Sponsors for several prescription drug
classes market their products directly to adolescents, but research
regarding how adolescents use risk and benefit information for
health-related decisions is limited. 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. We plan to conduct a randomized, controlled study in two
different medical conditions that assesses adolescents' perceptions
following exposure to DTC prescription drug advertising that varies
in benefit and risk onset and risk severity. 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. The study will enroll three
specific age groups (13–15, 16–17, 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. The study findings will inform FDA of relevant issues
related to DTC promotion directed at adolescent
populations.
US Code:
21
USC 393 Name of Law: Federal Food, Drug, and Cosmetic Act
US Code:
42 USC 300u(a)(4) Name of Law: Public Health Service Act
Ila Mizrachi 301 796-7726
ila.mizrachi@fda.hhs.gov
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.