[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

[[Page 65327]]

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).
                               ------------------------------------------------                  ---------------
    Total pretest/study                  6,350  ..............  ..............  ................  ..............
     participants.
                               ---------------------------------------------------------------------------------

[[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