[Federal Register Volume 82, Number 2 (Wednesday, January 4, 2017)]
[Notices]
[Pages 855-858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31845]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4487]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Consumer and Healthcare Professional Identification of 
and Responses to Deceptive Prescription Drug Promotion

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, ``Consumer and 
Healthcare Professional Identification of and Responses to Deceptive 
Prescription Drug Promotion.''

DATES: Submit either electronic or written comments on the collection 
of information by March 6, 2017.

ADDRESSES: You may submit comments as follows:

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 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-N-4487 for ``Consumer and Healthcare Professional 
Identification of and Responses to Deceptive Prescription Drug 
Promotion.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Division of Dockets Management 
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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A12M, 11601 
Landsdown St., North Bethesda, MD 20852, [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.

Consumer and Healthcare Professional Identification of and Responses to 
Deceptive Prescription Drug Promotion--OMB Control Number 0910--NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes the FDA to

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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(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.
    Prescription drug promotion sometimes includes false or misleading 
(i.e., deceptive \1\) claims, images, or other presentations; for 
instance, representations that a drug is more effective or less risky 
than is demonstrated by appropriate evidence. A number of empirical 
studies have examined the occurrence and influence of deceptive 
promotion, both in regard to prescription drugs (Ref. 1 and 2) and 
other products (Ref. 3 and 4). No research to our knowledge, however, 
has investigated the ability of consumers and healthcare professionals 
(HCPs) to independently identify deceptive prescription drug promotion. 
The ability to identify such promotion has important public health 
implications. If unable to identify deceptive promotion, consumers may 
ask their HCPs to prescribe specific drugs that they would not 
otherwise request. Likewise, HCPs unable to identify deceptive 
promotion may prescribe specific drugs that they would not otherwise 
prescribe. In the case that consumers and HCPs are able to identify 
deceptive promotion, then they may instead be equipped to incorporate 
such information into their medication decisions, and perhaps even 
report deceptive promotion to appropriate government regulators who can 
take corrective action. The FDA Bad Ad program, for example, encourages 
HCPs to report deceptive prescription drug promotion (Ref. 5), a goal 
which requires that HCPs successfully identify such promotion when it 
appears in the course of their duties. Likewise, similar programs could 
be implemented for consumers to report deceptive prescription drug 
promotion to FDA. Reports of deceptive promotion are useful to FDA 
because they allow investigators to focus their efforts in an era where 
the amount of promotion far exceeds the resources available to monitor 
everything.
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    \1\ Our use of the term deceptive is not meant to imply 
equivalence (or lack thereof) with use of the same term by the U.S. 
Federal Trade Commission. As defined in this document, we use this 
term to refer to presentations that are considered false or 
misleading within the context of prescription drug promotion.
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    The proposed project involves two studies examining participants' 
ability to detect and report deceptive (i.e., false or misleading) 
presentations in prescription drug promotion. The studies will be 
conducted concurrently and will focus on different health conditions. 
Each study will be administered to two separate populations (i.e., HCPs 
and consumers affected by the condition). HCPs will view mock 
pharmaceutical Web sites targeted toward physicians and consumers will 
view mock consumer-targeted pharmaceutical Web sites. The goal will be 
to keep the HCP and consumer-targeted Web sites as similar as possible, 
but to include content that is appropriate for the target audience. For 
example, HCP Web sites may contain more statistical information or 
medical terminology. A professional firm will create all mock Web sites 
such that they are indistinguishable from currently available 
prescription drug Web sites.
    Study 1 and 2 Sample. Study 1 will sample consumers diagnosed with 
chronic pain that has lasted at least 3 months. Chronic pain has an 
incidence rate of roughly 11 percent (Ref. 6). Study 2 will sample 
consumers diagnosed with obesity, defined as body mass index greater 
than or equal to 30 (35 percent incidence; Ref. 7). The HCP samples for 
both studies will include physicians whose primary medical specialty is 
either primary care or internal medicine and whose responsibilities 
involve direct patient care at least 50 percent of the time. For both 
consumers and HCPs, pretest participants will not be eligible for the 
main study.
    Pretesting. Pretesting will take place before the main studies to 
evaluate the procedures and measures 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 Web sites are 
understandable, viewable, and delivering intended messages; (2) 
identify and eliminate any challenges to embedding the mock Web sites 
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. Based on 
pretest findings, we will refine the mock Web sites, survey questions, 
and data collection process, as necessary, to optimize the full-scale 
study conditions.
    Main Studies. The proposed design for the main studies, including 
sample sizes, is summarized below and described next.

                      Study 1--Degree of Deception Based on the Number of Deceptive Claims
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                                                                      Experimental condition
                                                 ---------------------------------------------------------------
                   Population                                          Fewer           More
                                                  None (control)    violations      violations         Total
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HCPs............................................             125             125             125             375
Consumers w/chronic pain........................             125             125             125             375
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                        Study 2--Type of Deception Based on Implicit and Explicit Claims
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                                                                      Experimental condition
                   Population                    ---------------------------------------------------------------
                                                  None (control)     Implicit        Explicit          Total
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HCPs............................................             125             125             125             375
Obese consumers.................................             125             125             125             375
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    The purpose of Study 1 is to assess consumer and HCP response to 
promotional Web sites with varying levels of false or misleading 
presentations. In Study 1, degree of deception will be manipulated over 
three levels by altering the number of deceptive claims (none, fewer, 
more). It is possible that consumers and HCPs are only able to identify 
ads as deceptive when they include a greater number of violations, 
whereas ads with few violations may not be identified as deceptive. The 
experimental stimuli will be in the form of a Web page for a fictitious 
drug targeted toward consumers who have chronic pain or toward HCPs. 
The deceptive Web sites will contain various types of violations. The 
Web site with fewer violations will contain a subset of the deceptive 
claims, imagery, or other presentations included in the Web site with 
more violations. For example, if the fewer-violations Web site includes 
two violations, then the more-violations Web site will include the same 
two violations plus two or three additional violations (in the form of 
claims and/or graphics).
    Study 1 will help FDA address several key questions:
     What proportion of consumers and HCPs correctly identify a 
promotional piece as deceptive? Does the ability to identify deceptive 
promotion vary depending on the number of deceptive claims in a 
promotional piece?
     Does the degree of deception affect consumers' and HCPs' 
attitudes and behavioral intentions toward the promoted drug, including 
intended reporting to regulatory authorities?
     Is the effect of deceptive promotional pieces mediated by 
a person's ability to identify a promotional piece as deceptive (that 
is, do people who recognize a piece as deceptive discount the 
information in the piece, thereby adjusting their attitudes and 
intentions toward the product)?
    Whereas Study 1 focused on the level of deception (based solely on 
the number of false or misleading claims), Study 2 focuses on the type 
of deception (implicit versus explicit). Many deceptive promotional 
claims are implicit rather than being explicitly false (Ref. 1 and 4). 
An implicit claim suggests or implies an unstated piece of information. 
An explicit claim fully and clearly expresses information and leaves 
nothing to be implied. Study 2 will compare perceptions and beliefs 
that consumers and HCPs hold about a drug following exposure to one of 
three versions of a prescription drug Web site: (1) An explicitly false 
Web site, (2) a factually true but implicitly misleading Web site, or 
(3) a Web site with no deceptive claims (the control group).
    As with Study 1, we envision a pair of one-way factorial 
experiments, one conducted with a sample of consumers and the other 
with HCPs. Similar to Study 1, Study 2 will investigate how misleading 
implicit claims and explicitly false claims in prescription drug 
promotional pieces influence a person's ability to detect and respond 
appropriately to deception. The experimental stimuli will be in the 
form of a mockup of a pharmaceutical Web site targeted toward the 
relevant experimental population, obese consumers or HCPs who treat 
obese patients. The drug profile, including indication, risks, and logo 
branding will be fictitious. For the implicit misleading claim 
manipulations, we are interested in whether people infer false beliefs 
from the implicit communications.
    Study 2 will help FDA address several key questions:
     What proportion of consumers and HCPs correctly identify a 
promotional piece as deceptive? Does the ability to identify deceptive 
promotion vary depending on whether deceptive claims in a promotional 
piece are explicit versus implicit?
     Does the type of deception affect consumers' and HCPs' 
attitudes and behavioral intentions toward the promoted drug, including 
intended reporting to regulatory authorities?
     Is the effect of deceptive promotional pieces mediated by 
a person's ability to identify a promotional piece as deceptive (that 
is, do people who recognize a piece as deceptive discount the 
information in the piece, thereby adjusting their attitudes and 
intentions toward the product)?
    Measurement. Identifying how to measure consumers' and HCPs' 
ability to identify deceptive promotion as well as their reaction to 
such promotion is fundamental to achieving the research goals. A 
literature review revealed the importance of using a variety of 
measures to capture detection of deception. For direct measures, we 
will incorporate questions that ask participants to indicate whether 
there was any deception in the promotional piece and to rate the 
promotional piece in terms of how deceptive, credible, or trustworthy 
it was. Additionally, we will include claim-specific direct measures 
that allow people to click on any part of the Web site that they deem 
deceptive. Using responses to this variable, we can assess whether 
participants think there is any deception in a promotional piece; in 
instances where they do think there is deception, we can assess what 
aspects of the Web site contributed to that belief. We will also 
include indirect measures that identify whether participants believed 
the Web site expressed particular claims (e.g., claim recognition) as 
well as participants' beliefs about the veracity of any deceptive 
claims (e.g., claim truth, agreement, or acceptance). Moreover, we will 
assess whether participants believe the messages merit reporting to 
regulatory authorities (that is, FDA). To examine differences between 
experimental conditions, we will conduct inferential statistical tests 
such as analysis of variance. A copy of the draft questionnaire is 
available upon request.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                          Number of
             Activity                     Number of respondents         responses per   Total annual      Average burden per response       Total hours
                                                                         respondent       responses
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Pilot study screener completes....  4,286 (chronic pain).............               1           5,612  0.03 (2 minutes).................             187
                                    714 (obesity)
                                    612 (HCP)
                                   -----------------------------------
                                    5,612 total
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Main study screener completes.....  10,714 (chronic pain)............               1          14,031  0.03 (2 minutes).................             468
                                    1,786 (obesity)
                                    1,531 (HCP)
                                   -----------------------------------

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                                    14,031 total
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Pilot study completes.............  150 (chronic pain)...............               1             600  0.33 (20 minutes)................             200
                                    150 (obesity)
                                    300 (HCP)
                                   -----------------------------------
                                    600 total
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Main study completes..............  375 (chronic pain)...............               1           1,500  0.33 (20 minutes)................             500
                                    375 (obesity)
                                    750 (HCP)
                                   -----------------------------------
                                    1,500 total
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................  .................................  ..............  ..............  .................................           1,355
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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 Division of Dockets 
Management (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 Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. Faerber, A.E. and D.H. Kreling. ``Content Analysis of False and 
Misleading Claims in Television Advertising for Prescription and 
Nonprescription Drugs.'' Journal of General Internal Medicine, 2014. 
29(1): 110-118.
2. Symonds, T., C. Hackford, and L. Abraham. ``A Review of FDA 
Warning Letters and Notices of Violation Issued for Patient-Reported 
Outcomes Promotional Claims Between 2006 and 2012.'' Value in 
Health, 2014. 17: 433-437.
3. Mitra, A., M.A. Raymond, and C.D. Hopkins. ``Can Consumers 
Recognize Misleading Advertising Content in a Media Rich Online 
Environment?'' Psychology & Marketing, 2008. 25(7): 655-674.
4. Hastak, M., and M.B. Mazis. ``Deception by Implication: A 
Typology of Truthful but Misleading Advertising and Labeling 
Claims.'' Journal of Public Policy & Marketing, 2011. 30(2): 157-
167.
5. O'Donoghue, A.C., V. Boudewyns, K.J. Aikin, E. Geisen, et al. 
``Awareness of the FDA's Bad Ad Program and Education Regarding 
Pharmaceutical Advertising: A National Survey of Prescribers in 
Ambulatory Care Settings.'' Journal of Health Communication, 2015. 
20: 1330-1336.
6. Nahin, R.L. ``Estimates of Pain Prevalence and Severity in 
Adults: United States, 2012.'' Journal of Pain, 2015. 16(8): 769-
780.
7. U.S. Department of Health and Human Services, Centers for Disease 
Control and Prevention, National Center for Health Statistics 
(2015). ``Healthy Weight, Overweight, and Obesity Among Adults Aged 
20 and Over, By Selected Characteristics: United States, Selected 
Years 1988-1994 hrough 2009-2012 [Table].'' In Health, United 
States, 2014 with special feature on adults aged 55-64 (pp. 214-220; 
DHHS Publication No. 2015-1232). Retrieved from http://www.cdc.gov/nchs/data/hus/hus14.pdf.

    Dated: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31845 Filed 1-3-17; 8:45 am]
BILLING CODE 4164-01-P