Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study: Disease Information in Branded Promotional Material, 50737-50739 [2011-20814]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices
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.
Extra Label Drug Use in Animals—21
CFR Part 530 (OMB Control Number
0910–0325—Extension)
The Animal Medicinal Drug Use
Clarification Act of 1994 allows a
veterinarian to prescribe the extra-label
use of approved new animal drugs.
Also, it permits FDA, if it finds that
there is a reasonable probability that the
extra-label use of an animal drug may
present a risk to the public health, to
establish a safe level for a residue from
the extra-label use of the drug, and to
require the development of an analytical
method for the detection of residues
above that established safe level.
Although to date, we have not
established a safe level for a residue
from the extra-label use of any new
animal drug, and therefore, have not
required the development of analytical
methodology, we believe that there may
be instances when analytical
methodology will be required. We are
50737
therefore estimating the reporting
burden based on two methods being
required annually. The requirement to
establish an analytical method may be
fulfilled by any interested person. We
believe that the sponsor of the drug will
be willing to develop the method in
most cases. Alternatively, FDA, the
sponsor, and perhaps a third party may
cooperatively arrange for method
development. The respondents may be
sponsors of new animal drugs, State, or
Federal and/or State Agencies,
academia, or individuals.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
530.22(b) ..........................................................
2
1
2
4,160
8,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–20813 Filed 8–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0568]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study: Disease Information in Branded
Promotional Material
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled ‘‘Experimental Study:
Disease Information in Branded
Promotional Material.’’ The proposed
research will explore the nature of
emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:07 Aug 15, 2011
Jkt 223001
including information about a disease
and promotional information about a
specific drug treatment in the same
advertising piece.
DATES: Submit either electronic or
written comments on the collection of
information by October 17, 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–
796–3972,
Elizabeth.Berbakos@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
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: Disease
Information in Branded Promotional
Material—(OMB Control Number 0910–
New)
Regulatory Background: Section
1701(a)(4) of the Public Health Service
E:\FR\FM\16AUN1.SGM
16AUN1
50738
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices
Act (42 U.S.C. 300u(a)(4)) authorizes
FDA to conduct research relating to
health information. Section 903(b)(2)(c)
of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
393(b)(2)(c)) authorizes FDA to conduct
research relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act.
FDA regulations require prescription
drug advertisements to contain accurate
information about the benefits and risks
of the drug advertised. Generally, the
advertising must not be misleading
about the effectiveness of the drug.
Specifically, the ad must not contain a
representation or suggestion that the
drug is better than has been shown by
substantial evidence or useful in a
broader range of patients.1 The
regulations prohibit sponsors from, for
example, disseminating promotional
information that may broaden the
indications of medications beyond the
indication for which they have been
approved. This regulation is designed to
avoid misleading the audience by
overpromising the outcomes of a
particular drug and also to maintain a
level playing field among competitors.
As a public health agency, FDA
encourages the communication of
accurate health messages about medical
conditions and treatments. One way in
which broad disease information is
communicated to the public is through
disease awareness communications:
emcdonald on DSK2BSOYB1PROD with NOTICES
‘‘Disease awareness communications are
communications disseminated to consumers
or health care practitioners that discuss a
particular disease or health condition, but do
not mention any specific drug or device or
make any representation or suggestion
concerning a particular drug or device. Helpseeking communications are disease
awareness communications directed at
consumers. FDA believes that disease
awareness communications can provide
important health information to consumers
and health care practitioners, and can
encourage consumers to seek, and health care
practitioners to provide, appropriate
treatment. This is particularly important for
under-diagnosed, under-treated health
conditions, such as depression,
hyperlipidemia, hypertension, osteoporosis,
1 See 21 CFR 202.1(e)(6): ‘‘An advertisement for
a prescription drug is false, lacking in fair balance,
or otherwise misleading, or otherwise violative of
section 502(n) of the act, among other reasons if it:
(i) Contains a representation or suggestion, not
approved or permitted for use in the labeling, that
a drug is better, more effective, useful in a broader
range of patients (as used in this section, patients
means humans and in the case of veterinary drugs,
other animals), safer, has fewer, or less incidence
of, or less serious side effects or contraindications
than has been demonstrated by substantial evidence
or substantial clinical experience (as described in
paragraphs (e)(4)(ii)(b) and (c) of this section)
whether or not such representations are made by
comparison with other drugs or treatments * * *.’’
VerDate Mar<15>2010
18:07 Aug 15, 2011
Jkt 223001
and diabetes. Unlike drug and device
promotional labeling and prescription drug
and restricted device advertising, disease
awareness communications are not subject to
the requirements of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) and FDA
regulations.’’ 2
Some research has shown that disease
awareness advertising is viewed by
consumers as more informative and
containing less persuasive intent than
full product advertising.3
Sponsors may choose to include
disease information in their full product
promotions. Such information is
designed to educate the patient about
his or her disease condition. However,
in some cases a full description of the
medical condition may include
information about specific health
outcomes that are not part of a drug’s
approved indication. The current
project is designed to determine if
providing such information in branded
full product advertisements affects
perceptions of the product.
When broad disease information
accompanies or is included in an ad for
a specific drug, consumers may
mistakenly assume that the drug will
address all of the potential
consequences of the condition
mentioned in the ad by making
inferences that go beyond what is
explicitly stated in an advertisement.4
For example, the mention of diabetic
retinopathy in an advertisement for a
drug that lowers blood glucose may lead
consumers to infer that the drug will
prevent diabetic retinopathy, even if no
direct claim is made. The advertisement
may imply broader indications for the
promoted drug than are warranted,
leading consumers to infer effectiveness
of the drug beyond the indication for
which it was approved. If consumers are
able to distinguish between disease
information and product claims in an
ad, then they will not be misled by the
inclusion of disease information in a
2 See Draft Guidance for Industry: ‘‘ ‘HelpSeeking’ and Other Disease Awareness
Communications by or on Behalf of Drug and
Device Firms’’ (p. 1), available at https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/ucm070068.pdf. Last accessed February
16, 2011.
3 Lee-Wingate, S. and Y. Xie, ‘‘Consumer
perceptions of product-claim versus help-seeking
direct-to-consumer advertising,’’ International
Journal of Pharmaceutical and Healthcare
Marketing, 4(3), 232–246, 2010.
4 Burke, R.R., W.S. DeSarbo, R.L. Oliver, and T.S.
Robertson, ‘‘Deception by implication: An
experimental investigation,’’ Journal of Consumer
Research, 14(4), 483–494, 1988; Harris, R.J.,
‘‘Comprehension of pragmatic implication in
advertising,’’ Journal of Applied Psychology, 62,
603–608, 1977; Jacoby, J., and W. Hoyer, ‘‘The
comprehension and miscomprehension of print
communications,’’ New York: The Advertising
Educational Foundation, 1987.
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
branded ad. If consumers are unable to
distinguish these two, however, then
consumers may be misled into believing
that a particular drug is effective against
long-term consequences. The current
study will explore perceptions that
result from including both disease
information and promotional
information about a specific drug in the
same advertising piece.
Design Overview: We will investigate
the effects of adding disease information
to branded promotional materials on
consumer perceptions and
understanding. Disease information will
be examined in the context of direct-toconsumer (DTC) prescription drug print
advertisements. We hope to more
readily generalize our findings by
exploring the issues raised above in
three medical conditions varying in
severity and symptomatology. For
example, disease information in a
category such as oncology may be
viewed differently than a mild skin
condition or a non-symptomatic
condition such as high cholesterol.
We plan to examine two variables in
this study: The type of disease
information in the piece (information
about the disease and its possible
outcomes, versus information about the
disease without outcomes, versus no
information about the disease) and the
format of the information (integrated
with drug information versus
separated). Some participants will see
information about the disease that
avoids discussion of disease outcomes
the drug has not been shown to address,
such as, ‘‘Diabetes is a disease in which
blood sugar can vary uncontrollably,
leading to uncomfortable episodes of
high or low blood sugar.’’ Other
participants will see disease information
that mentions consequences of the
disease that go beyond the indication of
the advertised product, such as,
‘‘Untreated diabetes can lead to
blindness, amputation, and, in some
cases, death.’’ We will also examine the
way in which the disease information is
presented relative to the product claims
in the piece by varying the format:
Disease information mixed (integrated)
with product claims versus disease
information apart (separated) from
product claims. This study is
experimental in method and utilizes
random assignment to conditions.
Within medical condition, participants
will be randomly assigned to see one
version of the ad. Participants will be
recruited from a general population
sample to control for prior knowledge
about disease outcomes.
E:\FR\FM\16AUN1.SGM
16AUN1
50739
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices
The preliminary design is included as
follows:
TABLE 1—STUDY DESIGN
Condition A ........................
Format of disease information
Disease outcome
information
Medical condition
Integrated
Control
(no disease information)
Separated
No Outcomes
Outcomes
Condition B ........................
No Outcomes
Outcomes
Condition C ........................
No Outcomes
Outcomes
FDA estimates the burden of this
collection of information as follows: We
estimate the response burden to be 20
minutes in the pretests and the study,
for a burden of 1,985 hours. This will
be a one time (rather than annual)
collection of information. The
questionnaire is available upon request.
The response burden chart is listed as
follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN5
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
respondents
Average burden
per response
Total hours
Screener ............................................................
Pretests .............................................................
Study .................................................................
6,750
900
4,500
1
1
1
6,750
900
4,500
0.03 (2 min.) .....
0.33 (20 min.) ...
0.33 (20 min.) ...
203
297
1,485
Total ...........................................................
............................
............................
............................
...........................
1,985
Dated: August 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–20814 Filed 8–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0183]
Hung Ta Fan: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Hung Ta Fan for a period of 5 years from
importing articles of food or offering
such articles for importation into the
United States. FDA bases this order on
emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY:
5 There
are no capital costs or operating and
maintenance costs associated with this collection of
information.
VerDate Mar<15>2010
18:07 Aug 15, 2011
Jkt 223001
a finding that Mr. Fan was convicted of
a felony under Federal law for conduct
relating to the importation into the
United States of an article of food. Mr.
Fan was given notice of the proposed
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. As of July 13,
2011 (30 days after receipt of the
notice), Mr. Fan had not responded.
Mr. Fan’s failure to respond constitutes
a waiver of his right to a hearing
concerning this action.
DATES: This order is effective August 16,
2011.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs (HFC–230), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a
felony for conduct relating to the
importation into the United States of
any food.
On August 4, 2010, the United States
District Court for the Northern District
of Illinois accepted Mr. Fan’s guilty plea
and entered judgment against him for
the offense of conspiracy, in violation of
18 U.S.C. 371 and 2, for conspiring to
defraud the United States and to violate
18 U.S.C. 542 (entry of Goods into the
United States by means of false
statements) and 18 U.S.C. 545
(importation contrary to law).
FDA’s finding that debarment is
appropriate is based on the felony
conviction referenced herein for
conduct relating to the importation into
the United States of any food. The
factual basis for this conviction is as
follows: In or around March 2005 and
continuing until in or around November
2006, in violation of 18 U.S.C. 371 and
2, Mr. Fan agreed and conspired with
others to defraud the United States and
E:\FR\FM\16AUN1.SGM
16AUN1
]]>Agencies
[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Pages 50737-50739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20814]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0568]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study: Disease Information in Branded
Promotional Material
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled ``Experimental Study:
Disease Information in Branded Promotional Material.'' The proposed
research will explore the nature of including information about a
disease and promotional information about a specific drug treatment in
the same advertising piece.
DATES: Submit either electronic or written comments on the collection
of information by October 17, 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, 301-796-3972,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Experimental Study: Disease Information in Branded Promotional
Material--(OMB Control Number 0910-New)
Regulatory Background: Section 1701(a)(4) of the Public Health
Service
[[Page 50738]]
Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating
to health information. Section 903(b)(2)(c) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA
to conduct research relating to drugs and other FDA regulated products
in carrying out the provisions of the FD&C Act.
FDA regulations require prescription drug advertisements to contain
accurate information about the benefits and risks of the drug
advertised. Generally, the advertising must not be misleading about the
effectiveness of the drug. Specifically, the ad must not contain a
representation or suggestion that the drug is better than has been
shown by substantial evidence or useful in a broader range of
patients.\1\ The regulations prohibit sponsors from, for example,
disseminating promotional information that may broaden the indications
of medications beyond the indication for which they have been approved.
This regulation is designed to avoid misleading the audience by
overpromising the outcomes of a particular drug and also to maintain a
level playing field among competitors.
---------------------------------------------------------------------------
\1\ See 21 CFR 202.1(e)(6): ``An advertisement for a
prescription drug is false, lacking in fair balance, or otherwise
misleading, or otherwise violative of section 502(n) of the act,
among other reasons if it: (i) Contains a representation or
suggestion, not approved or permitted for use in the labeling, that
a drug is better, more effective, useful in a broader range of
patients (as used in this section, patients means humans and in the
case of veterinary drugs, other animals), safer, has fewer, or less
incidence of, or less serious side effects or contraindications than
has been demonstrated by substantial evidence or substantial
clinical experience (as described in paragraphs (e)(4)(ii)(b) and
(c) of this section) whether or not such representations are made by
comparison with other drugs or treatments * * *.''
---------------------------------------------------------------------------
As a public health agency, FDA encourages the communication of
accurate health messages about medical conditions and treatments. One
way in which broad disease information is communicated to the public is
through disease awareness communications:
``Disease awareness communications are communications
disseminated to consumers or health care practitioners that discuss
a particular disease or health condition, but do not mention any
specific drug or device or make any representation or suggestion
concerning a particular drug or device. Help-seeking communications
are disease awareness communications directed at consumers. FDA
believes that disease awareness communications can provide important
health information to consumers and health care practitioners, and
can encourage consumers to seek, and health care practitioners to
provide, appropriate treatment. This is particularly important for
under-diagnosed, under-treated health conditions, such as
depression, hyperlipidemia, hypertension, osteoporosis, and
diabetes. Unlike drug and device promotional labeling and
prescription drug and restricted device advertising, disease
awareness communications are not subject to the requirements of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA
regulations.'' \2\
---------------------------------------------------------------------------
\2\ See Draft Guidance for Industry: `` `Help-Seeking' and Other
Disease Awareness Communications by or on Behalf of Drug and Device
Firms'' (p. 1), available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070068.pdf.
Last accessed February 16, 2011.
---------------------------------------------------------------------------
Some research has shown that disease awareness advertising is
viewed by consumers as more informative and containing less persuasive
intent than full product advertising.\3\
---------------------------------------------------------------------------
\3\ Lee-Wingate, S. and Y. Xie, ``Consumer perceptions of
product-claim versus help-seeking direct-to-consumer advertising,''
International Journal of Pharmaceutical and Healthcare Marketing,
4(3), 232-246, 2010.
---------------------------------------------------------------------------
Sponsors may choose to include disease information in their full
product promotions. Such information is designed to educate the patient
about his or her disease condition. However, in some cases a full
description of the medical condition may include information about
specific health outcomes that are not part of a drug's approved
indication. The current project is designed to determine if providing
such information in branded full product advertisements affects
perceptions of the product.
When broad disease information accompanies or is included in an ad
for a specific drug, consumers may mistakenly assume that the drug will
address all of the potential consequences of the condition mentioned in
the ad by making inferences that go beyond what is explicitly stated in
an advertisement.\4\ For example, the mention of diabetic retinopathy
in an advertisement for a drug that lowers blood glucose may lead
consumers to infer that the drug will prevent diabetic retinopathy,
even if no direct claim is made. The advertisement may imply broader
indications for the promoted drug than are warranted, leading consumers
to infer effectiveness of the drug beyond the indication for which it
was approved. If consumers are able to distinguish between disease
information and product claims in an ad, then they will not be misled
by the inclusion of disease information in a branded ad. If consumers
are unable to distinguish these two, however, then consumers may be
misled into believing that a particular drug is effective against long-
term consequences. The current study will explore perceptions that
result from including both disease information and promotional
information about a specific drug in the same advertising piece.
---------------------------------------------------------------------------
\4\ Burke, R.R., W.S. DeSarbo, R.L. Oliver, and T.S. Robertson,
``Deception by implication: An experimental investigation,'' Journal
of Consumer Research, 14(4), 483-494, 1988; Harris, R.J.,
``Comprehension of pragmatic implication in advertising,'' Journal
of Applied Psychology, 62, 603-608, 1977; Jacoby, J., and W. Hoyer,
``The comprehension and miscomprehension of print communications,''
New York: The Advertising Educational Foundation, 1987.
---------------------------------------------------------------------------
Design Overview: We will investigate the effects of adding disease
information to branded promotional materials on consumer perceptions
and understanding. Disease information will be examined in the context
of direct-to-consumer (DTC) prescription drug print advertisements. We
hope to more readily generalize our findings by exploring the issues
raised above in three medical conditions varying in severity and
symptomatology. For example, disease information in a category such as
oncology may be viewed differently than a mild skin condition or a non-
symptomatic condition such as high cholesterol.
We plan to examine two variables in this study: The type of disease
information in the piece (information about the disease and its
possible outcomes, versus information about the disease without
outcomes, versus no information about the disease) and the format of
the information (integrated with drug information versus separated).
Some participants will see information about the disease that avoids
discussion of disease outcomes the drug has not been shown to address,
such as, ``Diabetes is a disease in which blood sugar can vary
uncontrollably, leading to uncomfortable episodes of high or low blood
sugar.'' Other participants will see disease information that mentions
consequences of the disease that go beyond the indication of the
advertised product, such as, ``Untreated diabetes can lead to
blindness, amputation, and, in some cases, death.'' We will also
examine the way in which the disease information is presented relative
to the product claims in the piece by varying the format: Disease
information mixed (integrated) with product claims versus disease
information apart (separated) from product claims. This study is
experimental in method and utilizes random assignment to conditions.
Within medical condition, participants will be randomly assigned to see
one version of the ad. Participants will be recruited from a general
population sample to control for prior knowledge about disease
outcomes.
[[Page 50739]]
The preliminary design is included as follows:
Table 1--Study Design
----------------------------------------------------------------------------------------------------------------
Format of disease information Control (no
Medical condition Disease outcome ---------------------------------------- disease
information Integrated Separated information)
----------------------------------------------------------------------------------------------------------------
Condition A.................... No Outcomes
-------------------------------------------------------------
Outcomes
----------------------------------------------------------------------------------------------------------------
Condition B.................... No Outcomes
-------------------------------------------------------------
Outcomes
----------------------------------------------------------------------------------------------------------------
Condition C.................... No Outcomes
-------------------------------------------------------------
Outcomes
----------------------------------------------------------------------------------------------------------------
FDA estimates the burden of this collection of information as
follows: We estimate the response burden to be 20 minutes in the
pretests and the study, for a burden of 1,985 hours. This will be a one
time (rather than annual) collection of information. The questionnaire
is available upon request.
The response burden chart is listed as follows:
Table 2--Estimated Annual Reporting Burden\5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener................................... 6,750 1 6,750 0.03 (2 min.)...................... 203
Pretests................................... 900 1 900 0.33 (20 min.)..................... 297
Study...................................... 4,500 1 4,500 0.33 (20 min.)..................... 1,485
------------------------------------------------------------------------------------------------------------
Total.................................. ................ ................ ................ ................................... 1,985
--------------------------------------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------
\5\ There are no capital costs or operating and maintenance
costs associated with this collection of information.
Dated: August 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20814 Filed 8-15-11; 8:45 am]
BILLING CODE 4160-01-P
