Document: 535 U.S. 357 THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES, et al.v.WESTERN STATES MEDICAL CENTER ET AL. No. 01-344. Supreme Court of the United States. Argued February 26, 2002. Decided April 29, CERTIORARI TO THE UNITED COURT APPEALS FOR NINTH CIRCUIT Drug compounding is a process by which pharmacist or doctor combines, mixes, alters ingredients to create medication tailored an individual patient's needs. The Food and Administration Modernization Act 1997 (FDAMA) exempts "compounded drugs" from Administration's (FDA) standard drug approval requirements under Federal Food, Drug, Cosmetic (FDCA), so long as providers compounded drugs abide several restrictions, including that prescription be "unsolicited," 21 U. S. C. § 353a(a), "not advertise promote any particular drug, class type drug," 353a(c). Respondents, group licensed pharmacies specialize in drugs, sought enjoin enforcement advertising solicitation provisions, arguing they violate First Amendment's free speech guarantee. District agreed granted respondents summary judgment, holding provisions constitute unconstitutional restrictions on commercial Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n N. Y., 447 557, 566. Affirming relevant part, Ninth Circuit held question fail Hudson's test because Government had not demonstrated would directly advance its interests alternatives less restrictive were unavailable. Held: FDAMA's prohibitions soliciting prescriptions for, advertising, amount speech. Pp. 366-377. (a) For regulation constitutionally permissible test, must concern lawful activity misleading, asserted governmental interest served substantial, "directly advanc[e]" [be] more extensive than necessary serve interest," S., at 366-368. (b) asserts three substantial underlie FDAMA: (1) preserving effectiveness integrity FDCA's new protection public health it provides; (2) availability for patients who, particularized medical reasons, cannot use commercially available products approved FDA; (3) achieving proper balance between those two competing interests. Preserving clearly important interest, permitting continuation practice with needs may obtain medications suited Because pharmacists do make enough money small-scale safety efficacy testing their economically feasible, however, sense require created meet unique undergo entire process. therefore able draw line large-scale manufacturing. argues speech-related provide just such line: As sell without first undergoing obtaining FDA approval. However, even assuming prohibition advance[s]" Government's interests, has failed demonstrate are [those] interest[s]." Hudson, supra, If can achieve manner does restrict speech, restricts so. E. g., Rubin Coors Brewing Co., 514 476, 490-491. Several non-speech-related means drawing manufacturing might possible here. example, could ban scale equipment products, prohibit anticipation receiving response already received, them offering wholesale other state persons entities resale. offered reason why possibilities, alone combination, insufficient prevent occurring undermine 368-373. (c) Even if argued (as dissent) motivated fear put people who need risk causing convince doctors prescribe anyway, justify restrictions. This rests questionable assumption unnecessary amounts bad decisions given truthful information, notion rejected justification in, e. Virginia Bd. Pharmacy Citizens Consumer Council, Inc., 425 748, 770. 373-376. (d) failure decision regulate unconstitutional, beneficial prohibited FDAMA be. Forbidding advertisement no mass-producing medications, but clienteles special needs, telling treating clients about alternative through compounding. serving children's hospital where many unable swallow pills prevented development allowed was previously only pill form administered another way. fact seemingly useful though doing appear further objective confirms unconstitutional. 376-377. 238 F. 3d 1090, affirmed. O'CONNOR, J., delivered opinion Court, SCALIA, KENNEDY, SOUTER, THOMAS, JJ., joined. filed concurring opinion, post, p. 377. Breyer, dissenting Rehnquist, Stevens Ginsburg, joined, 378. Deputy Solicitor General Kneedler cause petitioners. With him briefs Olson, Assistant Attorney McCallum, Matthew D. Roberts, Douglas Letter, Alex M. Azar II, Daniel Troy, Patricia J. Kaeding. Howard Hoffman brief respondents.* Justice O'Connor Court. 1 Section 127(a) (FDAMA Act), 111 Stat. 2328, 353a, refrain promoting drugs. subsections dealing solicitation, motion acceptable government set forth 566 (1980). court invalidated severing rest 127(a). 2 Appeals affirmed part reversed agreeing regarding promotion finding severable Petitioners challenged Appeals' constitutional petition certiorari, did file cross-petition. We address question, having occasion review severability determination. conclude, courts below, 127(a)'s we affirm. 3 * patient. Compounding typically used prepare available, patient allergic ingredient mass-produced product. It traditional component pharmacy, see Thompson, A Practical Guide Contemporary Practice 11.3 (1998), taught curriculum most pharmacy schools, American Council Pharmaceutical Education, Accreditation Standards Guidelines Professional Program Leading Doctor Degree, Standard 10(a) (adopted June 14, 1997). Many States specifically practices pharmacies. See, Cal. Code Regs., tit. 16, §§ 1716.2, 1751 (2002); Ind. Admin. Code, 856, 1-30-8, 1-30-18, 1-28-8 (2001); H. Rules Ann. Pharmacy, pts. PH 404, 702.01 22 Tex. 291.36 (2002). Some all offer services. 49 Pa. 27.18(p)(2) W. Va. St. Rules, 15, 19.4 Pharmacists upon receipt valid practitioner medication. Okla. 535:15-10-3, 535:15-10-9(d) Colo. State Board Rule 3.02.10 (2001). 4 1938 301-397, regulates manufacturing, marketing, distribution. 505(a) FDCA, 52 1052, amended, 76 784, provides "[n]o person shall introduce deliver introduction into interstate commerce unless application [with Administration] effective respect drug." 355(a). "[N]ew drug" defined 201(p)(1) 1041, 781, "[a]ny ... generally recognized, among experts qualified scientific training experience evaluate safe conditions prescribed, recommended, suggested labeling thereof." 321(p). FDCA invests power enforce requirements. 371(a). 5 approximately 50 years after enactment left continued applying eventually became concerned, some selling guise compounding, thereby avoiding In 1992, this concern, issued Compliance Policy Guide, announced "FDA may, exercise discretion, initiate federal actions when scope nature pharmacy's activities raises kinds concerns normally associated manufacturer results significant violations adulteration, misbranding Act." 7132.16 (hereinafter Guide), App. Pet. Cert. 76a. explained recognizes traditionally have extemporaneously manipulated reasonable quantities individually identified practitioner," subject Guide. Id., 71a. said, "that while retail exempted certain [FDCA], general exemption provisions" FDCA. 72a. stated believes increasing number establishments licenses engaged distributing, unapproved human outside bounds [FDCA]." Ibid. expressed "manufactured distributed [the] FDA's prior approval" harm health. 73a. 6 light these considerations, policy permit compound "very limited quantities" before document history "generated solely within established professional practitioner-patient-pharmacy relationship" maintained required law. 73a-75a. circumstances permitted raise "the manufacturer." listed nine examples believed raised considered agency determining whether bring action. These included: "[s]oliciting business (e. promoting, using salespersons) specific product classes, therapeutic classes products"; "[c]ompounding, regularly, inordinate amounts, essentially generic copies FDA-approved drugs; wholesale; "[d]istributing out state." 76a-77a. warned dispense third parties resale losing status entities. 75a. 7 Congress turned portions law enacted 1997. FDAMA, amends "new provided satisfy First, physician patient, or, prepared prescription, made "limited pharmacist's physician's orders relationship pharmacist, prescriber. 353a(a). Second, standards, 353a(b)(1)(A)-(B), list been withdrawn removed market found unsafe ineffective, 353a(b)(1)(C). Third, "compound regularly Secretary) product." 353a(b)(1)(D). Fourth, presents demonstrable difficulties terms effectiveness. 353a(b)(3)(A). Fifth, entered "memorandum understanding" addressing distribution "inordinate amounts" commerce, distribute exceeding five percent entity's total orders. 353a(b)(3)(B). Finally, litigation, "advertise service." 8 Respondents They promotional materials mail conferences inform physicians Fearing prosecuted materials, complaint Nevada, Act's requirement wish continue violates Free Speech Clause Amendment. Specifically, judgment respondents, 566, should enjoined. Western Medical Center Shalala, 69 Supp. 2d 1288 (Nev. 1999). intact. 9 appealed both part. 1090 disagreed, 127(a), explaining legislative intended exempt return Accordingly, entirety. 10 534 992 (2001), consider neither party petitioned certiorari issue, portion decision. Likewise, unrelated issue here remain unaffected. II 11 agree 748 (1976), case explicitly receives Amendment protection, reasons protection: "It matter [economic] decisions, aggregate, intelligent well-informed. To end, flow information indispensable." 765. Indeed, recognized "particular consumer's keen, keener far, his day's urgent political debate." 763. emphasized: 12 "The marketplace, like spheres our social cultural life, forum ideas flourish. vital, slight worth. But rule speaker audience, government, assess value presented. Thus, communication propose transaction entitled coverage Amendment." Edenfield Fane, 507 761, 767 (1993). 13 Although protected Amendment, See articulated permissible. Under ask threshold unlawful misleading. so, then next "whether substantial." is, "determine advances asserted," and, finally, interest." Each latter inquiries answered affirmative constitutional. 14 Neither appropriateness framework Members doubts analysis apply cases, see, Greater New Orleans Broadcasting Assn., Inc. States, 527 173, 197 (1999) (Thomas, judgment); 44 Liquormart, Rhode Island, 517 484, 501, 510-514 (1996) (opinion STEVENS, joined KENNEDY GINSBURG, JJ.); id., (SCALIA, 518 (THOMAS, judgment), there break ground. "`Central applied recent adequate basis decision.'" Lorillard Tobacco Co. Reilly, 533 525, 554-555 (2001) (quoting Orleans, 184). III 15 attempt defend prong test; i. e., argue advertisements Instead, satisfies remaining prongs test. 16 FDAMA. "preserv[ing] provides." Brief 19. second FDA." 19-20. "[a]chieving independently compelling itself 20. 17 Explaining critical safety. claims demonstrates proof rigorous, scientifically clinical studies impressions doctors, themselves compile sufficient data, relied upon. also premarket process, manufacturers proposed tests order best way guarantee 18 While praises acknowledges "because costly requiring would, practical matter, eliminate treatment." 26. eliminating undesirable sometimes care allergies, tolerate delivery systems, dosages. 19 every want And force stop providing Given this, That distinguish produced small sold large 20 line, that, advanc[e] interest[s] asserted." Those trigger — essentially, required. explains (or, view, desirable) responds situation, "[a]dvertising provision [such] service opposed itself) responsive customized 34. broad designed individual's "often need[s]." contends individuals. contrast associated, claims, production market. therefore, "a fair proxy actual largescale manufacturing," Congress' limit engage "rationally calculated" avoid creating "`a loophole allow unregulated occur compounding.'" 35 143 Cong. Rec. S9839 (Sept. 24, 1997) (statement Sen. Kennedy)). seems believe feasible. thus conditioning refraining ideal yet conducted Assuming true marketed indeed does, previous cases final clear 476 (1995), prohibiting beer labels displaying alcohol content "such limiting beers, marketing efforts emphasizing high strength ..., malt liquors." "all [these alternatives] intrusive rights" indicated "more necessary." 491. (plurality opinion) (striking down price alcoholic beverages "alternative forms involve restriction likely State's goal temperance"). very factors 1992 "commercial products." received. ibid. "[o]ffering resale." 77a. Alternately, either volume numbers prescriptions, sells state. Another possibility capping volume, gross revenue, profit period time. rely non-speechrelated limitation percentage sales out-of-state represent, 23 hint alternatives. Nowhere petitioners' explanation forbidding merely convenient Yet "[i]t well `the seeking uphold carries burden justifying it.'" 770 Bolger Youngs Products Corp., 463 60, 71, n. (1983)). simply anything, regulating last resort. strategy thought try. 24 dissent describes sale "patients them," 379 BREYER, J.) "Congress conclude `directly advance' " 384. briefs, ban. Although, dissent, conceivably sustained statutes hypothesized justifications reviewing determine rational. L. Tribe, Constitutional Law 1444-1446 (2d ed. 1988) (describing "rational basis" "conceivable test); also, Minnesota Clover Leaf Creamery 449 456, 466 (1981) (sustaining milk packaging Legislature rationally decided [the regulation] foster greater environmentally desirable alternatives" (emphasis deleted)). significantly stricter rational identify achieved restrictio[n] speech," 564, prove advances" met regard describes. 25 Aside (an willing based one magazine article survey, 383-384, Government), 368 (explaining claim forbidden false misleading). preventing dissemination members making information. feared received pharmacists, "choose low-cost, low-quality drive `professional' business" "destroy pharmacist-customer going another. fears advertising. 769. explained: 26 "There course, highly paternalistic approach. assume harmful, will perceive own informed, end open channels rather close them.... choice approaches ours Assembly's. precisely kind choice, dangers suppressing misuse freely makes us. whatever standards wishes pharmacists; subsidize protect competition ways.... keeping ignorance entirely offering." (citation omitted). 27 503 ("[B]ans against truthful, nonmisleading usually offensive respond `irrationally' truth.... directs us especially skeptical regulations seek keep dark what perceives good" omitted)). 28 statute interest. "must exclude area them." Post, 379. forbid sales. instead course individuals doctors. reduce demand nothing prescriptions. appropriate prescribing them, world permitted. 29 suggesting banning confused drugs' risks. 387 ("[The Government] systematic effect fully explain complicated risks issue"). argument precluded, misleading advertisements, satisfied far each labeled warning undergone unknown. 30 affect interested producing scale. posting notice informing customers children refuse take taste, change flavor, giving flavoring possible. belief 31 affirm 32 So ordered. Notes: Briefs ofamici curiae urging affirmance International Academy Alan Untereiner Arnon Siegel; National Community Association Kenneth Geller John Rector; Julian Whitaker, M.D., al. Jonathan Emord Claudia A. Lewis-Eng. Michael McConihe amicus curiae. 33 JUSTICE concurring. 34 I concur Court's 557 continue, adhere my view analyzed "I `commercial' least when, here, would-be recipients dark." 523 judgment). whom Chief Justice, Stevens, Ginsburg join, dissenting. 36 requires strict "new" "drugs." 355. CFR 310.3(h) (2002) (defining broadly). preclinical investigation separate tests, small, controlled healthy diseased humans double-blind side drug. Regulation 95-102 (K. Piña Pines eds. 1998). elaborate time-consuming regulatory regime otherwise notice. 37 At same time, "compounding" "by patient." Ante, 360-361. meets specified conditions, condition 353a(c) added). 38 holds speech" violation 564 concedes statutory tries "[p]reserv[e] process," ante, 369, assumes deciding "`directly advance'" 371. nonetheless finds other, ways. 372-373. disagree conclusion, seriously undervalues importance protecting public. 39 statute's objective. objective, concedes, confine untested, compounded, medically needed. supply capable being amounts. 40 majority's discussion focuses exclusionary need, virtually ignores second. "line" "distinguish so." 370 description overlooks specially untested convenience necessity. say, statute, look supplied (to help decide ordinary tested alternative) genuine simple convenience). Cf. S9840 (remarks Kennedy) (understanding "some ensure approach ordinarily manufacturing" others "intended qualify assurances quality since [they] comprehensive manufactured products"). 41 intermediate logically related primary minimizing basic inherently creates placing hands consumer. Where offset. convenience, necessity, offset unlikely present. 42 presumably nor anywhere suggests matters drug's whole story. Rep. 105-43, 67 (1997) (statute seeks assure "continued individualized therapy, prevent[ing] compounding" added)); accord, R. Conf. 105-399, 94 (1997). itself, reflects, lists distinguishing factors, one. 7132.16, reprinted 71a-77a Guide). why, faced "other section 353a inadequate Congress's desired interests." Appellants 99-17424 (CA9), 57. 55 nullify "`finely tuned balance'" "pharmacies until proven effective"). 43 Ensuring benefits authorities, testifying Congress, insisted doctor's represent determination need. Reform Legislation: Hearings Subcommittee Health Environment House Committee Commerce, 104th Cong., Sess., 120 Legislation) Mary K. Pendergast, Commissioner Senior Advisor Commissioner) (Allowing "good medicine" "an physician" patient"). Boards Model Art. I, 1.05(e) NABP Act) "[c]ompounding" involving "based Practitioner/patient/Pharmacist practice"). authorities compounds. 76a; Good Practices Applicable Licensed Pharmacies, Act, C.2, subpart (forbidding "solicit promote, advertise, definitions reflect similar distinctions. 105(e), (t), (u) "include devices" excluding reference definition compounding); Alaska 08.80.480(3) (15) (2000) (same); La. 37:1164(5) (25) (West 2000) Miss. 73-21-73(c) (s) (Lexis 1973-2000) Mont. 37-7-101(7) Rev. 318-1(III) (VIII) (Supp. 2001) 61-11-2(C) (Q) Ohio 3715.01(14) 2002) Stat., Tit. 59, 353.1(20) (26) 40-43-30(7) (29) Tenn. 63-10-404(4) (18) Occ. 551.003(9) (23) (2002 Pamphlet) 30-5-1b(c) (o) (1966-1998) (same). 45 policies consideration present, absent, originates doctor, advertisement. try generated doctor-to-patient-to-pharmacist, pharmacist-to-advertisement-to-patient-to-doctor. diminish likelihood genuinely receive them. 46 There considerable evidence No denies complex system relies find, assess, relying anecdotes. 47 Nor anyone deny carry After all, necessarily changing cf. 377, combining different new, ways, adding pain antihistamine counteract allergies ratio salve body absorb faster rate. combination quicker absorption rate working old can, patients, mean infection, serious effects, death. 11.5 (1998) Practice). 310.3(h)(1) (considering "substance composes new); 310.3(h)(3) combined proportions). 48 consumer oriented strong consumer-driven Institute Care Management, Factors Affecting Growth Prescription Expenditures iii (July 9, 1999) (three spent $313 million 1998 accounted 90% market); Kritz, Ask Your About Which Advertised Allergy Drugs Are Right You? Washington 6, 2000, Health, (The world's top allergy eighth best-selling almost $140 1999 advertising); Prevention Magazine (spending direct-to-consumer medicine increased $965.2 $1.33 billion often affirmatively request seen advertised. (84% consumers polled report accommodate drug); Henry Kaiser Family Foundation, Understanding Effects Direct-to-Consumer Advertising (Nov. (A foundation survey eight Americans asked advertisement). circumstances, reasonably it. When parent learns child's liquid form, skin cream enhanced penetration rate, sufferer antiinflammatory/allergy alleviate sinus headache sedative effects antihistamines, prescription. write absence arise lack testing, anecdote experience, reveal consequently surprising 71% active Physicians "believe pressures prescribe." Rosenthal, Berndt, Donohue, Frank, Epstein, Promotion Consumers, 346 Eng. Med. 498-505 (citing Lipsky, Opinions Experiences Regarding Direct-To-Consumer Advertising, Fam. Pract. 495-499 (1997)). 51 Of added small. together least, reach conclusion. fact, along learning about, obtaining, advance" goal. responding needs; it; goals. law, objectives Consider suggests. says `commercial products.'" 372. batches. quantity produced, doctor-patient achieve. 53 "could received." alternative, quantity, second, need-related 54 `[o]ffering objection. sales, reaching 56 "ca[p] profit." others, patientneed problem, simultaneously threatening whose represents beyond arbitrarily imposed quantitative limit. 57 Sixth, "non-speech-related prescription." patient-need problem Circuit. 380-381. 58 adds "[t]he insufficient." 373. "alternatives," sufficient. draws four alternatives, successfully unacceptable 59 causes health, implausible relevant. says, control flows "fear" "people drugs." 374. response, rationale; fails account considerations plausible (if properly stated); inconsistent interpretation Constitution. 60 oversimplification say "fear[s]" "would information." Rather, consequences multiple compound-drug initiated pharmacist-to-patient adverse cumulative seem perfectly own. taken together, apparently system, overall net harm. Legislation 121 David Kessler, FDA) (voicing "quality controls" drug-testing system). Consequently, leaves advise discuss physicians. forbids "information" provides, effect, insofar solicit business, issue. plausible. Part supra. 61 circulation prevents "this X." Nonetheless, automatically flexible examined restriction's proportionality, relation fit ends means. "substantial" necessary" ends. done concluded perspective, warrant strictest speechprotective tests. reached conclusion repress self-expression; rarely interfere functioning democratic processes; democratically determined venture protect, consumer, safety, environment. 499 ("[T]he transactions justifies concomitant `linked inextricably' transactions"); 12-15, 903 ("[C]ommercial doctrine" right speak hear expression goods services" original)). 62 Parts gives weight rationale, too readily existence applies doctrine strictly. Buckman Plaintiffs' Legal Comm., 531 341, 349 (flexibility "pursu[e] difficult (and competing) objectives"). Illinois Elections Socialist Workers Party, 440 188-189 (1979) (Blackmun, concurring) (warning overly demanding search alternatives). 63 Constitution demands lenient application, reflects distinctions contexts, regulation, which, particular, distinguishes protection. Otherwise, rigid transform ought legislature enacting protections. Due Process shows, transformation tragic misunderstanding. 189 concurring). IV 64 majority hold prohibits Doctors, channels. indication negative 11.4 (compounded "available" "widely disseminated" books, journals, monographs, vendors). Nor, exception, groups complained future. Amici Curiae (alleging, evidentiary support, knowing how get "competitively priced efficiently possble"). 65 Regardless, facial attack statute. focus consumer-directed addressed questions leave abeyance. Considering directed consumers, 66 dissent.

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