BREYER, J., DISSENTING
SORRELL V. IMS HEALTH INC.
564 U. S. ____ (2011)
SUPREME COURT OF THE UNITED STATES
NO. 10-779
WILLIAM H. SORRELL, ATTORNEY GENERAL OF VERMONT,
et al., PETITIONERS
v. IMS HEALTH INC.
et al.
on writ of certiorari to the united states court of
appeals for the second circuit
[June 23, 2011]
Justice Breyer, 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 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
commercial speech. For any or all of these reasons, the Court
should uphold the statute as constitutional.
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 prescriber 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.,
521 U. S. 457 (1997),
this Court considered the First Amendment’s application to federal
agricultural commodity mar-keting regulations that required growers
of fruit to make compulsory contributions to pay for collective
adver- tising. 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 1, 8, 9, 10, 11, 13, 14,
15.
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, 562 U. S. ___, ___–___ (2011)
(slip op., at 5–6). Thus, the First Amendment imposes tight
constraints upon government efforts to restrict,
e.g.,
“core” political speech, while imposing looser constraints when the
government seeks to restrict,
e.g., commercial speech, the
speech of its own employees, or the regulation-related speech of a
firm subject to a traditional regulatory program. Compare
Boos v.
Barry,
485 U. S. 312, 321
(1988) (political speech), with
Central Hudson Gas & Elec.
Corp. v.
Public Serv. Comm’n of N. Y.,
447 U. S. 557 (1980)
(commercial speech),
Pickering v.
Board of Ed. of
Township High School Dist. 205, Will Cty.,
391 U. S. 563 (1968)
(government employees), and
Glickman,
supra
(economic regulation).
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,
395 U. S. 367,
390 (1969); see
Abrams v.
United States,
250 U. S. 616, 630
(1919) (Holmes, J., dissenting). Without such a marketplace, the
public could not freely choose a government pledged to implement
policies that reflect the people’s informed will.
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.,
515 U. S. 618, 623
(1995) (“We have always been careful to distinguish commercial
speech from speech at the First Amendment’s core”). And they also
reflect the democratic importance of permitting an elected
government to implement through effective programs policy choices
for which the people’s elected representatives have voted.
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;
Bigelow v.
Virginia,
421 U. S. 809, 826
(1975). But at the same time it has applied a less than strict,
“intermediate” First Amendment test when the government directly
restricts commercial speech. Under that test, government laws and
regulations may significantly restrict speech, as long as they also
“directly advance” a “substantial” government interest that could
not “be served as well by a more limited restriction.”
Central
Hudson,
supra, at 564. Moreover, the Court has found
that “sales practices” that are “misleading, deceptive, or
aggressive” lack the protection of even this “intermediate”
standard.
44 Liquormart, Inc. v.
Rhode Island,
517 U. S. 484,
501 (1996) (opinion of Stevens, J.); see also
Central
Hudson,
supra, at 563;
Virginia Bd. of
Pharmacy v.
Virginia Citizens Consumer Council, Inc.,
425 U. S. 748,
772 (1976). And the Court has emphasized the need, in applying an
“intermediate” test, to maintain the
“ ‘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 (1978) (quoting
Virginia Bd. of
Pharmacy,
supra, at 771, n. 24; 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,
supra, at 475–476. “Our
function” in such cases, Justice Brandeis said, “is only to
determine the reasonableness of the legislature’s belief in the
existence of evils and in the effectiveness of the remedy
provided.”
New State Ice Co. v.
Liebmann,
285 U. S. 262,
286–287 (1932) (dissenting opinion);
Williamson v.
Lee
Optical of Okla., Inc.,
348 U. S. 483, 488
(1955) (“It is enough that there is an evil at hand for correction,
and that it might be thought that the particular legisla-tive
measure was a rational way to correct it”);
United States
v.
Carolene Products Co.,
304 U. S. 144, 152
(1938) (“[R]egulatory legislation affecting ordinary commercial
transactions is not to be pronounced unconstitutional” if it rests
“upon some rational basis within the knowledge and experience of
the legislators”).
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 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 ob-jectives. See
Glickman, 521 U. S., at 476 (“Doubts concerning the policy
judgments that underlie” a program requiring fruit growers to pay
for advertising they disagree with does not “justify reliance on
the First Amendment as a basis for reviewing economic
regulations”). Cf.
Johanns v.
Livestock Marketing
Assn.,
544 U.
S. 550, 560–562 (2005) (applying less scrutiny when the
compelled speech is made by the Government);
United States
v.
United Foods, Inc.,
533 U. S. 405, 411
(2001) (applying greater scrutiny where compelled speech was not
“ancillary to a more comprehensive program restricting marketing
autonomy”). To apply a “heightened” standard of review in such
cases as a matter of course would risk what then-Justice Rehnquist,
dissenting in
Central Hudson, described as a
“retur[n] to the bygone era of
Lochner v.
New York,
198 U. S. 45 (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.
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, 521 U. S., at 469. For one thing, Vermont’s
statute neither forbids nor requires anyone to say anything, to
engage in any form of symbolic speech, or to endorse any particular
point of view, whether ideological or related to the sale of a
product. Cf.
id., at 469–470. (And I here assume that
Central Hudson might otherwise apply. See Part III,
infra.)
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 tra-ditional, comprehensive regulatory regime. Cf.
United
Foods,
supra, at 411. The pharmaceutical drug
industry has been heavily regulated at least since 1906. See Pure
Food and Drugs Act, 34 Stat. 768. Longstanding statutes and
regulations require pharmaceutical companies to engage in complex
drug testing to ensure that their drugs are both “safe” and
“effective.” 21 U. S. C. §§355(b)(1), 355(d). Only then can
the drugs be marketed, at which point drug companies are subject to
the FDA’s exhaustive regulation of the content of drug labels and
the manner in which drugs can be advertised and sold. §352(f)(2);
21 CFR pts. 201–203 (2010).
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).
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, 245 F. 3d 809, reh’g denied, 267 F. 3d 1138
(CADC 2001). Medical specialists who obtain medical records for
their existing patients cannot purchase those records in order to
identify new patients. See 45 CFR §164.508(a)(3) (2010). Or,
speaking hypothetically, a public utilities commission that directs
local gas distributors to gather usage information for individual
customers might permit the distributors to share the data with
researchers (trying to lower energy costs) but forbid sales of the
data to appliance manufacturers seeking to sell gas stoves.
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
review might be informed by First Amendment considerations. But
regulatory actions of the kind present here have not previously
been thought to raise serious additional constitutional concerns
under the First Amendment. But cf.
Trans Union LLC v.
FTC,
536 U.
S. 915 (2002) (Kennedy, J., dissenting from denial of
certiorari) (questioning ban on use of consumer credit reports for
target marketing). The ease with which one can point to actual or
hypothet-ical examples with potentially adverse speech-related
effects at least roughly comparable to those at issue here
indicates the danger of applying a “heightened” or “intermediate”
standard of First Amendment review where typical regulatory actions
affect commercial speech (say, by withholding information that a
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
11–14. Nor has this Court
ever previously applied any form
of “heightened” scrutiny in any even roughly similar case. See
Los Angeles Police Dept. v.
United Reporting
Publishing Corp.,
528 U. S. 32 (1999) (no
heightened scrutiny); compare
Cincinnati v.
Discovery
Network, Inc.,
507 U. S. 410, 426
(1993) (“[C]ommercial speech can be subject to greater governmental
regulation than noncommercial speech” because of the government’s
“interest in preventing commercial harms”), with
ante, at
9–10, 11, 17–18, 24 (suggesting that
Discovery Network
supports heightened scrutiny when regulations target commercial
speech).
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 10–11. And the Court then emphasizes that this is
a case involving both “content-based” and “speaker-based”
restrictions. See
ante, at 8, 9, 10, 12, 14, 15, 16, 19,
20, 22, 24.
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, 333 F. Supp. 582 (DC 1971)
(three-judge court), summarily aff’d
sub nom.
Capital Broadcasting Co. v.
Acting Attorney
General,
405
U. S. 1000 (1972) (upholding ban on radio and television
marketing of tobacco). And the absence of any such precedent is
understandable.
Regulatory programs necessarily draw
distinctions on the basis of content.
Virginia Bd. of
Pharmacy, 425 U. S., at 761, 762 (“If there is a kind of
commercial speech that lacks all First Amendment protection, … it
must be distinguished by its content”). Electricity regulators, for
example, oversee company statements, pronouncements, and proposals,
but only about electricity. See,
e.g., Vt. Pub. Serv. Bd.
Rules 3.100 (1983), 4.200 (1986), 5.200 (2004). The Federal Reserve
Board regulates the content of statements, advertising, loan
proposals, and interest rate disclosures, but only when made by
financial institutions. See 12 CFR pts. 226, 230 (2011). And the
FDA oversees the form and content of labeling, advertising, and
sales proposals of drugs, but not of furniture. See 21 CFR pts.
201–203. Given the ubiquity of content-based regulatory categories,
why should the “content-based” nature of typical regulation require
courts (other things being equal) to grant legislators and
regulators
less deference? Cf.
Board of Trustees of
State Univ. of N. Y. v.
Fox,
492 U. S. 469, 481
(1989) (courts, in First Amendment area, should “provide the
Legislative and Executive Branches needed leeway” when regulated
industries are at issue).
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 manu-facturers 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 ex-cess oil” unless it
substantiates that claim with detailed backup testing, even though
opponents 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.,
531 U. S. 341, 350–351
(2001) (discussing effect of similar regulations in respect to
medical devices); see also Proposed Rule, Revised Effectiveness
Determination; Sunscreen Drug Products for Over-the-Counter Human
Use, 76 Fed. Reg. 35672 (2011) (proposing to prohibit marketing of
sunscreens with sun protection factor (SPF) of greater than 50 due
to insufficient data “to indicate that there is additional clinical
benefit”).
If the Court means to create constitutional
barriers to regulatory rules that might affect the
content
of a com-mercial 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 speakers. As the
examples that I have set forth illustrate, many regulations affect
only messages sent by a small class of regulated speakers, for
example, electricity generators or natural gas pipelines.
The Court also uses the words “aimed” and
“targeted” when describing the relation of the statute to drug
manufacturers.
Ante, at 8, 9, 12, 16. But, for the reasons
just set forth, to require “heightened” scrutiny on this 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 of
economic theories preferred by individual jurists. See
Lochner v.
New York,
198 U. S. 45, 75–76 (1905) (Holmes, J.,
dissenting). By inviting courts to scrutinize whether a State’s
legitimate regulatory interests can be achieved in less restrictive
ways whenever they touch (even indirectly) upon commercial speech,
today’s majority risks repeating the mistakes of the past in a
manner not anticipated by our precedents. See
Central
Hudson, 447 U. S., at 589 (Rehnquist, J., dissenting); cf.
Railroad Comm’n of Tex. v.
Rowan & Nichols Oil
Co.,
310 U. S.
573, 580–581 (1940) (“A controversy like this always calls for
fresh reminder that courts must not substitute their notions of
expediency and fairness for those which have guided the agencies to
whom the formulation and execution of policy have been
entrusted”).
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 un-forgiving 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.
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 17. Whatever the First Amendment relevance of
such discrimination, there is no evidence that it exists in
Vermont. The record contains no evidence that
prescriber-identifying data is widely disseminated. See App. 248,
255. Cf.
Burson v.
Freeman,
504 U. S. 191, 207
(1992) (plurality opinion) (“States adopt laws to address the
problems that confront them. The First Amendment does not require
States to regulate for problems that do not exist”);
Bates
v.
State Bar of Ariz.,
433 U. S. 350, 380
(1977) (“[T]he justification for the application of overbreadth
analysis applies weakly, if at all, in the ordinary commercial
context”).
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 data. See Vt. Stat. Ann., Tit. 18,
§4631(e)(1) (pharmacy reimbursement, patient care management,
health care research); §4631(e)(2) (drug dispensing); §4631(e)(3)
(communications between prescriber and pharmacy); §4631(e)(4)
(information to patients); §§4631(e)(5)–(6) (as otherwise provided
by state or federal law). Cf.
Trans Union Corp., 245
F. 3d, at 819 (rejecting an underinclusiveness challenge
because an exception to the Fair Credit Reporting Act concerned
“ ‘exactly the sort of thing the Act seeks to promote’ ”
(quoting
Trans Union Corp. v.
FTC, 81 F. 3d
228, 234 (CADC 1996)).
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 19. The Court apparently means that the statute
(1) prevents pharmaceutical companies from creating individualized
messages that would help them sell their drugs more effectively,
but (2) permits “counterdetailing” programs, which often promote
generic drugs, to create such messages using prescriber-identifying
data. I am willing to assume, for argument’s sake, that this
consequence would significantly increase the statute’s negative
impact upon commercial speech. But cf. 21 CFR §§202.1(e)(1),
202.1(e)(5)(ii) (FDA’s “fair balance” requirement); App. 193 (no
similar FDA requirement for nondrug manufacturers). The record
before us, however, contains no evidentiary basis for the
conclusion that any such individualized counterdetailing is
widespread, or exists at all, in Vermont.
The majority points out,
ante, at 4,
that Act 80, of which §4631 was a part, also created an
“evidence-based prescription drug education program,” in which the
Vermont Department of Health, the Department of Vermont Health
Access, and the University of Vermont, among others, work together
“to provide information and education on the therapeutic and
cost-effective utilization of prescription drugs” to health
professionals responsible for prescribing and dispensing
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 4. One witness explained that academic
detailers
in Pennsylvania work with state health officials
to identify physicians serving patients whose health care is
likewise state provided. App. 375. The other, an IMS Health
officer, observed that Vermont has its own multipayer database
containing prescriber-identifying data, which
could be
used to talk to doctors about their prescription patterns and the
lower costs associated with generics.
Id., at 313. But
nothing in the record indicates that any “counterdetailing” of this
kind
has ever taken place in fact in Vermont.
State-sponsored health care professionals sometimes meet with small
groups of doctors to discuss best practices and generic drugs
generally. See University of Vermont, College of Medicine, Office
of Primary Care, Vermont Academic Detailing Program (July 2010),
http://www.med.uvm.edu/ ahec/downloads/VTAD_overview_2010.07.08.pdf
(all Inter-net materials as visited June 21, 2011, and available in
Clerk of Court’s case file). Nothing in Vermont’s statute prohibits
brand-name manufacturers from undertaking a similar effort.
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.
B
The legitimate state interests
that the statute serves are “substantial.”
Central Hudson,
447 U. S., at 564. Vermont enacted its statute
“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 24.
The protection of public health falls within
the traditional scope of a State’s police powers.
Hillsborough
County v.
Automated Medical Laboratories, Inc.,
471 U. S. 707,
719 (1985). The fact that the Court normally exempts the regulation
of “misleading” and “deceptive” information even from the rigors of
its “intermediate” commercial speech scrutiny testifies to the
importance of securing “unbiased information,” see
44
Liquormart, 517 U. S., at 501 (opinion of Stevens, J.);
Central Hudson,
supra, at 563, as does the fact
that the FDA sets forth as a federal regulatory goal the need to
ensure a “fair balance” of information about marketed drugs, 21 CFR
§§202.1(e)(1), 202.1(e)(5)(ii). As major payers in the health care
system, health care spending is also of crucial state interest. And
this Court has affirmed the importance of maintaining “privacy” as
an important public policy goal—even in respect to information
already disclosed to the public for particular purposes (but not
others). See
Department of Justice v.
Reporters Comm.
for Freedom of Press,
489 U. S. 749, 762–771
(1989); see also Solove, A Taxonomy of Privacy, 154 U. Pa.
L. Rev. 477, 520–522 (2006); cf.
NASA v.
Nelson, 562 U. S. ___, ___–___ (2011) (slip op., at 8–9)
(discussing privacy interests in nondisclosure).
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, if anything, to do with the name or prior prescription
practices of the particular doctor to whom a detailer is speaking.
Shaping a detailing message based on an individual doctor’s prior
prescription habits may help sell more of a particular
manufacturer’s particular drugs. But it does so by diverting
attention from scientific research about a drug’s safety and
effectiveness, as well as its cost. This diversion comes at the
expense of public health and the State’s fiscal interests.
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 of 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),
id., at 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 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 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), 202.1(e)(5)(ii). 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 “unauthorized
persons” without consent). Exceptions to this norm are
comparatively few. See,
e.g., ibid. (identifying
“authorized persons”); Vt. Stat. Ann., Tit. 18, §4631(e); App. 248,
255 (indicating that prescriber-identifying data is not widely
disseminated). There is no indication that the State of Vermont, or
others in the State, makes use of this information for
counterdetailing efforts. See
supra, at 15.
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 confi-dential
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, 492 U.
S., at 480 (in commercial speech area, First Amendment requires “a
fit that is not necessarily perfect, but reasonable; that
represents not necessarily the single best disposition but one
whose scope is in proportion to the interest served” (internal
quotation marks omitted)); see also
United States v.
Edge Broadcasting Co.,
509 U. S. 418, 434
(1993) (The First Amendment does not “require that the Government
make progress on every front before it can make progress on any
front”);
Burson, 504 U. S., at 207 (plurality
opinion).
C
The majority cannot point to any
adequately supported, similarly effective “more limited
restriction.”
Central Hudson, 447 U. S., at 564. It says
that doctors “can, and often do, simply decline to meet with
detailers.”
Ante, at 20. This fact, while true, is beside
the point. Closing the office door entirely has no similar tendency
to lower costs (by focusing greater attention upon the comparative
advantages and disadvantages of generic drug alternatives). And it
would not protect the confidentiality of information already
released to, say, data miners. In any event, physicians are
unlikely to turn detailers away at the door, for those detailers,
whether delivering a balanced or imbalanced message, are
nonetheless providers of much useful information. See 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 24–25;
see also
ante, at 17. But the disclosure-permitting
exceptions here
are quite narrow, and they serve useful,
indeed essential purposes. See
supra, at 14. Compare Vt.
Stat. Ann., Tit. 18, §4631(e) with note following 42 U. S. C.
§1320d–2, p. 1190, and 45 CFR §164.512 (uses and disclosures not
requiring consent under the Health Insurance Portability and
Accountability Act of 1996). Regardless, this alternative is not “a
more limited restriction,”
Central Hudson,
supra, at 564 (emphasis added), for it would impose a
greater, not a
lesser, burden upon the
dissemination of information.
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,
521 U. S. 844, 874
(1997) (alternative must be “at least as effective in achieving the
legitimate purpose that the statute was enacted to serve”).
Respondents also suggest policies requiring use of generic drugs or
educating doctors 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. 4310; Doc. 414, at 60–61. And in any event,
such laws do not help protect prescriber 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 “[p]harmaceutical 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 “ ‘real and substantial’ ” or
“ ‘definite and concrete.’ ”
MedImmune, Inc. v.
Genentech, Inc.,
549 U. S. 118, 127
(2007) (quoting
Aetna Life Ins. Co. v.
Haworth,
300 U. S. 227,
240–241 (1937)) (Article III does not permit courts to entertain
such disputes).
The Court, however, strikes down
all three provisions, and so I add that I disagree with the
majority as to the constitutionality of the third restriction as
well—basically for the reasons I have already set out. The
prohibition against pharmaceutical firms using this
prescriber-identifying information works no more than modest First
Amendment harm; the prohibition is justified by the need to ensure
unbiased sales presentations, prevent unnecessarily high drug
costs, and protect the privacy of prescribing physicians. There is
no obvious equally effective, more limited alternative.
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 6–9.
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 2–6,
9–13, 17. At best the Court opens a Pandora’s Box of First
Amendment challenges to many ordinary regulatory practices that may
only incidentally affect a commercial message. See,
e.g.,
supra, at 7–8, 9–11. At worst, it reawakens
Lochner’s pre-New Deal threat of substituting judicial for
democratic decisionmaking where ordinary economic regulation is at
issue. See
Central Hudson, 447 U. S., at 589 (Rehnquist,
J., dissenting).
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.
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