Section 127(a) of the Food and Drug Administration Modernization Act of 1997 (FDAMA or Act), 111 Stat. 2328, 21 U. S. C. § 353a, exempts "compounded drugs" from the Food and Drug Administration's standard drug approval requirements as long as the providers of those drugs abide by several restrictions, including that they refrain from advertising or promoting particular compounded drugs. Respondents, a group of licensed pharmacies that specialize in compounding drugs, sought to enjoin enforcement of the subsections of the Act dealing with advertising and solicitation, arguing that those provisions violate the First Amendment's free speech guarantee. The District Court agreed with respondents and granted their motion for summary judgment, holding that the provisions do not meet the test for acceptable government regulation of commercial speech set forth in Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of N. Y., 447 U.S. 557, 566 (1980). The court invalidated the relevant provisions, severing them from the rest of § 127(a).
The Court of Appeals for the Ninth Circuit affirmed in part and reversed in part, agreeing that the provisions regarding advertisement and promotion are unconstitutional but finding them not to be severable from the rest of § 127(a). Petitioners challenged only the Court of Appeals' constitutional holding in their petition for certiorari, and respondents did not file a cross-petition. We therefore address only the constitutional question, having no occasion to review the Court of Appeals' severability determination. We conclude, as did the courts below, that § 127(a)'s provisions regarding advertisement and promotion amount to unconstitutional restrictions on commercial speech, and we therefore affirm.
Drug compounding is a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create
The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), 21 U. S. C. §§ 301-397, regulates drug manufacturing, marketing, and distribution. Section 505(a) of the FDCA, 52 Stat. 1052, as amended, 76 Stat. 784, provides that "[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed [with the Food and Drug Administration] is effective with respect to such drug." 21 U. S. C. § 355(a). "[N]ew drug" is defined by § 201(p)(1) of the FDCA, 52 Stat. 1041, as amended, 76 Stat. 781, as "[a]ny drug . . . not
For approximately the first 50 years after the enactment of the FDCA, the FDA generally left regulation of compounding to the States. Pharmacists continued to provide patients with compounded drugs without applying for FDA approval of those drugs. The FDA eventually became concerned, however, that some pharmacists were manufacturing and selling drugs under the guise of compounding, thereby avoiding the FDCA's new drug requirements. In 1992, in response to this concern, the FDA issued a Compliance Policy Guide, which announced that the "FDA may, in the exercise of its enforcement discretion, initiate federal enforcement actions . . . when the scope and nature of a pharmacy's activities raises the kinds of concerns normally associated with a manufacturer and . . . results in significant violations of the new drug, adulteration, or misbranding provisions of the Act." Compliance Policy Guide 7132.16 (hereinafter Guide), App. to Pet. for Cert. 76a. The Guide explained that the "FDA recognizes that pharmacists traditionally have extemporaneously compounded and manipulated reasonable quantities of drugs upon receipt of a valid prescription for an individually identified patient from a licensed practitioner," and that such activity was not the subject of the Guide. Id., at 71a. The Guide said, however, "that while retail pharmacies . . . are exempted from certain requirements of the [FDCA], they are not the subject of any general exemption from the new drug, adulteration, or misbranding provisions" of the FDCA. Id., at 72a. It stated that the "FDA believes that an increasing number of establishments with retail pharmacy licenses are engaged in
In light of these considerations, the Guide announced that it was FDA policy to permit pharmacists to compound drugs after receipt of a valid prescription for an individual patient or to compound drugs in "very limited quantities" before receipt of a valid prescription if they could document a history of receiving valid prescriptions "generated solely within an established professional practitioner-patient-pharmacy relationship" and if they maintained the prescription on file as required by state law. Id., at 73a—75a. Compounding in such circumstances was permitted as long as the pharmacy's activities did not raise "the kinds of concerns normally associated with a manufacturer." Id., at 76a. The Guide listed nine examples of activities that the FDA believed raised such concerns and that would therefore be considered by the agency in determining whether to bring an enforcement action. These activities included: "[s]oliciting business (e. g., promoting, advertising, or using salespersons) to compound specific drug products, product classes, or therapeutic classes of drug products"; "[c]ompounding, regularly, or in inordinate amounts, drug products that are commercially available . . . and that are essentially generic copies of commercially available, FDA—approved drug products"; using commercial scale manufacturing or testing equipment to compound drugs; offering compounded drugs at wholesale; and "[d]istributing inordinate amounts of compounded products out of state." Id., at 76a—77a. The Guide further warned that pharmacies could not dispense drugs to third parties for resale to individual patients without losing their status as retail entities. Id., at 75a.
Respondents are a group of licensed pharmacies that specialize in drug compounding. They have prepared promotional materials that they distribute by mail and at medical conferences to inform patients and physicians of the use and effectiveness of specific compounded drugs. Fearing that they would be prosecuted under the FDAMA if they continued to distribute those materials, respondents filed a complaint in the United States District Court for the District of Nevada, arguing that the Act's requirement that they refrain from advertising and promoting their products if they wish to continue compounding violates the Free Speech Clause of the First Amendment. Specifically, they challenged the requirement that prescriptions for compounded drugs be "unsolicited," 21 U. S. C. § 353a(a), and the requirement that pharmacists "not advertise or promote the compounding of any particular drug, class of drug, or type of drug," § 353a(c). The District Court granted summary judgment to respondents, finding that the FDAMA's speech-related provisions constitute unconstitutional restrictions on commercial speech under Central Hudson, 447 U. S., at 566, and that their enforcement should therefore be enjoined. Western States Medical Center v. Shalala, 69 F.Supp.2d 1288 (Nev. 1999). The District Court, however, found those provisions to be severable from the rest of § 127(a) of the FDAMA, 21 U. S. C. § 353a, and so left the Act's other compounding requirements intact.
The Government appealed both the holding that the speech-related provisions were unconstitutional and the holding that those provisions were severable from the rest of § 127(a). The Court of Appeals for the Ninth Circuit affirmed in part and reversed in part. Western States Med-
We granted certiorari, 534 U.S. 992 (2001), to consider whether the FDAMA's prohibitions on soliciting prescriptions for, and advertising, compounded drugs violate the First Amendment. Because neither party petitioned for certiorari on the severability issue, we have no occasion to review that portion of the Court of Appeals' decision. Likewise, the provisions of the FDAMA outside § 127(a), which are unrelated to drug compounding, are not an issue here and so remain unaffected.
The parties agree that the advertising and soliciting prohibited by the FDAMA constitute commercial speech. In Virginia Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976), the first case in which we explicitly held that commercial speech receives First Amendment protection, we explained the reasons for this protection: "It is a matter of public interest that [economic] decisions, in the aggregate, be intelligent and well-informed. To this end, the free flow of commercial information is indispensable." Id., at 765. Indeed, we recognized that a "particular consumer's interest in the free flow of commercial information . . . may be as keen, if not keener by far, than
Although commercial speech is protected by the First Amendment, not all regulation of such speech is unconstitutional. See Virginia Bd. of Pharmacy, supra, at 770. In Central Hudson, supra, we articulated a test for determining whether a particular commercial speech regulation is constitutionally permissible. Under that test we ask as a threshold matter whether the commercial speech concerns unlawful activity or is misleading. If so, then the speech is not protected by the First Amendment. If the speech concerns lawful activity and is not misleading, however, we next ask "whether the asserted governmental interest is substantial." Id., at 566. If it is, then we "determine whether the regulation directly advances the governmental interest asserted," and, finally, "whether it is not more extensive than is necessary to serve that interest." Ibid. Each of these latter three inquiries must be answered in the affirmative for the regulation to be found constitutional.
Neither party has challenged the appropriateness of applying the Central Hudson framework to the speech-related provisions at issue here. Although several Members of the Court have expressed doubts about the Central Hudson analysis and whether it should apply in particular cases, see, e. g., Greater New Orleans Broadcasting Assn., Inc. v.
The Government does not attempt to defend the FDAMA's speech-related provisions under the first prong of the Central Hudson test; i. e., it does not argue that the prohibited advertisements would be about unlawful activity or would be misleading. Instead, the Government argues that the FDAMA satisfies the remaining three prongs of the Central Hudson test.
The Government asserts that three substantial interests underlie the FDAMA. The first is an interest in "preserv[ing] the effectiveness and integrity of the FDCA's new drug approval process and the protection of the public health that it provides." Brief for Petitioners 19. The second is an interest in "preserv[ing] the availability of compounded drugs for those individual patients who, for particularized medical reasons, cannot use commercially available products that have been approved by the FDA." Id., at 19-20. Finally, the Government argues that "[a]chieving the proper balance between those two independently compelling but competing interests is itself a substantial governmental interest." Id., at 20.
Explaining these interests, the Government argues that the FDCA's new drug approval requirements are critical to the public health and safety. It claims that the FDA's
While it praises the FDCA's new drug approval process, the Government also acknowledges that "because obtaining FDA approval for a new drug is a costly process, requiring FDA approval of all drug products compounded by pharmacies for the particular needs of an individual patient would, as a practical matter, eliminate the practice of compounding, and thereby eliminate availability of compounded drugs for those patients who have no alternative treatment." Id., at 26. The Government argues that eliminating the practice of compounding drugs for individual patients would be undesirable because compounding is sometimes critical to the care of patients with drug allergies, patients who cannot tolerate particular drug delivery systems, and patients requiring special drug dosages.
Preserving the effectiveness and integrity of the FDCA's new drug approval process is clearly an important governmental interest, and the Government has every reason to want as many drugs as possible to be subject to that approval process. The Government also has an important interest, however, in permitting the continuation of the practice of compounding so that patients with particular needs may obtain medications suited to those needs. And it would not make sense to require compounded drugs created to meet the unique needs of individual patients to undergo the testing required for the new drug approval process. Pharmacists do not make enough money from
The Government argues that the FDAMA's speech-related provisions provide just such a line, i. e., that, in the terms of Central Hudson, they "directly advanc[e] the governmental interest[s] asserted." 447 U. S., at 566. Those provisions use advertising as the trigger for requiring FDA approval—essentially, as long as pharmacists do not advertise particular compounded drugs, they may sell compounded drugs without first undergoing safety and efficacy testing and obtaining FDA approval. If they advertise their compounded drugs, however, FDA approval is required. The Government explains that traditional (or, in its view, desirable) compounding responds to a physician's prescription and an individual patient's particular medical situation, and that "[a]dvertising the particular products created in the provision of [such] service (as opposed to advertising the compounding service itself) is not necessary to . . . this type of responsive and customized service." Brief for Petitioners 34. The Government argues that advertising particular products is useful in a broad market but is not useful when particular products are designed in response to an individual's "often unique need[s]." Ibid. The Government contends that, because of this, advertising is not typically associated with compounding for particular individuals. In contrast it is typically associated, the Government claims, with large-scale production of a drug for a substantial market. The Government argues that advertising,
The Government seems to believe that without advertising it would not be possible to market a drug on a large enough scale to make safety and efficacy testing economically feasible. The Government thus believes that conditioning an exemption from the FDA approval process on refraining from advertising is an ideal way to permit compounding and yet also guarantee that compounding is not conducted on such a scale as to undermine the FDA approval process. Assuming it is true that drugs cannot be marketed on a large scale without advertising, the FDAMA's prohibition on advertising compounded drugs might indeed "directly advanc[e]" the Government's interests. Central Hudson, 447 U. S., at 566. Even assuming that it does, however, the Government has failed to demonstrate that the speech restrictions are "not more extensive than is necessary to serve [those] interest[s]." Ibid. In previous cases addressing this final prong of the Central Hudson test, we have made clear that if the Government could achieve its interests in a manner that does not restrict speech, or that restricts less speech, the Government must do so. In Rubin v. Coors Brewing Co., 514 U.S. 476 (1995), for example, we found a law prohibiting beer labels from displaying alcohol content to be unconstitutional in part because of the availability of alternatives "such as directly limiting the alcohol content of beers, prohibiting marketing efforts emphasizing high alcohol strength . . . , or limiting the labeling ban only to malt liquors." Id., at 490-491. The fact that "all of [these alternatives] could advance the Government's asserted interest
Several non-speech-related means of drawing a line between compounding and large-scale manufacturing might be possible here. First, it seems that the Government could use the very factors the FDA relied on to distinguish compounding from manufacturing in its 1992 Guide. For example, the Government could ban the use of "commercial scale manufacturing or testing equipment for compounding drug products." Guide, App. to Pet. for Cert. 76a. It could prohibit pharmacists from compounding more drugs in anticipation of receiving prescriptions than in response to prescriptions already received. See ibid. It could prohibit pharmacists from "[o]ffering compounded drug products at wholesale to other state licensed persons or commercial entities for resale." Id., at 77a. Alternately, it could limit the amount of compounded drugs, either by volume or by numbers of prescriptions, that a given pharmacist or pharmacy sells out of state. See ibid. Another possibility not suggested by the Guide would be capping the amount of any particular compounded drug, either by drug volume, number of prescriptions, gross revenue, or profit that a pharmacist or pharmacy may make or sell in a given period of time. It might even be sufficient to rely solely on the non-speechrelated provisions of the FDAMA, such as the requirement that compounding only be conducted in response to a prescription or a history of receiving a prescription, 21 U. S. C. § 353a(a), and the limitation on the percentage of a pharmacy's total sales that out-of-state sales of compounded drugs may represent, § 353a(b)(3)(B).
The dissent describes another governmental interest—an interest in prohibiting the sale of compounded drugs to "patients who may not clearly need them," post, at 379 (opinion of Breyer, J.)—and argues that "Congress could . . . conclude that the advertising restrictions `directly advance' " that interest, post, at 384. Nowhere in its briefs, however, does the Government argue that this interest motivated the advertising ban. Although, for the reasons given by the dissent, Congress conceivably could have enacted the advertising ban to advance this interest, we have generally only sustained statutes on the basis of hypothesized justifications when reviewing statutes merely to determine whether they are rational. See L. Tribe, American Constitutional Law 1444-1446 (2d ed. 1988) (describing the "rational basis" or "conceivable basis" test); see also, e. g., Minnesota v. Clover Leaf Creamery Co., 449 U.S. 456, 466 (1981) (sustaining a milk packaging regulation under the "rational basis" test
Even if the Government had argued that the FDAMA's speech-related restrictions were motivated by a fear that advertising compounded drugs would put people who do not need such drugs at risk by causing them to convince their doctors to prescribe the drugs anyway, that fear would fail to justify the restrictions. Aside from the fact that this concern rests on the questionable assumption that doctors would prescribe unnecessary medications (an assumption the dissent is willing to make based on one magazine article and one survey, post, at 383-384, neither of which was relied upon by the Government), this concern amounts to a fear that people would make bad decisions if given truthful information about compounded drugs. See supra, at 368 (explaining that the Government does not claim the advertisements forbidden by the FDAMA would be false or misleading). We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. In Virginia Bd. of Pharmacy, the State feared that if people received price advertising from pharmacists, they would "choose the low-cost, low-quality service and drive the `professional' pharmacist out of business" and would "destroy the pharmacist-customer relationship" by going from one
See also 44 Liquormart, Inc. v. Rhode Island, 517 U. S., at 503 ("[B]ans against truthful, nonmisleading commercial speech . . . usually rest solely on the offensive assumption that the public will respond `irrationally' to the truth. . . . The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good" (citation omitted)).
Even if the Government had asserted an interest in preventing people who do not need compounded drugs from obtaining those drugs, the statute does not directly advance that interest. The dissent claims that the Government "must exclude from the area of permitted drug sales . . . those compounded drugs sought by patients who may not
The dissent may also be suggesting that the Government has an interest in banning the advertising of compounded drugs because patients who see such advertisements will be confused about the drugs' risks. See post, at 387 ("[The Government] fears the systematic effect . . . of advertisements that will not fully explain the complicated risks at issue"). This argument is precluded, however, by the fact that the Government does not argue that the advertisements are misleading. Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown.
If the Government's failure to justify its decision to regulate speech were not enough to convince us that the FDAMA's advertising provisions were unconstitutional, the amount of beneficial speech prohibited by the FDAMA would be. Forbidding the advertisement of compounded drugs would affect pharmacists other than those interested in producing drugs on a large scale. It would prevent pharmacists
Accordingly, we affirm the Court of Appeals' judgment that the speech-related provisions of FDAMA § 127(a) are unconstitutional.
Justice Thomas, concurring.
I concur because I agree with the Court's application of the test set forth in Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of N. Y., 447 U.S. 557 (1980). I continue, however, to adhere to my view that cases such as this should not be analyzed under the Central Hudson test. "I do not believe that such a test should be applied to a restriction of `commercial' speech, at least when, as here, the asserted interest is one that is to be achieved through keeping would-be recipients of the speech in the dark." 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 523 (1996) (opinion concurring in part and concurring in judgment).
Federal law requires strict safety and efficacy testing of all "new" prescription "drugs." 21 U. S. C. § 355. See 21 CFR § 310.3(h) (2002) (defining "new drug" broadly). This testing process requires for every "new drug" a preclinical investigation and three separate clinical tests, including small, controlled studies of healthy and diseased humans as well as scientific double-blind studies designed to identify any possible health risk or side effect associated with the new drug. Practical Guide to Food and Drug Law and Regulation 95-102 (K. Piña & W. Pines eds. 1998). The objective of this elaborate and time-consuming regulatory regime is to identify those health risks—both large and small—that a doctor or pharmacist might not otherwise notice.
At the same time, the law exempts from its testing requirements prescription drugs produced through "compounding"—a process "by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient." Ante, at 360-361. The exemption is available, however, only if the pharmacist meets certain specified conditions, including the condition that the pharmacist not "advertise or promote the compounding of any particular drug." 21 U. S. C. § 353a(c) (emphasis added).
The Court holds that this condition restricts "commercial speech" in violation of the First Amendment. See Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of N. Y., 447 U.S. 557, 564 (1980). It concedes that the statutory provision tries to "[p]reserv[e] the effectiveness and integrity of the . . . new drug approval process," ante, at 369, and it assumes without deciding that the statute might "`directly advance' " that interest, ante, at 371. It nonetheless finds the statute unconstitutional because it could advance that interest in other, less restrictive ways. Ante, at 372-373. I disagree with this conclusion, and I believe that the Court
In my view, the advertising restriction "directly advances" the statute's important safety objective. That objective, as the Court concedes, is to confine the sale of untested, compounded, drugs to where they are medically needed. But to do so the statute must exclude from the area of permitted drug sales both (1) those drugs that traditional drug manufacturers might supply after testing—typically drugs capable of being produced in large amounts, and (2) those compounded drugs sought by patients who may not clearly need them—including compounded drugs produced in small amounts.
The majority's discussion focuses upon the first exclusionary need, but it virtually ignores the second. It describes the statute's objective simply as drawing a "line" that will "distinguish compounded drugs produced on such a small scale that they could not undergo safety and efficacy testing from drugs produced and sold on a large enough scale that they could undergo such testing and therefore must do so." Ante, at 370 (emphasis added). This description overlooks the need for a second line—a line that will distinguish (1) sales of compounded drugs to those who clearly need them from (2) sales of compounded drugs to those for whom a specially tailored but untested drug is a convenience but not a medical necessity. That is to say, the statute, in seeking to confine distribution of untested tailored drugs, must look both at the amount supplied (to help decide whether ordinary manufacturers might provide a tested alternative) and at the nature of demand (to help separate genuine need from simple convenience). Cf. 143 Cong. Rec. S9840 (Sept. 24, 1997) (remarks of Sen. Kennedy) (understanding that "some of the conditions are intended to ensure that the volume of compounding does not approach that ordinarily associated
This second intermediate objective is logically related to Congress' primary end—the minimizing of safety risks. The statute's basic exemption from testing requirements inherently creates risks simply by placing untested drugs in the hands of the consumer. Where an individual has a specific medical need for a specially tailored drug those risks are likely offset. But where an untested drug is a convenience, not a necessity, that offset is unlikely to be present.
That presumably is why neither the Food and Drug Administration (FDA) nor Congress anywhere suggests that all that matters is the total amount of a particular drug's sales. That is why the statute's history suggests that the amount supplied is not the whole story. See S. Rep. No. 105-43, p. 67 (1997) (statute seeks to assure "continued availability of compounded drug products as a component of individualized therapy, . . . while . . . prevent[ing] small-scale manufacturing under the guise of compounding" (emphasis added)); accord, H. R. Conf. Rep. No. 105-399, p. 94 (1997). That is why the statute itself, as well as the FDA policy that the statute reflects, lists several distinguishing factors, of which advertising is one. See FDA Compliance Policy Guide 7132.16, reprinted in App. to Pet. for Cert. 71a—77a (hereinafter Compliance Policy Guide). And that is likely why, when faced with the possibility of severing the advertising restriction from the rest of the statute, the Government argued that the "other conditions in section 353a alone are inadequate to achieve Congress's desired balance among competing interests." See Brief for Appellants in No. 99-17424 (CA9), p. 57. See also id., at 55 (to nullify advertising restrictions would undermine "`finely tuned balance' " achieved
Ensuring that the risks associated with compounded drug prescriptions are offset by the benefits is also why public health authorities, testifying in Congress, insisted that the doctor's prescription represent an individualized determination of need. See, e. g., FDA Reform Legislation: Hearings before the Subcommittee on Health and the Environment of the House Committee on Commerce, 104th Cong., 2d Sess., 120 (1996) (hereinafter FDA Reform Legislation) (statement of Mary K. Pendergast, Deputy Commissioner of the FDA and Senior Advisor to the Commissioner) (Allowing traditional compounding is "good medicine" because "an individual physician" was making "an individualized determination for a patient"). See also National Association of Boards of Pharmacy, Model State Pharmacy Act and Rules, Art. I, § 1.05(e) (1996) (hereinafter NABP Model Act) (defining "[c]ompounding" as involving a prescription "based on the Practitioner/patient/Pharmacist relationship in the course of professional practice").
And that, in part, is why federal and state authorities have long permitted pharmacists to advertise the fact that they compound drugs, while forbidding the advertisement of individual compounds. See Compliance Policy Guide 76a; Good Compounding Practices Applicable to State Licensed Pharmacies, NABP Model Act, App. C.2, subpart A (forbidding pharmacists to "solicit business (e. g., promote, advertise, or use salespersons) to compound specific drug products"). The definitions of drug manufacturing and compounding used by the NABP and at least 13 States reflect similar distinctions. NABP Model Act, Art. I, §§ 105(e), (t), and (u) (defining drug manufacturing to "include the promotion and marketing of such drugs or devices" but excluding any reference to promotion or marketing from the definition of drug compounding); Alaska Stat. §§ 08.80.480(3) and (15) (2000)
These policies and statutory provisions reflect the view that individualized consideration is more likely present, and convenience alone is more likely absent, when demand for a compounding prescription originates with a doctor, not an advertisement. The restrictions try to assure that demand is generated doctor-to-patient-to-pharmacist, not pharmacist-to-advertisement-to-patient-to-doctor. And they do so in order to diminish the likelihood that those who do not genuinely need untested compounded drugs will not receive them.
There is considerable evidence that the relevant means— the advertising restrictions—directly advance this statutory objective. No one denies that the FDA's complex testing system for new drugs—a system that typically relies upon double-blind or other scientific studies—is more likely to find, and to assess, small safety risks than are physicians or pharmacists relying upon impressions and anecdotes. See supra, at 378.
Nor can anyone deny that compounded drugs carry with them special risks. After all, compounding is not necessarily a matter of changing a drug's flavor, cf. ante, at 377, but rather it is a matter of combining different ingredients in new, untested ways, say, adding a pain medication to an antihistamine to counteract allergies or increasing the ratio of approved ingredients in a salve to help the body absorb it
There is considerable evidence that consumer oriented advertising will create strong consumer-driven demand for a particular drug. See, e. g., National Institute for Health Care Management, Factors Affecting the Growth of Prescription Drug Expenditures iii (July 9, 1999) (three antihistamine manufacturers spent $313 million on advertising in 1998 and accounted for 90% of prescription drug antihistamine market); Kritz, Ask Your Doctor About . . . Which of the Many Advertised Allergy Drugs Are Right for You? Washington Post, June 6, 2000, Health, p. 9 (The manufacturer of the world's top selling allergy drug, the eighth best-selling drug in the United States, spent almost $140 million in 1999 on advertising); 1999 Prevention Magazine 10 (spending on direct-to-consumer advertising of prescription medicine increased from $965.2 million in 1997 to $1.33 billion in 1998).
And there is strong evidence that doctors will often respond affirmatively to a patient's request for a specific drug that the patient has seen advertised. See id., at 32 (84% of consumers polled report that doctors accommodate their request for a specific drug); Henry J. Kaiser Family Foundation, Understanding the Effects of Direct-to-Consumer Prescription Drug Advertising 3 (Nov. 2001) (A foundation survey found that more than one in eight Americans had asked
In these circumstances, Congress could reasonably conclude that doctors will respond affirmatively to a patient's request for a compounded drug even if the doctor would not normally prescribe it. When a parent learns that a child's pill can be administered in liquid form, when a patient learns that a compounded skin cream has an enhanced penetration rate, or when an allergy sufferer learns that a compounded antiinflammatory/allergy medication can alleviate a sinus headache without the sedative effects of antihistamines, that parent or patient may well ask for the desired prescription. And the doctor may well write the prescription even in the absence of special need—at least if any risk likely to arise from lack of testing is so small that only scientific testing, not anecdote or experience, would reveal it. It is consequently not surprising that 71% of the active members of the American Academy of Family Physicians "believe that direct-to-consumer advertising pressures physicians into prescribing drugs that they would not ordinarily prescribe." Rosenthal, Berndt, Donohue, Frank, & Epstein, Promotion of Prescription Drugs to Consumers, 346 New Eng. J. Med. 498-505 (2002) (citing Lipsky, The Opinions and Experiences of Family Physicians Regarding Direct-To-Consumer Advertising, 45 J. Fam. Pract. 495-499 (1997)).
Of course, the added risks in any such individual case may be small. But those individual risks added together can significantly affect the public health. At least, the FDA and Congress could reasonably reach that conclusion. And that fact, along with the absence of any significant evidence that the advertising restrictions have prevented doctors from learning about, or obtaining, compounded drugs, means that the FDA and Congress could also conclude that the advertising restrictions "directly advance" the statute's safety goal. They help to assure that demand for an untested compounded drug originates with the doctor, responding to an
I do not believe that Congress could have achieved its safety objectives in significantly less restrictive ways. Consider the several alternatives the Court suggests. First, it says that "the Government could ban the use of `commercial scale manufacturing or testing equipment for compounding drug products.' " Ante, at 372. This alternative simply restricts compounding to drugs produced in small batches. It would neither limit the total quantity of compounded drugs produced, nor help in any way to assure the kind of individualized doctor-patient need determination that the statute's advertising restriction are designed to help achieve.
Second, the Court says that the Government "could prohibit pharmacists from compounding more drugs in anticipation of receiving prescriptions than in response to prescriptions already received." Ibid. This alternative, while addressing the issue of quantity, does virtually nothing to promote the second, need-related statutory objective.
Third, the Court says the Government "could prohibit pharmacists from `[o]ffering compounded drug products at wholesale to other state licensed persons or commercial entities for resale." Ibid. This alternative is open to the same objection.
Fourth, the Court says the Government "could limit the amount of compounded drugs, either by volume or by numbers of prescriptions, that a given pharmacist or pharmacy sells out of state." Ibid. This alternative, applying only to out-of-state sales, would not significantly restrict sales, either in respect to amounts or in respect to patient need.
Fifth, the Court says that the Government could "ca[p] the amount of any particular compounded drug, either by drug volume, number of prescriptions, gross revenue, or profit." Ibid. This alternative, like the others, ignores the patientneed problem, while simultaneously threatening to prevent compounded drugs from reaching those who genuinely need them, say, a patient whose prescription represents one beyond the arbitrarily imposed quantitative limit.
Sixth, the Court says that the Government could rely upon "non-speech-related provisions of the FDAMA, such as the requirement that compounding only be conducted in response to a prescription." Ibid. This alternative also ignores the patient-need problem and was specifically rejected by the Government in the Court of Appeals for the Ninth Circuit. See supra, at 380-381.
The Court adds that "[t]he Government has not offered any reason why these possibilities, alone or in combination, would be insufficient." Ante, at 373. The Government's failure to do so may reflect the fact that only the Court, not any of the respondents, has here suggested that these "alternatives," alone or in combination, would prove sufficient. In fact, the FDA's Compliance Policy Guide, from which the Court draws its first four alternatives, specifically warned that these alternatives alone were insufficient to successfully distinguish traditional compounding from unacceptable manufacturing. See Compliance Policy Guide 77a.
The Court responds to the claim that advertising compounded drugs causes people to obtain drugs that do not promote their health, by finding it implausible given the need for a prescription and by suggesting that it is not relevant. The First Amendment, it says, does not permit the Government to control the content of advertising, where
It is an oversimplification to say that the Government "fear[s]" that doctors or patients "would make bad decisions if given truthful information." Ibid. Rather, the Government fears the safety consequences of multiple compound-drug prescription decisions initiated not by doctors but by pharmacist-to-patient advertising. Those consequences flow from the adverse cumulative effects of multiple individual decisions each of which may seem perfectly reasonable considered on its own. The Government fears that, taken together, these apparently rational individual decisions will undermine the safety testing system, thereby producing overall a net balance of harm. See, e. g., FDA Reform Legislation 121 (statement of David A. Kessler, Commissioner of the FDA) (voicing concerns about "quality controls" and the integrity of the drug-testing system). Consequently, the Government leaves pharmacists free to explain through advertisements what compounding is, to advertise that they engage in compounding, and to advise patients to discuss the matter with their physicians. And it forbids advertising the specific drug in question, not because it fears the "information" the advertisement provides, but because it fears the systematic effect, insofar as advertisements solicit business, of advertisements that will not fully explain the complicated risks at issue. And this latter fear is more than plausible. See Part I, supra.
I do not deny that the statute restricts the circulation of some truthful information. It prevents a pharmacist from including in an advertisement the information that "this pharmacy will compound Drug X." Nonetheless, this Court
I have explained why I believe the statute satisfies this more flexible test. See Parts I and II, supra. The Court, in my view, gives insufficient weight to the Government's regulatory rationale, and too readily assumes the existence of practical alternatives. It thereby applies the commercial speech doctrine too strictly. Cf. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 349 (2001) (flexibility necessary
In my view, the Constitution demands a more lenient application, an application that reflects the need for distinctions among contexts, forms of regulation, and forms of speech, and which, in particular, clearly distinguishes between "commercial speech" and other forms of speech demanding stricter constitutional protection. Otherwise, an overly rigid "commercial speech" doctrine will transform what ought to be a legislative or regulatory decision about the best way to protect the health and safety of the American public into a constitutional decision prohibiting the legislature from enacting necessary protections. As history in respect to the Due Process Clause shows, any such transformation would involve a tragic constitutional misunderstanding. See id., at 189 (Blackmun, J., concurring).
Finally, the majority would hold the statute unconstitutional because it prohibits pharmacists from advertising compounded drugs to doctors. Ante, at 376-377. Doctors, however, obtain information about individual drugs through many other channels. And there is no indication that restrictions on commercial advertising have had any negative effect on the flow of this information. See e. g., Contemporary Pharmacy Practice 11.4 (compounded drug information "available" and "widely disseminated" through books, journals, monographs, and vendors). Nor, with one exception, have doctors or groups of doctors complained that the statute will interfere with that flow of information in the future. But see Brief for Julian M. Whitaker, M.D., et al. as Amici Curiae 1 (alleging, without evidentiary support, that the regulations prevent doctors from knowing how to
Regardless, we here consider a facial attack on the statute. The respondents here focus their attack almost entirely upon consumer-directed advertising. They have not fully addressed separate questions involving the effect of advertising restrictions on information received by physicians. I would consequently leave these questions in abeyance. Considering the statute only insofar as it applies to advertising directed at consumers, I would hold it constitutional.
For these reasons, I dissent.
Michael H. McConihe filed a brief for the American Pharmaceutical Association as amicus curiae.