
[Federal Register Volume 80, Number 100 (Tuesday, May 26, 2015)]
[Notices]
[Pages 30077-30080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12582]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1819]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Spousal Influence on 
Consumer Understanding of and Response to Direct-to-Consumer 
Prescription Drug Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 June 
25, 2015.

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 ``Spousal Influence on Consumer Understanding of and Response to 
Direct-to-Consumer (DTC) Prescription Drug Advertisements''. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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.

Spousal Influence on Consumer Understanding of and Response to Direct-
to-Consumer Prescription Drug Advertisements--(OMB Control Number 0910-
NEW)

    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.
    Consumers are often thought of as individual targets for 
prescription drug advertisements (ads), as if they are always exposed 
to DTC ads individually and subsequently make judgments about 
advertised products on their own. However, judgments about prescription 
drugs portrayed in DTC television ads are likely made in social 
contexts much of the time. For example, a potential consumer and his or 
her spouse (e.g., marital or domestic partner) may view an ad together 
and discuss drug benefits, side effects, and risks. These social 
interactions may result in unique reactions relative to consumers who 
view DTC prescription drug television ads alone. For example, spouses 
may influence their partner by expressing concern about risks and side 
effects that might occur, or pressuring their partner to consider the 
drug despite its risks and side effects. These outcomes have important 
public health implications. The Office of Prescription Drug Promotion 
plans to examine differences between consumers viewing prescription 
drug ads with a spouse versus alone through empirical research.
    The main study will be preceded by pretesting designed to delineate 
the procedures and measures used in the main study. Pretest and main 
study participants will be couples who are married or in a marital-like 
living arrangement in which one member (consumer) has asthma and the 
other does not (spouse). All participants will be 18 years of age or 
older and married or cohabiting for 6 months or longer. We will exclude 
individuals who work in

[[Page 30078]]

healthcare or marketing settings because their knowledge and 
experiences may not reflect those of the average consumer. Data 
collection will take place in person.
    Participants will be randomly assigned to one of four experimental 
conditions in a 2 x 2 design, as depicted in Table 1. We will compare 
one version of an ad that depicts a low benefit and low risk drug with 
a second version that depicts a high benefit and high risk drug. 
Participants will be randomly assigned to view the ad alone or together 
with their spouse. Participants in both viewing conditions will 
individually complete a prequestionnaire. In the ``together'' 
condition, participants will view the ad with their spouse and then 
engage in a brief discussion together about the ad. In the ``alone'' 
condition, participants will view the ad without their spouse, take a 
short break, and then respond to a postquestionnaire consisting of 
questions about information in the ad. The short break in the ``alone'' 
condition will facilitate reflection about the ad to mirror discussion 
engaged in by those in the ``together'' condition. The consumer in the 
``together'' condition will complete the same postquestionnaire 
administered to those in the ``alone'' condition, and the spouse will 
complete a slightly different questionnaire that assesses key measures 
that relate to consumer reactions. These procedures are depicted in 
Table 2. Participation is estimated to take approximately 60 minutes.
    Measures are designed to assess memory and understanding of risk 
and benefit information as well as other ad content, intention to seek 
more information about the product, and variables pertaining to the 
consumer-spouse relationship such as relationship closeness and 
communication style. The questionnaire is available upon request.

                   Table 1--Experimental Study Design
------------------------------------------------------------------------
                                          Risk/benefit condition
                                 ---------------------------------------
        Viewing condition            Low risk/low       High risk/high
                                        benefit             benefit
------------------------------------------------------------------------
Alone...........................  Condition A.......  Condition B
Together........................  Condition C.......  Condition D
------------------------------------------------------------------------


   Table 2--Overview of Data Collection Process for Alone and Together
                               Conditions
------------------------------------------------------------------------
                                           Viewing condition
            Steps            -------------------------------------------
                                      Alone               Together
------------------------------------------------------------------------
1...........................  Consumer completes    Consumer and spouse
                               prequestionnaire.     complete
                                                     prequestionnaire
                                                     separately (spouse
                                                     completes selected
                                                     measures).
2...........................  Consumer views        Consumer and spouse
                               advertising stimuli   view advertising
                               alone.                stimuli together.
3...........................  5 minute break......  Couples engage in a
                                                     5 minute semi-
                                                     structured
                                                     conversation
                                                     related to the
                                                     advertising
                                                     stimuli.
4...........................  Consumer completes    Consumer and spouse
                               postquestionnaire.    complete
                                                     postquestionnaire
                                                     separately (spouse
                                                     completes selected
                                                     measures).
------------------------------------------------------------------------

    In the Federal Register of November 14, 2014 (79 FR 68278), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received comments from two organizations 
in response to our Federal Register notice. In the following section, 
we outline the observations and suggestions raised in the comments and 
provide our responses.
    (Comment from Abbvie) It is difficult to ascertain how the Agency 
will utilize the results of this study should it demonstrate that the 
perception of ads differs when viewed alone or with someone else. 
Regulating companion versus solitary viewing practices would present 
insurmountable legal and practical hurdles. Rather than conduct this 
study, we suggest that FDA resources and tax payer dollars would be 
better directed to research that enhances the quality of how we 
communicate benefit and risk information to consumers regardless of the 
setting in which the ad is viewed.
    (Response) Much research in the social sciences demonstrates the 
strong influence of environmental and social conditions under which 
humans think and act. In regard to prescription drug advertising, it 
may be that when a risk is perceived as particularly negative, viewing 
with a partner reinforces this perception. Conversely, it may be that 
partners downplay risks or emphasize benefits, leading to alternate 
perceptions and intentions. These potential outcomes have implications 
for public health. Thus, it is important to generate insight about not 
only the message portrayed in DTC TV ads but also the conditions under 
which these messages are received and processed. Pending findings from 
this research, organizations involved in developing DTC drug 
communications may be encouraged to remain aware of the social context 
in which DTC ads are often viewed and the influence of this context on 
consumer perceptions, judgments, and decisions. Consideration of this 
broader context may facilitate the development of better DTC drug 
communications that remain accurate and balanced regardless of setting.
    (Comment from Eli Lilly) Compelling a discussion between the 
consumer and spouse about the advertisement is likely to generate data 
that may or may not be applicable in a real-world setting. Consider 
removing the prescribed interaction and allow a discussion to occur if 
the couple so chooses.
    (Response) Allowing a discussion to occur if the couple chooses 
could confound the research design and undermine our ability to make 
conclusive statements. Implementing the procedures systematically 
across the sample is a stronger study design (Ref. 1). There is a long 
tradition in the social and behavioral sciences of studying marital 
communication as proposed (Ref. 2). This research tradition continues 
because this method is more objective than participant self-reports 
(Ref. 3). Also, measures taken from these spousal communications are 
linked with important real world outcomes including health behavior and 
well-being (Ref. 4, Ref. 5), divorce, and marital satisfaction (Ref. 6, 
Ref. 2). This research method compels a discussion between partners as 
a way to understand the content and style of their communication. Thus, 
our proposed study is in keeping with the methods in this research 
area.
    (Comment from Eli Lilly) We are challenged to understand how this 
research yields any useful, actionable information when it is 
impractical to

[[Page 30079]]

influence who is watching TV advertisements at any given time.
    (Response) As stated in response to a previous comment, it is 
important to generate insight about not only the message portrayed in 
DTC TV ads but also the conditions under which these messages are 
received and processed. Such insight may facilitate the development of 
better DTC drug communications regardless of setting.
    (Comment from Eli Lilly) Include a ``General Population'' control 
group.
    (Response) Researching each medical condition, or general 
population sample, requires significant resources. We are interested in 
response to the ads among consumers for whom the ad is personally 
relevant (i.e., they or their partner have been diagnosed with asthma). 
We are committed to conducting this research using our available 
resources while ensuring the integrity of the research by collecting 
data on a high prevalence condition for which participants might be 
thought of as sufficiently representative of the average consumer, thus 
allowing us to draw conclusions about broad perceptual and cognitive 
processing outcomes.
    (Comment from Eli Lilly) Q12 invites speculation from respondents 
who may be unable to evaluate what is or is not a ``serious'' side 
effect. Consider eliminating this question or re-phrasing to: ``Please 
rate the seriousness of the side effects for [Drug X] that you remember 
from the ad.''
    (Response) We have conducted cognitive interviews to refine and 
improve the survey questions. Through this process, we found that a 
number of participants had difficulty reading and/or answering Q12 in 
its original form. We also tested an alternative version of this 
question that conforms to the reviewer's re-phrasing, ``In your 
opinion, how serious are the side effects of [Drug X]?'' Many cognitive 
interview participants preferred this alternative version, and we will 
adopt it for the final questionnaire.
    (Comment from Eli Lilly) Response options in Q16 may be interpreted 
qualitatively (i.e., on the whole, the risks outweigh the benefits) or 
literally (i.e., how many more risks were stated than benefits). 
Rephrasing to reflect true intent is recommended.
    (Response) We appreciate this comment. This item was tested in a 
rigorous cognitive interview protocol and there was no indication that 
participants had difficulty interpreting the response options. However, 
we will also be conducting pretesting which will provide an additional 
opportunity to identify and remove questions that do not function as 
intended, further refining the questionnaire prior to the main study.
    (Comment from Eli Lilly) Q19b is ambiguous and unclear. Rephrasing 
or deletion is recommended.
    (Response) We tested this item as part of our cognitive interview 
protocol. The majority of participants understood this question, and 
their answers suggest that the question did a good job of 
distinguishing between those who focused on the arguments and facts 
presented in the ad versus those who paid more attention to peripheral 
cues, such as the visual narrative. Because the item functioned as 
intended, we intend to retain Q19b.
    (Comment from Eli Lilly) Q20 is ambiguous and unclear. Rephrasing 
or deletion is recommended.
    (Response) In our cognitive interviews, some participants had 
difficulty understanding the meaning of the introductory phrase ``In 
these thoughts''. Due to the ambiguity of Q20 as a whole, we will 
remove this item from the questionnaire.
    (Comment from Eli Lilly) Q21 instructions could bias respondents to 
evaluate each statement as risk-related. Consider rephrasing to, ``The 
following statements describe how people deal with various 
situations.''
    (Response) The Q21 battery is a validated scale specifically 
designed to measure attitudes toward risk (Ref. 7). Respondents are 
meant to evaluate the statements as though they are risk-related. 
Therefore, we will retain the Q21 battery.
    (Comment from Eli Lilly) The scale for Q25 should be made 
consistent with other scales to ensure internal consistency. A scale 
with a midpoint is recommended.
    (Response) When developing the questionnaires, we included a number 
of questions from existing multi-items scales. The number and format of 
response options differed from scale to scale (e.g., 6-points vs. 10-
points, fully labelled vs. anchors-only, etc.). We will revise the 
Likert-type response scales so that the number of levels and labeling 
formats across questions is consistent.
    To examine differences between experimental conditions, we will 
conduct inferential statistical tests such as analysis of variance. 
With the sample size described in Table 3, we will have sufficient 
power to detect small-to-medium sized effects in the main study.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
                                       Number of    responses      Total       Average burden per
              Activity                respondents      per         annual           response         Total hours
                                                    respondent   responses
----------------------------------------------------------------------------------------------------------------
                                                   Pretesting
----------------------------------------------------------------------------------------------------------------
Number to Complete the Screener.....          700            1          700  0.08 (5 minutes)......           56
Number of Completes.................          120            1          120  1.....................          120
----------------------------------------------------------------------------------------------------------------
                                                   Main Study
----------------------------------------------------------------------------------------------------------------
Number to Complete the Screener.....        4,060            1        4,060  0.08 (5 minutes)......          325
Number of Completes.................          792            1          792  1.....................          792
                                     ---------------------------------------------------------------------------
    Total...........................  ...........  ...........  ...........  ......................        1,293
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified all the Web site addresses in this reference section, 
but we are not responsible for any

[[Page 30080]]

subsequent changes to the Web sites after this document publishes in 
the Federal Register.)

Reis, H., and C. Judd, Handbook of Research Methods in Social and 
Personality Psychology, 2nd Ed. New York: Cambridge University Press 
(2014).
Kerig, P.K., and D.H. Baucom, (Eds.). Couple Observational Coding 
Systems, Mahwah, NJ: Erlbaum (2004).
Bakeman, R., Behavioral Observation and Coding, In H.T. Reis & C.M. 
Judd (Eds.) Handbook of Research Methods in Social and Personality 
Psychology,pp. 138-159. New York: Cambridge University Press (2000).
Ewart, C.K., C.B. Taylor, H.C. Kraemer, and W.S. Agras. ``High Blood 
Pressure and Marital Discord: Not Being Nasty Matters More Than 
Being Nice,'' Health Psychology, 10, pp. 155-163 (1991).
Spitzberg, B.H., and W.R. Cupach, Handbook of Interpersonal 
Competence Research, NY: Springer-Verlag (1989).
Gottman, J.M., What Predicts Divorce? The Relationship Between 
Marital Processes and Marital Outcomes. Hillsdale, NJ: Erlbaum 
(1994).
Rohrmann, B., ``Risk Attitude Scales: Concepts, Questionnaires, 
Utilizations [Project Report],'' University of Melbourne, Australia. 
Retrieved from http://www.rohrmannresearch.net/pdfs/rohrmann-racreport.pdf (2005).

    Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12582 Filed 5-22-15; 8:45 am]
 BILLING CODE 4164-01-P


