[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Pages 50737-50739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20814]
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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.
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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 http://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,
[email protected].
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.
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\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 * * *.''
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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\
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\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 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070068.pdf.
Last accessed February 16, 2011.
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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\
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\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.
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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.
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\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.
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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
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Format of disease information Control (no
Medical condition Disease outcome ---------------------------------------- disease
information Integrated Separated information)
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Condition A.................... No Outcomes
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Outcomes
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Condition B.................... No Outcomes
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Outcomes
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Condition C.................... No Outcomes
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Outcomes
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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\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent respondents
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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
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Total.................................. ................ ................ ................ ................................... 1,985
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\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