Agency Information Collection Activities; Proposed Collection; Comment Request; Communicating Composite Scores in Direct-to-Consumer Advertising, 51027-51030 [2012-20783]
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Federal Register / Vol. 77, No. 164 / Thursday, August 23, 2012 / Notices
total burden hours are lower than the
previously approved estimated total
burden hours of 6,226,350. The
estimated total burden hours are lower
because the amendments under FAR
Case 2010–009 removed the
requirement for Government approval of
contractor scrap procedures, and
submission of inventory schedules and
scrap lists from a contractor without
scrap procedurs, prior to allowing the
contractor to dispose of ordinary
production scrap. The practice
unnecessarily burdened contractors that
generated small amounts of scrap.
Number of Respondents: 14,875.
Responses per Respondent: 910.267.
Total Responses: 13,540,225.
Average Burden Hours per Response:
.3213.
Total Burden Hours: 4,350,650.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVCB), 1275
First Street NE., Washington, DC 20417,
telephone (202) 501–4755.
Please cite OMB Control No. 9000–
0075, Government Property, in all
correspondence.
Dated: August 17, 2012.
William Clark,
Acting Director, Federal Acquisition Policy
Division, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Govenrmentwide Policy.
[FR Doc. 2012–20741 Filed 8–22–12; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0892]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Communicating
Composite Scores in Direct-toConsumer Advertising
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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notice. This notice solicits comments on
research entitled, ‘‘Communicating
Composite Scores in Direct-to-Consumer
(DTC) Advertising.’’ This study is
designed to explore how consumers
understand and interpret composite
endpoint scores in DTC ads.
DATES: Submit written or electronic
comments on the collection of
information by October 22, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
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51027
when appropriate, and other forms of
information technology.
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(b)(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 (Refs. 1
and 2). In some cases, drug efficacy can
be measured by a single endpoint, such
as high blood pressure (Ref. 3). Often,
however, efficacy is measured by
multiple endpoints that are sometimes
combined into an overall score called a
composite score (Refs. 4 and 5). 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
understand whether consumers
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Federal Register / Vol. 77, No. 164 / Thursday, August 23, 2012 / Notices
recognize 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 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
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 outcomes.
We are aware of no quantitative
research on best practices for
communicating composite score
information to consumers. One related
area of research, communicating healthrelated information to consumers, offers
two practical recommendations that are
particularly relevant to communicating
composite scores in DTC
advertisements. First, because lessnumerate 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. 6 and 7). Second, although the
literature tends to suggest limiting the
amount of information presented in
advertisements (Refs. 7 to 9), 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:
1. Whether consumers are aware of
how efficacy is measured for specific
drugs;
2. How well consumers comprehend
the concept of composite scores;
3. Whether exposure to DTC
advertisements with composite
endpoint benefit information influences
consumers’ perceptions of a drug’s
efficacy and risk; and
4. Different methods for presenting
composite endpoint benefit information
in DTC ads to maximize consumer
comprehension and informed
decisionmaking.
The research will be conducted in two
studies. Using a general population
sample of adults, the first study will be
a web-based survey, with a pre-post
design, that will explore consumers’
awareness of how efficacy is measured
for drugs and consumers’
comprehension of the concept of
composite scores. The second study will
be a randomized, controlled study
conducted online using a web-based
panel to examine whether exposure to
DTC advertisements with composite
endpoint benefit information influences
consumers’ perceptions of a drug’s
efficacy and risk, and how DTC
advertisements can best deliver
composite endpoint benefit information
to maximize consumer comprehension
and informed decisionmaking.
Questionnaires for both studies are
available upon request.
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 endpoint
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 endpoint 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.
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. 6).
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 endpoint 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.
tkelley on DSK3SPTVN1PROD with NOTICES
TABLE 1—STUDY DESIGN FOR STUDY 2
Information presentation
Educational intervention
General indication
List of symptoms
Composite definition
Absent ......................................................................
Present .....................................................................
Arm 1 (n=267) ...........
Arm 4 (n=267) ...........
Arm 2 (n=267) ...........
Arm 5 (n=267) ...........
Arm 3 (n=267) ...........
Arm 6 (n=267) ...........
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Total
801
801
Federal Register / Vol. 77, No. 164 / Thursday, August 23, 2012 / Notices
51029
TABLE 1—STUDY DESIGN FOR STUDY 2—Continued
Information presentation
Educational intervention
General indication
Total ..................................................................
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
endpoint 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 endpoint. 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.’’
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
List of symptoms
Composite definition
534 ............................
534 ............................
534 ............................
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
endpoint, 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 factors. 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 No. 0910–
0677) where it was found to resonate
with participants. It will feature the
decathlon as an educational example of
Total
1,602
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 wins some and performs
well enough in others, 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
moderates any significant relations.
The sample for the second study will
include approximately 1,602
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. This
will be a one-time (rather than annual)
collection of information.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Screeners, Study 1 ..................................................
Pretest, Study 1 .......................................................
Main Survey, Study 1 ..............................................
Screeners, Study 2 ..................................................
Pretest, Study 2 .......................................................
Main Study, Study 2 ................................................
3,200
200
1,600
3,400
600
1,602
1
1
1
1
1
1
3,200
200
1,600
3,400
600
1,602
Total ..................................................................
10,602
........................
........................
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1 There
Average burden per
response
0.03
0.33
0.33
0.03
0.33
0.33
Total hours
(2 minutes) ........
(20 minutes) ......
(20 minutes) ......
(2 minutes) ........
(20 minutes) ......
(20 minutes) ......
96
66
528
102
198
529
....................................
1,519
are no capital costs or operating and maintenance costs associated with this collection of information.
The total respondent sample for this
data collection is 10,602. For Study 1,
we will sample 200 respondents for
pretesting and 1,600 respondents for the
full study. For Study 2, we will sample
600 respondents for pretesting and
1,602 participants for the full study. We
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estimate the response burden to be no
more than 20 minutes, for a total
burden, including screeners, of 1,519
hours.
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V. 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
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51030
Federal Register / Vol. 77, No. 164 / Thursday, August 23, 2012 / Notices
electronically at https://
www.regulations.gov. (FDA has verified
the Web site addresses, but we are 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(5), pp.
362–367, 2001.
2. ‘‘Guidance for Industry:
Postmarketing Studies and Clinical
Trials—Implementation of Section
505(o)(3) of the Federal Food, Drug, and
Cosmetic Act,’’ (https://www.fda.gov/
downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
UCM172001.pdf), 2008.
3. Rutan, G.H., R.H. 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(7), pp.
663–673, 1989.
4. Agency for Healthcare Research
and Quality, ‘‘Combining Measures Into
Composite or Summary Scores,’’
(https://www.ahrq.gov/qual/
perfmeasguide/), 2012.
5. American Medical Association,
‘‘Measures Development, Methodology,
and Oversight Advisory Committee:
Recommendations to PCPI Work Groups
on Composite Measures,’’ (https://
www.ama-assn.org/resources/doc/cqi/
composite-measures-framework.pdf),
2010.
6. 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
Guide, Food and Drug Administration,
U.S. Department of Health and Human
Services, (https://www.fda.gov/About
FDA/ReportsManualsForms/Reports/
ucm268078.htm), 2011.
7. Peters, E., D. Vastfijall, P. Slovic, et
al., ‘‘Numeracy and Decision Making,’’
Psychological Science, vol. 17(5), pp.
407–413, 2006.
8. 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(3), pp. 265–271, 2004.
9. 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.
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Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20783 Filed 8–22–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0246]
Kelly Dean Shrum: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act)
permanently debarring Kelly Dean
Shrum, from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Dr. Shrum was convicted of
a felony under Federal law for conduct
relating to the regulation of a drug
product under the FD&C Act. Dr. Shrum
was given notice of the proposed
permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Dr. Shrum failed to respond. Dr.
Shrum’s failure to respond constitutes a
waiver of his right to a hearing
concerning this action.
DATES: This order is effective August 23,
2012.
ADDRESSES: Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Division of Compliance
Policy (HFC–230), Office of
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the regulation of any
drug product under the FD&C Act.
On September 30, 2011, the U.S.
District Court for the Eastern District of
Arkansas entered judgment against Dr.
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Shrum for misbranding, a class A
misdemeanor in violation of 21 U.S.C.
sections 331(a), 333(a)(1), 352(c), and
352(f)(1), and health care fraud, a class
C felony in violation of 18 U.S.C.
sections 1347 and 2.
FDA’s finding that debarment is
appropriate is based on the felony
conviction referenced herein for
conduct relating to the regulation of a
drug product. The factual basis for this
conviction is as follows: Dr. Shrum was
a licensed physician practicing in the
state of Arkansas. Dr. Shrum offered
gynecological and obstetric services to
women, including providing forms of
birth control. Dr. Shrum favored the
intrauterine device (IUD) known as
MIRENA, which was made for BHCP,
Inc., by Bayer Schering Pharma OY
(Bayer). The only version of MIRENA
approved by FDA for marketing in the
United States was approved on
December 6, 2000, in New Drug
Application 21–225.
From in or about June of 2009, in the
Eastern District of Arkansas and
elsewhere, Dr. Shrum purchased a
foreign version of MIRENA for use in
his patients that was not FDA-approved.
The labeling of the unapproved IUD was
not in English, and did not include
adequate directions for use. Arkansas
Center for Women, Ltd. was registered
with the Arkansas Medicaid Program.
Dr. Shrum was listed as the only
physician affiliated with that clinic, and
he signed the Medicaid provider
contract on behalf of the Arkansas
Center for Women. Dr. Shrum submitted
claims to the Arkansas Medicaid
Program under the clinic’s provider
number for the FDA-approved MIRENA
IUD, which was specific to Bayer’s FDAapproved product.
From on or about January 15, 2008
through on or about June 12, 2009, Dr.
Shrum caused to be submitted claims
for reimbursement to the Arkansas
Medicaid Program, which included false
representations. Specifically, he billed
the Arkansas Medicaid Program as if he
were administering the FDA-approved
version of MIRENA, when he was
actually administering a non-FDA
approved IUD.
As a result of his convictions, on May
9, 2012, FDA sent Dr. Shrum a notice by
certified mail proposing to permanently
debar him from providing services in
any capacity to a person that has an
approved or pending drug product
application. The proposal was based on
a finding, under section 306(a)(2)(B) of
the FD&C Act, that Dr. Shrum was
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act.
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]]>Agencies
[Federal Register Volume 77, Number 164 (Thursday, August 23, 2012)]
[Notices]
[Pages 51027-51030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20783]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0892]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Communicating Composite Scores in Direct-to-Consumer
Advertising
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled, ``Communicating
Composite Scores in Direct-to-Consumer (DTC) Advertising.'' This study
is designed to explore how consumers understand and interpret composite
endpoint scores in DTC ads.
DATES: Submit written or electronic comments on the collection of
information by October 22, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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(b)(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 (Refs. 1 and 2). In some cases, drug
efficacy can be measured by a single endpoint, such as high blood
pressure (Ref. 3). Often, however, efficacy is measured by multiple
endpoints that are sometimes combined into an overall score called a
composite score (Refs. 4 and 5). 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 understand whether consumers
[[Page 51028]]
recognize 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 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 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 outcomes.
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. 6 and 7). Second, although the literature tends to
suggest limiting the amount of information presented in advertisements
(Refs. 7 to 9), 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:
1. Whether consumers are aware of how efficacy is measured for
specific drugs;
2. How well consumers comprehend the concept of composite scores;
3. Whether exposure to DTC advertisements with composite endpoint
benefit information influences consumers' perceptions of a drug's
efficacy and risk; and
4. Different methods for presenting composite endpoint benefit
information in DTC ads to maximize consumer comprehension and informed
decisionmaking.
The research will be conducted in two studies. Using a general
population sample of adults, the first study will be a web-based
survey, with a pre-post design, that will explore consumers' awareness
of how efficacy is measured for drugs and consumers' comprehension of
the concept of composite scores. The second study will be a randomized,
controlled study conducted online using a web-based panel to examine
whether exposure to DTC advertisements with composite endpoint benefit
information influences consumers' perceptions of a drug's efficacy and
risk, and how DTC advertisements can best deliver composite endpoint
benefit information to maximize consumer comprehension and informed
decisionmaking. Questionnaires for both studies are available upon
request.
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 endpoint 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 endpoint 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. 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. 6).
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 endpoint 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
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Information presentation
---------------------------------------------------------------------------------------------------------------------------------------------------------
Educational intervention General indication List of symptoms Composite definition Total
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Absent............................ Arm 1 (n=267)................... Arm 2 (n=267).................. Arm 3 (n=267).................. 801
Present........................... Arm 4 (n=267)................... Arm 5 (n=267).................. Arm 6 (n=267).................. 801
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[[Page 51029]]
Total......................... 534............................. 534............................ 534............................ 1,602
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 endpoint 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 endpoint. 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.''
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 endpoint, 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 factors. 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 No. 0910-0677) where it was found to resonate
with participants. It 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 wins some and performs well enough in others, 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 moderates any significant relations.
The sample for the second study will include approximately 1,602
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. This
will be a one-time (rather than annual) collection of information.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screeners, Study 1.......................... 3,200 1 3,200 0.03 (2 minutes).......................... 96
Pretest, Study 1............................ 200 1 200 0.33 (20 minutes)......................... 66
Main Survey, Study 1........................ 1,600 1 1,600 0.33 (20 minutes)......................... 528
Screeners, Study 2.......................... 3,400 1 3,400 0.03 (2 minutes).......................... 102
Pretest, Study 2............................ 600 1 600 0.33 (20 minutes)......................... 198
Main Study, Study 2......................... 1,602 1 1,602 0.33 (20 minutes)......................... 529
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Total................................... 10,602 .............. .............. .......................................... 1,519
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The total respondent sample for this data collection is 10,602. For
Study 1, we will sample 200 respondents for pretesting and 1,600
respondents for the full study. For Study 2, we will sample 600
respondents for pretesting and 1,602 participants for the full study.
We estimate the response burden to be no more than 20 minutes, for a
total burden, including screeners, of 1,519 hours.
V. 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
[[Page 51030]]
electronically at https://www.regulations.gov. (FDA has verified the Web
site addresses, but we are 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(5), pp. 362-367, 2001.
2. ``Guidance for Industry: Postmarketing Studies and Clinical
Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug,
and Cosmetic Act,'' (https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf), 2008.
3. Rutan, G.H., R.H. 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(7), pp. 663-673, 1989.
4. Agency for Healthcare Research and Quality, ``Combining Measures
Into Composite or Summary Scores,'' (https://www.ahrq.gov/qual/perfmeasguide/), 2012.
5. American Medical Association, ``Measures Development,
Methodology, and Oversight Advisory Committee: Recommendations to PCPI
Work Groups on Composite Measures,'' (https://www.ama-assn.org/resources/doc/cqi/composite-measures-framework.pdf), 2010.
6. 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 Guide, Food and Drug Administration,
U.S. Department of Health and Human Services, (https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm268078.htm), 2011.
7. Peters, E., D. Vastfijall, P. Slovic, et al., ``Numeracy and
Decision Making,'' Psychological Science, vol. 17(5), pp. 407-413,
2006.
8. 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(3),
pp. 265-271, 2004.
9. 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: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20783 Filed 8-22-12; 8:45 am]
BILLING CODE 4160-01-P
