[Federal Register Volume 78, Number 93 (Tuesday, May 14, 2013)]
[Notices]
[Pages 28224-28227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11363]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0892]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Communicating 
Composite Scores in Direct-to-Consumer 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 June 
13, 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 [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title, ``Communicating Composite Scores in Direct-to-Consumer (DTC) 
Advertising.'' Also include 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, 
[email protected].

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.

Communicating Composite Scores in Direct-to-Consumer (DTC) 
Advertising--(OMB Control Number 0910-New)

I. 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 903(b)(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.

II. Composite Scores

    To market their products, pharmaceutical companies must demonstrate 
to FDA the efficacy and safety of their drugs, typically through well-
controlled clinical trials (Ref. 1) (see section 505 of the FD&C Act; 
21 U.S.C. 355). In some cases, drug efficacy can be measured by a 
single endpoint, such as high blood pressure (Ref. 2). Often, however, 
efficacy is measured by multiple endpoints that are sometimes combined 
into an overall score called a composite score (Ref. 3). For example, 
nasal allergy relief is measured by examining individual symptoms such 
as runny nose, congestion, nasal itchiness, and sneezing. Each symptom 
is measured on its own. An overall score is computed from the 
individual symptom measurements; if a drug has a significantly better 
overall score than the comparison group (e.g., placebo), it can be 
marketed for the relief of allergy symptoms. However, although a drug 
may have a significantly better score overall, it may not have a 
significantly better score on a particular aspect (e.g., runny nose). 
Scientists and medical professionals have had training to understand 
the difference between composite score endpoints and single endpoints, 
but members of the general public may not understand the difference.
    Given the frequency of DTC advertising, it is important to 
determine whether consumers understand composite scores as they are 
currently communicated and how best to communicate such scores to lay 
audiences in general. Because most DTC prescription drug ads do not 
explicitly state that they used composite scores to demonstrate 
efficacy or they provide little explanation of how these scores are 
calculated, it is also important to investigate whether consumers 
understand how composite scores are used for measuring drug efficacy.
    Prior research on composite scores is scant. Therefore, in 
September 2011, FDA conducted a focus group study (OMB control number 
0910-0677) to better understand how consumers understand the concept of 
composite scores. Prior to the focus group, few participants had heard 
the term ``composite score,'' none were aware of how the scores might 
be used in clinical trials, and most participants had difficulty 
correctly interpreting efficacy information that was based on composite 
scores. Once the moderator explained composite scores to

[[Page 28225]]

participants, some reassessed their opinion of the advertised drug's 
effectiveness and said they thought that the information on 
effectiveness was ``much less convincing,'' in many cases because it 
was unclear whether the drug would work for a particular symptom. As a 
result, some participants said they would want a drug ad to include 
more detailed information on the effectiveness of the drug on each 
component of the composite score. However, others felt that the ads 
already provided enough information on effectiveness and that adding 
more statistical details would make the ads more complicated, thus 
decreasing the likelihood that consumers would read them.
    The focus group findings suggest that research is required to 
examine how the inclusion of increasingly detailed information affects 
understanding of composite scores and influences perceptions of 
efficacy. This is especially important given the many marketed 
prescription drugs that are based on composite scores.
    We are aware of no quantitative research on best practices for 
communicating composite score information to consumers. One related 
area of research, communicating health-related information to 
consumers, offers two practical recommendations that are particularly 
relevant to communicating composite scores in DTC advertisements. 
First, because less-numerate and less-literate consumers may not 
understand the information as well, examining differences in 
comprehension of composite scores by numeracy- and literacy-relevant 
demographic characteristics such as education level and age is 
important (Refs. 4 and 5). Second, although the literature tends to 
suggest limiting the amount of information presented in advertisements 
(Ref. 5 to 7), examining the amount of detail that best facilitates 
comprehension of composite scores is warranted.

III. Research Purpose

    Given the lack of research on consumer understanding of composite 
scores and how to best present this information in DTC advertisements, 
the main goal of the current research is to evaluate how consumers 
interpret and respond to DTC prescription drug advertising that 
includes benefit information based on composite scores. Specifically, 
this research will explore:
     Whether consumers are aware of how efficacy is measured 
for specific drugs;
     How well consumers comprehend the concept of composite 
scores;
     Whether exposure to DTC advertisements with composite 
scores influence consumers' perceptions of a drug's efficacy and risk; 
and
     Different methods for presenting composite scores in DTC 
ads to maximize consumer comprehension and informed decision making.

IV. Design Overview

    Study 1. In this phase, individuals in a general population sample 
of 1,600 adults of varying education levels will answer an Internet 
survey designed to explore whether consumers recognize composite scores 
in DTC ads and their understanding of composite scores. The survey will 
be conducted with a probability-based consumer panel of U.S. adults.
    As part of the survey, participants will view a print ad that 
contains claims based on composite scores and respond to questions 
about the ad to assess whether they recognized that composite scores 
were used. Other outcomes will include ad comprehension, perceived 
efficacy, and perceived risk as they relate to their understanding of 
composite scores. We will also examine whether and in what ways 
participants' perceived efficacy and perceived risk change after they 
are given a definition and examples of composite scores. Questions will 
also explore consumers' understanding of how the effectiveness of drugs 
is measured in general.
    This exploratory survey will not be used to test specific 
hypotheses about the outcome measures. However, we will explore the 
differences in responses to the ad before and after information about 
composite scores is provided. We will also examine differences in the 
comprehension of the composite score concept and in the features of the 
ad by education level and age because literature suggests that less-
educated and older consumers may not understand this type of 
information as well (Ref. 4).
    Study 2. Unlike Study 1, Study 2 will be a randomized, controlled 
study. Study 2 will examine different ways to present the information 
that arises from a composite score and different ways to explain the 
concept of a composite score (an educational intervention). Outcome 
measures will include consumers' awareness and comprehension of the 
composite score concept, perceived drug efficacy, and risk recall. 
Participants will be randomly assigned to experimental arms in a 3 x 2 
design as shown in table 1.

                                        Table 1--Study Design for Study 2
----------------------------------------------------------------------------------------------------------------
                                            Information presentation
-----------------------------------------------------------------------------------------------------------------
                                                                                  Composite
     Educational intervention      General  indication   List of  symptoms        definition           Total
----------------------------------------------------------------------------------------------------------------
Absent...........................  Arm 1 (n=290)......  Arm 2 (n=290)......  Arm 3 (n=290)......             870
Present..........................  Arm 4 (n=290)......  Arm 5 (n=290)......  Arm 6 (n=290)......             870
                                  ------------------------------------------------------------------------------
    Total........................  580................  580................  580................           1,740
----------------------------------------------------------------------------------------------------------------

    This study will manipulate two variables: Three types of 
information presentations and the presence or absence of an educational 
intervention. In terms of information presentation, there are many 
aspects of composite scores that could be communicated and one research 
project cannot test them all. In this study, we have chosen to examine 
three different information presentations that may or may not help 
consumers understand the composite score concept. These different 
information presentations were chosen based on a review of the 
literature and a review of past DTC submissions.
    The three different information presentations are described as 
follows:
    General Indication. The first information presentation is the 
indication of the product. In this condition, participants will see the 
drug indication but will not see any explicit statement that the drug's 
benefits are based on a composite score. This is a common way that 
composite scores are currently communicated. An example of this 
presentation is: ``Drug A treats and helps prevent seasonal nasal 
allergy symptoms.''

[[Page 28226]]

    List of Symptoms. The next information presentation will include 
the drug indication and all of the symptoms that are used to make up 
the composite score. This condition, like the general indication 
condition, will not include an explicit statement referencing composite 
scores. This is also a common way that composite scores are currently 
communicated. An example of this presentation is: ``Drug A treats and 
helps prevent seasonal nasal allergy symptoms: Congestion, runny nose, 
nasal stuffiness, nasal itching, and sneezing.''
    Composite Definition. The final information presentation will 
present the indication, describe that the drug's benefits are based on 
a composite score, and explicitly define a composite score. To our 
knowledge, this would be a new way to communicate composite scores. An 
example of this presentation is: ``Drug A treats and helps prevent 
seasonal nasal allergy symptoms. Drug A's effectiveness is based on a 
composite score. A composite score is a single measure of how well a 
drug works based on a combination of symptoms. Drug A may not be as 
effective in addressing each factor individually.''
    We will also manipulate whether or not participants see a specific 
educational intervention. This intervention was developed from prior 
focus groups (OMB control number 0910-0677) where it was found to 
resonate with participants. In these focus groups, medical examples 
were confusing, so non-medical examples were explored. This example 
will feature the decathlon as an educational example of a composite 
score. For example, ``Drug A's effectiveness is based on a composite 
score. A composite score is like a decathlon. In that event, athletes 
compete in 10 events, such as the long jump, the shot put, and the 50-
yard dash. An athlete may not win all events, but if he or she performs 
well enough in some events, he or she may be the winner based on a 
combination of scores for each event.''
    We will test whether the educational intervention, the information 
presentation, and the interaction of the two affect outcomes such as 
consumers' awareness and comprehension of the composite score concept, 
perceived drug efficacy, and risk recall. We will test whether numeracy 
and literacy moderate any significant relations.
    The sample for the second study will include approximately 1,740 
participants who have been diagnosed with seasonal allergies. The 
protocol will take place via the Internet. Participants will be 
randomly assigned to view one print ad for a fictitious prescription 
drug that treats seasonal allergies and will answer questions about it. 
The entire process is expected to take no longer than 20 minutes.
    In the Federal Register of August 23, 2012 (77 FR 51027), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received four public submissions. One 
submission discussed bird flu, and another submission discussed graphic 
warnings on cigarette packages. Both of these comments are outside the 
scope of the present project and will not be discussed further. In the 
following section, we outline the observations and suggestions raised 
in the other two submissions and provide our responses:
    (Comment 1) One comment mentioned the respondents who were 
identified as screeners, wondering who these individuals were and what 
their roles will be.
    (Response) These individuals are members of the Internet panel who 
are screened for participation. They originate from the same source as 
participants who complete the whole survey but either do not meet the 
criteria in the screener or choose not to participate in the study.
    (Comment 2) One comment mentioned that ensuring adequate power is 
an important consideration.
    (Response) We agree that power analysis is critical to ensure that 
participants' time is used wisely and that the research meets high 
standards of rigor. We have conducted power analyses to do this.
    (Comment 3) One comment questioned whether the understanding of 
composite scores is more applicable to print or video ads and suggested 
that we ensure we are delivering the sample ad in the medium consumers 
will be most likely to use.
    (Response) Because this is the first study to our knowledge that 
specifically examines the understanding of composite scores, we have 
chosen to examine them in the context of magazine ads. Magazine ads for 
prescription drugs are common. Pending the results of the current 
research, we may examine the issues in video format.
    (Comment 4) One comment mentioned that we have not addressed the 
issue of non-response.
    (Response) We will perform a non-response analysis to determine 
whether respondents were biased in the direction of any demographic 
characteristics.
    (Comment 5) The comment suggested that because FDA conducted focus 
groups on the understanding of composite scores there is no need to 
conduct quantitative research.
    (Response) FDA respectfully disagrees. Focus groups are small, 
qualitative interviews among a group of individuals. Focus groups are 
composed of individuals who are not representative of any population, 
and the number of people queried is too small to draw firm conclusions. 
The value of focus group research is the exploration of topics for 
potential future study, to determine what language people use to 
discuss topics, and to strengthen the details of future quantitative 
research that may be conducted by FDA. What we learned from the focus 
groups on composite scores is that there is a need for research to 
determine how widespread misconceptions are and whether there are 
methods available to remedy them. To gain confidence in our qualitative 
findings, more quantitative measures are necessary.
    (Comment 6) This comment suggested that because a health care 
professional is involved in the prescribing of prescription drugs, the 
misunderstanding of composite scores is mitigated.
    (Response) We agree that the health care professional is the 
prescriber and that the consumer or patient has a layer of protection 
before consuming prescription drugs. However, direct-to-consumer 
advertising is directed at consumers before they talk to their health 
care professionals--in fact, driving consumers to their health care 
professionals is a primary goal of DTC ads. If sponsors choose to 
communicate with consumers in such a manner, then it makes sense to 
examine the understandability of their messages.
    (Comment 7) This comment stated that because the meaning of 
composite scores in serious medical conditions may differ from that in 
allergy situations, FDA should take care in not generalizing beyond 
what the results suggest in the nasal allergy category.
    (Response) We agree. Because we have designed only two studies to 
examine this issue, we have by necessity chosen one medical condition 
for each. We will be cautious in applying the findings of our research.
    (Comment 8) This comment suggested leveraging the brief summary to 
improve consumer understanding of composite scores. They suggest 
including a signal, such as an asterisk, to information in the brief 
summary about composite scores. They also suggest that the brief 
summary draft guidance could include language about what the proper

[[Page 28227]]

explanation of composite scores could be.
    (Response) This comment appears to address the draft guidance 
``Brief Summary: Disclosing Risk Information in Consumer-Directed Print 
Advertisements,'' and is thus beyond the scope of this project. We 
encourage the commenter to consider submitting comments to the docket 
for that guidance, Docket No. 2004D-0042. Comments can be made to any 
guidance at any time.
    (Comment 9) This comment requests that FDA publish a strategic plan 
that clearly shows which studies are independent and which are 
connected to each other. This comment also suggests that FDA publish in 
a timely manner the results of studies posted on the Office of 
Prescription Drug Promotion Web page.
    (Response) We agree that timely results should be made available to 
the public. In the last few years, we have had an increase in the 
number of research studies and they are all in various states of 
development. We will publicize them as results become available. We 
agree the Web page should be updated and are constantly working to make 
that happen. Please note that this study is the first to explore 
composite scores and does not build on any prior research from our 
office.
    (Comment 10) This comment suggests that an assessment of drug 
effectiveness and risk recall is outside the scope of the stated 
interest in the study and that information on this study is being 
collected elsewhere.
    (Response) Assessment of effectiveness and risk information are 
within the scope of our stated interests in composite scores. Anything 
that is included in a DTC ad has the potential to influence the balance 
of risks and benefits that must be considered when a consumer makes the 
decision to speak with their health care professional about a 
prescription drug. Perceptions of effectiveness are central to issues 
of understanding composite scores because inappropriate presentations 
of composite scores overstate the efficacy of the drug. FDA is always 
concerned about the communication of risks in DTC promotion. Therefore, 
it is important to understand if variations in the presentation of 
composite scores influence the understanding of risks as well. 
Nonetheless, we are not collecting information on how composite scores 
may affect risk and benefit accuracy in other studies.
    (Comment 11) This comment requests that the results of this study, 
which address print ads, not be broadly applied to other forms of 
advertising such as Web sites, smart phones, and social media.
    (Response) We have chosen to investigate the concept of composite 
scores in a static print medium. The concepts we are exploring in this 
research apply to any similar medium, including static elements of Web 
sites.
    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
----------------------------------------------------------------------------------------------------------------
Phase 1
    Informed Consent............           1,800               1           1,800            0.03              54
    Pretest.....................             200               1             200            0.30              60
    Main study..................           1,600               1           1,600            0.30             480
Phase 2
    Informed Consent............           2,202               1           2,202            0.03              66
    Pretest.....................             462               1             462            0.30             139
    Main study..................           1,740               1           1,740            0.30             522
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............           1,321
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

V. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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 the Web site addresses in this reference section, but FDA 
is not responsible for any subsequent changes to the Web sites after 
this document publishes in the Federal Register.)

    1. Lipsky, M. S. and L. K. Sharp, ``From Idea to Market: The 
Drug Approval Process,'' Journal of the American Board of Family 
Practitioners, vol. 14, pp. 362-367, 2001.
    2. Rutan, G. H., R.cH. McDonald, and L. H. Kuller, ``A 
Historical Perspective of Elevated Systolic vs. Diastolic Blood 
Pressure From an Epidemiological and Clinical Trial Viewpoint,'' 
Journal of Clinical Epidemiology, vol. 42, pp. 663-673, 1989.
    3. The Physician Consortium for Performance Improvement (PCPI) 
convened by the American Medical Association, ``Measures 
Development, Methodology, and Oversight Advisory Committee: 
Recommendations to PCPI Work Groups on Composite Measures,'' (http://www.ama-assn.org/resources/doc/cqi/composite-measures-framework.pdf), 2010.
    4. Fagerlin, A., and E. Peters, ``Quantitative Information,'' 
In: B. Fishoff, N.T. Brewer, and J.S. Downs (Eds.), Communicating 
Risks and Benefits: An Evidence-Based User's Guide, Food and Drug 
Administration, U.S. Department of Health and Human Services, 
(http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm268078.htm), 2011.
    5. Peters, E., D. Vastfijall, P. Slovic, et al., ``Numeracy and 
Decision Making,'' Psychological Science, vol. 17, pp. 407-413, 
2006.
    6. Gurmankin, A. D., J. Baron, and K. Armstrong, ``The Effects 
of Numerical Statements of Risk on Trust and Comfort With 
Hypothetical Physician Risk Communication,'' Medical Decision 
Making, vol. 24, pp. 265-271, 2004.
    7. Edwards, A., R. Thomas, R. Williams, et al., ``Presenting 
Risk Information to People With Diabetes: Evaluating Effects and 
Preferences for Different Formats by a Web-Based Randomized 
Controlled Trial,'' Patient Education Counseling, vol. 63, pp. 336-
349, 2006.


    Dated: May 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11363 Filed 5-13-13; 8:45 am]
BILLING CODE 4160-01-P