[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58011-58018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0465]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study: 
Effect of Promotional Offers in Direct-to-Consumer Prescription Drug 
Print Advertisements on Consumer Product Perceptions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October 
19, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Experimental Study: Effect of Promotional Offers in Direct-to-
Consumer Prescription Drug Print Advertisements on Consumer Product 
Perceptions.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In compliance with 44 U.S.C. 3507, FDA has submitted the following 
proposed collection of information to OMB for review and clearance.

Experimental Study: Effect of Promotional Offers in Direct-to-Consumer 
Prescription Drug Print Advertisements on Consumer Product 
Perceptions--(OMB Control Number 0910-New)

    Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 352(n)) requires advertisements for prescription 
drugs to include, among other things, ``such information in brief 
summary relating to side effects, contraindications, and effectiveness 
as shall be required in regulations.'' Under this authority, FDA has 
issued regulations to require most prescription drug advertisements to 
provide a ``true statement of information in brief summary relating to 
side effects, contraindications, and effectiveness.'' (Sec.  202.1(e) 
(1) (21 CFR 202.1(e)(1)). To satisfy this requirement, an advertisement 
that makes claims about a prescription drug must also include a ``fair 
balance'' of information about the benefits and risks of the advertised 
product, in terms of both content and presentation (Sec.  
202.1(e)(5)(ii)). In part, Sec.  202.1(e)(6)(i) states that [a]n 
advertisement for a prescription drug is false, lacking in fair 
balance, or otherwise misleading, or otherwise violative of section 
502(n) of the act, among other reasons, if it [c]ontains a 
representation or suggestion, not approved or permitted for use in the 
labeling, that a drug is better, more effective, useful in a broader 
range of conditions or patients (as used in Sec.  202.1 ''patients'' 
means humans and in the case of veterinary drugs, other animals) safer, 
has fewer, or less incidence of, or less serious side effects or 
contraindications than has been demonstrated by substantial evidence or 
substantial clinical experience (as described in paragraphs 
(e)(4)(ii)(b) and (e)(4)(ii)(c) of Sec.  202.1) whether or not such 
representations are made by comparison with other drugs or treatments, 
and whether or not such a representation or suggestion is made directly 
or through use of published or unpublished literature, quotations, or 
other references.
    FDA's current regulations provide a limited exception to the 
requirement in Sec.  202.1(e)(1), of presenting a true statement of 
information in brief summary, for ``reminder advertisements'' 
(``reminder ads'')--advertisements that draw attention to the name of 
the product but do not make representations about the product's 
indication(s) or dosage recommendations (Sec.  202.1(e)(2)(i)). 
(Certain drugs are not permitted to qualify for the reminder 
advertisement exemption.) To meet the terms of this exemption, 
reminders ads must in general be limited to the proprietary and 
established name of the product and the established name of each active 
ingredient in the drug product. Reminder ads may also (optionally) 
contain information about the product's quantitative ingredients, 
dosage form, quantity, price, and manufacturer, as well as other 
written, printed, or graphic matter containing no representation or 
suggestion relating to the product. Further, reminder ads that are 
intended to provide consumers with information concerning the price 
charged for a prescription drug product need not meet the terms of 
Sec.  202.1(e)(2)(i) in order to be exempt from Sec.  202.1(e)(1) if 
they meet all of the conditions in Sec.  200.200 (21 CFR 200.200). That 
regulation, in turn, applies to prescription drug reminders ads that 
are intended solely to provide consumers with information concerning 
the price charged for a prescription for a particular drug product, and 
the reminder ad contains no representation or suggestion concerning the 
drug product's safety, effectiveness, or indications for use (Sec.  
200.200(a)(1) and (b)).
    A topic of ongoing interest for consumer product manufacturers and 
retailers is the use of consumer-oriented sales promotions such as free 
trial offers, discounts, money-back guarantees, and rebates. Such 
promotions are widely used in many product categories, including 
prescription drugs.
    Prior research has demonstrated that the type of promotion offered 
can affect how consumers respond to the promotion (Refs. 1, 2, and 3). 
Price incentives \1\ may act as cues about product quality. For 
example, a price incentive may not only act as an economic incentive to 
buy the product, it may also artificially enhance consumers' 
perceptions of the product's quality (Ref. 4). In the case that

[[Page 58012]]

consumers can readily test the performance of some products (termed 
``experience'' goods; Ref. 5), this misperception is quickly corrected 
through the consumer's use of the product. In situations where little 
information about the product is available or when consumers are 
unmotivated to seek further information, consumers may use price as a 
heuristic cue to ascertain the quality of a product. Rao (2005; Ref. 6) 
has referred to the use of price as a cue to quality as the ``price-
quality heuristic,'' where heuristics are conceptualized as mental 
shortcuts that minimize cognitive effort to process information and are 
used when individuals are unable or unwilling to engage in more 
analytical processing of information (Ref. 7). For example, if length 
of warranty is strongly believed to be a good predictor of quality, 
then consumers may perceive a product as higher quality when a long 
warranty is present than when one is not present (Ref. 8). Thus, price 
incentives may have the potential to act as an ``inference rule'' (or 
heuristic; Refs. 7 and 9) and, when present, they may preempt consumers 
from thinking carefully about the product information contained in the 
advertisement (i.e., fully elaborating on the information). This could 
result in either favorable or unfavorable beliefs about the product 
(Refs. 10 and 11). If a price incentive offer acts as a mental 
heuristic in such a way as to result in an unbalanced or misleading 
impression of the product's safety or efficacy, however, this would 
raise concerns for FDA.
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    \1\ In this document, we use the terms ``price incentive'' and 
``coupon'' interchangeably to refer to the types of promotional 
offers to be addressed in our study.
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    Consumers vary in their reactions to price incentive promotions, 
and researchers and economists have proposed a number of explanations 
for why some consumers are sensitive to these tactics. Two such traits 
are ``price consciousness'' and ``belief in the price-quality 
relationship.'' Price consciousness is defined as the degree to which 
the consumer focuses exclusively on paying low prices. Belief in the 
price-quality relationship is defined as the degree to which one 
believes a higher price indicates superior quality (Ref. 12). A broader 
trait of ``value consciousness'' has also been used. This trait 
involves assumptions about the construct of perceived value and its 
relationship (a ratio) with the constructs of perceived quality and 
perceived price.
    While price incentive promotions have been extensively studied in 
the context of package goods, information on their effects in direct-
to-consumer (DTC) prescription drug ads is limited. One relevant study 
(Ref. 13) found that a free-trial offer in a DTC ad for a high 
cholesterol drug resulted in more favorable perceptions of the product 
and the ad (both rated as good/bad, favorable/unfavorable, and 
pleasant/unpleasant), and greater intentions to ask about the product. 
No differences were found in terms of perceived product risk. However, 
the study did not measure perceptions of product risk and benefit 
separately, or comprehension of risk and benefit information. 
Additionally, no attempt was made to control for factors that may 
predispose individuals toward coupon use nor was the study conducted 
with the target population (high cholesterol sufferers). We propose to 
expand on this initial study by measuring perceived product risk and 
benefit separately, measuring risk and benefit comprehension, 
investigating a variety of price incentive offers, recruiting a wider 
range of the target audience from malls and online, and by measuring 
traits that may predispose individuals to be susceptible to coupon 
influence.
    The current study will examine what effect, if any, the presence of 
promotional offers in DTC prescription drug ads have on the following: 
(1) Consumers' perceptions of product risks and benefits, (2) recall of 
product risks and benefits, and (3) strongly held beliefs that may act 
as potential moderators.
    Design Overview: Study 1: This study will examine types of 
promotional offers (for example, free trial offer; money off cost; 
money back guarantee; buy one, get one free; and no offer) in three 
types of drug advertisements (prescription drug full product, over-the-
counter (OTC), and prescription drug reminder). The fictitious test 
product will treat insomnia and will be modeled on an actual drug used 
to treat this condition. Participants will be consumers who have 
insomnia or who self-identify as having met the diagnostic criteria for 
insomnia. Prescription drug full product advertisements contain 
information about both benefits and risks, OTC drug advertisements 
contain benefit information but not risk information, and prescription 
drug reminder advertisements do not contain either benefit or risk 
information.
    Study 1 will be administered in two modes, online and mall-
intercept, in order to assess the effects of mode on study results. 
Table 1 of this document illustrates the design; the specific 
promotional offers examined will be determined through pretesting. 
Offers that demonstrate the most effect on perceptions of product 
efficacy and risk will be selected for the main study.
    Study 1 is experimental in method: participants will be randomly 
assigned to read one ad version. After reading the ad, participants 
will answer a series of questions about the drug. We will test how the 
offer type affects their recall of the benefit and risk information, 
their perceptions of the benefits and risks of the drug, their 
perceptions of the incentive, and their behavioral intention to look 
for more information about the product and try the product. We will 
also test how mode of administration (online versus mall intercept) 
affects these variables.

                            Table 1--Study 1 Design, Mode 1 (Online, Internet Panel)
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                                                                Type of advertisement
                                   -----------------------------------------------------------------------------
   Promotional offer  (examples)        Efficacy and risk                                  None (prescription
                                       (prescription full)       Efficacy only (OTC)            reminder)
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Free trial offer..................                   Online                    Online                    Online
Buy one, get one free.............                   Online                    Online                    Online
Money off cost....................                   Online                    Online                    Online
Money back guarantee..............                   Online                    Online                    Online
Control: No offer.................                   Online                    Online                    Online
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[[Page 58013]]


                                Table 2--Study 1 Design, Mode 2 (Mall Intercept)
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                                                                Type of advertisement
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   Promotional offer  (examples)        Efficacy and risk                                  None (prescription
                                       (prescription full)       Efficacy only (OTC)            reminder)
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Free trial offer..................                     Mall                      Mall                      Mall
Buy one, get one free.............                     Mall                      Mall                      Mall
Money off cost....................                     Mall                      Mall                      Mall
Money back guarantee..............                     Mall                      Mall                      Mall
Control: No offer.................                     Mall                      Mall                      Mall
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    Study 2: We propose to replicate the online mode from Study 1 in a 
second medical condition, high blood pressure.

                                Table 3--Study 2 Design (Online, Internet Panel)
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                                                                Type of advertisement
                                   -----------------------------------------------------------------------------
   Promotional offer  (examples)        Efficacy and risk                                  None (prescription
                                       (prescription full)       Efficacy only (OTC)            reminder)
----------------------------------------------------------------------------------------------------------------
Free trial offer..................                   Online                    Online                    Online
Buy one, get one free.............                   Online                    Online                    Online
Money off cost....................                   Online                    Online                    Online
Money back guarantee..............                   Online                    Online                    Online
Control: No offer.................                   Online                    Online                    Online
----------------------------------------------------------------------------------------------------------------

    The test product in Study 2 will be for the treatment of high blood 
pressure. Participants will be consumers who have been told by a health 
care professional that they have high blood pressure. As with Study 1, 
this study is experimental in method: participants will be randomly 
assigned to read one ad version. After reading the ad, participants 
will answer a series of questions about the drug. We will test how the 
offer type affects perceived efficacy, perceived risk, behavioral 
intention, and recall of the benefit and risk information.
    Data will be collected using an Internet protocol (Studies 1 and 2) 
and mall intercept (Study 1). Consumers who have insomnia or self-
identify as meeting the criteria for insomnia will be recruited for 
Study 1 and consumers who have been told by a health care professional 
that they have high blood pressure will be recruited for Study 2. 
Because the task presumes basic reading abilities, all selected 
participants must speak and read English fluently. Participants must be 
18 years or older. We will use analysis of variance and regressions to 
test hypotheses. Interviews are expected to last no more than 20 
minutes. A total of 5,850 participants will be involved in the studies. 
This will be a one-time (rather than annual) collection of information.
    In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice 
for public comment in the Federal Register of September 22, 2010 (75 FR 
57798) Docket No FDA-2010-N-0465). FDA received five comments. In the 
following section, we outline the observations and suggestions raised 
in the comments and provide our responses.
    Two comments wrote in support of the study. We thank those who 
commented for their support of this research.
    (Comment 1) One comment spoke against FDA conducting the research, 
saying (in part), ``[T]his survey is so unnecessary and such a waste of 
tax dollars * * * [W]e all know already how consumers take this 
information * * * [Y]ou can see from teh (sic) way the ads are 
presented what the big money big pharma con men are up to.''
    (Response) We thank the citizen that took the time to comment on 
this study. The purpose of this study is to examine the potential 
impact on perceptions of product safety and efficacy of price 
incentives included in the body of a prescription drug advertisement. 
We disagree that the field has definitively answered the question of 
how consumers will ``take this information.'' As described in the 
background section of the study in Ref. 13 (Bhutada), one study that 
examined the impact of a price incentive in a prescription drug print 
advertisement found that consumers who saw an ad with a price incentive 
had favorable perceptions of the product and the ad, perceptions of the 
product and greater intentions to ask about the product. No differences 
were found in terms of perceived product risk. However, the study did 
not measure perceptions of product risk and benefit separately, or 
comprehension of risk and benefit information. In addition, we note 
that the findings of other academic studies in this field point in two 
different directions; research shows the presence of price incentives 
can foster beliefs about product quality or diminish beliefs about 
product quality. Therefore, the lack of information about the potential 
influence of price incentive offers on risk and benefit comprehension 
and the conflicting findings in the current literature make this is an 
opportune area in which to conduct an empirical study.
    Two comments included multiple points about the study justification 
and design. We thank those who provided the comments for taking the 
time to provide detailed comments on our study and respond to their 
points in the paragraphs that follow.
    (Comment 2) This comment suggested that the proposed study is not 
necessary for the proper performance of FDA's functions because no 
evidence of a serious or widespread problem with price incentives has 
been identified.
    (Response) FDA disagrees with this assertion. While no ``serious or 
widespread problem'' has been previously identified, the Agency has 
observed increasing use of a variety of price incentive promotional 
offers in DTC print advertisements for

[[Page 58014]]

prescription drugs. The proposed study is intended to help the Agency 
better understand what effect, if any, these price incentive promotions 
have on consumer perceptions of risk and benefit information about the 
advertised prescription drugs. Improving FDA's understanding of these 
effects will assist the Agency in proactively meeting its 
responsibility to implement the FD&C Act. As already noted, both the 
FD&C Act and existing regulations issued to implement it are concerned 
with ensuring that prescription drug advertisements, including DTC 
print ads, provide appropriate risk and benefit information and are not 
otherwise misleading. (See, e.g., 21 U.S.C. 352(n) and 321(n); 
202.1(e);) The study will provide information to help the Agency assess 
how these mandates can be met where price incentives are employed, and 
is therefore ``necessary for the proper performance of FDA's functions 
* * *'' (44 U.S.C. 3508).
    (Comment 3) This comment suggested that the inclusion of a truthful 
price incentive in an otherwise compliant DTC advertisement cannot 
render the advertisement false, misleading or lacking fair balance 
under the FD&C Act regardless of the psychological theories implicated. 
The comment further asserted that the inclusion of a truthful price 
incentive into an otherwise compliant DTC ad cannot serve as the basis 
for FDA to initiate regulatory action against the ad under the FD&C 
Act.
    (Response) FDA believes that if the inclusion of a ``truthful'' 
price incentive in promotional material results in an unbalanced net 
impression of the drug product, that this would create a misleading 
impression of risk and benefit. As explained in FDA's draft guidance 
for industry entitled ``Presenting Risk Information in Prescription 
Drug and Medical Device Promotion,'' it is important to emphasize that 
when FDA evaluates the risk communication in a promotional piece, FDA 
looks not just at specific risk-related statements, but at the net 
impression--i.e., the message communicated by all elements of the piece 
as a whole. The purpose of the evaluation is to determine whether the 
piece as a whole conveys an accurate and non-misleading impression of 
the benefits and risks of the promoted product. Manufacturers should 
therefore focus not just on individual claims or presentations, but on 
the promotional piece as a whole. A promotional communication that 
conveys a deceptive net impression of the product could be misleading, 
even if specific individual claims or presentations are not misleading 
(Ref. 14).
    Thus, even if a price incentive included in an advertisement is in 
fact ``truthful,'' the net impression of the promotional piece as a 
whole can be unbalanced or misleading, which may in turn violate 
existing regulations. FDA proposes this study to help determine whether 
or not including a price incentive in a DTC print advertisement for a 
prescription drug can result in an unbalanced or otherwise misleading 
net impression of the drug product.
    (Comment 4) This comment stated that the study may provide 
interesting information about the effect of price incentives on 
consumer attitudes toward a brand and useful information on optimal 
advertising practices, but it cannot provide information relevant to 
the statutory and regulatory requirements applicable to DTC 
advertising.
    (Response) FDA disagrees that the study cannot provide information 
relevant to the statutory and regulatory requirements applicable to DTC 
advertising. As noted previously, this study will examine issues that 
are well within FDA's regulatory authority--whether the inclusion of 
price incentives in prescription drug ads impacts a consumer's 
understanding of the risk and benefit information of the drug. In 
particular, we are interested to learn whether the inclusion of price 
incentives can interfere with the fair balance of information and cause 
a misleading net impression. Knowing whether or not misleading 
impressions result is a prerequisite to considering how any such 
misleading effects should be addressed.
    (Comment 5) One comment contends that the citation to Sec.  
202.1(e)(6)(i) included in the 60-day notice (75 FR 57798) is 
inaccurately truncated, and further asserts that the only indirect 
claims and representations subject to this regulation are those made 
through use of literature, quotations, or other references. The comment 
argues that because price incentives do not involve the use of 
published or unpublished literature, quotations or other references, 
this provision does not provide a legal basis for the proposed study or 
for the Agency to regulate the heuristic effects (if any) of price 
incentives.
    (Response) In response to the comment's concern that FDA 
inaccurately truncated the regulation, and to avoid misunderstanding, 
FDA has included a longer excerpt of Sec.  202.1(e)(6) in this notice 
than was included in the prior notice. However, FDA disagrees with the 
comment's conclusion about the justification for the proposed study.
    As an initial matter, as noted, FDA has authority under section 
502(n) of the FD&C Act to specify by regulation how to present the 
brief summary of risk and benefit information required in prescription 
drug advertisements. This authority, together with FDA's authority to 
conduct research relating to drugs (21 U.S.C. 393(d)(2)(c)), amply 
supports the proposed study. FDA need not establish that it would bring 
enforcement actions under Sec.  202.1(e)(6)(i) or any other specific 
provisions of the present regulations in order to justify conducting a 
study that is intended to provide a better empirical understanding of 
the impact, if any, on risk and benefit information communication where 
price incentives are included in DTC print advertisements for 
prescription drugs. The results of this study will help to inform FDA's 
review of, and regulatory policies for, prescription drug advertising 
subject to section 502(n) of the FD&C Act.
    Turning specifically to Sec.  202.1(e)(6), we disagree with the 
comment's construction of that regulation. As indicated in the 
prefatory text of Sec.  202.1(e)(6), the specifics that follow are 
``among other reasons'' that an advertisement for a prescription drug 
is false, lacking in fair balance, or otherwise misleading, indicating 
that these are examples and not an exclusive list as the comment 
assumes. In the same vein, Sec.  202.1(e)(6)(i) states that an 
advertisement may not contain: A representation or suggestion, not 
approved or permitted for use in the labeling, that a drug is better, 
more effective, useful in a broader range of conditions or patients (as 
used in Sec.  202.1 ``patients'' means humans and in the case of 
veterinary drugs, other animals) safer, has fewer, or less incidence 
of, or less serious side effects or contraindications than has been 
demonstrated by substantial evidence or substantial clinical experience 
(as described in paragraphs (e)(4)(ii)(b) and (e)(4)(ii)(c) of Sec.  
202.1) whether or not such representations are made by comparison with 
other drugs or treatments, and whether or not such a representation or 
suggestion is made directly or through use of published or unpublished 
literature, quotations, or other references.
    This phrasing prohibits ``a representation or suggestion, not 
approved or permitted for use in the labeling'' even if the 
representation or suggestion is not made via the means given as 
examples in the regulation. Thus, FDA has consistently, and

[[Page 58015]]

appropriately, examined both direct and indirect representations and 
suggestions when examining the net impression presented in a 
prescription drug advertisement.
    (Comment 6) One comment asserts that the citation to Sec.  
202.1(e)(6)(xviii) is inappropriate because this regulation concerns 
only the presentation of heading and subheadings and FDA is studying 
the mere fact that a price incentive has been made, not the way in 
which headline, subheadline, or pictorial or other graphic matter are 
used to communicate that price incentive.
    (Response) FDA does not need to rely on Sec.  202.1(e)(6)(xviii) to 
justify the proposed study therefore we have removed the reference to 
this regulation.
    (Comment 7) One comment contends that the scientific research 
identified does not provide justification for conducting the study nor 
does it provide support for the proposition that promotional offers 
have the capacity to act as a cue or a heuristic with respect to 
prescription drugs.
    (Response) We acknowledge that there is little research on the 
impact of price incentive offers in prescription drug advertising. The 
paucity of existing research is a primary motivation for the proposed 
research. The question of whether or not a price incentive offer can 
affect perceptions of and recall of prescription drug efficacy and risk 
is an empirical one and will be tested in the proposed study.
    (Comment 8) One comment directly questioned the need to conduct 
this study in light of the results found by Bhutada et al. (Ref. 13; 
2009). Specifically, the comment asserts that the study found no effect 
of a price incentive on consumer comprehension of risks or benefits of 
the prescription drug.
    (Response) As noted previously, the Bhutada et al. study did not 
measure perceptions of product risk and benefit separately. Perceptions 
of product risk and benefit were measured on a scale with risk at one 
end and benefits at the other, so it was not possible to assess the 
effects of the price incentive on risks and benefits separately. 
Further, comprehension of risk and benefit information was not measured 
at all, so it is impossible to determine from this study if there was 
an effect on comprehension. The current proposed study will extend this 
initial study by measuring perceived product risk and benefit 
separately, measuring risk and benefit comprehension, investigating a 
variety of promotional offers, recruiting a wider range of the target 
audience from malls and online, and by measuring traits that may 
predispose individuals to be susceptible to influence in their 
perceptions of risk or benefit by a price incentive.
    (Comment 9) One comment asserts that heuristic effects are not 
claims, either expressed or implied, and since reminder ads do not 
include any safety or effectiveness information, there is no basis even 
to argue that they may preempt consumers from thinking carefully about 
the product information contained in the reminder ad.
    (Response) It is an empirical question whether price incentives 
operate as a heuristic cue and further, whether those cues impact 
perceptions of product characteristics (in this case, the product's 
efficacy and risk). As the literature on heuristic judgment 
demonstrates, individuals are frequently faced with situations in which 
they are required to make judgments using incomplete information and 
are able to do so (Refs. 15 and 16). Therefore, it is reasonable to 
test whether an incentive can influence this judgment in the context of 
both a full-product and a reminder DTC prescription drug advertisement.
    (Comment 10) One comment asserts that the regulation explicitly 
permits companies to include information about price within reminder 
ads. The comment argues that because price incentives pertain to price, 
this regulation provides no legal basis for the proposed study or for 
the Agency to regulate price incentives contained in reminder ads.
    (Response) FDA acknowledges that current regulations permit 
reminder ads to include price information under defined conditions, 
while remaining exempt from the requirement for a ``true statement of 
information in brief summary.'' FDA does not intend to use the results 
of this study to regulate drug prices. In this study, FDA is only 
seeking to assess the effects, if any, of the presence of various 
offers in DTC advertisements on consumers' perceptions of product risks 
and benefits. As stated previously, we will use ``reminder ads'' in 
this study to understand the effect of offers on consumer perceptions 
of safety and efficacy. Reminder ads present a useful tool in 
determining this effect as broad safety and efficacy information is not 
otherwise provided in such advertisements. Results of this preliminary 
study will help FDA in its assessment of drug ads and in broader 
assessment of its regulatory policy for effectuating section 502(n) of 
the FD&C Act and other legal authorities governing drug promotion.
    (Comment 11) One comment said that FDA has not established 
standards by which to judge the results of the study. This comment 
asserted that even if consumers have a more positive view of the safety 
or effectiveness of a product with a price incentive compared to one 
that does not, this does not automatically deem the ad false, lacking 
in fair balance, or otherwise misleading.
    (Response) To judge the results of our study, we take our cue from 
the related field of research conducted on potentially misleading 
claims and employed frequently by the Federal Trade Commission in their 
investigations of advertising claims (Ref. 17). In this research, an ad 
with the content at issue removed serves as an appropriate experimental 
control. Based on this precedent, an ad without a price incentive is an 
appropriate control in this study.
    (Comment 12) One comment stated that unless FDA can establish that 
differences in perceptions of safety or efficacy are not due to 
differences in price and/or the size of the price incentive, any 
restrictions or requirements on price incentives will require FDA to 
regulate prescription drug pricing.
    (Response) As previously acknowledged, the FD&C Act does not 
provide FDA with authority to regulate prescription drug pricing and 
that is not the purpose or intended outcome of this study. The purpose 
of the currently proposed study is to investigate how different 
purchase incentives, including ones that may affect the actual price of 
the product, may operate in the context of a DTC ad. If we find that 
some types or all types of offers do influence viewers' comprehension 
and perceptions of safety or effectiveness, then, as suggested by this 
comment, the next logical step may be to conduct further study to 
disentangle the effects of the presence of the offer itself and the 
magnitude of the price incentives. In one research study we do not have 
the ability to examine all variables of interest, however, and we 
believe the variables we have chosen for the proposed study are 
reasonable.
    (Comment 13) One comment asserted that by equating cues and 
inference rules with product claims, FDA risks imposing restrictions on 
DTC advertising based on potential deception rather than actual 
deception, which the comment argues is fraught with risk under the 
First Amendment. This comment cites the following from Washington Legal 
Foundation v. Henney (56 F. Supp. 2d 81, 85 (D.D.C. 1999)), ``FDA may 
not restrict speech based on its perception that the speech

[[Page 58016]]

could, may, or might mislead.'' The comment urges FDA to carefully 
consider First Amendment issues before proceeding with the study.
    (Response) We have carefully considered First Amendment issues in 
designing this study. The Washington Legal Foundation v. Henney case 
cited by the comment notes that ``the government must demonstrate that 
the restricted speech, by nature, is more likely to mislead than to 
inform'' (Id. at 85). It is the goal of the proposed study to 
investigate whether a price incentive may or may not be ``more likely 
to mislead than to inform.''] Our participants will view a fictitious 
but realistic DTC print ad and answer questions about that ad. From 
their answers we will be able to determine their responses to the 
information in the ad. Thus, we will measure whether the ad is actually 
misleading and not potentially misleading. The experimental control 
afforded by participants' random assignment to different experimental 
conditions ensures that we will be able to pinpoint the source of any 
differences in responses to ad variations by comparing responses of 
participants who see the variables of interest (in this case, the 
offer) versus those who do not.
    (Comment 14) One comment stated that the proposed study appears to 
be designed more to assess the effect of coupons on brand attitudes and 
consumer impressions and does not appear to be tailored to assess the 
effect of price incentives on statutory and regulatory requirements. In 
other words, the comment argues that FDA has no regulatory authority to 
manage or regulate consumer attitudes or impressions toward a brand.
    (Response) As noted previously, the study is designed to determine 
whether price incentive offers embedded in prescription drug ads can 
result in a misleading net impression of risk and benefit, which may in 
turn violate existing regulations under the FD&C Act. We will measure 
the effect of the offer on consumer's understanding of the product's 
efficacy and safety and the net impression of the product created by a 
promotional piece in regards to that piece alone, which will inform our 
review of DTC prescription drug advertising generally. FDA does not 
intend to regulate or manage consumer attitudes or impressions towards 
a particular brand.
    (Comment 15) One comment questioned the utility of including the 
reminder and OTC test arms in the study as these advertisements do not 
include both safety and effectiveness information.
    (Response) As stated previously, individuals are frequently faced 
with situations in which they are required and able to make judgments 
using incomplete information. As detailed previously, the inclusion of 
a prescription reminder ad and an OTC ad provides experimental control. 
We will compare perceptions of the product attributes among 
participants who see: (1) Full risk and efficacy information (full ad), 
(2) only efficacy information (OTC ad), and (3) neither risk nor 
efficacy information (prescription reminder ad). The question of 
whether an incentive can influence this judgment in the context of a 
DTC prescription drug advertisement is the empirical question we are 
addressing in the proposed study.
    (Comment 16) Two comments requested FDA provide more information on 
the study population and study design including the primary research 
questions, stimuli, endpoints, and action standards.
    (Response) The proposed questionnaire has been and continues to be 
available upon request. We refer to pages 57800 and 57801 of the 60-day 
notice (75 FR 57798) where the study design was described. We have 
described the primary research questions in more detail in this 30-day 
notice. Specific hypotheses and the analysis plan are included in this 
document.
    (Comment 17) One comment requested that FDA specify the types of 
advertisements to be used in the study (i.e., spread, gatefold, \1/3\ 
page ad). Another comment requested that FDA engage the services of an 
advertising agency that specializes in the development of DTC print 
advertisements. Further, the comment asserted that the location of the 
promotional offer may have an impact on consumer perceptions of product 
risks and benefits and requested FDA define the location of the offer 
and clarify if it will be varied in the test ads.
    (Response) The full product DTC ad will be two pages, including a 
brief summary. The OTC ad and reminder ad will each be one page. We 
have contracted with an organization that produces realistic ads and 
stimuli to ensure that we will show respondents realistic materials. 
The location of the promotional offer will be standardized as much as 
possible across all test conditions and will be incorporated in such a 
way as to not obscure the description of either the risks or benefits 
in the full product ad.
    (Comment 18) One comment requested FDA identify and study more 
general disclosures that are not directly related to safety or 
effectiveness info, such as ``consult with a physician to discuss 
whether this drug is right for you.''
    (Response) We appreciate the comment about widening the scope of 
the disclosures to be studied. Based upon the suggestion of our peer 
reviewers, we have changed the focus of the second study to examine a 
second medical condition and will not be investigating disclosures as 
part of this initial study. We encourage other interested entities to 
engage in research on disclosures.
    (Comment 19) One comment requested that the study population be 
limited to individuals who have been diagnosed with the medical 
condition of interest and exclude those merely `at risk' of developing 
the condition because those who do not have the medical condition may 
be much less attentive to the information in the ad and thus skew the 
study results. In another paragraph, the same comment questioned the 
need to conduct the proposed study in the target population since doing 
so would not yield different results from Bhutada et al. (2009) who did 
not use diagnosed individuals.
    (Response) As these two suggestions are contradictory, we offer our 
reasoning behind selecting participants in Study 1 who are either 
diagnosed or fit the criteria for diagnosis of insomnia (formerly 
referred to as ``at risk''). One purpose of a purchase incentive is to 
encourage new users to try a product (Ref. 18). Similarly, the first of 
the Pharmaceutical Research and Manufacturers of America's (PhRMA) 
guiding principles on direct to consumer advertising (Ref. 19) states 
that ``* * * DTC advertising of prescription medicines can benefit the 
public health by * * * motivating patients to contact their physicians 
and engage in a dialogue about health concerns * * *'' Inclusion of an 
incentive might encourage a consumer who recognizes the symptoms 
described in the advertisement to discuss the condition with a doctor 
or other health care professional. Thus, we conclude that both 
diagnosed patients and those individuals who self-report meeting the 
diagnostic criteria for the advertised medical condition but have not 
yet been diagnosed are a valid sample for Study 1. We are limiting our 
Study 2 sample to individuals who have been diagnosed with high blood 
pressure by a health care professional.
    (Comment 20) One comment requested that demographic information 
such as age, education, income, ethnicity, race, a baseline assessment 
of health literacy, and whether the

[[Page 58017]]

consumer is currently being treated with a prescription drug for the 
condition being studied be included in the information collection.
    (Response) Demographic and health literacy information will be 
collected.
    (Comment 21) One comment requested that FDA use prudence when 
broadly interpreting the results from this study and developing 
subsequent guidance based on these study results, and requested that 
the results of the study not be applied beyond print ads or, 
alternatively, to expand the study to include Internet promotion.
    (Response) At this time we cannot expand the study to encompass 
Internet promotion. We concur that there are media-specific factors 
that influence information processing between static (e.g., print) and 
dynamic (e.g., video) platforms, and will note that our study was 
conducted with print ads in our interpretation of the results. However, 
we contend that the cognitive processes used in understanding and 
interpreting incentive information are likely to apply across 
promotional platforms.
    (Comment 22) Two comments mentioned that the study does not assess 
how consumer perceptions of product risks and benefits are translated 
into a discussion with their health care provider. One comment stated 
that because these products can only be purchased after a discussion 
with a health care provider, the study be redesigned so that consumer 
perceptions are measured after a discussion with a health care 
provider.
    (Response) We concur that this study does not address behaviors, 
such as how ad perceptions are translated into a discussion with a 
health care provider. As noted previously, one purpose of DTC 
advertising is to motivate consumers to engage in a discussion with 
their health care provider about health concerns. Another purpose, 
supported by research findings (Refs. 20 and 21), is to increase 
awareness of available treatments. DTC advertising does not exist 
solely in the confines of a doctor's office; rather, DTC advertising 
targets consumers outside of a doctor's office, with the goal of 
prompting consumers to ask their physicians about the product. In 
deciding whether or not to discuss a particular product with their 
health care provider, consumers presumably are engaging in some sort of 
judgment about the product being promoted. Therefore, clear 
communication of risks and benefits is needed for consumers before a 
consultation with a physician, and it is valid to measure these 
impressions.
    (Comment 23) One commenter requested that FDA provide clarity on 
the timing of this study vis-a-vis other FDA DTC studies and make 
available the results of previous DTC studies on the Division of Drug 
Marketing Advertising and Communications (DDMAC) Research Web page.
    (Response) The timing of this study is not dependent on other 
research currently underway. We have taken steps to publish reports 
from our previous research on the DDMAC Web page (see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090276.htm). When the 
current project is concluded, we will report on the study.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 4--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
                    Activity                        Number of     responses per   Total annual         Average burden per response          Total hours
                                                   respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener.......................................           8,500               1           8,500  .03 (2 minutes)........................             283
Pretests.......................................           1,000               1           1,000  .33 (20 minutes).......................             333
Study 1: Online................................           1,950               1           1,950  .33 (20 minutes).......................             650
Study 1: Mall intercept........................           1,950               1           1,950  .33 (20 minutes).......................             650
Study 2........................................           1,950               1           1,950  .33 (20 minutes).......................             650
                                                --------------------------------------------------------------------------------------------------------
    Total......................................          15,350  ..............  ..............  .......................................           2,566
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. 4 p.m., Monday through Friday. (FDA 
has verified the Web site addresses, but we are not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)

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accessed January 5, 2011.
20. Aikin, K.J., J.S.,Swasy, and A.C. Braman, ``Patient and 
Physician Attitudes and Behaviors Associated With Direct-to-Consumer 
Promotion of Prescription Drugs: Summary of FDA Survey Research 
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Prescription Medicines,'' Prevention Magazine, Emmaus, PA: Rodale, 
Inc, 2010.

    Dated: September 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23926 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P