[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65326-65329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25963]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1151]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Direct-to-Consumer Promotion
Directed at Adolescents
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled, ``Experimental Study of
Direct-to-Consumer (DTC) Promotion Directed at Adolescents.'' This
study is designed to examine how adolescents interpret DTC advertising
directed at them.
DATES: Submit written or electronic comments on the collection of
information by December 30, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at
Adolescents--(0910--NEW)
Regulatory Background
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 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(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.
Adolescents and DTC
Sponsors for several prescription drug classes market their
products directly to vulnerable groups, including adolescents. Such DTC
marketing to adolescents raises a variety of potential concerns.
Adolescents are a unique audience for DTC drug marketing because their
cognitive abilities are different than those of adults, and they are
usually dependent on adults for health insurance coverage, health care
provider access, and prescription drug payment. Despite this
uniqueness, research regarding how adolescents use risk and benefit
information for health-related decisions is limited. If considered at
all in healthcare communication research, age is typically treated as
simply another segment of the audience (Ref. 1), and researchers fail
to consider how information processing (how people understand
information) in response to ad exposure might differ among adolescents
versus older viewers.
The FD&C Act requires manufacturers, packers, and distributors that
advertise prescription drugs to disclose certain information about a
product's uses and risks to potential consumers in all advertisements.
Consumers must consider tradeoffs with regard to the product's risks
and benefits in deciding whether to ask their health care professionals
about the product. Presenting technically factual information is
important, but other factors can also affect potential consumers.
Information processing capacity, the relevance and vividness of the
information, and contextual factors such as family dynamics likely
affect how adolescent consumers weigh the potential risks and benefits
of using a product.
Despite the lack of previous research specific to DTC drug
marketing to adolescents, existing theoretical and empirical data make
a strong case for treating adolescence as a unique life stage during
which vulnerabilities that can affect informed decision-making must be
taken into account. Well-known theories of adolescent development have
long pointed to developmental changes that occur during the
transitional period as an individual moves from childhood to young
adulthood (Ref. 2). For instance, Erikson (Refs. 3, 4) describes an
often turbulent psychosocial crisis that occurs as adolescents strive
to develop their unique identify. Piaget (Refs. 5, 6) and Kohlberg
(Ref. 7) describe changes in stages relative to cognitive processing
and reasoning that occur in this period, as the adolescent becomes
increasingly capable of more abstract thinking. Different cognitive,
social and emotional, and developmental processes in the adolescent
brain mature simultaneously and at different rates, affecting decision-
making by age. All of these factors can influence how adolescents
perceive and process information as well as weigh risks and benefits.
The need for understanding how adolescents weigh risks and benefits
is particularly critical given the potential
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adverse events associated with use of the drug classes that are
marketed directly to adolescents. Suicide and suicidal ideation has
been associated with some of these classes, including a commonly used
class of acne medications. The risk and benefit information needs to be
clearly presented in ways that adolescents can understand.
Interpretation of more subtle messages in the advertisements, along
with the lens through which adolescents view the message, must be
understood. For example, given the potential stigma of acne and
adolescents' heightened concerns about peer perceptions, marketing that
emphasizes these two features in subtle ways might minimize the
attention given to any risk information provided. This suggests the
need to systematically explore the role of various factors that would
be expected to influence adolescent decision-making, such as peer and
family perceptions of stigma.
Research Purpose
We plan to conduct a randomized, controlled study in two different
medical conditions that assesses adolescents' perceptions following
exposure to different types of DTC prescription drug advertising. We
plan to compare adolescents' perceptions to those of young adult
counterparts. Each participant will view a web-based promotional
campaign for either a fictitious Attention Deficit Hyperactivity
Disorder (ADHD) medication or a fictitious acne medication. Because
adolescents typically depend on their parents for prescription drug
purchases, we also will include a sample of parents matched to their
adolescent children to explore similarities and differences in
perceptions for these matched pairs.
Within the two medical conditions, we propose to explore the role
of three different factors that may influence adolescent understanding
and perceptions of DTC. Two of these factors include timing issues: the
timing of the onset of benefits and the timing of the onset of risks.
Adolescents may be particularly likely to give more credence to
benefits that occur immediately and may be likely to discount risks
that do not occur immediately. Research suggests that the frontal lobe,
which controls self-regulatory functions, is not fully developed until
the mid-20s (Ref. 8), which may lead to difficulty in impulse control
and planning, and thus decision-making. Other research suggests that
adolescents are more likely to engage in risky behavior, although
whether they do this because they discount their own likelihood of
experiencing risks or if they cannot help themselves despite having
adequate perceptions of their own vulnerability has not been determined
(Refs. 9, 10). Given the variety of prescription drug products on the
market with varying benefit and risk profiles, these factors (benefit
and risk timing) will enable us to investigate its role in adolescent
processing of DTC ads.
We also propose to determine whether the severity of the risk
within each condition influences adolescent decision-making in relation
to DTC. Risk perceptions and risk taking have been active topics of
exploration with regard to adolescents and thus the severity of the
risks may play a role in determining whether and how adolescents attend
to the benefit-risk profile of the prescription drugs they see
advertised. This factor will also help us generalize further to
different types of products, although we recognize that it will not
cover the gamut of prescription drug products.
Although the variables we are examining are all attributes of the
drug products themselves and do not reflect particular behaviors of
sponsors, this information will be crucial in determining what types of
prescription drugs may require additional care when advertising them to
adolescents. One strength of the proposed study is that with two
different medical conditions and multiple different variations in the
benefit and risk profiles of the drugs, we will obtain a good
representation of adolescent response to DTC ads. Moreover, in
comparing adolescents with adults, we will have a better idea of how
perceptions and understanding of benefits and risks in DTC ads differ
across this part of the lifespan.
Design Overview
Within each of the two medical conditions, we will randomly assign
participants to one of a number of experimental conditions. We propose
for each medical condition a 2 (risk onset: immediate, delayed) x 2
(benefit onset: immediate, delayed) x 2 (risk severity: high, low)
factorial design, based on the rationale in the prior section.
We will use the same risk (within medical conditions) to control
for differences in severity (e.g. dry skin vs. cancer) and avoid
confounds.
Table 1--Experimental Conditions With Three Independent Variables
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Variable 1: Timing of risk: Immediate Variable 1: Timing of risk: Delayed
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Variable 2: Severity of risk (low) Variable 2: Severity of risk (high) Variable 2: Severity of risk (low) Variable 2: Severity of risk (high)
Comparison group ------------------------------------------------------------------------------------------------------------------------------------------------------------------
Variable 3: Timing Variable 3: Timing Variable 3: Timing Variable 3: Timing Variable 3: Timing Variable 3: Timing Variable 3: Timing Variable 3: Timing
of benefit of benefit of benefit of benefit of benefit of benefit of benefit of benefit
(immediate) (delayed) (immediate) (delayed) (immediate) (delayed) (immediate) (delayed)
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Study 1 (Medical condition A, Acne)
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Younger adolescents.......... Group 1............ Group 2............ Group 3............ Group 4........... Group 5........... Group 6........... Group 7........... Group 8.
(13-15).....................
Older adolescents............ Group 9............ Group 10........... Group 11........... Group 12.......... Group 13.......... Group 14.......... Group 15.......... Group 16.
(16-19).....................
Young adults................. Group 17........... Group 18........... Group 19........... Group 20.......... Group 21.......... Group 22.......... Group 23.......... Group 24.
(25-30).....................
Parents...................... Group 25........... Group 26........... Group 27........... Group 28.......... Group 29.......... Group 30.......... Group 31.......... Group 32.
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Study 2 (Medical condition B, ADHD)
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Younger adolescents.......... Group 1............ Group 2............ Group 3............ Group 4........... Group 5........... Group 6........... Group 7........... Group 8.
(13-15).....................
Older adolescents............ Group 9............ Group 10........... Group 11........... Group 12.......... Group 13.......... Group 14.......... Group 15.......... Group 16.
(16-19).....................
[[Page 65328]]
Young adults................. Group 17........... Group 18........... Group 19........... Group 20.......... Group 21.......... Group 22.......... Group 23.......... Group 24.
(25-30).....................
Parents...................... Group 25........... Group 26........... Group 27........... Group 28.......... Group 29.......... Group 30.......... Group 31.......... Group 32.
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We will conduct the studies with two medical conditions that have
particular relevance for adolescents--acne and ADHD. For acne, we will
target a sample that has been diagnosed with, or, through self-report,
has experienced the condition. For ADHD, we will target a sample that
has been diagnosed with the condition. If an appropriate sample size
cannot be obtained for ADHD, we will extend the sample by including
adolescents with family members who have been diagnosed with ADHD to
help ensure participants are interested in and paying attention to the
topic.
The study will enroll three specific age groups (13-15, 16-19, and
25-30). We propose to explore differences in effects of the ad
manipulations across these three age groups on a variety of outcomes,
including benefit and risk recall, benefit and risk perceptions, and
behavioral intentions. Certain ads may communicate more or less
effectively with specific age groups. The presentation of immediate
versus delayed risks, for example, might differentially affect teens
and young adults. Additionally, we propose to examine factors unique to
adolescent healthcare including relationship between parent and child,
issues of stigma, and risk taking.
We will also recruit parents of the two younger age groups into the
sample to explore potential differences between teen and parental
perceptions. There are three reasons for including parents in the
sample:
1. Adolescents and adults bring varied experiences and
developmental capacities to everyday decisions. As a result, they may
differ both in their perceptions of risks and benefits and in their
evaluations of DTC. Matching parents and adolescents in the sample will
allow us to conduct additional analyses to explore similarities and
differences between parental and adolescent perceptions. By having
parents of two age groups, we can compare these groups to see if there
are differences in parent-child risk-perception concordance/discordance
across adolescence as a function of age.
2. Parents will serve as a fourth age group, which will allow us to
conduct additional comparisons between the age categories. Increasing
the number of age categories will allow us to look for differences
between a greater range of age groups, and to see if clear patterns of
age differences exist (e.g., it could be that the most significant
differences are observed when comparing young adolescents and those
over 30 years of age).
3. Including parent-child dyads will address the need for empirical
data comparing adolescents' and their parents' evaluations of DTC
prescription drug advertising.
Select experimental conditions will be pretested with 1061
participants to assess questionnaire wording and implementation. Based
on power analyses, the main study will include 5,120 completed
participants, which will allow us enough power to test several possible
covariates (factors other than our manipulated variables) that may have
effects, such as demographic information.
The protocol will take place via the Internet. Participants will be
randomly assigned to view one Web site ad for a fictitious prescription
drug that treats either acne or ADHD and will answer questions about
it. The entire process is expected to take no longer than 30 minutes.
This will be a one-time (rather than annual) collection of information.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Pretest 1 screener (\1/2\ 2,812 1 2,812 .08 (5 min.).... 225
acne, \1/2\ ADHD).
Pretest 2 screener (all one 6,400 1 6,400 .08 (5 min.).... 512
illness).
Main study screener (acne).... 6,400 1 6,400 .08 (5 min.).... 512
Main study screener (ADHD).... 25,600 1 25,600 .08 (5 min.).... 2,048
Pretest 1..................... 450 1 450 0.5 (30 min.)... 225
Pretest 2..................... 700 1 700 0.5 (30 min.)... 350
Main study, 13-15 year olds 1,300 1 1,300 0.5 (30 min.)... 650
(both acne and ADHD).
Main study, 16-19-year olds 1,300 1 1,300 0.5 (30 min.)... 650
(both acne and ADHD).
Main study, young adults (both 1,300 1 1,300 .5 (30 min.).... 650
acne and ADHD).
Main study, parents (both acne 1,300 1 1,300 .5 (30 min.).... 650
and ADHD).
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Total pretest/study 6,350 .............. .............. ................ ..............
participants.
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[[Page 65329]]
Total................. .............. .............. .............. ................ 6,472
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The total respondent sample for this data collection is 6,350,
including the two pretests. We estimate the response burden to be 30
minutes, for a total collection burden, including screeners, of 6,472
hours.
References
1. Southwell, B. G., ``On the Need for a Life-Span Approach to
Health Campaign Evaluation.'' Health Communication, 25 (6-7), 525-
528, 2010.
2. Lerner, R. M. and L. Steinberg, ``The Scientific Study of
Adolescent Development.'' In R. M. Lerner and L. Steinberg (Eds.),
Handbook of Adolescent Psychology (3rd ed., Vol. 1: Individual Bases
of Adolescent Development). Hoboken, NJ: John Wiley and Sons, 2009.
3. Erikson, E. H. The Child and Society. New York: Norton, 1963.
4. Erikson, E. H. Dimensions of a New Identity. New York: Norton,
1974.
5. Piaget, J. The Origins of Intelligence in Children. New York:
Internal University Press, 1952.
6. Piaget, J. The Child's Conception of the World. Totowa, NJ:
Littlefield, Adams, 1972.
7. Kohlberg, L. ``Stage and Sequence. The Cognitive Developmental
Approach to Socialization.'' In D. A. Goslin (Ed.), Handbook of
Socialization Theory of Research (pp. 347-380). Chicago: Rand
McNally, 1969.
8. Rubia, K., S. Overmeyer, E. Taylor, et al., ``Functional
Frontalisation with Age: Mapping Neurodevelopmental Trajectories
with fMRI.'' [Clinical Trial Research Support, Non-U.S. Gov't.].
Neuroscience and Biobehavioral Reviews, 24(1), 13-19, 2000.
9. Goldberg, J. H., B. L. Halpern-Felsher, and S. G. Millstein,
``Beyond Invulnerability: The Importance of Benefits in Adolescents'
Decision to Drink Alcohol.'' Health Psychology, 21(5), 477-484. doi:
10.1037/0278-6133.21.5.477, 2002.
10. Albert, D. and L. Steinberg, ``Judgment and Decision Making in
Adolescence.'' Journal of Research on Adolescence, 21(1), 211-224.
doi: 10.1111/j.1532-7795.2010.00724.x, 2011.
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25963 Filed 10-30-13; 8:45 am]
BILLING CODE 4160-01-P