Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Comparative Direct-to-Consumer Advertising, 38663-38666 [2011-16628]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES6
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
Summary of FDA Survey Research
Results, Final Report, November 19,
2004,’’ accessed online at https://
www.fda.gov/downloads/Drugs/
ScienceResearch/ResearchAreas/
DrugMarketingAdvertisingand
CommunicationsResearch/
UCM152860.pdf.
2. Aikin, K.J., ‘‘Consumer Comprehension
and Preference for Variations in the
Proposed Over-the-Counter Drug
Labeling Format, Final Report,’’ 1998.
3. Vigilante, W.J. and M.S. Wogalter, ‘‘The
Preferred Order of Over-the-Counter
(OTC) Pharmaceutical Label
Components,’’ Drug Information Journal,
vol. 31, pp. 973–988, 1997.
4. Levy, A.S., S.B. Fein, and R.E. Schucker,
‘‘More Effective Nutrition Label Formats
Are Not Necessarily More Preferred, ’’
Journal of the American Dietetic
Association, vol. 92, pp. 1230–1234,
1992.
5. Lorch, R. and E. Lorch, ‘‘Effects of
Organizational Signals on TextProcessing Strategies,’’ Journal of
Educational Psychology, vol. 87, pp.
537–544, 1995.
6. Lorch, R. and E. Lorch, ‘‘Effects of
Organizational Signals on Free Recall of
Expository Text,’’ Journal of Educational
Psychology, vol. 88, pp. 38–48, 1996.
7. Lorch, R., E. Lorch, and W. Inman, ‘‘Effects
of Signaling Topic Structure on Text
Recall,’’ Journal of Educational
Psychology, vol. 85, pp. 281–290, 1993.
8. Schwartz, L.M., S. Woloshin, and H.G.
Welch, ‘‘Using a Drug Facts Box to
Communicate Drug Benefits and Harms:
Two Randomized Trials,’’ Annals of
Internal Medicine, vol. 150, pp. 516–527,
2009, accessed online at https://
www.annals.org/cgi/content/full/
0000605-200904210-00106v1.
9. Webb, T.L. and P. Sheeran, ‘‘Does
Changing Behavioral Intentions
Engender Behavior Change? A MetaAnalysis of the Experimental Evidence,’’
Psychological Bulletin, vol. 132, pp. 249–
268, 2006.
10. ‘‘Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental Study:
Presentation of Quantitative
Effectiveness Information to Consumers
in Direct-to-Consumer (DTC) Television
and Print Advertisements for
Prescription Drugs,’’ Federal Register,
vol. 75, pp. 373–379, January 5, 2010.
11. ‘‘Agency Information Collection
Activities; Proposed Collection;
Comment Request; Study of Clinical
Efficacy Information in Professional
Labeling and Direct-to-Consumer Print
Advertisements for Prescription Drugs,’’
Federal Register, vol. 75, pp. 34142–
34146, June 16, 2010.
12. FDA, About the Center for Drug
Evaluation and Research Page, DDMAC
Research, (https://www.fda.gov/
AboutFDA/CentersOffices/CDER/ucm
090276.htm).
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
Dated: June 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–16552 Filed 6–30–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No FDA–2011–N–0457]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Comparative Direct-toConsumer Advertising
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 of Comparative
Direct-to-Consumer (DTC) Advertising.
This study is designed to explore how
consumers understand and interpret
DTC ads that explicitly compare the
efficacy, dosing, and risks, among other
items, of two similar drugs whether
comparisons are named or unnamed.
DATES: Submit either electronic or
written comments on the collection of
information by August 30, 2011.
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.,
P150–400B, 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
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
38663
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 of Comparative
Direct-to-Consumer (DTC) Advertising
Regulatory Background—(OMB Control
No. 0910–New)
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the Food and
Drug Administration (FDA) to conduct
research relating to health information.
Section 903(b)(2)(c) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 393(b)(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.
Regulations specify that sponsors
cannot make comparative efficacy
claims in advertising for prescription
drugs without substantial evidence,
most often in the form of wellcontrolled clinical trials, to support
such claims (21 U.S.C. 202.1(e)(6)(ii); 21
U.S.C. 314.126). FDA has permitted
some comparisons based on labeled
attributes, such as indication, dosing,
and mechanism of action. When
substantial evidence does not yet exist,
sponsors may use communication
E:\FR\FM\01JYN1.SGM
01JYN1
38664
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
techniques that invite implicit
comparisons, such as making indirect
comparisons, using comparative visuals,
and using vaguer language. This study
is designed to apply the existing
comparative advertising literature to
DTC advertising, where little research
has been conducted to date.
Moreover, as part of the American
Recovery and Reinvestment Act of 2009
(ARRA), the Agency for Healthcare
Research and Quality (AHRQ) is in the
process of securing a large compendium
of information on the comparative
effectiveness of medical treatments in
14 priority medical conditions,
including: Arthritis, cancer, dementia,
depression, diabetes, and substance
abuse.1 As part of this process, they will
fund a set of CHOICE (Clinical and
Health Outcomes Initiative in
Comparative Effectiveness) studies
designed to explore comparative
effectiveness. When this large project is
completed, FDA will have additional
information to consider when regulating
DTC advertising. It is possible that more
DTC advertising will be comparative in
nature. In preparation for this change,
FDA is embarking on the proposed
research to ensure that it has adequate
information to assess whether
comparative DTC ads provide truthful
and nonmisleading information to
consumers.
products, such as electronics, food
products, and automobiles.
Marketing and advertising studies
have investigated the influence of
comparative ads, particularly in contrast
to noncomparative ads.2 Research
specifically investigating the effects of
comparative advertising on consumer
attitudes—including attitudes toward
the ad, the brand, and product use—has
produced mixed results.3 The research
findings on the superiority of
comparative versus noncomparative ads
on purchase intentions, however, have
been more conclusive. Relative to
noncomparative ads, comparative ads
were shown to result in greater purchase
intentions.4 Finally, other evidence
suggests that there may be more
potential for consumers to confuse
brands when viewing comparative
versus noncomparative ads. Brands
advertised in a comparative format were
shown to be more likely to be perceived
as similar to the leading brand than
brands advertised in a noncomparative
format.5
few DTC ads include efficacy-based
comparisons; 9 however, this may
change given the current national focus
on comparative effectiveness research.
Given the growing opportunities for
comparative prescription drug
advertising, the present study aims to
investigate how consumers interpret
and react to DTC comparative drug ads.
Specifically, the study will explore two
types of drug comparisons in DTC ads:
(1) Drug efficacy comparisons; and (2)
other evidence-based comparisons, such
as dosing, mechanism of action, and
indication. The study findings will
inform FDA of relevant consumer issues
relating to comparative DTC advertising.
mstockstill on DSK4VPTVN1PROD with NOTICES6
A. Comparative Advertising
Comparative advertisements typically
compare two or more named or
recognizably presented brands of the
same product category, although some
comparative advertisements implicitly
compare a product to other brands by
making superiority statements (e.g.,
‘‘Only Brand A can be cooked in five
minutes or less.’’). These ads are
frequently used for commercial
B. Comparative Prescription Drug
Advertisements
Despite extensive research on
comparative advertising of consumer
products and a limited number of
studies on how DTC ads could help
consumers compare drugs,6 very little
research has been conducted on
comparative prescription drug
advertisements.7 Consequently, it is
unclear whether these findings are
applicable to comparative drug ads or
how such claims influence consumers’
perceived efficacy of advertised drugs.
Currently, most DTC ad comparisons
focus on drug attributes, such as
differences in dosing or administration
method.8 Because few head-to-head
clinical trials have been conducted, very
C. Design Overview
This study will be conducted in two
concurrent parts with random
assignment to experimental condition.
The goal of Phase I is to: (a) Explore
how consumers understand and
interpret ads that explicitly compare the
efficacy of two similar drugs; and (b)
learn whether including the name of the
comparison drug affects comprehension
and perceptions. We have defined
named comparisons as ads that
explicitly compare the drug’s efficacy to
another named medication. An example
of this is: ‘‘Drug A was shown to be
more effective than Drug B at lowering
high cholesterol.’’ We have defined
unnamed comparisons as ads that
implicitly compare the drug’s efficacy to
other medications. An example of this
is: ‘‘Compared to other medications,
Drug A lowered cholesterol in more
patients.’’ The control condition will
not include a comparison to another
drug.
We will explore the issue of named
versus unnamed comparisons in print
ads and television ads in a 2×3 factorial
design as follows:
1 https://www.ahrq.gov/fund/cerfactsheets/. Last
accessed May 23, 2011.
2 Ang, S. H., and S. B. Leong (1994),
‘‘Comparative advertising: superiority despite
interference?’’, Asia Pacific Journal of Management,
11(1), 33–46; Demirdjian, Z. S. (1983), ‘‘Sales
effectiveness of comparative advertising: An
experimental field investigation,’’ Journal of
Consumer Research, 10, 362–364; Grewal, D., S.
Kavanoor, E. F. Fern; C. Costley, and J. Barnes
(1997), ‘‘Comparative versus noncomparative
advertising: a meta-analysis,’’ Journal of Marketing,
61(4), 1–15; Priester, J. R., J. Godek, D.J.
Nayakankuppum, and K. Park (2004), ‘‘Brand
congruity and comparative advertising: When and
why comparative advertisements lead to greater
elaboration,’’ Journal of Consumer Psychology,
14(1⁄2), 115–123.
3 See, for example, Grewal, D., S. Kavanoor, E. F.
Fern, C. Costley, and J. Barnes (1997), ‘‘Comparative
versus noncomparative advertising: A metaanalysis,’’ Journal of Marketing, 61(4), 1–15; Rogers,
J. C., and T. G. Williams, (1989), ‘‘Comparative
advertising effectiveness: Practitioners’ perceptions
versus academic research findings,’’ Journal of
Advertising Research, 29(5), 22–37.
4 Ang, S. H., S. B. Leong (1994), ‘‘Comparative
advertising: superiority despite interference?’’, Asia
Pacific Journal of Management, 11(1), 33–46;
Demirdjian, Z. S. (1983), ‘‘Sales effectiveness of
comparative advertising: An experimental field
investigation,’’ Journal of Consumer Research, 10,
362–364; Grewal, D., S. Kavanoor, E. F. Fern, C.
Costley, and J. Barnes (1997), ‘‘Comparative versus
noncomparative advertising: a meta-analysis,’’
Journal of Marketing, 61(4), 1–15; Miniard, P. W.,
M. J. Barone, R. L. Rose, and K. C. Manning (1994),
‘‘A re-examination of the relative persuasiveness of
comparative and noncomparative advertising,’’
Advances in Consumer Research, 21(1), 299–303.
5 Droge, C. and R. Y. Darmon (1987), ‘‘Associative
positioning strategies through comparative
advertising: Attribute versus overall similarity
approaches,’’ Journal of Marketing Research, 24,
377–388; Gorn, G. J.and C.B. Weinberg (1984), ‘‘The
impact of comparative advertising on perception
and attitude: Some positive findings, Journal of
Consumer Research, 11, 719–727; Iyer, E. S. (1988),
‘‘The influence of verbal content and relative
newness on the effectiveness of comparative
advertising,’’ Journal of Advertising,, 17(3), 15–21.
6 See, for example, Schwartz, L. M., S. Woloshin,
and H. G. Welch (2009), ‘‘Using a drug facts box to
communicate drug benefits and harms: two
randomized trials,’’ Annals of Internal Medicine,
150(8), 516–527; Hauber, A. B., A. F. Mohamed, F.
R. Johnson, and H. Falvey (2009), ‘‘Treatment
preferences and medication adherence of people
with Type 2 diabetes using oral glucose-lowering
agents,’’ Diabetic Medicine: A Journal of the British
Diabetic Association, 26(4), 416–424.
7 Mitra, A., J. Swasy, and K. Aikin (2006), ‘‘How
do consumers interpret market leadership claims in
direct-to-consumer advertising of prescription
drugs?’’, Advances in Consumer Research, 33, 381–
387.
8 Applications for FDA Approval to Market a New
Drug, 21 CFR 314.126. (2008), retrieved from https://
edocket.access.gpo.gov/cfr_2008/aprqtr/pdf/
21cfr314.126.pdf.
9 Mitra, A., J. Swasy, and K. Aikin (2006), ‘‘How
do consumers interpret market leadership claims in
direct-to-consumer advertising of prescription
drugs?’’, Advances in Consumer Research, 33, 381–
387.
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
E:\FR\FM\01JYN1.SGM
01JYN1
38665
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
TABLE 1—PROPOSED DESIGN OF PHASE I (2 × 3)
Type of Ad
Labeling of Comparison Drug
Named
Unnamed
Control
Print ..........................................................................................................................................................
Television .................................................................................................................................................
mechanism of action, and risk. In this
phase, we also examine the salience of
the comparison drug by manipulating
whether the comparison drug is named
in the ad or not. In this case, an example
of a named comparison is: ‘‘Drug A is
taken only once a month, unlike Drug B,
which you have to take every day.’’ An
example of a relevant unnamed
comparison is: ‘‘Drug A is the only
medication that treats both high
cholesterol and high blood pressure.’’
Finally, we will explore whether the
presence of a visual aid alters the
understanding of these presentations.
The control condition will not include
a comparison to another drug.
These factors will be combined in a
(2[type of ad] × 2[labeling of comparison
drug] × 2[presence of visual] × 4[type of
comparison] + 2[controls]) factorial
design. For ease of illustration, the
design is shown separately for print and
television ads.
In both phases, we will examine the
effects of these manipulated variables
on several dependent measures,
including perceived benefit and risk,
comprehension of benefit and risk
information, and behavioral intentions.
We will also include demographic
variables (such as gender and education
level), and other variables such as
health knowledge as covariates to
determine if they have any influence on
the measures of interest.
The sample will include
approximately 8,000 participants who
have been diagnosed with osteoarthritis
(Phase I) or high cholesterol (Phase II).
The protocol will take place via the
Internet. Participants will be randomly
assigned to view one print or one
television ad for a fictitious prescription
drug that treats either osteoarthritis or
high cholesterol and will answer
questions about it. The entire process is
expected to take no longer than 20
minutes. This will be a one time (rather
than annual) collection of information.
FDA estimates the burden of this
collection of information as follows:
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Screener ...............................................................................
Pretest ..................................................................................
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
No. of responses per
respondent
No. of respondents
Activity
PO 00000
Frm 00067
16,000
600
Fmt 4703
Sfmt 4703
Total annual
responses
1
1
E:\FR\FM\01JYN1.SGM
16,000
600
01JYN1
Average burden per response
.03 (2 min.)
.33 (20 min.)
Total hours
480
200
EN01JY11.013</GPH>
mstockstill on DSK4VPTVN1PROD with NOTICES6
The goal of Phase II is to determine
how ads that include evidence-based
comparisons are understood by
consumers. These ads often compare
factual characteristics from the drug
labels (e.g., dosing, mechanism of
action). These characteristics do not
necessarily affect drug efficacy, yet
consumers may infer that one drug is
better or more effective than another.
We will examine four such
comparisons: Indication, dosing,
38666
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
No. of responses per
respondent
No. of respondents
Activity
Total annual
responses
Average burden per response
Total hours
Main Study ...........................................................................
8,000
1
8,000
.33 (20 min.)
2,640
Total ..............................................................................
........................
........................
........................
........................
3,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Grants Management Contact
Gladys Melendez-Bohler, Office of
Acquisition and Grant Services (OAGS),
Food and Drug Administration, 5630
Fishers Lane, rm. 1078, Rockville, MD
20857, Tele.: 301–827–7175; e-mail:
Gladys-Melendez-Bohler@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.fda.gov/Food/NewsEvents/
default.htm.
[FR Doc. 2011–16628 Filed 6–30–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0012]
Food and Drug Administration (FDA)
and Marine Environmental Sciences
Consortium/Dauphin Island Sea Lab
Collaboration (U19)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
mstockstill on DSK4VPTVN1PROD with NOTICES6
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of a cooperative agreement
between the Center for Food Safety and
Applied Nutrition (CFSAN) and the
Marine Environmental Sciences
Consortium/Dauphin Island Sea Lab
(DISL). The goal of the DISL is marine
science education, basic and applied
marine science research, coastal zone
management policy, and educating the
general public.
DATES: Important dates are as follows:
1. The application due date is August
1, 2011.
2. The anticipated start date is
September, 2011.
3. The opening date is the date the
Funding Opportunity is published in
the Federal Register.
4. The expiration date is August 2,
2011.
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
Scientific/Programmatic Contact
Robert Dickey, Office of Food Safety,
Gulf Coast Seafood Laboratory, One
Iberville Dr., PO. D1–1, rm. 122 (HFS
400), Dauphin Island, AL 36528,. Tele.:
251–690–3368; e-mail:
Robert.Dickeyr@fda.hhs.gov.
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
SUPPLEMENTARY INFORMATION:
RFA–FD–11–015; 93.103.
A. Background
This FOA issued by the FDA/Office of
Food Safety is soliciting a sole source
grant application from the Dauphin
Island Sea Lab (DISL). FDA is
authorized to enforce the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
as amended (21 U.S.C. 301 et seq.). In
fulfilling its responsibilities under the
FD&C Act, FDA among other things,
directs its activities toward promoting
and protecting the public health by
ensuring the safety and security of foods
(Appendix A). To accomplish its
mission, FDA must stay abreast of the
latest developments in research and also
communicate with stakeholders about
complex scientific and public health
issues. Increased development of
research, education and outreach
partnerships with the Marine
Environmental Science ConsortiumDauphin Island Sea Lab (DISL) will
greatly contribute to FDA’s mission.
The DISL is one of Alabama’s most
valuable assets and adds immeasurably
to the quality of life in the state and
beyond. The DISL network of 21
institutions enrolls students worldwide
in degree programs delivered in
classrooms, laboratories, education
centers, and online. The DISL’s
nationally ranked programs, leadingedge research collaborations, and
innovative business partnerships
provide an environment to support
diverse multidisciplinary exchanges
with FDA. The scientific, public health
and policy expertise within FDA
provide opportunities for collaborations
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
that support the DISL mission and
strategic themes to provide access to
high-quality education, research
discovery, and knowledge-based
services responsive to both the promises
and demands of the state and the nation
in the new century.
B. Research Objectives
FDA Gulf Coast Seafood Laboratory
(GCSL) and the Marine Environmental
Science Consortium of the DISL (the
Parties) have a shared interest in
scientific progress in the diverse
disciplines that directly and indirectly
affect seafood safety and human and
animal health. The Parties also endorse
scientific training for faculty, students
and staff to foster a well-grounded
foundation in interdisciplinary fields in
which academia and government share
mutual interest.
The cooperative agreement will
establish terms of collaboration between
FDA and DISL to support these shared
interests that can be pursued through
programs of collaborative research,
public outreach, cooperative
international initiatives, disciplinary
training, and exchange of scientists and
staff, including a program of graduate
student internships.
The types of activities expected to
develop from this agreement include:
• Exchanges between university
faculty and staff and FDA scientists and
staff;
• Educational opportunities for
qualified students (graduate), staff
members and faculty members in the
Parties’ laboratories, classroom and
offices;
• Joint meetings for education and
research;
• Research collaborations;
• Cooperative international activities
including outreach; and
• Sharing of unique facilities and
equipment for increased cost
efficiencies for scientific endeavors;
• Promulgation and communication
of identified collaborative efforts
through appropriate means;
• Adjunct, affiliates and research
facility appointments for appropriate
FDA professional staff, provided that
appointment of such candidates will
advance specific programmatic
E:\FR\FM\01JYN1.SGM
01JYN1
]]>Agencies
[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Notices]
[Pages 38663-38666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16628]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No FDA-2011-N-0457]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Comparative Direct-to-Consumer
Advertising
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 of Comparative
Direct-to-Consumer (DTC) Advertising. This study is designed to explore
how consumers understand and interpret DTC ads that explicitly compare
the efficacy, dosing, and risks, among other items, of two similar
drugs whether comparisons are named or unnamed.
DATES: Submit either electronic or written comments on the collection
of information by August 30, 2011.
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.,
P150-400B, 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 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 of Comparative Direct-to-Consumer (DTC) Advertising
Regulatory Background--(OMB Control No. 0910-New)
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the Food and Drug Administration (FDA) to
conduct research relating to health information. Section 903(b)(2)(c)
of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
393(b)(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.
Regulations specify that sponsors cannot make comparative efficacy
claims in advertising for prescription drugs without substantial
evidence, most often in the form of well-controlled clinical trials, to
support such claims (21 U.S.C. 202.1(e)(6)(ii); 21 U.S.C. 314.126). FDA
has permitted some comparisons based on labeled attributes, such as
indication, dosing, and mechanism of action. When substantial evidence
does not yet exist, sponsors may use communication
[[Page 38664]]
techniques that invite implicit comparisons, such as making indirect
comparisons, using comparative visuals, and using vaguer language. This
study is designed to apply the existing comparative advertising
literature to DTC advertising, where little research has been conducted
to date.
Moreover, as part of the American Recovery and Reinvestment Act of
2009 (ARRA), the Agency for Healthcare Research and Quality (AHRQ) is
in the process of securing a large compendium of information on the
comparative effectiveness of medical treatments in 14 priority medical
conditions, including: Arthritis, cancer, dementia, depression,
diabetes, and substance abuse.\1\ As part of this process, they will
fund a set of CHOICE (Clinical and Health Outcomes Initiative in
Comparative Effectiveness) studies designed to explore comparative
effectiveness. When this large project is completed, FDA will have
additional information to consider when regulating DTC advertising. It
is possible that more DTC advertising will be comparative in nature. In
preparation for this change, FDA is embarking on the proposed research
to ensure that it has adequate information to assess whether
comparative DTC ads provide truthful and nonmisleading information to
consumers.
---------------------------------------------------------------------------
\1\ https://www.ahrq.gov/fund/cerfactsheets/. Last accessed May
23, 2011.
---------------------------------------------------------------------------
A. Comparative Advertising
Comparative advertisements typically compare two or more named or
recognizably presented brands of the same product category, although
some comparative advertisements implicitly compare a product to other
brands by making superiority statements (e.g., ``Only Brand A can be
cooked in five minutes or less.''). These ads are frequently used for
commercial products, such as electronics, food products, and
automobiles.
Marketing and advertising studies have investigated the influence
of comparative ads, particularly in contrast to noncomparative ads.\2\
Research specifically investigating the effects of comparative
advertising on consumer attitudes--including attitudes toward the ad,
the brand, and product use--has produced mixed results.\3\ The research
findings on the superiority of comparative versus noncomparative ads on
purchase intentions, however, have been more conclusive. Relative to
noncomparative ads, comparative ads were shown to result in greater
purchase intentions.\4\ Finally, other evidence suggests that there may
be more potential for consumers to confuse brands when viewing
comparative versus noncomparative ads. Brands advertised in a
comparative format were shown to be more likely to be perceived as
similar to the leading brand than brands advertised in a noncomparative
format.\5\
---------------------------------------------------------------------------
\2\ Ang, S. H., and S. B. Leong (1994), ``Comparative
advertising: superiority despite interference?'', Asia Pacific
Journal of Management, 11(1), 33-46; Demirdjian, Z. S. (1983),
``Sales effectiveness of comparative advertising: An experimental
field investigation,'' Journal of Consumer Research, 10, 362-364;
Grewal, D., S. Kavanoor, E. F. Fern; C. Costley, and J. Barnes
(1997), ``Comparative versus noncomparative advertising: a meta-
analysis,'' Journal of Marketing, 61(4), 1-15; Priester, J. R., J.
Godek, D.J. Nayakankuppum, and K. Park (2004), ``Brand congruity and
comparative advertising: When and why comparative advertisements
lead to greater elaboration,'' Journal of Consumer Psychology,
14(\1/2\), 115-123.
\3\ See, for example, Grewal, D., S. Kavanoor, E. F. Fern, C.
Costley, and J. Barnes (1997), ``Comparative versus noncomparative
advertising: A meta-analysis,'' Journal of Marketing, 61(4), 1-15;
Rogers, J. C., and T. G. Williams, (1989), ``Comparative advertising
effectiveness: Practitioners' perceptions versus academic research
findings,'' Journal of Advertising Research, 29(5), 22-37.
\4\ Ang, S. H., S. B. Leong (1994), ``Comparative advertising:
superiority despite interference?'', Asia Pacific Journal of
Management, 11(1), 33-46; Demirdjian, Z. S. (1983), ``Sales
effectiveness of comparative advertising: An experimental field
investigation,'' Journal of Consumer Research, 10, 362-364; Grewal,
D., S. Kavanoor, E. F. Fern, C. Costley, and J. Barnes (1997),
``Comparative versus noncomparative advertising: a meta-analysis,''
Journal of Marketing, 61(4), 1-15; Miniard, P. W., M. J. Barone, R.
L. Rose, and K. C. Manning (1994), ``A re-examination of the
relative persuasiveness of comparative and noncomparative
advertising,'' Advances in Consumer Research, 21(1), 299-303.
\5\ Droge, C. and R. Y. Darmon (1987), ``Associative positioning
strategies through comparative advertising: Attribute versus overall
similarity approaches,'' Journal of Marketing Research, 24, 377-388;
Gorn, G. J.and C.B. Weinberg (1984), ``The impact of comparative
advertising on perception and attitude: Some positive findings,
Journal of Consumer Research, 11, 719-727; Iyer, E. S. (1988), ``The
influence of verbal content and relative newness on the
effectiveness of comparative advertising,'' Journal of Advertising,,
17(3), 15-21.
---------------------------------------------------------------------------
B. Comparative Prescription Drug Advertisements
Despite extensive research on comparative advertising of consumer
products and a limited number of studies on how DTC ads could help
consumers compare drugs,\6\ very little research has been conducted on
comparative prescription drug advertisements.\7\ Consequently, it is
unclear whether these findings are applicable to comparative drug ads
or how such claims influence consumers' perceived efficacy of
advertised drugs.
---------------------------------------------------------------------------
\6\ See, for example, Schwartz, L. M., S. Woloshin, and H. G.
Welch (2009), ``Using a drug facts box to communicate drug benefits
and harms: two randomized trials,'' Annals of Internal Medicine,
150(8), 516-527; Hauber, A. B., A. F. Mohamed, F. R. Johnson, and H.
Falvey (2009), ``Treatment preferences and medication adherence of
people with Type 2 diabetes using oral glucose-lowering agents,''
Diabetic Medicine: A Journal of the British Diabetic Association,
26(4), 416-424.
\7\ Mitra, A., J. Swasy, and K. Aikin (2006), ``How do consumers
interpret market leadership claims in direct-to-consumer advertising
of prescription drugs?'', Advances in Consumer Research, 33, 381-
387.
---------------------------------------------------------------------------
Currently, most DTC ad comparisons focus on drug attributes, such
as differences in dosing or administration method.\8\ Because few head-
to-head clinical trials have been conducted, very few DTC ads include
efficacy-based comparisons; \9\ however, this may change given the
current national focus on comparative effectiveness research. Given the
growing opportunities for comparative prescription drug advertising,
the present study aims to investigate how consumers interpret and react
to DTC comparative drug ads. Specifically, the study will explore two
types of drug comparisons in DTC ads: (1) Drug efficacy comparisons;
and (2) other evidence-based comparisons, such as dosing, mechanism of
action, and indication. The study findings will inform FDA of relevant
consumer issues relating to comparative DTC advertising.
---------------------------------------------------------------------------
\8\ Applications for FDA Approval to Market a New Drug, 21 CFR
314.126. (2008), retrieved from https://edocket.access.gpo.gov/cfr_2008/aprqtr/pdf/21cfr314.126.pdf.
\9\ Mitra, A., J. Swasy, and K. Aikin (2006), ``How do consumers
interpret market leadership claims in direct-to-consumer advertising
of prescription drugs?'', Advances in Consumer Research, 33, 381-
387.
---------------------------------------------------------------------------
C. Design Overview
This study will be conducted in two concurrent parts with random
assignment to experimental condition. The goal of Phase I is to: (a)
Explore how consumers understand and interpret ads that explicitly
compare the efficacy of two similar drugs; and (b) learn whether
including the name of the comparison drug affects comprehension and
perceptions. We have defined named comparisons as ads that explicitly
compare the drug's efficacy to another named medication. An example of
this is: ``Drug A was shown to be more effective than Drug B at
lowering high cholesterol.'' We have defined unnamed comparisons as ads
that implicitly compare the drug's efficacy to other medications. An
example of this is: ``Compared to other medications, Drug A lowered
cholesterol in more patients.'' The control condition will not include
a comparison to another drug.
We will explore the issue of named versus unnamed comparisons in
print ads and television ads in a 2x3 factorial design as follows:
[[Page 38665]]
Table 1--Proposed Design of Phase I (2 x 3)
------------------------------------------------------------------------
Type of Ad Labeling of Comparison Drug
------------------------------------------------------------------------
Named Unnamed Control
------------------------------------------------------------------------
Print............................ ........... ........... ...........
Television....................... ........... ........... ...........
------------------------------------------------------------------------
The goal of Phase II is to determine how ads that include evidence-
based comparisons are understood by consumers. These ads often compare
factual characteristics from the drug labels (e.g., dosing, mechanism
of action). These characteristics do not necessarily affect drug
efficacy, yet consumers may infer that one drug is better or more
effective than another. We will examine four such comparisons:
Indication, dosing, mechanism of action, and risk. In this phase, we
also examine the salience of the comparison drug by manipulating
whether the comparison drug is named in the ad or not. In this case, an
example of a named comparison is: ``Drug A is taken only once a month,
unlike Drug B, which you have to take every day.'' An example of a
relevant unnamed comparison is: ``Drug A is the only medication that
treats both high cholesterol and high blood pressure.'' Finally, we
will explore whether the presence of a visual aid alters the
understanding of these presentations. The control condition will not
include a comparison to another drug.
These factors will be combined in a (2[type of ad] x 2[labeling of
comparison drug] x 2[presence of visual] x 4[type of comparison] +
2[controls]) factorial design. For ease of illustration, the design is
shown separately for print and television ads.
[GRAPHIC] [TIFF OMITTED] TN01JY11.013
In both phases, we will examine the effects of these manipulated
variables on several dependent measures, including perceived benefit
and risk, comprehension of benefit and risk information, and behavioral
intentions. We will also include demographic variables (such as gender
and education level), and other variables such as health knowledge as
covariates to determine if they have any influence on the measures of
interest.
The sample will include approximately 8,000 participants who have
been diagnosed with osteoarthritis (Phase I) or high cholesterol (Phase
II). The protocol will take place via the Internet. Participants will
be randomly assigned to view one print or one television ad for a
fictitious prescription drug that treats either osteoarthritis or high
cholesterol and will answer questions about it. The entire process is
expected to take no longer than 20 minutes. This will be a one time
(rather than annual) collection of information.
FDA estimates the burden of this collection of information as
follows:
Table 4--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
No. of
Activity No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Screener........................ 16,000 1 16,000 .03 (2 min.) 480
Pretest......................... 600 1 600 .33 (20 min.) 200
[[Page 38666]]
Main Study...................... 8,000 1 8,000 .33 (20 min.) 2,640
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 3,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16628 Filed 6-30-11; 8:45 am]
BILLING CODE 4160-01-P
