Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer Television and Print Advertisements for Prescription Drugs, 29490-29493 [E9-14501]
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29490
Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices
total estimated annualized burden hours
are 10,832.
ESTIMATED ANNUALIZED BURDEN TABLE
No. of
respondents
Type of respondent
Form name
Hospital Chief Executive Officer .....................
Ancillary Service Executive ............................
Hospital Induction (NHAMCS–101) ................
Freestanding ASC Induction (NHAMCS–
101FS).
Ambulatory Unit Induction (NHAMCS–101U)
ED Patient Record form NHAMCS–100 (ED)
Ancillary Service Executive ............................
Physician/Registered Nurse/Medical Record
Clerk.
Physician/Registered Nurse/Medical Record
Clerk.
Physician/Registered Nurse/Medical Record
Clerk.
Medical Record Clerk .....................................
Physician/Physician Assistant/Nurse Practitioner/Nurse Midwife.
Dated: June 15, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Office of
the Chief Science Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–14553 Filed 6–19–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0263]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Presentation of Quantitative
Effectiveness Information to
Consumers in Direct-to-Consumer
Television and Print Advertisements
for Prescription Drugs
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
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
the Experimental Study of Presentation
of Quantitative Effectiveness
Information to Consumers in Direct-toConsumer (DTC) Television and Print
Advertisements for Prescription Drugs.
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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
SUPPLEMENTARY INFORMATION:
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Average
burden per
response
(in hours)
482
200
1
1
1
1.5
1,779
225
1
100
1
7/60
128
200
6/60
208
100
6/60
425
133
1/60
255
OPD Patient Record form NHAMCS–100
(OPD).
ASC Patient Record Form NHAMCS–100
(ASC).
Pulling and re-filing Patient Records (ED,
OPD, and ASC).
Cervical Cancer Screening Supplement
(CCSS) (NHAMCS–906).
This study is designed to communicate
quantitative information about product
benefits in DTC print and television ads.
DATES: Submit written or electronic
comments on the collection of
information by [August 21, 2009
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: Liz
Berbakos, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3792.
No. of
responses per
respondent
1
15/60
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.
Experimental Study of Presentation of
Quantitative Effectiveness Information
to Consumers in Direct-to-Consumer
(DTC) Television and Print
Advertisements for Prescription
Drugs—New
The Federal Food, Drug, and Cosmetic
Act (the act) requires that
manufacturers, packers, and distributors
(sponsors) who advertise prescription
human and animal drugs, including
biological products for humans, disclose
in advertisements certain information
about the advertised product’s uses and
risks.1 By its nature, the presentation of
1 For prescription drugs and biologics, section
502 of the act requires advertisements to contain
‘‘information in brief summary relating to side
effects, contraindications, and effectiveness’’ (21
U.S.C. 352(n)).
2 See Swartz, L., S. Woloshin, W. Black, et al., The
Role of Numeracy in Understanding the Benefit of
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Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices
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this information is likely to evoke active
trade-offs by consumers, i.e.,
comparisons with the perceived risks of
not taking treatment, and comparisons
with the perceived benefits of taking a
treatment.2 FDA has an interest in
fostering safe and proper use of
prescription drugs, an activity that
engages both risks and benefits.
Therefore, an examination of ways to
improve consumers’ understanding of
this information is central to this
regulatory task.
Under the act, FDA engages in a
variety of communication activities to
ensure that patients and health care
providers have the information they
need to make informed decisions about
treatment options, including the use of
prescription drugs. FDA regulations (21
CFR 201.57) describe the content of
required product labeling, and FDA
reviewers ensure that labeling contains
accurate and complete information
about the known risks and benefits of
each drug.
FDA regulations require that
prescription drug advertisements that
make (promotional) claims about a
product also include risk information in
a ‘‘balanced’’ manner (21 CFR
202.1(e)(5)(ii)), both in terms of the
content and presentation of the
information. This balance applies to
both the front, display page of an
advertisement, as well as including the
brief summary page. However, beyond
the ‘‘balance’’ requirement there is
limited guidance and research to direct
or encourage sponsors to present benefit
claims that are informative, specific,
and reflect clinical effectiveness data.
Research and guidance to sponsors on
how to present benefit and efficacy
information in prescription drug
advertisements is limited. For example,
‘‘benefit claims,’’ broadly defined,
appearing in advertisements are often
presented in general language that does
not inform patients of the likelihood of
efficacy and are often simply variants of
an ‘‘intended use’’ statement. One
content analysis of DTC advertising by
Woloshin and Schwartz (2001)3 found
that information about product benefits
and risks is often presented in an
unbalanced fashion. The researchers
classified the ‘‘promotional techniques’’
used in the advertisements. Emotional
appeals were observed in 67 percent of
the ads while vague and qualitative
benefit terminology was found in 87
percent of the ads. Only 9 percent
contained data. However, for risk
information, half the advertisements
used data to describe side-effects,
typically with lists of side-effects that
generally occurred infrequently.
Similarly, a content analysis by Frosch
et al. (2007)4 found that only a small
proportion of product-claim ads gave
specific information about the
population prevalence of the medical
condition being advertised. The authors
criticize DTC for presenting ‘‘best-case
scenarios that can distort and inflate
consumers’ expectations about what
prescription drugs can accomplish’’
(Froch et al., 2007, p. 12) without
disclosing how many consumers are
likely to experience that benefit.
Some research has proposed that
providing quantitative information
about product efficacy enables
consumers to make better choices about
potential therapy. One possible format
(termed the ‘‘drug facts’’ box by its
creators) for this information has
recently received attention.5 In these
studies, the drug facts box format
contained information about the
product’s efficacy and safety in terms of
rate (how many people in the clinical
trial experienced a benefit or side effect
compared to placebo). As expected, this
study showed that consumers who were
provided efficacy information used it.
Participants receiving efficacy
information (without other potentially
valuable information about the drug)
were more likely to correctly choose the
product with the higher efficacy than
consumers who saw the brief summary
that did not contain this information.
Although these results are intriguing,
additional research is necessary to
uncover important information about
how consumers understand
effectiveness information about
prescription drug products from DTC
advertisements. For example, the
research to date does not address
whether simply adding efficacy rate
information and qualitative summations
to a consumer-friendly brief summary
would enable consumers to find and
report the correct answer, or if the
Screening Mammography, Annals of Internal
Medicine, 127(11), 966–72, 1997.
3 Woloshin, S. and L. Schwartz, Direct to
Consumer Advertisements for Prescription Drugs:
What Are Americans Being Told, Lancet, 358,
1141–46, 2001.
4 Frosch, D.L., P.M. Krueger, R.C. Hornik, et al.,
Creating Demand for Prescription Drugs: A Content
Analysis of Television Direct-to-Consumer
Advertising, Annals of Family Medicine, 5(1), 6–13,
2007.
5 Schwartz, L.M., S. Woloshin, H.G. Welch, The
Drug Facts Box: Providing Consumers With Simple
Tabular Data on Drug Benefit and Harm, Medical
Decision Making, 27, 655–692, 2007; Schwartz,
L.M., S. Woloshin, H.G. Welch, Communicating
Drug Benefits and Harms With a Drug Facts Box:
Two Randomized Trials, Annals of Internal
Medicine, 150, 516–527, 2009; Woloshin, S., L.M.
Schwartz, H.G. Welch, The Value of Benefit Data in
Direct-to-Consumer Drug Ads, Health Affairs, Suppl
Web Exclusives, W4–234–245, 2004.
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29491
presentation of information in a chart
format itself increases comprehension.
Further, these data cannot address the
best way in which to convey numerical
information; percents were used but
another format, such as frequencies,
may be more effective at communicating
quantitative information. Previous
research shows that individuals have
great difficulty processing numerical
concepts (e.g., Beyth-Marom, 1982;
Bowman, 2002; Cohen, Ferrell, and
Johnson, 2002).6 A few studies have
attempted to determine what different
formats make these concepts least
troublesome (e.g., Fagerlin, Wang, and
Ubel, 2005; Lipkus, 2007),7 however,
most research into the communication
of numerical concepts concentrates on
risk information. We are not aware of
research looking into the integration of
quantitative information about
effectiveness or benefits into the body of
the advertisement itself. The addition of
this information may help consumers
make better healthcare decisions,
provided they can understand it.
It is also not known if ways of
communicating product efficacy work
equally well across print and television
DTC media. To our knowledge, research
on presenting quantitative information
in risk communication has been
conducted exclusively with static
modalities. The ideal format for
presenting quantitative information may
vary as a function of presentation. The
amount of mental processing capacity
each individual can devote to
understanding a message varies
depending on how long individuals
have to look at the material and whether
the material is self-paced or presented at
an uncontrollable speed. As a result,
some forms of quantitative information
may lend themselves to print, rather
than broadcast. This particular
understanding is crucial to the riskbenefit tradeoff that patients must make
with the consultation of a health care
professional in order to achieve the best
health outcomes.
The proposed study will examine: (1)
Various ways of communicating
6 Beyth-Marom, R., How Probable is Probable? A
Numerical Translation of Verbal Probability
Expressions, Journal of Forecasting, 1, 257–269,
1982; Bowman, M.L., The Perfidity of Percentiles,
Archives of Clinical Neuropsychology, 17, 295–303,
2002; Cohen, D.J., J.M. Ferrell, N. Johnson, What
Very Small Numbers Mean, Journal of Experimental
Psychology: General, 131, 424–442, 2002.
7 Fagerlin, A., C. Wang, P.A. Ubel, Reducing the
Influence of Anecdotal Reasoning on People’s
Health Care Decisions: Is a Picture Worth a
Thousand Statistics? Medical Decision Making, 25,
398–405, 2005; Lipkus, I., Numeric, Verbal, and
Visual Formats of Conveying Health Risks:
Suggested Best Practices and Future
Recommendations, Medical Decision Making, 27,
697–713, 2007.
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Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices
quantitative efficacy in DTC print ads
and (2) whether the findings translate to
DTC television ads.
Design Overview: This study will be
conducted in two concurrent parts; one
examining quantitative information in
DTC print advertisements and the other
examining such information in DTC
television advertisements. Three factors
will be examined: Drug efficacy, visual
format, and type of statistic. Drug
efficacy (low versus high) is defined by
a quantifiable, objective metric that can
be conveyed in graphical
representations of the drug versus the
comparator reference drug (in this case,
placebo). ‘‘High’’ efficacy is noticeably
better than the placebo, whereas ‘‘low’’
efficacy is minimally better than the
placebo. Visual format is defined as
various methods through which efficacy
can be visually represented. We have
chosen to investigate three different
formats: Bar graph, pictograph, and pie
chart. Type of statistic is defined as the
type of statistical information conveyed:
Frequency, relative frequency, or
percentage. These factors will be
combined in a partially crossed factorial
design as follows:
TABLE 1.—TYPE OF VISUAL FORMAT X TYPE OF STATISTIC CONVEYED X EFFICACY LEVEL
Type of Visual Format
Type of Statistic
Efficacy Level
✓
✓
✓
✓
✓
✓
✓
✓
N/A
✓
✓
✓
N/A
✓
N/A
N/A
N/A
✓
N/A
N/A
N/A
High Efficacy
✓
N/A
N/A
N/A
Low Efficacy
✓
N/A
N/A
N/A
High Efficacy
✓
N/A
N/A
N/A
Low Efficacy
✓
N/A
N/A
N/A
N/A
The test product will be for the
treatment of high cholesterol and
modeled on an actual drug used to treat
that condition (such as Lipitor©). The
product labeling will be used as the
reference for defining the high- and lowefficacy levels and the objective metrics
for clinical performances. Because both
parts of the study will run concurrently,
experimental conditions will be
identical in both the print and television
portions.
Participants will read or view one ad
version. After reading the ad,
participants will make a series of
judgments about the drug. The mean
✓
Low Efficacy
None
✓
High Efficacy
Relative Frequency + Absolute Rate
✓
Low Efficacy
Relative Frequency
Pictograph
High Efficacy
Combination Frequency + Percentage
Bar Chart
Low Efficacy
Percentage
Pie Chart
High Efficacy
Frequency
None
✓
N/A
N/A
N/A
difference between the low- and highefficacy condition will serve as the
baseline for testing whether this
difference varies across various
graphical presentations, with the
exception of the No Information
(control) condition. In other words, our
analyses will involve two steps. In step
1, within each format, we will test
whether participants were able to
distinguish between low- and highefficacy drugs. In step 2, within each
efficacy level, we will test whether
participants’ estimates of efficacy differ
across formats and examine the
accuracy of these estimates.
Interviews are expected to last no
more than 20 minutes. A total of 4,500
participants will be involved in the 2
parts of the study. This will be a one
time (rather than annual) collection of
information.
FDA estimates the burden of this
collection of information as follows:
The total respondent sample for this
data collection is 4,500 (2,225 in each
part). We estimate the response burden
to be 20 minutes, for a burden of 1,485
hours.
The response burden chart is listed in
table 2 of this document.
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
4,500
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1There
4,500
.33
1,485
4,500
Total
1
1
4,500
.33
1,485
are no capital costs or operating and maintenance costs associated with this collection of information.
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29493
Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices
Dated: June 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–14501 Filed 6–19–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Cross-Site Evaluation of the
Infant Adoption Awareness Training
Program for Projects Initially Funded in
Fiscal Year 2006–NEW.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), Childrens
Bureau (CB), will conduct the Cross-Site
Evaluation of the Infant Adoption
Awareness Training Program (IAATP).
Title XII, subtitle A, of the Childrens
Health Act of 2000 (CHA) authorizes the
Department of Health and Human
Services to make Infant Adoption
Awareness Training grants available to
national, regional, and local adoption
organizations for the purposes of
developing and implementing programs
that train the staff of public and nonprofit private health service
organizations to provide adoption
information and referrals to pregnant
women on an equal basis with all other
courses of action included in non-
directive counseling of pregnant
women. Participants in the training
include individuals who provide
pregnancy or adoption information and
those who will provide such services
after receiving the training, with Title X
(relating to voluntary family planning
projects), section 330 (relating to
community health centers, migrant
health centers, and centers serving
homeless individuals and residents of
public housing), and CHA-funded
school-based health centers, receiving
priority to receive the training. A total
of six organizations were awarded
IAATP funding in 2006.
Section 1201(a)(2)(A) of the IAATP
legislation requires grantees to develop
and deliver trainings that are consistent
with the Best Practice Guidelines for
Infant Adoption Awareness Training.
The IAATP guidelines address training
goals, basic skills, curriculum and
training structure. A complete
description of the guidelines is available
at https://www.acf.hhs.gov/programs/cb/
programs_fund/discretionary/iaatp.htm.
In addition, grantees are required to
conduct local evaluation of program
outcomes and participate in the national
evaluation of the extent to which IAATP
training objectives are met. The Infant
Adoption Awareness Training Program:
Trainee Survey is the primary data
collection instrument for the national
cross-site evaluation. Respondents will
complete the survey prior to receiving
training and approximately 90 days after
the training to assess the extent to
which trainees demonstrate sustained
gains in their knowledge about
adoption, and to determine the impact
of the training on their subsequent work
with pregnant women.
1. Do health care workers who
participate in the IAATP training:
Demonstrate enhanced knowledge,
attitudes, skills, and behaviors with
respect to adoption counseling
following completion of the program?
Provide adoption information to
pregnant women on an equal basis with
other pregnancy planning options?
Demonstrate enhanced awareness of
community adoption-related resources
and refer expectant mothers to them as
needed?
2. Are trainees more confident about
discussing all three pregnancy planning
options (parenting, abortion, and
adoption) in a non-directive counseling
style than they were prior to
participating in the training? Cross-site
evaluation data will be collected on an
annual basis throughout the five-year
funding period. Pre-test and follow-up
versions of the survey are expected to
require approximately 10 to 15 minutes
to complete. Estimated response time
for the follow-up survey includes time
for respondents to access the Web-based
survey, complete the survey online, and
electronically submit the survey.
Respondents will not need to
implement a recordkeeping system or
compile source data in order to
complete the survey. Where possible,
fields in the follow-up version of the
survey will be pre-filled with static data
from the respondents pre-test (e.g.,
demographics, agency type) in order to
further expedite completion of the
survey and minimize respondent
burden.
Respondents: Infant Adoption
Awareness Program Trainees.
ANNUAL BURDEN ESTIMATES
Number of respondents
Instrument
Number of responses per
respondent
Average burden hours per
response
1,200
1,200
1
1
0.15
0.10
IAATP: Trainee Survey Pre-Test Administration .............................................
IAATP: Trainee Survey Follow-Up Administration ...........................................
Total burden
hours
180
120
Estimated Total Annual Burden Hours: 300.
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Additional Information
OMB Comment
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following:
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Office of Management and Budget,
Paperwork Reduction Project, Fax: 202–
395–6974, Attn: Desk Officer for the
Administration for Children and
Families.
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]]>Agencies
[Federal Register Volume 74, Number 118 (Monday, June 22, 2009)]
[Notices]
[Pages 29490-29493]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14501]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0263]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Presentation of Quantitative
Effectiveness Information to Consumers in Direct-to-Consumer Television
and Print Advertisements for Prescription Drugs
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 the Experimental Study of Presentation of
Quantitative Effectiveness Information to Consumers in Direct-to-
Consumer (DTC) Television and Print Advertisements for Prescription
Drugs. This study is designed to communicate quantitative information
about product benefits in DTC print and television ads.
DATES: Submit written or electronic comments on the collection of
information by [August 21, 2009
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: Liz Berbakos, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3792.
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.
Experimental Study of Presentation of Quantitative Effectiveness
Information to Consumers in Direct-to-Consumer (DTC) Television and
Print Advertisements for Prescription Drugs--New
The Federal Food, Drug, and Cosmetic Act (the act) requires that
manufacturers, packers, and distributors (sponsors) who advertise
prescription human and animal drugs, including biological products for
humans, disclose in advertisements certain information about the
advertised product's uses and risks.\1\ By its nature, the presentation
of
[[Page 29491]]
this information is likely to evoke active trade-offs by consumers,
i.e., comparisons with the perceived risks of not taking treatment, and
comparisons with the perceived benefits of taking a treatment.\2\ FDA
has an interest in fostering safe and proper use of prescription drugs,
an activity that engages both risks and benefits. Therefore, an
examination of ways to improve consumers' understanding of this
information is central to this regulatory task.
---------------------------------------------------------------------------
\1\ For prescription drugs and biologics, section 502 of the act
requires advertisements to contain ``information in brief summary
relating to side effects, contraindications, and effectiveness'' (21
U.S.C. 352(n)).
\2\ See Swartz, L., S. Woloshin, W. Black, et al., The Role of
Numeracy in Understanding the Benefit of Screening Mammography,
Annals of Internal Medicine, 127(11), 966-72, 1997.
---------------------------------------------------------------------------
Under the act, FDA engages in a variety of communication activities
to ensure that patients and health care providers have the information
they need to make informed decisions about treatment options, including
the use of prescription drugs. FDA regulations (21 CFR 201.57) describe
the content of required product labeling, and FDA reviewers ensure that
labeling contains accurate and complete information about the known
risks and benefits of each drug.
FDA regulations require that prescription drug advertisements that
make (promotional) claims about a product also include risk information
in a ``balanced'' manner (21 CFR 202.1(e)(5)(ii)), both in terms of the
content and presentation of the information. This balance applies to
both the front, display page of an advertisement, as well as including
the brief summary page. However, beyond the ``balance'' requirement
there is limited guidance and research to direct or encourage sponsors
to present benefit claims that are informative, specific, and reflect
clinical effectiveness data.
Research and guidance to sponsors on how to present benefit and
efficacy information in prescription drug advertisements is limited.
For example, ``benefit claims,'' broadly defined, appearing in
advertisements are often presented in general language that does not
inform patients of the likelihood of efficacy and are often simply
variants of an ``intended use'' statement. One content analysis of DTC
advertising by Woloshin and Schwartz (2001)\3\ found that information
about product benefits and risks is often presented in an unbalanced
fashion. The researchers classified the ``promotional techniques'' used
in the advertisements. Emotional appeals were observed in 67 percent of
the ads while vague and qualitative benefit terminology was found in 87
percent of the ads. Only 9 percent contained data. However, for risk
information, half the advertisements used data to describe side-
effects, typically with lists of side-effects that generally occurred
infrequently. Similarly, a content analysis by Frosch et al. (2007)\4\
found that only a small proportion of product-claim ads gave specific
information about the population prevalence of the medical condition
being advertised. The authors criticize DTC for presenting ``best-case
scenarios that can distort and inflate consumers' expectations about
what prescription drugs can accomplish'' (Froch et al., 2007, p. 12)
without disclosing how many consumers are likely to experience that
benefit.
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\3\ Woloshin, S. and L. Schwartz, Direct to Consumer
Advertisements for Prescription Drugs: What Are Americans Being
Told, Lancet, 358, 1141-46, 2001.
\4\ Frosch, D.L., P.M. Krueger, R.C. Hornik, et al., Creating
Demand for Prescription Drugs: A Content Analysis of Television
Direct-to-Consumer Advertising, Annals of Family Medicine, 5(1), 6-
13, 2007.
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Some research has proposed that providing quantitative information
about product efficacy enables consumers to make better choices about
potential therapy. One possible format (termed the ``drug facts'' box
by its creators) for this information has recently received
attention.\5\ In these studies, the drug facts box format contained
information about the product's efficacy and safety in terms of rate
(how many people in the clinical trial experienced a benefit or side
effect compared to placebo). As expected, this study showed that
consumers who were provided efficacy information used it. Participants
receiving efficacy information (without other potentially valuable
information about the drug) were more likely to correctly choose the
product with the higher efficacy than consumers who saw the brief
summary that did not contain this information.
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\5\ Schwartz, L.M., S. Woloshin, H.G. Welch, The Drug Facts Box:
Providing Consumers With Simple Tabular Data on Drug Benefit and
Harm, Medical Decision Making, 27, 655-692, 2007; Schwartz, L.M., S.
Woloshin, H.G. Welch, Communicating Drug Benefits and Harms With a
Drug Facts Box: Two Randomized Trials, Annals of Internal Medicine,
150, 516-527, 2009; Woloshin, S., L.M. Schwartz, H.G. Welch, The
Value of Benefit Data in Direct-to-Consumer Drug Ads, Health
Affairs, Suppl Web Exclusives, W4-234-245, 2004.
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Although these results are intriguing, additional research is
necessary to uncover important information about how consumers
understand effectiveness information about prescription drug products
from DTC advertisements. For example, the research to date does not
address whether simply adding efficacy rate information and qualitative
summations to a consumer-friendly brief summary would enable consumers
to find and report the correct answer, or if the presentation of
information in a chart format itself increases comprehension.
Further, these data cannot address the best way in which to convey
numerical information; percents were used but another format, such as
frequencies, may be more effective at communicating quantitative
information. Previous research shows that individuals have great
difficulty processing numerical concepts (e.g., Beyth-Marom, 1982;
Bowman, 2002; Cohen, Ferrell, and Johnson, 2002).\6\ A few studies have
attempted to determine what different formats make these concepts least
troublesome (e.g., Fagerlin, Wang, and Ubel, 2005; Lipkus, 2007),\7\
however, most research into the communication of numerical concepts
concentrates on risk information. We are not aware of research looking
into the integration of quantitative information about effectiveness or
benefits into the body of the advertisement itself. The addition of
this information may help consumers make better healthcare decisions,
provided they can understand it.
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\6\ Beyth-Marom, R., How Probable is Probable? A Numerical
Translation of Verbal Probability Expressions, Journal of
Forecasting, 1, 257-269, 1982; Bowman, M.L., The Perfidity of
Percentiles, Archives of Clinical Neuropsychology, 17, 295-303,
2002; Cohen, D.J., J.M. Ferrell, N. Johnson, What Very Small Numbers
Mean, Journal of Experimental Psychology: General, 131, 424-442,
2002.
\7\ Fagerlin, A., C. Wang, P.A. Ubel, Reducing the Influence of
Anecdotal Reasoning on People's Health Care Decisions: Is a Picture
Worth a Thousand Statistics? Medical Decision Making, 25, 398-405,
2005; Lipkus, I., Numeric, Verbal, and Visual Formats of Conveying
Health Risks: Suggested Best Practices and Future Recommendations,
Medical Decision Making, 27, 697-713, 2007.
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It is also not known if ways of communicating product efficacy work
equally well across print and television DTC media. To our knowledge,
research on presenting quantitative information in risk communication
has been conducted exclusively with static modalities. The ideal format
for presenting quantitative information may vary as a function of
presentation. The amount of mental processing capacity each individual
can devote to understanding a message varies depending on how long
individuals have to look at the material and whether the material is
self-paced or presented at an uncontrollable speed. As a result, some
forms of quantitative information may lend themselves to print, rather
than broadcast. This particular understanding is crucial to the risk-
benefit tradeoff that patients must make with the consultation of a
health care professional in order to achieve the best health outcomes.
The proposed study will examine: (1) Various ways of communicating
[[Page 29492]]
quantitative efficacy in DTC print ads and (2) whether the findings
translate to DTC television ads.
Design Overview: This study will be conducted in two concurrent
parts; one examining quantitative information in DTC print
advertisements and the other examining such information in DTC
television advertisements. Three factors will be examined: Drug
efficacy, visual format, and type of statistic. Drug efficacy (low
versus high) is defined by a quantifiable, objective metric that can be
conveyed in graphical representations of the drug versus the comparator
reference drug (in this case, placebo). ``High'' efficacy is noticeably
better than the placebo, whereas ``low'' efficacy is minimally better
than the placebo. Visual format is defined as various methods through
which efficacy can be visually represented. We have chosen to
investigate three different formats: Bar graph, pictograph, and pie
chart. Type of statistic is defined as the type of statistical
information conveyed: Frequency, relative frequency, or percentage.
These factors will be combined in a partially crossed factorial design
as follows:
Table 1.--Type of Visual Format x Type of Statistic Conveyed x Efficacy Level
----------------------------------------------------------------------------------------------------------------
Type of Visual Format
----------------------------------------------------------------------------------------------------------------
Type of Statistic Efficacy Level None Pie Chart Bar Chart Pictograph
----------------------------------------------------------------------------------------------------------------
Frequency High Efficacy [check] [check] [check] [check]
---------------------------------------------------------------------------------
Low Efficacy [check] [check] [check] [check]
----------------------------------------------------------------------------------------------------------------
Percentage High Efficacy [check] [check] [check] N/A
---------------------------------------------------------------------------------
Low Efficacy [check] [check] [check] N/A
----------------------------------------------------------------------------------------------------------------
Combination Frequency + High Efficacy [check] N/A N/A N/A
Percentage
---------------------------------------------------------------------------------
Low Efficacy [check] N/A N/A N/A
----------------------------------------------------------------------------------------------------------------
Relative Frequency High Efficacy [check] N/A N/A N/A
---------------------------------------------------------------------------------
Low Efficacy [check] N/A N/A N/A
----------------------------------------------------------------------------------------------------------------
Relative Frequency + Absolute High Efficacy [check] N/A N/A N/A
Rate
---------------------------------------------------------------------------------
Low Efficacy [check] N/A N/A N/A
----------------------------------------------------------------------------------------------------------------
None N/A [check] N/A N/A N/A
----------------------------------------------------------------------------------------------------------------
The test product will be for the treatment of high cholesterol and
modeled on an actual drug used to treat that condition (such as
Lipitor[sscopy]). The product labeling will be used as the reference
for defining the high- and low-efficacy levels and the objective
metrics for clinical performances. Because both parts of the study will
run concurrently, experimental conditions will be identical in both the
print and television portions.
Participants will read or view one ad version. After reading the
ad, participants will make a series of judgments about the drug. The
mean difference between the low- and high-efficacy condition will serve
as the baseline for testing whether this difference varies across
various graphical presentations, with the exception of the No
Information (control) condition. In other words, our analyses will
involve two steps. In step 1, within each format, we will test whether
participants were able to distinguish between low- and high-efficacy
drugs. In step 2, within each efficacy level, we will test whether
participants' estimates of efficacy differ across formats and examine
the accuracy of these estimates.
Interviews are expected to last no more than 20 minutes. A total of
4,500 participants will be involved in the 2 parts of the study. This
will be a one time (rather than annual) collection of information.
FDA estimates the burden of this collection of information as
follows:
The total respondent sample for this data collection is 4,500
(2,225 in each part). We estimate the response burden to be 20 minutes,
for a burden of 1,485 hours.
The response burden chart is listed in table 2 of this document.
Table 2.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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4,500 1 4,500 .33 1,485
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Total 4,500 1 4,500 .33 1,485
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 29493]]
Dated: June 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-14501 Filed 6-19-09; 8:45 am]
BILLING CODE 4160-01-S
