Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads, 34672-34677 [2015-14880]
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Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
annually, for a total of two responses.
We estimate the reporting burden to be
2 hours per response, for a total burden
of 4 hours. We estimate that two
respondents will submit one Form FDA
1993 report annually, for a total of two
responses. We estimate the reporting
burden to be 0.5 hours per response, for
a total burden of 1 hour. We estimate
that two respondents will submit one
Form FDA 1815 report annually, for a
total of two responses. We estimate the
reporting burden to be 0.5 hours per
response, for a total burden of 1 hour.
With regard to records maintenance,
we estimate that approximately two
recordkeepers will spend 0.05 hours
annually maintaining the additional
pasteurization records required by
§ 1210.15, for a total of 0.10 hours
annually.
No burden has been estimated for the
tagging requirement in § 1210.22
because the information on the tag is
either supplied by us (permit number)
or is disclosed to third parties as a usual
and customary part of the shipper’s
normal business activities (type of
product, shipper’s name and address).
Under 5 CFR 1320.3(c)(2), the public
disclosure of information originally
supplied by the Federal Government to
the recipient for the purpose of
disclosure to the public is not subject to
review by the Office of Management and
Budget under the Paperwork Reduction
Act. Under 5 CFR 1320.3(b)(2)), the
time, effort, and financial resources
necessary to comply with a collection of
information are excluded from the
burden estimate if the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary because they would occur in
the normal course of business activities.
Dated: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Food and Cosmetic Export Certificate
Applications Process’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
SUMMARY:
On April
23, 2015, the Agency submitted a
proposed collection of information
entitled, ‘‘Food and Cosmetic Export
Certificate Applications Process’’ 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 assigned OMB
control number 0910–0793. The
approval expires on May 31, 2018. 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: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–14879 Filed 6–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1794]
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Impact of Ad
Exposure Frequency on Perception
and Mental Processing of Risk and
Benefit Information in Direct-toConsumer Prescription Drug Ads
[Docket No. FDA–2014–N–2347]
AGENCY:
[FR Doc. 2015–14888 Filed 6–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
HHS.
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Food and Cosmetic Export Certificate
Applications Process
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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ACTION:
Notice.
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.
SUMMARY:
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Fax written comments on the
collection of information by July 17,
2015.
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:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910-New and
title ‘‘Impact of Ad Exposure Frequency
on Perception and Mental Processing of
Risk and Benefit Information in DirectTo-Consumer Prescription Drug Ads.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
DATES:
Impact of Ad Exposure Frequency on
Perception and Mental Processing of
Risk and Benefit Information in Directto-Consumer Prescription Drug Ads;
OMB Control Number 0910–NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to
conduct research relating to health
information. Section 1003(d)(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 FDAregulated products in carrying out the
provisions of the FD&C Act.
In a typical promotional campaign,
consumers may be exposed to a directto-consumer (DTC) prescription drug ad
any number of times. Perceptual and
cognitive effects of increased ad
exposure frequency have been studied
extensively using non-drug ads. For
instance, one study demonstrated that a
commercial message repeated twice
generates better recall than a message
broadcast only once (Ref. 1). Another
study demonstrated that increased ad
exposures improve product attitudes
and recall for product attributes,
particularly when the substance of the
repeat messages is varied (Ref. 2).
Generally, it has been argued that first
exposure to an ad results in attention,
second exposure affects learning of the
advertised message, and third and
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subsequent exposures reinforce the
learning effects of the second exposure
(Ref. 3). To our knowledge, the literature
concerning ad exposure frequency has
not been extended to include specific
attention to prescription drug ads.
Prescription drug ads are unique in that
they are required to provide both benefit
and risk information whereas other ad
types tend to include only benefit
information. The Office of Prescription
Drug Promotion (OPDP) plans to
examine the effects of variation in ad
exposure frequency on perception and
mental processing of risk and benefit
information in DTC prescription drug
ads through empirical research.
The main study will be preceded by
up to two pretests designed to delineate
the procedures and measures used in
the main study. Across pretests and the
main study, participants will be
individuals who have been diagnosed
with seasonal allergies. All participants
will be 18 years of age or older. We will
exclude individuals who work in
healthcare or marketing settings because
their knowledge and experiences may
not reflect those of the average
consumer. Participants will be recruited
in one of two geographic locations
(Washington, DC and Raleigh, North
Carolina) for in-person administration of
protocols.
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The experimental design is
summarized below. Participants will be
randomly assigned to view a
prescription drug ad one, two, or four
times as part of clutter reels embedded
in 42 minutes of TV programming. They
will then answer preprogrammed survey
questions on laptops. Measures are
designed to assess perception, memory,
judgments about the ad, intentions to
use the medication advertised, and
possible moderators of effects, such as
need for cognition and demographics.
The questionnaire is available upon
request.
TABLE 1—STUDY DESIGN
Episode #1
Episode #2
Experimental arm number
Clutter Reel 1
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1 (views ad 1 time) ....................
2 (views ad 2 times) ...................
3 (views ad 4 times) ...................
Clutter Reel 2
Clutter Reel 3
Clutter Reel 4
Clutter Reel 5
..........................
..........................
Mock DTC ad ..
..........................
..........................
..........................
..........................
Mock DTC ad ..
Mock DTC ad ..
..........................
..........................
Mock DTC ad ..
..........................
..........................
..........................
In the Federal Register of November
12, 2014 (79 FR 67172), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received five public
submissions. In the following section,
we outline the observations and
suggestions raised in the comments and
provide our responses. Comments that
are not PRA-relevant (e.g., ‘‘Ban DTC’’)
or do not relate to the proposed study
are not included below or addressed in
our responses.
(Comment from Valeant
Pharmaceuticals) Develop and publish a
strategic plan for how FDA will collate
and make use of data from all FDAsponsored studies concerning consumer
and physician perception and
comprehension of prescription drug
advertising and promotion.
(Response) The OPDP research Web
page (Ref. 4) has recently been updated
to reflect the current status of completed
and ongoing research. As stated on our
Web page, OPDP maintains an active
research program designed to
investigate applied and theoretical
issues in the communication of risk and
benefit information in DTC and
professional promotional prescription
drug materials. OPDP’s research
supports FDA’s goal of science-based
policy while maintaining its
commitment to protect the public
health. The research provides FDA
management with evidence that can be
considered along with other relevant
research in future policy decisions.
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(Comment from Valeant
Pharmaceuticals) Provide data to
confirm limiting the study recruitment
to Washington, DC and Raleigh Durham,
NC area is representative of the entire
United States.
(Response) The research questions
examined in this study (e.g., risk and
benefit recall as a function of the
number of target ad exposures) are
believed to apply to human judgment
and decision making and not to be
contingent upon geographic residence.
We acknowledge that collecting data
across a greater number of geographic
locations may provide value, but choose
to allocate our limited funding in ways
we believe more appropriately ensure
the integrity of the research. For
example, the requirement that
participants view 60 minutes of
programming led us to collect data in
person, which allows for us to supervise
participant engagement with the survey
and therefore ensure that stimuli are, in
fact, viewed. Although the current
research includes limited geographic
diversity, note that other forms of
diversity (e.g., gender, age, and race)
will be sought during recruitment and
accounted for in our analyses.
(Comment from Valeant
Pharmaceuticals) Six exposures during
the same 42-minute television program
are not reflective of how advertising is
delivered and could inadvertently bias
the results.
(Response) The study design has been
revised such that the experimental
groups will view the ad one, two, or
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Clutter Reel 6
Mock DTC ad
Mock DTC ad
Mock DTC ad
four times over the course of the 60minute viewing period. Additional
details about this change are provided
in later responses.
(Comment from Valeant
Pharmaceuticals) Consumer
comprehension of benefit and risk is not
solely based on the viewing of the DTC
TV ad in isolation. Consumer
comprehension should take into
account the role of the healthcare
professional and other materials.
(Response) We appreciate that
consumer judgment and decision
making often results from multiple
information sources. In many cases,
DTC TV ads serve as the first source of
information received, and therefore may
influence whether or not additional
information is sought, and ultimately
whether or not a product is requested
from a healthcare professional. Through
broad research on DTC advertising, we
seek to ensure that consumers are
appropriately informed about the risks
and benefits of prescription drugs across
all information sources, when viewed in
isolation or in combination with other
sources.
(Comment from Valeant
Pharmaceuticals) Because the study is
limited to one DTC TV ad and one
therapeutic area, the results should not
be broadly applied to other forms of
advertising or other therapeutic areas.
(Response) We agree that results
should not be broadly applied to other
forms of advertising. We do not agree
that results necessarily need be
restricted to the selected therapeutic
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area. Our primary research question for
the study is whether increasing ad
exposure frequency will result in
different risk or benefit perceptions than
less exposure to the ad. This question
pertains to human perception and
judgment and is not thought to be
unique to any particular therapeutic
area. Nonetheless, we agree that
replication of this research using other
forms of advertising and different
therapeutic areas would be valuable.
(Comment from Abbvie) It is not clear
how the proposed collection is
necessary for the proper performance of
FDA’s functions. It is difficult to
ascertain how the Agency will utilize
the results of this study within its
statutory authority. For example, should
the results of this study demonstrate
that the frequency of ad exposure
matters, how would the Agency modify
the airing frequency of DTC TV ads or
the frequency at which consumers are
exposed to the advertisements in a real
world setting? Rather than conduct this
study, we suggest that FDA resources
and taxpayer dollars would be better
directed to research that enhances the
quality of how we communicate benefit
and risk information to consumers
regardless of the medium and the
frequency of the exposure. Guidance is
needed on the best practices for
communicating benefit and risk
information to consumers who are
prescribed prescription drugs. This is
particularly important as the quality of
the communication has the power to
result in a better informed consumer.
(Response) This research reflects the
need to understand not only the
message that consumers receive, but
also the delivery of those messages, and
how that delivery influences perception,
judgment, and decision making. It may
be that full comprehension of benefit
information is achieved upon a single
exposure, whereas full comprehension
of risk information requires multiple
exposures. Insight on this topic may
allow FDA to make more informed
judgments regarding consumer
information processing of DTC
television ads.
(Comment from Abbvie) Should the
Agency proceed with this study, FDA
could enhance the quality, utility, and
clarity of the information to be collected
by avoiding introducing bias into the
way the survey is conducted. For
example, in the draft survey (version
10.22.14), FDA creates an artificial
setting in which participants are
instructed to watch the commercials
that air during a 90-minute TV program
during which the same ad airs three to
six times. This is very different from the
airing and viewing frequency of DTC
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ads that occur today. Hence, we
question the applicability of the results
of this study to a real world setting.
(Response) Please note that stimuli
play for 60 minutes (not 90), and that
the original design involved airing of
the ad one, three, or six times (not three
to six). We appreciate that six viewings
would be unusual and so the study
design has been revised such that the
experimental groups will view the ad
one, two, or four times over the course
of the 60-minute viewing period.
Additional details about this change are
provided in later responses.
(Comment from Eli Lilly) The FDA
sample does not currently include a
‘‘General Population’’ control group, as
all participants will be screened to
qualify when identified as suffering
from seasonal allergies, a condition that
could be relieved by the drug described
in advertisement. It may be helpful to
the FDA’s analysis plan to include a
control group.
(Response) Researching each medical
condition, or general population
sample, requires significant resources.
We are committed to conducting this
research using our available resources
while ensuring the integrity of the
research by collecting data on a high
prevalence condition for which
participants might be thought of as
sufficiently representative of the average
consumer, thus allowing us to draw
conclusions about broad perceptual and
cognitive processing outcomes.
(Comment from Eli Lilly) In the
proposed study design, respondents will
watch a 42-minute television program
with an embedded clutter reel of ads.
Within this time period, respondents
will be exposed to a drug ad 1, 3, or 6
times and then administered a survey
instrument. While we acknowledge that
a consumer can be exposed to an ad 6
times or more, we do not believe 6
exposures in such a compressed time
period represents a reasonable realworld experience and is likely to
overstate consumer reaction,
particularly given that such reactions
will be tested immediately after
viewing. We believe the current design
imposes a risk of creating artificial
differences between the study arms by
skewing perception, judgment, retention
of information, intent, etc., ultimately
leading to erroneous conclusions and
unactionable expectations.
Specifically, research data on
multiple ad exposures and ‘‘effective
frequency’’ is long established. Based
upon multiple studies, experience, and
client preference across industries, a
leading global media-buying firm with
whom we work generally adheres to two
(2) ‘‘units’’ per hour as its standard (i.e.
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a broadcast advertisement is delivered
to the intended audience in a single
program no more than twice each hour).
While there may be occasions where
some advertisers allow for increased
frequency (such as holiday weeks or the
like), the norm tends to gravitate to no
more than two per hour. This implies
that in the consumer packaged goods
space, 6 exposures in a 42-minute
television program exceeds standard
practice. In the drug advertising
category, that level of exposure would
be well beyond reasonable expectations.
We recommend that FDA limit study
arms to more realistic scenarios (e.g. 1,
2, and 3 exposures) or, alternatively, to
spread out the higher frequency arm
(e.g. 6) over a longer study period,
preferably with a longitudinal design, to
more closely represent how consumers
receive and process information in a
real-world environment.
(Response) We appreciate this insight.
The study design has been revised such
that the experimental groups will view
the ad one, two, or four times over the
course of the 60-minute viewing period.
We consider the one and two exposure
conditions to be realistic. The fourexposure condition, while limited in its
ecological validity, allows for
experimental examination of
‘‘excessive’’ exposures, which may be
associated with outcomes such as
consumer wearout; that is, deterioration
or diminishment of effects of ad
repetition on mental processing after a
certain amount of exposure. Also, it is
important to note that in studying
advertising effects, it is necessary to
create enough difference in the
manipulations between experimental
groups to allow for variation in
outcomes to be detected. Given the
laboratory setting, it is not possible to
extend the viewing period longer than 1
hour without significantly increasing
the burden on respondents.
(Comment from Eli Lilly) We were
unable to determine if the study arms
that will see multiple exposures will be
exposed to the same version of the ad
or variations of the ad. We recommend
utilizing the same version of the ad for
consistency between the study arms.
(Response) These participants will
view the same ad across all exposures.
(Comment from Eli Lilly) In the prestimulus instructions/disclosure
section, we recommend removing ‘‘on
behalf of a public health agency.’’ This
language may trigger the respondent,
who would see it before being exposed
to the clutter reel, to be on the alert for
health-related content and create bias
that is not accurate in a real-world
setting.
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(Response) We agree with this
concern. This language has been revised
to ‘‘on behalf of a government agency.’’
(Comment from Eli Lilly) In the poststimulus/survey instrument instructions
section, we recommend removing
references to (a) ‘‘a drug ad’’ and, (b)
specific product name. Introducing this
language provides the name of the
product they are asked to identify in the
first survey instrument question. It may
also create unnecessary bias by
identifying for the respondent the
subject of the survey instrument.
(Response) These references have
been removed.
(Comment from Eli Lilly) We
recommend combining Questions 6 and
7 (risks and benefits) and randomizing
the order. We believe this will more
accurately represent recall rather than
grouping risks together and benefits
together.
(Response) In natural settings,
consumers may think about drug
benefits and risks simultaneously or
separately. We argue that there are
empirical advantages to collecting data
on these measures separately. There is
literature to suggest personally relevant
threatening information may be
defensively processed (Refs. 5, 6, and 7)
and thus processed differently than
benefit information. We prefer to
compare responses to benefit and risk
items to one another, and combining
them into one question would hinder
this analysis. Moreover, note that in
related literature, these constructs are
typically measured with independent
scales, or at least independent scales
within a single scale. This assessment is
based on an ongoing literature review
concerning item and scale measure
development.
Additionally, splitting these measures
reduces psychological burden on
participants. It is believed to be easier
for participants to respond to seven
items concerning benefits in one matrix,
followed by seven items concerning
risks in another matrix, than for
participants to respond to 14 items
about both benefits and risks in a single
matrix. Omitting items would reduce
our ability to adequately measure either
benefits or risks. Relatedly, collecting
data on benefits and risks separately
may increase the likelihood that
participants take time to process each
item and respond accurately.
(Comment from Eli Lilly) We
recommend adding a ‘‘Don’t Know’’
answer choice for Questions 9, 10, and
13 as respondents may be unable to
assess the likelihood or seriousness of
side effects, or effectiveness of the
product. The current range of answers
may force inaccurate or speculative
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responses; a ‘‘Don’t Know’’ answer
would be a legitimate choice and
informative for the study. Our standard
practice is to provide a ‘‘Don’t Know’’
option whenever it could be a valid
answer.
(Response) We understand the value
of providing such responses for items of
a factual nature. The drawback to
providing such response options to
these questions, however, is that we
may lose information by allowing
respondents to choose an easy response
instead of giving the item some thought.
Research by Krosnick et al. (Ref. 8)
demonstrated that providing ‘‘no
opinion’’ options likely results in the
loss of data without any corresponding
increase in the quality of the data. Thus,
we prefer not to add these options to the
survey.
(Comment from Eli Lilly) We
recommend randomizing the answers to
Question 15 to avoid order bias. We
note that the answer choices are in
sequence of probable behavior after
being informed by advertising.
(Response) Indeed, ordering of items
was chosen to reflect sequence of
probable behavior after being informed
by advertising. We believe maintaining
this continuum most appropriately
reflects decision making on the part of
the consumer. Moreover, we have
conducted surveys both with and
without randomizing these items, and
no differences in responses were
observed.
(Comment from Eli Lilly) For
Question 16, we suggest explicitly
stating ‘‘after being prescribed by a
doctor’’ to the end of the question. The
question currently does not provide this
context, leaving respondents to interpret
whether or not they are to consider how
they feel about ‘‘taking’’ Drug X without
guidance from a learned intermediary.
We believe this may render the data on
this question ambiguous.
(Response) We have incorporated this
suggestion into the revised
questionnaire.
(Comment from Eli Lilly) For
Questions 20 a and b, we suggest
spelling out ‘‘FDA.’’
(Response) We have incorporated this
suggestion into the revised
questionnaire.
(Comment from Eli Lilly) For
Questions 20 a and c, we recommend
eliminating the adverb ‘‘extremely’’ as it
may create ambiguity. It would be
reasonable for some people to answer
‘‘false’’ to ‘‘extremely effective’’ while
also believing simply ‘‘effective’’ was
true, while other respondents may not
see a distinction. This may skew the
data artificially toward ‘‘false.’’
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(Response) Indeed, participants may
respond differently depending on
whether or not the adverb ‘‘extremely’’
is included. The item is designed to
assess perceptions of whether only
extremely effective products are
approved by the FDA (likewise, only
‘‘serious’’ risks are assessed in Q20b and
Q20d.) We prefer to retain this item
because it captures the intended
outcome we wish to measure, whereas
an item that excludes the adverb
‘‘extremely’’ would not. Also note that
these items have been previously
published elsewhere and we prefer to
match the original language (Ref. 9).
(Comment from Eli Lilly) We
recommend eliminating Question 20 g,
which seems redundant with 20 f. If
respondents were to answer False for 20
f but True for 20 g, it would provide no
insight but could skew perceptions of
the data. If the question is retained, we
recommend eliminating the word ‘‘in’’
(i.e. ‘‘believe in’’), which in this context
may connote a broader judgment about
the drug industry, for which there is
ample existing data, than of the
regulatory oversight of drug
advertisements. The language creates
bias by implying that misleading
information is embedded in drug ads,
skewing the data toward ‘‘false.’’
(Response) We have deleted Q20g,
and modified Q20f as follows: ‘‘All of
the information in prescription drug
commercials is approved by the U.S.
Food and Drug Administration.’’ In
addition, we have added the following
items: ‘‘All of the benefit information in
prescription drug commercials is
approved by the U.S. Food and Drug
Administration,’’ and ‘‘All of the risk
information in prescription drug
commercials is approved by the U.S.
Food and Drug Administration.’’
(Comment from Eli Lilly) For
Question 20 h, we recommend changing
the word ‘‘safest’’ to ‘‘safe,’’ which may
force respondents to make a subjective
judgment about what constitutes
‘‘safest’’ (i.e. is there a set of safest, or
simply the single-most safest drug?)
even though they may believe that all
advertised drugs have been deemed to
be safe. This may strongly skew data
toward ‘‘false.’’
(Response) We appreciate that asking
about ‘‘safest’’ versus ‘‘safe’’ drugs will
likely result in different responses. We
prefer to retain the current language
because it captures the intended
outcome we wish to measure.
Nonetheless, we will be careful to
restrict our interpretation of findings
pertaining to this question based on
these potential differences in
responding.
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(Comment from Eli Lilly) Questions
21 a and b seem to be leading questions
that may strongly bias respondents to
presuppose that the ad is misleading
and that the survey instrument is simply
trying to understand the extent to which
it is misleading. We acknowledge that
the answer choices allow respondents to
select ‘‘not at all misleading,’’ but fourfifths of the answer options represent
degrees of ‘‘misleading,’’ which may
create strong response bias. Although 21
c provides the alternative question, by
the time the respondents reach this
question they will have been biased by
the previous two questions that the ad
is misleading, skewing the data toward
‘‘not truthful.’’ We recommend this
section be revised.
(Response) These three items were
included in the survey for the purposes
of cognitive testing. Results from
cognitive testing suggest that
participants have difficulty answering
the question about ‘‘truthful’’ because
they feel they do not know the truth.
They generally provide the same answer
to both questions that ask about how
misleading the ad is. We therefore will
omit questions 21a and 21c.
(Comment from Eli Lilly) For
Questions 24 and 25, we recommend
adding ‘‘or difficult’’ to the question to
minimize biasing respondents that the
product is ‘‘easy’’ to use and to make the
question and answer choices consistent.
(Response) We have incorporated this
suggestion into the revised
questionnaire.
(Comment from Eli Lilly) We are
concerned that Question 27 has
potential to create bias and to confuse
respondents. It contains language that
may trigger respondents to believe they
should be ‘‘concerned’’ to some extent.
The question language combined with
the inference of doctor’s involvement is
potentially confusing. We suggest
revising this question, perhaps to
something more simple like: ‘‘If you
were considering taking [Drug X], how
would you feel about the side effects
mentioned in the ad?’’
(Response) The suggested revised
version of Q27 points out to participants
that the ad notes side effects and so also
‘‘biases’’ participants but in a slightly
different way. The core assumption that
there are always side effects to be
considered in some form seems
sufficiently reflective of contemporary
DTC prescription drugs and thus we
prefer not to change the language.
(Comment from Eli Lilly) For
Question 28, we recommend using
‘‘Neither Agree nor Disagree’’ as the
midpoint of the scale, consistent with
previous scale language in the survey
instrument.
(Response) This measure of need for
cognition has been published and
validated in the literature (Ref. 10).
Thus, we prefer not to change the
wording.
(Comment from Eli Lilly) Question
28 b is potentially unclear. We
recommend revising the question.
(Response) This measure of need for
cognition has been published and
validated in the literature. Thus, we
prefer not to change the wording.
(Comment from Eli Lilly) Question 29
seems to have an omitted word. We
recommend revising to: ‘‘How confident
are you about filling out medical forms
by yourself?’’
(Response) This is an item that has
been used in the literature, and thus we
prefer not to change the wording (Ref.
11).
(Comment from Eli Lilly) We
recommend revising Question 31 by
deleting or amending the language
‘‘Below are statements other people
have made about their medications.’’
This language appears unnecessary and
may bias respondents by implying that,
because the statements are included in
the survey instrument, they are truthful
and may warrant the respondents to feel
that way to some extent.
(Response) This item has been
validated in the literature (Ref. 12) and
thus we prefer not to change the
language.
(Comment from Eli Lilly) Also for
Question 31, we recommend using
‘‘Neither Agree nor Disagree’’ as the
language midpoint of the scale,
consistent with previous scale language
in the survey instrument.
(Response) This item is from the
Beliefs in Medicines Questionnaire.
This item has been validated in the
literature and thus we prefer not to
change the language.
(Comment from Eli Lilly) In Questions
35 and 36, we believe there could be
variability in consumers’ definition of
what constitutes ‘‘serious’’ side effect
without additional definition. We
recommend the survey design consider
providing additional context for the
consumer in the question wording.
(Response) We agree there is likely to
be variability in how consumers define
serious side effects. We examined these
items in cognitive testing. Based on
results from that cognitive testing,
respondents generally define ‘‘serious’’
side effects as those that require medical
attention or that are life threatening. It
does not seem that respondents have
trouble answering this question.
To examine differences between
experimental conditions, we will
conduct inferential statistical tests such
as analysis of variance. With the sample
size described below, we will have
sufficient power to detect small-tomedium sized effects in the main study.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Pretest 1 screener completes (assumes 10% eligible) .......
Pretest 2 screener completes (assumes 10% eligible) .......
Number of main study screener completes (assumes 10%
eligible) .............................................................................
Pretest 1 completes 2 ...........................................................
Pretest 2 completes 2 ...........................................................
Number of completes, main study 2 .....................................
1,050
1,050
1
1
1,050
1,050
.08 (5 min.)
.08 (5 min.)
84
84
6000
125
125
620
1
1
1
1
6000
125
125
620
.08 (5 min.)
1.5
1.5
1.5
480
188
188
930
Total ..............................................................................
........................
........................
........................
........................
1,954
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
While target sample sizes for pretests are 105 and for main study is 600, we have accounted for some potential overage in the burden
table. As data is being collected in two locations simultaneously, it may be possible that the target will be exceeded if alternates are included in
order to try to achieve the target.
2 Note:
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Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
References
asabaliauskas on DSK5VPTVN1PROD with NOTICES
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site address in this reference
section, but we are not responsible for
any subsequent changes to the Web site
after this document publishes in the
Federal Register.)
1. Singh, S. N., D. Linville, and A.
Sukhdial, ‘‘Enhancing the Efficacy of Split
Thirty-Second Television Commercials: An
Encoding Variability Application,’’ Journal of
Advertising, 24, pp. 13–23 (1995).
2. Haugtvedt, C. P., et al., ‘‘Advertising
Repetition and Variation Strategies:
Implications for Understanding Attitude
Strength,’’ Journal of Consumer Research, 21,
pp. 176–189 (1994).
3. Naples, M. J., ‘‘Effective Frequency:
Then and Now,’’ Journal of Advertising
Research, 37, pp. 7–12 (1997).
4. https://www.fda.gov/AboutFDA/
CentersOffices/
OfficeofMedicalProductsandTobacco/CDER/
ucm090276.htm.
5. Janis, I. L. and S. Feshbach, ‘‘Effects of
Fear-Arousing Communications,’’ Journal of
Abnormal and Social Psychology, 48, pp. 78–
92 (1953).
6. Liberman, A. and S. Chaiken, ‘‘Defensive
Processing of Personally Relevant Health
Messages,’’ Personality and Social
Psychology Bulletin, 18, pp. 669–679 (1992).
7. Smith, S. M. and R. E. Petty, ‘‘Message
Framing and Persuasion: A Message
Processing Analysis,’’ Personality and Social
Psychology Bulletin, 22, pp. 257–268 (1996).
8. Krosnick, J. A., A. L. Holbrook, M. K.
Berent, et al., ‘‘The Impact of ‘No Opinion’
Response Options on Data Quality: NonAttitude Reduction or an Invitation to
Satisfice?’’ Public Opinion Quarterly, 66, pp.
371–403 (2002).
9. Woloshin, S. and L. M. Schwartz,
‘‘Communicating Data About the Benefits
and Harms of Treatment: A Randomized
Trial,’’ Annals of Internal Medicine, 155, pp.
87–96 (2011).
10. Cacioppo, J. T. and R. E. Petty, ‘‘The
Efficient Assessment of Need for Cognition,’’
Journal of Personality Assessment, 48, pp.
306–307 (1984).
11. Chew, L. D., J. M. Griffin, M. R. Partin,
et al., ‘‘Validation of Screening Questions for
Limited Health Literacy in a Large VA
Outpatient Population,’’ Journal of General
Internal Medicine, 23, pp. 561–566 (2008).
12. Horne, R., J. Weinman, and M.
Hankins, ‘‘The Beliefs About Medicines
Questionnaire: The Development and
Evaluation of a New Method for Assessing
the Cognitive Representation of Medication,’’
Psychology & Health, 14, pp. 1–24 (1999).
VerDate Sep<11>2014
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Dated: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–14880 Filed 6–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1566]
Naming of Drug Products Containing
Salt Drug Substances; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Naming of Drug Products
Containing Salt Drug Substances’’
which replaces the draft guidance of the
same title that published on December
26, 2013. This guidance describes the
United States Pharmacopeia’s (USP’s)
‘‘Monograph Naming Policy for Salt
Drug Substances in Drug Products and
Compounded Preparations,’’ which
became official on May 1, 2013, and
how the Center for Drug Evaluation and
Research (CDER) is implementing it.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mamta Gautam-Basak, Center for Drug
Evaluation and Research (CDER), Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–0712.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
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34677
‘‘Naming of Drug Products Containing
Salt Drug Substances’’ that replaces the
draft of the same title that published on
December 26, 2013 (78 FR 78366). This
guidance is being published to explain
how CDER is implementing the USP’s
policy entitled ‘‘Monograph Naming
Policy for Salt Drug Substances in Drug
Products and Compounded
Preparations.’’ It is a naming and
labeling policy applicable to drug
products that contain an active
ingredient that is a salt. The policy
stipulates that USP will use the name of
the active moiety, instead of the name
of the salt, when creating a drug product
monograph title and the strength will be
expressed in terms of the active moiety.
The policy allows for exceptions under
specified circumstances. CDER is now
applying this policy to new prescription
drug products under development
under section 505 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 355).
The USP Salt Policy became official
on May 1, 2013, and USP is now
applying it to all new drug product
monographs for products that contain
an active ingredient that is a salt. It
affects the development of new drug
products because a USP monograph title
for a new drug product, in most
instances, serves as the nonproprietary
or ‘‘established’’ name of the related
drug product (section 502(e)(3) of the
FD&C Act) (21 U.S.C. 352(e)). If a drug
product’s label or labeling contains a
name that is inconsistent with the
applicable monograph title, it risks
being misbranded (section
502(e)(1)(A)(i) of the FD&C Act).
This guidance describes the USP
policy and discusses how CDER and
industry can implement the policy.
Following the policy will help reduce
medication errors caused by a mismatch
between the established name and
strength on the label of drug products
that contain a salt. In addition, we
anticipate that this policy will help
health care practitioners calculate
equivalent doses when changing from
one dosage form to another, even if the
products contain active ingredients that
are different salts, because the strengths
and names will both be based on the
active moiety.
In the Federal Register of December
26, 2013 (78 FR 78366), this guidance
was published as a draft guidance. We
have carefully reviewed and considered
the comments that were received on the
draft guidance and have made changes
for clarification.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation 21 CFR 10.115. This
guidance represents CDER’s current
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]]>Agencies
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34672-34677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14880]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1794]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Impact of Ad Exposure
Frequency on Perception and Mental Processing of Risk and Benefit
Information in Direct-to-Consumer Prescription Drug Ads
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 July
17, 2015.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title ``Impact of Ad Exposure Frequency on Perception and Mental
Processing of Risk and Benefit Information in Direct-To-Consumer
Prescription Drug Ads.'' Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
Impact of Ad Exposure Frequency on Perception and Mental Processing of
Risk and Benefit Information in Direct-to-Consumer Prescription Drug
Ads; OMB Control Number 0910-NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(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.
In a typical promotional campaign, consumers may be exposed to a
direct-to-consumer (DTC) prescription drug ad any number of times.
Perceptual and cognitive effects of increased ad exposure frequency
have been studied extensively using non-drug ads. For instance, one
study demonstrated that a commercial message repeated twice generates
better recall than a message broadcast only once (Ref. 1). Another
study demonstrated that increased ad exposures improve product
attitudes and recall for product attributes, particularly when the
substance of the repeat messages is varied (Ref. 2). Generally, it has
been argued that first exposure to an ad results in attention, second
exposure affects learning of the advertised message, and third and
[[Page 34673]]
subsequent exposures reinforce the learning effects of the second
exposure (Ref. 3). To our knowledge, the literature concerning ad
exposure frequency has not been extended to include specific attention
to prescription drug ads. Prescription drug ads are unique in that they
are required to provide both benefit and risk information whereas other
ad types tend to include only benefit information. The Office of
Prescription Drug Promotion (OPDP) plans to examine the effects of
variation in ad exposure frequency on perception and mental processing
of risk and benefit information in DTC prescription drug ads through
empirical research.
The main study will be preceded by up to two pretests designed to
delineate the procedures and measures used in the main study. Across
pretests and the main study, participants will be individuals who have
been diagnosed with seasonal allergies. All participants will be 18
years of age or older. We will exclude individuals who work in
healthcare or marketing settings because their knowledge and
experiences may not reflect those of the average consumer. Participants
will be recruited in one of two geographic locations (Washington, DC
and Raleigh, North Carolina) for in-person administration of protocols.
The experimental design is summarized below. Participants will be
randomly assigned to view a prescription drug ad one, two, or four
times as part of clutter reels embedded in 42 minutes of TV
programming. They will then answer preprogrammed survey questions on
laptops. Measures are designed to assess perception, memory, judgments
about the ad, intentions to use the medication advertised, and possible
moderators of effects, such as need for cognition and demographics. The
questionnaire is available upon request.
Table 1--Study Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
Episode #1 Episode #2
Experimental arm number -----------------------------------------------------------------------------------------------------------------------
Clutter Reel 1 Clutter Reel 2 Clutter Reel 3 Clutter Reel 4 Clutter Reel 5 Clutter Reel 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 (views ad 1 time)............. .................. .................. .................. .................. .................. Mock DTC ad
2 (views ad 2 times)............ .................. .................. Mock DTC ad....... .................. .................. Mock DTC ad
3 (views ad 4 times)............ Mock DTC ad....... .................. Mock DTC ad....... Mock DTC ad....... .................. Mock DTC ad
--------------------------------------------------------------------------------------------------------------------------------------------------------
In the Federal Register of November 12, 2014 (79 FR 67172), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received five public submissions. In the
following section, we outline the observations and suggestions raised
in the comments and provide our responses. Comments that are not PRA-
relevant (e.g., ``Ban DTC'') or do not relate to the proposed study are
not included below or addressed in our responses.
(Comment from Valeant Pharmaceuticals) Develop and publish a
strategic plan for how FDA will collate and make use of data from all
FDA-sponsored studies concerning consumer and physician perception and
comprehension of prescription drug advertising and promotion.
(Response) The OPDP research Web page (Ref. 4) has recently been
updated to reflect the current status of completed and ongoing
research. As stated on our Web page, OPDP maintains an active research
program designed to investigate applied and theoretical issues in the
communication of risk and benefit information in DTC and professional
promotional prescription drug materials. OPDP's research supports FDA's
goal of science-based policy while maintaining its commitment to
protect the public health. The research provides FDA management with
evidence that can be considered along with other relevant research in
future policy decisions.
(Comment from Valeant Pharmaceuticals) Provide data to confirm
limiting the study recruitment to Washington, DC and Raleigh Durham, NC
area is representative of the entire United States.
(Response) The research questions examined in this study (e.g.,
risk and benefit recall as a function of the number of target ad
exposures) are believed to apply to human judgment and decision making
and not to be contingent upon geographic residence. We acknowledge that
collecting data across a greater number of geographic locations may
provide value, but choose to allocate our limited funding in ways we
believe more appropriately ensure the integrity of the research. For
example, the requirement that participants view 60 minutes of
programming led us to collect data in person, which allows for us to
supervise participant engagement with the survey and therefore ensure
that stimuli are, in fact, viewed. Although the current research
includes limited geographic diversity, note that other forms of
diversity (e.g., gender, age, and race) will be sought during
recruitment and accounted for in our analyses.
(Comment from Valeant Pharmaceuticals) Six exposures during the
same 42-minute television program are not reflective of how advertising
is delivered and could inadvertently bias the results.
(Response) The study design has been revised such that the
experimental groups will view the ad one, two, or four times over the
course of the 60-minute viewing period. Additional details about this
change are provided in later responses.
(Comment from Valeant Pharmaceuticals) Consumer comprehension of
benefit and risk is not solely based on the viewing of the DTC TV ad in
isolation. Consumer comprehension should take into account the role of
the healthcare professional and other materials.
(Response) We appreciate that consumer judgment and decision making
often results from multiple information sources. In many cases, DTC TV
ads serve as the first source of information received, and therefore
may influence whether or not additional information is sought, and
ultimately whether or not a product is requested from a healthcare
professional. Through broad research on DTC advertising, we seek to
ensure that consumers are appropriately informed about the risks and
benefits of prescription drugs across all information sources, when
viewed in isolation or in combination with other sources.
(Comment from Valeant Pharmaceuticals) Because the study is limited
to one DTC TV ad and one therapeutic area, the results should not be
broadly applied to other forms of advertising or other therapeutic
areas.
(Response) We agree that results should not be broadly applied to
other forms of advertising. We do not agree that results necessarily
need be restricted to the selected therapeutic
[[Page 34674]]
area. Our primary research question for the study is whether increasing
ad exposure frequency will result in different risk or benefit
perceptions than less exposure to the ad. This question pertains to
human perception and judgment and is not thought to be unique to any
particular therapeutic area. Nonetheless, we agree that replication of
this research using other forms of advertising and different
therapeutic areas would be valuable.
(Comment from Abbvie) It is not clear how the proposed collection
is necessary for the proper performance of FDA's functions. It is
difficult to ascertain how the Agency will utilize the results of this
study within its statutory authority. For example, should the results
of this study demonstrate that the frequency of ad exposure matters,
how would the Agency modify the airing frequency of DTC TV ads or the
frequency at which consumers are exposed to the advertisements in a
real world setting? Rather than conduct this study, we suggest that FDA
resources and taxpayer dollars would be better directed to research
that enhances the quality of how we communicate benefit and risk
information to consumers regardless of the medium and the frequency of
the exposure. Guidance is needed on the best practices for
communicating benefit and risk information to consumers who are
prescribed prescription drugs. This is particularly important as the
quality of the communication has the power to result in a better
informed consumer.
(Response) This research reflects the need to understand not only
the message that consumers receive, but also the delivery of those
messages, and how that delivery influences perception, judgment, and
decision making. It may be that full comprehension of benefit
information is achieved upon a single exposure, whereas full
comprehension of risk information requires multiple exposures. Insight
on this topic may allow FDA to make more informed judgments regarding
consumer information processing of DTC television ads.
(Comment from Abbvie) Should the Agency proceed with this study,
FDA could enhance the quality, utility, and clarity of the information
to be collected by avoiding introducing bias into the way the survey is
conducted. For example, in the draft survey (version 10.22.14), FDA
creates an artificial setting in which participants are instructed to
watch the commercials that air during a 90-minute TV program during
which the same ad airs three to six times. This is very different from
the airing and viewing frequency of DTC ads that occur today. Hence, we
question the applicability of the results of this study to a real world
setting.
(Response) Please note that stimuli play for 60 minutes (not 90),
and that the original design involved airing of the ad one, three, or
six times (not three to six). We appreciate that six viewings would be
unusual and so the study design has been revised such that the
experimental groups will view the ad one, two, or four times over the
course of the 60-minute viewing period. Additional details about this
change are provided in later responses.
(Comment from Eli Lilly) The FDA sample does not currently include
a ``General Population'' control group, as all participants will be
screened to qualify when identified as suffering from seasonal
allergies, a condition that could be relieved by the drug described in
advertisement. It may be helpful to the FDA's analysis plan to include
a control group.
(Response) Researching each medical condition, or general
population sample, requires significant resources. We are committed to
conducting this research using our available resources while ensuring
the integrity of the research by collecting data on a high prevalence
condition for which participants might be thought of as sufficiently
representative of the average consumer, thus allowing us to draw
conclusions about broad perceptual and cognitive processing outcomes.
(Comment from Eli Lilly) In the proposed study design, respondents
will watch a 42-minute television program with an embedded clutter reel
of ads. Within this time period, respondents will be exposed to a drug
ad 1, 3, or 6 times and then administered a survey instrument. While we
acknowledge that a consumer can be exposed to an ad 6 times or more, we
do not believe 6 exposures in such a compressed time period represents
a reasonable real-world experience and is likely to overstate consumer
reaction, particularly given that such reactions will be tested
immediately after viewing. We believe the current design imposes a risk
of creating artificial differences between the study arms by skewing
perception, judgment, retention of information, intent, etc.,
ultimately leading to erroneous conclusions and unactionable
expectations.
Specifically, research data on multiple ad exposures and
``effective frequency'' is long established. Based upon multiple
studies, experience, and client preference across industries, a leading
global media-buying firm with whom we work generally adheres to two (2)
``units'' per hour as its standard (i.e. a broadcast advertisement is
delivered to the intended audience in a single program no more than
twice each hour). While there may be occasions where some advertisers
allow for increased frequency (such as holiday weeks or the like), the
norm tends to gravitate to no more than two per hour. This implies that
in the consumer packaged goods space, 6 exposures in a 42-minute
television program exceeds standard practice. In the drug advertising
category, that level of exposure would be well beyond reasonable
expectations.
We recommend that FDA limit study arms to more realistic scenarios
(e.g. 1, 2, and 3 exposures) or, alternatively, to spread out the
higher frequency arm (e.g. 6) over a longer study period, preferably
with a longitudinal design, to more closely represent how consumers
receive and process information in a real-world environment.
(Response) We appreciate this insight. The study design has been
revised such that the experimental groups will view the ad one, two, or
four times over the course of the 60-minute viewing period. We consider
the one and two exposure conditions to be realistic. The four-exposure
condition, while limited in its ecological validity, allows for
experimental examination of ``excessive'' exposures, which may be
associated with outcomes such as consumer wearout; that is,
deterioration or diminishment of effects of ad repetition on mental
processing after a certain amount of exposure. Also, it is important to
note that in studying advertising effects, it is necessary to create
enough difference in the manipulations between experimental groups to
allow for variation in outcomes to be detected. Given the laboratory
setting, it is not possible to extend the viewing period longer than 1
hour without significantly increasing the burden on respondents.
(Comment from Eli Lilly) We were unable to determine if the study
arms that will see multiple exposures will be exposed to the same
version of the ad or variations of the ad. We recommend utilizing the
same version of the ad for consistency between the study arms.
(Response) These participants will view the same ad across all
exposures.
(Comment from Eli Lilly) In the pre-stimulus instructions/
disclosure section, we recommend removing ``on behalf of a public
health agency.'' This language may trigger the respondent, who would
see it before being exposed to the clutter reel, to be on the alert for
health-related content and create bias that is not accurate in a real-
world setting.
[[Page 34675]]
(Response) We agree with this concern. This language has been
revised to ``on behalf of a government agency.''
(Comment from Eli Lilly) In the post-stimulus/survey instrument
instructions section, we recommend removing references to (a) ``a drug
ad'' and, (b) specific product name. Introducing this language provides
the name of the product they are asked to identify in the first survey
instrument question. It may also create unnecessary bias by identifying
for the respondent the subject of the survey instrument.
(Response) These references have been removed.
(Comment from Eli Lilly) We recommend combining Questions 6 and 7
(risks and benefits) and randomizing the order. We believe this will
more accurately represent recall rather than grouping risks together
and benefits together.
(Response) In natural settings, consumers may think about drug
benefits and risks simultaneously or separately. We argue that there
are empirical advantages to collecting data on these measures
separately. There is literature to suggest personally relevant
threatening information may be defensively processed (Refs. 5, 6, and
7) and thus processed differently than benefit information. We prefer
to compare responses to benefit and risk items to one another, and
combining them into one question would hinder this analysis. Moreover,
note that in related literature, these constructs are typically
measured with independent scales, or at least independent scales within
a single scale. This assessment is based on an ongoing literature
review concerning item and scale measure development.
Additionally, splitting these measures reduces psychological burden
on participants. It is believed to be easier for participants to
respond to seven items concerning benefits in one matrix, followed by
seven items concerning risks in another matrix, than for participants
to respond to 14 items about both benefits and risks in a single
matrix. Omitting items would reduce our ability to adequately measure
either benefits or risks. Relatedly, collecting data on benefits and
risks separately may increase the likelihood that participants take
time to process each item and respond accurately.
(Comment from Eli Lilly) We recommend adding a ``Don't Know''
answer choice for Questions 9, 10, and 13 as respondents may be unable
to assess the likelihood or seriousness of side effects, or
effectiveness of the product. The current range of answers may force
inaccurate or speculative responses; a ``Don't Know'' answer would be a
legitimate choice and informative for the study. Our standard practice
is to provide a ``Don't Know'' option whenever it could be a valid
answer.
(Response) We understand the value of providing such responses for
items of a factual nature. The drawback to providing such response
options to these questions, however, is that we may lose information by
allowing respondents to choose an easy response instead of giving the
item some thought. Research by Krosnick et al. (Ref. 8) demonstrated
that providing ``no opinion'' options likely results in the loss of
data without any corresponding increase in the quality of the data.
Thus, we prefer not to add these options to the survey.
(Comment from Eli Lilly) We recommend randomizing the answers to
Question 15 to avoid order bias. We note that the answer choices are in
sequence of probable behavior after being informed by advertising.
(Response) Indeed, ordering of items was chosen to reflect sequence
of probable behavior after being informed by advertising. We believe
maintaining this continuum most appropriately reflects decision making
on the part of the consumer. Moreover, we have conducted surveys both
with and without randomizing these items, and no differences in
responses were observed.
(Comment from Eli Lilly) For Question 16, we suggest explicitly
stating ``after being prescribed by a doctor'' to the end of the
question. The question currently does not provide this context, leaving
respondents to interpret whether or not they are to consider how they
feel about ``taking'' Drug X without guidance from a learned
intermediary. We believe this may render the data on this question
ambiguous.
(Response) We have incorporated this suggestion into the revised
questionnaire.
(Comment from Eli Lilly) For Questions 20 a and b, we suggest
spelling out ``FDA.''
(Response) We have incorporated this suggestion into the revised
questionnaire.
(Comment from Eli Lilly) For Questions 20 a and c, we recommend
eliminating the adverb ``extremely'' as it may create ambiguity. It
would be reasonable for some people to answer ``false'' to ``extremely
effective'' while also believing simply ``effective'' was true, while
other respondents may not see a distinction. This may skew the data
artificially toward ``false.''
(Response) Indeed, participants may respond differently depending
on whether or not the adverb ``extremely'' is included. The item is
designed to assess perceptions of whether only extremely effective
products are approved by the FDA (likewise, only ``serious'' risks are
assessed in Q20b and Q20d.) We prefer to retain this item because it
captures the intended outcome we wish to measure, whereas an item that
excludes the adverb ``extremely'' would not. Also note that these items
have been previously published elsewhere and we prefer to match the
original language (Ref. 9).
(Comment from Eli Lilly) We recommend eliminating Question 20 g,
which seems redundant with 20 f. If respondents were to answer False
for 20 f but True for 20 g, it would provide no insight but could skew
perceptions of the data. If the question is retained, we recommend
eliminating the word ``in'' (i.e. ``believe in''), which in this
context may connote a broader judgment about the drug industry, for
which there is ample existing data, than of the regulatory oversight of
drug advertisements. The language creates bias by implying that
misleading information is embedded in drug ads, skewing the data toward
``false.''
(Response) We have deleted Q20g, and modified Q20f as follows:
``All of the information in prescription drug commercials is approved
by the U.S. Food and Drug Administration.'' In addition, we have added
the following items: ``All of the benefit information in prescription
drug commercials is approved by the U.S. Food and Drug
Administration,'' and ``All of the risk information in prescription
drug commercials is approved by the U.S. Food and Drug
Administration.''
(Comment from Eli Lilly) For Question 20 h, we recommend changing
the word ``safest'' to ``safe,'' which may force respondents to make a
subjective judgment about what constitutes ``safest'' (i.e. is there a
set of safest, or simply the single-most safest drug?) even though they
may believe that all advertised drugs have been deemed to be safe. This
may strongly skew data toward ``false.''
(Response) We appreciate that asking about ``safest'' versus
``safe'' drugs will likely result in different responses. We prefer to
retain the current language because it captures the intended outcome we
wish to measure. Nonetheless, we will be careful to restrict our
interpretation of findings pertaining to this question based on these
potential differences in responding.
[[Page 34676]]
(Comment from Eli Lilly) Questions 21 a and b seem to be leading
questions that may strongly bias respondents to presuppose that the ad
is misleading and that the survey instrument is simply trying to
understand the extent to which it is misleading. We acknowledge that
the answer choices allow respondents to select ``not at all
misleading,'' but four-fifths of the answer options represent degrees
of ``misleading,'' which may create strong response bias. Although 21 c
provides the alternative question, by the time the respondents reach
this question they will have been biased by the previous two questions
that the ad is misleading, skewing the data toward ``not truthful.'' We
recommend this section be revised.
(Response) These three items were included in the survey for the
purposes of cognitive testing. Results from cognitive testing suggest
that participants have difficulty answering the question about
``truthful'' because they feel they do not know the truth. They
generally provide the same answer to both questions that ask about how
misleading the ad is. We therefore will omit questions 21a and 21c.
(Comment from Eli Lilly) For Questions 24 and 25, we recommend
adding ``or difficult'' to the question to minimize biasing respondents
that the product is ``easy'' to use and to make the question and answer
choices consistent.
(Response) We have incorporated this suggestion into the revised
questionnaire.
(Comment from Eli Lilly) We are concerned that Question 27 has
potential to create bias and to confuse respondents. It contains
language that may trigger respondents to believe they should be
``concerned'' to some extent. The question language combined with the
inference of doctor's involvement is potentially confusing. We suggest
revising this question, perhaps to something more simple like: ``If you
were considering taking [Drug X], how would you feel about the side
effects mentioned in the ad?''
(Response) The suggested revised version of Q27 points out to
participants that the ad notes side effects and so also ``biases''
participants but in a slightly different way. The core assumption that
there are always side effects to be considered in some form seems
sufficiently reflective of contemporary DTC prescription drugs and thus
we prefer not to change the language.
(Comment from Eli Lilly) For Question 28, we recommend using
``Neither Agree nor Disagree'' as the midpoint of the scale, consistent
with previous scale language in the survey instrument.
(Response) This measure of need for cognition has been published
and validated in the literature (Ref. 10). Thus, we prefer not to
change the wording.
(Comment from Eli Lilly) Question 28 b is potentially unclear. We
recommend revising the question.
(Response) This measure of need for cognition has been published
and validated in the literature. Thus, we prefer not to change the
wording.
(Comment from Eli Lilly) Question 29 seems to have an omitted word.
We recommend revising to: ``How confident are you about filling out
medical forms by yourself?''
(Response) This is an item that has been used in the literature,
and thus we prefer not to change the wording (Ref. 11).
(Comment from Eli Lilly) We recommend revising Question 31 by
deleting or amending the language ``Below are statements other people
have made about their medications.'' This language appears unnecessary
and may bias respondents by implying that, because the statements are
included in the survey instrument, they are truthful and may warrant
the respondents to feel that way to some extent.
(Response) This item has been validated in the literature (Ref. 12)
and thus we prefer not to change the language.
(Comment from Eli Lilly) Also for Question 31, we recommend using
``Neither Agree nor Disagree'' as the language midpoint of the scale,
consistent with previous scale language in the survey instrument.
(Response) This item is from the Beliefs in Medicines
Questionnaire. This item has been validated in the literature and thus
we prefer not to change the language.
(Comment from Eli Lilly) In Questions 35 and 36, we believe there
could be variability in consumers' definition of what constitutes
``serious'' side effect without additional definition. We recommend the
survey design consider providing additional context for the consumer in
the question wording.
(Response) We agree there is likely to be variability in how
consumers define serious side effects. We examined these items in
cognitive testing. Based on results from that cognitive testing,
respondents generally define ``serious'' side effects as those that
require medical attention or that are life threatening. It does not
seem that respondents have trouble answering this question.
To examine differences between experimental conditions, we will
conduct inferential statistical tests such as analysis of variance.
With the sample size described below, we will have sufficient power to
detect small-to-medium sized effects in the main study.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Pretest 1 screener completes 1,050 1 1,050 .08 (5 min.) 84
(assumes 10% eligible).........
Pretest 2 screener completes 1,050 1 1,050 .08 (5 min.) 84
(assumes 10% eligible).........
Number of main study screener 6000 1 6000 .08 (5 min.) 480
completes (assumes 10%
eligible)......................
Pretest 1 completes \2\......... 125 1 125 1.5 188
Pretest 2 completes \2\......... 125 1 125 1.5 188
Number of completes, main study 620 1 620 1.5 930
\2\............................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,954
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Note: While target sample sizes for pretests are 105 and for main study is 600, we have accounted for some
potential overage in the burden table. As data is being collected in two locations simultaneously, it may be
possible that the target will be exceeded if alternates are included in order to try to achieve the target.
[[Page 34677]]
References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov. (FDA
has verified the Web site address in this reference section, but we are
not responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
1. Singh, S. N., D. Linville, and A. Sukhdial, ``Enhancing the
Efficacy of Split Thirty-Second Television Commercials: An Encoding
Variability Application,'' Journal of Advertising, 24, pp. 13-23
(1995).
2. Haugtvedt, C. P., et al., ``Advertising Repetition and
Variation Strategies: Implications for Understanding Attitude
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3. Naples, M. J., ``Effective Frequency: Then and Now,'' Journal
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4. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm.
5. Janis, I. L. and S. Feshbach, ``Effects of Fear-Arousing
Communications,'' Journal of Abnormal and Social Psychology, 48, pp.
78-92 (1953).
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Personally Relevant Health Messages,'' Personality and Social
Psychology Bulletin, 18, pp. 669-679 (1992).
7. Smith, S. M. and R. E. Petty, ``Message Framing and
Persuasion: A Message Processing Analysis,'' Personality and Social
Psychology Bulletin, 22, pp. 257-268 (1996).
8. Krosnick, J. A., A. L. Holbrook, M. K. Berent, et al., ``The
Impact of `No Opinion' Response Options on Data Quality: Non-
Attitude Reduction or an Invitation to Satisfice?'' Public Opinion
Quarterly, 66, pp. 371-403 (2002).
9. Woloshin, S. and L. M. Schwartz, ``Communicating Data About
the Benefits and Harms of Treatment: A Randomized Trial,'' Annals of
Internal Medicine, 155, pp. 87-96 (2011).
10. Cacioppo, J. T. and R. E. Petty, ``The Efficient Assessment
of Need for Cognition,'' Journal of Personality Assessment, 48, pp.
306-307 (1984).
11. Chew, L. D., J. M. Griffin, M. R. Partin, et al.,
``Validation of Screening Questions for Limited Health Literacy in a
Large VA Outpatient Population,'' Journal of General Internal
Medicine, 23, pp. 561-566 (2008).
12. Horne, R., J. Weinman, and M. Hankins, ``The Beliefs About
Medicines Questionnaire: The Development and Evaluation of a New
Method for Assessing the Cognitive Representation of Medication,''
Psychology & Health, 14, pp. 1-24 (1999).
Dated: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14880 Filed 6-16-15; 8:45 am]
BILLING CODE 4164-01-P
