[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Notices]
[Pages 38663-38666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16628]


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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.

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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 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 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., 
P150-400B, 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 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.
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    \1\ http://www.ahrq.gov/fund/cerfactsheets/. Last accessed May 
23, 2011.
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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\
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    \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.
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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.
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    \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.
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    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.
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    \8\ Applications for FDA Approval to Market a New Drug, 21 CFR 
314.126. (2008), retrieved from http://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.
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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)
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            Type of Ad                  Labeling of Comparison Drug
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                                      Named       Unnamed      Control
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Print............................  ...........  ...........  ...........
Television.......................  ...........  ...........  ...........
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    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\
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                                                      No. of
            Activity                  No. of       responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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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
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    Total.......................  ..............  ..............  ..............  ..............           3,320
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\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