[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
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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