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, 45773-45776 [E8-18091]
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Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Notices
a State’s programs and provides
assurances the programs will be
administered in conformity with the
specific requirements stipulated in title
IV–E. The plan must include all
applicable State statutory, regulatory, or
policy references and citation for each
requirement as well as supporting
documentation. A State may use the
pre-print format prepared by the
Children’s Bureau of the Administration
for Children and Families or a different
format on the condition that the format
used includes all of the title IV–E State
plan requirements of the Act.
Respondents: State and Territorial
Agencies (State Agencies) administering
or supervising the administration of the
title TV–B program.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses
Average
burden hours
per response
Total burden
hours
Title IV–E State Plan .......................................................................................
13
1
15
195
Estimated Total Annual Burden
Hours: 195.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication.
Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: July 30, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–17869 Filed 8–5–08; 8:45 am]
ACTION:
Notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Customer/Partner Service Surveys’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
In the
Federal Register of April 10, 2008 (73
FR 19510), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has
assignedOMB control number 0910–
0360. The approval expires on July 31,
2011. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17906 Filed 8–5–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
BILLING CODE 4160–01–S
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[Docket No. FDA–2008–N–0202] (formerly
Docket No. 2008N–0009)
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Customer/Partner Service Surveys
AGENCY:
Food and Drug Administration,
HHS.
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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-toConsumer Prescription Drug
Broadcast Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
baguilar@omb.eop.gov. 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),
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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.
mstockstill on PROD1PC66 with NOTICES
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-toConsumer (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
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Jkt 214001
‘‘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
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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
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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 PRArelated, 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 subexperiment 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 BURDEN1
No. of
Respondents
21 CFR Section
21 U.S.C. 393(b)(2)(c) Screener, pretesting
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
Hours
1,600
1
1,600
.03
48
800
1
800
.16
128
21 U.S.C. 393(b)(2)(c) Screener, study
4,800
1
4,800
.03
144
21 U.S.C. 393(b)(2)(c) Questionnaire, study
2,400
1
2,400
.25
600
mstockstill on PROD1PC66 with NOTICES
21 U.S.C. 393(b)(2)(c) Questionnaire, pretesting
Total
1There
930
are no capital costs or operating and maintenance costs associated with this collection of information.
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45776
Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Notices
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
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2008–0462]
Printing of Coast Guard Light Lists
Coast Guard, DHS.
Notice.
AGENCY:
ACTION:
SUMMARY: The Coast Guard publishes
Light List Volumes 1–4 and 6–7
annually; with Volume 5 being
published biennially. In order to adjust
to a new printing cycle, the Coast Guard
will not publish the 2008 editions of the
Light Lists as required by 33 CFR 72.05–
1 (50 FR 50904), except for Light List
Volume 5 (Mississippi River System).
The Coast Guard is changing the
publication cycle of the Light List so
that annual editions are available early
in each calendar year. Since the printing
of the 2007 editions occurred in
November 2007, they will remain
effective for approximately 14 months.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, email Mr. Frank Parker, U.S. Coast Guard
Headquarters, at frank.parker@uscg.mil
call or telephone him at 202–372–1551.
SUPPLEMENTARY INFORMATION: Between
the printing of editions, each Light List
is required to be kept up-to-date every
week by applying corrections published
in the applicable Coast Guard Local
Notices to Mariners or the National
Geospatial-Intelligence Agency’s (NGA)
Weekly Notice to Mariners. The
requirement to apply corrections is
stated in each volume. By applying the
corrections, mariners are able to
maintain up-to-date publications
regardless of the frequency of newly
printed editions. With the cost of each
Light List being between $35–$50,
mariners will not have to incur the costs
of the new editions in 2008. The 2009
editions of Volumes 1–4 and 6–7 will be
published in early 2009.
To ensure ample and adequate
notification is made to the mariner, the
Coast Guard will publish information
regarding this temporary change to the
printing cycle in the notices to mariners,
on the Coast Guard’s Navigation Center
(NAVCEN) Web site (https://
www.navcen.uscg.gov), and other forms
of communications. Coast Guard
inspectors will also be informed of this
temporary change.
Dated: July 23, 2008.
James A. Watson,
Rear Admiral, U.S. Coast Guard, Director of
Prevention Policy.
[FR Doc. E8–18084 Filed 8–5–08; 8:45 am]
BILLING CODE 4910–15–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice; 60-day notice and
request for comments; new collection,
1660–NW32; FEMA Form 90–152.
AGENCY:
SUMMARY: The Federal Emergency
Management Agency, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
agencies to take this opportunity to
comment on a new information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
notice seeks comments concerning the
FEMA Public Assistance Program
Customer Satisfaction Survey results to
measure program performance.
SUPPLEMENTARY INFORMATION: Executive
Order 12862 requires that all Federal
agencies survey customers to determine
the kind and quality of services they
want and their level of satisfaction with
existing services. The Government
Performance and Results Act (GPRA)
requires agencies to set missions and
goals, and measure performance against
them. FEMA will fulfill these
requirements by collecting customer
satisfaction with service and program
evaluation information through
administration of surveys of the Disaster
Assistance Directorate (DAD) external
customers.
Collection of Information
Title: FEMA Public Assistance
Program Customer Satisfaction Survey.
Type of Information Collection: New.
OMB Number: 1660–NW32.
Form Numbers: FEMA Form 90–152,
FEMA Public Assistance Program
Customer Satisfaction Survey.
Abstract: The purpose of the FEMA
Public Assistance Program Customer
Satisfaction Survey is to measure
program performance against standards
for performance and customer service:
measure achievement of GPRA
objectivities: and generally gauge and
make improvements to disaster services
that increase customer satisfaction and
program effectiveness.
Affected Public: Business or other forprofit, Not-for-profit, Farms, Federal
Government, State, Local and Tribal
Government.
Estimated Total Annual Hour Burden:
1,920 hours.
ANNUAL HOUR BURDEN
mstockstill on PROD1PC66 with NOTICES
PA Mailed Survey ................................................................
PA Focus Groups ................................................................
Total ..............................................................................
Estimated Cost: The estimated annual
cost to the Federal Government is
$348,678.57.
Comments: Written comments are
solicited to (a) Evaluate whether the
proposed data collection is necessary for
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No. of respondents
Frequency of
responses
Hour burden
per response
(hours)
Annual responses
Total annual
hour burden
(hours)
(A)
Project/activity (survey, form(s), focus group, worksheet,
etc.)
(B)
(C)
(D) = (A x B)
(E) = (C x D)
1
1
........................
0.3
12
........................
3,200
80
3,280
the proper performance of the agency,
including whether the information shall
have practical utility; (b) evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
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3,200
80
3,280
960
960
1,920
the methodology and assumptions used;
(c) enhance the quality, utility, and
clarity of the information to be
collected; and (d) minimize the burden
of the collection of information on those
who are to respond, including through
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]]>Agencies
[Federal Register Volume 73, Number 152 (Wednesday, August 6, 2008)]
[Notices]
[Pages 45773-45776]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18091]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 baguilar@omb.eop.gov. 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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Total 930
----------------------------------------------------------------------------------------------------------------
\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
