[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76046-76049]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0176]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study: 
Examination of Corrective Direct-to-Consumer Television Advertising

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 January 
25, 2013.

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, ``Experimental Study: Examination of Corrective Direct-to-
Consumer Television Advertising.'' Also include

[[Page 76047]]

the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@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.

Experimental Study: Examination of Corrective Direct-to-Consumer 
Television Advertising--(OMB Control Number 0910--New)

    Section 1701(a)(4) of the Public Health Service Act (42 CFR 
300u(a)(4)) authorizes the Food and Drug Administration (FDA) to 
conduct research relating to health information. Section 903(b)(2)(c) 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 CFR 
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.
    FDA regulations require prescription drug ads to contain accurate 
information about the benefits and risks of the drug advertised. When 
this is not the case, corrective advertising is designed to dissipate 
or correct erroneous beliefs resulting from a false claim (Refs. 1 and 
2). Corrective advertising emerged in public debate in the United 
States in the 1970s as a hypothetical remedy for deceptive advertising, 
having first been proposed by Georgetown University law students in 
1969 as a way of dispelling the effects of deceptive advertising (Ref. 
3). Corrective advertising is one remedy FDA may request in response to 
false or misleading prescription drug promotion. In 2009, for example, 
Bayer HealthCare Pharmaceuticals produced and aired corrective DTC 
advertising for Yaz, a birth control pill, following a warning from FDA 
regarding misleading claims (Ref. 4). Despite these developments, 
researchers and policymakers currently lack empirical literature 
regarding the various influences of corrective DTC ads on prescription 
drug consumers. The current project will examine the influence of 
corrective messages in the realm of consumer directed prescription drug 
advertising.

Design Overview

    Phase 1 will vary the exposure to the messages (original ad alone 
vs. original + corrective vs. corrective ad alone). The goal of Phase 1 
is to examine how exposure to a combination of original and corrective 
DTC ads affects message recall, message comprehension, perceived drug 
efficacy, perceived drug risk, and intentions to ask about or use the 
drug. Specifically, we will compare consumers who see both the original 
and corrective ad with those who see only the original ad, only the 
corrective ad, and neither ad. Participants in the Control condition 
will see a reminder ad for the product to control for brand name 
exposure.

  Table 1--Design of Phase 1: Original Exposure by Corrective Exposure
------------------------------------------------------------------------
                                         Exposure to corrective ad
     Exposure to original ad     ---------------------------------------
                                          Yes                 No
------------------------------------------------------------------------
Yes.............................  ..................  ..................
No..............................  ..................  Control (Reminder
                                                       ad)
------------------------------------------------------------------------

    Phase 2 will examine the similarity of the corrective ad's theme 
and visual elements to those of the original ad (same ad elements vs. 
some similar ad elements vs. different ad elements) and the exposure 
delay (time) between viewing the original ad and the corrective ad (no 
delay vs. 1 week delay vs. 1 month delay vs. 6 month delay). The 
purpose of Phase 2 is to examine whether a corrective ad's ability to 
correct misinformation is related to: (1) Corrective ad similarity to 
the original ad and (2) time delay between original ad and corrective 
ad exposure.
    We will systematically vary these two characteristics to create a 
study with a 4 (similarity to original ad) x 4 (exposure delay) design 
(see Table 2).

                   Table 2--Design of Phase 2: Corrective Ad Similarity by Exposure Time Delay
----------------------------------------------------------------------------------------------------------------
                                 Multiple exposure pod  (2           Time between Original and Corrective
   Corrective ad similarity     viewings per sitting, for a  ---------------------------------------------------
                                   total of 6 exposures*)         None        1 Week      1 Month      6 Months
----------------------------------------------------------------------------------------------------------------
Same ad elements as original
Some similar elements as
 original
Different ad elements than
 original
Control (Do not see
 corrective)*
----------------------------------------------------------------------------------------------------------------
*The control condition will be used to examine the impact of time delay on perceptions and intentions.

    Prior to conducting the main study, we will pretest the stimuli, 
questionnaires, and data collection process. The first set of pretests 
will focus on the stimuli to: (1) Ensure participants perceive the 
stimuli as realistic and (2) ensure participants notice and comprehend 
the original and corrective messages in the ads. The second pretest 
will focus on the questionnaires and data collection process. Its 
purpose will be to: (1) Ensure that survey questions solicit responses 
that meet the study's analytic goals and (2) ensure data are captured 
and stored accurately for each question. The pretests are not intended 
to affect the study design, sample or burden.
    All parts of this study will be administered over the Internet. A 
total of 6,650 interviews will be completed. Participants will be 
randomly assigned to view one version of a DTC prescription drug 
television ad. Following their perusal of this ad, they will answer 
questions about their recall and understanding of the benefit and risk 
information, their perceptions of the benefits and risks of the drug, 
and their intent to ask a doctor about the medication.
    Demographic and numeracy information will be collected. In 
addition, participants will answer questions about their familiarity 
with their medical condition. The entire procedure is expected to last 
approximately 25 minutes in Phase 1 and 1 hour in Phase 2. This will be 
a one-time (rather than annual) information collection.
    Participants will be randomly assigned to view one version of a DTC 
prescription drug television ad. Following their perusal of this ad, 
they will answer questions about their recall and understanding of the 
benefit and risk information, their perceptions of the benefits and 
risks of the drug, and their intent to ask a doctor about the

[[Page 76048]]

medication. Demographic and numeracy information will be collected. In 
addition, participants will answer questions about their familiarity 
with their medical condition. The entire procedure is expected to last 
approximately 20 minutes. This will be a one-time (rather than annual) 
information collection.
    In the Federal Register of February 29, 2012 (77 FR 12307), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received three public submissions. In 
the following section, we outline the observations and suggestions 
raised in the comments and provide our responses.
    (Comment 1) One comment expressed support for the survey.
    (Response) We thank this commenter for his support of our study.
    (Comment 2) One comment expressed the concern that the Internet 
sample would not measure individuals over 65 due to difficulties using 
the Internet.
    (Response) We have conferred with the Internet Panel provider for 
this study about this issue. According to GfK,\1\ the 65+ Panelists are 
among the most reliable respondents and their representation on the 
panel (15.7 percent) is reasonably proportionate to their 
representation in the General Population (16.7 percent).
---------------------------------------------------------------------------

    \1\ Formerly Knowledge Networks.
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    (Comment 3) One comment stated a ``medium prevalence'' condition 
may not represent conditions that cluster in particular demographic 
groups.
    (Response) Recruitment to KnowledgePanel[supreg] is based upon a 
random selection of residential addresses. Every residential address in 
the United States has an equal probability of selection within each 
recruitment cohort (cohort sizes may vary from recruitment wave to wave 
and the residential housing stock changes over time which results in 
differing probability of selection between recruitment waves). Thus, 
mailings have a proportional likelihood of reaching any specific 
demographic group. Finally, as the weights are calculated based upon 
Current Population Survey benchmarks, final adjustment of survey 
respondents to the U.S. population can be easily made. The panel 
recruits in English and Spanish with all mailings being bilingual.
    We plan to use asthma and weight loss as our two medical 
conditions. While the particulars of an individual corrective campaign 
may vary, the type of violation (for example, overstatement of 
efficacy, minimization of risk) can occur in any drug class. Therefore, 
we believe that the cognitive processes involved in understanding a 
claim and subsequently addressing problematic claims applies across 
multiple medical conditions. Those with debilitating conditions might 
be less likely to respond to the recruitment and survey invitations but 
it is likely that they would be less likely to respond to other modes 
of survey data collection as well.
    Finally, we note that this is a randomized control trial design: we 
are not attempting to make population estimates from these results.
    (Comment 4) One comment asked if the participants would be a random 
and representative selection of the target audience.
    (Response) We are planning to recruit panel members who self-report 
having been diagnosed with asthma (Phase 1) or self-identify as having 
a weight problem with a BMI of 25 or above (Phase 2). These are the 
relevant target audiences for the medical conditions being advertised. 
As described above, the panel of active profiled adults is weighted to 
be representative of the U.S. population on age, gender, race, Hispanic 
ethnicity, language proficiency, region, metro status, education, 
household income, home ownership, and Internet access using post-
stratification adjustments to offset nonresponse or noncoverage bias.
    (Comment 5) One comment stated that even if participants are 
randomly selected, the final study sample may be self-selected due to 
dropout over time.
    (Response) We agree that dropout is a concern common to all 
longitudinal research. We plan to employ the following techniques to 
improve retention of respondents over time:
    1. It is very important to notify respondents at the time of their 
invitation that this is a longitudinal survey and that we intend to 
contact them multiple times during the duration of the survey. This in 
an important part of the informed consent procedure. We will therefore 
explicitly ask respondents if we can contact them in the future. This 
will allow us to contact them even if they leave the panel.
    2. Periodic contact also provides a vehicle to retain engagement 
with respondents and can be conducted via email. KnowledgePanel[supreg] 
members are accustomed to receiving periodic communication about 
surveys that they previously participated in and respond well to 
periodic contact.
    3. When later survey waves are fielded, respondents will be 
reminded that they participated in the earlier survey wave, that we 
appreciated their agreeing to participate in subsequent survey waves 
and that this survey is a follow-on to the prior survey wave. The date 
of the prior survey field wave will be included.
    4. Finally, even if a respondent has left the panel, respondents 
have given explicit permission, as was noted in item 1 above, to 
contact them regarding this survey. Thus we do not anticipate an 
unusual loss of participation on subsequent survey waves. In past 
multiwave surveys, it was not unusual for 75 percent to 85 percent of 
respondents to the first wave of a study to respond to a subsequent 
survey wave more than 1 year later.
    (Comment 6) One comment questioned whether the study would be 
adequately powered to ensure meaningful results.
    (Response) We have powered our study to detect small to medium 
effect sizes. We have provided a power analysis for both the main study 
phases and pretests.
    (Comment 7) One comment suggested that rather than similarity and 
time delay, the proposed study should include an evaluation of both: 
(1) A truly informative, nondistracting, clear and conspicuous 
corrective ad and (2) an unclear and inconspicuous corrective ad.
    (Response) We appreciate the suggestion to include clarity as an 
independent variable. Because we cannot study every variable of 
potential interest in a single study, we offer the following 
explanation for our choice of similarity and time delay. FDA has 
previously provided guidance on ways in which separate ads may be 
implemented in such a way as to be perceived as linked to one another:

    Psychology and marketing research suggests that the greater the 
perceptual similarity between disease awareness communications and 
reminder or product claim promotions (i.e., similarities in terms of 
their themes, such as story lines, or other presentation elements, 
such as colors, logos, tag lines, graphics, etc.), and the closer 
they are presented physically or in time to one another, the more 
likely it is that the separate messages contained in the two pieces 
will be remembered together in memory as one entity. Perceptual 
similarity is an important factor because research indicates that 
pieces are most likely to be linked together in memory when they 
have prominent cues in common, such as distinctive visual elements, 
a common narrator or background music, or a common story line. (Ref. 
5.)

The recommendations in this guidance were based on the social science 
literature which suggests these properties influence people's 
associations. We selected similarity and time delay as our independent 
variables of interest in this study in order to

[[Page 76049]]

provide information on the effectiveness of FDA guidance on this issue.
    (Comment 8) Two comments expressed concern that the time delay 
conditions were not realistic, stating that a time delay of 6 months to 
a year might be more realistic.
    (Response) We agree that a 6-month exposure delay more closely 
approximates real-world exposure to original and corrective messaging. 
In response to concerns about the realism of our approach, we have 
changed the study design in two ways (see Table 2). First, participants 
will view the stimuli embedded in a ``clutter reel'' of other ads three 
times over a 3-week period to approximate multiple exposures in a real-
world context. Second, we have added a 6-month delay condition.
    (Comment 9) One comment critiqued the references included in the 
60-day Federal Register notice, stating:

    ``* * * the references offered in the instant [sic] notice 
seemed less concerned with presenting corrective advertising in a 
manner most likely to inform the consumer about the safety and 
efficacy of a given product and more concerned with determining 
whether the corrective ad might be bad for sales. Furthermore, the 
only example of application of a judicial remedy to enforce 
corrective advertising cited by one of these references distorted 
the clear intent of the opinion cited.''

    (Response) Some of the research on corrective advertising, as the 
commentator notes, has assessed potential damage to an advertiser's 
reputation. Darke and colleagues (2008, Ref. 1) note the possibility of 
reputational damage, for example. Other papers cited in the 60-day 
notice, though, do not focus primarily on reputational damage. Mazis' 
work, both in the 1970s and 1980s and then again more recently (e.g., 
Mazis, 2001, Ref. 6), as we have seen a resurgence of corrective 
advertising, has been concerned with the efficacy of corrective 
messages. Mazis and colleagues (1983, Ref. 3), for example, focused 
attention on the extent to which viewers actually noticed and 
remembered the corrective message inserted into Listerine ads. 
Moreover, our study was designed to address a gap in the literature--
there is scant work on the specific efficacy of televised corrective 
ads intended to address claims made regarding prescription drugs--
rather than to simply extend and replicate past literature. The primary 
focus of our study is correction of misperceptions that arise from 
prescription drug advertising. The dependent variables we describe in 
the 60-day notice do not include advertiser reputation but rather are 
comprised of constructs such as belief in advertised claims that 
overstate efficacy or minimize risk, perceived risk of the advertised 
drug, and perceived efficacy of the advertised drug.
    Please note that in response to all comments received, whether we 
have adopted the suggestions or not, we will specifically examine the 
items mentioned in cognitive testing. During this testing, nine 
respondents will participate in the survey while explaining why and how 
they have chosen their answers and which questions they find difficult 
to respond to or to understand.
    FDA estimates the burden of this collection of information as 
follows:

                                          Table 3--Estimated Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     No. of
            Activity                 No. of       responses per   Total annual    Average burden    Total hours
                                   respondents     respondent       responses        response
----------------------------------------------------------------------------------------------------------------
Sample availability (pretests            24,635  ..............  ..............  ...............  ..............
 and main survey)..............
Screener completes (60%).......          14,891               1          14,891           0.0333             496
Eligible (85%).................          12,658  ..............  ..............  ...............  ..............
Pretest (stimuli) completes               1,450               1           1,450           0.333              483
 (65%).........................
Pretest (questionnaire)                     200               1             200           0.5                100
 completes (65%)...............
Phase 1 completes (65%)........           1,000               1           1,000            .416              417
Phase 2 completes (45%)........           4,000               1           4,000           1                4,000
Pretest/Study completes........           6,650  ..............  ..............  ...............  ..............
    Total......................  ..............  ..............  ..............  ...............           5,496
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

FDA estimates the total annual estimated burden imposed by this 
collection of information as 5,496 hours for this one-time collection.
V. References
    The following references have been placed on display at the 
Division of Dockets Management and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday (FDA has verified the 
Web site addresses of the following references, but FDA is not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register).

1. Darke, P. R., Ashworth, L., and Ritchie, R. J. B. (2008). Damage 
from corrective advertising: Causes and cures. Journal of Marketing, 
72, 81-97;
2. Mazis, M. B. & Adkinson, J. E. (1976). An experimental evaluation 
of a proposed corrective advertising remedy. Journal of Marketing 
Research, 13, 178-183.
3. Mazis, M. B., McNeill, D. L., & Bernhardt, K. L. (1983). Day-
after recall of Listerine corrective commercials. Journal of Public 
Policy & Marketing, 2, 29-37.
4. Singer, N. (2009, February 11). A birth control pill that 
promised too much. The New York Times, p. B1.
5. From Guidance for Industry: ``Help-Seeking'' and Other Disease 
Awareness Communications by or on Behalf of Drug and Device Firms. 
Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070068.pdf. 
Last accessed November 23, 2012.
6. Mazis, M. B. (2001). FTC v. Novartis: The return of corrective 
advertising? Journal of Public Policy & Marketing, 20, 114-122.

    Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31028 Filed 12-21-12; 4:15 pm]
BILLING CODE 4160-01-P