[Federal Register Volume 73, Number 250 (Tuesday, December 30, 2008)]
[Notices]
[Pages 79887-79889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31057]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-N-0451] (formerly Docket No. 2007N-0321)
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental
Evaluation of the Impact of Distraction on Consumer Understanding of
Risk and Benefit Information in Direct-to-Consumer Prescription Drug
Broadcast Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995. Due to an administrative error, this
document is being republished.
DATES: Fax written comments on the collection of information by January
29, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Experimental Evaluation of the Impact of Distraction on
Consumer Understanding of Risk and Benefit Information in Direct-to-
Consumer Prescription Drug Broadcast Advertisements.'' Also include the
FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Experimental Evaluation of the Impact of Distraction on Consumer
Understanding of Risk and Benefit Information in Direct-to-Consumer
Prescription Drug Broadcast Advertisements
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(b)(2)(c) of the Federal Food, Drug, and
Cosmetic Act (the 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 act.
FDA regulations require that advertisements that make claims about
a prescription drug include a ``fair balance'' of information about the
benefits and risks of advertised products, in terms of both content and
presentation. Ads can present information in ways that can optimize or
skew the relative balance of risks and benefits. Both healthcare
providers and consumers have expressed concerns to FDA about the
effectiveness of its regulation of manufacturers' Direct-to-Consumer
(DTC) prescription drug advertising, especially as it relates to
assuring balanced communication of risks compared with benefits.
One characteristic of DTC television broadcast ads is the use of
compelling visuals. Many assert that the visuals present during the
product risk presentation are virtually always positive in tone and
often depict product benefits. A consistently raised question is
whether advertising visuals of benefits interferes with consumers'
understanding and processing of the risk information in the ad's audio
or text.
The manner in which required risk information is presented in DTC
ads has been recently addressed in the Food and Drug Administration
Amendments Act of 2007 (FDAAA). Section 901(3) of FDAAA states that the
major statement in DTC broadcast ads ``shall be presented in a clear,
conspicuous and neutral manner.'' Further, the Secretary of Health and
Human Services ``shall establish standards for determining whether the
major statement is presented in such a manner.'' FDAAA does not define
how the objective of ``clear, conspicuous, and neutral'' is to be
achieved.
The purpose of the proposed study is, in part, to determine whether
the use of competing, compelling visual information about potential
drug benefits interferes with viewers' processing and comprehension of
risk information about drugs in DTC advertising or with their cognitive
representations of the drugs. Positive visual images could influence
the processing of risk-related information and the final representation
of the advertised drug in multiple ways. First, compelling visuals
could simply distract consumers from carefully considering and encoding
the risk information. To the extent that compelling visuals cause them
to attend to or to process risk information less, participants exposed
to risk information with simultaneous compelling positive visuals
should recall fewer risks (and perhaps fewer benefits) than do
participants exposed to the risk information without the positive
visuals. Second, compelling visuals may affect the way consumers think
about the brand, specifically their attitudes toward the advertised
brand. An attitude is simply an association between an object and a
degree of positivity or negativity. Thus, the impact of varying visual
displays during the presentation of audio risks may be manifested in
varying attitudes toward the brand. This is important because brand
attitudes may be an important determinant of future behavior toward the
brand. In contexts where product information is complex, initial
impressions based on more subtle processes may have as significant an
impact on behavioral tendencies as impressions based upon more
``cognitively-effortful'' factual information. Because visual cues are
typically easier to process than verbal information, initial attitudes
for this group are likely to be greatly influenced by these cues. Under
many circumstances, people rely much less on facts that they know, such
as the number of risks associated with, for example, ibuprofen, and
much more on general feelings they have, such as strong positivity
toward a brand, such as the Advil brand of ibuprofen. Compelling
visuals during the audio risk presentation of DTC broadcast
advertisements have the potential to lead a consumer to form a positive
opinion of a drug for no other reason than that it is presented in the
same context as positive images.
Another purpose of the present study is to examine the role of
textual elements in the processing of risk information. Sponsors often
place
[[Page 79888]]
superimposed text (``supers'') onto the screen to clarify spoken
information or to provide extra information that is not included in the
audio. For example, information that fulfills certain requirements
(such as adequate provision statements, for example ``See our ad in * *
*'') and limits claims of product use may appear. Providing verbatim
text repetition of the risks required to be in the audio portion in
broadcast ads may facilitate processing the risks, but only if viewers
pay attention to the text. Viewers' attention may be affected by both
the prominence of the textual information and the combined effects of
text prominence and different visual information. The proposed study
examines these associations.
A final purpose of this study is to provide FDA with information on
defining the presentation of the major statement as ``clear,
conspicuous, and neutral'' as required by FDAAA. We have limited data
about how consumers perceive risk and benefit information in DTC
broadcast ads as a function of exposure to different content and
presentations. Therefore, we do not fully understand the influence of
visual and textual factors on the conveyance of a balanced or
``neutral'' picture of the product.
This study will investigate the impact of visual distraction and
the interplay of different sensory modalities (oral, visual) used to
present risk and benefit information during a television prescription
drug advertisement. Data from this study will provide useful
information for FDA as it considers whether it is appropriate to
develop guidance to help improve how broadcast ads present a
prescription drug's risks and benefits. This study will also provide
preliminary data on how FDA might interpret the ``clear, conspicuous,
and neutral'' standard. The data should help us plan whether additional
research is needed to develop the standards called for in FDAAA.
Overview: To investigate the overall and interactive role of visual
images and text presentations during the audio presentation of risk
information in television DTC ads, we will create a variety of ads for
a new (fictitious) brand of high blood pressure medication. The ads
will vary only in the type of information shown on screen during the
presentation of required risk information (the ``major statement''). We
will conduct pretesting to determine whether participants will view one
version of the test ad two times or if the test ad will be viewed in
the context of other ads (``clutter reel''). Respondents will answer
questions about the test ad, including information about product risks
and benefits, whether they intend to ask the doctor about the product,
basic comprehension of the risk and benefit information, and their
general attitudes toward the product. This experimental design will
allow for comparisons between conditions in a controlled presentation
where only the visual information varies.
Design: The study includes two primary designs that, taken
together, investigate three different variables.
A one-way, five condition design will examine the impact of degree
of consistency between visuals presented during orally presented
(audio) risk information. The visuals will be either very consistent,
somewhat consistent, neutral, somewhat inconsistent, or very
inconsistent with the audio risk information. The consistent conditions
will visually reinforce the product risks by presenting the words of
the risks on the screen as they are being spoken. The inconsistent
conditions will reinforce the product's benefits by presenting visuals
that suggest blood pressure being decreased from high to normal levels.
The degree or magnitude of consistency will be manipulated by including
fewer pieces of information, interspersed with images of the fictitious
drug logo. A control or ``neutral'' condition will consist of showing
the brand logo during the entire audio risk presentation.
The second design will be a two-way factorial design combining each
level of one independent variable with each level of a second
independent variable. The first variable consists of three levels of
visual ``tone''--neutral, mildly positive, and highly positive. The
second variable consists of three levels of prominence of ``supers''--
level one, level two, and no super (control).
Because the control cell in each of the 2 designs will overlap
(neutral, no supers), both designs together will amount to a total of
13 separate ``cells'' and corresponding versions of advertisements for
the fictitious brand.
In a separate sub-experiment, five selected cells taken from across
the two designs will assess implicit attitudes using the Attitude
Misattribution Procedure (AMP). The questions asked of the participants
in the AMP conditions will be reduced in number to account for the
additional time needed to administer the AMP.
Eligible participants for the study (n=2,400, following pretesting)
will be recruited from Synovate Inc.'s online Internet panel. They will
be 40 years of age or older to increase the likelihood of including
members of the population most likely to have high blood pressure. At
least 30 percent of the recruited sample within each of the designs
will have equal to or less than a high school education. The
composition of participants in each format condition will be balanced
with respect to gender (50% female, +[sol]- 10%). Panel members who
meet age and education requirements will not be screened further for
disease condition.
Dependent Measures: The primary dependent variables are recall and
comprehension of risk and benefit information. We will also investigate
behavioral intention and attitudes toward the fictitious brand. In a
separate sub-experiment using only five cells throughout both designs,
we will use the AMP, in addition to some explicit measures, to collect
implicit attitude measures that should not be affected by social
desirability biases.
In the Federal Register of August 22, 2007 (72 FR 47051), FDA
published a 60-day notice requesting public comment on the information
collection provisions. Thirty commenters responded. In total, this
amounted to approximately 29 distinct comments that specifically
referenced the study. Of these, 12 were not PRA related. As a result of
the comments that were PRA-related, FDA made extensive modifications to
the study's methodology and design. As reflected in these
modifications, we agreed to do the following: Change from a mall-
intercept to an Internet administered procedure, limit use of the AMP
to a sub-experiment consisting of only five of the experimental
conditions, add questions addressing the advertised (fictitious) drug's
benefits, and make certain changes to the wording of the questions.
Changing the administration procedure also allows us to double our
sample size and test more conditions. In response to comments received
both from the commenters and from our peer reviewers, we also decided
to conduct significantly more pretesting than originally planned, to
address the suggestion that the test ad should be embedded in a clutter
reel of other ads and to test the validity of the stimulus
manipulations (the mocked up advertisements). We disagreed, primarily
because of time and complexity constraints, with suggestions to do the
following: (1) Add more independent variables, (2) recruit a different
set of participants, (3) change the use of Chinese characters in the
(now more limited) AMP-measured conditions, (4) add certain additional
dependent measures, (5) increase or decrease the number of behavioral
intention questions (both were requested), (6) control for baseline
[[Page 79889]]
attitudes (because this is not needed in an experimental design and we
are using a fictitious drug for the stimulus materials), or (7) get
industry approval and public comment on the mocked up ads.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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21 U.S.C. 1,600 1 1,600 .03 48
393(b)(2)(c)
Screener,
pretesting
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21 U.S.C. 800 1 800 .16 128
393(b)(2)(c)
Questionnaire
, pretesting
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21 U.S.C. 4,800 1 4,800 .03 144
393(b)(2)(c)
Screener,
study
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21 U.S.C. 2,400 1 2,400 .25 600
393(b)(2)(c)
Questionnaire
, study
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Total 920
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-31057 Filed 12-29-08; 8:45 am]
BILLING CODE 4160-01-S