Agency Information Collection Activities; Proposed Collection; Comment Request; Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion, 855-858 [2016-31845]
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manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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.
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:
SUMMARY:
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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
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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: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
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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,
PRAStaff@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.
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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Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices
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.
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 consumertargeted 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
Experimental condition
Population
None
(control)
HCPs ................................................................................................................
Consumers w/chronic pain ..............................................................................
Fewer
violations
125
125
More
violations
125
125
Total
125
125
375
375
STUDY 2—TYPE OF DECEPTION BASED ON IMPLICIT AND EXPLICIT CLAIMS
Experimental condition
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Population
None
(control)
HCPs ................................................................................................................
Obese consumers ............................................................................................
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.
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125
125
As defined in this document, we use this term to
refer to presentations that are considered false or
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Implicit
Explicit
125
125
Total
125
125
375
375
misleading within the context of prescription drug
promotion.
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Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices
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?
857
• 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
Number of respondents
Pilot study screener completes ...............
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Activity
Number of
responses per
respondent
4,286 (chronic pain) .....
714 (obesity)
612 (HCP)
Total annual
responses
Average
burden per
response
Total hours
1
5,612
0.03 (2 minutes) ..........
187
1
14,031
0.03 (2 minutes) ..........
468
5,612 total
Main study screener completes ..............
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10,714 (chronic pain) ...
1,786 (obesity)
1,531 (HCP)
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Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
Number of respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
14,031 total
Pilot study completes ..............................
150 (chronic pain) ........
150 (obesity)
300 (HCP)
1
600
0.33 (20 minutes) ........
200
1
1,500
0.33 (20 minutes) ........
500
........................
........................
......................................
1,355
600 total
Main study completes .............................
375 (chronic pain) ........
375 (obesity)
750 (HCP)
1,500 total
Total .................................................
1 There
......................................
are no capital costs or operating and maintenance costs associated with this collection of information.
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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
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16:46 Jan 03, 2017
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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 https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Biochemistry and Biophysics
of Membranes Study Section.
PO 00000
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Date: January 31, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Nuria E. Assa-Munt, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4164,
MSC 7806, Bethesda, MD 20892, (301) 451–
1323, assamunu@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Synthetic and Biological
Chemistry A Study Section.
Date: January 31–February 1, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel, 1700 Tysons
Boulevard, McLean, VA 22102.
Contact Person: Anita Szajek, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4187,
Bethesda, MD 20892, 301–827–6276,
anita.szajek@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–14–
264 Global Omics Approaches Targeting
Adverse Pregnancy and Neonatal Outcomes
Utilizing Existing Cohorts.
Date: January 31, 2017.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Lisa Steele, Ph.D.,
Scientific Review Officer, PSE IRG, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, 301–594–
6594, steeleln@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
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Agencies
[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]
[[Page 855]]
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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.
-----------------------------------------------------------------------
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
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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, PRAStaff@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.
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
[[Page 856]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Experimental condition
---------------------------------------------------------------
Population Fewer More
None (control) violations violations Total
----------------------------------------------------------------------------------------------------------------
HCPs............................................ 125 125 125 375
Consumers w/chronic pain........................ 125 125 125 375
----------------------------------------------------------------------------------------------------------------
Study 2--Type of Deception Based on Implicit and Explicit Claims
----------------------------------------------------------------------------------------------------------------
Experimental condition
Population ---------------------------------------------------------------
None (control) Implicit Explicit Total
----------------------------------------------------------------------------------------------------------------
HCPs............................................ 125 125 125 375
Obese consumers................................. 125 125 125 375
----------------------------------------------------------------------------------------------------------------
[[Page 857]]
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of respondents responses per Total annual Average burden per response Total hours
respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot study screener completes.... 4,286 (chronic pain)............. 1 5,612 0.03 (2 minutes)................. 187
714 (obesity)
612 (HCP)
-----------------------------------
5,612 total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Main study screener completes..... 10,714 (chronic pain)............ 1 14,031 0.03 (2 minutes)................. 468
1,786 (obesity)
1,531 (HCP)
-----------------------------------
[[Page 858]]
14,031 total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot study completes............. 150 (chronic pain)............... 1 600 0.33 (20 minutes)................ 200
150 (obesity)
300 (HCP)
-----------------------------------
600 total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Main study completes.............. 375 (chronic pain)............... 1 1,500 0.33 (20 minutes)................ 500
375 (obesity)
750 (HCP)
-----------------------------------
1,500 total
---------------------------------------------------------------------------------------------------------------------
Total......................... ................................. .............. .............. ................................. 1,355
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 https://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