[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52472-52477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22567]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3516]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Disease Awareness and Prescription Drug Promotion on 
Television

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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, ``Disease Awareness and 
Prescription Drug Promotion on Television.''

DATES: Submit either electronic or written comments on the collection 
of information by December 17, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 17, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note

[[Page 52473]]

that if you include your name, contact information, or other 
information that identifies you in the body of your comments, that 
information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-3516 for ``Disease Awareness and Prescription Drug Promotion 
on Television.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10:00 a.m.-12:00 
p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected]. For copies of the questionnaire contact: Office 
of Prescription Drug Promotion (OPDP) Research Team, 
[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.

Disease Awareness and Prescription Drug Promotion on Television (OMB 
Control Number 0910--NEW)

    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 (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.
    The FDA's Center for Drug Evaluation and Research (CDER), Office of 
Prescription Drug Promotion (OPDP) is responsible for ensuring that 
prescription drug promotional materials are truthful, balanced, and 
accurately communicated. This project is being proposed as part of the 
research program of OPDP. OPDP's research program supports this mission 
by providing scientific evidence to help ensure that our policies 
related to prescription drug promotion will have the greatest benefit 
to public health. Toward that end, we have consistently conducted 
research to evaluate the aspects of prescription drug promotion that we 
believe are most central to our mission, focusing in particular on 
three main topic areas: Advertising features, including content and 
format; target populations; and research quality. Through the 
evaluation of advertising features we assess how elements such as 
graphics, format, and disease and product characteristics impact the 
communication and understanding of prescription drug risks and 
benefits; focusing on target populations allows us to evaluate how 
understanding of prescription drug risks and benefits may vary as a 
function of audience; and our focus on research quality aims at 
maximizing the quality of research data through analytical methodology 
development and investigation of sampling and response issues. This 
study falls under the topic of both target populations and advertising 
features.
    Because we recognize the strength of data and the confidence in the 
robust nature of the findings is improved through the results of 
multiple converging studies, we continue to develop evidence to inform 
our thinking. We evaluate the results from our studies within the 
broader context of research and findings from other sources, and this 
larger body of knowledge collectively informs our

[[Page 52474]]

policies as well as our research program. Our research is documented on 
our homepage, which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. 
The website includes links to the latest Federal Register notices and 
peer-reviewed publications produced by our office. The website 
maintains information on studies we have conducted, dating back to a 
DTC survey conducted in 1999.
    The present research concerns disease awareness and prescription 
drug promotion communications on television. When pharmaceutical 
companies market a new drug, they often also release disease awareness 
communications about the medical condition the new drug is intended to 
treat (Ref. 1; Ref. 2). FDA is interested in whether and to what extent 
this practice may result in consumers confusing or otherwise 
misinterpreting the different information and claims presented in 
disease awareness communications and prescription drug promotion. Prior 
research has documented that in both print (Ref. 3) and online (Ref. 4) 
contexts, consumers tend to conflate the information presented in 
prescription drug promotional materials with information presented in 
disease awareness communications. Specifically, the results of these 
studies suggest consumers incorrectly ascribe benefits to a 
prescription drug as a result of being exposed to information in a 
disease awareness communication that broadly describes the symptoms and 
negative consequences of the disease. There are ways in which this 
effect can be attenuated. For example, prior research has indicated 
that greater visual distinctiveness between the two ad types can 
ameliorate such confusion (Ref. 3). The present research seeks to 
extend previous studies of print and online promotion to the context of 
television promotion, and broadly examine how perceptual similarity 
between the two communication types, as well as their temporal 
proximity and exposure frequency, may impact the nature and extent of 
viewer confusion.
    Fors Marsh Group (FMG) is conducting this research under the 
guidance and supervision of FDA to determine how the similarity, 
temporal positioning, and frequency of exposure to disease awareness 
communications and prescription drug television promotion impact 
consumer perception and understanding of the benefits and risks of a 
prescription drug product. These objectives will be achieved using two 
experimental studies. The first study will explore the impact on 
consumer perception and comprehension of different levels of temporal 
separation between the disease awareness communication and prescription 
drug promotion within a single period of television programming, as 
well as the level of similarity versus distinctiveness between these 
communication types. Temporal separation is defined as the spacing or 
proximity between the disease awareness communication and prescription 
drug promotion in the hour-long programming, for example, if they are 
shown back-to-back or if they are separated by other ads or television 
programming. Similarity/distinctiveness is defined by variations 
between the disease awareness communication and prescription drug 
promotion, including visual and presentation elements such as the 
setting, actors, and colors. The second study will experimentally 
examine the impact of disease awareness communication temporal 
separation and exposure frequency on consumer perception and 
comprehension. Temporal separation in this second study again refers to 
the spacing or proximity between the disease awareness communication 
and prescription drug promotion but is operationally defined as either 
one day or one week. Exposure frequency is defined as the number of 
times that participants will view the disease awareness communication, 
either one, three, or six times. The results of this latter study will 
examine the practice of ``seeding the market,'' in which pharmaceutical 
companies release disease awareness communications before releasing 
product promotion communications. Similarity versus distinctiveness 
will also be examined in this study.
    We propose the following hypotheses for this research:
    Study 1:
    H1: Increased perceptual similarity between a disease awareness 
communication and a prescription drug promotion will result in 
significantly more conflation of the information presented in both 
pieces.
    H2: Increased temporal proximity between a disease awareness 
communication and a prescription drug promotion will result in 
significantly more conflation of the information presented in both 
pieces.
    Study 2:
    H1: Increased frequency of exposure to a disease awareness 
communication before exposure to a prescription drug promotion will 
result in significantly more conflation of the information presented in 
both pieces.
    H2: Increased temporal proximity between a disease awareness 
communication and a prescription drug promotion will result in 
significantly more conflation of the information presented in both 
pieces.
    H3: Increased perceptual similarity between a disease awareness 
communication and a prescription drug promotion will result in 
significantly more conflation of the information presented in both 
pieces.
    In each instance, conflation is operationalized as the extent to 
which an individual remembers and attributes benefits to a product that 
is based on information presented in a disease awareness communication 
and not in the drug promotion.
    To address these hypotheses, Study 1 will employ a 3x4 factorial 
design in which participants are randomly assigned to one disease 
awareness communication condition, plus one control condition where 
participants will not view a disease awareness communication. The 
extent to which the disease awareness communication is perceptually 
similar to the product promotion communication will vary, as will the 
temporal separation of the disease awareness communication and product 
promotion communication. Table 1 depicts our design visually.

                                                          Table 1--Study 1 Experimental Design
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                                                                                 Disease awareness and product ad temporal separation
                                      Perceptual similarity --------------------------------------------------------------------------------------------
        Disease awareness ad              to product ad                                   Within same           In neighboring       In non-neighboring
                                                                  Back to back         commercial pod \1\      commercial pods        commercial pods
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Yes................................  Similar...............
                                     Semi-similar..........
                                     Distinct..............

[[Page 52475]]

 
No.................................  N/A...................
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                                     [GRAPHIC] [TIFF OMITTED] TN17OC18.023
                                     
    Study 2 will employ a 2x2x3 factorial design in which participants 
are randomly assigned to one disease awareness communication condition. 
The varying factors in Study 2 are the temporal separation between the 
disease awareness and product promotion communication, the number of 
exposures to the disease awareness communication, and the perceptual 
similarity of the disease awareness communication to the product 
promotion communication. Table 3 visually depicts our design. Of note, 
to reduce the overall number of experimental conditions for Study 2, no 
semi-similar experimental condition is used.
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    \1\ A commercial pod refers to a group of ads into which the 
test ad is inserted, designed to simulate an advertising break 
during a television program. As depicted in Table 2, by neighboring 
commercial pods, we mean commercial pods separated only by 
television programming and no other commercial pods. By non-
neighboring commercial pods, we mean commercial pods separated by 
both television programming and one or more (one, as studied here) 
other commercial pods.

                                      Table 3--Study 2 Experimental Design
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                                                                   Exposures to disease awareness ad
   Time delay until product ad        Perceptual     -----------------------------------------------------------
 exposure (temporal separation)    similarity of ads     One exposure       Three exposures      Six exposures
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One Day.........................  Similar...........
                                  Distinct..........
One Week........................  Similar...........
                                  Distinct..........
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                                  [GRAPHIC] [TIFF OMITTED] TN17OC18.024
                                  
    Study 1 and 2 Sample. The targeted voluntary sample for both 
studies will comprise adults who self-report a current asthma 
diagnosis, a lifetime incidence of asthma, or experience a large number 
of asthma symptoms. These groups are believed to be very likely to be 
targeted by disease awareness and product promotion

[[Page 52476]]

communications for asthma. The combined incidence rate of these groups 
is 22.2% (Ref. 5; Ref. 6). In addition, several exclusion criteria are 
specified. These include: (1) Training or employment as a healthcare 
professional, (2) employment with a pharmaceutical company, an 
advertising agency, a market research company, or the Department of 
Health and Human Services (HHS), and (3) participation in market 
research within the past three months on the topic of prescription 
drugs. Pretest participants will also be ineligible for the main study.
    Pretesting. Pretesting will take place before the main studies to 
evaluate the procedures used in the main studies. Each of the two 
pretests will have the same design as its respective main study 
(pretest 1 for Study 1 and pretest 2 for Study 2). The purpose of both 
pretests will be to: (1) Ensure that the mock stimuli are 
understandable, viewable, and delivering intended messages; (2) 
identify and eliminate any challenges to embedding the mock stimuli 
within the online survey; (3) ensure that survey questions are 
appropriate and meet the analytical goals of the research; and (4) 
pilot test the methods, including examining response rates and timing 
of survey. The two pretests will be conducted simultaneously.\2\ Based 
on pretest findings, we will refine the mock stimuli, survey questions, 
and data collection process, as necessary, to optimize the full-scale 
study conditions.
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    \2\ Pretesting will be preceded by cognitive interviewing, not 
described here. Cognitive interviews are used to probe a small 
sample of participants on how and why they responded to various 
questions as they did, resulting in strong measurement instruments.
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    Measurement. Our planned analyses are designed to address the key 
hypotheses. For both Study 1 and Study 2, we anticipate that the 
primary analysis will be analysis of variance (ANOVA) to compare the 
main and interaction effects of the experimental factors.
    The focal dependent variable will be conflation--a measure of 
memory and perceptions regarding the promoted drug relative to the 
information presented in the disease awareness communication. 
Conflation will be measured by using the number of benefits that are 
incorrectly attributed to the prescription drug product based on 
responses to a number of both open-ended and closed-ended items.
    Other key dependent variables will reflect perceptions and 
attitudes toward the product ad. These include measures of:
    1. Perception of product promotion effectiveness;
    2. Behavioral intentions toward the drug;
    3. Perceived efficacy of the drug; and
    4. Perceived risks of the drug.
    In addition to the primary variables of interest, we have also 
identified potential covariates that will be included in the analyses:
    1. Knowledge about asthma;
    2. Health literacy; and
    3. Perceived ad effectiveness.
    We expect that knowledge about asthma and increased health literacy 
may moderate any conflation that results from ad similarity, temporal 
proximity, and frequency of exposure. Perceptions of promotion 
effectiveness, on the other hand, can be examined both as an outcome/
dependent variable but also as a covariate that examines involvement 
with the product promotion. Greater involvement may attenuate 
conflation in that it directs more in-depth processing of both the 
disease awareness communication and product promotion, and therefore 
more correct understanding of the claims in each (Ref. 7; Ref. 8; Ref. 
9).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 5--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Study 1 Pretest screener........             385               1             385  0.08 (~5 min.)              31
Study 2 Pretest screener........             329               1             329  0.08 (~5 min.)              26
Study 1 screener................           3,007               1           3,007  0.08 (~5 min.)             241
Study 2 screener................           2,643               1           2,643  0.08 (~5 min.)             211
Study 1 Pretest.................             270               1             270  1.33 (~1 hr 20             360
                                                                                           min.)
Study 2 Pretest.................             158               1             158       0.53 (~32              84
                                                                                           min.)
Study 1.........................           2,105               1           2,105  1.33 (~1 hr 20           2,800
                                                                                           min.)
Study 2.........................           1,269               1           1,269  0.53 (32 min.)             673
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,426
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. https://www.fiercepharma.com/marketing/unbranded-pharma-ad-what-are-they-good-for-actually-quite-a-bit-marketer-panelists-say?mkt_tok=eyJpIjoiWkRnelpUSmlORFpoWkdNMSIsInQiOiJPaENIUERpT0tnUmt6Y1BPMk9LTnpreUI3bUtPOVRzRnh1RzNuWUtYQmp0cWJhcW05UFhlcllwTzI3V0RJSndjVkZLR3NGUHBLamJOZmJSK2FZeWtIVXczeFRFcmtEV0NFaVdCSjArUmx4dUlRVHZpUzFFOWlVY0dNb1RzOU9XayJ9&mrkid=20932234.
2. https://www.fiercepharma.com/marketing/avanir-launches-nuedexta-brand-campaign-retires-danny-glover-pba-disease-awareness-ad.
3. Aikin, K. J., Sullivan, H. W., & Betts, K. R. (2016). Disease 
information in direct-to-consumer prescription drug print ads. 
Journal of Health Communication, 21, 228-239.
4. Sullivan, H. W., O'Donoghue, A. C., Rupert, D. J., Willoughby, J. 
F., Amoozegar, J. B., & Aikin, K. J. (2016). Are disease awareness 
links on prescription drug websites misleading?

[[Page 52477]]

A randomized study. Journal of Health Communication, 21, 1198-1207.
5. Centers for Disease Control and Prevention. (2018a, May 18). 2016 
National Health Interview Survey (NHIS) data. Retrieved from https://www.cdc.gov/asthma/nhis/2016/table2-1.htm.
6. Centers for Disease Control and Prevention. (2018b, May 15). Most 
recent asthma data. Retrieved from https://www.cdc.gov/asthma/most_recent_data.htm.
7. Petty, R. E., & Cacioppo, J. T. (1979). Issue involvement can 
increase or decrease persuasion by enhancing message-relevant 
cognitive responses. Journal of Personality and Social Psychology, 
37, 1915-1926. doi: 10.1037/0022-3514.37.10.1915.
8. Petty, R. E., & Cacioppo, J. T. (1986). The elaboration 
likelihood model of persuasion. Advances in Experimental Social 
Psychology, 19, 123-205. doi: 10.1016/S0065-2601(08)60214-2.
9. Petty, R. E., Cacioppo, J. T., & Goldman, R. (1981). Personal 
involvement as a determinant of argument-based persuasion. Journal 
of Personality and Social Psychology, 41, 847-855. doi: 10.1037/
0022-3514.41.5.847.

    Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22567 Filed 10-16-18; 8:45 am]
 BILLING CODE 4164-01-P


