Document ID: FDA-2011-N-0568-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study; Disease Information in Branded Promotional Material
Posted Date: 2011-08-16T04:00Z

[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]

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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, 
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.
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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
                                -------------------------------------------------------------
                                 Outcomes
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Condition C....................  No Outcomes
                                -------------------------------------------------------------
                                 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