[Federal Register Volume 73, Number 152 (Wednesday, August 6, 2008)]
[Notices]
[Pages 45773-45776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18091]


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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.

DATES: Fax written comments on the collection of information by 
September 5, 2008.

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 <a href="/cdn-cgi/l/email-protection#3153505644585d5043715e5c531f545e411f565e47"><span class="__cf_email__" data-cfemail="cfadaea8baa6a3aebd8fa0a2ade1aaa0bfe1a8a0b9">[email protected]</span></a>. 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),

[[Page 45774]]

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 if 
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) 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. Since 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 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

[[Page 45775]]

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, 5 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, 5 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% 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, +/- 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: (1) Change from a mall-intercept to an 
Internet administered procedure, (2) limit use of the AMP to a sub-
experiment consisting of only five of the experimental conditions, (3) 
add questions addressing the advertised (fictitious) drug's benefits, 
and (4) 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 by the 
commenters and by 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: (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 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      Total
        21 CFR Section            Respondents        per Response        Responses           Response      Hours
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 393(b)(2)(c)                     1,600                  1              1,600                .03   48
 Screener, pretesting
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 393(b)(2)(c)                       800                  1                800                .16  128
 Questionnaire, pretesting
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 393(b)(2)(c)                     4,800                  1              4,800                .03  144
 Screener, study
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 393(b)(2)(c)                     2,400                  1              2,400                .25  600
 Questionnaire, study
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Total                                                                                                      930
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 45776]]

    Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18091 Filed 8-5-08; 8:45 am]
BILLING CODE 4160-01-S


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