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TOMMY G. THOMPSON,
SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL., PETITIONERS
v.
WESTERN STATES MEDICAL CENTER
SUPREME COURT OF
THE UNITED STATES
535 U.S. 357; 122 S. Ct. 1497; 152 L. Ed. 2d 563
Decided April 29, 2021
Certiorari to the United States Court of Appeals for the Ninth Circuit
SYLLABUS
Drug
compounding is a process by which a pharmacist or doctor combines, mixes,
or alters ingredients to create a medication tailored to an individual
patient’s needs. The Food and Drug Administration Modernization Act of
1997 (FDAMA) exempts “compounded drugs” from the Food and Drug
Administration’s (FDA) standard drug approval requirements under the Federal
Food, Drug, and Cosmetic Act (FDCA), so long as the providers of the compounded
drugs abide by several restrictions, including that the prescription be
“unsolicited,” 21 U.S.C. § 353a(a), and that the providers “not
advertise or promote the compounding of any particular drug, class of
drug, or type of drug,” § 353a(c). Respondents, a group of licensed
pharmacies that specialize in compounding drugs, sought to enjoin enforcement
of the advertising and solicitation provisions, arguing that they violate
the First Amendment’s free speech guarantee. The District Court agreed
and granted respondents summary judgment, holding that the provisions
constitute unconstitutional restrictions on commercial speech under Central
Hudson Gas & Elec. Corp. v. Public Serv. Comm’n of N. Y., 447
U.S. 557, 566, 65 L. Ed. 2d 341, 100 S. Ct. 2343. Affirming in relevant
part, the Ninth Circuit held that the restrictions in question fail Central
Hudson‘s test because the Government had not demonstrated
that the restrictions would directly advance its interests or that alternatives
less restrictive of speech were unavailable.
Held:
The FDAMA’s prohibitions on soliciting prescriptions for, and advertising,
compounded drugs amount to unconstitutional restrictions on commercial
speech.
(a)
For a commercial speech regulation to be constitutionally permissible
under the Central Hudson test, the speech in question must concern
lawful activity and not be misleading, the asserted governmental interest
to be served by the regulation must be substantial, and the regulation
must “directly advance” the governmental interest and “not
[be] more extensive than is necessary to serve that interest,” 447
U.S. at 566.
(b)
The Government asserts that three substantial interests underlie the FDAMA:
(1) preserving the effectiveness and integrity of the FDCA’s new drug
approval process and the protection of the public health it provides;
(2) preserving the availability of compounded drugs for patients who,
for particularized medical reasons, cannot use commercially available
products approved by the FDA; and (3) achieving the proper balance between
those two competing interests. Preserving the new drug approval process
is clearly an important governmental interest, as is permitting the continuation
of the practice of compounding so that patients with particular needs
may obtain medications suited to those needs. Because pharmacists do not
make enough money from small-scale compounding to make safety and efficacy
testing of their compounded drugs economically feasible, however, it would
not make sense to require compounded drugs created to meet the unique
needs of individual patients to undergo the entire new drug approval process.
The Government therefore needs to be able to draw a line between small-scale
compounding and large-scale drug manufacturing. The Government argues
that the FDAMA’s speech-related provisions provide just such a line: As
long as pharmacists do not advertise particular compounded drugs, they
may sell compounded drugs without first undergoing safety and efficacy
testing and obtaining FDA approval. However, even assuming that the FDAMA’s
prohibition on advertising compounded drugs “directly advances”
the Government’s asserted interests, the Government has failed to demonstrate
that the speech restrictions are “not more extensive than is necessary
to serve [those] interests.” Central Hudson, supra, at 566.
If the Government can achieve its interests in a manner that does not
restrict commercial speech, or that restricts less speech, the Government
must do so. E.g., Rubin v. Coors Brewing Co., 514 U.S. 476, 490-491,
131 L. Ed. 2d 532, 115 S. Ct. 1585. Several non-speech-related means of
drawing a line between compounding and large-scale manufacturing might
be possible here. For example, the Government could ban the use of commercial
scale manufacturing or testing equipment in compounding drug products,
prohibit pharmacists from compounding more drugs in anticipation of receiving
prescriptions than in response to prescriptions already received, or prohibit
them from offering compounded drugs at wholesale to other state licensed
persons or commercial entities for resale. The Government has not offered
any reason why such possibilities, alone or in combination, would be insufficient
to prevent compounding from occurring on such a scale as to undermine
the new drug approval process.
(c)
Even if the Government had argued (as does the dissent) that the FDAMA’s
speech-related restrictions were motivated by a fear that advertising
compounded drugs would put people who do not need such drugs at risk by
causing them to convince their doctors to prescribe the drugs anyway,
that fear would fail to justify the restrictions. This concern rests on
the questionable assumption that doctors would prescribe unnecessary medications
and amounts to a fear that people would make bad decisions if given truthful
information, a notion that the Court rejected as a justification for an
advertising ban in, e.g., Virginia Bd. of Pharmacy v. Virginia
Citizens Consumer Council, Inc., 425 U.S. 748, 770, Pp. 15-18, 48
L. Ed. 2d 346, 96 S. Ct. 1817.
(d)
If the Government’s failure to justify its decision to regulate speech
were not enough to convince the Court that the FDAMA’s advertising provisions
were unconstitutional, the amount of beneficial speech prohibited by the
FDAMA would be. Forbidding the advertisement of compounded drugs would
prevent pharmacists with no interest in mass-producing medications, but
who serve clienteles with special medical needs, from telling the doctors
treating those clients about the alternative drugs available through compounding.
For example, a pharmacist serving a children’s hospital where many patients
are unable to swallow pills would be prevented from telling the children’s
doctors about a new development in compounding that allowed a drug that
was previously available only in pill form to be administered another
way. The fact that the FDAMA would prohibit such seemingly useful speech
even though doing so does not appear to directly further any asserted
governmental objective confirms that the prohibition is unconstitutional.
238 F.3d 1090, affirmed.
«1500»
delivered the opinion of the Court.
Section 503A of the Food
and Drug Administration Modernization Act of 1997 (FDAMA or Act), 111
Stat. 2328, 21 U.S.C. § 353a, exempts “compounded drugs” from
the Food and Drug Administration’s standard drug approval requirements
as long as the providers of those drugs abide by several restrictions,
including that they refrain from advertising or promoting particular compounded
drugs. Respondents, a group of licensed pharmacies that specialize in
compounding drugs, sought to enjoin enforcement of the subsections of
the Act dealing with advertising and solicitation, arguing that those
provisions violate the First Amendment’s free speech guarantee. The District
Court agreed with respondents and granted their motion for summary judgment,
holding that the provisions do not meet the test for acceptable government
regulation of commercial speech set forth in Central Hudson Gas &
Elec. Corp. v. Public Serv. Comm’n of N. Y., 447 U.S. 557,
566, 65 L. Ed. 2d 341, 100 S. Ct. 2343 (1980). The court invalidated the
relevant provisions, severing them from the rest of § 503A.
The Court of Appeals for
the Ninth Circuit affirmed in part and reversed in part, agreeing that
the provisions regarding advertisement and promotion are unconstitutional
but finding them not to be severable from the rest of § 503A. Petitioners
challenged only the Court of Appeals’ constitutional holding in their
petition for certiorari, and respondents did not file a cross-petition.
We therefore address only the constitutional question, having no occasion
to review the Court of Appeals’ severability determination. We conclude,
as did the courts below, that § 503A’s provisions regarding advertisement
and promotion amount to unconstitutional restrictions on commercial speech,
and we therefore affirm.
I
Drug compounding is a process
by which a pharmacist or doctor combines, mixes, or alters ingredients
to create a medication tailored to the needs of an individual patient.
Compounding is typically used to prepare medications that are not commercially
available, such as medication for a patient who is allergic to an ingredient
in a mass-produced product. It is a traditional component of the practice
of pharmacy, see J. Thompson, A Practical Guide to Contemporary Pharmacy
Practice 11.3 (1998), and is taught as part of the standard curriculum
at most pharmacy schools, see American Council on Pharmaceutical Education,
Accreditation Standards and Guidelines for the Professional Program in
Pharmacy Leading to the Doctor of Pharmacy Degree, Standard 10(a) (adopted
June 14, 2021). Many States specifically regulate compounding practices
as part of their regulation of pharmacies. See, e.g., Cal. Code
Regs. tit. 16, § § 1716.2, 1751 (2002); Ind.
Admin. Code, tit. 856, § § 1-30-8, 1-30-18,
1-28-8 (2001); N.
H. Code Admin. Rules Ann. Pharmacy, pts. PH 404, PH 702.01 (2002); 22
Tex. Admin. Code § 291.36
(2002). Some require all licensed pharmacies to offer compounding services.
See, e.g., 49 Pa.
Code § 27.18(p)(2) (2002); W. Va. Code St.
Rules, tit. 15, § 19.4 (2002). Pharmacists may provide compounded drugs
to patients only upon receipt of a valid prescription «1501» from a doctor or other medical practitioner
licensed to prescribe medication. See, e.g., Okla. Admin. Code
§ § 535:15-10-3, 535:15-10-9(d) (2001); Colorado
State Board of Pharmacy Rule
3.02.10 (2001).
The Federal Food, Drug, and
Cosmetic Act of 1938 (FDCA), 21 U.S.C. § § 301-397, regulates drug manufacturing,
marketing, and distribution. Section 505(a) of the FDCA, 52 Stat. 1052,
as amended, 76 Stat. 784, provides that “no person shall introduce
or deliver for introduction into interstate commerce any new drug, unless
an approval of an application filed [with the Food and Drug Administration]
. . . is effective with respect to such drug.” 21 U.S.C. § 355(a).
“New drug” is defined by § 201(p)(1) of the FDCA, 52 Stat.
1041, as amended 76 Stat. 781, as “any drug . . . not generally recognized,
among experts qualified by scientific training and experience to evaluate
the safety and effectiveness of drugs, as safe and effective for use under
the conditions prescribed, recommended, or suggested in the labeling thereof.”
21 U.S.C. § 321(p). The FDCA invests the Food and Drug Administration
(FDA) with the power to enforce its requirements. § 371(a).
For approximately the first
50 years after the enactment of the FDCA, the FDA generally left regulation
of compounding to the States. Pharmacists continued to provide patients
with compounded drugs without applying for FDA approval of those drugs.
The FDA eventually became concerned, however, that some pharmacists were
manufacturing and selling drugs under the guise of compounding, thereby
avoiding the FDCA’s new drug requirements. In 1992, in response to this
concern, the FDA issued a Compliance Policy Guide, which announced that
the “FDA may, in the exercise of its enforcement discretion, initiate
federal enforcement actions . . . when the scope and nature of a pharmacy’s
activities raises the kinds of concerns normally associated with a manufacturer
and . . . results in significant violations of the new drug, adulteration,
or misbranding provisions of the Act.” Compliance Policy Guide 7132.16
(hereinafter Guide), App. to Pet. for Cert. 76a. The Guide explained that
the “FDA recognizes that pharmacists traditionally have extemporaneously
compounded and manipulated reasonable quantities of drugs upon receipt
of a valid prescription for an individually identified patient from a
licensed practitioner,” and that such activity was not the subject
of the Guide. Id.,
at 71a. The Guide said, however, “that while retail pharmacies .
. . are exempted from certain requirements of the [FDCA], they are not
the subject of any general exemption from the new drug, adulteration,
or misbranding provisions” of the FDCA. Id.,
at 72a. It stated that the “FDA believes that an increasing number
of establishments with retail pharmacy licenses are engaged in manufacturing,
distributing, and promoting unapproved new drugs for human use in a manner
that is clearly outside the bounds of traditional pharmacy practice and
that constitute violations of the [FDCA].” Ibid. The Guide
expressed concern that drug products “manufactured and distributed
in commercial amounts without [the] FDA’s prior approval” could harm
the public health. Id.,
at 73a.
In light of these considerations,
the Guide announced that it was FDA policy to permit pharmacists to compound
drugs after receipt of a valid prescription for an individual patient
or to compound drugs in “very limited quantities” before receipt
of a valid prescription if they could document a history of receiving
valid prescriptions “generated solely within an established professional
practitioner-patient-pharmacy relationship” and if they maintained
the prescription on file as required by state law. Id.,
at 73a-75a. Compounding in such circumstances was permitted as long as
the pharmacy’s activities did not raise “the kinds of concerns normally
associated with a manufacturer.” Id.,
at 76a. The Guide listed nine examples of activities that the FDA believed
raised such concerns «1502» and
that would therefore be considered by the agency in determining whether
to bring an enforcement action. These activities included: “soliciting
business (e.g., promoting, advertising, or using salespersons)
to compound specific drug products, product classes, or therapeutic classes
of drug products”; “compounding, regularly, or in inordinate
amounts, drug products that are commercially available . . . and that
are essentially generic copies of commercially available, FDA-approved
drug products”; using commercial scale manufacturing or testing equipment
to compound drugs; offering compounded drugs at wholesale; and “distributing
inordinate amounts of compounded products out of state.” Id.,
at 76a to 77a. The Guide further warned that pharmacies could not dispense
drugs to third parties for resale to individual patients without losing
their status as retail entities. Id.,
at 75a.
Congress turned portions
of this policy into law when it enacted the FDAMA in 1997. The FDAMA,
which amends the FDCA, exempts compounded drugs from the FDCA’s “new
drug” requirements and other requirements provided the drugs satisfy
a number of restrictions. First, they must be compounded by a licensed
pharmacist or physician in response to a valid prescription for an identified
individual patient, or, if prepared before the receipt of such a prescription,
they must be made only in “limited quantities” and in response
to a history of the licensed pharmacist’s or physician’s receipt of valid
prescription orders for that drug product within an established relationship
between the pharmacist, the patient, and the prescriber. 21 U.S.C. §
353a(a). Second, the compounded drug must be made from approved ingredients
that meet certain manufacturing and safety standards, § § 353a(b)(1)(A)-(B),
and the compounded drug may not appear on an FDA list of drug products
that have been withdrawn or removed from the market because they were
found to be unsafe or ineffective. § 353a(b)(1)(C). Third, the pharmacist
or physician compounding the drug may not “compound regularly or
in inordinate amounts (as defined by the Secretary) any drug products
that are essentially copies of a commercially available drug product.”
§ 353a(b)(1)(D). Fourth, the drug product must not be identified by the
FDA as a drug product that presents demonstrable difficulties for compounding
in terms of safety or effectiveness. § 353a(b)(3)(A). Fifth, in States
that have not entered into a “memorandum of understanding” with
the FDA addressing the distribution of “inordinate amounts”
of compounded drugs in interstate commerce, the pharmacy, pharmacist,
or physician compounding the drug may not distribute compounded drugs
out of State in quantities exceeding five percent of that entity’s total
prescription orders. § 353a(b)(3)(B). Finally, and most relevant for this
litigation, the prescription must be “unsolicited,” § 353a(a),
and the pharmacy, licensed pharmacist, or licensed physician compounding
the drug may “not advertise or promote the compounding of any particular
drug, class of drug, or type of drug.” § 353a(c). The pharmacy, licensed
pharmacist, or licensed physician may, however, “advertise and promote
the compounding service.” Ibid.
Respondents are a group of
licensed pharmacies that specialize in drug compounding. They have prepared
promotional materials that they distribute by mail and at medical conferences
to inform patients and physicians of the use and effectiveness of specific
compounded drugs. Fearing that they would be prosecuted under the FDAMA
if they continued to distribute those materials, respondents filed a complaint
in the United States District Court for the District of Nevada, arguing
that the Act’s requirement that they refrain from advertising and promoting
their products if they wish to continue compounding violates the Free
Speech Clause of the First Amendment. Specifically, they challenged the
requirement that prescriptions for compounded drugs be «1503» “unsolicited,” 21 U.S.C. § 353a(a),
and the requirement that pharmacists “not advertise or promote the
compounding of any particular drug, class of drug, or type of drug,”
§ 353a(c). The District Court granted summary judgment to respondents,
finding that the FDAMA’s speech-related provisions constitute unconstitutional
restrictions on commercial speech under Central Hudson, 447 U.S.
at 566, and that their enforcement should therefore be enjoined. Western
States Medical
Center v. Shalala,
69 F. Supp. 2d 1288 (Nev.
1999). The District Court, however, found those provisions to be severable
from the rest of § 503A of the FDAMA, 21 U.S.C. § 353a, and so left the
Act’s other compounding requirements intact.
The Government appealed both
the holding that the speech-related provisions were unconstitutional and
the holding that those provisions were severable from the rest of § 503A.
The Court of Appeals for the Ninth Circuit affirmed in part and reversed
in part. Western
States Medical
Center v. Shalala,
238 F.3d 1090 (2001). The Court of Appeals agreed that the FDAMA’s advertisement
and solicitation restrictions fail Central Hudson‘s test for permissible
regulation of commercial speech, finding that the Government had not demonstrated
that the speech restrictions would directly advance its interests or that
alternatives less restrictive of speech were unavailable. The Court of
Appeals disagreed, however, that the speech-related restrictions were
severable from the rest of § 503A, 21 U.S.C. § 353a, explaining that
the FDAMA’s legislative history demonstrated that Congress intended to
exempt compounding from the FDCA’s requirements only in return for a prohibition
on promotion of specific compounded drugs. Accordingly, the Court of Appeals
invalidated § 503A in its entirety.
We granted certiorari, 534
U.S. 992 (2001), to consider whether the FDAMA’s prohibitions on soliciting
prescriptions for, and advertising, compounded drugs violate the First
Amendment. Because neither party petitioned for certiorari on the severability
issue, we have no occasion to review that portion of the Court of Appeals
decision. Likewise, the provisions of the FDAMA outside § 503A, which
are unrelated to drug compounding, are not an issue here and so remain
unaffected.
II
The parties agree that the
advertising and soliciting prohibited by the FDAMA constitute commercial
speech.
In Virginia Bd. of Pharmacy
v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748,
48 L. Ed. 2d 346, 96 S. Ct. 1817 (1976), the first case in which we explicitly
held that commercial speech receives First Amendment protection, we explained
the reasons for this protection: “It is a matter of public interest
that [economic] decisions, in the aggregate, be intelligent and well-informed.
To this end, the free flow of commercial information is indispensable.”
Id., at 765.
Indeed, we recognized that a “particular consumer’s interest in the
free flow of commercial information . . . may be as keen, if not keener
by far, than his interest in the day’s most urgent political debate.”
Id., at 763.
We have further emphasized:
“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. Thus, even
a communication that does no more than propose a commercial transaction
is entitled to the coverage of the First Amendment.” Edenfield
v. Fane, 507 U.S. 761, 767, 123 L. Ed. 2d 543, 113 S. Ct.
1792 (1993).
Although commercial speech
is protected by the First Amendment, not all «1504»
regulation of such speech is unconstitutional. See Virginia Bd. of
Pharmacy, supra, at 770. In Central Hudson,
supra, we articulated a test for determining whether a particular
commercial speech regulation is constitutionally permissible. Under that
test we ask as a threshold matter whether the commercial speech concerns
unlawful activity or is misleading. If so, then the speech is not protected
by the First Amendment. If the speech concerns lawful activity and is
not misleading, however, we next ask “whether the asserted governmental
interest is substantial.” Id.,
at 566. If it is, then we “determine whether the regulation directly
advances the governmental interest asserted,” and, finally, “whether
it is not more extensive than is necessary to serve that interest.”
Ibid. Each of these latter three inquiries must be answered in
the affirmative for the regulation to be found constitutional.
Neither party has challenged
the appropriateness of applying the Central Hudson
framework to the speech-related provisions at issue here. Although
several Members of the Court have expressed doubts about the Central
Hudson analysis and whether it should apply in particular cases, see,
e.g., Greater New Orleans Broadcasting Assn., Inc. v. United
States, 527 U.S. 173, 197, 144 L. Ed. 2d 161, 119 S. Ct. 1923 (1999)
(THOMAS, J., concurring in judgment); 44 Liquormart, Inc. v.
Rhode Island, 517 U.S. 484, 501, 510-514, 134 L. Ed. 2d 711, 116 S.
Ct. 1495 (1996) (opinion of STEVENS, J., joined by KENNEDY, and GINSBURG,
JJ.); id., at 517 (SCALIA, J., concurring in part and concurring
in judgment); id., at 518 (THOMAS, J., concurring in part and concurring
in judgment), there is no need in this case to break new ground. “‘Central
Hudson, as applied in our more recent commercial speech
cases, provides an adequate basis for decision.’” Lorillard Tobacco
Co. v. Reilly, 533 U.S.
525, 554-555, 150 L. Ed. 2d 532, 121 S. Ct. 2404
(2001) (quoting Greater New Orleans, supra, at 184).
III
The Government does not attempt
to defend the FDAMA’s speech-related provisions under the first prong
of the Central Hudson test; i.e.,
it does not argue that the prohibited advertisements would be about unlawful
activity or would be misleading. Instead, the Government argues that the
FDAMA satisfies the remaining three prongs of the Central
Hudson test.
The Government asserts that
three substantial interests underlie the FDAMA. The first is an interest
in “preserving the effectiveness and integrity of the FDCA’s new
drug approval process and the protection of the public health that it
provides.” Brief for Petitioners 19. The second is an interest in
“preserving the availability of compounded drugs for those individual
patients who, for particularized medical reasons, cannot use commercially
available products that have been approved by the FDA.” Id.,
at 19-20. Finally, the Government argues that “achieving the proper
balance between those two independently compelling but competing interests
is itself a substantial governmental interest.” Id.,
at 20.
Explaining these interests,
the Government argues that the FDCA’s new drug approval requirements are
critical to the public health and safety. It claims that the FDA’s experience
with drug regulation demonstrates that proof of the safety and effectiveness
of a new drug needs to be established by rigorous, scientifically valid
clinical studies because impressions of individual doctors, who cannot
themselves compile sufficient safety data, cannot be relied upon. The
Government also argues that a premarket approval process, under which
manufacturers are required to put their proposed drugs through tests of
safety and effectiveness in order to obtain FDA approval to market the
drugs, is the «1505» best way to
guarantee drug safety and effectiveness.
While it praises the FDCA’s
new drug approval process, the Government also acknowledges that “because
obtaining FDA approval for a new drug is a costly process, requiring FDA
approval of all drug products compounded by pharmacies for the particular
needs of an individual patient would, as a practical matter, eliminate
the practice of compounding, and thereby eliminate availability of compounded
drugs for those patients who have no alternative treatment.” Id.,
at 26. The Government argues that eliminating the practice of compounding
drugs for individual patients would be undesirable because compounding
is sometimes critical to the care of patients with drug allergies, patients
who cannot tolerate particular drug delivery systems, and patients requiring
special drug dosages.
Preserving the effectiveness
and integrity of the FDCA’s new drug approval process is clearly an important
governmental interest, and the Government has every reason to want as
many drugs as possible to be subject to that approval process. The Government
also has an important interest, however, in permitting the continuation
of the practice of compounding so that patients with particular needs
may obtain medications suited to those needs. And it would not make sense
to require compounded drugs created to meet the unique needs of individual
patients to undergo the testing required for the new drug approval process.
Pharmacists do not make enough money from small-scale compounding to make
safety and efficacy testing of their compounded drugs economically feasible,
so requiring such testing would force pharmacists to stop providing compounded
drugs. Given this, the Government needs to be able to draw a line between
small-scale compounding and large-scale drug manufacturing. That line
must distinguish compounded drugs produced on such a small scale that
they could not undergo safety and efficacy testing from drugs produced
and sold on a large enough scale that they could undergo such testing
and therefore must do so.
The Government argues that
the FDAMA’s speech-related provisions provide just such a line, i.e.,
that, in the terms of Central Hudson, they “directly advance
the governmental interests asserted.” 447 U.S.
at 566. Those provisions use advertising as the trigger for requiring
FDA approval — essentially, as long as pharmacists do not advertise particular
compounded drugs, they may sell compounded drugs without first undergoing
safety and efficacy testing and obtaining FDA approval. If they advertise
their compounded drugs, however, FDA approval is required. The Government
explains that traditional (or, in its view, desirable) compounding responds
to a physician’s prescription and an individual patient’s particular medical
situation, and that “advertising the particular products created
in the provision of [such] service (as opposed to advertising the compounding
service itself) is not necessary to . . . this type of responsive and
customized service.” Brief for Petitioners 34. The Government argues
that advertising particular products is useful in a broad market but is
not useful when particular products are designed in response to an individual’s
“often unique needs.” Ibid. The Government contends that,
because of this, advertising is not typically associated with compounding
for particular individuals. In contrast it is typically associated, the
Government claims, with large-scale production of a drug for a substantial
market. The Government argues that advertising, therefore, is “a
fair proxy for actual or intended large-scale manufacturing,” and
that Congress’ decision to limit the FDAMA’s compounding exemption to
pharmacies that do not engage in promotional activity was “rationally
calculated” to avoid creating “‘a loophole that would allow
unregulated drug manufacturing to occur under the guise of pharmacy compounding.’”
Id., at 35
(quoting 143 «1506» Cong. Rec. S9839 (Sept. 24, 1997) (statement of Sen. Kennedy)).
The Government seems to believe
that without advertising it would not be possible to market a drug on
a large enough scale to make safety and efficacy testing economically
feasible. The Government thus believes that conditioning an exemption
from the FDA approval process on refraining from advertising is an ideal
way to permit compounding and yet also guarantee that compounding is not
conducted on such a scale as to undermine the FDA approval process. Assuming
it is true that drugs cannot be marketed on a large scale without advertising,
the FDAMA’s prohibition on advertising compounded drugs might indeed “directly
advance” the Government’s interests. Central Hudson,
447 U.S.
at 566. Even assuming that it does, however, the Government has failed
to demonstrate that the speech restrictions are “not more extensive
than is necessary to serve [those] interests.” Ibid. In previous
cases addressing this final prong of the Central Hudson
test, we have made clear that if the Government could achieve its
interests in a manner that does not restrict speech, or that restricts
less speech, the Government must do so. In Rubin v. Coors Brewing
Co., 514 U.S. 476, 131 L. Ed. 2d 532, 115 S. Ct. 1585 (1995),
for example, we found a law prohibiting beer labels from displaying alcohol
content to be unconstitutional in part because of the availability of
alternatives “such as directly limiting the alcohol content of beers,
prohibiting marketing efforts emphasizing high alcohol strength . . .,or
limiting the labeling ban only to malt liquors.” Id.,
at 490-491. The fact that “all of [these alternatives] could advance
the Government’s asserted interest in a manner less intrusive to . . .
First Amendment rights,” indicated that the law was “more extensive
than necessary.” Id.,
at 491. See also 44 Liquormart, Inc. v. Rhode Island, 517
U.S. at 507 (plurality opinion) (striking down a prohibition on advertising
the price of alcoholic beverages in part because “alternative forms
of regulation that would not involve any restriction on speech would be
more likely to achieve the State’s goal of promoting temperance”).
Several non-speech-related
means of drawing a line between compounding and large-scale manufacturing
might be possible here. First, it seems that the Government could use
the very factors the FDA relied on to distinguish compounding from manufacturing
in its 1992 Compliance Policy Guide. For example, the Government could
ban the use of “commercial scale manufacturing or testing equipment
for compounding drug products.” Compliance Policy Guide, App. to
Pet. for Cert. 76a. It could prohibit pharmacists from compounding more
drugs in anticipation of receiving prescriptions than in response to prescriptions
already received. See ibid. It could prohibit pharmacists from
“offering compounded drugs at wholesale to other state licensed persons
or commercial entities for resale.” Id.,
at 77a. Alternately, it could limit the amount of compounded drugs, either
by volume or by numbers of prescriptions, that a given pharmacist or pharmacy
sells out of State. See ibid. Another possibility not suggested
by the Compliance Policy Guide would be capping the amount of any particular
compounded drug, either by drug volume, number of prescriptions, gross
revenue, or profit that a pharmacist or pharmacy may make or sell in a
given period of time. It might even be sufficient to rely solely on the
non-speech-related provisions of the FDAMA, such as the requirement that
compounding only be conducted in response to a prescription or a history
of receiving a prescription, 21 U.S.C. § 353a(a), and the limitation
on the percentage of a pharmacy’s total sales that out-of-state sales
of compounded drugs may represent, § 353a(b)(3)(B).
The Government has not offered
any reason why these possibilities, alone or in combination, would be
insufficient to «1507» prevent compounding
from occurring on such a scale as to undermine the new drug approval process.
Indeed, there is no hint that the Government even considered these or
any other alternatives. Nowhere in the legislative history of the FDAMA
or petitioners’ briefs is there any explanation of why the Government
believed forbidding advertising was a necessary as opposed to merely convenient
means of achieving its interests. Yet “it is well established that
‘the party seeking to uphold a restriction on commercial speech carries
the burden of justifying it.’” Edenfield v. Fane, 507
U.S. at 770 (quoting Bolger v. Youngs Drug Products Corp.,
463 U.S. 60, 71, n. 20, 77 L. Ed. 2d 469, 103 S. Ct. 2875 (1983)). The
Government simply has not provided sufficient justification here. If the
First Amendment means anything, it means that regulating speech must be
a last — not first — resort. Yet here it seems to have been the first
strategy the Government thought to try.
The dissent describes another
governmental interest — an interest in prohibiting the sale of compounded
drugs to “patients who may not clearly need them,” post,
at 2 (opinion of BREYER, J.) — and argues that “Congress could
. . . conclude that the advertising restrictions ‘directly advance’”
that interest, post, at 8. Nowhere in its briefs, however, does
the Government argue that this interest motivated the advertising ban.
Although, for the reasons given by the dissent, Congress conceivably could
have enacted the advertising ban to advance this interest, we have generally
only sustained statutes on the basis of hypothesized justifications when
reviewing statutes merely to determine whether they are rational. See
L. Tribe, American Constitutional Law 1444-1446 (2d ed. 1988) (describing
the “rational basis” or “conceivable basis” test);
see also, e.g., Minnesota v. Clover Leaf Creamery Co.,
449 U.S. 456, 466, 66 L. Ed. 2d 659, 101 S. Ct. 715 (1981) (sustaining
a milk packaging regulation under the “rational basis” test
because “the Minnesota Legislature could rationally have decided
that [the regulation] might foster greater use of environmentally desirable
alternatives” (emphasis deleted)). The Central Hudson test
is significantly stricter than the rational basis test, however, requiring
the Government not only to identify specifically “a substantial interest
to be achieved by [the] restriction on commercial speech,” 447 U.S.
at 564, but also to prove that the regulation “directly advances”
that interest and is “not more extensive than is necessary to serve
that interest,” id., at 566. The Government has not met any
of these requirements with regard to the interest the dissent describes.
Even if the Government had
argued that the FDAMA’s speech-related restrictions were motivated by
a fear that advertising compounded drugs would put people who do not need
such drugs at risk by causing them to convince their doctors to prescribe
the drugs anyway, that fear would fail to justify the restrictions. Aside
from the fact that this concern rests on the questionable assumption that
doctors would prescribe unnecessary medications (an assumption the dissent
is willing to make based on one magazine article and one survey, post
at 7, neither of which was relied upon by the Government), this concern
amounts to a fear that people would make bad decisions if given truthful
information about compounded drugs. See supra, at 10 (explaining
that the Government does not claim the advertisements forbidden by the
FDAMA would be false or misleading). We have previously rejected the notion
that the Government has an interest in preventing the dissemination of
truthful commercial information in order to prevent members of the public
from making bad decisions with the information. In Virginia Bd. of
Pharmacy, the State feared that if people received price advertising
from pharmacists, they would “choose the low-cost, low-quality service
and drive the ‘professional’ pharmacist out «1508» of business” and would “destroy
the pharmacist-customer relationship” by going from one pharmacist
to another. We found these fears insufficient to justify a ban on such
advertising. 425 U.S.
at 769. We explained:
“There
is, of course, an alternative to this highly paternalistic approach. That
alternative is to assume that this information is not in itself harmful,
that people will perceive their own best interests if only they are well
enough informed, and that the best means to that end is to open the channels
of communication rather than to close them . . . . But the choice among
these alternative approaches is not ours to make or the Virginia General
Assembly’s. It is precisely this kind of choice, between the dangers of
suppressing information, and the dangers of its misuse if it is freely
available, that the First Amendment makes for us. Virginia is free to
require whatever professional standards it wishes of its pharmacists;
it may subsidize them or protect them from competition in other ways.
But it may not do so by keeping the public in ignorance of the entirely
lawful terms that competing pharmacists are offering.” Id., at 770 (citation omitted).
See also 44 Liquormart,
Inc. v. Rhode Island,
517 U.S.
at 503 (“Bans against truthful, nonmisleading commercial speech .
. . usually rest solely on the offensive assumption that the public will
respond ‘irrationally’ to the truth. The First Amendment directs us to
be especially skeptical of regulations that seek to keep people in the
dark for what the government perceives to be their own good” (citation
omitted)).
Even if the Government had
asserted an interest in preventing people who do not need compounded drugs
from obtaining those drugs, the statute does not directly advance that
interest. The dissent claims that the Government “must exclude from
the area of permitted drug sales . . . those compounded drugs sought by
patients who may not clearly need them.” Post, at 2. Yet the
statute does not directly forbid such sales. It instead restricts advertising,
of course not just to those who do not need compounded drugs, but also
to individuals who do need compounded drugs and their doctors. Although
the advertising ban may reduce the demand for compounded drugs from those
who do not need the drugs, it does nothing to prevent such individuals
from obtaining compounded drugs other than requiring prescriptions. But
if it is appropriate for the statute to rely on doctors to refrain from
prescribing compounded drugs to patients who do not need them, it is not
clear why it would not also be appropriate to rely on doctors to refrain
from prescribing compounded drugs to patients who do not need them in
a world where advertising was permitted.
The dissent may also be suggesting
that the Government has an interest in banning the advertising of compounded
drugs because patients who see such advertisements will be confused about
the drugs’ risks. See post, at 11 (“[the Government] fears
the systematic effect . . . of advertisements that will not fully explain
the complicated risks at issue”). This argument is precluded, however,
by the fact that the Government does not argue that the advertisements
are misleading. Even if the Government did argue that it had an interest
in preventing misleading advertisements, this interest could be satisfied
by the far less restrictive alternative of requiring each compounded drug
to be labeled with a warning that the drug had not undergone FDA testing
and that its risks were unknown.
If the Government’s failure
to justify its decision to regulate speech were not enough to convince
us that the FDAMA’s advertising provisions were unconstitutional, the
amount of beneficial speech prohibited by the FDAMA would be. Forbidding
the advertisement of compounded drugs would affect pharmacists other than
«1509» those interested in producing drugs on a large scale.
It would prevent pharmacists with no interest in mass-producing medications,
but who serve clienteles with special medical needs, from telling the
doctors treating those clients about the alternative drugs available through
compounding. For example, a pharmacist serving a children’s hospital where
many patients are unable to swallow pills would be prevented from telling
the children’s doctors about a new development in compounding that allowed
a drug that was previously available only in pill form to be administered
another way. Forbidding advertising of particular compounded drugs would
also prohibit a pharmacist from posting a notice informing customers that
if their children refuse to take medications because of the taste, the
pharmacist could change the flavor, and giving examples of medications
where flavoring is possible. The fact that the FDAMA would prohibit such
seemingly useful speech even though doing so does not appear to directly
further any asserted governmental objective confirms our belief that the
prohibition is unconstitutional.
Accordingly, we affirm the
Court of Appeals’ judgment that the speech-related provisions of FDAMA
§ 503A are unconstitutional.
So ordered.
JUSTICE THOMAS, concurring.
I concur because I agree
with the Court’s application of the test set forth in Central Hudson
Gas & Elec. Corp. v. Public Serv. Comm’n. of N. Y., 447 U.S.
557, 65 L. Ed. 2d 341, 100 S. Ct. 2343 (1980).
I continue, however, to adhere to my view that cases such as this should
not be analyzed under the Central Hudson
test. “I do not believe that such a test should be applied to a restriction
of ‘commercial’ speech, at least when, as here, the asserted interest
is one that is to be achieved through keeping would-be recipients of the
speech in the dark.” 44 Liquormart, Inc. v. Rhode Island,
517 U.S.
484, 523, 134 L. Ed. 2d 711, 116 S. Ct. 1495 (1996)
(opinion concurring in part and concurring in judgment).
JUSTICE BREYER, with
whom THE CHIEF JUSTICE, JUSTICE STEVENS, and JUSTICE
GINSBURG join, dissenting.
Federal law requires strict
safety and efficacy testing of all “new” prescription “drugs.”
21 U.S.C. § 355. See 21 CFR § 310.3(h) (2002) (defining “new drug”
broadly). This testing process requires for every “new drug”
a preclinical investigation and three separate clinical tests, including
small, controlled studies of healthy and diseased humans as well as scientific
double-blind studies designed to identify any possible health risk or
side effect associated with the new drug. Practical Guide to Food and
Drug Law and Regulation, 95-102 (K. Pina & W. Pines eds. 1998). The
objective of this elaborate and time-consuming regulatory regime is to
identify those health risks — both large and small — that a doctor or
pharmacist might not otherwise notice.
At the same time, the law
exempts from its testing requirements prescription drugs produced through
“compounding,” — a process “by which a pharmacist or doctor
combines, mixes or alters ingredients to create a medication tailored
to the needs of an individual patient.” Ante, at 2. The exemption
is available, however, only if the pharmacist meets certain specified
conditions, including the condition that the pharmacist not “advertise
or promote the compounding of any particular drug.” 21 U.S.C.
§ 353a(c) (emphasis added).
The Court holds that this
condition restricts “commercial speech” in violation of the
First Amendment. See Central Hudson Gas & Elec. Corp. v. Public
Serv. Comm’n of N. Y., 447 U.S. 557, 564, 65 L. Ed. 2d 341, 100 S.
Ct. 2343 (1980). It concedes that the statutory provision tries to “preserv[e]
the effectiveness and integrity of the . . . new drug approval process,”
ante, at 11, and it assumes without deciding that the statute might
“‘directly «1510» advance’”
that interest, ante, at 13. It nonetheless finds the statute unconstitutional
because it could advance that interest in other, less restrictive ways.
Ante, at 14-15, 17. I disagree with this conclusion, and I believe
that the Court seriously undervalues the importance of the Government’s
interest in protecting the health and safety of the American public.
I
In my view, the advertising
restriction “directly advances” the statute’s important safety
objective. That objective, as the Court concedes, is to confine the sale
of untested, compounded, drugs to where they are medically needed. But
to do so the statute must exclude from the area of permitted drug sales
both (1) those drugs that traditional drug manufacturers might supply
after testing– typically drugs capable of being produced in large amounts,
and (2) those compounded drugs sought by patients who may not clearly
need them — including compounded drugs produced in small amounts.
The majority’s discussion
focuses upon the first exclusionary need, but it virtually ignores the
second. It describes the statute’s objective simply as drawing a “line”
that will “distinguish compounded drugs produced on such a small
scale that they could not undergo safety and efficacy testing from drugs
produced and sold on a large enough scale that they could undergo such
testing and therefore must do so.” Ante, at 11-12 (emphasis added).
This description overlooks the need for a second line — a line that will
distinguish (1) sales of compounded drugs to those who clearly need them
from (2) sales of compounded drugs to those for whom a specially tailored
but untested drug is a convenience but not a medical necessity. That is
to say, the statute, in seeking to confine distribution of untested tailored
drugs, must look both at the amount supplied (to help decide whether ordinary
manufacturers might provide a tested alternative) and at the nature of
demand (to help separate genuine need from simple convenience). Cf. 143
Cong. Rec. S9840 (Sept. 24, 1997) (remarks of Sen. Kennedy) (understanding
that “some of the conditions are intended to ensure that the volume
of compounding does not approach that ordinarily associated with drug
manufacturing” while others are “intended to ensure that the
compounded drugs that qualify for the exemption have appropriate assurances
of quality and safety since [they] would not be subject to the more comprehensive
regulatory requirements that apply to manufactured drug products”).
This second intermediate
objective is logically related to Congress’ primary end — the minimizing
of safety risks. The statute’s basic exemption from testing requirements
inherently creates risks simply by placing untested drugs in the hands
of the consumer. Where an individual has a specific medical need for a
specially tailored drug those risks are likely offset. But where an untested
drug is a convenience, not a necessity, that offset is unlikely to be
present.
That presumably is why neither
the Food and Drug Administration (FDA) nor Congress anywhere suggests
that all that matters is the total amount of a particular drug’s sales.
That is why the statute’s history suggests that the amount supplied is
not the whole story. See S. Rep. No. 105-43, p. 67 (1997) (statute seeks
to assure “continued availability of compounded drug products as
a component of individualized therapy, . . . while . . . preventing small-scale
manufacturing under the guise of compounding”) (emphasis added);
accord, H. R. Conf. Rep. No. 105-399, p. 94 (1997). That is why the statute
itself, as well as the FDA policy that the statute reflects, lists several
distinguishing factors, of which advertising is one. See FDA Compliance
Policy Guide 7132.16, reprinted in App. to Pet. for Cert. «1511» at 71a-77a (hereinafter Compliance Policy
Guide). And that is likely why, when faced with the possibility of severing
the advertising restriction from the rest of the statute, the Government
argued that the “other conditions in section 353a alone are inadequate
to achieve Congress’s desired balance among competing interests.”
See Brief for Appellants in No. 99-17424 (CA9), p. 57. See also id., at
55. (to nullify advertising restrictions would undermine “‘finely
tuned balance’” achieved by requiring that “pharmacies refrain
from promoting and soliciting prescriptions for particular compounded
drug products until they have been proven safe and effective”).
Ensuring that the risks
associated with compounded drug prescriptions are offset by the benefits
is also why public health authorities, testifying in Congress, insisted
that the doctor’s prescription represent an individualized determination
of need. See, e.g., FDA Reform Legislation: Hearings before the Subcommittee
on Health and the Environment of the House Committee on Commerce, 104th
Cong., 2d Sess., p. 120 (1996) (Statement of Mary K. Pendergast, Deputy
Commissioner of the FDA and Senior Advisor to the Commissioner) (Allowing
traditional compounding is “good medicine” because “an
individual physician” was making “an individualized determination
for a patient”) (hereinafter FDA Reform Legislation). See also National
Association of Boards of Pharmacy, Model State Pharmacy Act and Rules,
Art I, § 1.05(e) (1996) (NABP Model Act) (defining “compounding”
as involving a prescription “based on the Practitioner/patient/Pharmacist
relationship in the course of professional practice”).
And that, in part, is why
federal and state authorities have long permitted pharmacists to advertise
the fact that they compound drugs, while forbidding the advertisement
of individual compounds. See Compliance Policy Guide 76a; Good Compounding
Practices Applicable to State Licensed Pharmacies, NABP Model Act App.
C.2, subpart A, (forbidding pharmacists to “solicit business (e.g.,
promote, advertise, or use salespersons) to compound specific drug products”).
The definitions of drug manufacturing and compounding used by the NABP
and at least 13 States reflect similar distinctions. NABP Model Act, Art.
I, § § 105(e), (t), and (u) (defining drug manufacturing to “include
the promotion and marketing of such drugs or devices” but excluding
any reference to promotion or marketing from the definition of drug compounding);
Alaska Stat. § 08.80.480(3) and (15) (2000) (same); La. Rev. Stat. Ann.
§ 37:1164(5) and (25) (West 2000) (same); Miss. Code Ann. § § 73-21-73(c)
and (s) (Lexis 1973-2000) (same); Mont. Code Ann. § § 37-7-101(7) (1997)
(same); N. H. Rev. Stat. Ann. § § 318-1(III) and (VIII) (Supp. 2001)
(same); N. M. Stat. Ann. § 61-11-2(C) and (Q) (2001) (same); Ohio Rev.
Code Ann. § 3715.01 (14) (West Supp. 2002) (same); Okla.
Stat., Tit 59, § 353.1(20) and (26) (Supp. 2002) (same); S. C. Code Ann.
§ § 40-43-30(7) and (29) (2001); Tenn. Code Ann. § § 63-10-404(4) and
(18) (1997)(same); Tex. Occ. Code Ann. § § 551.003(9) and (23) (2002
Pamphlet) (same); W. Va. Code Ann. § § 30-5-1b(c) and (o) (1966-1998)
(same).
These policies and statutory
provisions reflect the view that individualized consideration is more
likely present, and convenience alone is more likely absent, when demand
for a compounding prescription originates with a doctor, not an advertisement.
The restrictions try to assure that demand is generated doctor-to-patient-to-pharmacist,
not pharmacist-to-advertisement-to-patient-to-doctor. And they do so in
order to diminish the likelihood that those who do not genuinely need
untested compounded drugs will not receive them.
There is considerable evidence
that the relevant means — the advertising restrictions — directly advance
this statutory objective. No one denies that the FDA’s complex testing
system for new drugs — a system that typically relies upon double-blind,
or other scientific studies — is more «1512» likely to find, and to assess, small safety
risks than are physicians or pharmacists relying upon impressions and
anecdotes. See supra, at 1.
Nor can anyone deny that
compounded drugs carry with them special risks. After all, compounding
is not necessarily a matter of changing a drug’s flavor, cf. ante, at
17, but rather it is a matter of combining different ingredients in new,
untested ways, say, adding a pain medication to an antihistamine to counteract
allergies or increasing the ratio of approved ingredients in a salve to
help the body absorb it at a faster rate. And the risks associated with
the untested combination of ingredients or the quicker absorption rate
or the working conditions necessary to change an old drug into its new
form can, for some patients, mean infection, serious side effects, or
even death. See, e.g., J. Thompson, Practical Guide to Contemporary Pharmacy
Practice 11.5 (1998) (hereinafter Contemporary Pharmacy Practice). Cf.
21 CFR § 310.3(h)(1) (2002) (considering a drug to be “new”
and subject to the approval process if the “substance which composes
such drug” is new); § 310.3(h)(3) (considering a drug to be “new”
and subject to the approval process if approved ingredients are combined
in new proportions).
There is considerable evidence
that consumer oriented advertising will create strong consumer-driven
demand for a particular drug. See, e.g., National Institute for Health
Care Management, Factors Affecting the Growth of Prescription Drug Expenditures
iii (July 9, 2021) (three antihistamine manufacturers spent $ 313 million
on advertising in 1998 and accounted for 90% of prescription drug antihistamine
market); Kritz, Ask Your Doctor About . . . Which of the Many Advertised
Allergy Drugs Are Right for You? Washington Post, June 6, 2000, Health,
p. 9 (The manufacturer of the world’s top selling allergy drug, the eighth
best-selling drug in the United States, spent almost $ 140 million in
1999 on advertising); 1999 Prevention Magazine 10 (spending on direct-to-consumer
advertising of prescription medicine increased from $ 965.2 million in
1997 to $ 1.33 billion in 1998).
And there is strong evidence
that doctors will often respond affirmatively to a patient’s request for
a specific drug that the patient has seen advertised. See id., at 32 (84%
of consumers polled report that doctors accommodate their request for
a specific drug); Henry J. Kaiser Family Foundation, Understanding the
Effects of Direct-to-Consumer Prescription Drug Advertising 3 (Nov. 2001)
(A Foundation survey found that more than one in eight Americans had asked
for –and received — a specific prescription from their doctor in response
to an advertisement).
In these circumstances, Congress
could reasonably conclude that doctors will respond affirmatively to a
patient’s request for a compounded drug even if the doctor would not normally
prescribe it. When a parent learns that a child’s pill can be administered
in liquid form, when a patient learns that a compounded skin cream has
an enhanced penetration rate, or when an allergy sufferer learns that
a compounded antiinflammatory/allergy medication can alleviate a sinus
headache without the sedative effects of antihistamines, that parent or
patient may well ask for the desired prescription. And the doctor may
well write the prescription even in the absence of special need — at
least if any risk likely to arise from lack of testing is so small that
only scientific testing, not anecdote or experience, would reveal it.
It is consequently not surprising that 71% of the active members of the
American Academy
of Family Physicians “believe that direct-to-consumer advertising
pressures physicians into prescribing drugs that they would not ordinarily
prescribe.” Rosenthal, Berndt, Donohue, Frank, & Epstein, Promotion
of Prescription Drugs to Consumers, 346 New Eng. J. Med. 498-505 (2002)
(citing Lipsky, The Opinions and Experiences of Family Physicians Regarding
«1513» Direct-To-Consumer Advertising,
45 J. Fam. Pract. 495-499 (1997)).
Of course, the added risks
in any such individual case may be small. But those individual risks added
together can significantly affect the public health. At least, the FDA
and Congress could reasonably reach that conclusion. And that fact, along
with the absence of any significant evidence that the advertising restrictions
have prevented doctors from learning about, or obtaining, compounded drugs,
means that the FDA and Congress could also conclude that the advertising
restrictions “directly advance” the statute’s safety goal. They
help to assure that demand for an untested compounded drug originates
with the doctor, responding to an individual’s special medical needs;
they thereby help to restrict the untested drug’s distribution to those
most likely to need it; and they thereby advance the statute’s safety
goals. There is no reason for this Court, as a matter of constitutional
law, to reach a different conclusion.
II
I do not believe that Congress
could have achieved its safety objectives insignificantly less restrictive
ways. Consider the several alternatives the Court suggests. First, it
says that “the Government could ban the use of ‘commercial scale
manufacturing or testing equipment in compounding drug products.’”
Ante, at 14. This alternative simply restricts compounding to drugs produced
in small batches. It would neither limit the total quantity of compounded
drugs produced, nor help in any way to assure the kind of individualized
doctor-patient need determination that the statute’s advertising restriction
are designed to help achieve.
Second, the Court says that
the Government “could prohibit pharmacists from compounding more
drugs in anticipation of receiving prescriptions than in response to prescriptions
already received.” Ibid. This alternative, while addressing the
issue of quantity, does virtually nothing to promote the second, need-related
statutory objective.
Third, the Court says the
Government “could prohibit pharmacists from ‘offering compounded
drugs at wholesale to other state licensed persons or commercial entities
for resale.” Ibid. This alternative is open to the same objection.
Fourth, the Court says the
Government “could limit the amount of compounded drugs, either by
volume or by numbers of prescriptions, that a given pharmacist or pharmacy
sells out of State.” Ibid. This alternative, applying only to out-of-state
sales, would not significantly restrict sales, either in respect to amounts
or in respect to patient need. In fact, it could prevent compounded drugs
from reaching out-of-state patients who genuinely need them.
Fifth, the Court says that
the Government could “cap the amount of any particular compounded
drug, either by drug volume, number of prescriptions, gross revenue, or
profit.” Ibid. This alternative, like the others, ignores the patient-need
problem, while simultaneously threatening to prevent compounded drugs
from reaching those who genuinely need them, say, a patient whose prescription
represents one beyond the arbitrarily imposed quantitative limit.
Sixth, the Court says that
the Government could rely upon “non-speech-related provisions of
the FDAMA, such as the requirement that compounding only be conducted
in response to a prescription.” Ibid. This alternative also ignores
the patient-need problem and was specifically rejected by the Government
in the Court of Appeals for the Ninth Circuit. See supra, at 4.
The Court adds that “the
Government has not offered any reason why these possibilities, alone or
in combination, would be insufficient.” Ante, at 14. The Government’s
failure to do so may reflect the fact that only the Court, not any of
the respondents, has here suggested that these “alternatives,”
«1514» alone or in combination, would prove sufficient.
In fact, the FDA’s Compliance Policy Guide, from which the Court draws
its first four alternatives, specifically warned that these alternatives
alone were insufficient to successfully distinguish traditional compounding
from unacceptable manufacturing. See Compliance Policy Guide 77a.
III
The Court responds to the
claim that advertising compounded drugs causes people to obtain drugs
that do not promote their health, by finding it implausible given the
need for a prescription and by suggesting that it is not relevant. The
First Amendment, it says, does not permit the Government to control the
content of advertising, where doing so flows from “fear” that
“people would make bad decisions if given truthful information about
compounded drugs.” Ante, at 15. This response, however, does not
fully explain the Government’s regulatory rationale; it fails to take
account of considerations that make the claim more than plausible (if
properly stated); and it is inconsistent with this Court’s interpretation
of the Constitution.
It is an oversimplification
to say that the Government “fears” that doctors or patients
“would make bad decisions if given truthful information.” Ante,
at 15. Rather, the Government fears the safety consequences of multiple
compound-drug prescription decisions initiated not by doctors but by pharmacist-to-patient
advertising. Those consequences flow from the adverse cumulative effects
of multiple individual decisions each of which may seem perfectly reasonable
considered on its own. The Government fears that, taken together, these
apparently rational individual decisions will undermine the safety testing
system, thereby producing overall a net balance of harm. See, e.g., FDA
Reform Legislation 121 (Statement of David A. Kessler, Commissioner of
the FDA) (voicing concerns about “quality controls” and the
integrity of the drug-testing system). Consequently, the Government leaves
pharmacists free to explain through advertisements what compounding is,
to advertise that they engage in compounding, and to advise patients to
discuss the matter with their physicians. And it forbids advertising the
specific drug in question, not because it fears the “information”
the advertisement provides, but because it fears the systematic effect,
insofar as advertisements solicit business, of advertisements that will
not fully explain the complicated risks at issue. And this latter fear
is more than plausible. See Part I, supra.
I do not deny that the statute
restricts the circulation of some truthful information. It prevents a
pharmacist from including in an advertisement the information that “this
pharmacy will compound Drug X.” Nonetheless, this Court has not previously
held that commercial advertising restrictions automatically violate the
First Amendment. Rather, the Court has applied a more flexible test. It
has examined the restriction’s proportionality, the relation between restriction
and objective, the fit between ends and means. In doing so, the Court
has asked whether the regulation of commercial speech “directly advances”
a “substantial” governmental objective and whether it is “more
extensive than is necessary” to achieve those ends. See Central
Hudson, 447 U.S.
at 566. It has done so because it has concluded that, from a constitutional
perspective, commercial speech does not warrant application of the Court’s
strictest speech-protective tests. And it has reached this conclusion
in part because restrictions on commercial speech do not often repress
individual self-expression; they rarely interfere with the functioning
of democratic political processes; and they often reflect a democratically
determined governmental decision to regulate a commercial venture in order
to protect, for example, the consumer, the public health, individual safety,
or the environment. See, e.g., 44 Liquormart, Inc. v. Rhode «1515»
Island, 517 U.S. 484, 499, 134 L. Ed. 2d 711, 116 S. Ct. 1495
(1996) (“The State’s power to regulate commercial transactions justifies
its concomitant power to regulate commercial speech that is ‘linked inextricably’
to those transactions”); L. Tribe, American Constitutional Law §
12-15, p. 903 (2d ed. 1988) (“commercial speech doctrine” seeks
to accommodate “the right to speak and hear expression about goods
and services” with “the right of government to regulate the
sales of such goods and services”) (emphasis in original).
I have explained why I believe
the statute satisfies this more flexible test. See Parts I and II, supra.
The Court, in my view, gives insufficient weight to the Government’s regulatory
rationale, and too readily assumes the existence of practical alternatives.
It thereby applies the commercial speech doctrine too strictly. Cf. Buckman
Co. v. Plaintiffs’ Legal Comm., 531 U.S.
341, 349, 148 L. Ed. 2d 854, 121 S. Ct. 1012 (2001)
(flexibility necessary if FDA is to “pursue difficult (and often
competing) objectives”). See also Illinois Bd. of Elections v. Socialist
Workers Party, 440 U.S. 173, 188-189, 59 L. Ed. 2d 230, 99 S. Ct. 983
(1979) (Blackmun, J., concurring) (warning against overly demanding search
for less restrictive alternatives).
In my view, the Constitution
demands a more lenient application, an application that reflects the need
for distinctions among contexts, forms of regulation, and forms of speech,
and which, in particular, clearly distinguishes between “commercial
speech” and other forms of speech demanding stricter constitutional
protection. Otherwise, an overly rigid “commercial speech” doctrine
will transform what ought to be a legislative or regulatory decision about
the best way to protect the health and safety of the American public into
a constitutional decision prohibiting the legislature from enacting necessary
protections. As history in respect to the Due Process Clause shows, any
such transformation would involve a tragic constitutional misunderstanding.
See id., at 189 (Blackmun, J., concurring).
IV
Finally, the majority would
hold the statute unconstitutional because it prohibits pharmacists from
advertising compounded drugs to doctors. Ante, at 17, 18. Doctors, however,
obtain information about individual drugs through many other channels.
And there is no indication that restrictions on commercial advertising
have had any negative effect on the flow of this information. See e.g.,
Contemporary Pharmacy Practice 11.4 (compounded drug information “available”
and “widely disseminated” through books, journals, monographs,
and vendors). Nor, with one exception, have doctors or groups of doctors
complained that the statute will interfere with that flow of information
in the future. But see Brief for Juilian M. Whitaker, M. D. et al. as
Amicus Curiae 1 (alleging, without evidentiary support, that the regulations
prevent doctors from knowing how to get “competitively priced compounded
drugs as efficiently as possible”).
Regardless, we here consider
a facial attack on the statute. The respondents here focus their attack
almost entirely upon consumer-directed advertising. They have not fully
addressed separate questions involving the effect of advertising restrictions
on information received by physicians. I would consequently leave these
questions in abeyance. Considering the statute only insofar as it applies
to advertising directed at consumers, I would hold it constitutional.
For these reasons, I dissent.
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