
[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Pages 37051-37055]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0568]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 July 
20, 2012.

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 emailed to

[[Page 37052]]

oira_submission@omb.eop.gov. All comments should be identified with 
the OMB control number 0910-new and title, ``Experimental Study: 
Experimental Study: Disease Information in Branded Promotional 
Material.'' Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@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: Disease Information in Branded Promotional 
Material--(OMB Control Number 0910-New)

I. Regulatory Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 1003(d)(2)(c) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(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 
(Ref. 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.
    Rationale: 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 act) and FDA 
regulations.''(Ref. 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 (Ref. 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 (Ref. 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.
    Design Overview: We will investigate the effects of adding disease 
outcome information to branded promotional materials on consumer 
perceptions and understanding. This information will be examined in the 
context of direct-to-consumer prescription drug print advertisements. 
We hope to more readily generalize our findings by exploring the issues 
raised in this document in three medical conditions varying in severity 
and symptomatology: Chronic obstructive pulmonary disease (COPD), 
lymphoma, and anemia.
    We plan to examine two variables in this study: the type of disease 
information (possible disease outcomes, versus non-outcome information, 
versus no information) 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.'' A third group will see drug product information only 
(no disease information). 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. We are exploring a number of different options for 
implementing these two variables. For example: alternating paragraphs 
of product and disease information, disease information on one page and 
product information on another page, use of different colors and fonts 
for disease and product information, and different visuals for disease 
and product information. Final format variations will be determined 
through pretesting. The pretests are designed only to make sure the 
particulars of the main study are implemented in the best way possible. 
The results of the pretests will not increase the burden on respondents 
in the main study, nor will the main study design change as a result of 
the pretests.
    This study utilizes random assignment to conditions. Within

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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.
    The design is described in Table 1:

                                              Table 1--Study Design
----------------------------------------------------------------------------------------------------------------
                                                               Format of disease and product information
                                Disease information  -----------------------------------------------------------
      Medical condition                 plus                                               Control  (no disease
                                                         Integrated        Separated              info)
----------------------------------------------------------------------------------------------------------------
COPD.........................  Non-outcome..........
                               Outcomes.............
Lymphoma.....................  Non-outcome..........
                               Outcomes.............
Anemia.......................  Non-outcome..........
                               Outcomes.............
----------------------------------------------------------------------------------------------------------------

    Data will be collected using an Internet protocol. Participants 
will be recruited from a general population sample to control for prior 
knowledge about disease outcomes. 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 
ANOVAs and regressions to test hypotheses. Interviews are expected to 
last no more than 20 minutes. A total of 4,650 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 16, 2011 (76 FR 50737), FDA 
published a 60-day notice for public comment on the proposed collection 
of information. FDA received one public submission. In the following 
section, we outline the observations and suggestions raised in the 
submission and provide our responses.
    (Comment 1) One statement suggested we add a multiple choice 
question to obtain a baseline of how consumers research information 
about their disease in other forms and if they are actively engaged in 
health care decisions.
    (Response) We agree this question is interesting, but feel it is 
outside the scope of the current study. The purpose of the study is to 
examine how disease outcome and product information contained within 
the same piece influences perceptions of product benefit.
    (Comment 2) One comment stated that the inclusion of the MedWatch 
reporting statement discloses the prescription status of the product 
and suggested rewording the question about the type of product being 
tested.
    (Response) We have reworded the question, removing the choice 
options ``household cleaner'' and ``herbal supplement'' and added a 
``don't know'' option.
    (Comment 3) Two statements said that open-ended questions would 
result in subjective data interpretation and suggested either replacing 
them with closed-ended questions or deleting. These statements also 
suggested that procedures for coding, categorizing and analyzing 
verbatim responses be established in advance, and that comparable 
questions about both benefits and risks be included.
    (Response) We have established baseline codes for the open-ended 
questions and included parallel questions to assess perceptions of 
benefits and risks (see draft questionnaire). Other codes will be 
established through pretesting. We will have two independent raters for 
coding and we will calculate inter-rater reliability. Disagreements 
between coders will be resolved through discussion. In addition, our 
open-ended questions are accompanied by closed-ended questions.
    (Comment 4) One comment stated that those previously diagnosed with 
the medical condition may respond differently than the newly diagnosed.
    (Response) We agree that length of diagnosis could impact responses 
to information. We are recruiting a general population sample and plan 
to use medical condition as a covariate. We have added a question to 
assess time since diagnosis among those who self-identify as having the 
condition of interest.
    (Comment 5) The submission suggested deleting items: (1) Attitudes 
about the product; (2) multiple items measuring the same construct 
(risk, benefit); and (3) perceptions of the risk/benefit tradeoff.
    (Response) We have addressed these suggestions in the following 
ways. We have deleted the questions measuring product attitudes. We 
believe that two questions measuring risk and benefits are necessary to 
assess the reliability (Ref. 5) of each construct and so have kept both 
questions. With regard to the final point, we agree that the risk/
benefit ratio is different for each patient, but we also think that the 
perceived risk/benefit ratio for a product is influenced by the 
information presented in the ad. It is relevant here in that the risk/
benefit assessment may be influenced by the perception that the disease 
outcome information is a product characteristic.
    (Comment 6) One statement suggested deleting the questions related 
to behavioral intention, while another statement suggested expanding 
these questions.
    (Response) As these statements are contradictory, we offer our 
reasoning behind including these questions. In an ideal situation, we 
would be able to measure actual behaviors that may result from exposure 
to a particular promotional campaign. Because we cannot do that, we 
propose to measure participants' intended behavior; that is, the 
likelihood that they would engage in specific outcome behaviors that 
may occur as a result of exposure to the product and disease 
information. This is in concordance with the recommendations of the 
November 17, 2011, meeting of the Risk Communication Advisory 
Committee, which suggested behavioral intention as an important 
variable to measure in research studies on promotion.
    (Comment 7) One comment stated that the questions assessing recall 
included false benefit items but were not balanced with statements to 
recall true/factual disease awareness information and suggested 
including true statements from the disease awareness information.
    (Response) Our use of the term ``false benefit'' in the 
questionnaire notes may have caused confusion. In the draft 
questionnaire, ``false benefit'' simply refers to disease 
characteristics that are not part of the product's indication. The 
purpose of this question is to first

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determine which, if any, of the outcome claims are being interpreted by 
the participant as product benefits. Following this question is an 
open-ended question intended to measure what it was about the ad that 
suggested that (see questionnaire). We have revised the questionnaire 
notes to read ``outcome'' and ``non-outcome'' for clarity.
    (Comment 8) One statement asked for more detail about the study 
design and stimuli layout and offered specific suggestions on variables 
to include in the study: Vary the presentation of the disease 
information using headers with and without disclaimers, use a control 
test ad with no headers, use branded colors, non-branded colors, etc. 
to maximize understanding of whether consumers are able to distinguish 
between disease information and product claims and whether the format 
enhances understanding.
    (Response) We have included a description of the study design in 
both the 60-day and 30-day Federal Register notices. We are exploring a 
number of different options for implementing the layout of the stimuli. 
For example: Alternating paragraphs of product and disease information, 
disease information on one page and product information on another 
page, use of identical or different colors and fonts for disease and 
product information, and different visuals for disease and product 
information. Final format variations will be determined through 
pretesting. This is the first study of this issue and therefore we are 
focusing on a small number of variations. It is not feasible to include 
every possible variation. We appreciate the layout suggestions 
provided.
    (Comment 9) One statement addressed the recruitment process, 
requesting that we disclose how participants will be recruited and 
recommending mall intercept recruitment because recruiting participants 
online may not be reflective of the consumer likely to observe print 
advertising.
    (Response) We plan to recruit and conduct the study online to use 
our resources most efficiently.
    (Comment 10) One statement asked for a rationale for our sample 
size.
    (Response) We have provided a rationale for our sample size in the 
Power Analysis.
    (Comment 11) One statement requested details on the assignment to 
conditions, saying it was unclear if the study will include a 
sufficiently stratified sample based on language abilities, preexisting 
knowledge/disease awareness, age, gender, etc.
    (Response) Participants will be randomly assigned to conditions. An 
attempt will be made to have an equal number of males and females in 
each experimental cell. Approximately 20 percent of participants in 
each cell will have a high school education or less, with a range of 
education and race/ethnicity represented in each condition. The 
following screening criteria will be employed: participants must be age 
18 and over, must not work for a pharmaceutical company, an advertising 
agency, a market research company, or be health care professionals.
    (Comment 12) One statement asked that the screener specify if only 
those previously diagnosed with the condition will be eligible to 
participate, saying those previously diagnosed with the medical 
condition may engage differently than those who are recently diagnosed.
    (Response) We agree that those who have the medical condition may 
react differently than those who do not. We plan to use diagnosis as a 
covariate in our analyses.
    The total annual estimated burden imposed by this collection of 
information is 1,873 hours for this one-time collection.
    The response burden chart is listed in table 2.

                                  Table 2--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                      No. of
            Activity                  No. of       responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses    per response 2
----------------------------------------------------------------------------------------------------------------
Sample outgo (pretests and main           27,679  ..............  ..............  ..............  ..............
 survey)........................
Number of screener completes               9,688               1           9,688            2/60             323
 (35%)..........................
Number eligible (80%)...........           7,750  ..............  ..............  ..............  ..............
Number of completes, Pretests                900               1             900           20/60             300
 (60%)..........................
Number of completes, Study (60%)           3,750               1           3,750           20/60           1,250
Number of pretest/study                    4,650  ..............  ..............  ..............  ..............
 completes......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,873
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\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''.

II. References

    The following references have been placed on display in the 
Division of Dockets Management, (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and 
may be seen by interested persons between 9 a.m. and 4 p.m., Monday 
through Friday. (FDA has verified the Web site addresses, but we are 
not responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)

    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 * * *''
    2. Draft Guidance for Industry: `Help-Seeking' and Other Disease 
Awareness Communications by or on Behalf of Drug and Device Firms'' 
(pg. 1). Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070068.pdf. 
Last accessed June 8, 2012.
    3. Lee-Wingate, S. and Xie, Y. (2010). Consumer perceptions of 
product-claim versus help-seeking direct-to-consumer advertising. 
``International Journal of Pharmaceutical and Healthcare 
Marketing,'' 4(3), 232-246.
    4. Burke, R. R., DeSarbo, W. S., Oliver, R. L., and Robertson, 
T. S. (1988). Deception by implication: An experimental 
investigation. ``Journal of Consumer Research,'' 14(4), 483-

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494; Harris, R. J. (1977) Comprehension of pragmatic implication in 
advertising. ``Journal of Applied Psychology,'' 62, 603-608; Jacoby, 
J. and Hoyer, W. (1987). ``The comprehension and miscomprehension of 
print communications.'' New York: The Advertising Educational 
Foundation.
    5. Guidance for Industry: Patient Reported Outcome Measures: Use 
in Medical Product Development to Support Labeling Claims. Available 
at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071975.pdf. 
Last accessed November 16, 2011.
    6. Transcript available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM283132.pdf. Last accessed 
January 4, 2012.

    Dated: June 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14989 Filed 6-19-12; 8:45 am]
BILLING CODE 4160-01-P


