This ICR is
approved consistent with amended supporting statement.
Specifically, FDA acknowledges that there is a tradeoff between the
specificity and control of the research setting, and consequently
the utility of the findings, and the generalizability of the
findings to the field as a whole. While this study has internal
validity, therefore, FDA acknowledges that it has limited external
validity. Thus, FDA agrees that this study will not be used to
directly inform policy but, rather, that this study represents the
first step in FDA's process of investigating this issue
scientifically. The study is one piece of the puzzle that will help
FDA fulfill its mission to protect public health from false and
misleading DTC prescription drug advertisements.
Inventory as of this Action
36 Months From Approved
FDA regulations require that
advertisements that make claims about a prescription drug include a
"fair balance" of information about the benefits and risks of
advertised products, in terms of both content and presentation. Ads
can present information in ways that can optimize or skew the
relative balance of risks and benefits. Both healthcare providers
and consumers have expressed concerns to FDA about the
effectiveness of its regulation of manufacturers'
Direct-to-Consumer (DTC) prescription drug advertising, especially
as it relates to assuring balanced communication of risks compared
The purpose of the proposed
study is to gather empirical evidence to address concerns that the
use of competing, compelling visual information about potential
drug benefits in DTC advertsing interfers with viewers' processing
and comprehension of risk information about drugs.