Off-Label Drug Promotion and the Use of DisclaimersfalseMcKenney,.docx

Off-Label Drug Promotion and the Use of Disclaimers*
falseMcKenney, Dina. Texas Law Review92.1 (2013): 231-252.
Abstract (summary)
In July 2012, the Department of Justice (DOJ) announced a
record health care fraud settlement: GlaxoSmithKline would pay
$3 billion, in part to resolve allegations that the company
engaged in off-label promotion of pharmaceutical drugs such as
Paxil and Wellbutrin. According to both the DOJ and the Food
and Drug Administration (FDA), promoting a drug for an off-
label use is a violation of the Federal Food, Drug, and Cosmetic
Act's misbranding provisions. In one of many allegations
against GlaxoSmithKline, the government contended that the
company unlawfully promoted Paxil for pediatric use, despite
the fact that it was only approved for treating depression in
individuals eighteen years of age and older. Part I examines the
current regulatory scheme in place for off-label promotion and
the possible benefits and consequences of allowing the
promotion of off-label uses. Part II discusses how current case
law regarding commercial speech threatens the government's
off-label promotion prosecution scheme.
Paxil and Wellbutrin. According to both the DOJ and the Food
Act's misbranding provisions. In one of many allegations
against GlaxoSmithKline, the government contended that the
company unlawfully promoted Paxil for pediatric use, despite
the fact that it was only approved for treating depression in
individuals eighteen years of age and older. Part I examines the
current regulatory scheme in place for off-label promotion and
the possible benefits and consequences of allowing the

promotion of off-label uses. Part II discusses how current case
law regarding commercial speech threatens the government's
off-label promotion prosecution scheme.
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Introduction
Paxil and Wellbutrin.1 According to both the DOJ and the Food

Act (FDCA)'s misbranding provisions.2 In one of many
allegations against GlaxoSmithKline, the government contended
that the company unlawfully promoted Paxil for pediatric use,
despite the fact that it was only approved for treating depression
in individuals eighteen years of age and older.3 Other recent
high-dollar settlements in off-label promotion cases include
pharmaceutical company Eli Lilly's settlement for an excess of
$1.4 billion4 and Pfizer's settlement for $2.3 billion.5
The FDA generally prohibits marketing drugs for unapproved
uses through criminal enforcement under the FDCA's
misbranding provisions.6 Although it is the government's
position that off-label promotion is illegal, the constitutionality
of such a regulatory system is contested and unsettled. The
Second Circuit recently held that to prevent a pharmaceutical
company from promoting a lawful, albeit off-label, use of a
drug violates that company's right to free speech.7 The DOJ has
resisted such an interpretation and continues to pursue claims
against companies for engaging in this conduct.8 Adding more
uncertainty, the Ninth Circuit recently upheld a wire fraud
conviction related to off-label promotion, despite the
defendant's argument that he had a First Amendment right to
circulate "a plausible scientific opinion" about an off-label
use.9 Inconsistencies surrounding the constitutionality of
enforcement of the FDCA's misbranding provisions present
uncertainty for the pharmaceutical industry that is untenable.
Constitutionality aside, it remains a topic of debate whether off-
label promotion should be prohibited from a policy standpoint.
There is a widely acknowledged public interest in disseminating
information about the medical efficacy of drugs,10 and should
companies have to wait for FDA approval before circulating this
information, the resulting delay might prevent individuals from
receiving possible treatments not otherwise available. But at the
same time, there is a potential for abuse of off-label promotion.
Critics argue that, left unregulated, pharmaceutical companies
might utilize loopholes in the system, and this behavior could
threaten the integrity of the current FDA-approval system and

have deleterious effects on consumers of drugs for off-label
uses. This Note sets forth the competing interests and proposes
that the FDA implement a two-tiered disclaimer system that
would allow the medical community to benefit from off-label
uses while simultaneously encouraging pharmaceutical
companies to secure FDA approval for these uses.
Part I examines the current regulatory scheme in place for off-
label promotion and the possible benefits and consequences of
allowing the promotion of off-label uses. Part II discusses how
current case law regarding commercial speech threatens the
government's off-label- promotion prosecution scheme. Part III
examines the current guidance- driven system and proposes a
possible solution to address both the possible
unconstitutionality and the policy implications of a blanket ban:
The FDA could implement a two-tiered disclaimer system for
off-label promotions.
I. An Overview of Misbranding and Off-Label Promotion
Despite all the agitation about off-label promotion and the
monetary settlements that pharmaceutical companies have paid,
nowhere in the Food, Drug, and Cosmetic Act is off-label
promotion expressly prohibited.11 Rather, the government has
read into the FDCA's misbranding provisions a prohibition of
off-label promotion.
A. The FDCA's Misbranding Provisions and the Government's
Theory of Prosecution
The FDA must approve a drug for a specific use before that
drug can be introduced into interstate commerce.12 The FDCA
sets out requirements for FDA approval, which include clinical
trials that demonstrate safety.13 FDA approval for a drug
typically costs between $100 million and $880 million, and the
process takes anywhere from six to fifteen years to complete.14
The FDCA also prohibits the introduction of a drug into
interstate commerce that is misbranded,15 and a drug is
misbranded if, among other criteria, its label does not include
"adequate directions for use."16 The label encompasses not only
the physical label on the bottle, but all the materials that

accompany a drug, such as packaging inserts and
advertisements.17
According to FDA regulations, the intended use of a drug
"refer[s] to the objective intent of the persons legally
responsible for the labeling of [the drug]."18 This intent can be
determined by "oral or written statements by such persons or
their representatives."19 It is therefore the government's
contention that off-label promotion evinces an intent that the
drug be used for a purpose that is not included on the label.20
Therefore, because the label does not contain adequate
directions for use, the drug is misbranded in violation of the
FDCA.21
Violation of the FDCA's misbranding provisions carries
criminal consequences and penalties.22 The most notable
consequence is that violators of the FDCA risk being barred
from participation in government health care programs.23 This
penalty alone might account for pharmaceutical companies'
willingness to settle off-label promotion claims: if found
criminally liable, the companies might lose lucrative business
from Medicare and state health care programs. As noted by one
set of commentators, "[t]he Government's business-crippling
exclusion power, which may be wielded even before conviction,
makes it virtually impossible to test the Government's theories
in court."24 Additionally, FDCA violations can also be brought
under the False Claims Act, which leads to monetary
penalties.25
Despite the significant penalties associated with off-label
promotion for pharmaceutical companies, physicians are granted
wide latitude in using their medical judgment, and are therefore
allowed to prescribe drugs for off- label uses.26 In fact,
depending on the field, off-label prescribing can be quite
prevalent.27
B. Off-Label Promotion
Commentators disagree about the extent to which off-label
promotion should be regulated from a policy standpoint. There
are numerous benefits of allowing information about alternative

uses of pharmaceuticals to circulate throughout the medical
community. And yet, some argue there is a potential for abuse.
This subpart presents commonly articulated arguments both in
favor and against permitting off-label promotion, not to assess
their validity, but because these policy arguments are implicated
in ensuring that a speech restriction comports with the
commercial speech doctrine.28
So why is the FDA even concerned with the off-label promotion
of FDA-approved drugs? One main reason that the FDA
prohibits off-label promotion is to protect the integrity of the
FDA approval process. The high costs associated with FDA
approval have led one set of commentators to suggest that
"pharma has limited incentive to submit market-approved
products for additional FDA testing. In fact, if an approved drug
has a large off-label market, there is a significant financial risk
for drug manufacturers in seeking FDA validation for these
uses."29 Another commentator notes, "[t]he FDA was concerned
that manufacturers would get approval for a 'cheap, narrow
indication and the next day begin selling the drug for multiple,
broad, and profitable other indications.'"30 Ultimately, a ban on
off-label promotion addresses concerns that a company might
"circumvent existing regulatory protections."31
Without FDA approval, the medical community might not be
sure of the safety and efficacy of an off-label use.
Pharmaceutical companies conduct their own research into off-
label uses, but there is debate as to the reliability of such
studies.32 In their article on off-label promotion, Dr. Fazal
Khan and Justin Holloway discuss the practice of
"ghostwriting," whereby a pharmaceutical company hires
organizations to distribute articles about off-label uses of drugs,
but the affiliation between the article and the company is not
made known to the public.33 "Because physicians rely on
medical literature," one commentator notes, "the concern about
ghostwriting is that doctors might change their prescribing
habits after reading certain articles, unaware they were
commissioned by a drug company."34

Khan and Holloway's article also discusses the use of gag
clauses to prevent unfavorable results from company-sponsored
studies from reaching the public.35 Clinical trial agreements
between pharmaceutical companies and private research
organizations might contain clauses that prevent third parties
from examining the data from trials.36 Khan and Holloway
argue that the ultimate effect of gag clauses is that "[n]egative
results are . . . routinely underreported or unreported
altogether."37
Practices such as ghostwriting and using gag clauses could
result in a lack of data transparency that leaves the medical
community in the dark as to the medical benefits and risks of
off-label uses. This lack of information could have detrimental
effects when a drug becomes widely prescribed for an off-label
use.38
Yet despite these apparent risks, there are noted benefits of off-
label promotion. The most obvious is that the public health is
improved where physicians are made aware of alternative
treatment programs and can knowledgably prescribe medicine
for these uses.39 During general clinical trials, a
pharmaceutical company might become aware of a new potential
use for a drug. Because of the time and cost associated with
approving drugs for new uses, if such approval were required
for marketing, the company might make a conscious decision to
forgo approval and not discuss this off-label use with the
medical community.40 In such a situation, the public would lose
access to a potential treatment for an ailment.41
The high cost of FDA approval underlies several other
justifications for allowing off-label promotion. It could be
argued that allowing marketing for off-label uses decreases the
costs of drugs to the consumers. Should pharmaceutical
companies be required to seek approval for all uses, any
increased cost associated with FDA approval might be passed
on to the public through price increases.42 Additionally,
requiring costly FDA approval might stifle innovation in
pharmaceutical companies, which is contrary to the public

health goal of wide access to treatment.
Considering all of these factors, it remains a topic of debate
whether off-label promotion is an area that warrants such a
strict regulatory scheme.
II. The Constitutionality of Off-Label Promotion Restrictions
Regardless of whether off-label promotion should be regulated
from a public policy perspective, the constitutionality of a
blanket ban on such promotion is a widely contested and
discussed issue, especially in the wake of recent litigation.
Opponents of the current ban on off-label promotion argue that
a ban on truthful, nonmisleading speech is a violation of the
First Amendment's free speech protection.43 Advocates of the
current system respond that the government has an interest in
regulating such speech.44
A. Commercial Speech Protection
In Central Hudson Gas & Electric Corp. v. Public Service
Commission of New York,45 the Supreme Court set forth the
commercial speech test.46 Under this four-part test, a
government restriction on speech is permissible where (1) it
concerns lawful, nonmisleading speech, (2) the government has
a substantial interest in regulating the speech, (3) the regulation
directly advances this substantial interest, and (4) the restriction
is not more extensive than necessary to achieve the substantial
interest.47
In 2002, the Court heard a challenge to restrictions on drug
advertisement in Thompson v. Western States Medical
Center.48 In determining that a ban on a physician's compound-
drug advertisement was unconstitutional, the Court found that
the restriction was not narrowly tailored so as to satisfy the
fourth prong of the test.49 Although acknowledging that the
government had a substantial interest in, inter alia,
"preserv[ing] the effectiveness and integrity of the FDCA's new
drug approval process and the protection of the public health
that it provides,"50 the Court noted alternatives available to
achieve this interest in a more tailored way.51
Given the similarities between drug advertisement in Western

States Medical and off-label drug promotion under the FDCA,
this decision sparked commentators to predict the impending
demise of the off-label promotion ban.52 Immediately following
Western States Medical, the FDA solicited comments from the
public in an effort to determine the constitutionality of a variety
of the FDCA's statutory provisions.53 The notice asked, among
other questions, "[w]ould permitting speech by manufacturer,
distributor, and marketer about off-label uses undermine the
[FDCA]'s requirement that new uses must be approved by the
FDA? If so, how? If not, why not? What is the extent of FDA's
ability to regulate speech concerning off-label uses?"54 Many
of the comments the FDA received in response to its request
maintained that the off-label promotion ban was
unconstitutional.55 Pfizer's response, for example, urged the
FDA to "refine its existing guidelines to broaden and clarify
permitted non- promotional dissemination of off-label
information."56
B. Recent Cases: Sorrell, Caronia, and Harkonen
Yet despite the flurry of concern, over a decade later, the
Supreme Court has yet to rule on the constitutionality of a
general ban on off-label promotion. Recent cases have signaled
not only some distaste for the somewhat permissive commercial
speech test, but also that a challenge to the constitutionality of
an off-label promotion ban in the Supreme Court might be
successful.
In 2011, the Court heard a First Amendment challenge to a
Vermont statute that restricted "data-mining," in Sorrell v. IMS
Health Inc.57 The law at issue generally prohibited the sale of
pharmacy records regarding physician-prescribing practices for
the purposes of marketing.58 Noting that the statute was content
based and speaker based, the Court determined the statute was
subject to heightened judicial scrutiny.59 The court also
commented that concluding that the restrictions were content
based was "all but dispositive."60 In striking down the
restriction as unconstitutional, the Court noted that the
restriction did not advance the government's interest in

preserving the privacy of physicians because the information
could be sold for any purpose besides marketing.61 Much like
the response to Western States Medical, because of the
similarities between the data-mining restriction in Sorrell and
off-label promotion restrictions, commentators noted that
Sorrell might signal the end of the off-label promotion ban.62
By far the most notable off-label promotion case to date is the
Second Circuit's recent decision in United States v. Caronia.63
"[The] decision in United States v. Caronia," according to one
source, "has the potential to turn the criminal enforcement
scheme of the Federal Food, Drug and Cosmetic Act, or FDCA,
on its head."64 At trial, Alfred Caronia, a pharmaceutical
representative for Orphan Medical, Incorporated, was found
guilty of conspiracy to introduce a misbranded drug into
interstate commerce in violation of 21 U.S.C. § 331(a).65 The
drug at issue, Xyrem, is a central-nervous-system depressant
that is approved by the FDA for narcoleptics with cataplexy or
excessive daytime sleepiness.66 Xyrem must be accompanied by
a "black box" warning notifying consumers "that the drug's
safety and efficacy were not established in patients under 16
years of age, and the drug had 'very limited' experience among
elderly patients."67
Despite these approved uses, Caronia was recorded suggesting
to a prospective customer that the drug could be used for
insomnia, fibromyalgia, periodic leg movement, Parkinson's,
other sleep disorders, muscle disorders, chronic pain, and
daytime fatigue.68 On other occasions, Caronia and Dr. Peter
Gleason, a doctor hired by Caronia to discuss Xyrem at "speaker
programs," were recorded suggesting the drug could be used in
children under the age of sixteen and in adults older than sixty-
five.69 Caronia moved to dismiss the charges on the basis that
an application of the FDCA's misbranding provisions to prohibit
his conduct was unconstitutional under the First Amendment.70
The trial court denied the motion, and Caronia was found guilty
of conspiracy to misbrand at trial in October 2008.71
On appeal, the Second Circuit relied heavily upon the Court's

decision in Sorrell.72 In fact, because Sorrell was decided while
this case was pending on appeal, the Second Circuit ordered
supplemental briefing regarding what impact, if any, the
Supreme Court's decision in Sorrell had upon Caronia.73 The
majority opinion used Sorrell to decide that the government's
construction of the FDCA's misbranding provisions constituted
content-based and speaker-based restrictions on speech.74 A
ban on off-label promotion, the court determined, is content
based because "it distinguishes between favored speech and
disfavored speech on the basis of the ideas or views
expressed."75 The off-label restrictions permit speech about
FDA-approved uses but prohibit speech about off-label use,
despite the off-label use itself being permissible.76 And the
restriction is speaker based because, while pharmaceutical
companies are prohibited from discussing off-label uses,
academics and individuals in the medical community are free to
discuss and prescribe for these uses.77
Having determined the restrictions qualified for heightened
judicial scrutiny, the court then determined the government's
application of the misbranding provisions could not withstand
even the less stringent standard under Central Hudson.78 The
speech was not false or misleading under prong one because it
concerned off-label use, which was lawful and because off-label
promotion "is not in and of itself false or misleading."79 In
examining the second prong, the court agreed with the
government that there existed a substantial governmental
interest in "preserving the effectiveness and integrity of the
FDCA's drug approval process, and . . . reducing patient
exposure to unsafe and ineffective drugs."80
The court determined that the restriction on off-label promotion
did not satisfy the third or fourth prongs of the test and, in
doing so, invoked many of the policy considerations discussed
previously in subpart I(B). When examining whether the
restriction advanced the government's interest, the court focused
on the legality of off-label use and noted that the restriction
"paternalistically interferes with the ability of physicians and

patients to receive potentially relevant treatment information;
such barriers to information about off-label use could inhibit, to
the public's detriment, informed and intelligent treatment
decisions."81 The restriction also failed the fourth prong of the
test, as the court determined it was more extensive than
necessary.82 The court noted many alternatives available to the
government that would achieve its interest in a more tailored
way.83 Because the off-label promotion restriction could not
pass the Central Hudson test, the court determined that "the
government cannot prosecute pharmaceutical manufacturers and
their representatives under the FDCA for speech promoting the
lawful, off-label use of an FDA-approved drug."84
Despite the semblance of clarity that the majority opinion in
Caronia offers, the ban on off-label promotion is not dead. The
FDA declined to file a writ of certiorari, stating that the agency
"does not believe that the [Caronia] decision will significantly
affect the agency's enforcement of the drug misbranding
provisions of the [FDCA]."85 One commentator notes that this
decision might be tactical: The FDA might be concerned that
Caronia would give the Court an opportunity to expand Sorrell
by striking down the FDA's current prosecution scheme, and it
would rather wait for a case involving particularly egregious
conduct on the part of the defendant to test its prosecution
theories.86 If the Supreme Court struck down a ban on off-label
promotion, it would surely be, as noted in the dissent in
Caronia, the end of "the very foundations of our century-old
system of drug regulation."87
Adding another level of complexity is the Ninth Circuit's recent
decision in United States v. Harkonen,88 in which the court
upheld the wire fraud conviction of the former Chief Executive
Officer of InterMune Incorporated.89 Although Harkonen was
initially indicted for both misbranding and wire fraud, a jury
found him guilty only of wire fraud.90 The wire fraud
conviction was based on a press release that circulated
information about an off-label use of the drug Actimmune.91
The drug was approved for the treatment of two rare pediatric

diseases, and InterMune conducted a clinical trial to determine
if the drug would be effective for another use: to treat
idiopathic pulmonary fibrosis.92 Harkonen issued a press
release discussing the success of this trial, yet the Ninth Circuit
maintained that "[a]t trial, nearly everybody actually involved
in [the clinical trial] testified that the Press Release
misrepresented [the] results."93 In a brief opinion, the Ninth
Circuit upheld the conviction and found unpersuasive the
defendant's argument that the conviction violated his First
Amendment rights, stating that "[t]he First Amendment does not
protect fraudulent speech."94
Because of the connection with off-label promotion, Harkonen
has been closely followed by the medical community,95 and
many might be confused about how the courts' decisions in
Harkonen and Caronia might be reconciled. The most obvious
difference between these cases is the perceived nature of the
speech at issue. Albeit brief, the Ninth Circuit's opinion spoke
quite unfavorably about what it saw as the fraudulent nature of
the press release's contents,96 whereas the Second Circuit noted
that Caronia's speech was truthful and nonmisleading.97
Additionally, in Harkonen, the court did not even apply the
commercial speech test.98
On March 29, 2013, Harkonen filed a petition for rehearing en
banc,99 which was denied on May 7, 2013.100 On August 5,
2013, Harkonen filed a petition for a writ of certiorari:101 any
subsequent decision might clarify any possible tension between
these two cases.
C. Practical Effects of Recent Case Law
After the Second and Ninth Circuits' respective opinions in
Caronia and Harkonen, there remains confusion over the
constitutionality of the current enforcement scheme of the
FDCA's misbranding provisions. One commentator has
predicted a shift in government rhetoric following Caronia:
whereas previous announcements of settlements contained
allegations of "off-label promotion," a recent DOJ press release
instead focused on the company's intent that a drug be used for

off-label purposes.102 A shift in the focus back onto the
misbranding provisions themselves perhaps evinces the FDA's
unwillingness to renounce its position on off-label promotion.
This is also supported by the FDA's statement that "it does not
believe that the [Caronia] decision will significantly affect the
agency's enforcement of the drug misbranding provisions of the
Food, Drug, and Cosmetic Act."103
Although some companies have filed for injunctive relief from
prosecution under the FDCA's misbranding provisions on First
Amendment grounds, those cases have settled before the First
Amendment issue was heard. For example, Allergan,
Incorporated, filed for a declaratory judgment in the United
States District Court for the District of Columbia.104 In its
memorandum in support, the company argued, inter alia, that
"Allergan's [off-label promotion speech] is protected as
'commercial speech' under the Supreme Court's recent decision
in Western States."105 The following year, Allergan reached a
settlement with the government wherein it agreed to plead
guilty to misbranding and to pay $600 million.106 As part of
the settlement, the company agreed to dismiss the First
Amendment action against the government.107 A similar
arrangement was recently made with Par Pharmaceutical,
wherein the company agreed to dismiss injunctive relief claims
as part of a larger agreement to resolve allegations that it
promoted the drug Megace ES for off-label uses.108 Therefore,
even though the constitutionality of a ban on off-label
promotion has been brought into question, courts have been
unable to reach the constitutional issue in these declaratory-
judgment actions.
III. A Two-Tiered Disclaimer System
To address the concerns expressed by both the Second Circuit in
Caronia and critics of the current regulatory scheme, the FDA
must address prong three and prong four of the Central Hudson
test.109
Faced with the possible unconstitutionality of the current
system, the FDA needs to balance the competing arguments in

favor and against allowing off-label promotion. It must create a
system that allows the benefits of off-label promotion,
specifically the dissemination of information regarding
alternative treatment options, while addressing any potential
negatives by encouraging companies to seek FDA approval for
new uses and to explain the science behind the claims of
efficacy. A two- tiered disclosure system could accomplish
these goals.
A. The Current System: A Ban on Off-Label Promotion with
Exceptions
The current off-label promotion ban does contain some
exceptions, which take the form of nonbinding
recommendations that are set forth in FDA guidance
publications.110 Most notably, the FDA permits pharmaceutical
companies to reprint medical journal articles that discuss
unapproved new uses, subject to certain requirements.111 Under
the guidance, if a pharmaceutical company complies with the
requirements, the "FDA does not intend to consider the
distribution of such medical and scientific information . . . as
establishing intent that the product be used for an unapproved
new use."112 Under a draft guidance released in December
2011, pharmaceutical companies would be able to respond to
unsolicited requests about off-label uses.113
But, for the most part, these guidances do not cover the type of
broad activity at issue in cases like Caronia. Where
pharmaceutical representatives discuss unapproved uses with
the medical community, these casual conversations are unlikely
to involve unsolicited requests for information or distribution of
reprinted journal articles. Therefore, the FDA could implement
guidance that covers this type of activity; this could be
accomplished with the creation of a disclaimer system that
requires pharmaceutical companies and their representatives to
disclose certain information when discussing off-label uses of a
drug.
B. The Practicability of a Disclaimer System
There are four main benefits to the use of a disclaimer system to

regulate off-label promotion.
First, creating a disclaimer system recognizes the general
constitutionality of the FDCA's misbranding provisions. Caronia
did not strike down these provisions, just the enforcement
system that criminalized truthful, nonmisleading speech.114
There is no need, therefore, to overhaul the entire system.
Rather, a disclaimer system can be created in the same way that
the FDA has created the exceptions for reprint circulations and
responses to unsolicited requests.115 The FDA can create a
"Guidance for Industry" that announces that the FDA has no
intention of bringing misbranding charges against individuals
and entities that discuss off-label uses in accordance with the
contents of the guidance.
Second, the FDA's requirement of disclaimers in other areas
makes the use of disclaimers for off-label promotion feasible
from an administrability standpoint. Disclaimers are familiar
to pharmaceutical companies. Anybody who watches television
has seen countless advertisements for drugs that contain a
lengthy recitation of potential side effects. This is because the
FDA requires that drug advertisements include a "[t]rue
statement of information in brief summary relating to side
effects, contraindications, and effectiveness."116 Such
mandated statements are commonplace in the industry, and this
familiarity makes it possible for the FDA to require disclosure
of certain information when promoting a drug for an off-label
use.
Third, a disclaimer system can be tailored in a way to address
the government's concerns with off-label promotion while
simultaneously encouraging the benefits of promotion and
would, therefore, satisfy the third prong of the Central Hudson
test. The government can materially advance its stated interest
in protecting the FDA-approval process and consumer safety by
creating a two-tiered disclaimer system. The government can
create one set of disclaimers for the discussion of off-label uses
of drugs for which the company is seeking FDA approval, and a
second, more rigorous set of disclaimers that would apply if the

company were not seeking FDA approval for the off-label use.
The system would therefore encourage companies to seek FDA
approval of new uses while increasing the public's access to
information on medical alternatives.
Finally, the use of disclaimers has been widely acknowledged
by courts as a constitutional alternative to an outright ban on
speech and thus would satisfy the fourth prong of the Central
Hudson test. In Caronia, in determining that a blanket ban on
off-label promotion failed to meet the fourth prong, the Second
Circuit noted several alternatives available to the government
that would advance its interests.117 Among the alternatives was
the use of disclaimers: "The government could develop its
warning or disclaimer systems . . . ."118 Disclaimers were
mentioned as a constitutional alternative to commercial speech
restrictions in Western States Medical,119 Citizens United v.
Federal Election Commission,120 Pearson v. Shalala,121 and
Washington Legal Foundation v. Friedman.122 As stated by the
district judge in Washington Legal Foundation, requiring
disclaimers "comports with the Supreme Court's preference for
combating potentially problematic speech with more
speech."123 Should the FDA implement such a system, it would
therefore likely placate critics of the current system by
addressing concerns that the restriction is too broad. The
following subpart provides an example of what a two-tiered
disclaimer system could look like in practice, although the
individual disclaimer requirements within each tier could be
altered as needed to increase the system's effectiveness.124
C. Tier One: Seeking FDA Approval
The first tier would apply to the promotion of a drug for an off-
label use for which the pharmaceutical company is currently
seeking FDA approval and would require disclaimers that
address the government's concern with the lack of data
transparency and the possible detrimental effects that off-label
uses could have on the public. In this tier, off-label promotion
of a drug should include disclosure of possible side effects
associated with consumption of the drug.125 The disclaimer

should include a statement that the off-label use is not approved
by the FDA126 and an acknowledgment that the purpose of the
FDA is to ensure that drugs introduced into the marketplace are
safe and effective. The FDA could require the pharmaceutical
company to disclose, where applicable, that studies have not yet
reached the level of statistical significance required for FDA
approval.127
All of these statements are truthful, nonmisleading statements
about the testing and FDA approval of the drug and serve the
purpose of informing the physicians and the medical community
that the efficacy of this substance has not yet been established
within FDA standards. Of course, once the FDA-approval
process is complete for the off-label use, this disclaimer would
no longer be necessary in promoting the drug for that approved
use.
D. Tier Two: Not Seeking FDA Approval
The second tier of the disclaimer system would apply to the
discussion of an off-label use for which the pharmaceutical
company is not seeking FDA approval. This tier should
therefore contain heightened requirements aimed at encouraging
the company to seek FDA approval so that less stringent
disclaimers apply to the promotion.
In addition to the statements required in the first tier, when
promoting a drug for an off-label use for which the company is
not seeking FDA approval the pharmaceutical company should
disclose the relationship between the organization that
conducted any studies and the manufacturer so as to decrease
any appearance of impartiality.128
The FDA could also require the pharmaceutical company to
state, where applicable, that depending on the method of
analysis, the underlying data might not support the stated
conclusions and that the scientific community might not agree
on the conclusiveness of the study.129 Tier-two disclaimers
should also include an acknowledgment that proving the
efficacy and safety of drugs for this use requires continuous and
ongoing testing.

Finally, the company might be required to disclose all testing
that reached conclusions that are inconsistent with the claims of
efficacy or safety contained in the off-label promotion.130 The
government could therefore ensure that the medical community
is making informed prescribing decisions based on the entirety
of the data available.
These additional requirements are not so onerous that the
company will forgo off-label promotion altogether, but are
enough of a burden that the company might seek FDA approval
to reach a lower standard of disclaimers. Under a two-tiered
system, pharmaceutical companies are encouraged to seek FDA
approval for off-label uses, and this achieves the government
interest in protecting the FDA-approval process. The disclaimer
system also requires the company to disclose information that
would increase data transparency.
Therefore, the system satisfies the third prong of the Central
Hudson test: a two-tiered disclaimer system materially advances
the government's interest in "preserving the effectiveness and
integrity of the FDA's drug approval process, and . . . reducing
patient exposure to unsafe and ineffective drugs."131
E. Remaining Issues
Despite the benefits of this system, the issue remains whether
the FDA would require agency approval of disclaimers prior to
off-label promotion.132 For comparison purposes, the FDA
does not require approval of most drug advertisements prior to
publication.133 From an administrability standpoint, the FDA
might not be able to review all off- label drug disclaimers
quickly, and any delay in securing required approval would
frustrate the main benefit of off-label promotion: having
scientific information available to the medical community.
Additionally, any disclaimer guidance issued would reflect an
enforcement scheme that the FDA will not prosecute those that
comply with the disclaimer requirements.134 There would be,
therefore, an initial agency determination of whether
disclaimers do comport with the recommendations prior to
prosecution for misbranding.

A second issue concerns whether the proposed system
sufficiently encourages companies to seek FDA approval for
new uses. Some commentators have expressed skepticism that
"simple" disclaimers might not achieve this government
interest.135 While a two-tiered system might address concerns
with a "simple" disclaimer system, the FDA could combine this
disclaimer system with additional programs targeted to
incentivize companies to seek FDA approval. For example, the
FDA might also require that companies seek FDA approval for
new uses once prescriptions for those uses reach a specified
threshold, or the FDA could "create new benefits that accrue
upon receipt of new drug approval."136 The FDA is not
required to implement a single policy to advance all of its
interests. As noted by the court in Caronia when discussing
possible alternative restrictions, "[t]he possibilities are
numerous indeed."137
A final issue is whether a two-tiered disclaimer system would
withstand "heightened judicial scrutiny," assuming such a
standard applies to off-label speech restrictions. In Caronia, the
Second Circuit determined that, under Sorrell, heightened
scrutiny does apply,138 yet the court examined the restriction
using the "intermediate" standard under Central Hudson.139
One set of commentators has suggested that "[t]his second
analysis is probably due to the fact that Sorrell failed to
articulate a specific standard of review."140 The precise manner
in which speech restrictions for off-label marketing would be
examined under heightened judicial scrutiny is therefore
uncertain. Future application of heightened judicial scrutiny to
would-be commercial speech restrictions by courts in other
contexts will help clarify this important issue.
Conclusion
Off-label promotion has its benefits: it allows scientific
information about potential treatments to be circulated in the
medical community and increases the public's access to these
treatments. Currently, the FDA sees the potential for abuse of
off-label promotion as too great and has created a restriction on

off-label promotion that recent case law indicates might be
struck down as unconstitutional at any moment.
A two-tiered disclaimer system is a potential solution to this
problem. By requiring all off-label promotions to be
accompanied by information about the science behind the
claims, the FDA increases data transparency. And by increasing
the disclaimer burden for promotion of drugs for which the
manufacturer is not seeking FDA approval, the FDA encourages
manufacturers to seek FDA approval. Not only does this system
advance the government's interest, it is so narrowly tailored as
to withstand constitutional analysis under the Central Hudson
test.
-Dina McKenney
Footnote
* I would like to thank Stacy Brainin and Barry McNeil for
their thoughtful guidance and suggestions throughout the
writing process. I am also grateful to the staff and editors of the
Texas Law Review for their hard work in editing this Note.
1. Press Release, U.S. Dep't of Justice, GlaxoSmithKline to
Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations
and Failure to Report Safety Data (July 2, 2012),
http://www.justice.gov/opa/pr/2012/July/12-civ-842.html. The
high monetary amount was due, in part, to settlement of civil
claims under the False Claims Act. Id.; see also infra note 25
and accompanying text.
2. See, e.g., Press Release, U.S. Dep't of Justice, supra note 1
("After the FDA approves the product as safe and effective for a
specified use, a company's promotional activities must be
limited to the intended uses that FDA approved. In fact,
promotion by the manufacturer for . . . 'off-label uses' . . .
renders the product 'misbranded.'").
3. Id.
4. Press Release, U.S. Dep't of Justice, Pharmaceutical
Company Eli Lilly to Pay Record $1.415 Billion for Off-Label
Drug Marketing (Jan. 15, 2009) [hereinafter Eli Lilly to Pay],
http://www.justice.gov/usao/pae/News/2009/jan/lillyrelease.pdf.

5. Press Release, U.S. Dep't of Justice, Justice Department
Announces Largest Health Care Fraud Settlement in Its History
(Sept. 2, 2009), http://www.justice.gov/opa/pr/2009/September/
09-civ-900.html.
6. See, e.g., Eli Lilly to Pay, supra note 4 (describing the
criminal charge brought against Eli Lilly for introducing
misbranded drugs into interstate commerce and stressing the
FDA's commitment to prosecuting off-label-marketing
violations of the FDCA).
7. United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012).
8. See infra notes 102--03 and accompanying text.
9. United States v. Harkonen, 510 F. App'x 633, 635 (9th Cir.
2013); Reply Brief of Dr. W. Scott Harkonen on Principal
Appeal and Response of Dr. W. Scott Harkonen to the
Government's Cross-Appeal on Sentencing at 13, Harkonen, 510
F. App'x 633 (Nos. 11-10209 & 11-10242).
10. The FDA itself has recognized the value of this information.
E.g., FOOD AND DRUG ADMINISTRATION, GUIDANCE
FOR INDUSTRY: GOOD REPRINT PRACTICES FOR THE
DISTRIBUTION OF MEDICAL JOURNAL ARTICLES AND
MEDICAL OR SCIENTIFIC REFERENCE PUBLICATIONS
ON UNAPPROVED NEW USES OF APPROVED DRUGS AND
APPROVED OR CLEARED MEDICAL DEVICES 3 (2009)
[hereinafter GOOD REPRINT PRACTICES], available at
http://www.fda.gov/ohrms/dockets/98fr/fda-2008-d-0053-
gdl.pdf ("FDA does recognize, however, the important public
health and policy justification supporting dissemination of
truthful and non-misleading medical journal articles and
medical or scientific reference publications on unapproved uses
of approved drugs . . . .").
11. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301--
399 (2006); see also Caronia, 703 F.3d at 154 (observing that
the FDCA and its implementing regulations do not expressly
prohibit marketing or promoting drugs for off-label uses).
12. 21 U.S.C. § 355(a).
13. Id. § 355(d).

14. Margaret Z. Johns, Informed Consent: Requiring Doctors to
Disclose Off-Label Prescriptions and Conflicts of Interest, 58
HASTINGS L.J. 967, 973 (2007). For a brief description of the
process of FDA approval, see generally id. at 973--75.
15. 21 U.S.C. § 331(a).
16. Id. § 352(f).
17. Id. § 321(m).
18. 21 C.F.R. § 201.128 (2013).
19. Id.
20. See, e.g., FOOD AND DRUG ADMINISTRATION, DRAFT
GUIDANCE FOR INDUSTRY: RESPONDING TO
UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION
ABOUT PRESCRIPTION DRUGS AND MEDICAL DEVICES 2
(2011), available at http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM28
5145.pdf ("Statements that promote a drug or medical device for
uses other than those approved or cleared by FDA may be used
as evidence of a new intended use.").
21. See GOOD REPRINT PRACTICES, supra note 10, at 2--3
("An approved drug that is marketed for an unapproved use
(whether in labeling or not) is misbranded because the labeling
of such drug does not include 'adequate directions for use' . . .
." (quoting 21 U.S.C. § 352(f))).
22. See 21 U.S.C. § 333(a) (prescribing imprisonment and fines
for violations of 21 U.S.C. § 331).
23. See 42 U.S.C. § 1320a-7(b)(7) (2006) (establishing the
permissive exclusion from Medicare and state health care
programs of entities that participate in fraud); 42 C.F.R. §
1001.901(a) (2012) (permitting the OIG to exclude entities that
violate the Medicare false claims statute); id. § 1001.951(a)
(permitting the OIG to exclude entities that violate the Anti-
Kickback Statute).
24. John Nassikas et al., Arnold & Porter, LLP, Requiem for the
Off-Label Regime? The Rise and Coming Fall of the
Government's "Off-Label Promotion" Prosecution Theories, at
G-2 (2012),

http://www.arnoldporter.com/resources/documents/Requiem%20
for%20the%20Off-Label %20Regime.pdf (internal citation
omitted).
25. Although the penalties associated with False Claims Act
violations are not the subject of this Note, it is worth
mentioning that these violations result in monetary fines. For
example, the settlements of GlaxoSmithKline, Eli Lilly, and
Pfizer were of FCA claims brought for violations of the FDCA.
See supra notes 1, 4--5 and accompanying text. For a discussion
of liability for off- label promotion under the False Claims Act,
see generally Stephanie Greene, False Claims Act Liability for
Off-Label Promotion of Pharmaceutical Products, 110 PENN
ST. L. REV. 41 (2005).
26. See John E. Osborn, Can I Tell You the Truth? A
Comparative Perspective on Regulating Off-Label Scientific and
Medical Information, 10 YALE J. HEALTH POL'Y L. &
ETHICS 299, 303-- 05 (2010) (describing physicians' ability to
prescribe off-label).
27. See Randall S. Stafford, Regulating Off-Label Drug Use-
Rethinking the Role of the FDA, 358 NEW ENG. J. MED. 1427,
1427 (2008) (noting that a 2006 study of 160 common drugs
indicated that off-label uses accounted for 21% of
prescriptions).
28. See infra notes 45--51, 81--84, and accompanying text.
29. Fazal Khan & Justin Holloway, Verify, Then Trust: How to
Legalize Off-Label Drug Marketing, 117 PENN ST. L. REV.
407, 410 (2012).
30. Steven R. Salbu, Off-Label Use, Prescription, and
Marketing of FDA-Approved Drugs: An Assessment of
Legislative and Regulatory Policy, 51 FLA. L. REV. 181, 205--
06 (1999) (quoting James G. Dickinson, FDA Letter, Deputy's
Speech, Define a Dilemma, MED. MARKETING & MEDIA,
Oct. 1996, at 12, 14).
31. Id. at 206.
32. See generally Christopher T. Robertson, The Money Blind:
How to Stop Industry Bias in Biomedical Science, Without

Violating the First Amendment, 37 AM. J.L. & MED. 358
(2011) (arguing that there is inherent bias in scientific research
that is paid for by pharmaceutical companies).
33. See Khan & Holloway, supra note 29, at 418--20 (describing
the logistics of ghostwriting).
34. Natasha Singer, Medical Papers by Ghostwriters Pushed
Therapy, N.Y. TIMES, Aug. 4, 2009,
http://www.nytimes.com/2009/08/05/health/research/05ghost.ht
ml?pagewanted=all&_ r=0.
35. Khan & Holloway, supra note 29, at 421--25 (describing the
logistics of gag clauses in sponsored studies).
36. Id. at 421.
37. Id.
38. A commonly cited example is "fen-phen," which was
prescribed to approximately six million people before a study
revealed the drugs might cause heart valve defects in up to one-
third of patients. Gina Kolata, How Fen-Phen, A Diet "Miracle,"
Rose and Fell, N.Y. TIMES, Sept. 23, 1997,
http://www.nytimes.com/1997/09/23/science/how-fen-phen-a-
diet-miracle-rose-and-fell. html?pagewanted=all&src=pm.
39. See Coleen Klasmeier & Martin H. Redish, Off-Label
Prescription Advertising, the FDA and the First Amendment: A
Study in the Values of Commercial Speech Protection, 37 AM.
J.L. & MED. 315, 318 (2011) ("[B]oth patients and prescribers
would often be aided by the dissemination of information to the
medical profession about these valuable off-label uses-uses that
health care practitioners may well be unfamiliar with absent
such communications."); see also Wash. Legal Found. v.
Friedman, 13 F. Supp. 2d 51, 56 (1998) ("As off-label uses are
presently an accepted aspect of a physician's prescribing
regimen, the open dissemination of scientific and medical
information regarding these treatments is of great import."). The
FDA has there is an "important public health and policy
justification supporting dissemination of truthful and non-
misleading medical journal articles and medical or scientific
reference publications" about off-label uses. GOOD REPRINT

PRACTICES, supra note 10.
40. See Salbu, supra note 30, at 193--94 ("Proponents of off-
label processes focus predominantly on their potential to
expedite the development and availability of effective new
treatments. . . . If off-label use of drugs can help patients, then
off-label marketing may enable the greatest number of potential
beneficiaries to receive the treatments best suited to their
needs.").
41. This is frequently the case with "orphan" diseases-diseases
so rare that seeking FDA approval for a drug use is not
justifiable for the pharmaceutical company from a cost
standpoint. Gregory Conko, Hidden Truth: The Perils and
Protection of Off-Label Drug and Medical Device Promotion,
21 HEALTH MATRIX 149, 155--56 (2011).
42. Salbu, supra note 30, at 195.
43. E.g., Klasmeier & Redish, supra note 39, at 349 ("[T]he
FDA's prohibition of manufacturer's off-label promotion of
prescription drugs unambiguously violates the controlling
doctrinal framework for the constitutional protection of
commercial speech.").
44. E.g., Margaret Gilhooley, Commercial Speech, Drugs,
Promotion and a Tailored Advertisement Moratorium, 21
HEALTH MATRIX 97, 97 (2011) (noting that "the safety risks
to the public rightly deserve great weight under the commercial
speech doctrine"). See generally, e.g., David Orentlicher, The
Commercial Speech Doctrine in Health Regulation: The Clash
Between the Public Interest in a Robust First Amendment and
the Public Interest in Effective Protection from Harm, 37 AM.
J.L. & MED. 299 (2011) (weighing the First Amendment and
public health interests in discussing off-label promotion).
45. 447 U.S. 557 (1980).
46. Id. at 566.
47. Id.
48. 535 U.S. 357 (2002).
49. Id. at 371--72.
50. Id. at 368 (alteration in original) (internal quotation marks

omitted).
51. Id. at 372.
52. See, e.g., A. Elizabeth Blackwell & James M. Beck, Drug
Manufacturers' First Amendment Right to Advertise and
Promote Their Products for Off-Label Use: Avoiding a Pyrrhic
Victory, 58 FOOD & DRUG L.J. 439, 439 (2003) ("The
constitutionality of [off-label promotion] policies has long been
questioned, and the Supreme Court's recent decision in
Thompson v. Western States Medical Center raises to new
heights doubts regarding FDA's ability to withstand First
Amendment challenge in this area." (footnote omitted)); Jeffrey
N. Gibbs et al., Ripe for Revision: Reassessing the
Constitutionality of Food and Drug Administration Restrictions
on Protected Speech, 58 FOOD & DRUG L.J. 331, 332 (2003)
("FDA's policies that restrict the dissemination of truthful
scientific information that may discuss off-label uses of
approved products are vulnerable to attack on constitutional
grounds.").
53. Request for Comment on First Amendment Issues, 67 Fed.
Reg. 34,942 (May 16, 2002).
54. Id. at 34,944.
55. Krista Hessler Carver, A Global View of the First
Amendment Constraints on FDA, 63 FOOD & DRUG L.J. 151,
209 & n.521 (2008).
56. Comments of Pfizer Inc., Docket No. 02N-0209, at 156
(Sept. 13, 2002), available at
http://www.fda.gov/ohrms/dockets/dailys/02/Sep02/091602/800
27f2d.pdf (responding to Request for Comment on First
Amendment Issues, 67 Fed. Reg. 34,942).
57. 131 S. Ct. 2653 (2011).
58. Id. at 2659.
59. Id. at 2663--64.
60. Id. at 2667.
61. Id. at 2668.
62. See, e.g., Lynn C. Tyler, The FDA's Regulation of Off-
Label Promotion: Has the Supreme Court's Opinion in Sorrell v.

IMS Health Cracked the Foundation?, in RECENT
DEVELOPMENTS IN FOOD AND DRUG LAW 41, 42 (2013
ed.) ("[A]t a minimum, [Sorrell] casts some doubt on the
constitutionality of the FDA's regulation of off-label
promotion.").
63. 703 F.3d 149 (2d Cir. 2012).
64. Winston Y. Chan & Deena B. Klaber, Off-Label Promotion:
Still a Crime?, RECORDER (S.F.), Jan. 14, 2013, at 1.
65. Caronia, 703 F.3d at 152, 155--56.
66. Id. at 155.
67. Id.
68. Id. at 156.
69. Id. at 156--57.
70. Id. at 158.
71. Id. at 158--59.
72. Id. at 163.
73. John R. Fleder, New Twists and Turns in Off-Label
Marketing, FDA LAW BLOG (Sept. 21, 2011, 1:43 PM),
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/0
9/new-twists- and-turns-in-off-label-marketing.html.
74. Caronia, 703 F.3d at 164.
75. Id. at 165 (internal quotation marks omitted).
76. Id.
77. Id.
78. Id. at 164--68.
79. Id. at 165.
80. Id. at 166. See supra subpart I(B) for a discussion of these
policy arguments.
81. Caronia, 703 F.3d at 166 (emphasis added) (internal
quotation marks omitted).
82. Id. at 167.
83. Id. at 167--68.
84. Id. at 169.
85. Thomas M. Burton, FDA Won't Appeal Free-Speech
Marketing Decision, WALL ST. J., Jan. 23, 2013,
http://online.wsj.com/article/SB10001424127887324539304578

260323575925896 .html (internal quotation marks omitted).
86. See Ellyn L. Sternfield, FDA Will Not Appeal Second
Circuit Decision in U.S. v. Caronia, JD SUPRA L. NEWS, Jan.
30, 2013, http://www.jdsupra.com/legalnews/fda-will-not-
appeal-second- circuit-decis-61328/ ("By not appealing Caronia,
the FDA preserves the enforcement authority left intact by
Caronia and its First Amendment arguments for a FDCA case in
which it has a stronger position, such as when the marketing at
issue is alleged to be false or misleading.").
87. Caronia, 703 F.3d at 169 (Livingston, J., dissenting).
88. 510 F. App'x 633 (9th Cir. 2013).
89. Id. at 635; see also Karen Gullo, Ex-InterMune CEO
Harkonen's Wire-Fraud Conviction Upheld, BLOOMBERG,
Mar. 5, 2013, http://www.bloomberg.com/news/2013-03-05/ex-
intermune- ceo-harkonen-s-wire-fraud-conviction-upheld.html
(identifying Harkonen as "Ex-Intermune Inc. (ITMN) Chief
Executive Officer").
90. Verdict Form, United States v. Harkonen, No. 3:08-cr-
00164-MHP (N.D. Cal. 2009).
91. See Brief for the United States as Appellee/Cross-Appellant
at 23--27, Harkonen, 510 F. App'x 633 (Nos. 11-10209 & 11-
10242) (discussing the contents of the press release at issue and
framing the press release as the basis of Harkonen's wire fraud
conviction).
92. Id. at 5--7.
93. Harkonen, 510 F. App'x at 636. The court noted that, in
analyzing the data, Harkonen stated that he would "cut that data
and slice it until [he] got the kind of results [he was] looking
for." Id. (alterations in original) (internal quotation marks
omitted).
94. Id.
95. See, e.g., Chan & Klaber, supra note 64, at 1 ("Though
Harkonen was not convicted under the FDCA . . . his appeal
still stands to have a significant effect on determining what
pharmaceutical companies and their sales representatives can
and cannot say in promoting drugs.").

96. Harkonen, 510 F. App'x at 636--37.
The majority in Caronia even clarified that "a defendant may be
prosecuted for untruthfully promoting the off-label use of an
FDA-approved drug, e.g., making false or misleading statements
about a drug." Id. at 165 n.10.
98. For a side-by-side comparison of the material facts of the
two cases, see Michael Loucks, Caronia and Harkonen-Lessons
for the Gov't, LAW360 (Apr. 23, 2013, 1:15 PM),
http://www.law360.com/articles/434448/caronia-and-harkonen-
lessons-for-the-gov-t.
99. Petition for Rehearing En Banc, Harkonen, 510 F. App'x
633 (Nos. 11-10209 & 11- 10242).
100. Order Denying Petition for Rehearing En Banc, Harkonen,
510 F. App'x 633 (Nos. 11- 10209 & 11-10242).
101. Harkonen, 510 F. App'x 633, petition for cert. filed, 82
U.S.L.W. 3090 (U.S. Aug. 5, 2013) (No. 13-180).
102. Erika Kelton, Off-Label Pharma Prosecutions Won't Be
Silenced By First Amendment Decision, FORBES (Jan. 4, 2013,
1:10 PM), http://www.forbes.com/sites/erikakelton/2013/01/04/
off-label-pharma-prosecutions-wont-be-silenced-by-first-
amendment-decision/ ("Expect to hear the term 'misbranding'
being emphasized more than 'off-label,' and 'intended use'
replacing 'promotion' in supporting the misbranding charges
brought by the government.").
103. Burton, supra note 85 (internal quotation marks omitted).
104. Memorandum of Law in Support of Motion for Preliminary
Injunction, Allergan, Inc. v. United States, No. 1:09-cv-01879-
JDB (D.D.C. 2009).
105. Id. at 21.
106. Allergan to Pay $600 Million to Resolve Off-Label
Marketing Allegations, Agrees to Drop First Amendment Suit,
THOMPSON INFO. SERVS., Sept. 1, 2010,
http://www.thompson
.com/public/newsbrief.jsp?cat=FOODDRUG&id=3069. The
misbranding plea related to the promotion of its drug Botox for

off-label uses. Id.
107. Id.
108. Thomas Sullivan, Par Pharmaceuticals Settles Off-Label
Case, Drops First Amendment Case, POL'Y & MED. (Mar. 25,
2013, 5:01 AM), http://www.policymed.com/2013/03/par-
pharmaceuticals-settles-off-label-case-drops-first-amendment-
case.html.
109. Commentators have offered several potential solutions to
align off-label promotion regulations with the First Amendment.
See, e.g., Blackwell & Beck, supra note 52, at 459--61
(discussing various nonspeech-restrictive approaches the FDA
could take to regulate off-label promotion).
110. See 21 C.F.R. § 10.115(b)(1) (2012) ("Guidance documents
are documents prepared for FDA staff, applicants/sponsors, and
the public that describe the agency's interpretation of or policy
on a regulatory issue.").
111. See GOOD REPRINT PRACTICES, supra note 10, at 3
(acknowledging, implicitly, that distribution of truthful and
nonmisleading publications to health care professionals may
advance public health and setting forth criteria for both the
substance of medical journal articles and the means of
disseminating such articles).
112. Id. at 4.
113. See FOOD AND DRUG ADMINISTRATION, supra note
20, at 6 (recognizing that the FDA has "long taken the position"
that pharmaceutical companies can respond to such unsolicited
requests so long as they "provid[e] truthful, balanced, non-
misleading, and non-promotional scientific or medical
information that is responsive to a specific request" and that
this is so even if the response consists of "unapproved or
uncleared indications or conditions of use").
114. United States v. Caronia, 703 F.3d 149, 168--69 (2d Cir.
2012).
115. See supra notes 110--13 and accompanying text.
116. 21 C.F.R. § 202.1(e) (2012).
117. Caronia, 703 F.3d at 168.

118. Id.
119. 535 U.S. 357, 376 (2002).
120. 558 U.S. 310, 368 (2010).
121. 164 F.3d 650, 655--60 (D.C. Cir. 1999).
122. 13 F. Supp. 2d 51, 73 (D.D.C. 1998).
123. Id.; see also Whitney v. California, 274 U.S. 357, 377
(1927) (Brandeis, J., concurring) ("[T]he remedy to be applied
is more speech, not enforced silence.").
124. For a pre-Caronia discussion of the use of disclaimers for
circulating reprints, see Margaret Gilhooley, Drug Regulation
and the Constitution After Western States, 37 U. RICH. L. REV.
901, 921--30 (2003). See also Kristie LaSalle, A Prescription
for Change: Citizens United's Implications for Regulation of
Off-Label Promotion of Prescription Pharmaceuticals, 19 J.L. &
POL'Y 867, 907--10 (2011) (noting how the Court's discussion
of disclaimers in Citizens United signals the applicability of
disclaimers to off-label promotion regulation). The FDA's
guidance for reprint practices also contains requirements that
reprints "be accompanied by a prominently displayed and
permanently affixed statement disclosing" various information.
GOOD REPRINT PRACTICES, supra note 10, at 5--6.
125. A similar disclosure is required for circulating reprints.
GOOD REPRINT PRACTICES, supra note 10, at 5--6.
126. This statement is also required when circulating reprints.
Id.
127. Professor Gilhooley recommended such a disclaimer for
reprints, noting that "the physician needs the benefit of knowing
how the studies in the medical journal differ from the testing
the FDA requires." Gilhooley, supra note 124, at 927.
Therefore, she recommended that "[t]o adequately inform
physicians, there should be a disclosure reporting the extent to
which the medical journal article, relied on to support the off-
label use, fails to meet the usual FDA standards for drug
testing." Id.
128. When circulating reprints under the FDA's guidance, the
reprint must be accompanied by a statement disclosing the

manufacturer's interest in the drug, any author known to have a
financial interest in the drug, and any person known to provide
funding for the study. GOOD REPRINT PRACTICES, supra
note 10, at 4. The effect of such a disclosure is similar to the
proposed disclaimer in that it decreases the appearance of
neutrality that might be associated with a scholarly publication.
129. It is possible, however, that a court would determine that
promotion using such data in the absence of this disclaimer is
false and misleading and therefore undeserving of First
Amendment protection. See supra notes 96--97 and
accompanying text.
130. A similar, but less extensive, requirement exists when
circulating reprints. When a company distributes reprints it
must include "a representative publication, when such
information exists, that reaches contrary or different
conclusions regarding the unapproved use." GOOD REPRINT
PRACTICES, supra note 10, at 5.
132. When discussing the use of disclaimers for reprint
distribution, Professor Gilhooley advocated for a notification
requirement whereby the manufacturer submitted materials to
the FDA. Gilhooley, supra note 124, at 928--29. Professor
Gilhooley noted that in Pearson v. Shalala, the D.C. Circuit
recognized the need for FDA approval of disclaimers in the
context of unapproved claims on dietary supplements. Id. at 929
(citing Pearson v. Shalala, 164 F.3d 650, 657--58 (D.C. Cir.
1999)).
133. Carver, supra note 55, at 164.
134. See supra subpart III(A).
135. See Conko, supra note 41, at 180 ("[S]imple disclaimers
alone may not be sufficient to incentivize manufacturers to
navigate the supplemental approval process."); see also
Blackwell & Beck, supra note 52, at 457 ("[R]eplacing FDA's
existing speech-restrictive policies with narrower speech
restrictions, while it might advance FDA's interest in preventing
consumer deception, would leave FDA still in search of new

policies designed to advance its interest in maintaining control
over 'new' uses of regulated products.").
136. Blackwell & Beck, supra note 52, at 459--61 (describing
potential nonspeech-restrictive alternatives to regulating off-
label promotion that would encourage a company to seek FDA
approval for new uses).
138. See supra notes 72--77 and accompanying text.
139. See supra note 78 and accompanying text.
140. Marc J. Scheineson & Guillermo Cuevas, United States v.
Caronia: The Increasing Strength of Commercial Free Speech
and Potential New Emphasis on Classifying Off-Label
Promotion As "False and Misleading," 68 FOOD & DRUG L.J.
201, 210 (2013); see also Tamara R. Piety, "A Necessary Cost
of Freedom"? The Incoherence of Sorrell v. IMS, 64 ALA. L.
REV. 1, 53--54 (2012) (stating that the Court in Sorrell did not
"explicitly overrul[e] Central Hudson or acknowledg[e] that it
was announcing a new standard by which to evaluate
commercial speech" and that "the Court rendered the
commercial speech doctrine incoherent and sowed further
confusion about what the appropriate test is").
Word count: 9222
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Copyright University of Texas, Austin, School of Law
Publications, Inc. 2013
Indexing (details)
Cite
Subject
Settlements & damages;
FDA approval;
Fraud;
Pharmaceutical industry
Location
United States--US
Classification
4330: Litigation9190: United States8641: Pharmaceuticals
industry
Title
Off-Label Drug Promotion and the Use of Disclaimers*
Author
McKenney, Dina
Publication title
Texas Law Review
Volume
92
Issue
1
Pages
231-252
Number of pages

22
Publication year
2013
Publication date
2013
Year
2013
Publisher
University of Texas, Austin, School of Law Publications, Inc.
Place of publication
Austin
Country of publication
United States
Publication subject
Law
ISSN
00404411
CODEN
TXLRA2
Source type
Scholarly Journals
Language of publication
English
Document type
Feature
Document feature
References
The Ban on "Off-Label" Pharmaceutical Promotion:
Constitutionally Permissible Prophylaxis Against False or
Misleading Commercial Speech?
falseGreenwood, KateAmerican Journal of Law and
Medicine37.2/3 (2011): 278-98.
Abstract (summary)
Critics of the Food & Drug Administration's ban on off-label

promotion often claim that it violates the First Amendment
because it suppresses pharmaceutical manufacturers' truthful
speech about their legal-and beneficial-products. Characterizing
the ban on off-label promotion in this way has more than
rhetorical significance. Bans on truthful, non-misleading speech
elicit special skepticism because of the belief that they "usually
rest solely on the offensive assumption that the public will
respond 'irrationally' to the truth." The legislative history of the
provisions of the Food Drug and Cosmetic Act that underlie the
ban on off-label promotion, however, reveals that Congress was
concerned that physicians were responding rationally to false
and misleading promotional claims. In this Article, I explore the
doctrinal questions raised by conceiving of the ban on off-label
promotion not as a ban on "truthful speech to physicians" but
instead as a prophylaxis against false and misleading
pharmaceutical promotion. I review the evidence that false and
misleading claims were commonplace before the ban's adoption
and persist today, along with the enforcement challenges the
FDA confronted at that time and would confront were the ban
lifted, and conclude the government likely could develop the
factual record necessary to establish that Congress' rejection of
an after-the-fact case-by-case approach to combating false and
misleading prescription drug promotion is constitutional.
[PUBLICATION ABSTRACT]

[PUBLICATION ABSTRACT]
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Headnote
I. INTRODUCTION
In 1962, a physician named Miles Robinson testified before the
House Committee on Interstate and Foreign Commerce about
the advertising and promotion of prescription drugs, including
the tranquilizer Mellaril, the side effects of which include both
the serious movement disorder tardive dyskinesia and sudden
death. Mellaril's manufacturer was promoting the drug to
general practitioners to treat, in the manufacturer's words,
"tense, nervous patients seen in everyday practice ... for chronic

fatigue, insomnia, anxiety, and apprehension, vague digestive
disorders, etc."1 Dr. Robinson testified that he was "impressed
with that 'etc' It just tapers off into the wide, blue yonder where
tranquilizers are claimed to be good for everything."2
Promotional abuses like those Dr. Robinson described were part
of the impetus for Congress to amend the Food and Drug
Administration's (FDA) organic statute, the Federal Food, Drug,
and Cosmetic Act (FDCA), to require that a manufacturer
demonstrate to the FDA's satisfaction that, in addition to being
safe, a drug is effective for a given use before marketing it for
that use.3 The 1962 amendments to the FDCA (often termed the
Harris -Kefauver Amendments after their congressional
sponsors) require that manufacturers seeking agency approval of
a new drug, or- importantly- of a new use for an already-
approved drug, produce:
evidence consisting of adequate and well -controlled
investigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the
effectiveness of the drug involved, on the basis of which it
could fairly and responsibly be concluded by such experts that
the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof.4
This statutory language underlies the FDA's requirement that a
drug undergo preclinical testing followed by clinical trials in
humans before an indication, method of administration, patient
population, or, in some circumstances, dose, is enshrined on the
product's agency-approved label.5 While physicians are free to
prescribe a drug that has been approved for one use for any
other use they deem appropriate, manufacturers may only
promote it for its approved use or uses.6
The precise contours of the ban on off-label promotion derive
from the Harris-Kefauver Amendments and the FDCA's
misbranding provisions, as well as the FDCA's implementing
regulations, court decisions, and various agency interpretations
of the governing law.7 While manufacturers are not permitted to

promote their products for unapproved uses, multiple avenues
for dissemination of information about such uses remain
available to them. For example, manufacturers are not limited to
the label when they engage in scientific exchange.8 Their
physicians and scientists can discuss research into off-label uses
via medical journal articles,9 and they can respond to
physicians' requests for information about such uses.10 Subject
to certain limitations, manufacturers are also permitted to fund
off-label continuing medical education programs for practicing
physicians11 and to provide physicians with, among other
things, peer-reviewed medical journal articles discussing
offlabel uses.12 These avenues notwithstanding, the disconnect
between off -label use and the rules governing off-label
promotion forces manufacturers to leave promising sales
opportunities unexploited. Manufacturers also complain that the
ban prevents them from providing physicians who are
prescribing the manufacturers' products for off-label uses with
important information about those uses.
It is not surprising, then, that the ban on off-label promotion is
controversial. Its critics argue that it is also unconstitutional.
Specifically, they claim that the ban violates the First
Amendment because it suppresses pharmaceutical
manufacturers' truthful speech about their legal products.13 The
manufacturer in a recent constitutional challenge to the ban,
Allergan v. United States, pointedly limited its complaint to the
ban's effect on "truthful speech to physicians."14
Characterizing the FDA's requirement that a drug that is
approved for one use may not be promoted for another as a
"ban[] against truthful, nonmisleading commercial speech" has
more than rhetorical significance.15 Such bans elicit special
skepticism because of the belief that they "usually rest solely on
the offensive assumption that the public will respond
'irrationally' to the truth."16 By contrast, regulations targeting
false and misleading speech merit much more relaxed review,
because "[w]hen a State regulates commercial messages to
protect consumers from misleading, deceptive, or aggressive

sales practices, or requires the disclosure of beneficial
consumer information, the purpose of its regulation is consistent
with the reasons for according constitutional protection to
commercial speech . . . ."17 The legislative history of the
Harris-Kefauver Amendments reveals that one of Congress'
principal concerns was that physicians were
respondingrationally- to false and misleading promotional
claims.18 This Article explores the doctrinal questions raised by
conceiving of the ban on off-label promotion not as a ban on
"truthful speech to physicians" but instead as a prophylaxis
against false and misleading pharmaceutical promotion.
The Article proceeds as follows. In Part II, I review the
circumstances under which the government can adopt a
prophylactic rule that targets false and misleading commercial
speech but incidentally sweeps in some truthful, non-misleading
speech. I also review the discussions of false and misleading
prescription drug promotion in Washington Legal Foundation v.
Friedman, the highly-influential district court decision
invalidating the ban on off-label promotion as applied to
continuing medical education courses, medical textbooks, and
peer-reviewed journal articles, and Thompson v. Western
States,19 in which the Supreme Court invalidated restrictions on
pharmacists' promotion of drug compounding. Notably, while
the WLF Court used broad freedom-of-speech favoring
language, the injunction it adopted was "narrowly applicable"20
and incorporated requirements- for example that companies
could only distribute reprints of articles that originally appeared
in bona-fide peer-reviewed journals- that without doubt
excluded truthful, nonmisleading speech from constitutional
protection. In Part III, I analyze a number of prophylactic bans
of other types of commercial speech that have withstood
constitutional challenge and point to commonalities they share
with the promotion of pharmaceuticals to physicians. Finally, in
Part IV, I review the extant empirical evidence of false and
misleading prescription drug promotion, as well as the
enforcement challenges the FDA confronted before the adoption

of the ban on off-label promotion and would confront were the
ban lifted. I conclude that the government likely could develop
the factual record necessary to establish "that in fact [off-label
promotion] is subject to abuse" and, thereby, establish that
Congress' rejection of an after-the-fact case-by-case approach to
policing such promotion is constitutional.21
II. COMMERCIAL SPEECH DOCTRINE, FALSE OR
MISLEADING SPEECH, AND THE BAN ON OFF-LABEL
PROMOTION
To determine whether commercial speech regulation comports
with the Constitution, courts apply the familiar test set forth in
Central Hudson Gas & Electric Corp. v. Public Service
Commission.22 The test's first prong is "whether the expression
is protected by the First Amendment."23 Speech that concerns
unlawful activity or is false, deceptive, or misleading is
unprotected and thus the analysis ends.24 If "truthful and
nonmisleading expression will be snared along with fraudulent
or deceptive commercial speech,"25 a court must move to the
Central Hudson test's second prong, "whether the asserted
governmental interest is substantial," third prong, "whether the
regulation directly advances that interest," and fourth prong,
"whether the regulation is more extensive than necessary to
serve the asserted interest."26 The government bears the burden
of demonstrating that its regulation meets the Central Hudson
test and if it can "achieve its interests in a manner that does not
restrict speech, or that restricts less speech, [it] must do so."27
A. THE SUBSTANTIAL GOVERNMENT INTEREST IN
ENSURING THE ACCURACY OF PRESCRIPTION DRUG
PROMOTION
In Washington Legal Foundation v. Friedman, the court
determined as a preliminary matter that the off-label
information contained in the continuing medical education
courses, medical textbooks, and peer-reviewed journal articles
at issue was true, or, at least, not always or necessarily false.28
In response to an argument from the FDA that the FDCA
"prescribes a specific system for determining the 'truth' of

claims about drugs and devices"- making off-label promotion
per se false or misleading- the court famously wrote that the
agency "exaggerate[d] its overall place in the universe."29 The
WLF court concluded that the government did not have a
legitimate interest in "ensuring that physicians receive accurate
and unbiased information so that they may make informed
prescription choices . . . ."30
By contrast, the WLF court found that the government's interest
in "providing manufacturers with ample incentive to get
previously unapproved uses on label" was both legitimate and
substantial.31 The court explained that it would not revisit
Congress' conclusion that "it benefits the public health to
require manufacturers to get all uses approved by the FDA"
because doing so would require the court to decide a policy
question, namely "whether compelling manufacturers to get new
uses on-label is wise government policy when considered
against the backdrop of present day medical realities, financial
constraints and procedural burdens . . . ."32 The WLF court also
determined that the ban on off-label promotion was a reasonable
means to the end of preserving the integrity of the new drug
approval process.33 As the FDA has explained, "[t]he new drug
approval process would be crippled if drug manufacturers could
obtain approval of a drug for one use, then promote the drug for
other, unapproved uses without first demonstrating through the
approval process that the drug was safe and effective for each
new use."34
While the WLF court declined to hold that off-label promotion
was per se false or misleading, its discussion of the issues
suggests that it took seriously the government's concerns about
false or misleading pharmaceutical promotion. First, the WLF
court explained that there were "less-burdensome alternatives"
to the challenged restrictions on disseminating journal articles
and textbooks and supporting continuing medical education
programs. The "most obvious" alternative was "full, complete,
and unambiguous disclosure by the manufacturer"35 that the
FDA had not approved the use or uses discussed. Such a

disclosure would not seem to advance the government's interest
in preserving manufacturers' incentive to file supplemental new
drug applications, however. The court did not deny this,
explaining that the purpose of the disclosure would be to
"assuage[] concerns that the message communicated is
inherently or potentially misleading."36
Relatedly, the WLF court took pains to emphasize that there
remained a number of levers available to the FDA "to ensure
that the information manufacturers wish to distribute is
scientifically reliable."37 The FDA could require that
companies limit their distribution of off-label article reprints to
those that appeared in "bona fide peer-review journal[s]" and
their distribution of textbooks to those published by "bona fide
independent publisherCs]."38 The FDA could also bar
companies from funding off-label continuing medical education
sessions unless they were developed and presented by an
accredited "independent program provider."39
The WLF court did not spell out why the First Amendment
permitted these limits which, while less restrictive than a
blanket ban on off -label promotion, nonetheless sweep in a
significant amount of true, non-misleading speech. There is no
connection between these requirements and the government's
interest in preserving manufacturers' incentive to file
supplemental new drug applications, except that they limit the
type (and thereby, perhaps, the amount) of off-label promotion
that companies can do.40 If restricting the amount of off-label
promotion to preserve the incentive to file were the only goal, a
system in which manufacturers could engage in a limited
amount of off-label promotion using the method or methods of
their choice might hew more closely to First Amendment ideals.
For example, a company could choose to promote an off-label
use by having its sales representatives conduct a limited number
of sales calls, sponsoring a limited number of speaker programs,
or buying a limited number of print advertisements in medical
journals. That the WLF court did not consider alternatives like
this, or, for that matter, question the need to ensure that the

information disseminated was "scientifically reliable," is further
evidence that it did not discount the FDA's concerns about false
or misleading off-label promotion. The outcome of the case is
telling: the court's injunction was "narrowly applicable,"41 and
the off-label promotion ban continued to be sweeping.
In Thompson v. Western States, the Supreme Court did not tarry
on the initial inquiry into whether the regulated speech was
protected by the First Amendment because the government did
not claim that an advertisement informing patients that a
pharmacist could compound particular drugs would be false or
misleading.42 The government's concern was that if
compounding services were advertised, more patients would ask
their doctors to prescribe compounded drugs. This would upset
the delicate balance that Congress hoped to strike between
maintaining the integrity of the new drug approval process, on
the one hand, and preserving access to unstudied compounded
formulations for individual patients in need, on the other.
Like the WLF court, the Western States court held that
preserving the integrity of the new drug approval process is a
sufficiently substantial government interest to support
regulation.43 The court nonetheless invalidated the proscription
of compounding advertising because it found that Congress gave
inadequate consideration to "non-speech-related means of
drawing a line between [small-scale] compounding," which
would not threaten the new drug approval process, "and large-
scale manufacturing," which could.44 After arriving at this
holding, the court went on to state that even if compounding
advertising were misleading, banning it would not be a
reasonable response because the government could take "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."45 This
suggestion should be limited to the facts of the case. It is hard
to believe that the First Amendment would limit the
government's arsenal against misleading advertising to the use
of a disclaimer that consumers would only be exposed to once

they had already purchased the product being advertised.
As a general matter, "[t]here is no question that [the
governmental] interest in ensuring the accuracy of commercial
information in the marketplace is substantial,"46 and neither
WLF nor Western States creates an exception for
pharmaceutical marketing. The government cannot limit
physicians' access to scientifically reliable materials solely
because they demand critical evaluation. It can, however, place
limits on prescription drug promotion, to preserve the integrity
of the new drug approval process, but also to ensure that the
information conveyed is not false or misleading.47
B. THE QUESTION OF "FIT"
Once a court holds that a speech regulation serves a substantial
government interest, the court must evaluate whether the
regulation directly and materially advances the interest and
whether in doing so the regulation sweeps in no more truthful
speech than necessary.48 In determining whether a regulation
sweeps more broadly than necessary, courts consider whether
the regulation leaves alternative speech channels open and
whether there are lessspeech-limiting approaches that would
achieve the same ends.49
While there is not a perfect fit between the very rigorous new
drug approval process and the false and misleading off-label
promotion that the FDA would like to suppress, perfection is
not required,50 particularly where the false or misleading
speech in question has potential public health implications.51
The agency's focus in deciding whether to approve a drug for a
new use is on the advisability of using the drug to treat a given
disease or condition; its primary concern is not what truthful
claims the manufacturer can make about the drug. That said, the
approval process does directly and materially advance the goal
of ensuring that pharmaceutical product promotion is truthful
and non-misleading, because manufacturers are required to
develop "a certain 'floor' of risk-benefit information" for each
approved use.52 As a result, manufacturers are likely to have
the information they need to contextualize, qualify, and

otherwise ensure that their on-label promotional claims are not
misleading. Also of relevance to the question of fit is the fact
that while "off-label promotion" is banned, avenues for
dissemination of off-label information exist. In addition, the
ban can, in many cases, be surmounted by conducting the
necessary further research and submitting a supplemental new
drug application.
III. RECENT CASE LAW REGARDING PROPHYLACTIC
COMMERCIAL SPEECH REGULATION
A. CASE LAW UPHOLDING LEGISLATIVE
DETERMINATIONS OF THE TRUTH OF PARTICULAR
CLAIMS
In several recent false advertising cases, courts reviewed
legislative determinations of the truth of particular claims and
upheld them against First Amendment challenges. These
holdings are not directly applicable to the ban on off-label
promotion, which extends beyond any particular claim or
claims. They do, however, indicate courts' openness to what
Professor Rebecca Tushnet terms a "wholesale" approach to
commercial speech regulation.53
In Benson v. Kwikset, a California appeals court upheld a state
statute forbidding the use of the claim "Made in the U.S.A."
unless the product in question was substantially made here from
parts that were also substantially made here.54 The Benson
court held that the statute was constitutionally permissible
because it "constitute[d] a legislative determination that
representations suggesting merchandise was made in the United
States are misleading unless the producer's manufacturing
processes satisfy the strictures of the statute."55
In another California case, Bronco Wine Company v. Jolly, an
appeals court found similarly, that a state statute prohibiting the
use of the word "Napa" to advertise a wine unless a large
percentage of the grapes used to make the wine were grown in
Napa County was "a valid regulation of inherently misleading
commercial speech."56 Of relevance to the ban on offlabel
promotion, the court also held that while "more sophisticated

wine consumers may not be misled . . . the Legislature could
reasonably conclude that not all wine consumers are equally
knowledgeable."57
Lastly, in Piazza's Seafood World v. Odom, the Fifth Circuit
found that a statute providing that "[n]o person shall advertise,
sell, offer or expose for sale, or distribute food or food products
as 'Cajun,' 'Louisiana Creole,' or any derivative thereof unless
the food or food product . . . [was] produced, processed, or
manufactured in Louisiana" could not be enforced against the
plaintiff in the case.58 The plaintiff imported fish from China
and sold the fish under the labels "Cajun Boy" and "Cajun
Delight."59 Because the plaintiff labeled his fish with the
country of origin and sold mainly to wholesalers, the Fifth
Circuit affirmed the district court's finding that the plaintiff's
use of the word "Cajun" was not misleading.60 Despite its
finding that the word "Cajun" was not misleading under the
circumstances, the district court declined to find the statute
facially invalid.61 The district court noted that "in some cases
the use of the term Cajun to describe non-Louisiana products
would be inherently misleading and inherently misleading
speech is not subject to First Amendment protections."62 The
district court concluded that there "surely" would be "factual
scenarios where the Cajun Labeling Law will apply unfettered
by a First Amendment challenge."63
B. CASE LAW UPHOLDING BANS OR OTHER
REGULATION OF PARTICULAR PROMOTIONAL METHODS
There are also a number of recent false advertising cases in
which the courts have upheld bans or other regulation not of
specific claims but of particular promotional methods. In
Walraven v. NC Board of Chiropractic Examiners, the Fourth
Circuit affirmed a district court decision finding constitutional a
ninety-day waiting period for in-person or telephonic
solicitation of accident victims by chiropractors.64 After
concluding that "nondeceptive advertising of chiropractic
services is protected speech under the First Amendment," the
district court determined that the challenged regulations

materially advance at least one substantial governmental
interest- "the protection of a particular segment of the public
from invasive (and potentially coercive and/or misleading)
solicitation tactics under circumstances in which they may be
particularly vulnerable."65 The court went on to find that the
regulations satisfied the third and fourth prongs of the Central
Hudson test because they "singl[ed] out for regulation only
speech which is particularly susceptible to fraud and
overreaching (i.e., in -person and telephonic solicitation) and
which is targeted at a protected class (i.e., recent victims of car
accidents)."66
The court next examined whether the plaintiff's proposed less-
restrictive alternative, that she be permitted to telemarket using
a proposed script "from which . . . her contracted telemarketers
would be instructed not to deviate," was a viable substitute for
the challenged regulations.67 The court found that it was not,
explaining as follows:
Written solicitations are capable of being screened for
compliance by a state regulatory authority before they are ever
mailed. By contrast, telephonic solicitations (even scripted
ones) do not take place in a controlled environment and
improper deviations from the script are not susceptible to
detection until after the harm is done (provided that a
disgruntled consumer even bothers to report the violation to the
relevant authorities) . . . .68
Similarly, in Goodman v. Illinois Department of Financial and
Professional Regulation, the Seventh Circuit upheld an Illinois
law forbidding medical professionals from using agents to
market their services against a challenge from a chiropractor
who wanted to engage in telemarketing.69 The plaintiff
chiropractor "claimed that he would take special care to ensure
that his telemarketers did not deviate from their prepared script
and did not impart false and misleading information."70 He also
claimed that his efforts would benefit the recent car accident
victims he planned to target because there are health benefits
associated with immediate treatment.71 The government argued

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