Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer Print Advertisements, 38658-38663 [2011-16552]
Download as PDF
<![CDATA[
38658
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
National Coordinator for review and
coordination in the Eligibility/
Enrollment Systems APD approval
assignment. The information requested
on the Checklist will be used to
determine and approve enhanced FFP to
States and to determine how States are
complying with the seven standards and
conditions; Form Number: CMS–10385
(OMB#: 0938–1125); Frequency:
Occasionally; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 56; Total Annual
Responses: 168; Total Annual Hours:
204. (For policy questions regarding this
collection contact Richard Friedman at
410–786–4451. For all other issues call
410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
E-mail your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on August 1, 2011.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov.
Dated: June 28, 2011.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2011–16599 Filed 6–30–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
mstockstill on DSK4VPTVN1PROD with NOTICES6
President’s Committee for People With
Intellectual Disabilities; Notice of
Committee Meeting via Conference
Call
AGENCY: President’s Committee for
People with Intellectual Disabilities
(PCPID), HHS.
ACTION: Notice of committee meeting via
conference call.
DATES: Tuesday, July 19, 2011, from 1
p.m. to 2:30 p.m. EST. This meeting, to
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
be held via audio conference call, is
open to the public.
Details for accessing the full
Committee Conference Call are cited
below: Toll Free Dial-In Number: 800–
779–1436. Pass Code: PCPID.
Individuals who will need
accommodations for a disability in order
to participate in the PCPID Meeting via
audio conferencing (assistive listening
devices, materials in alternative format
such as large print or Braille) should
notify Genevieve Swift, PCPID
Executive Administrative Assistant, at
Edith.Swift@acf.hhs.gov, or by
telephone at 202–619–0634, no later
than Tuesday, July 12, 2011. PCPID will
attempt to meet requests for
accommodations made after that date,
but cannot guarantee ability to grant
requests received after this deadline.
Agenda: Committee Members will
discuss the potential topics, themes, and
trends for the PCPID 2011 Annual
Report to the President.
Additional Information: For further
information, please contact Laverdia
Taylor Roach, President’s Committee for
People with Intellectual Disabilities,
The Aerospace Center, Second Floor
West, 370 L’Enfant Promenade, SW.,
Washington, DC 20447. Telephone:
202–619–0634. Fax: 202–205–9519.
E-mail: LRoach@acf.hhs.gov.
PCPID
acts in an advisory capacity to the
President and the Secretary of Health
and Human Services, through the
Administration on Developmental
Disabilities, on a broad range of topics
relating to programs, services and
supports for persons with intellectual
disabilities. The PCPID Executive Order
stipulates that the Committee shall: (1)
Provide such advice concerning
intellectual disabilities as the President
or the Secretary of Health and Human
Services may request; and (2) provide
advice to the President concerning the
following for people with intellectual
disabilities: (A) Expansion of
educational opportunities; (B)
promotion of homeownership; (C)
assurance of workplace integration; (D)
improvement of transportation options;
(E) expansion of full access to
community living; and (F) increasing
access to assistive and universally
designed technologies.
SUPPLEMENTARY INFORMATION:
Dated: June 27, 2011.
Laverdia Taylor Roach,
PCPID.
[FR Doc. 2011–16604 Filed 6–30–11; 8:45 am]
BILLING CODE 4184–01–P
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0417]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study of Format Variations in the Brief
Summary of Direct-to-Consumer Print
Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 1,
2011.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title, ‘‘Experimental Study of Format
Variations in the Brief Summary of
Direct-to-Consumer Print
Advertisements.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Experimental Study of Format
Variations in the Brief Summary of
Direct-to-Consumer Print
Advertisements—(OMB Control
Number 0910–New)
Section 502(n) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
352(n)) specifies that ads for
prescription drugs and biological
products must provide a true statement
of information ‘‘in brief summary’’
E:\FR\FM\01JYN1.SGM
01JYN1
38659
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
about the advertised product’s ‘‘side
effects, contraindications, and
effectiveness.’’ The prescription drug
advertising regulations (§ 202.1(e)(3)(iii)
(21 CFR 202.1(e)(3)(iii))) specify that the
information about risks must include
each specific side effect and
contraindication from the advertised
drug’s FDA-approved labeling,
including the Warnings, Precautions,
Adverse Reactions, and other relevant
sections. Some of the current
approaches to fulfilling the brief
summary requirement, while adequate
from a regulatory perspective, result in
ads that may be difficult to read and
understand when used in consumerdirected promotion.
In recent years, FDA has become
concerned about the adequacy of the
brief summary in direct-to-consumer
(DTC) print advertisements for
prescription drugs. Because the
regulations do not specify how to
address each risk, sponsors can use
discretion in fulfilling the brief
summary requirement under
§ 202.1(e)(3)(iii). Frequently, sponsors
print in small type, verbatim, the riskrelated sections of the approved product
labeling (also called the package insert,
professional labeling, prescribing
information, and direction circular).
This labeling is written for health
professionals, using medical
terminology. While adequate to fulfill
the brief summary requirement for print
advertisements, this method may not be
the most ideal. Research has shown that
while many consumers will make the
effort to read the brief summary in
prescription drug print advertisements
if they are especially interested in the
drug, as a general rule consumers
typically read little or none of the brief
summary information (Ref. 1). Health
practitioners themselves have indicated
they often have difficulty finding
information they actively seek in
package inserts (see 65 FR 81082,
December 22, 2000, for a discussion of
studies supporting the use of a
highlights section in physician
labeling). There may be other ways to
fulfill this requirement that improve
consumers’ ability to find and
comprehend the information in this
important document.
There is evidence suggesting that both
information content and the format in
which it is presented will impact
comprehension. For instance, research
with the format of over-the-counter
(OTC) drug labels (Refs. 2 and 3), the
nutrition facts label (Ref. 4), and other
information formats (Refs. 5 to 7)
demonstrates that information presented
with section headings, graphics (such as
bullets), and other design elements is
more easily read than information
presented in paragraph format.
Research conducted by FDA and
others has examined the content and
format of the brief summary specifically.
For instance, FDA conducted a series of
relevant studies (OMB control numbers
0910–0591 and 0910–0611). Schwartz,
Woloshin, and Welch have compared
one format for adding quantitative and
qualitative benefit and risk information
to the brief summary (Ref. 8).
Specifically, Schwartz et al. designed a
prescription drug facts box similar in
format to the nutrition facts panel and
OTC drug facts panel. The box contains
a number of elements, including
qualitative and quantitative (both
absolute frequency and absolute
difference) information about benefits
and risks. This study showed that
consumers who were provided efficacy
information in a prescription drug facts
box were more likely to correctly choose
the product with the higher efficacy
than consumers who saw the brief
summary using medical language from
the prescribing information. However, it
is unclear which elements of the drug
facts box are necessary to improve
consumer understanding. For instance,
it is not known whether simply adding
efficacy rate information to a consumerfriendly brief summary would be
sufficient to enable consumers to
understand a product’s efficacy or
whether qualitative summations are
necessary as well.
The current study will add to
previous research by systematically
examining these different elements to
determine whether and how to add
qualitative and quantitative benefit and
risk information to the brief summary.
The results of this study will inform
FDA of the usefulness and parameters of
various format and content options for
the brief summary.
Design Overview: This study will be
conducted in two concurrent parts; one
examining variations on the benefit
information presented in DTC print
advertisements and the other examining
variations on the risk information
presented in DTC print advertisements.
The factors studied will be the type of
information (i.e., the addition of
quantitative and qualitative information
in a box format) and the level of efficacy
or risk. We will vary the level of efficacy
and risk such that the largest effect is
noticeably different from the placebo,
whereas the smallest effect is minimally
different from the placebo. These factors
will be combined in a factorial design as
follows:
TABLE 1—PROPOSED DESIGN (4x5 + 2)
Efficacy level
Information type
mstockstill on DSK4VPTVN1PROD with NOTICES6
Absolute Frequency ...
Absolute Frequency +
Qualitative Label.
Absolute Difference +
Qualitative Label.
Absolute Frequency +
Absolute Difference
+ Qualitative Label.
Smallest
effect
Smaller effect
Mid-size
effect
Larger effect
81% vs. 82% .............
Fewer 81% vs. 82%
61% vs. 82% .............
Fewer 61% vs. 82%
41% vs. 82% .............
Fewer 41% vs. 82%
21% vs. 82% .............
Fewer 21% vs. 82%
1% vs. 82%.
Fewer 1% vs. 82%.
Fewer (1%) ...............
Fewer (21%) .............
Fewer (41%) .............
Fewer (61%) .............
Fewer (81%).
Fewer (1%) 81% vs.
82%.
Fewer (21%) 61% vs.
82%.
Fewer (41%) 41% vs.
82%.
Fewer (61%) 21% vs.
82%.
Fewer (81%) 1% vs.
82%.
Largest effect
Note: Two other cells will be tested: (1) No information and (2) Qualitative label only (fewer). This design (22 cells) will also be used to test
risk information (for a total of 44 cells). The specific numbers in the table are placeholders only. Qualitative label example: ‘‘Fewer people taking
drug X had disease/symptom Y.’’
The test product will be for the
treatment of a high prevalence medical
condition and modeled on an actual
drug used to treat that condition.
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
Participants will be consumers who
have been diagnosed with the medical
condition of interest. They will be
randomly assigned to read one ad
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
version. After reading the ad,
participants will answer a series of
questions about the drug. We will test
how the information type affects
E:\FR\FM\01JYN1.SGM
01JYN1
38660
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES6
perceived efficacy, perceived risk,
behavioral intention, and accurate
understanding of the benefit and risk
information.
Interviews are expected to last no
more than 20 minutes. A total of 11,750
participants will be involved in the
study. This will be a one-time (rather
than annual) collection of information.
In the Federal Register of August 31,
2010 (75 FR 53312), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Four responses were
received, each of which included
several comments.
I. Study Design
(Comment 1) Several suggestions
related to participant demographics,
measuring health literacy, and
determining what our primary research
questions are. One question related to
the test DTC advertisements to be used
in the study.
(Response) We agree that the study
design should include the variables of
age, education, ethnicity, and race; these
are included in the questionnaire. We
will ask whether participants can read,
understand, and speak English.
We will measure subjective health
literacy and the related concept of
numeracy, which is relevant for this
research as we are studying the
comprehension of quantitative
information. To clarify, we will not
limit our sample to those who are
currently being treated with a
prescription drug for the condition
being assessed; however, the
questionnaire includes questions about
prescription drug use.
Regarding the primary research
questions, as stated in the 60-day notice,
the current study will add to previous
research by systematically examining
the different elements in the drug facts
box tested in previous research (Ref. 8)
to determine whether and how to add
qualitative and quantitative benefit and
risk information to the brief summary.
Specifically, we will test whether the
inclusion of a qualitative label and/or
the inclusion of quantitative
information affects consumers’
understanding of the information and
their perceptions of the product.
We have contracted with an
organization that produces realistic ads
and stimuli to ensure that we will show
respondents realistic materials.
(Comment 2) This comment states
that there was not enough detail in the
60-day Federal Register notice, such as
no description of the criteria for
determining the amount and type of risk
and benefit information to provide in
the box format. Another question noted
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
that qualitative terms depend on many
factors. This comment also recommends
that we consider implementing a crossover study design to address
interpatient variability. This comment
suggested considering caregivers and
consumers who do not have the medical
condition treated by the drug. The final
question in this comment asked how the
tools were qualified or validated for
their intended use.
(Response) The questionnaire, which
has information about how questions
will be asked and how behavioral
intention will be assessed, was available
upon request during the first comment
period and will continue to be available
during the second comment period.
Information about how risk information
will be portrayed, what statistical
analyses will be performed, subject
recruitment, and pretest content is
addressed in this document.
We agree that a major challenge of the
drug facts box format is deciding the
amount and content of risk information
to include; however, this type of study
cannot address this issue. To replicate
and extend past research, we will use
the drug facts box from a previous study
(Ref. 8) with slight modifications to the
risk information (e.g., the addition of a
serious risk, different rates of side
effects in the placebo and active drug
groups).
We agree that qualitative terms
depend on many factors; however, this
study does not address the feasibility of
creating qualitative terms but rather
tests whether qualitative terms affect
consumer comprehension. As requested,
we will note this in our conclusions.
Conducting a cross-over design would
significantly increase study length, and
repeated exposure to the same stimuli
with minor changes may affect
participants’ responses. We have
conducted power analyses and believe
we can find interpretable results
without conducting a cross-over design.
To ensure that our participants are
motivated to consider the information
presented in the study and to conserve
resources, we will limit our sample to
people who have the medical condition
of interest.
Cognitive testing will be used to test
questionnaire items prior to their use,
and similar items have been used in our
previous studies. The items have face
validity, and several are drawn from
well-tested items used in the
psychology literature (for example,
behavioral intentions; Ref. 9). Finally,
we will pretest the study manipulations.
(Comment 3) This comment included
three statements about the details of the
proposed study. First, the comment
questioned why we chose to test
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
percents and frequencies and not
relative differences in this study.
Second, this comment pointed out that
the differences in the stimuli should be
stated as percentage points, not as
percentages. Third, the comment asks
whether the risk and benefit information
will be presented in the same
mathematical expression and whether
they will be presented independently.
(Response) We focus on percents and
frequencies because we are replicating
and extending previous research on a
drug facts box (Ref. 8), which included
percents and frequencies but not
relative differences. The study found
that the drug facts box outperformed a
traditional brief summary. The drug
facts box tested had several elements
that differed from the traditional brief
summary, including percents,
frequencies (i.e., XX/100), and
qualitative labels. From these results, it
is not possible to tell which elements of
the drug facts box were responsible for
the effects found. This study aims to test
systematically the elements of the drug
facts box to determine which, if any,
improves consumer comprehension.
We will change percentages to
percentage points in our stimuli.
To clarify, when participants see
benefit information in a certain
information type (or mathematical
expression, for example, percents), they
will also see risk information in that
same information type (for example,
percents). However, the efficacy level
(from smallest to largest effect) will be
manipulated in one design, and the risk
level (from smallest to largest effect)
will be manipulated in a separate
design.
(Comment 4) The comment suggested
that we redesign the study such that
participants would view the study
materials and then answer questions
about the materials only after consulting
with a physician. This comment lists a
number of practical issues surrounding
how to create drug facts boxes and notes
that this study will provide limited
practical information on how to format
the brief summary for drugs with
multiple indication, multiple studies, or
multiple outcomes. Another
recommendation from the comment is
to include conditions that test relative
difference. The comment suggests
eliminating the ‘‘largest effect’’ cells.
(Response) We cannot ask
participants to incur the financial and
personal (time) cost of visiting a doctor
to discuss a treatment for the purposes
of research. This is not feasible or
ethical. We cannot ethically ask them to
go to their doctor to discuss a fictitious
drug (nor would the doctor be able to
discuss a fictitious drug with them), and
E:\FR\FM\01JYN1.SGM
01JYN1
38661
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
we cannot ethically recommend a real
product for them to discuss with their
doctor. Aside from the feasibility and
ethical issues, this is an unnecessary
step to answer our research questions
about participants’ comprehension of a
widely disseminated written form of
information. Moreover, the assumption
behind this recommendation, that
physician consultations are the ‘‘context
in which prescription drug
advertisements are actually used,’’ is
questionable. DTC advertising does not
exist solely in the confines of a doctor’s
office; rather, DTC advertising targets
consumers outside of a doctor’s office,
with the goal of prompting consumers to
ask their physicians about the product.
Therefore, clear communication of risks
and benefits is needed for consumers
before a consultation with a physician.
We agree that there are several
practical issues surrounding the utility
of the drug facts box; however, these
issues are outside the scope of the
proposed study. This study does not
address how information would be
chosen for inclusion in drug facts boxes
but rather whether and how consumers
can understand the information
presented. As stated in the response to
comment 7, our first step will be to
study a simple version of the drug facts
box, with one indication.
We agree that relative difference is an
interesting way to present quantitative
information and are currently studying
this presentation in another study (Refs.
10 and 11). However, as noted in the
response to comment 3, in this study we
are systematically testing the elements
of the drug facts box presented in past
research (Ref. 8) to determine which, if
any, improves consumer
comprehension.
We agree that these ‘‘largest effect’’
cells may be unrealistic and plan to use
pretests to determine the number of
levels and the content of the levels (e.g.,
the differences used) to be included in
the main study.
II. Publication of the Study
(Comment 5) This comment requested
that FDA provide clarity on the timing
and strategy for the conduct of this
study with respect to other planned
studies.
The comment recommends that FDA
publish findings from this study and
previous studies on the Division of Drug
Marketing, Advertising, and
Communications (DDMAC) Web page
(Ref. 12).
(Response) To clarify, this study will
begin after two related studies (Refs. 10
and 11) have been conducted. The
results from these studies may inform
the execution of this study. The study
will not be superseded by related
research results, as none of the other
research examines the drug facts box
format for the brief summary.
We agree and have taken steps to
publish reports from our previous
research on the DDMAC Web page (Ref.
12). When the current project is
concluded, we will post the findings on
the DDMAC Web page as well.
(Comment 6) Much of this comment
focused on previous research. First, this
comment requests that we disclose the
results of previous research. Second,
this comment recommends that we wait
to begin new studies until results of
previous research have been publicly
reported.
(Response) As stated in the response
to comment 5, we agree and have taken
steps to publish findings from our
previous research on the DDMAC Web
page (ref. 12). Unfortunately, the lengthy
research process does not allow us to
comply with the second request. To
continue having an active research
program, we must submit new proposals
while previous projects are ongoing. As
stated in response to comment 5, as
research projects develop, we will take
results of previous research in account.
III. Product Labeling
(Comment 7) A comment noted that
product labeling is multifaceted and
recommended that conclusions should
be flexible to address these wide
variations in product attributes. Another
suggestion was to consider a label
format that includes multiple endpoints.
(Response) We agree that product
labeling is multifaceted and will tailor
our conclusions to acknowledge that we
tested one simple version of the drug
facts box.
As a first step, we plan to study a
simple version of the drug facts box,
with one indication. If consumers
cannot understand the information in a
drug facts box with one indication, they
are not likely to understand the
information in the drug facts box with
multiple indications. In addition, testing
an ad with one endpoint is realistic as
drug ads often promote only one
indication even if a drug has multiple
indications.
(Comment 8) Another comment
suggested that, along with testing the
qualitative label, ‘‘fewer people taking
Drug X had symptom Y,’’ we should
also test the qualitative label, ‘‘more
people taking Drug X received effective
relief from symptom Y.’’
(Response) Unfortunately, we do not
have the resources to test multiple
qualitative labels in this study; however,
we will test the qualitative label
suggested by the comment in place of
our original language.
IV. Revised Study Design
This study will be conducted in two
concurrent parts; one examining
variations on the benefit information
presented in DTC print advertisements
and the other examining variations on
the risk information presented in DTC
print advertisements. The factors
studied will be the type of information
(i.e., the addition of quantitative and
qualitative information in a box format)
and the level of efficacy or risk. We will
vary the level of efficacy and risk such
that the largest effect is noticeably
different from the placebo, whereas the
smallest effect is minimally different
from the placebo. We plan to use
pretests to determine the number of
levels and the content of the levels (e.g.,
the differences used) to be included in
the main study. We will also pretest
whether participants should have access
to the ad while completing the
questionnaire. The following design
includes the maximum number of levels
we would include. These factors will be
combined in a factorial design as
follows:
TABLE 2—BENEFIT DESIGN (4 × 5 + 2)
mstockstill on DSK4VPTVN1PROD with NOTICES6
Efficacy level
Information type
Smallest effect
(1) Absolute Frequency.
(2) Absolute Frequency + Qualitative
Label.
VerDate Mar<15>2010
Smaller effect
Mid-size effect
Larger effect
19% vs. 18% .............
39% vs. 18% .............
59% vs. 18% .............
79% vs. 18% .............
99% vs. 18%.
More 19% vs. 18% ...
More 39% vs. 18% ...
More 59% vs. 18% ...
More 79% vs. 18% ...
More 99% vs. 18%.
18:54 Jun 30, 2011
Jkt 223001
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
E:\FR\FM\01JYN1.SGM
01JYN1
Largest effect
38662
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
TABLE 2—BENEFIT DESIGN (4 × 5 + 2)—Continued
Efficacy level
Information type
Smallest effect
(3) Absolute Difference
+ Qualitative Label.
(4) Absolute Frequency + Absolute
Difference + Qualitative Label.
Smaller effect
Mid-size effect
More (1 percentage
More (21 percentage
point).
points).
More (1 percentage
More (21 percentage
point) 19% vs. 18%.
points) 39% vs.
18%.
Larger effect
Largest effect
More (41 percentage
points).
More (41 percentage
points) 59% vs.
18%.
More (61 percentage
points).
More (61 percentage
points) 79% vs.
18%.
More (81 percentage
points).
More (81 percentage
points) 99% vs.
18%.
Note: Qualitative label example: ‘‘More people taking drug X had heartburn relief.’’ There are two additional conditions: a no information condition and a qualitative label only (More) condition.
TABLE 3—RISK DESIGN (4 × 5 + 2)
Risk level
Information type
Smallest effect
(1) Absolute Frequency.
(2) Absolute Frequency + Qualitative
Label.
(3) Absolute Difference
+ Qualitative Label.
(4) Absolute Frequency + Absolute
Difference + Qualitative Label.
Smaller effect
Mid-size effect
Larger effect
Largest effect
3% vs. 2% .................
23% vs. 2% ...............
43% vs. 2% ...............
63% vs. 2% ...............
83% vs. 2%.
More 3% vs. 2% .......
More 23% vs. 2% .....
More 43% vs. 2% .....
More 63% vs. 2% .....
More 83% vs. 2%.
More (1 percentage
point).
More (1 percentage
point) 3% vs. 2%.
More (21 percentage
More (41 percentage
More (61 percentage
More (81 percentage
points).
points).
points).
points).
More (21 percentage
More (41 percentage
More (61 percentage
More (81 percentage
points) 23% vs. 2%.
points) 43% vs. 2%.
points) 63% vs. 2%.
points) 83% vs.
2%.
Note: Qualitative label example: ‘‘More people taking drug X had side effect Y.’’ There are two additional conditions: a no information condition
and a qualitative label only (More) condition.
In the benefit design, we will use the
mid-size effect for the risk information
in all conditions and vary the
information type to match the benefit
information type (e.g., participants who
see absolute frequency benefit
information will also see absolute
frequency risk information). Similarly,
in the risk design, we will use the midsize effect for the benefit information in
all conditions and vary the information
type to match the risk information type.
The test product will be for the
treatment of gastroesophageal reflux
disease and modeled on an actual drug
used to treat this condition. Participants
will be consumers who have heartburn
or acid reflux disease. They will be
randomly assigned to read one ad
version. After reading the ad,
participants will answer a series of
questions about the drug. We will test
how the information type affects
perceived efficacy, perceived risk,
behavioral intention, and accurate
understanding of the benefit and risk
information. The questionnaires for the
risk and benefit designs will have
identical questions; however, the order
will differ. In the risk design, questions
about risk will appear before questions
about benefits; in the benefit design
questions about benefits will appear
before questions about risks.
Data will be collected using an
Internet protocol. Consumers who have
heartburn or acid reflux disease will be
recruited for the study. Because the task
presumes basic reading abilities, all
selected participants must speak and
read English fluently. Participants must
be 18 years or older. We will use
Levene’s test of homogeneity of
variances, analysis of variances, and
regressions to test hypotheses.
FDA estimates the burden of this
collection of information as follows:
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours) 2
Total hours
mstockstill on DSK4VPTVN1PROD with NOTICES6
Screener ...............................................................................
Pretest ..................................................................................
Main Study ...........................................................................
30,000
750
11,000
1
1
1
30,000
750
11,000
2/60
20/60
20/60
1,000
250
3,667
Total ..............................................................................
........................
........................
........................
........................
4,917
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60.’’
2 Burden
V. References
FDA has verified the Web site
addresses, but FDA is not responsible
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
1. Aikin, K.J., J.L. Swasy, and A.C. Braman,
‘‘Patient and Physician Attitudes and
Behaviors Associated With DTC
Promotion of Prescription Drugs—
E:\FR\FM\01JYN1.SGM
01JYN1
mstockstill on DSK4VPTVN1PROD with NOTICES6
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
Summary of FDA Survey Research
Results, Final Report, November 19,
2004,’’ accessed online at https://
www.fda.gov/downloads/Drugs/
ScienceResearch/ResearchAreas/
DrugMarketingAdvertisingand
CommunicationsResearch/
UCM152860.pdf.
2. Aikin, K.J., ‘‘Consumer Comprehension
and Preference for Variations in the
Proposed Over-the-Counter Drug
Labeling Format, Final Report,’’ 1998.
3. Vigilante, W.J. and M.S. Wogalter, ‘‘The
Preferred Order of Over-the-Counter
(OTC) Pharmaceutical Label
Components,’’ Drug Information Journal,
vol. 31, pp. 973–988, 1997.
4. Levy, A.S., S.B. Fein, and R.E. Schucker,
‘‘More Effective Nutrition Label Formats
Are Not Necessarily More Preferred, ’’
Journal of the American Dietetic
Association, vol. 92, pp. 1230–1234,
1992.
5. Lorch, R. and E. Lorch, ‘‘Effects of
Organizational Signals on TextProcessing Strategies,’’ Journal of
Educational Psychology, vol. 87, pp.
537–544, 1995.
6. Lorch, R. and E. Lorch, ‘‘Effects of
Organizational Signals on Free Recall of
Expository Text,’’ Journal of Educational
Psychology, vol. 88, pp. 38–48, 1996.
7. Lorch, R., E. Lorch, and W. Inman, ‘‘Effects
of Signaling Topic Structure on Text
Recall,’’ Journal of Educational
Psychology, vol. 85, pp. 281–290, 1993.
8. Schwartz, L.M., S. Woloshin, and H.G.
Welch, ‘‘Using a Drug Facts Box to
Communicate Drug Benefits and Harms:
Two Randomized Trials,’’ Annals of
Internal Medicine, vol. 150, pp. 516–527,
2009, accessed online at https://
www.annals.org/cgi/content/full/
0000605-200904210-00106v1.
9. Webb, T.L. and P. Sheeran, ‘‘Does
Changing Behavioral Intentions
Engender Behavior Change? A MetaAnalysis of the Experimental Evidence,’’
Psychological Bulletin, vol. 132, pp. 249–
268, 2006.
10. ‘‘Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental Study:
Presentation of Quantitative
Effectiveness Information to Consumers
in Direct-to-Consumer (DTC) Television
and Print Advertisements for
Prescription Drugs,’’ Federal Register,
vol. 75, pp. 373–379, January 5, 2010.
11. ‘‘Agency Information Collection
Activities; Proposed Collection;
Comment Request; Study of Clinical
Efficacy Information in Professional
Labeling and Direct-to-Consumer Print
Advertisements for Prescription Drugs,’’
Federal Register, vol. 75, pp. 34142–
34146, June 16, 2010.
12. FDA, About the Center for Drug
Evaluation and Research Page, DDMAC
Research, (https://www.fda.gov/
AboutFDA/CentersOffices/CDER/ucm
090276.htm).
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
Dated: June 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–16552 Filed 6–30–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No FDA–2011–N–0457]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Comparative Direct-toConsumer 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
the Experimental Study of Comparative
Direct-to-Consumer (DTC) Advertising.
This study is designed to explore how
consumers understand and interpret
DTC ads that explicitly compare the
efficacy, dosing, and risks, among other
items, of two similar drugs whether
comparisons are named or unnamed.
DATES: Submit either electronic or
written comments on the collection of
information by August 30, 2011.
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:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
P150–400B, Rockville, MD 20850,
301–796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
38663
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 Comparative
Direct-to-Consumer (DTC) Advertising
Regulatory Background—(OMB Control
No. 0910–New)
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the Food and
Drug Administration (FDA) to conduct
research relating to health information.
Section 903(b)(2)(c) of the Federal Food,
Drug, and Cosmetic Act (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.
Regulations specify that sponsors
cannot make comparative efficacy
claims in advertising for prescription
drugs without substantial evidence,
most often in the form of wellcontrolled clinical trials, to support
such claims (21 U.S.C. 202.1(e)(6)(ii); 21
U.S.C. 314.126). FDA has permitted
some comparisons based on labeled
attributes, such as indication, dosing,
and mechanism of action. When
substantial evidence does not yet exist,
sponsors may use communication
E:\FR\FM\01JYN1.SGM
01JYN1
]]>Agencies
[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Notices]
[Pages 38658-38663]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16552]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0417]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study of
Format Variations in the Brief Summary of Direct-to-Consumer Print
Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
1, 2011.
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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title, ``Experimental Study of Format Variations in the Brief Summary
of Direct-to-Consumer Print Advertisements.'' Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Experimental Study of Format Variations in the Brief Summary of Direct-
to-Consumer Print Advertisements--(OMB Control Number 0910-New)
Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(n)) specifies that ads for prescription drugs and biological
products must provide a true statement of information ``in brief
summary''
[[Page 38659]]
about the advertised product's ``side effects, contraindications, and
effectiveness.'' The prescription drug advertising regulations (Sec.
202.1(e)(3)(iii) (21 CFR 202.1(e)(3)(iii))) specify that the
information about risks must include each specific side effect and
contraindication from the advertised drug's FDA-approved labeling,
including the Warnings, Precautions, Adverse Reactions, and other
relevant sections. Some of the current approaches to fulfilling the
brief summary requirement, while adequate from a regulatory
perspective, result in ads that may be difficult to read and understand
when used in consumer-directed promotion.
In recent years, FDA has become concerned about the adequacy of the
brief summary in direct-to-consumer (DTC) print advertisements for
prescription drugs. Because the regulations do not specify how to
address each risk, sponsors can use discretion in fulfilling the brief
summary requirement under Sec. 202.1(e)(3)(iii). Frequently, sponsors
print in small type, verbatim, the risk-related sections of the
approved product labeling (also called the package insert, professional
labeling, prescribing information, and direction circular). This
labeling is written for health professionals, using medical
terminology. While adequate to fulfill the brief summary requirement
for print advertisements, this method may not be the most ideal.
Research has shown that while many consumers will make the effort to
read the brief summary in prescription drug print advertisements if
they are especially interested in the drug, as a general rule consumers
typically read little or none of the brief summary information (Ref.
1). Health practitioners themselves have indicated they often have
difficulty finding information they actively seek in package inserts
(see 65 FR 81082, December 22, 2000, for a discussion of studies
supporting the use of a highlights section in physician labeling).
There may be other ways to fulfill this requirement that improve
consumers' ability to find and comprehend the information in this
important document.
There is evidence suggesting that both information content and the
format in which it is presented will impact comprehension. For
instance, research with the format of over-the-counter (OTC) drug
labels (Refs. 2 and 3), the nutrition facts label (Ref. 4), and other
information formats (Refs. 5 to 7) demonstrates that information
presented with section headings, graphics (such as bullets), and other
design elements is more easily read than information presented in
paragraph format.
Research conducted by FDA and others has examined the content and
format of the brief summary specifically. For instance, FDA conducted a
series of relevant studies (OMB control numbers 0910-0591 and 0910-
0611). Schwartz, Woloshin, and Welch have compared one format for
adding quantitative and qualitative benefit and risk information to the
brief summary (Ref. 8). Specifically, Schwartz et al. designed a
prescription drug facts box similar in format to the nutrition facts
panel and OTC drug facts panel. The box contains a number of elements,
including qualitative and quantitative (both absolute frequency and
absolute difference) information about benefits and risks. This study
showed that consumers who were provided efficacy information in a
prescription drug facts box were more likely to correctly choose the
product with the higher efficacy than consumers who saw the brief
summary using medical language from the prescribing information.
However, it is unclear which elements of the drug facts box are
necessary to improve consumer understanding. For instance, it is not
known whether simply adding efficacy rate information to a consumer-
friendly brief summary would be sufficient to enable consumers to
understand a product's efficacy or whether qualitative summations are
necessary as well.
The current study will add to previous research by systematically
examining these different elements to determine whether and how to add
qualitative and quantitative benefit and risk information to the brief
summary. The results of this study will inform FDA of the usefulness
and parameters of various format and content options for the brief
summary.
Design Overview: This study will be conducted in two concurrent
parts; one examining variations on the benefit information presented in
DTC print advertisements and the other examining variations on the risk
information presented in DTC print advertisements. The factors studied
will be the type of information (i.e., the addition of quantitative and
qualitative information in a box format) and the level of efficacy or
risk. We will vary the level of efficacy and risk such that the largest
effect is noticeably different from the placebo, whereas the smallest
effect is minimally different from the placebo. These factors will be
combined in a factorial design as follows:
Table 1--Proposed Design (4x5 + 2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy level
Information type --------------------------------------------------------------------------------------------------------------------
Smallest effect Smaller effect Mid-size effect Larger effect Largest effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
Absolute Frequency................. 81% vs. 82%........... 61% vs. 82%........... 41% vs. 82%.......... 21% vs. 82%.......... 1% vs. 82%.
Absolute Frequency + Qualitative Fewer 81% vs. 82%..... Fewer 61% vs. 82%..... Fewer 41% vs. 82%.... Fewer 21% vs. 82%.... Fewer 1% vs. 82%.
Label.
Absolute Difference + Qualitative Fewer (1%)............ Fewer (21%)........... Fewer (41%).......... Fewer (61%).......... Fewer (81%).
Label.
Absolute Frequency + Absolute Fewer (1%) 81% vs. 82% Fewer (21%) 61% vs. Fewer (41%) 41% vs. Fewer (61%) 21% vs. Fewer (81%) 1% vs.
Difference + Qualitative Label. 82%. 82%. 82%. 82%.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Two other cells will be tested: (1) No information and (2) Qualitative label only (fewer). This design (22 cells) will also be used to test risk
information (for a total of 44 cells). The specific numbers in the table are placeholders only. Qualitative label example: ``Fewer people taking drug
X had disease/symptom Y.''
The test product will be for the treatment of a high prevalence
medical condition and modeled on an actual drug used to treat that
condition. Participants will be consumers who have been diagnosed with
the medical condition of interest. They will be randomly assigned to
read one ad version. After reading the ad, participants will answer a
series of questions about the drug. We will test how the information
type affects
[[Page 38660]]
perceived efficacy, perceived risk, behavioral intention, and accurate
understanding of the benefit and risk information.
Interviews are expected to last no more than 20 minutes. A total of
11,750 participants will be involved in the study. This will be a one-
time (rather than annual) collection of information.
In the Federal Register of August 31, 2010 (75 FR 53312), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Four responses were received, each of which
included several comments.
I. Study Design
(Comment 1) Several suggestions related to participant
demographics, measuring health literacy, and determining what our
primary research questions are. One question related to the test DTC
advertisements to be used in the study.
(Response) We agree that the study design should include the
variables of age, education, ethnicity, and race; these are included in
the questionnaire. We will ask whether participants can read,
understand, and speak English.
We will measure subjective health literacy and the related concept
of numeracy, which is relevant for this research as we are studying the
comprehension of quantitative information. To clarify, we will not
limit our sample to those who are currently being treated with a
prescription drug for the condition being assessed; however, the
questionnaire includes questions about prescription drug use.
Regarding the primary research questions, as stated in the 60-day
notice, the current study will add to previous research by
systematically examining the different elements in the drug facts box
tested in previous research (Ref. 8) to determine whether and how to
add qualitative and quantitative benefit and risk information to the
brief summary. Specifically, we will test whether the inclusion of a
qualitative label and/or the inclusion of quantitative information
affects consumers' understanding of the information and their
perceptions of the product.
We have contracted with an organization that produces realistic ads
and stimuli to ensure that we will show respondents realistic
materials.
(Comment 2) This comment states that there was not enough detail in
the 60-day Federal Register notice, such as no description of the
criteria for determining the amount and type of risk and benefit
information to provide in the box format. Another question noted that
qualitative terms depend on many factors. This comment also recommends
that we consider implementing a cross-over study design to address
interpatient variability. This comment suggested considering caregivers
and consumers who do not have the medical condition treated by the
drug. The final question in this comment asked how the tools were
qualified or validated for their intended use.
(Response) The questionnaire, which has information about how
questions will be asked and how behavioral intention will be assessed,
was available upon request during the first comment period and will
continue to be available during the second comment period. Information
about how risk information will be portrayed, what statistical analyses
will be performed, subject recruitment, and pretest content is
addressed in this document.
We agree that a major challenge of the drug facts box format is
deciding the amount and content of risk information to include;
however, this type of study cannot address this issue. To replicate and
extend past research, we will use the drug facts box from a previous
study (Ref. 8) with slight modifications to the risk information (e.g.,
the addition of a serious risk, different rates of side effects in the
placebo and active drug groups).
We agree that qualitative terms depend on many factors; however,
this study does not address the feasibility of creating qualitative
terms but rather tests whether qualitative terms affect consumer
comprehension. As requested, we will note this in our conclusions.
Conducting a cross-over design would significantly increase study
length, and repeated exposure to the same stimuli with minor changes
may affect participants' responses. We have conducted power analyses
and believe we can find interpretable results without conducting a
cross-over design.
To ensure that our participants are motivated to consider the
information presented in the study and to conserve resources, we will
limit our sample to people who have the medical condition of interest.
Cognitive testing will be used to test questionnaire items prior to
their use, and similar items have been used in our previous studies.
The items have face validity, and several are drawn from well-tested
items used in the psychology literature (for example, behavioral
intentions; Ref. 9). Finally, we will pretest the study manipulations.
(Comment 3) This comment included three statements about the
details of the proposed study. First, the comment questioned why we
chose to test percents and frequencies and not relative differences in
this study. Second, this comment pointed out that the differences in
the stimuli should be stated as percentage points, not as percentages.
Third, the comment asks whether the risk and benefit information will
be presented in the same mathematical expression and whether they will
be presented independently.
(Response) We focus on percents and frequencies because we are
replicating and extending previous research on a drug facts box (Ref.
8), which included percents and frequencies but not relative
differences. The study found that the drug facts box outperformed a
traditional brief summary. The drug facts box tested had several
elements that differed from the traditional brief summary, including
percents, frequencies (i.e., XX/100), and qualitative labels. From
these results, it is not possible to tell which elements of the drug
facts box were responsible for the effects found. This study aims to
test systematically the elements of the drug facts box to determine
which, if any, improves consumer comprehension.
We will change percentages to percentage points in our stimuli.
To clarify, when participants see benefit information in a certain
information type (or mathematical expression, for example, percents),
they will also see risk information in that same information type (for
example, percents). However, the efficacy level (from smallest to
largest effect) will be manipulated in one design, and the risk level
(from smallest to largest effect) will be manipulated in a separate
design.
(Comment 4) The comment suggested that we redesign the study such
that participants would view the study materials and then answer
questions about the materials only after consulting with a physician.
This comment lists a number of practical issues surrounding how to
create drug facts boxes and notes that this study will provide limited
practical information on how to format the brief summary for drugs with
multiple indication, multiple studies, or multiple outcomes. Another
recommendation from the comment is to include conditions that test
relative difference. The comment suggests eliminating the ``largest
effect'' cells.
(Response) We cannot ask participants to incur the financial and
personal (time) cost of visiting a doctor to discuss a treatment for
the purposes of research. This is not feasible or ethical. We cannot
ethically ask them to go to their doctor to discuss a fictitious drug
(nor would the doctor be able to discuss a fictitious drug with them),
and
[[Page 38661]]
we cannot ethically recommend a real product for them to discuss with
their doctor. Aside from the feasibility and ethical issues, this is an
unnecessary step to answer our research questions about participants'
comprehension of a widely disseminated written form of information.
Moreover, the assumption behind this recommendation, that physician
consultations are the ``context in which prescription drug
advertisements are actually used,'' is questionable. DTC advertising
does not exist solely in the confines of a doctor's office; rather, DTC
advertising targets consumers outside of a doctor's office, with the
goal of prompting consumers to ask their physicians about the product.
Therefore, clear communication of risks and benefits is needed for
consumers before a consultation with a physician.
We agree that there are several practical issues surrounding the
utility of the drug facts box; however, these issues are outside the
scope of the proposed study. This study does not address how
information would be chosen for inclusion in drug facts boxes but
rather whether and how consumers can understand the information
presented. As stated in the response to comment 7, our first step will
be to study a simple version of the drug facts box, with one
indication.
We agree that relative difference is an interesting way to present
quantitative information and are currently studying this presentation
in another study (Refs. 10 and 11). However, as noted in the response
to comment 3, in this study we are systematically testing the elements
of the drug facts box presented in past research (Ref. 8) to determine
which, if any, improves consumer comprehension.
We agree that these ``largest effect'' cells may be unrealistic and
plan to use pretests to determine the number of levels and the content
of the levels (e.g., the differences used) to be included in the main
study.
II. Publication of the Study
(Comment 5) This comment requested that FDA provide clarity on the
timing and strategy for the conduct of this study with respect to other
planned studies.
The comment recommends that FDA publish findings from this study
and previous studies on the Division of Drug Marketing, Advertising,
and Communications (DDMAC) Web page (Ref. 12).
(Response) To clarify, this study will begin after two related
studies (Refs. 10 and 11) have been conducted. The results from these
studies may inform the execution of this study. The study will not be
superseded by related research results, as none of the other research
examines the drug facts box format for the brief summary.
We agree and have taken steps to publish reports from our previous
research on the DDMAC Web page (Ref. 12). When the current project is
concluded, we will post the findings on the DDMAC Web page as well.
(Comment 6) Much of this comment focused on previous research.
First, this comment requests that we disclose the results of previous
research. Second, this comment recommends that we wait to begin new
studies until results of previous research have been publicly reported.
(Response) As stated in the response to comment 5, we agree and
have taken steps to publish findings from our previous research on the
DDMAC Web page (ref. 12). Unfortunately, the lengthy research process
does not allow us to comply with the second request. To continue having
an active research program, we must submit new proposals while previous
projects are ongoing. As stated in response to comment 5, as research
projects develop, we will take results of previous research in account.
III. Product Labeling
(Comment 7) A comment noted that product labeling is multifaceted
and recommended that conclusions should be flexible to address these
wide variations in product attributes. Another suggestion was to
consider a label format that includes multiple endpoints.
(Response) We agree that product labeling is multifaceted and will
tailor our conclusions to acknowledge that we tested one simple version
of the drug facts box.
As a first step, we plan to study a simple version of the drug
facts box, with one indication. If consumers cannot understand the
information in a drug facts box with one indication, they are not
likely to understand the information in the drug facts box with
multiple indications. In addition, testing an ad with one endpoint is
realistic as drug ads often promote only one indication even if a drug
has multiple indications.
(Comment 8) Another comment suggested that, along with testing the
qualitative label, ``fewer people taking Drug X had symptom Y,'' we
should also test the qualitative label, ``more people taking Drug X
received effective relief from symptom Y.''
(Response) Unfortunately, we do not have the resources to test
multiple qualitative labels in this study; however, we will test the
qualitative label suggested by the comment in place of our original
language.
IV. Revised Study Design
This study will be conducted in two concurrent parts; one examining
variations on the benefit information presented in DTC print
advertisements and the other examining variations on the risk
information presented in DTC print advertisements. The factors studied
will be the type of information (i.e., the addition of quantitative and
qualitative information in a box format) and the level of efficacy or
risk. We will vary the level of efficacy and risk such that the largest
effect is noticeably different from the placebo, whereas the smallest
effect is minimally different from the placebo. We plan to use pretests
to determine the number of levels and the content of the levels (e.g.,
the differences used) to be included in the main study. We will also
pretest whether participants should have access to the ad while
completing the questionnaire. The following design includes the maximum
number of levels we would include. These factors will be combined in a
factorial design as follows:
Table 2--Benefit Design (4 x 5 + 2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy level
Information type --------------------------------------------------------------------------------------------------------------------
Smallest effect Smaller effect Mid-size effect Larger effect Largest effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Absolute Frequency............. 19% vs. 18%........... 39% vs. 18%........... 59% vs. 18%.......... 79% vs. 18%.......... 99% vs. 18%.
(2) Absolute Frequency + More 19% vs. 18%...... More 39% vs. 18%...... More 59% vs. 18%..... More 79% vs. 18%..... More 99% vs. 18%.
Qualitative Label.
[[Page 38662]]
(3) Absolute Difference + More (1 percentage More (21 percentage More (41 percentage More (61 percentage More (81 percentage
Qualitative Label. point). points). points). points). points).
(4) Absolute Frequency + Absolute More (1 percentage More (21 percentage More (41 percentage More (61 percentage More (81 percentage
Difference + Qualitative Label. point) 19% vs. 18%. points) 39% vs. 18%. points) 59% vs. 18%. points) 79% vs. 18%. points) 99% vs. 18%.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Qualitative label example: ``More people taking drug X had heartburn relief.'' There are two additional conditions: a no information condition and
a qualitative label only (More) condition.
Table 3--Risk Design (4 x 5 + 2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risk level
Information type --------------------------------------------------------------------------------------------------------------------
Smallest effect Smaller effect Mid-size effect Larger effect Largest effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Absolute Frequency............. 3% vs. 2%............. 23% vs. 2%............ 43% vs. 2%........... 63% vs. 2%........... 83% vs. 2%.
(2) Absolute Frequency + More 3% vs. 2%........ More 23% vs. 2%....... More 43% vs. 2%...... More 63% vs. 2%...... More 83% vs. 2%.
Qualitative Label.
(3) Absolute Difference + More (1 percentage More (21 percentage More (41 percentage More (61 percentage More (81 percentage
Qualitative Label. point). points). points). points). points).
(4) Absolute Frequency + Absolute More (1 percentage More (21 percentage More (41 percentage More (61 percentage More (81 percentage
Difference + Qualitative Label. point) 3% vs. 2%. points) 23% vs. 2%. points) 43% vs. 2%. points) 63% vs. 2%. points) 83% vs. 2%.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Qualitative label example: ``More people taking drug X had side effect Y.'' There are two additional conditions: a no information condition and a
qualitative label only (More) condition.
In the benefit design, we will use the mid-size effect for the risk
information in all conditions and vary the information type to match
the benefit information type (e.g., participants who see absolute
frequency benefit information will also see absolute frequency risk
information). Similarly, in the risk design, we will use the mid-size
effect for the benefit information in all conditions and vary the
information type to match the risk information type.
The test product will be for the treatment of gastroesophageal
reflux disease and modeled on an actual drug used to treat this
condition. Participants will be consumers who have heartburn or acid
reflux disease. They will be randomly assigned to read one ad version.
After reading the ad, participants will answer a series of questions
about the drug. We will test how the information type affects perceived
efficacy, perceived risk, behavioral intention, and accurate
understanding of the benefit and risk information. The questionnaires
for the risk and benefit designs will have identical questions;
however, the order will differ. In the risk design, questions about
risk will appear before questions about benefits; in the benefit design
questions about benefits will appear before questions about risks.
Data will be collected using an Internet protocol. Consumers who
have heartburn or acid reflux disease will be recruited for the study.
Because the task presumes basic reading abilities, all selected
participants must speak and read English fluently. Participants must be
18 years or older. We will use Levene's test of homogeneity of
variances, analysis of variances, and regressions to test hypotheses.
FDA estimates the burden of this collection of information as
follows:
Table 4--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Activity respondents responses per responses response (in Total hours
respondent hours) \2\
----------------------------------------------------------------------------------------------------------------
Screener........................ 30,000 1 30,000 2/60 1,000
Pretest......................... 750 1 750 20/60 250
Main Study...................... 11,000 1 11,000 20/60 3,667
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,917
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
minutes per response]/60.''
V. References
FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.
1. Aikin, K.J., J.L. Swasy, and A.C. Braman, ``Patient and Physician
Attitudes and Behaviors Associated With DTC Promotion of
Prescription Drugs--
[[Page 38663]]
Summary of FDA Survey Research Results, Final Report, November 19,
2004,'' accessed online at https://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisingandCommunicationsResearch/UCM152860.pdf.
2. Aikin, K.J., ``Consumer Comprehension and Preference for
Variations in the Proposed Over-the-Counter Drug Labeling Format,
Final Report,'' 1998.
3. Vigilante, W.J. and M.S. Wogalter, ``The Preferred Order of Over-
the-Counter (OTC) Pharmaceutical Label Components,'' Drug
Information Journal, vol. 31, pp. 973-988, 1997.
4. Levy, A.S., S.B. Fein, and R.E. Schucker, ``More Effective
Nutrition Label Formats Are Not Necessarily More Preferred, ''
Journal of the American Dietetic Association, vol. 92, pp. 1230-
1234, 1992.
5. Lorch, R. and E. Lorch, ``Effects of Organizational Signals on
Text-Processing Strategies,'' Journal of Educational Psychology,
vol. 87, pp. 537-544, 1995.
6. Lorch, R. and E. Lorch, ``Effects of Organizational Signals on
Free Recall of Expository Text,'' Journal of Educational Psychology,
vol. 88, pp. 38-48, 1996.
7. Lorch, R., E. Lorch, and W. Inman, ``Effects of Signaling Topic
Structure on Text Recall,'' Journal of Educational Psychology, vol.
85, pp. 281-290, 1993.
8. Schwartz, L.M., S. Woloshin, and H.G. Welch, ``Using a Drug Facts
Box to Communicate Drug Benefits and Harms: Two Randomized Trials,''
Annals of Internal Medicine, vol. 150, pp. 516-527, 2009, accessed
online at https://www.annals.org/cgi/content/full/0000605-200904210-00106v1.
9. Webb, T.L. and P. Sheeran, ``Does Changing Behavioral Intentions
Engender Behavior Change? A Meta-Analysis of the Experimental
Evidence,'' Psychological Bulletin, vol. 132, pp. 249-268, 2006.
10. ``Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request;
Experimental Study: Presentation of Quantitative Effectiveness
Information to Consumers in Direct-to-Consumer (DTC) Television and
Print Advertisements for Prescription Drugs,'' Federal Register,
vol. 75, pp. 373-379, January 5, 2010.
11. ``Agency Information Collection Activities; Proposed Collection;
Comment Request; Study of Clinical Efficacy Information in
Professional Labeling and Direct-to-Consumer Print Advertisements
for Prescription Drugs,'' Federal Register, vol. 75, pp. 34142-
34146, June 16, 2010.
12. FDA, About the Center for Drug Evaluation and Research Page,
DDMAC Research, (https://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090276.htm).
Dated: June 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16552 Filed 6-30-11; 8:45 am]
BILLING CODE 4160-01-P
