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, 57798-57801 [2010-23632]
Download as PDF
<![CDATA[
57798
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices
Address: 2500 NW. 79th Avenue,
Suite 200, Miami, FL 33122.
Date Revoked: August 26, 2010.
Reason: Failed to maintain a valid
bond.
Sandra L. Kusumoto,
Director, Bureau of Certification and
Licensing.
[FR Doc. 2010–23679 Filed 9–21–10; 8:45 am]
BILLING CODE 6730–01–P
FEDERAL MARITIME COMMISSION
Rescission of Order of Revocation
Notice is hereby given that the Order
revoking the following license is being
rescinded by the Federal Maritime
Commission pursuant to section 19 of
the Shipping Act of 1984 (46 U.S.C.
Chapter 409) and the regulations of the
Commission pertaining to the licensing
of Ocean Transportation Intermediaries,
46 CFR Part 515.
License Number: 004063F.
Name: VIP Transport, Inc.
Address: 2703 Wardlow Road,
Corona, CA 91720.
Order Published: FR: 9/1/2010
(Volume 75, No. 169, Pg. 53697).
Sandra L. Kusumoto,
Director, Bureau of Certification and
Licensing.
[FR Doc. 2010–23675 Filed 9–21–10; 8:45 am]
BILLING CODE 6730–01–P
FEDERAL MARITIME COMMISSION
emcdonald on DSK2BSOYB1PROD with NOTICES
Ocean Transportation Intermediary
License Applicants
Notice is hereby given that the
following applicants have filed with the
Federal Maritime Commission an
application for a license as a NonVessel-Operating Common Carrier
(NVO) and/or Ocean Freight Forwarder
(OFF)—Ocean Transportation
Intermediary (OTI) pursuant to section
19 of the Shipping Act of 1984 as
amended (46 U.S.C. Chapter 409 and 46
CFR 515). Notice is also hereby given of
the filing of applications to amend an
existing OTI license or the Qualifying
Individual (QI) for a license.
Interested persons may contact the
Office of Transportation Intermediaries,
Federal Maritime Commission,
Washington, DC 20573.
Allright Shipping, Inc. (NVO & OFF),
1350 Bronx River Avenue, Bronx, NY
10472. Officer: Denzil Barker,
President, (Qualifying Individual).
Application Type: New NVO & OFF
License.
Cambria Global Logistics, LLC (OFF),
12140 Quilting Lane, Boca Raton, FL
VerDate Mar<15>2010
17:32 Sep 21, 2010
Jkt 220001
33428. Officers: Panu Virtanen,
Managing Member, (Qualifying
Individual). Kathleen Virtanen,
Managing Member. Application Type:
New OFF License.
Glory Express Inc. (NVO), 19825
Hamilton Avenue, Torrance, CA
90502. Officer: JinYoung Bae,
President/Secretary/CFO, (Qualifying
Individual). Application Type: QI
Change.
K&K Express, LLC dba K2 Logistics
(NVO & OFF), 2980 Commers Drive,
#100, Eagan, MN 55121. Officers:
Wanda L. Dessent, Vice PresidentInternational-Houston, (Qualifying
Individual). Christiaan Walhof, CEO/
President/CFO. Application Type: QI
Change.
Overseas Cargo, Inc. (NVO & OFF), 9614
Pondwood Road, Boca Raton, FL
33428. Officer: Suramya (A.K.A. Ron)
T. Atapattu, President/Secretary/
Treasurer/Director, (Qualifying
Individual). Application Type: New
NVO & OFF License.
Smile Cha dba SMH Global Transport
(NVO), 8636 York Circle, La Palma,
CA 90623. Officer: Smile Cha, Sole
Proprietor, (Qualifying Individual).
Application Type: New NVO License.
Westwind Shipping and Logistics, Inc.
(NVO), 38 West 32nd Street, Suite
1309B, New York, NY 10001. Officer:
Harry Taurani, President/Secretary/
Treasurer/CFO, (Qualifying
Individual). Application Type: New
NVO License.
World Class Solutions LLC (NVO &
OFF), 3901 NW 79th Avenue, Suite
230, Doral, FL 33166. Officer:
Jorgelina G. Marsaglia, President,
(Qualifying Individual). Application
Type: New NVO & OFF License.
Dated: September 17, 2010.
Karen V. Gregory,
Secretary.
[FR Doc. 2010–23676 Filed 9–21–10; 8:45 am]
BILLING CODE 6730–01–P
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:
PO 00000
Notice.
Frm 00063
Fmt 4703
Sfmt 4703
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-toConsumer 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.
DATES: Submit either electronic or
written comments on the collection of
information by November 22, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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,
Elizabeth.Berbakos@fda.hhs.gov.
SUMMARY:
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
SUPPLEMENTARY INFORMATION:
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.
E:\FR\FM\22SEN1.SGM
22SEN1
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices
emcdonald on DSK2BSOYB1PROD with NOTICES
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-toConsumer (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
VerDate Mar<15>2010
17:32 Sep 21, 2010
Jkt 220001
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 consumeroriented 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
2 See for example, deGroot, I.M., G. Antonides, D.
Read, et al., ‘‘The Effects of Direct Experience on
Consumer Product Evaluation,’’ Journal of SocioEconomics, 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.
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
57799
readily test the performance of the
products (termed ‘‘experience’’ goods4),
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.
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
heuristic6) 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.
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
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.
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 https://
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
E:\FR\FM\22SEN1.SGM
Continued
22SEN1
57800
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices
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).
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 pricequality 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.
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 study11 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.
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
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 ad13) 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.
Main Study Design
Type of Advertisement
Promotional
Offer
(examples)
Full Product
Reminder
OTC
Free trial offer
Online
Mall
Online
Mall
Online
Mall
Buy one, get
one free
Online
Mall
Online
Mall
Online
Mall
Money off cost
Online
Mall
Online
Mall
Online
Mall
Money back
guarantee
Online
Mall
Online
Mall
Online
Mall
Control: No offer
Online
Mall
Online
Mall
Online
Mall
emcdonald on DSK2BSOYB1PROD with NOTICES
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
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.
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.
11 Bhutada, N.S., C.L. Cook, and M. Perri,
‘‘Consumer Responses to Cupons in Direct-toConsumer Advertising of Prescription Drugs,’’
Health Marketing Quarterly, 26, 333–346, 2009.
12 Because FDA does not have the authority to
regulate prescription drug pricing we will not
examine prescription drug prices.
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.
VerDate Mar<15>2010
17:32 Sep 21, 2010
Jkt 220001
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
E:\FR\FM\22SEN1.SGM
22SEN1
57801
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices
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
Type of Context
(examples)
Money Back
Guarantee
Offer 2
To be determined
Offer 3
To be determined
Additional information about risk
Additional information about efficacy
Additional information about efficacy and risk
Control: No Context
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 BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Pretests
1,000
1
1,000
.33
330
Main study: online
3,750
1
3,750
.33
1,238
Main study: mall intercept
2,250
1
2,250
.33
743
Supplementary study
3,000
1
3,000
.33
990
Total
10,000
1There
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0447]
emcdonald on DSK2BSOYB1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices
Third-Party Review Under the Food
and Drug Administration
Modernization Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
3,301
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
VerDate Mar<15>2010
18:32 Sep 21, 2010
Jkt 220001
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection requirements for
the information collection in ‘‘Medical
Devices Third-Party Review under the
Food and Drug Administration
Modernization Act of 1997.’’
DATES: Submit either electronic or
written comments on the collection of
information by November 22, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
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,
including each proposed extension of an
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22SEN1.SGM
22SEN1
]]>Agencies
[Federal Register Volume 75, Number 183 (Wednesday, September 22, 2010)]
[Notices]
[Pages 57798-57801]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23632]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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
---------------------------------------------------------------------------
of information by November 22, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://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,
Elizabeth.Berbakos@fda.hhs.gov.
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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 https://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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\12\ Because FDA does not have the authority to regulate
prescription drug pricing we will not examine prescription drug
prices.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Main Study Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
Type of Advertisement
--------------------------------------------------------------------------------------------------------------------------------------------------------
Full Product Reminder OTC
Promotional Offer (examples) -----------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Free trial offer Online Mall Online Mall Online Mall
--------------------------------------------------------------------------------------------------------------------------------------------------------
Buy one, get one free Online Mall Online Mall Online Mall
--------------------------------------------------------------------------------------------------------------------------------------------------------
Money off cost Online Mall Online Mall Online Mall
--------------------------------------------------------------------------------------------------------------------------------------------------------
Money back guarantee Online Mall Online Mall Online Mall
--------------------------------------------------------------------------------------------------------------------------------------------------------
Control: No offer Online Mall Online Mall Online Mall
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
------------------------------------------------------------------------
Type of Context Money Back Offer 2 To be Offer 3 To be
(examples) Guarantee determined determined
------------------------------------------------------------------------
Additional ................. ................. .................
information
about risk
------------------------------------------------------------------------
Additional ................. ................. .................
information
about efficacy
------------------------------------------------------------------------
Additional ................. ................. .................
information
about efficacy
and risk
------------------------------------------------------------------------
Control: No ................. ................. .................
Context
------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Pretests 1,000 1 1,000 .33 330
----------------------------------------------------------------------------------------------------------------
Main study: online 3,750 1 3,750 .33 1,238
----------------------------------------------------------------------------------------------------------------
Main study: mall intercept 2,250 1 2,250 .33 743
----------------------------------------------------------------------------------------------------------------
Supplementary study 3,000 1 3,000 .33 990
----------------------------------------------------------------------------------------------------------------
Total 10,000 .................. ................ ............ 3,301
----------------------------------------------------------------------------------------------------------------
\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
