[Federal Register Volume 75, Number 183 (Wednesday, September 22, 2010)]
[Notices]
[Pages 57798-57801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the Experimental Study: Effect of 
Promotional Offers in Direct-to-Consumer Prescription Drug Print 
Advertisements on Consumer Product Perceptions. This study is designed 
to investigate the impact of the presence of coupons offering purchase 
incentives such as free-trial offers, discounts, and money-back 
guarantees on consumers' perceptions of product risks and benefits in 
direct-to-consumer (DTC) print ads.\1\ Notice of proposed information 
collection for this project was previously published in the Federal 
Register of December 15, 2008 (73 FR 76034). This notice is being 
republished due to significant revisions in the burden and study 
design.
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    \1\ While the Federal Food, Drug and Cosmetic Act (the FD&C Act) 
provides FDA with authority to regulate prescription drug 
advertisements that are false or misleading, the FD&C Act does not 
provide FDA with the authority to regulate the pricing of 
prescription drugs. Thus, FDA is merely interested in studying the 
effects, if any, of the presence of various promotional offers in 
DTC advertisements on consumers' perceptions of product risks and 
benefits, and recognizes that it does not actually regulate the 
dollar or other incentive amount of coupons, price incentives, or 
rebate offers with respect to how they affect the price of 
prescription drugs or biological products.

DATES:  Submit either electronic or written comments on the collection 
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of information by November 22, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the

[[Page 57799]]

Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. ``Collection of information'' is 
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information before submitting the 
collection to OMB for approval. To comply with this requirement, FDA is 
publishing notice of the proposed collection of information set forth 
in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

    Regulatory Background--Section 1701(a)(4) of the Public Health 
Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research 
relating to health information. Section 903(d)(2)(C) of the FD&C Act 
(21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to 
drugs and other FDA regulated products in carrying out the provisions 
of the FD&C Act.
    FDA regulations require that an advertisement that makes claims 
about a prescription drug include a ``fair balance'' of information 
about the benefits and risks of the advertised product, in terms of 
both content and presentation (21 CFR 202.1(e)(5)(ii)). In part, ``[a]n 
advertisement for a prescription drug is false, lacking in fair 
balance, or otherwise misleading* * * 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* * *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* * *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'' (21 CFR 
202.1(e)(6)(i)). Further, the regulations state that an advertisement 
may be misleading if it ``[u]ses headline, subheadline, or pictorial or 
other graphic matter in a way that is misleading'' (21 CFR 
202.1(e)(6)(xviii)).
    Advertisements that draw attention to the name of the product but 
do not make representations about the product's indication(s) or dosage 
recommendations are called reminder advertisements. As a general 
matter, reminder ads may mention the proprietary and established name 
of the product and (optionally) contain information about the product's 
ingredients, dosage form, quantity, price, and manufacturer (21 CFR 
202.1(e)(2)(i)). Other written, printed, or graphic information is not 
prohibited in reminder ads as long as that information does not make a 
representation or suggestion relating to the product beyond those 
permitted.
Rationale. 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, 
rebates, and sweepstakes. Coupon 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.\2\ For example, a 
price incentive may not only act as an economic incentive to buy the 
product, but may also artificially enhance consumers' perceptions of 
the product's quality.\3\ In cases where consumers can readily test the 
performance of the products (termed ``experience'' goods\4\), this 
misperception is quickly corrected through the consumer's use of the 
product. However, because prescription drugs are both more complex and 
riskier than simpler experience products, misperceptions before product 
use are a serious concern.
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    \2\ See for example, deGroot, I.M., G. Antonides, D. Read, et 
al., ``The Effects of Direct Experience on Consumer Product 
Evaluation,'' Journal of Socio-Economics, 38(3), 509-519, 2009; 
DelVecchio, D., D.H. Henard, and T.H. Freling, ``The Effect of Sales 
Promotion on Post-Promotion Brand Preference: A Meta-Analysis,'' 
Journal of Retailing, 82(3), 203-213, 2006; Mico, C.C. and T.G. 
Chowdhury, ``The Effect of Message's Regulatory Focus and Product 
Type on Persuasion,'' Journal of Marketing Theory and Practice, 
18(2), 181-190, 2010.
    \3\ LeClerc, F. and J.D.C. Little, ``Can Advertising Copy Make 
FSI Coupons More Effective?,'' Journal of Marketing Research, 34(4), 
473-484, 1997.
    \4\ Wolk, A. and C. Ebling, ``Multi-Channel Price 
Differentiation: An Empirical Investigation of Existence and 
Causes,'' International Journal of Research in Marketing, 27(2), 
142-150, 2010.
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    Price incentives may mislead consumers because consumers may use 
the incentives as cues about product quality. 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.\5\ Thus, price incentives may 
have the potential to act as an ``inference rule'' (or heuristic\6\) 
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.\7\ If the 
promotional offer is used as a mental heuristic in such a way as to 
result in a misleading impression of the product, however, this raises 
concerns.
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    \5\ Johar, G.V. and C.J. Simmons, ``The Use of Concurrent 
Disclosures to Correct Invalid Inferences,'' Journal of Consumer 
Research, 26(4), 307, 2000.
    \6\ Chaiken, S., A. Liberman, and A. Eagly, ``Heuristic and 
Systematic Proocessing Within and Beyond the Persuasion Context,'' 
1989; In J.S. Uleman and J.A. Bargh (Eds.), Unintended Thought 
(chapter 7, p. 212-252), Guilford Press: New York; Bettman J.R., 
M.F. Luce, and J.W. Payne, ``Constructive Consumer Choice 
Processes,'' Journal of Consumer Research, 25(3), 187-217, 1998.
    \7\ Alba, J.W. and H. Marmorstein, ``The Effects of Frequency 
Knowledge on Consumer Decision Making,'' Journal of Consumer 
Research, 14(1), 14-25, 1987; Inman, J.J., L. McAlister, and W.D. 
Hoyer, ``Promotion Signal: Proxy for a Price Cut?,'' Journal of 
Consumer Research, 17(1), 74-81, 1990.
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    It may be possible to encourage more thorough processing of 
information and reduce reliance on heuristics through the inclusion of 
additional information designed to qualify and be processed at the same 
time as the claim in question. For example, disclosures (statements 
that qualify, limit, or explain a particular claim) are intended to be 
an information remedy to combat potential deception.\8\ Research is 
mixed on the

[[Page 57800]]

effectiveness of disclosures, particularly those that take the form of 
a disclaimer.\9\ However, there may be other ways to add information 
that is effective in changing processing. One possibility is including 
specific information about a prescription drug product's efficacy from 
labeling. This information may act as a signal with regard to the 
quality of the information (good or bad). By extension, this signal may 
affect the use of processing heuristics. Depending on the type of 
signal and the extent to which consumers process the signal, full 
elaboration of the product information may be enhanced (as use of 
heuristics decreases).
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    \8\ FTC (Federal Trade Commission) (1983), Federal Trade 
Commission policy statement on deception, appended to Cliffdale 
Associates, Inc., 103 F.T.C. 110 (1984), Available at http://www.ftc.gov/bcp/policystmt/ad-decept.htm, Last accessed September 8, 
2010; Hoy, M.G and M.O. Lwin, ``An International Perspective of 
Online Disclosure Information: A Comparison of Banner Ad Disclosures 
from United States, United Kingdom and Singapore Websites,'' Journal 
of Consumer Policy, 31, 327-347, 2008.
    \9\ See, for example, France, K.R. and P.F. Bone, ``Policy 
Makers' Paradigms and Evidence From Consumer Interpretations of 
Dietary Supplement Labels,'' Journal of Consumer Affairs, 39(1), 27-
51, 2005; Mason, M.J., D.L. Scammon, and X. Fang, ``The Impact of 
Warnings, Disclaimers and Product Experience on Consumers' 
Perceptions of Dietary Supplements,'' Journal of Consumer Affairs, 
41(1) 74-99, 2007.
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    Consumers vary in their reactions to promotions such as coupons 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.\10\ 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.
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    \10\ Garretson, J.A. and S. Burton, ``Highly Coupon and Sale 
Prone Consumers: Benefits Beyond Price Savings,'' Journal of 
Advertising Research, 43, 162-172, 2003.
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    While promotions have been extensively studied in the context of 
package goods, information on their effects in DTC prescription drug 
ads is limited. One relevant study\11\ 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), 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. 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). The current study will expand on this initial 
study by investigating a variety of promotional offers, recruiting a 
wider range of the target audience from malls and online, measuring 
traits that may predispose individuals to be susceptible to coupon 
influence, and by exploring the effects of disclosures on the 
processing of product information.
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    \11\ Bhutada, N.S., C.L. Cook, and M. Perri, ``Consumer 
Responses to Cupons in Direct-to-Consumer Advertising of 
Prescription Drugs,'' Health Marketing Quarterly, 26, 333-346, 2009.
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    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) 
comprehension of product risks and benefits, and (3) strongly held 
beliefs that may act as potential moderators. The study will also 
explore ways in which additional contextual information can be used to 
enhance processing of the product information in the advertisement.\12\
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    \12\ Because FDA does not have the authority to regulate 
prescription drug pricing we will not examine prescription drug 
prices.
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Design Overview
    This study will examine type of promotional offer (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 reminder ad, prescription drug full product ad, and 
over-the-counter (OTC) drug ad\13\) in a medium prevalence medical 
condition (defined as 10 percent prevalence in the adult U.S. 
population). The study will be administered in two modes, online and 
mall-intercept, in order to assess the effects of mode on study 
results. The following table illustrates the design; the specific 
promotional offers examined will be determined through pretesting. This 
study is experimental in method: participants will be randomly assigned 
to condition.
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    \13\ Prescription drug full product advertisements contain 
information about both benefits and risks, whereas prescription drug 
reminder advertisements do not contain this information. OTC drug 
advertisements contain benefit information but not risk information, 
thus making it a good choice for an experimental comparison.
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Main Study Design

 
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                                                                                      Type of Advertisement
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                                                    Full Product                            Reminder                                 OTC
     Promotional Offer  (examples)     -----------------------------------------------------------------------------------------------------------------
 
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Free trial offer                                   Online               Mall             Online               Mall             Online               Mall
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Buy one, get one free                              Online               Mall             Online               Mall             Online               Mall
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Money off cost                                     Online               Mall             Online               Mall             Online               Mall
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Money back guarantee                               Online               Mall             Online               Mall             Online               Mall
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Control: No offer                                  Online               Mall             Online               Mall             Online               Mall
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    We also propose to conduct a supplementary exploratory study to 
examine the influence of additional information as a form of context. 
The supplementary study will examine the effect of some forms of 
qualifying context in a full product prescription drug ad. This 
supplementary study will examine type of context (for example, 
additional information about product risks, additional information 
about product benefits, additional information

[[Page 57801]]

about both risks and benefits, and no additional information) in three 
different promotional offers (money back guarantee and two others) in a 
medium prevalence medical condition (defined previously). This 
supplemental study will be conducted online. One type of offer examined 
will be money back guarantee; we will choose the other two types of 
promotional offers based on the results of the main study. The exact 
wording of the qualifying context to be examined will be determined 
through pretesting. This study is experimental in method: Participants 
will be randomly assigned to condition.
Supplementary Study Design

 
------------------------------------------------------------------------
                                      Type of Offer
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Type of Context      Money Back       Offer 2  To be     Offer 3  To be
   (examples)        Guarantee          determined         determined
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Additional       .................  .................  .................
 information
 about risk
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Additional       .................  .................  .................
 information
 about efficacy
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Additional       .................  .................  .................
 information
 about efficacy
 and risk
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Control: No      .................  .................  .................
 Context
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    Interviews are expected to last no more than 20 minutes. A total of 
10,000 participants will be involved in the pretesting and two phases 
of the study. This will be a one time (rather than annual) collection 
of information.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                No. of       Annual Frequency     Total Annual      Hours per
      21 CFR Section          Respondents      per Response         Responses       Response       Total Hours
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Pretests                             1,000                   1             1,000           .33               330
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Main study: online                   3,750                   1             3,750           .33             1,238
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Main study: mall intercept           2,250                   1             2,250           .33               743
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Supplementary study                  3,000                   1             3,000           .33               990
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Total                               10,000  ..................  ................  ............             3,301
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23632 Filed 9-21-10; 8:45 am]
BILLING CODE 4160-01-S