Lead Opinion
OPINION OF THE COURT
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delivered the opinion of the Court.
Vermont law restricts the sale, disclosure, and use of pharmacy records that reveal the prescribing practices of individual doctors. Vt. Stat. Ann., Tit. 18, § 4631 (Supp. 2010). Subject to certain exceptions, the information may not be sold, disclosed by pharmacies for marketing purposes, or used for marketing by pharmaceutical manufacturers. Vermont argues that
I
A
Pharmaceutical manufacturers promote their drugs to doctors through a process called “detailing.” This often involves
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a scheduled visit to a doctor’s office to persuade the doctor to prescribe a particular pharmaceutical. Detailers bring drug samples as well as medical studies that explain the “details” and potential advantages of various prescription drugs. Interested physicians listen, ask questions, and receive followup data. Salespersons can be more effective when they know the background and purchasing preferences of their clientele, and pharmaceutical salespersons are no exception. Knowledge of a physician’s prescription practices—called “pre-scriber-identifying information”—enables a detailer better to ascertain which doctors are likely to be interested in a particular drug and how best to present a particular sales message. Detailing is an expensive undertaking, so pharmaceutical companies most often use it to promote high-profit brand-name drugs protected by patent. Once a brand-name drug’s patent expires, less expensive bio-equivalent generic alternatives are manufactured and sold.
Pharmacies, as a matter of business routine and federal law, receive prescriber-identifying information when processing prescriptions. See 21 U.S.C. § 353(b); see also Vt. Bd. of Pharmacy Admin. Rule 9.1 (2009); Rule 9.2. Many pharmacies sell this information to “data miners,” firms that analyze prescriber-identifying information and produce reports on prescriber behavior. Data miners lease these reports to pharmaceutical manufacturers subject to nondisclosure agreements. Detailers, who represent the manufacturers, then use the reports to refine their marketing tactics and increase sales.
In 2007, Vermont enacted the Prescription Confidentiality Law. The measure is also referred to as Act 80. It has several components. The central provision of the present case is § 4631(d).
“A health insurer, a self-insured employer, an electronic transmission intermediary, a pharmacy, or other similar entity shall not sell, license, or exchange for value regulated records containing prescriber-identifiable information, nor permit the use of regulated
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records containing prescriber-identifiable information for marketing or promoting a prescription drug, unless the pre-scriber consents .... Pharmaceutical manufacturers and pharmaceutical marketers shall not use prescriber-identifiable information for marketing or promoting a prescription drug unless the prescriber consents . . . .”
The quoted provision has three component parts. The provision begins by prohibiting pharmacies, health insurers, and similar entities from selling prescriber-identifying information, absent the prescriber’s consent. The
Separate statutory provisions elaborate the scope of the prohibitions set out in § 4631(d). “Marketing” is defined to include “advertising, promotion, or any activity” that is “used to influence sales or the market share of a prescription drug.” § 4631(b)(5). Section 4631(c)(1) further provides that Vermont’s Department of Health must allow “a prescriber to give consent for his or her identifying information to be used for the purposes” identified in § 4631(d). Finally, the Act’s prohibitions on sale, disclosure, and use are subject to a list of exceptions. For example, prescriber-identifying information may be disseminated or used for “health care research”; to enforce “compliance” with health insurance formularies
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or preferred drug lists; for “care management educational communications provided to” patients on such matters as “treatment options”; for law enforcement operations; and for purposes “otherwise provided by law.” § 4631(e).
Act 80 also authorized funds for an “evidence-based prescription drug education program” designed to provide doctors and others with “information and education on the therapeutic and cost-effective utilization of prescription drugs.” § 4622(a)(1). An express aim of the program is to advise prescribers “about commonly used brand-name drugs for which the patent has expired” or will soon expire. § 4622(a)(2). Similar efforts to promote the use of generic pharmaceuticals are sometimes referred to as “counter-detailing.” App. 211; see also IMS Health Inc. v. Ayotte,
Act 80 was accompanied by legislative findings. 2007 Vt. Laws No. 80, § 1. Vermont found, for example, that the “goals of marketing programs are of
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goals of the state” and that the “marketplace for ideas on medicine safety and effectiveness is frequently one-sided in that brand-name companies invest in expensive pharmaceutical marketing campaigns to doctors.” §§ 1(3), (4). Detailing, in the legislature’s view, caused doctors to make decisions based on “incomplete and biased information.” § 1(4). Because they “are unable to take the time to research the quickly changing pharmaceutical market,” Vermont doctors “rely on information provided by pharmaceutical representatives.” § 1(13). The legislature further found that detailing increases the cost of health care and health insurance, § 1(15); encourages hasty and excessive reliance on brand-name drugs, before the profession has observed their effectiveness as compared with older and less expensive generic alternatives, § 1(7); and fosters disruptive and repeated marketing visits tantamount to harassment, §§ K27M28). The legislative findings further noted that use of prescriber-identifying information “increase [s] the effect of detailing programs” by allowing detailers to target their visits to particular doctors. §§ K23M26). Use of prescriber-identifying data also helps detailers shape their messages by “tailoring” their “presentations to individual pre-scriber styles, preferences, and attitudes.” § 1(25).
B
The present case involves two consolidated suits. One was brought by three Vermont data miners, the other by an association of pharmaceutical manufacturers that produce brand-name drugs. These entities are the respondents here. Contending that § 4631(d) violates their First Amendment rights as incorporated by the Fourteenth Amendment, respondents sought declaratory and injunctive relief against petitioners, the Attorney General and other officials of the State of Vermont.
After a bench trial, the United States District Court for the District of Vermont denied relief.
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(2009). The District Court found that “[p]harmaceutical manufacturers are essentially the only paying customers of the data vendor industry” and that, because detailing unpatented generic drugs is not “cost-effective,” pharmaceutical sales representatives “detail only branded drugs.” Id., at 451, 442. As the District Court further concluded, “the Legislature’s determination that [prescriber-identifying] data is an effective marketing tool that enables detailers to increase sales of new drugs is supported in the record.” Id., at 451. The United States Court of Appeals for the Second Circuit reversed and remanded. It held that § 4631(d) violates the First Amendment by burdening the speech of pharmaceutical marketers and data miners without an adequate justification.
The decision of the Second Circuit is in conflict with decisions of the United States Court of Appeals for the First Circuit concerning similar legislation enacted by Maine and New Hampshire. See IMS Health Inc. v. Mills,
II
The beginning point is the text of
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exceptions set out at § 4631(e). See Tr. of Oral Arg. 19-20. It might be argued that the State’s newfound interpretation comes too late in the day. See Sprietsma v. Mercury Marine,
In any event, § 4631(d) cannot be sustained even under the interpretation the State now adopts. As a consequence this Court can assume that the opening clause of § 4631(d) prohibits pharmacies, health insurers, and similar entities from selling pre-scriber-identifying information, subject to the statutory exceptions set out at § 4631(e). Under that reading, pharmacies may sell the information to private or academic researchers, see § 4631(e)(1), but not, for example, to pharmaceutical marketers. There is no dispute as to the remainder of § 4631(d). It prohibits pharmacies, health insurers, and similar entities from disclosing or otherwise allowing prescriber-identifying information to be used for marketing. And it bars pharmaceutical manufacturers and detailers from using the information for marketing. The questions now are whether § 4631(d) must be tested by heightened judicial scrutiny and, if so, whether the State can justify the law.
A
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On its face, Vermont’s law enacts content- and speaker-based restrictions on the sale, disclosure, and use of
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prescriber-identifying information. The provision first forbids sale subject to exceptions based in large part on the content of a purchaser’s speech. For example, those who wish to engage in certain “educational communications,” § 4631(e)(4), may purchase the information. The measure then bars any disclosure when recipient speakers will use the information for marketing. Finally, the provision’s second sentence prohibits pharmaceutical manufacturers from using the information for marketing. The statute thus disfavors marketing, that is, speech with a particular content. More than that, the statute disfavors specific speakers, namely pharmaceutical manufacturers. As a result of these content- and speaker-
Any doubt that § 4631(d) imposes an aimed, content-based burden on detailers is dispelled by the record and by formal legislative findings. As the District Court noted, “[p]harma-ceutical manufacturers are essentially the only paying customers of the data vendor industry”; and the almost invariable rule is that detailing by pharmaceutical manufacturers is in support of brand-name drugs.
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v. Fane,
Act 80 is designed to impose a specific, content-based burden on protected expression. It follows that heightened judicial scrutiny is warranted. See Cincinnati v. Discovery Network, Inc.,
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matter of degree” and that the “Government’s content-based burdens must satisfy the same rigorous scrutiny as its content-based bans.” United States v. Playboy Entertainment Group, Inc.,
The First Amendment requires heightened scrutiny whenever the government creates “a regulation of speech because of disagreement with the message it conveys.” Ward v. Rock Against Racism,
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The State argues that heightened judicial scrutiny is unwarranted because its law is a mere commercial regulation.
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It is true that restrictions on protected expression are distinct from restrictions on economic activity or, more generally, on nonex-pressive conduct. It is also true that the First Amendment does not prevent restrictions directed at commerce or conduct from imposing incidental burdens on speech. That is why a ban on race-based hiring may require employers to remove “ ‘White Applicants Only’ ” signs, Rumsfeld v. Forum for Academic and Institutional Rights, Inc.,
But § 4631(d) imposes more than an incidental burden on protected expression. Both on its face and in its
Vermont further argues that § 4631(d) regulates not speech but simply access to information. Pre-scriber-identifying information was generated in compliance with a
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legal mandate, the State argues, and so could be considered a kind of governmental information. This argument finds some support in Los Angeles Police Dept. v. United Reporting Publishing Corp.,
United. Reporting is distinguishable in at least two respects. First, Vermont has imposed a restriction on access to information in private hands. This confronts the Court with a point reserved, and a situation not addressed, in United. Reporting. Here, unlike in United. Reporting, we do have “a case in which the government is prohibiting a speaker from conveying information that the speaker already possesses.” Id., at 40,
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Seattle Times, do not themselves possess information whose disclosure has been curtailed. That information, however, is in the hands of pharmacies and other private entities. There is no question that the “threat of prosecution . . . hangs over their heads.” United Reporting,
United. Reporting is distinguishable for a second and even more important reason. The plaintiff in United. Reporting had neither “attempted] to qualify” for access to the government’s information nor presented an as-applied claim in this Court. Id., at 40,
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a content- and speaker-based burden on respondents’ own speech. That consideration provides a separate basis for distinguishing United. Reporting and requires heightened judicial scrutiny.
The State also contends that heightened judicial scrutiny is unwarranted in this case because sales, transfer, and use of prescriber-identifying information are conduct, not speech. Consistent with that submission, the United States Court of Appeals for the First Circuit has characterized prescriber-identifying information as a mere “commodity” with no greater entitlement to First Amendment protection than “beef jerky.” Ayotte,
This Court has held that the creation and dissemination of information are speech within the meaning of the First Amendment. See, e.g., Bartnicki, supra, at 527,
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The State asks for an exception to the rule that information is speech, but there is no need to consider that request in this case. The State has imposed content- and speaker-based restrictions on the availability and use of prescriber-identifying information. So long as they do not engage in marketing, many speakers can obtain and use the information. But detail-ers cannot. Vermont’s statute could be compared with a law prohibiting trade magazines from purchasing or using ink. Cf. Minneapolis Star,
B
In the ordinary case it is all but dispositive to conclude that a law is content based and, in practice, viewpoint discriminatory. See R. A. V.,
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Amendment. Thompson v. Western States Medical Center,
The State’s asserted justifications for § 4631(d) come under two general headings. First, the State contends that its law is necessary to protect medical privacy, including physician confidentiality, avoidance of harassment, and the integrity of the doctor-patient relationship. Second, the State argues that § 4631(d) is integral to the achievement of policy objectives—namely, improved public health and reduced healthcare costs. Neither justification withstands scrutiny.
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Vermont argues that its physicians have a “reasonable expectation” that their prescriber-identifying information “will not be used for purposes other than . . . filling and processing” prescriptions. See 2007 Vt. Laws No. 80, § 1(29). It may be assumed that, for many reasons, physicians have an interest in keeping their prescription decisions confidential. But § 4631(d) is not drawn to serve that interest. Under Vermont’s law, pharmacies may share prescriber-identifying information with anyone for any reason save one: They must not allow the information to be used for marketing. Exceptions further allow pharmacies to sell prescriber-identifying
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information for certain purposes, including “health care research.” § 4631(e). And the measure permits insurers, researchers, journalists, the State itself, and others to use the information. See § 4631(d); cf. App. 370-372; id., at 211. All but conceding that § 4631(d) does not in itself advance confidentiality interests, the State suggests that other laws might impose separate bars on the disclosure of pre-scriber-identifying information. See Vt. Bd. of Pharmacy Admin. Rule 20.1. But the potential effectiveness of other measures cannot justify the distinctive set of prohibitions and sanctions imposed by § 4631(d).
Perhaps the State could have addressed physician confidentiality through “a more coherent policy.” Greater New Orleans Broadcasting, supra, at 195,
The State points out that it allows doctors to forgo the advantages of § 4631(d) by consenting to the sale, disclosure, and use of their prescriber-identifying information. See § 4631(c)(1). It is true that private decisionmaking can avoid governmental partiality and thus insulate privacy measures from First Amendment challenge. See Rowan v. Post Office
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Dept.,
Respondents suggest that a further defect of § 4631(d) lies in its presumption of applicability absent a physician’s election to the contrary. Vermont’s law might burden less speech if it came into operation only after an individual choice, but a revision to that effect would not necessarily save § 4631(d). Even reliance on a prior election would not suffice, for instance, if available categories of coverage by design favored speakers of one political persuasion over another. Rules that burden protected expression may not be sustained when the options provided by the State are too narrow to advance legitimate interests or too broad to protect speech. As already explained, § 4631(d) permits extensive use of prescriber-identifying information and so does not advance the State’s asserted interest in physician confidentiality. The limited range of available privacy options instead reflects the State’s impermissible purpose to burden
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disfavored speech. Vermont’s argument accordingly fails, even if the availability and scope of private election might be relevant in other contexts, as when the statute’s design is unrelated to any purpose to advance a preferred message.
Vermont argues that detailers’ use of prescriber-identifying information undermines the doctor-patient relationship by allowing detailers to influence treatment decisions.
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According to the State, “unwanted pressure occurs” when doctors learn that their prescription decisions are being “monitored” by detailers. 2007 Vt. Laws No. 80, § 1(27). Some physicians accuse detailers of “spying” or of engaging in “underhanded” conduct in order to “subvert” prescription decisions. App. 336, 380, 407-408; see also id., at 326-328. And Vermont claims that detailing makes people “anxious” about whether doctors have their patients’ best interests at heart. Id., at 327. But the State does not explain why detailers’ use of prescriber-identifying information is more likely to prompt these objections than many other uses permitted by § 4631(d). In any event, this asserted interest is contrary to basic First Amendment principles. Speech remains protected even when it may “stir people to action,” “move them to tears,” or “inflict great pain.” Snyder v. Phelps,
The State contends that § 4631(d) advances important public policy goals by lowering the costs of medical services and promoting public health. If prescriber-identifying information were available for use by detailers, the State contends, then detailing would be effective in promoting brand-name drugs that are more expensive and less safe than generic alternatives. This logic is set out at length in the legislative findings accompanying § 4631(d). Yet at oral argument here, the State declined to acknowledge that § 4631(d)’s objective purpose and practical effect were to inhibit detailing and alter doctors’ prescription decisions. See Tr. of Oral Arg.
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5-6. The State’s reluctance to embrace its own legislature’s rationale reflects the vulnerability of its position.
While Vermont’s stated policy goals may be proper, § 4631(d) does not advance them in a permissible way. As the Court of Appeals noted, the “state’s own explanation of how” § 4631(d) “advances its interests cannot be said to be direct.”
As Vermont’s legislative findings acknowledge, the premise of § 4631(d) is that the force of speech can justify the government’s attempts to stifle it. Indeed the State defends the law by insisting that “pharmaceutical marketing has a strong influence on doctors’ prescribing practices.” Brief for Petitioners 49-50. This reasoning is incompatible with the First Amendment. In an attempt to reverse a disfavored trend in public opinion, a State could not ban campaigning with slogans, picketing with signs, or marching during the daytime. Likewise the State may not seek to remove a popular but disfavored product from the marketplace
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by prohibiting truthful, nonmisleading advertisements that contain impressive endorsements or catchy jingles. That the State finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.
The defect in Vermont’s law is made clear by the fact that many listeners find detailing instructive. Indeed the record demonstrates that some Vermont doctors view targeted detailing based on prescriber-identifying information as “very helpful” because it allows detailers to shape their mes
Vermont may be displeased that detailers who use prescriber-iden-tifying information are effective in promoting brand-name drugs. The State can express that view through its own speech. See Linmark, supra, at 97,
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direction. “The commercial marketplace, like other spheres of our social and cultural life, provides a forum where ideas and information flourish. Some of the ideas and information are vital, some of slight worth. But the general rule is that the speaker and the audience, not the government, assess the value of the information presented.” Edenfield, supra, at 767,
It is true that content-based restrictions on protected expression are sometimes permissible, and that principle applies to commercial speech. Indeed the government’s legitimate interest in protecting consumers from “commercial harms” explains “why commercial speech can be subject to greater governmental regulation than noncommercial speech.” Discovery Network, 507 U.S., at 426,
The State nowhere contends that detailing is false or misleading within the meaning of this Court’s First Amendment precedents. See Thompson, supra, at 373,
The capacity of technology to find and publish personal information, including records required by the government, presents serious and unresolved issues with respect to personal privacy and the dignity it seeks to secure. In considering
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how to protect those interests, however, the State cannot engage in content-based discrimination to advance its own side of a debate.
If Vermont’s statute provided that prescriber-identifying information could not be sold or disclosed except in narrow circumstances then the State might have a stronger position. Here, however, the State gives possessors of the information broad discretion and wide latitude in disclosing the information, while at the same time restricting the information’s use by some speakers and for some purposes, even while the State itself can use the information to counter the speech it seeks to suppress. Privacy is a concept too integral to the person and a right too essential to freedom to allow its manipulation to support just those ideas the government prefers.
When it enacted § 4631(d), the Vermont Legislature found that the “marketplace for ideas on medicine safety and effectiveness is frequently one-sided in that brand-name companies invest in expensive pharmaceutical marketing campaigns to doctors.” 2007 Vt. Laws No. 80, § 1(4). “The goals of marketing programs,” the legislature said, “are often in conflict with the goals of the state.” § 1(3). The text of § 4631(d), associated legislative findings, and the record developed in the District Court establish that Vermont enacted its law for this end. The State has burdened a form of protected expression that it found too persuasive. At the same time, the State has left unburdened those speakers whose messages are in accord with its own views. This the State cannot do.
The judgment of the Court of Appeals is affirmed.
It is so ordered.
Dissenting Opinion
SEPARATE OPINION
with whom Justice Ginsburg and Justice Kagan join, dissenting.
The Vermont statute before us adversely affects expression in one, and only one, way. It deprives pharmaceutical
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and data-mining companies of data, collected pursuant to the government’s regulatory mandate, that could help pharmaceutical companies create better sales messages. In my view, this effect on expression is inextricably related to a lawful governmental effort to regulate a commercial enterprise. The First Amendment does not require courts to apply a special “heightened” standard of review when reviewing such an effort. And, in any event, the statute meets the First Amendment standard this Court has previously applied when the government seeks to regulate
I
The Vermont statute before us says pharmacies and certain other entities
“shall not [(1)] sell . . . regulated records containing prescriber-identifiable information, nor [(2)] permit the use of [such] records . . . for marketing or promoting a prescription drug, unless the pre-scriber consents.” Vt. Stat. Ann., Tit. 18, § 4631(d) (Supp. 2010).
It also says that
“[(3)] [p]harmaceutical manufacturers and pharmaceutical marketers shall not use prescriber-identifiable information for marketing or promoting a prescription drug unless the prescriber consents.” Ibid.
For the most part, I shall focus upon the first and second of these prohibitions. In Part IV, I shall explain why the third prohibition makes no difference to the result.
II
In Glickman v. Wileman Brothers & Elliott, Inc.,
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regulations that required growers of fruit to make compulsory contributions to pay for collective advertising. The Court reviewed the lawfulness of the regulation’s negative impact on the growers’ freedom voluntarily to choose their own commercial messages “under the standard appropriate for the review of economic regulation.” Id., at 469,
In this case I would ask whether Vermont’s regulatory provisions work harm to First Amendment interests that is disproportionate to their furtherance of legitimate regulatory objectives. And in doing so, I would give significant weight to legitimate commercial regulatory objectives—as this Court did in Glickman. The far stricter, specially “heightened” First Amendment standards that the majority would apply to this instance of commercial regulation are out of place here. Ante, at 557, 563, 565, 566, 568, 570, 571,
A
Because many, perhaps most, activities of human beings living together in communities take place through speech, and because speech-related risks and offsetting justifications differ depending upon context, this Court has distinguished for First Amendment purposes among different contexts in which speech takes place. See, e.g., Snyder v. Phelps,
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These test-related distinctions reflect the constitutional importance of maintaining a free marketplace of ideas, a marketplace that provides access to “social, political, esthetic, moral, and other ideas and experiences.” Red Lion Broadcasting Co. v. FCC,
At the same time, our cases make clear that the First Amendment offers considerably less protection to the maintenance of a free marketplace for goods and services. See Florida Bar v. Went For It, Inc.,
Thus this Court has recognized that commercial speech including advertising has an “informational function” and is not “valueless in the marketplace of ideas.” Central Hudson, supra, at 563,
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Council, Inc.,
“ ‘commonsense’ distinction between speech proposing a commercial transaction, which occurs in an area traditionally subject to government regulation, and other varieties of speech.” Ohralik v. Ohio State Bar Assn.,436 U.S. 447 , 455-456,98 S. Ct. 1912 ,56 L. Ed. 2d 444 (1978) (quoting Virginia Bd. of Pharmacy, supra, at 771, n. 24,96 S. Ct. 1817 ,48 L. Ed. 2d 346 ; emphasis added).
The Court has also normally applied a yet more lenient approach to ordinary commercial or regulatory legislation that affects speech in less direct ways. In doing so, the Court has taken account of the need in this area of law to defer significantly to legislative judgment—as the Court has done in cases involving the Commerce Clause or the Due Process Clause. See Glickman,
To apply a strict First Amendment standard virtually as a matter of course when a court reviews ordinary economic regulatory programs (even if that program has a modest impact upon a firm’s ability to shape a commercial message) would work at cross-purposes with this more basic constitutional approach. Since ordinary regulatory programs can
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affect speech, particularly commercial speech, in myriad ways, to apply a “heightened” First Amendment standard of review whenever such a program burdens speech would transfer from legislatures to judges the primary power to weigh ends and to choose means, threatening to distort or undermine legitimate legislative objectives. See Glickman, supra, at 476,
“retur[n] to the bygone era of Lochner v. New York,198 U.S. 45 [25 S. Ct. 539 ,49 L. Ed. 937 ] (1905), in which it was common practice for this Court to strike down economic regulations adopted by a State based on the Court’s own notions of the most appropriate means for the State to implement its considered policies.”447 U.S., at 589 ,100 S. Ct. 2343 ,65 L. Ed. 2d 341 .
B
There are several reasons why the Court should review Vermont’s law “under the standard appropriate for the review of economic regulation,” not “under a heightened standard appropriate for the review of First Amendment issues.” Glickman,
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of a product. Cf. id., at 469-470,
For another thing, the same First Amendment standards that apply to Vermont here would apply to similar regulatory actions taken by other States or by the Federal Government acting, for example, through Food and Drug Administration (FDA) regulation. (And the Federal Government’s ability to pre-empt state laws that interfere with existing or contemplated federal forms of regulation is here irrelevant.)
Further, the statute’s requirements form part of a traditional, comprehensive regulatory regime. Cf. United Foods, supra, at 411,
Finally, Vermont’s statute is directed toward information that exists only by virtue of government regulation. Under federal law, certain drugs can be dispensed only by a pharmacist operating under the orders of a medical practitioner. 21 U.S.C. § 353(b). Vermont regulates the qualifications, the fitness, and the practices of pharmacists themselves, and requires pharmacies to maintain a “patient record system” that, among other things, tracks who prescribed which drugs. Vt. Stat. Ann., Tit. 26, §§ 2041(a), 2022(14) (Supp. 2010); Vt. Bd. of Pharmacy Admin. Rules (Pharmacy Rules) 9.1, 9.24(e) (2009). But for these regulations, pharmacies would have no way to know who had told customers to buy which drugs (as is the case when a doctor tells a patient to take a daily dose of aspirin).
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Regulators will often find it necessary to create tailored restrictions on the use of information subject to their regulatory jurisdiction. A car dealership that obtains credit scores for customers who want car loans can be prohibited from using credit data to search for new customers. See 15 U.S.C. § 1681b (2006 ed. and Supp. III); cf. Trans Union Corp. v. FTC,
Such regulatory actions are subject to judicial review, e.g., for compliance with applicable statutes. And they would normally be subject to review under the Administrative Procedure Act to make certain they are not “arbitrary, capricious, [or] an abuse of discretion.” 5 U.S.C. § 706(2)(A) (2006 ed.). In an appropriate case, such re
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commercial speaker might use to shape the content of a message).
Thus, it is not surprising that, until today, this Court has never found that the First Amendment prohibits the government from restricting the use of information gathered pursuant to a regulatory mandate—whether the information rests in government files or has remained in the hands of the private firms that gathered it. But cf. ante, at 566-570,
C
The Court (suggesting a standard yet stricter than Central Hudson) says that we must give content-based restrictions that burden speech “heightened” scrutiny. It adds that “[c]ommercial speech is no exception.” Ante, at 566,
But neither of these categories— “content-based” nor “speaker-based”— has ever before justified greater scrutiny when regulatory activity affects commercial speech. See, e.g., Capital Broadcasting Co. v. Mitchell,
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Regulatory programs necessarily draw distinctions on the basis of content. Virginia Bd. of Pharmacy,
Nor, in the context of a regulatory program, is it unusual for particular rules to be “speaker-based,” affecting only a class of entities, namely, the regulated firms. An energy regulator, for example, might require the manufacturers of home appliances to publicize ways to reduce energy consumption, while exempting producers of industrial equipment. See, e.g., 16 CFR pt. 305 (2011) (prescribing labeling requirements for certain home appliances); Nev. Admin. Code §§ 704.804, 704.808 (2010) (requiring utilities to provide consumers with information on conservation). Or a trade regulator might forbid a particular firm to make the true claim that its cosmetic product contains “cleansing grains that scrub away dirt and excess oil” unless it substantiates that claim with detailed backup testing, even though opponent
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of cosmetics use need not substantiate their claims. Morris, F. T. C. Orders Data To Back Ad Claims, N. Y. Times, Nov. 3, 1973, p. 32; Boys’ Life, Oct. 1973, p. 64; see 36 Fed. Reg. 12058 (1971). Or the FDA might control in detail just what a pharmaceutical firm can, and cannot, tell potential purchasers about its products. Such a firm, for example, could not suggest to a potential purchaser (say, a doctor) that he or she might put a pharmaceutical drug to an “off label” use, even if the manufacturer, in good faith and with considerable evidence, believes the drug will help. All the while, a third party (say, a researcher) is free to tell the doctor not to use the drug for that purpose. See 21 CFR pt. 99; cf. Buckman Co. v. Plaintiffs’ Legal Comm.,
If the Court means to create constitutional barriers to regulatory rules that might affect the content of a commercial message, it has embarked upon an unprecedented task—a task that threatens significant judicial interference with widely accepted regulatory activity. Cf., e.g., 21 CFR pts. 201-203. Nor would it ease the task to limit its “heightened” scrutiny to regulations that only affect certain
The Court also uses the words “aimed” and “targeted” when describing the relation of the statute to drug manufacturers. Ante, at 564, 565, 567, 572, 578,
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basis is to require its application early and often when the State seeks to regulate industry. Any statutory initiative stems from a legislative agenda. See, e.g., Message to Congress, May 24, 1937, H. R. Doc. No. 255, 75th Cong., 1st Sess., 4 (request from President Franklin Roosevelt for legislation to ease the plight of factory workers). Any administrative initiative stems from a regulatory agenda. See, e.g., Exec. Order No. 12866, 58 Fed. Reg. 51735 (1993) (specifying how to identify regulatory priorities and requiring agencies to prepare agendas). The related statutes, regulations, programs, and initiatives almost always reflect a point of view, for example, of the Congress and the administration that enacted them and ultimately the voters. And they often aim at, and target, particular firms that engage in practices about the merits of which the Government and the firms may disagree. Section 2 of the Sherman Act, 15 U.S.C. § 2, for example, which limits the truthful, nonmisleading speech of firms that, due to their market power, can affect the competitive landscape, is directly aimed at, and targeted at, monopolists.
In short, the case law in this area reflects the need to ensure that the First Amendment protects the “marketplace of ideas,” thereby facilitating the democratic creation of sound government policies without improperly hampering the ability of government to introduce an agenda, to implement its policies, and to favor them to the exclusion of contrary policies. To apply “heightened” scrutiny when the regulation of commercial activities (which often involve speech) is at issue is unnecessarily to undercut the latter constitutional goal. The majority’s view of this case presents that risk.
Moreover, given the sheer quantity of regulatory initiatives that touch upon commercial messages, the Court’s vision of its reviewing task threatens to return us to a happily bygone era when judges scrutinized legislation for its interference with economic liberty. History shows that the power was much abused and resulted in the constitutionalization
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of economic theories preferred by individual jurists. See Lochner v. New York,
Nothing in Vermont’s statute undermines the ability of persons opposing the State’s policies to speak their mind or to pursue a different set of policy objectives through the democratic process. Whether Vermont’s regulatory statute “targets” drug companies (as opposed to affecting them unintentionally) must be beside the First Amendment point.
This does not mean that economic regulation having some effect on speech is always lawful. Courts typically review the lawfulness of statutes for rationality and of regulations (if federal) to make certain they are not “arbitrary, capricious, [or] an abuse of discretion.” 5 U.S.C. § 706(2)(A). And our valuable free-speech tradition may play an important role in such review. But courts do not normally view these matters as requiring “heightened” First Amendment scrutiny—and particularly not the unforgiving brand of “intermediate” scrutiny employed by the majority. Because the imposition of “heightened” scrutiny in such instances would significantly change the legislative/judicial balance, in a way that would significantly weaken the legislature’s authority to regulate commerce and industry, I would not apply a “heightened” First Amendment standard of review in this case.
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III
Turning to the constitutional merits, I believe Vermont’s statute survives application of Central Hudson’s “intermediate” commercial speech standard as well as any more limited “economic regulation” test.
A
The statute threatens only modest harm to commercial speech. I agree that it withholds from pharmaceutical companies information that would help those entities create a more effective selling message. But I cannot agree with the majority that the harm also involves unjustified discrimination in that it permits “pharmacies” to “share prescriber-identifying information with anyone for any reason” (but marketing). Ante, at 572,
The absence of any such evidence likely reflects the presence of other legal rules that forbid widespread release of prescriber-identifying information. Vermont’s Pharmacy Rules, for example, define “unprofessional conduct” to include “[d]ivulging or revealing to unauthorized persons patient or practitioner information or the nature of professional pharmacy services rendered.” Rule 20.1(i) (emphasis added); see also Reply Brief for Petitioners 21. The statute reinforces this prohibition where pharmaceutical marketing is at issue. And the exceptions that it creates are narrow and concern common and often essential uses of prescription
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data. See Vt.
Nor can the majority find record support for its claim that the statute helps “favored” speech and imposes a “burde[n]” upon “disfavored speech by disfavored speakers.” Ante, at 574,
The majority points out, ante, at 560,
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prescription drugs, Vt. Stat. Ann., Tit. 18, § 4622(a)(1). See generally §§ 4621-4622. But that program does not make use of prescriber-identifying data. Reply Brief for Petitioners 11.
The majority cites testimony by two witnesses in support of its statement that “States themselves may supply the prescriber-identifying information used in [counterdetailing] programs.” Ante, at 560,
The upshot is that the only commercial-speech-related harm that the record shows this statute to have brought about is the one I have previously described: the withholding of information collected through a regulatory program, thereby preventing companies from shaping a commercial message they believe maximally effective. The absence of precedent suggesting that this kind of harm is serious reinforces the conclusion that the harm here is modest at most.
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B
The legitimate state interests that the statute serves are “substantial.” Central Hudson,
“to advance the state’s interest in protecting the public health of Vermonters, protecting the privacy of prescribers and prescribing information, and to ensure costs are contained in the private health care sector, as well as for state purchasers of prescription drugs, through the promotion of less costly drugs and ensuring prescribers receive unbiased information.” § 4631(a).
These objectives are important. And the interests they embody all are “neutral” in respect to speech. Cf. ante, at 579,
The protection of public health falls within the traditional scope of a State’s police powers. Hillsborough County v. Automated Medical Laboratories, Inc.,
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At the same time, the record evidence is sufficient to permit a legislature to conclude that the statute “directly advances” each of these objectives. The statute helps to focus sales discussions on an individual drug’s safety, effectiveness, and cost, perhaps compared to other drugs (including generics). These drug-related facts have everything to do with general information that drug manufacturers likely possess. They have little,
Vermont compiled a substantial legislative record to corroborate this line of reasoning. See Testimony of Sean Flynn (Apr. 11, 2007), App. in No. 09-1913-cv(L) etc. (CA2), p. A-1156 (hereinafter CA2 App.) (use of data mining helps drug companies “to cover up information that is not in the best light of their drug and to highlight information that makes them look good”); Volker & Outterson, New Legislative Trends Threaten the Way Health Information Companies Operate, Pharmaceutical Pricing & Reimbursement 2007, id.., at A-4235 (one former detailer considered prescriber-identifying data the “ ‘greatest tool in planning our approach to manipulating doctors’ ” (quoting Whitney, Big (Brother) Pharma: How Drug Reps Know Which Doctors To Target, New Republic, Aug. 29, 2006, http://www. tnr.com/article/84056/health-care-eli-lilly-pfizer-ama); Testimony of Paul Harrington (May 3, 2007), CA2 App. A-1437 (describing data-mining practices as “secret and manipulative activities by the marketers”); Testimony of Julie Brill (May 3, 2007), id., at A-1445 (restrictions on data mining “ensur[e] that the FDA’s requirement of doctors receiving fair and balanced information
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actually occurs”); Written Statement of Jerry Avorn & Aaron Kesselheim, id., at A-4310 (citing studies that “indicate that more physician-specific detailing will lead to more prescriptions of brand-name agents, often with no additional patient benefit but at much higher cost to patients and to state-based insurance programs, which will continue to drive up the cost of health care”); id., at A-4311 (“Making it more difficult for manufacturers to tailor their marketing strategies to the prescribing histories of individual physicians would actually encourage detailers to present physicians with a more neutral description of the product”); see also Record in No. 1:07-cv-00188-jgm (D Vt.), Doc. 414, pp. 53-57, 64 (hereinafter Doc. 414) (summarizing record evidence).
These conclusions required the legislature to make judgments about whether and how to ameliorate these problems. And it is the job of regulatory agencies and legislatures to make just these kinds of judgments. Vermont’s attempts to ensure a “fair balance” of information is no different from the FDA’s similar requirement, see 21 CFR §§ 202.1(e)(1), (e)(5)(H). No one has yet suggested that substantial portions of federal drug regulation are unconstitutional. Why then should we treat Vermont’s law differently?
The record also adequately supports the State’s privacy objective. Regulatory rules in Vermont make clear that the confidentiality of an individual doctor’s prescribing practices remains the norm. See, e.g., Pharmacy Rule 8.7(c) (“Prescription and other patient health care information shall be secure from access by the public, and the information shall be kept confidential”); Pharmacy Rule 20.1(i) (forbidding disclosure of patient or prescriber information to “un
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or others in the State, makes use of this information for counterdetailing efforts. See supra, at 594-595,
Pharmaceutical manufacturers and the data miners who sell information to those manufacturers would like to create (and did create) an additional exception, which means additional circulation of otherwise largely confidential information. Vermont’s statute closes that door. At the same time, the statute permits doctors who wish to permit use of their prescribing practices to do so. §§ 4631(c)—(d). For purposes of Central Hudson, this would seem sufficiently to show that the statute serves a meaningful interest in increasing the protection given to prescriber privacy. See Fox,
C
The majority cannot point to any adequately supported, similarly effective “more limited restriction.” Central Hudson,
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Manchanda & Honka, The Effects and Role of Direct-to-Physician Marketing in the Pharmaceutical Industry: An Integrative Review, 5 Yale J. Health Pol’y L. & Ethics 785, 793-797, 815-816 (2005); Ziegler, Lew, & Singer, The Accuracy of Drug Information From Pharmaceutical Sales Representatives, 273 JAMA 1296 (1995). Forcing doctors to choose between targeted detailing and no detailing at all could therefore jeopardize the State’s interest in promoting public health.
The majority also suggests that if the “statute provided that prescriber-identifying information could not be sold or disclosed except in narrow circumstances then the State might have a stronger position.” Ante, at 580,
Respondents’ alternatives are no more helpful. Respondents suggest that “Vermont can simply inform physicians that pharmaceutical companies . . . use prescription history information to communicate with doctors.” Brief for Respondent Pharmaceutical Research and Manufacturers of America 48. But how would that help serve the State’s basic purposes? It would not create the “fair balance” of information in pharmaceutical marketing that the State, like the FDA, seeks. Cf. Reno v. American Civil Liberties Union,
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about their benefits. Brief for Respondent Pharmaceutical Research and Manufacturers of America 54-55. Such programs have been in effect for some time in Vermont or other States, without indication that they have prevented the imbalanced sales tactics at which Vermont’s statute takes aim. See, e.g., Written Statement of Jerry Avorn & Aaron Kesselheim, CA2 App. A-4310; Doc. 414, at 60-61. And in any event, such laws do not help protect pre-scriber privacy.
Vermont has thus developed a record that sufficiently shows that its statute meaningfully furthers substantial state interests. Neither the majority nor respondents suggests any equally effective “more limited” restriction. And the First Amendment harm that Vermont’s statute works is, at most, modest. I consequently conclude that, even if we apply an “intermediate” test such as that in Central Hudson, this statute is constitutional.
IV
What about the statute’s third restriction, providing that “ [pharmaceutical manufacturers and pharmaceutical marketers” may not “use prescriber-identifiable information for marketing or promoting a prescription drug unless the prescriber consents”? Vt. Stat. Ann., Tit. 18, § 4631(d) (emphasis added). In principle, I should not reach this question. That is because respondent pharmaceutical manufacturers, marketers, and data miners seek a declaratory judgment and injunction prohibiting the enforcement of this statute. See 28 U.S.C. § 2201; App. 49-128. And they have neither shown nor claimed that they could obtain significant amounts of “prescriber-identifiable information” if the first two prohibitions are valid. If, as I believe, the first two statutory prohibitions (related to selling and disclosing the information) are valid, then the dispute about the validity of the third provision is not “ Veal and substantial’ ” or “ ‘definite and concrete.’ ” MedImmune, Inc. v. Genentech, Inc., 549
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U.S. 118, 127,
The Court, however, strikes down
V
In sum, I believe that the statute before us satisfies the “intermediate” standards this Court has applied to restrictions on commercial speech. A fortiori it satisfies less demanding standards that are more appropriately applied in this kind of commercial regulatory case—a case where the government seeks typical regulatory ends (lower drug prices, more balanced sales messages) through the use of ordinary regulatory means (limiting the commercial use of data gathered pursuant to a regulatory mandate). The speech-related consequences here are indirect, incidental, and entirely commercial. See supra, at 585-588,
The Court reaches its conclusion through the use of important First Amendment categories—“content-based,” “speaker-based,” and “neutral”—but without taking full account of the regulatory context, the nature of the speech effects, the values these First Amendment categories seek to promote, and prior precedent. See supra, at 581-585, 589-592, 597,
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reawakens Lochner’s pre-New Deal threat of substituting judicial for democratic decisionmaking where ordinary economic regulation is at issue. See Central Hudson,
Regardless, whether we apply an ordinary commercial speech standard or a less demanding standard, I believe Vermont’s law is consistent with the First Amendment. And with respect, I dissent.
