding grounded the court's is not Janssen, virtually were Amer- non-existent." personal autonomy the abstract notion of but Laws, Drug Drug ica’s First Food and 30 Food specific right rather in the to act in order to (1975). sug- Cosm. L.J. This save own one's life. gests early country's that in this there patient's were no restrictions on access to Pyrich, 13. See Charles J. Walsh & Alissa Ra- medication, regardless potentially life-saving tionalizing Regulation Prescription may of whatever restrictions have been Drugs Perspectives and Medical Devices: on placed physicians, pharmacists, apothecar- Reform, Private and Tort 48 Rut- Certification ies, poisons, Note, or misbranded or adulterated (1996); gers L. Rev. 890-91 669-72; Janssen, See id. at Out- substances. Catch-22 Persons with AIDS: To Have or History, Easy Investigational line at 426-28. But Dis- Not To Have Access to cf. - Therapies Early Drugs, Approval New sent at 1951, in the appears that a It not until Durham- It thus was L.Ed. 823 Amendment, Congress any Humphrey still could obtain use, category drugs, drug prescription even created the for medicinal benefit, i.e., subject drugs that are unsafe for self-medi- therapeutic albeit had no can used while under a on narcotics in 1914 cation but which placed to the controls 25, Act of Oct. supervision. Act. of Dec. doctor’s See by the Harrison Narcotic Act (1951) (codified 17,1914, 1951, at 21 38 65 Stat. 648 Stat. 785.14 353(b)). § U.S.C. 1938, the in enacted FDCA Congress require drug more in 1962 did Only Congress to deaths of than one response the children, provide empirical many of them manufacturers evi- people, hundred Sulfanilamide, drug of a ingesting Elixir which dence of the effectiveness from merely drug’s opposed safety.18 See had been marketed as antibiotic. Amendments, Secretary Agriculture of on The Kefauver-Harris Report (1960) Sulfanilamide, 87-781, 780 Due to Elixir S. Pub.L. No. 76 Stat. Deaths (codified 124, 1, Cong., 2d 1-3 in scattered Doc. No. 75th Sess. sections U.S.C. (“1937 (1982 1986)), §§ For & Report”).15 Supp. the first 301-81 IV were time, Congress response manu- in to the rash of birth required drug enacted test, review, the FDA all discovered whose moth- facturers and defects babies ease drugs safety prior their com- ers had taken Thalidomide to morn- new ing caused pregnancy.19 mercial distribution. Pub.L. No. sickness (1938) (codified as amended Kefauver-Harris Amendments trans- 52 Stat. §§ approval seq.); Report drug regulation U.S.C. 301 et formed and Act, First, drug respects. at 1-3. Under the 1938 new several commercially only required marketed FDA to could be after Amendments review Appli- drug safety filed a New for both Drug the manufacturer new effective- (“NDA”) specified the FDA that set ness that to cation demonstrate ef- required medical and scientific information at- fectiveness manufacturers forth were safety. testing drug’s “adequate The 1938 Act submit data well- not, however, drug investigations.” require did manufac- controlled U.S.C. 355(d). Second, § approval turers to receive affirmative FDA the Amendments au- Rather, FDA to human marketing drug.16 approve before an thorized the clini- trials, automatically regulate advertising, cal drug NDA became effective with- in- facilities, spect drug-manufacturing in a time frame the FDA set unless drug promulgate good manufacturing practices. determined that was unsafe required drug its commercial barred distribution.17 Amendments also man- 14, Jr., generally Zelenay, Zelenay, supra L. 16. 14. See James See note at 264—65. Prescription Drug User Fee Act: a Faster Is Drug Always Food and a Better Administration 17. Id. Administration?, Drug Food and & Food Drug (2005); L.J. 263-64 R. Sal- Steven Greenberg, supra 18. & See note bu, Regulation Drug Treatments HIV n. 23. Access, A and AIDS: Contractarian Model of Reg. (1994); J. On 11 Yale 406-09 cf. 41; Salbu, supra 19. at 408 n. note Whipple ex rel. State Minnesota v. Martin generally Harvey Munro, Teff & Colin R. Thalid- son, 65 L.Ed. Legal 1-10(1976); Jans- omide: The Aftermath sen, History, Outline at 438. Salbu, supra 15. See note any to the FDA in- For over half of our history, ufacturers to disclose Nation’s then, Act, until the enactment of they regarding received the ad- the 1906 formation person could obtain access any new consequences approved drugs.20 verse any government without interference for the legislation This set framework whatsoever. Even after enactment of the system drug regulation currently Congress FDCA imposed no limi- place. tation on the commercial marketing of new scrutiny Despite the increased federal of drugs drugs’ based effectiveness. important drugs, aspects Rather, time, at that the FDA could unregulated by are interrupt the sale of new based on government appear always to have its determination that a drug new was unregulated. regulatory been “The FDA’s regulation unsafe. Government drugs of authority extends manufacturers of premised on concern a drug’s over drugs physicians but not the efficacy, who dis- as opposed safety, to its is of Thus, recent pense may pre- origin. today, them.”21 a doctor And even a patient may drug use a for unapproved purposes drug scribe a to a for a purpose drug may even where the be unsafe or other than that for which the FDA has ineffective for purpose. the off-label De- approved drug. the use of the Such “off- spite contrary, the FDA’s claims to the may drug label” use occur even is therefore, it cannot be said that govern- not deemed safe or effective for that use. ment control of to potentially life- Further, it appears that the FDA has nev- saving firmly ingrained medication “is now prohibited prescription er either off-label in our understanding appropriate of the drugs.22 or off-label use of In recent government,” role of Appellee’s Br. at years, moving permit has been so as to overturn the long-standing tradi- promote manufacturers to of the use right self-preservation.24 tion of the purposes their for off-label in limit- See Food and ed circumstances.23 Drug C. Administration Modernization Act of (codi- Pub.L. No. 111 Stat. 2296 The Alliance’s claim also squarely falls in fied scattered sections of 21 U.S.C. Supreme within the realm of 301-81). §§ “implicit concept Court has held are in the 901; Pyrich, 20. supra right See Walsh & note from the Due Process Clause and Su- Zelenay, supra see also note at 266. preme precedents construing Court the Due supra Process Clause. See n. 12. The funda- Salbu, Off-Use, Prescription, 21. Steven R. action, action, right risky mental to take even Marketing FDA-ApprovedDrugs: An Assess interference, government free from in order Legislative Regulatory Policy, ment undergirds to save one’s own life the court's Chaney, 189-92 See Fla. L. Rev. relatively point Our is that decision. 718 F.2d at 1180. drug regulation, particu- short-lived larly regards effectiveness of a new Salbu, supra 22. See note at 189-92. not, drug, suggests, is as the dissent sufficient government acquired to establish that the 23. See id. 211. right by possession. title to this adverse logic plainly same would not serve to estab- not, suggests, court does as the dissent right merely lish to recreational be- "infer[] constitutional to be free from cause, grand sweep in the of the Nation’s regulation” regula- from "the lack of federal history, regulations relatively prior these are of re- past. tion" in this area to the recent Rather, vintage. at 493. Dissent the court infers the cent Palko, life-sustain- liberty.” refusing 302 U.S. at well as interest of ordered 281, 110 Specifically, the claimed medical Id. at ing 58 S.Ct. 149. treatment.” by the conclusion Court’s implied S.Ct. 2841. protects due Cruzan that analysis A similar leads the conclusion life-sustaining to refuse person’s protects Process Clause Due Cruzan, 497. U.S. treatment. See liberty claimed the Alliance interest Court, Writing for the 110 S.Ct. 2841. Part supra ill members. See Rehnquist noted in examin- Chief Justice III.A. The of the Due Process Clause text of the doctrine of informed ing origins protecting and “life.” “liberty” refers early consent that the Court had observed similarly no clear textual Although there is sacred, is held more “[n]o refusing die” or life- “right basis for the common carefully guarded, by more treatment, sustaining medical law, every than individual to recognized, light Cruzan Court per- possession and control of his own law constitutionally protected common son, free from all restraint or interference inviolability liberty based on interests others, unquestiona- clear unless body, one’s that an has a due individual 269, Id. authority of law.” S.Ct. ble right process to make an informed decision R. v. (quoting Union Co. Pacific conduct, withdrawing engage by to in 1000, Botsford, 141 U.S. treatment, will cause death.25 that one’s (1891)). L.Ed. The Court reasoned logical corollary is that an individual the logical corollary “[t]he that doctrine also free to for herself must be decide patient is the of informed consent that any to whether or unknown assume known generally possesses right the not to con- might taking risks of a medication that sent, is, that to Id. at refuse treatment.” prolong her life. 270, Confronting 2841. the Cruzan, “perplex- time a Like the claimed in the right first what it described as question strong right by moral to free of ing unusually claimed Alliance be overtones,” imposition and ethical id. at 110 S.Ct. FDA does not treatment involve government language by government turned to the or subsi- Court Rather, guardians prece- dy. Amendment and its much as the Fourteenth did, to Alli- patient dent determine “the United comatose in Cruzan whether government step in grants States Constitution what is com- ance seeks to have the parlance ‘right changing policy mon referred to as a aside so the individ- ” die,’ right id. that ual “[t]he The Court reasoned self-determination is not violat- principle competent person that has a ed. Alliance claims that there is constitutionally protected liberty protected right interest life-saving in unwanted inves- refusing potentially medical treatment choose use may successfully from our prior tigational be inferred decisions.” If qualification, protected Id. Without the Court stated: cleared Phase I. there is a liberty “It cannot Due Pro- in disputed that the interest self-determination life-sustaining cess an in life refuse protects right Clause interest as includes balancing constitutionally deprivation It was interest in course of of that Cruzan, liberty against permissible.” individual’s interest the rele- 497 U.S. at government holding vant interests that the Court indi- S.Ct. 2841. The Court’s allowed government protect consequences cated "the dramatic involved exer- autonomous life-sustaining [life-sustaining] cise of the treat- refusal treatment refuse ment; inquiry right. would to whether the it did not undermine the inform treatment, though § even this will hasten volved a suit under 42 U.S.C. death, liberty then the same interest must brought by the mother of a man who was of access complementary include working shot while po- undercover for the medication, life-sustaining potentially in lice department. The court in Butera did light explicit protection of the accorded suggest not advisory that the admonition reasoning “life.”26 is not unlike that Our in Dronenburg, preclud- F.2d at Eisenstadt, Court 405 ed either the substantive due process in- where the Court quiry or the conclusion that a fundamental held that the right to be free from unwant- implicated. was government ed intrusion into the funda- decisions the other circuits on mental decision whether to have children which the FDA relies likewise fail to sup- contracep- establishes a of access to port its position that there no substan- tion. tive due poten- of access to Contrary position, nothing to the FDA’s tially life-saving treatment. United States precedent in this court’s or that of the Burzynski Institute, Cancer Research other circuit appeal courts of conflicts with (5th Cir.1987), 819 F.2d 1301 which held analysis. Although our the district court that the patient doctor and had not stated concluded, in reliance our decision a constitutional tort based on the allegedly Dronenbivrg, 741 F.2d lower improper seizure of the doctor’s may courts not consider claims to new records they and thus that did not over- process rights princi- substantive due come the claim qualified defendant’s ples previously identified the Su- immunity, id. legal bears no Court, preme supra page this factual question relevance to the before court has addressed pro- substantive due this court. The statement in Camohan v. See, cess claims on a number of occasions. States, (9th United F.2d e.g., N.Y. Ophthalmological Soc’y State v. Cir.1980), that Bowen, (D.C.Cir.1988). “[c]onstitutional 854 F.2d 1379 privacy personal liberty give do not pertinently, Most in v. Butera District of Columbia, right individuals (D.C.Cir.2001), the to obtain cancer [the 235 F.3d 637 the confronted, drug] laetrile free quali- court in the of the lawful exercise of context a defense, immunity government dictum; fied the claim a police power,” sub- was life, process right personal stantive due the Ninth Circuit never reached the merits security, bodily integrity. Butera in- right of the claimed fundamental of access 26. Finally, The dissent fails to see how mistakenly suggests the court can the dissent the life-saving from a "concept liberty” reason to refuse treat- court offends the of ordered life-saving ment to a of access to "contrary treat- because the court's decision is - ment, go expressed Congress Dissent but the two the will of and the Execu- hand in hand. In either instance —refusal or tive and to the deference courts owe to the key patient’s right access—the is the to make democratic branches on such controversial - government Although her own decision free from inter- matters.” Dissent at 498 499. Moreover, liberty” necessarily ference. of access to term "ordered remains unclear, investigational new that have cleared somewhat it cannot for a broad stand principle political Phase I trials is different from and does not of deference to the branch- imply general right life-saving questions to receive es whenever "unknown of science” treatment, dissent, Otherwise, as the Dissent at are involved. See id. it would presumed. political the district court Nor does the establish a zone in which the branch- question regulate persons court reach the whether there is es would be free to uncon- by preserved such a for that is not the Alliance's strained the individual liberties claim. in the Constitution. heeding liberty interests ar- protected was dismissed for failure complaint

as Court, by remedies. ticulated administrative to exhaust govern- no where there are alternative Further, out in pointed the Alliance a termi- ment-approved options, treatment brief, patients ill in its ill, mentally competent patient’s nally adult States, F.2d 455 United Rutherford potentially life-saving informed access Camohan, (10th Cir.1980), like those in investigational determined laetrile, a new cancer sought access to I Phase trials to be suffi- after Phase I drug that had not cleared FDA’s ciently expanded for human trials safe ap- safety hurdle and thus had not been protection Due warrants under the Pro- testing on humans in proved expanded prerogative cess Clause. The asserted trials, at 456-57. ongoing clinical see id. pa- prevent the FDA—to rejected to lae- The Tenth Circuit from using potentially life-saving tient trile, partic- of a reasoning that choice II medication to which those in Phase clini- ular treatment or medication is “within the upon impinges cal trials have access—thus governmental protecting area of interest liberty deeply an individual rooted our course, health.” Id. at public Of self-pres- Nation’s and tradition of regulating interest no government’s Glucksberg, ervation. 521 U.S. at of a funda- bearing the identification Flores, 2258; Rather, right. is to be mental interest 113 S.Ct. 1439. district court never if, after, recog- considered a court question reached the the chal- whether right; point, a fundamental nizes lenged protected FDA policy violates this to the government the burden shifts interest, liberty and we therefore remand narrowly “compel- tailored demonstrate case to the district court to determine burdening Be- ling right. interest” in barring policy whether the FDA’s cause the FDA had neither eliminated the post-Phase investigational new drugs possibility poison that laetrile was a nor by terminally narrowly tai- approved testing basic human compelling governmental lored to a' serve trials, government’s in Phase I interest interest. might well have been suffi- Rutherford ciently compelling to restricting warrant GRIFFITH, dissenting. Judge, Circuit case, drug. gov- access to In the this variety Experimental drugs present a of may prove ernment’s interest to be weaker patients. potential risks and benefits to access because Alliance seeks drugs may harm patients; Some others FDA, investigational drugs new may help. Acting at the direction of Con- trials, after Phase I human has deemed gress, Drug Food and Administration sufficiently testing human safe for a (“FDA”) determines and balances those beings. substantial number human during testing pro- and risks benefits words, Alliance for other seeks for input cess from the enjoyed members the same access scientific and medical communities. Some- ill terminally lucky those patients support times initial scientific conclusions in enough spot to secure a Phase II trials. early ill providing seriously patients access hastening dis Accordingly, experimental we hold that the testing process. they do dismissing trict court erred the Alli Sometimes not. 12(b)(6) complaint pursuant ance’s to Rule The examines science behind conclude, drug judgment for failure each new and makes a to state claim. We analysis provide about what level of will applying Glucksberg access sufficiently an effective that carries benefit with patients with minimal risk. But group level of acceptable risk. One there is no evidence in this Nation’s histo- ill the FDA terminally patients believes ry and traditions of a to access ex- Abigail too cautious. The Alliance for Bet- perimental drugs. Balancing the risks and (the Developmental Drugs ter Access to benefits found at the forefront of uncertain “Alliance”) a different favors balance been, science and medicine has good terminally ill patients would allow access reason, province the historical of the demo- experimental drugs to all after the first cratic branches. Because can find no phase testing complete. of FDA judicial basis the Constitution or prece- argues guar- Alliance that the Constitution dents to remove function from the antees them this access. branches, elected I respectfully dissent. must, course,

Courts be cautious acceding a litigant’s

about claim of a I. newly-discovered right. constitutional To People good will wish for scientists to here, succeed the Alliance must show that effective, develop safe cures for experimental drugs the access to it seeks ill patients as quickly possible. patients is “fundamental Alliance could have taken its argument to [is], right[ libert[y] objectively, which ] Congress and attempted to convince our ‘deeply rooted this Nation’s Nation’s ” lawmakers that the current bal- tradition,’ Washington Glucksberg, safety ance between and risk is scientifical- 702, 720-21, 117 S.Ct. ly or morally misguided and that terminal- (1997) L.Ed.2d 772 (quoting Moore v. East ly early should have the Cleveland, to experimental drugs that the Alliance 52 L.Ed.2d 531 (plurality opinion)), “ Congress seeks. could hearings have held ‘implicit concept of ordered subject on the and heard viewpoints liberty,’ jus- such that liberty ‘neither nor ” scientists, doctors, patients, advocacy sacrificed,’ tice would exist [it] w[as] (like Alliance), moralists, groups ethi- (quoting 521 U.S. at 117 S.Ct. 2258 cists, Congress and citizens. could then Connecticut, 319, 325-26, Palko v. lawmaking exercise its function striking (1937)). 82 L.Ed. Al- early availability new balance between though previously others have argued for and the need for understanding sufficient the creation right, today, similar until toxicity potential benefits of no circuit court has assented to such a experimental drugs. The Alliance could claim. majority creates a fundamen- FDA, agency also work with the as the right by making tal a series of inferences Alliance, suggested in a letter to the prohibited by Glucksberg. From the fact “help expand patient promising access to always regu- that the Government has not [by] working] spon- new treatments drugs, majority lated the infers constitu- sors and with FDA to better under- [the] tional to be free from such regula- sponsors stand the reasons not to choose tion. From the common law of defense [early programs create these necessity access] [al- and the prohibiting tradition bat- medication, ready existing tery regula- under the FDA’s majority forced the identify and to additional incentives tions] infers a fundamental participation.” for drugs medication. From the fact that Just as the phase testing litigants argued the first of FDA Court reminded who last have under- gone testing, majority term in some infers that Gonzales v. Raich that substantive drugs probably those will marijuana have medical due allowed them to use regulatory approval process created “perhaps even purposes,

for medicinal experi- Congress and FDA for new legal avenues is than these important more 505(a) Food, of the drugs. mental Section in which the voices process, the democratic (“FDCA”), 21 Drug, and Cosmetic Act respondents these allied with of voters 355(a), § introduction of bars the U.S.C. day in the halls of may one be heard drugs into interstate commerce until new 1, -, Congress.” 545 approved sponsor’s applica- FDA has 2195, 2215, 162 L.Ed.2d 1 Of drug application A new must contain tion. course, level of ac- changing present reports investigations “full which have experimental drugs through the cess to or not such been made show whether would involve intense democratic branches for use such drug drug is safe and whether and moral de- complicated scientific 355(b)(1)(A). § Id. is effective use.” regulate how about best new bates testing a on humans for drug Before new drugs. effectiveness, safety sponsor must approval for the FDA’s an investi- submit allowing Instead the elected branches (“IND”), drug new debates, gational application see Alliance ar- these to resolve 355(i)(l); pt. 312, § see id. also C.F.R. mandates gues that Constitution containing detailed information establish- outcome, particu- regardless of desired testing appropriate, that human ing by Congress already lar balance struck § 21 C.F.R. 312.23. view, and the Executive. In the Alliance’s Due Process the Constitution Clause of Testing drug safety a new and effec- patients a funda- guarantees generally humans treating tiveness re- “right drugs quires phases. mental access to three sometimes four § 312.21. I involves the ini- Phase I See id. Phase cleared trials” because those drug tial introduction a new into human enough are “safe to be tested in subjects. study usually A Phase I consists “simply yet met ha[ve] humans” twenty subjects eighty and is “de- argu- FDA’s standards.” Based signed to the metabolism determine ment, majority a fundamental creates pharmacologic actions of the [new] that, right and under the Consti- concludes humans, the side associated with effects tution, ill, mentally compe- “a terminally doses, and, increasing gain possible, patient’s po- adult tent informed access early evidence on effectiveness.” Id. tentially life-saving investigational 312.21(a)(1). majority § and I differ determined FDA after by the Phase understanding importance in our sufficiently expanded I trials to be safe for testing that Phase I. occurs after protection human trials warrants under majority implies that the FDA is primarily Maj. atOp. the Due Process Clause.” concerned with effectiveness after Phase I The Alliance’s proposed new constitu- right argued and that the the Alli- tional exempt would regulation ance would override majori- legislative Contrary much of the and for effectiveness.1 to the (“The Maj. Op completed,” addressing 1. See Alliance’s claim have been and not risks, safety, challenge government's also does not ... fact that later studies address authority regulate relationship to overall substances deemed and the benefit-risk a health, id. at 482 added); public safety, drug) (emphasis to and new harmful wel- fare.”); ("Only Congress require (suggesting drug id. in 1962 did "side provide investigational drugs may empirical to of the new manufacturers evidence effects question drug opposed still be in of the of a as to after the Phase trials effectiveness ing ty’s phases all the FDA’s benefits as called for the FDCA and suggestion, accompanying regulations. its drugs new involve test- testing process for ing safety. addressing for In addition to regulatory FDA has pro- several drug, of a Phase II effectiveness new grams in to place hasten research of the are used “to determine the com- studies safety and for drugs effectiveness termi- and asso- mon short-term side effects risks nally severely ill patients and allow 312.21(b). § drug.” ciated Id. with early scientifically access where and medi- “gather ... Phase III studies additional cally example, For warranted. under its safety information and about effectiveness Track” program, agency “Fast has “es- procedures designed that is needed to evaluate the overall bene- tablished expedite to evaluation, development, relationship of and drug.” fit-risk Id. market- 312.21(c). ing therapies of new to § intended treat requires FDA further persons life-threatening with severely- and drugs go through some to Phase IV stud- illnesses, debilitating especially where no ies, which “delineate additional information satisfactory therapy alternative exists.” risks, benefits, drug’s opti- about the and § 21 C.F.R. 312.80. Fast Track allows the § mal use.” Id. 312.85. application require- to waive its IND To guide process, Congress this has di- “unnecessary ment if it is or cannot be “[sjcientific to rected the FDA establish achieved,” 312.10, § id. and even a allows advisory panels” “provid[e] to scien- expert request waiver to be made an emer- “[i]n tific advice and recommendations to the ... gency by telephone or rapid other regarding investigation a Secretary clinical communication,” id. The Accelerated Ap- drug approval marketing of a or the of proval program provides a truncated ap- 355(n)(l). Quite § drug.” a U.S.C. proval process drug prod- for “certain new specifically, Congress has mandated that ucts that have safety been studied their panels the FDA on include these scientists treating and effectiveness serious or variety disciplines. from a See id. life-threatening provide illnesses and that 355(n)(3).2 Thus, § today issue is meaningful therapeutic patients benefit terminally ill whether fun- existing § over treatments.” Id. 314.500. procure damental and use an ex- categorizes The FDA some drugs, perimental drug including nearly before the FDA and the all drugs, “pri- cancer as community drugs” its sci- ority scientific have evaluated and seeks accelerate their correspond- availability. and entific and medical risks merit, ("Gov- manufacture,

merely drug’s safety.”); id. at 483 or utilization of such drugs; regulation premised ernment con- (B) expertise members diverse in such drug's efficacy, opposed cern over new fields as clinical and administrative medi- safety, origin.”). of recent cine, pharmacy, pharmacology, pharmacoe- conomics, sciences, biological physical 355(n)(3) Section Title United States professions; and other related Code, provides: interests, (C) representative of consumer appointments Secretary shall make drug representative of interests panel panel each ... so that each shall manufacturing industry directly affect- of— consist brought ed the matter to be before the (A)members qualified by training who are panel; and experience safety (D) special- evaluate the two or more members who are particular expertise effectiveness of be referred to or have ists other who, feasible, panel to the extent disease or condition for which proposed possess experience develop- review is to be indicated. skill and in the under the that should be about standards Congress that ties contends The Alliance Although marketed.” have struck the met is FDA not before and the safety. community early access and the cancer “some members of balance between view, carefully these constructed to suggested In its that FDA needs [the] have years by expe- the system refined over programs, strong clinical trial maintain allow mem- sufficiently its rience, drugs, do of cancer approval the basis drugs experimental Alliance], to the others, bers access criti- like have ... [the de- Accordingly, the Alliance they need. heavily on relying too FDA] cized [the the FDA a com- submitted to veloped and approval.” certain trials before completing argued proposal that there is prehensive “[i]n FDA noted that the realm The pa- facing tradeoff risk-benefit “different to reviewing products medical treat serious ill and have are who tients who diseases, there is inev- life-threatening and Although options.” treatment no other availability of early itable tension between mar- agreed that “[e]xtensive the Alliance products patients, especially patients to inter- regarding drug evidence shalling of disease, refractory and the need to with actions, and optimization, dose the like” provide to a reason- obtain sufficient data pa- to drugs for new treat “appropriate expectation of benefit and lack able alternatives,” Alli- tients other the with excessive harm.” steps may that well suggested ance “these previously its scientific Having exercised delay that fatal” for entail a terminal ap- to “strike the judgment and medical con- Accordingly, the Alliance patients. com- propriate balance between these two patients that “should tended goals,” FDA noted its conclu- peting the ability to for a treat- opt have the reasonably precise “a sion that estimate evidentiary ment met a lower response “enough experience rate” and respect safety effica- hurdle with effects” “criti- detect serious adverse are cy.” suggested, proposal Alliance’s cal” determining experimental when things, other that the FDA allow among Most early drugs “the of ill- should be made available. access based risk ness, injury, potential- or death from the disease cancer experimental “have drug.” ly toxicity, the potentially large absence the lethal ef- promulgated regula- a new should patient’s remaining quality fects on a tion, contended, Alliance that would Accordingly, judg- in the life.” FDA’s experimental sponsors allow market ment, patients “it does not serve well circumstances, drugs, after under some widely too make available before completion of Phase I trials. is a reasonable assessment of such there decisions, guide patient expe- risks to Several senior FDA officials reviewed managing Accepting rience in them.” proposed regulation. the Alliance’s proposal upset ap- Alliance’s “would concluded that the “raised officials Alliance seeking that the FDA is propriate balance questions about important expand- several maintain, by weight almost giving total further ed access we believe deserve early availability giving goal consideration,” but questioned whether recognition importance to the of mar- little put Alli- specific proposal forward keting drugs knowledge with reasonable ance have the intended desirable “would likely physicians their The officials conclud- patients.” effects for toxicity.” their clinical benefit and With “suggestion points ed Alliance’s rejected FDA, Alli- significant range proposal of opinion area of turned to the courts rather than provider within communi- ance ” Congress and now asks us to create a new ficed.: 521 U.S. at 117 S.Ct. 2258 Palko, provide (quoting constitutional that will 302 U.S. at 58 S.Ct. 149). experimental drugs they level of access to majority properly states the Glucksberg test, seek. but makes several critical application. errors its dispute To understand the constitutional case, it this is critical to understand The majority structures analysis what this case is not about. Neither the around the Glucksberg inquiry— first Congress Constitution nor has authorized whether the “deeply claimed root- this Court to which of gives determine these two ed”—and short shrift to the second litigants scientifically part has more and med- part it is of “ordered liber- —whether ically scientists, physi- ty.” sound view. majority relies three com- cians, officials, acting pursuant to ex- mon law concepts, none of which is ad- press statutory authority, have Alliance, determined vanced as evidence of a experimental fundamental, that blanket access to deeply rooted right pro- patients present (1) for terminal would unac- cure and experimental use drugs: ceptable (2) scientific and medical risks. Con- common law defense of necessity; an trary to the FDA’s scientific and medical individual’s common law in being interest views, that, the Alliance believes at least battery; free from common law patients, liability benefits for interference with a rescue. experimental drug usually outweigh majority discuss, will however, does not completes its risks after the FDA I Phase evidence of a procure fundamental trials. The issue presents this case and use experimental drugs —because a narrow one: whether the Due Process none In exists. the absence of such a tradition, Clause of the Constitution mandates ac- the majority argue is left to cess to experimental drugs that have the creation of a fundamental from a cleared Phase of FDA testing, such that series of Glucksberg, inferences. mindful Congress protect terminally cannot ill pa- danger minting courts experimental tients from the risks interests, from an amalgam prohibits us present unless it uses a narrowly creating means new substantive due achieving tailored toward in- compelling rights by inference.

terest in limiting access. rights may Fundamental “not sim- [be] ply deduced from abstract concepts per-

II. autonomy.” sonal Glucksberg, 521 U.S. at In Glucksberg, Instead, Court set 117 S.Ct. 2258. to be funda- forth a two-part mental, test for determining there must be evidence that the whether an asserted right is fundamental any place “asserted has in our Na- under the Constitution. “[T]he Due Pro- tion’s traditions.” Id. at added). specially protects cess Clause (emphasis Quite those funda- simply, are, mental rights and liberties majority provided which ob- no evidence of a jectively, ‘deeply rooted in this Nation’s right, deeply rooted in our history Nation’s traditions, and tradition ....’” Glucksberg, procure experi- use U.S. (quoting drugs. contrary, major- S.Ct. 2258 mental To the Moore, 1932). ity A concedes that new drugs have been “ right must also ‘implicit concept be regulated early part since the of the last liberty,’ of ordered such that century. Maj. ‘neither liber- atOp. 481. But even ty justice nor would exist sacri- ... may just [it] w[as] where other “decision[s] Oakland, seeking group the decision as profound personal purposes marijuana for medicinal treatment,” access these medical unwanted

refuse necessity was a de- argued that “because as funda protected not are other decisions law, necessity common medical fense at enjoyed never they “ha[ve] mental Sub- read into the Controlled should be Glucksberg, 521 protection.” legal similar 490, 121 1711. at S.Ct. Act.” Id. stances 725, 117 at S.Ct. U.S. matter, noted that the Court As an initial suf- interest alone a common law Nor is federal whether open question is an “it right a fundamental ficient to establish authority recognize courts ever Glucksberg, the Constitution. under by provided not statute.” necessity defense 725, (inquiring 117 2258 S.Ct. 521 U.S. added). at common “Even (emphasis Id. with “this right is consistent whether law, necessity was some- defense of tradi- history and constitutional Nation’s our consti- And under what controversial. tions”) added); v. Ingraham (emphasis crimes system, in which federal tutional 1401, 673, 651, Wright, 430 U.S. by com- rather than are defined statute “ (1977) (looking to ‘those 711 L.Ed.2d 51 (internal law, Id. especially it is so.” mon law recognized at common long privileges omitted). “not did citations The Court hap- orderly pursuit essential to the however, necessity can decide, whether added) ”) (emphasis by free men’ piness when the federal statute ever be a defense Nebraska, 262 U.S. Meyer v. (quoting it,” id. at expressly provide does 625, 67 L.Ed. “[ujnder 1711, any 491, 121 S.Ct. because (1923)). that the common agree I cannot necessity, principle one conception legal majority concepts discussed law succeed when The defense cannot is clear: right under a fundamental demonstrate has made a determi- legislature itself law, values,” At necessi- marks Glucksberg. (quotation “[a] common id. nation of omitted). ‘traditionally covered the situa- The of the FDCA ty defense structure beyond just Congress prohibited the ac- that: has physical forces does tion where drugs, see experimental illegal general conduct the control rendered tor’s ” 355(a), prescribed § and has 21 U.S.C. v. evils.’ United States lesser of two may experimental drugs detail how Cooperative, Buyers’ Oakland Cannabis by the scientific and and used studied S.Ct. 355(i). communities, § Giv- medical see id. States (quoting United L.Ed.2d conclusion that Supreme en the Court’s Bailey, 444 U.S. necessity common re- law defense of (1980)). Putting 62 L.Ed.2d cannot override a mains controversial and between a common aside the difference by the already determined judgment value I right, a constitutional defense and law majority’s I how the legislature, cannot see a court can doubt about how have serious by the com- supported proposed law, know, as a matter of constitutional necessity. mon law doctrine of evils will be the lesser of two pa- all by providing “required Supreme achieved Court experimental a careful de- substantive-due-process access to all Phase cases tients drugs pres- the risks these of the asserted fundamental lib- drugs, given scription event, Glucksberg, any erty Court’s interest.” ent. marks omit- (quotation indicates guidance Oakland ted). case, at issue in this necessity is not common law doctrine of majority concludes has in this Nation’s deeply rooted Alliance, by the carefully described been traditions. to access law for preventing aid from reaching an- other, potentially life-saving drugs when no alter see Restatement (First) of Torts Maj. § native treatment is available. See majority infers from III(A). Op. Part The Alliance has narrow principles liberty these in pro- interest ly right. described its asserted curing using experimental drugs. But Cf Glucksberg, 521 117 S.Ct. 2258 Glucksberg does not authorize courts to (carefully-described asserted was “a create substantive due process rights by to right commit suicide which in itself inference. principles These precisely are so”). right cludes a to in doing assistance the type of “abstract concepts personal majority evidence, provides The never autonomy” that do not constitute evidence however, that right the Alliance’s asserted of a fundamental right. Glucksberg, 521 deeply rooted and in implicit ordered at They S.Ct. 2258. are liberty. Instead, majority infers its concepts indeterminate that cannot meet right from principles, several broad Glucksberg’s description careful require- none of which would meet Glucksberg’s ment. majority The provided has no evi- “asserted, description careful requirement. Maj. dence that the Alliance’s right (the III(B), Part Op. “right at 479 any of con has place our Nation’s traditions.” (the body”), trol over one’s “right id. to Glucksberg, 521 U.S. at 117 S.Ct. 2258 (“the self-defense”), added). right id. self-pres (emphasis Simply put, under (“the ervation”), n. 12 specific right Glucksberg, the Alliance’s right asserted life”), act order to save one’s own 483 n. fails because it not deeply rooted and (the action, “fundamental right to take implicit liberty, in ordered and the various action, risky even government free from principles described the majority fail interference, in order to save one’s they own because are not carefully described.3 life”); (the III(C), Part at right to “be of majority’s analysis remainder free to decide ... any whether to assume prove sets out to an unremarkable proposi- known or taking unknown risks of a medi tion: the government federal reg- has might life”), cation that ... prolong n. ulated for approximately years. (the “right life-saving access to treat From regulation the lack of federal prior ment” key with “the [being] patient’s majority infers a constitutional right to make her own decision free from regulation. to be free from It is not interference”). government sweeping difficult to see the claims of fun- majority prin- concludes that analysis these damental an such ciples deeply are rooted pas- based would support. Congress Because did not sage from describing significantly Blackstone regulate marijuana indi- until rela- being vidual’s interest in battery tively (ie., free from day late the constitutional law, 1937), Raich, at common see see Gonzales v. Blackstone, William *129, *134, -, and a provision 162 L.Ed.2d 1 Commentaries (2005), of the Restatement discussing when one there must be a pro- tradition of person will be liable under the common tecting marijuana Congress use. Because support In an effort to presents. its inferences from the critical distinction this case interests, majority briefly common law suggested Court has never that an cases, privacy Maj. Op. turns to several govern- see individual has a to override the 481 n. majority regulation cases that the drug safety earlier ment’s and to take with, best, and, necessary support concludes are not unknown risks holding, worst, id. majority consequences. at 481. The misses fatal in a majority concedes But the Op. at 481. until 1866 when narcotics regulate

did not only analyzes that it footnote long created opium, taxed heavily it that the Govern- to “establish the FDCA founding, see United Nation’s our before this acquired title to [not] ment Moore, 486 F.2d States n. 24. Id. at 499 J., possession.” (D.C.Cir.1973) by adverse (Wright, dis- n. 50 Thus, majority appears agree that individuals it must be senting), provides no evi- history of the FDCA narcotics free and use acquire help dence, Glucksberg, that would under not the law. But this is regulation. is, That Alliance meet its burden. that we regulation suggests lack of prior A does not demonstrate history of the FDCA un- evaluating the care in exercise must individual’s protecting an a tradition right to of a constitutional tested assertion drugs; it Indeed, experimental use procure regulation. from new be free govern- the federal only establishes that right, fundamental considering an asserted “ experimen- always regulated ment has not us to ‘exercise Glucksberg directs drugs. tal are asked to whenever we utmost care ” field.’ ground in this break new recognize majority also fails 720, (quoting Collins 117 S.Ct. 2258 at begin did not drug regulation 125, 115, Heights, 503 U.S. Harker Society of England, In “when FDCA. (1992)). 1061, But L.Ed.2d 261 [ie., char- was pharmacists] Apothecaries al- has not fact that the Government ([in] 1617), master independently tered little a concern tells us ways regulated inspect empowered wardens were and a constitu- an individual has whether about the of- and to before any pharmacy burn pursue that concern. tional drugs preparations and door all fender’s Co., 338 U.S. v. Morton Salt United States or unwholesome.” they corrupt deemed Urdang’s 632, 647, 94 L.Ed. Kremers, and Kremers Edward (“The Pharmacy long ed.1976). History have been powers (4th fact that of may call for close scruti- well unexercised century, power to examine the “In the 18th exist; they grant- but ny as to whether drug- and apothecaries, of chemists shops ed, by being allowed to lie they are not lost College Physi- of given to the gists was dormant, any pow- ([in] 1723), more than nonexistent involving ques- and cases cians unchallenged prescripted by an judged by ers can be a court drugs tionable were exercise.”). partly and physicians of composed partly ([in] 1730).” Id. at 111-12. apothecaries of great a deal of majority devotes FDCA, Nation, history Colony Virginia set- analysis to the In this that, the dis- addressing contrast an act in 1736 ting passed “[i]n out to show in than was “neces- drugs of more principles” pensing ancient evidenced these Restatement, practice had “regula- sary or useful” because Blackstone and the intolerable.” Id. “dangerous in and drugs to new has a become tion of access (Louisi- Territory Maj. of Orleans at 158.4 country origin.” that is of recent this sought Physician” a Virginia's regulated "the in the Art of Specifically, act 4. address the concern that Colony.” Physic[] Id. The Practice of in this (the often, long physic practice making up noted that art or Sake of Act too for the Bills, disease, things, [surgeons, apothecar- by, among expensive dis- healing other ies, commonly up apprentices] load their Pa- drugs) taken and their pensing "is most Quantities thereof, followed, greater than by Surgeons, Apothecaries, or tients with concealing necessaiy useful, all their or Apprenticeships to are served such as prevent Dis- Trades, Compositions, well to prove very unskillful who often those ana) requiring a a fundamental passed an act demonstrates to be regulation today. free order diploma and examination dispense drugs and thus pharmacists majority’s analogy Nor does to Cru public; also to the Louisiana grant access Director, Department zan v. Missouri drugs of deteriorated prohibited sale Health, 2841, 111 at poisons. restricted the sale of Id. (1990), L.Ed.2d 224 and forced medication 182-84, 214; Cowen, The see David L. explain why at common law there is a Development fundamental, State Pharmaceutical deeply right to rooted “self- Pharmacy Law, Vol. 37 No. Maj. Op. preservation,” protecting at History, ill, “terminally (noting mentally competent that the act adult patient’s potentially informed access to that were prohibited sale life-saving investigational deter moulded, “injured, discomposed, sophis- or mined the FDA after Phase trials placed restrictions on sale ticated” and sufficiently for expanded safe human “any suspicious dangerous remedy”). trials,” Cruzan, id. the Su in 1817 legislation South Carolina enacted preme Court that the United “assume[d] licenses, pharmacists requiring to obtain grant compe States Constitution would Kremers, supra, at followed person constitutionally protected tent Georgia in 1825 and Alabama id. lifesaving hydration to refuse By twenty-five at 214. least nutrition,” although the Court indicated regulat- or territories had statutes states consequences “the dramatic involved adulteration, ing and few others had laws in particular] [life-sustaining] [a refusal of poisons. Id. addressing at The histo- inquiry treatment would inform the toas ry regulation of country this does deprivation whether the of that is interest protecting not evidence a tradition of a constitutionally permissible.” 497 at U.S. instead, right of drugs; access to it evi- assump 110 S.Ct. 2841. Court’s government responding dences to new right tion that there is a to refuse lifesav they Cowen, risks as are presented. ing treatment in some was circumstances (“The supra, history at 56 of laws state predicated “the common-law rule pertaining pharmacy obviously to reflect[s] batteryf that forced medication was a and] development pharmacy scientifically, long legal protecting tradition the deci professionally, economically.”). to medical sion refuse unwanted treat majority’s analysis historical of the FDCA 521 at Glueksberg, ment.” U.S. 117 Congress expressed has demonstrates Cruzan); (discussing see S.Ct. 2258 Cru regulating drugs a keen interest in sci- as zan, 269, 110 at S.Ct. 2841. But a progressed. Congress re- ence has has protecting tradition individual freedom sponded evolving technology to medical forced, life-saving, medical but treat But, evolving regulation. unlike ment not does evidence a constitutional majority, I do by not see how the decision to providing tradition of affirmative access Congress to an regulate harmful, fatal, area concern potentially a and even com early part century good.5 of the twentieth mercial Practice, covery engage Value their as of the true to make an informed decision administer; they conduct, treatment, is what which become by withdrawing Grievance, intolerable, dangerous as Maj. Op. will one’s cause death.” at poorer People, well to Sort of as others. added). Glueksberg (emphasis specifically As added). (emphasis

Id. recog- majority argues 5. The that "Cruzan process nized a due ... an individual has minally to have a patients seem of Cruzan’s discussion light competent involuntary individual refuse

“right of a make uninformed and an treatment,” medical U.S. choice. added), ma- (emphasis help majority’s It cause does not to limit its

jority attempts rejected that the Court sev- “mentally competent” patient who challenges eral similar to the FDCA and to experimental access” has “informed brought statutory grounds. related laws majority Maj. Op. at 486. The drugs. See, Raich, at-, e.g., U.S. competence, what mental explains never (“the context, require. drugs, would As the FDA dispensing this of new response propos- noted in to the Alliance’s use, their must approve even when doctors al, available, little it is “with so data hard approval”); await federal United States truly to understand how a could Rutherford, 442 U.S. potential risks —or informed about (1979) (“we per- 61 L.Ed.2d 68 are drug.” By with the benefits —associated legislative and con- by suaded early stage into an injecting patients interpretation of the sistent administrative testing experimental FDA’s for implicit exemption that no [FDCA] drugs, majority’s allows ter- approach ill is neces- used experimental to take minally sary congressional objectives”); to attain is, any- drugs unknowingly without —that Oakland, cf. potential having knowledge one risks (with respect whether is an there and benefits. fail to see how such a necessity” implied exemption “medical rejected supported Cruzan. Cruzan prosecution marijuana use under the argument incompetent person an that an Act, generally Controlled Substances has a absent withdraw treatment “[w]hether, matter, speaking, policy and, expressed competent intent in- while created exemption ques- should be is a stead, upheld requirement state’s judicial for legislative judgment, tion clear re- convincing prior evidence omitted). inference”) (quotation marks To garding person’s an incompetent wishes to sure, Supreme ad- Court has not 279-80, withdraw treatment. 497 argument dressed the constitutional raised explained, 2841. S.Ct. As Court by contrary to Alliance. But the tradi- difficulty petitioners’ claim is “[t]he by majority, tion there is a asserted that begs question: in a sense it An rejecting arguments tradition of courts person make an incompetent is able to that the affirma- provides Constitution an voluntary and informed choice to exercise right tive of access particular medical hypothetical right a to refuse treatment or reasonably prohibited by treatments any right.” 280, other Id. 110 S.Ct. decision, majority’s ter- Under Government.6 however, noted, Cruzan, 279, argument rejecting (quoting 497 U.S. at 2841) added). right that a (emphasis there is fundamental to commit (z.e., doing suicide and receive so assistance in 6. No circuit court acceded to an affirma- has engage in conduct that will cause one's See, e.g., Clay- tive access claim. Mitchell v. death), "although described as often Cruzan ton, 772, (7th Cir.1993) ("most 995 F.2d case, 'right a to die' [the Court] a fact, federal courts have held that does w[as], precise: [the Court] more as right not have a granted constitutional to obtain compe sumed that the Constitution particular type of 'constitutionally right treatment or obtain treat- persons protected tent ” particular govern- provider ment lifesaving hydration and nutrition.' refuse 722-23, reasonably type Glucksberg, prohibited ment 521 U.S. at 117 S.Ct. has that procure experi- right The decision to and use have a to “potentially life-saving enjoyed legal pro- mental never treatment,” id. at although majori- tection, let alone risen to the level of a ty appears exempt the Controlled Sub- libert[y] right[] “fundamental which stances Act and regulation state from its [is], objectively, deeply rooted in this Na- right, constitutional id. at 479 & n. 11. Glucksberg, tion’s and tradition.” majority’s vague potentially allusion to 720-21, (quota- 521 U.S. at life-saving drugs demonstrates its difficul- omitted). tion marks The amendments ty in explaining what its constitu- by Congress through- made to the FDCA right protects. tional That difficulty arises century, Maj. out Op. the twentieth because at issue here is a novel and unfa- Congress, show that and the miliar area of science. The Alliance con- FDA, responded continuously to new patients tends that would be better served by presented evolving technology. risks by allowing them to assume unknown risks Indeed, pre- because the risks and benefits regardless any of whether benefit of an experimental sented drugs are dif- experimental remains uncertain. drug, majority ferent with each new The FDA disagrees and concludes that not even sure what level of patients will be best served provide. constitutional will The ma- jority suggests that receiving experimental drugs only when Inst., provider''); (5th Ophthal treatment or N.Y. State search 819 F.2d 1313-14 Bowen, mological Soc’y 1987); 854 F.2d Yellowley, Cir. Lambert v. cf. (D.C.Cir.1988) ("We disagree that the 588, 590, 596-97, 71 L.Ed. privacy comprehensive constitutional (where determined, Congress ly protects by patients all choices made Prohibition, implementing "practicing physicians subjects scrutiny’ their to 'strict malt, physicians differ about the value of vi- government all interference with choice of nous, spirituous liquors for medicinal medical treatment. There is no basis under purposes, preponderating opin- [and] privacy extending current case law for such against purposes,” ion is their use such stringent protection every bearing, decision rejected physician's the Court claim of a indirectly, person's however on a health and constitutional to "use ... such medi- denied, physical well-being.”), cert. opinion cines and medical treatment as in his 104 L.Ed.2d 1003 patients'] are best calculated to effect [his States, (1989); Carnohan v. United 616 F.2d health,” holding cure and establish their 117.0, (9th Cir.1980) (“Constitutional practice "there is no medicine which privacy personal liberty do not power is not subordinate ... to the of Con- give individuals the to obtain cancer [the gress necessary proper to make laws .... drug] laetrile free of the lawful exercise of High authority being medical in conflict toas government police power.”); v. Rutherford spirituous the medicinal value of and vinous States, 455, (10th United 616 F.2d Cir. would, indeed, liquors beverage, taken as a it 1980) ("[T]he patient['s] ... selection of a strange Congress power lacked the treatment, medication, particular or at least liquor that the of determine necessities governmental is within the area of interest in problem require permissible a limitation of protecting public premarketing health. The ”); prescriptions Maryland, .... Watson v. [FDCA], 355, requirement § 21 U.S.C. 644, 218 U.S. 30 S.Ct. 54 L.Ed. 987 Congressional authority is an exercise of (1910) ("It require is too well settled to dis- patient's limit the choice of medication. This day police power at this cussion that the of [Supreme is clear under the deci Court's] regulation 544, the states extends to the of certain ...."), sions on remand 442 U.S. callings, 2470, denied, particularly trades and (1979), those which S.Ct. 61 L.Ed.2d 68 cert. 937, 336, closely public concern the health. There is 449 U.S. 66 L.Ed.2d 160 (1980); perhaps profession properly open no more see also Sammon v. N.J. Bd. Med. of

Examiners, 639, (3d regulation such than that which embraces the 66 F.3d 645 n. 10 Cir. 1995); medicine.”). Burzynski practitioners United v. Re- States Cancer of uncertainty, rather that courts should knowledge pa- but is “reasonable there leg- to reasonable pay particular their clinical deference physicians likely and of tients Jones, 463 at toxicity.” judgments.” But islative U.S. and their “[t]he benefit view, my In said 365 n. 103 S.Ct. 3043. thing that can be about certain into injects courts un- knowledge therapy majority’s approach and state of present finality of and medicine questions not known science ... that science has reached contrary expressed and to the Certainly, .... denial of con- does so will judgment of and to Congress Congress ... in deal- Executive power stitutional ought like this not to courts owe the democratic ing with situation deference branches on such controversial matters. dogmatic adherence one view rest psychiatric is- another on controversial disagreements” over scientific “These States, v. United sues.” Greenwood [Govern- issues “do not tie the medical 366, 375-76, L.Ed. in setting hands bounds its ment’s] Greenwood addressed an issue fact, ... precisely laws. In it is where ap- principle but the same psychiatry, legislatures disagreement such exists disputed scientific plies to and medical have afforded in been the widest latitude view, major- my in this issues case. v. drafting such statutes.” Kansas Hen- judgment made ity has its own about the dricks, n. 521 U.S. 356-60 & risks of providing medical benefits and (1997) (state’s S.Ct. 138 L.Ed.2d 501 drugs pa- experimental comported civil commitment statute That is Congress rightly a role tients. requiring substantive due com- has, occupied through exercise pedophile “psychiatric mitment of a where I powers, delegated Article the FDA professionals complete [were] not har- for enforcement. ... as mony casting pedophilia ‘mental ” “ illnesses;’ ‘concept although other states would Our Nation’s ordered liber ” 721, 117 commitment, Glucksberg, required legis- not civil ty,’ 521 U.S. S.Ct. Palko, in light was due wide latitude (quoting lature 149), majority contemplate disagreement). sug- that medical does gests judges completed should the scientific uncer which have resolve testing sufficiently bear presented by experimental drugs. tainties Phase I small majority “recognized confidently Court has re medical risk. ‘uncertainty judgment, that scientific but can- peatedly diagnosis makes not. profes experimental by this field the tentativeness of These are ” FDA, judgment.’ very their nature. sional Jones United Unlike States, 355(n), § Congres- 365 n. we do not have 103 S.Ct. U.S.C. advisory (quoting sionally-provided panels 77 L.Ed.2d 694 scientific 410) Greenwood, 375, 76 disposal. Congress 350 U.S. at our “When under- in areas (rejecting argument Congress fraught to act with medical takes uncertainties, legislative constitutionally provide op- could not for com scientific mentally of the ill especially mitment based tions must be broad courts because, a ar cautious prior litigant legisla- criminal act should be not to rewrite tion, assuming, that gued, proffered psychiatric arguendo, judges his research even prior exposure problem not with direct to the dangerous showed acts do more might future les make wiser predict dangerousness). “The choices.” Marshall States, 417, 427, drawn is not that [the ha[s] son United U.S. Court] in the this L.Ed.2d 618 government may not act face of history and con- cell Nation’s traditions stem research and treatment? Per- Our democratic will template haps significantly, that the branches most potential what between the uncertain achieve balances must a treatment have in order for the technology. and benefits of medical risks to Constitution mandate access? Massachusetts, Jacobson v. majority Because the does not answer (1905) 11, 30, 49 L.Ed. question, this last the District Court faces (“We that, assume when the statute must impossible task on remand. The ma ... question passed, legislature was the jority concludes that the District Court opposing was not unaware of these theo- must “determine whether the policy FDA’s ries, compelled, necessity, was barring to post-Phase access I investiga choose between them. It was not com- drugs by terminally tional new ill patients pelled involving to commit matter narrowly compelling tailored serve a safety health and to the final deci- public governmental Maj. Op interest.” at 486. jury. part sion of a court or It is no of the matter, preliminary As a majority nev jury a court or a function of determine explains why er the District Court must likely

which one of two modes was determine that FDA compelling, protection the most effective for the of the narrowly tailored in preventing interest disease.”). public against Our Nation’s access passed to all that have or will concept liberty, along ordered with our term, pass Phase I. Just this history, traditions and do not call for Court reminded Appeals the Court of usurp judgment courts of the scien- confronting “when a constitutional flaw in communities, tific and medical expressed statute, try to limit we the solution to the through Congress and the Executive Branch, problem. prefer, . for example, that science does not warrant al- We to en early join only lowing experimental access to the unconstitutional applications drugs the leaving Alliance demands. of a statute while applica other ” Ayotte tions in force .... v. Planned III. , —- England Parenthood N. New U.S. majority’s to procure and -,-, 163 L.Ed.2d experimental drugs use raises a number of Raines, (citing United States v. vexing questions that are now constitu- 17, 20-22, 4 L.Ed.2d issues, potentially tional insulated from (1960)). requiring Rather than tug pull political process. District Court all determine whether If a right, has such a patients should have access are with serious medical condi- experimental drugs to all after Phase I tions entitled to the same benefit testing, why it remains unclear the District If logic corresponding access? an in- Court should not undertake the more re digent potentially life-saving cannot afford inquiry majority’s strained of whether the treatment, would the Constitution man- right guarantees specific date access to such care under the drugs sought individual members of the recognized by majority? pa- Can a Alliance. (ie., any drug marijuana tient access Raich, majority’s approach, Under facial purposes, medicinal 2215) -, believes, every in the District Court must examine S.Ct she FDA physician, poten- drug undergoing testing every consultation with a it is tially life-saving? may undergo testing. majority’s Would the ever right guarantee federally-funded access to It must then evaluate whether the FDCA’s limited drugs knowledge now scientific unapproved evaluate access

prohibition exemptions drug for limited Phase I and determine corresponding about a compelling a interest and are drug life-saving serve that is potentially access whether narrowly light in all of require protec- tailored enough to constitutional all risks benefits of potential different tion. and the of all drugs needs experimental pres failed to Because Alliance has Although the Gov- terminally patients. objective establishing deep a ent evidence a likely will show that it has most ernment procure ly experi rooted and use regulating access to compelling interest drags, I rational apply mental would basis toxicity po- and the drugs with unknown process challenge. to its due review death, the risks to hasten unknown tential Glucksberg, U.S. experimental of these and benefits held in 2258. As the Court re judicial a ex- nearly impossible make will challenge by terminally pa a jecting level whether some amination claiming safety tients the FDCA’s prohibition a would be more nar- short of them, requirement apply did “the majority’s rowly protect tailored to drug generally considers a safe [FDA] access. constitutional gain justi expected therapeutic when the Moreover, the level of benefit a by fies entailed its For the risk use. show, have to in order demonstrate will ill, else, as for a anyone drug is majority’s right drug that under the inflicting potential unsafe death or life-saving, enigma. remains an potentially physical injury possibil is not offset majority by “poten- means Whatever ity therapeutic Rutherford, benefit.” tially,” suggests its use of that term 2470. Al enough some will not demonstrate terminally ill though patients desperately benefit, simultaneously potential while treatments, death need curative their can extraordinary risks. presenting Consider- certainly hastened the use of a be toxic ing potential of an experimen- benefits drug. drug Prior distribution of out drug light require tal of its risks will studies, side of controlled the Government step Court to into the role of the District ensuring basis for there rational today, FDA. Before scientists scientifically medically acceptable is a FDA, physicians at consultation knowledge level of about the risks and greater

with the scientific and medical drug. benefits of such would affirm through advisory communities scientific of District Court. decision panels, applied disputed and often limited knowledge experimen- scientific about an determining

tal what level of ac- given ill pa-

cess should

tients and what medical circumstances majori-

warrant such access. Under the

ty’s approach, the United States District

Court for District of must Columbia

Case Details

Case Name: Abigail Alliance for Better Access to Developmental Drugs & Washington Legal Foundation v. Von Eschenbach

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

Date Published: May 2, 2006

Citation: 445 F.3d 470

Docket Number: 04-5350

Court Abbreviation: D.C. Cir.