Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion, 58411-58421 [2017-26704]
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SUPPLEMENTARY INFORMATION:
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I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Refusal of Inspection by a Foreign
Food Establishment or Foreign
Government.’’ We are issuing the draft
guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of the FDA on this topic. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternate
approach if it satisfies the requirements
of the applicable statutes and
regulations. The guidance is not subject
to Executive Order 12866.
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353), enacted
on January 4, 2011, amended the FD&C
Act to expand and enhance our ability
to ensure that imported food products
meet U.S. standards and are safe for
consumers. Among the FSMA changes
to the FD&C Act, we now must refuse
admission of a food into the United
States if it is from a foreign factory,
warehouse, or other establishment of
which the owner, operator, or agent in
charge, or the government of the foreign
country, refuses to permit entry of
United States inspectors or other
individuals duly designated by the
Secretary of Health and Human
Services, upon request, to inspect such
factory, warehouse, or other
establishment (section 807(b) of the
FD&C Act (21 U.S.C. 384c(b))). In
addition, the FD&C Act, at section
807(b), states that an owner, operator, or
agent in charge is considered to have
refused an inspection if the owner,
operator, or agent in charge does not
permit an inspection of a factory,
warehouse, or other establishment
during the 24-hour period after we
submit an inspection request, or after
such other time period, as agreed upon
by FDA and the foreign factory,
warehouse, or other establishment.
This draft guidance, when finalized,
will provide information for foreign
food establishments subject to our
inspection, as well as foreign
governments, on when we may consider
that a foreign food establishment or a
government of a foreign country has
refused to permit an inspection by us as
provided in section 807(b) of the FD&C
Act.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA website listed in the previous
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sentence to find the most current
version of the guidance.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26692 Filed 12–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–4487]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
SUMMARY:
Fax written comments on the
collection of information by January 11,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—New and
title ‘‘Consumer and Healthcare
Professional Identification of and
Responses to Deceptive Prescription
Drug Promotion.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
DATES:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Consumer and Healthcare Professional
Identification of and Responses to
Deceptive Prescription Drug Promotion
OMB Control Number 0910—NEW
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I. Background
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act. Under the
FD&C Act and implementing
regulations, promotional labeling and
advertising about prescription drugs are
generally required to be truthful, nonmisleading, and to reveal facts material
to the presentations made about the
product being promoted (see FD&C Act
sections 201(n) and 502(a) and (n) (21
U.S.C. 321(n) and 352(a) and (n)); see
also 21 CFR 202.1).
Prescription drug promotion
sometimes includes false or misleading
(collectively, 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 (Refs. 1 and 2) and
other products (Refs. 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 of consumers and HCPs to
identify deceptive prescription drug
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 who are unable
to identify deceptive promotion may
prescribe specific drugs that they would
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 used in this document, this term refers to
presentations that are considered false or
misleading within the context of prescription drug
promotion.
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not otherwise prescribe. On the other
hand, if consumers and HCPs are able
to identify deceptive promotion, they
may appropriately discount or disregard
such information in their medication
decisions, and perhaps even report
deceptive promotion to appropriate
government regulators who can take
corrective action.
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
review everything. 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.
The mission of the Office of
Prescription Drug Promotion (OPDP)
within FDA is to protect the public
health by helping to ensure that
prescription drug promotion is truthful,
balanced, and accurately
communicated, and to guard against
deceptive promotion through
comprehensive surveillance,
enforcement, and educational programs.
As part of this mission, it is critical that
OPDP adequately understand the
capacity of consumers and HCPs to
detect false and misleading claims as
well as these populations’ processing of
such claims. This understanding will
help OPDP to identify best practices for
addressing false and misleading claims
in prescription drug promotion. The
research described here will provide
evidence to inform consideration of the
approaches best suited to fulfill OPDP’s
mission to protect the public from
deceptive promotion.
The proposed project involves two
studies examining volunteer
participants’ ability to detect and report
deceptive 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
websites targeted toward physicians and
consumers will view mock consumer-
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targeted pharmaceutical websites. The
goal will be to keep the HCP and
consumer-targeted websites as similar as
possible, but to include content that is
appropriate for the target audience. For
example, HCP websites may contain
medical terminology, whereas the
consumer websites would utilize
consumer friendly language. A
professional firm will create all mock
websites such that they are generally
indistinguishable from currently
available prescription drug websites.
II. Study 1 and 2
Study 1 and 2 sample. Study 1 will
sample consumers who self-report
chronic pain that has lasted at least 3
months and HCPs 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.
Chronic pain has an incidence rate of
roughly 11 percent (Ref. 6) in the
population. Study 2 will sample
consumers who self-report obesity,
defined as body mass index greater than
or equal to 30 (35 percent incidence;
Ref. 7) and include the same types of
HCPs as study 1. 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 websites are
understandable, viewable, and
delivering intended messages; (2)
identify and eliminate any challenges to
embedding the mock websites 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
websites, 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.
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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
Population
None
(control)
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HCPs ................................................................................................................
Obese consumers ............................................................................................
The purpose of Study 1 is to assess
consumer and HCP response to
promotional websites 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 websites
will contain various types of violations.
The website with fewer violations will
contain a subset of the deceptive claims,
imagery, or other presentations included
in the website with more violations. For
example, if the fewer-violations website
includes two violations, then the moreviolations website 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
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125
125
attitudes and intentions toward the
product)?
Whereas Study 1 focuses 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 (Refs. 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 website:
(1) An explicitly false website, (2) a
factually true but implicitly misleading
website, or (3) a website 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
website targeted toward the relevant
experimental population, obese
consumers or HCPs who treat obese
patients. As with study 1, 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
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Implicit
Explicit
125
125
Total
125
125
375
375
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 website 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
website contributed to that belief. We
will also include indirect measures that
identify whether participants believed
the website expressed particular claims
(e.g., claim recognition) as well as
participants’ beliefs about the veracity
of any deceptive claims (e.g., claim
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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.
In the Federal Register of January 4,
2017 (82 FR 855), FDA published a 60day notice requesting public comment
on the proposed collection of
information. Comments received along
with our responses to the comments are
provided below. Comments that are not
PRA-relevant or do not relate to the
proposed study are not included. For
brevity, some public comments are
paraphrased and therefore may not
reflect the exact language used by the
commenter. We assure commenters that
the entirety of their comments was
considered even if not fully captured by
our paraphrasing. Question numbering
here (e.g., Q30) reflects numbering from
the original draft questionnaire, shared
by request at the time of the 60-day
notice. The following acronyms are used
here: FRN = Federal Register Notice;
DTC = direct-to-consumer; HCP =
healthcare professional; FDA and ‘‘The
Agency’’ = Food and Drug
Administration; OPDP = FDA’s Office of
Prescription Drug Promotion.
(Comment 1) regulations.gov tracking
number 1k1–8ubr–t0de (verbatim with
header and footer language removed):
We are supportive of the study, but
have the following recommendations.
We propose that additional study
arms be included that explore various
scenarios/websites which test both the
number of deceptive claims in
conjunction with the degree of
deception. Currently, the study is
structured to measure the impact of the
number of deceptions in a promotional
website (Study 1) separately from the
degree of the deception (explicit vs
implicit, in Study 2). However, it would
also be beneficial to measure other
combinations to see which factor or
combination of factors had the greatest
impact on HCPs and Consumers’ overall
perception of the website. For example,
a single explicit lie may be more
impactful than 15 implied deceptions.
The current study will not be able to
draw any conclusions regarding that
scenario. Testing additional
combinations of the number of
deceptions in a website along with
deceptive claims of varying severity
would enable a better comparison and
understanding of what ultimately drives
HCPs and Consumers’ perception of
deceptive prescription promotion.
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(Response) We thank the commenter
for their support and for this suggestion.
While certainly a viable research idea,
cost implications of creating and testing
additional stimuli for this purpose bar
us from pursuing it. We encourage
researchers to pursue this idea in future
research.
(Comment 2) regulations.gov tracking
number 1k1–8v15–11b6 (some
comments summarized for brevity;
others provided verbatim):
a. Given the stated purpose of the
pretests, sample size can be
substantially reduced, and revised to a
qualitative approach.
(Response) In addition to the
quantitative pretest, we have already
conducted a qualitative test of stimuli
and questionnaire materials via
cognitive interviews. Changes based on
cognitive interviews are reflected in our
updated survey materials. In regard to
sample size, the number of pretest
participants per experimental condition
(n = 50) was chosen based on a power
analysis, and is considered to be the
minimum effective size to allow for
assessment of the quantitative outcomes
specified in the 60-day FRN. Examples
of quantitative outcomes include
assessment of response rates and timing
of the survey.
b. To reduce bias, add a screening
question to exclude respondents who
are opposed to taking prescription
medicines.
(Response) The survey length does
not allow for a full exploration of
attitudes toward prescription drug use.
However, to assess opposition to
prescription drug use more generally,
we added one item to the survey that
has been used successfully in previous
FDA surveys. This item will be used in
the pretest survey as a potential
covariate and may or may not be
retained in the main study survey
depending on its performance.
The item reads: ‘‘In what situations
would you consider taking prescription
drugs?’’
• I would never take them.
• I would take them only for serious
health conditions.
• I would take them for moderate and
serious health conditions.
• I would take them for most health
conditions, including minor problems.
c. Consider revising item scales to
include a mid-point to allow
respondents to express neutral views
(unless objective is to force a selection).
(Response) Given the focus of the
questions, we believe that offering a
neutral response option is not necessary
to measure opinions and attitudes
accurately. Consequently, our objective
is to force a selection and have
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participants make at least a weak
commitment in either a positive or
negative direction. Of concern is that
offering a neutral midpoint could
potentially encourage ‘‘satisficing’’—
cuing participants to choose a neutral
response because it is offered (Ref. 8).
Additionally, providing a midpoint
leads to the loss of information
regarding the direction in which people
lean (Ref. 9). Research has found that
neither format (either with or without a
neutral point) is necessarily better or
produces more valid or reliable results
(Ref. 10). Instead, it should be left to the
researcher to determine the goals of the
study. During cognitive testing, a
majority of participants were satisfied
with the response options and all
participants felt comfortable choosing a
response in the absence of a midpoint.
Use of a midpoint is an issue we have
examined in previous studies and we
determined that we achieve valid and
reliable responses without a midpoint.
To increase consistency with measures
used in previous studies, and in support
of the arguments presented above, we
are opting to exclude a midpoint.
Finally, if a participant does not feel
that they can choose a response because
of a lack of a neutral option, they will
be able to skip the question.
d. In Study 1, remove Q21 and Q30
due to potentially leading nature of
items.
(Response) To avoid redundancy, we
dropped Q21. In Q30, we ask
participants to click on anything they
think is misleading, and we note that if
they do not think anything is
misleading, they can click ‘‘none.’’
Consequently, we are not strongly
presupposing there are misleading
claims. To address some of the wording
concerns for this item, we changed the
question to ask about inaccurate
information instead of misleading
information and we moved the ‘‘None’’
response to be more prominent above
the image.
(Comment 3) regulations.gov tracking
number 1k1–8v3z–nzst (summarized for
brevity):
The commenter expresses concern
about the practical utility of the
research, reasons for which are covered
by comments 3a through 3e. In the case
that FDA continues with the research,
the commenter makes several
recommendations which are covered by
comments 3f through 3cc. Comments 3f
through 3h concern the study stimuli,
comment 3i pertains to subject
recruitment, and comments 3j through
3cc concern the study questionnaires.
a. The identification of deceptive
promotion is FDA’s assigned
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responsibility, not the duty of HCPs and
consumers.
(Response) As discussed above, the
mission of OPDP within FDA is to
protect the public health by helping to
ensure that prescription drug promotion
is truthful, balanced, and accurately
communicated, and to guard against
false and misleading promotion through
comprehensive surveillance,
enforcement, and educational programs.
As part of this mission, it is critical that
OPDP adequately understand the
capacity of consumers and HCPs to
detect false and misleading claims as
well as these populations’ processing of
such claims. This understanding will
help FDA/OPDP to identify best
practices for addressing deceptive
claims in prescription drug promotion.
Moreover, we note that sponsors are not
generally required to submit
promotional pieces to FDA prior to
dissemination, and limited resources
prevent OPDP from reviewing all
promotional materials in the
marketplace. Voluntary HCP and
consumer reporting of false and
misleading promotional pieces
contribute to the accomplishment of
FDA/OPDP’s mission.
b. Deceptive drug promotion is not a
prevalent issue that requires further
studying.
(Response) Numerous studies have
examined the prevalence of false or
misleading claims and presentations in
DTC advertising, and FDA frequently
issues compliance letters addressing
false and misleading claims and
presentations (Refs. 1 and 2).
Consequently, FDA disagrees with this
assertion.
c. FDA’s proposed studies fail to
acknowledge the role of the HCP as the
‘‘learned intermediary.’’
(Response) The present research takes
into consideration both consumer and
HCP responses to false or misleading
promotion. Consumers often wish to
participate in shared decision making
with HCPs when selecting prescription
drugs and may request specific
prescription drugs from their HCPs
based on promotions they have seen in
the marketplace. Because information
consumers receive through DTC
prescription drug promotion can impact
these requests, it is important to
investigate consumers’ ability to assess
prescription drug product efficacy and
risks as conveyed in promotional pieces.
And although HCPs have medical
training and clinical expertise, we are
not aware of research that investigates
whether such training and expertise
translates into an ability to detect false
or misleading promotion in the
marketplace. Consequently, the present
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research investigates both consumer and
HCP ability to identify and discount
deceptive prescription drug promotion.
d. The proposed studies are
duplicative of recent FDA research
concerning HCP willingness to report
deceptive promotion.
The commenter suggests that if FDA
wishes to investigate consumer
reporting, the Agency should create two
separate studies. The first should gauge
consumer aptitude in identifying false
or misleading prescription drug
promotion. Depending on the results of
the first study, the Agency could
potentially undertake a second study,
surveying subject willingness to report
false or misleading drug promotion.
This approach would avoid potential
error associated with influence of earlier
questions regarding deception on later
questions regarding reporting.
(Response) FDA conducted a survey
of HCPs in 2013 in which respondents
were asked about their familiarity with
the Bad Ad program and willingness to
report misleading advertising (Ref. 5).
The current study is quite different in
scope from the previous research. The
current study consists of an
experimental design that will enable us
to determine whether HCPs can detect
misleading advertising, not just whether
they are willing to report it. We do
include questions at the end of the
survey asking similar questions as those
in the 2013 survey, but the purpose here
is in connection to HCP ability to detect
misleading advertising. Moreover, our
use of similar questions here reflects a
well-established technique in scientific
research, used to determine whether
previous findings can be replicated or
not.
In response to the second comment
recommending division of this project
into two separate studies, we believe
that proposal to be an inefficient use of
resources. Regarding concerns about the
order of questions affecting subsequent
responses, we chose to distribute
deception-related items throughout the
survey, rather than ask all deception
items first and then other outcome
measures second. Also, we include
‘‘masking’’ items on the same screen as
deception-related items to mask the
intent of the questions. The results from
cognitive interviews confirm that this
approach was successful. Consequently,
we have no evidence to suggest that
earlier questions related to deception
will influence subsequent questions
related to reporting.
e. FDA already has created and
implemented consumer programs to
report deceptive promotion.
(Response) The proposed research can
inform program needs at present,
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whether such needs involve
reevaluation of past programs such as
EthicAd, or extensions of existing
programs such as the Bad Ad program
or other actions.
f. Validating Stimuli. It is not clear
how the Agency will determine that a
study stimulus is deceptive. FDA notes
in the PRA Notice that 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.’’ It seems unrealistic for
FDA to conduct research with primary
care physicians (PCPs) and consumers
who do not understand the Agency’s
standards or have access to the training
and resources of an FDA reviewer.
Further, except for literal falsity,
whether a particular communication is
false or misleading must be based on
empirical evidence. Promotional pieces
do not exist in a vacuum. These
communications interact with the
overall health information ecosystem,
including the internet. FDA needs to
first validate that the study stimuli are
indeed deceptive before including the
stimuli in either proposed study with
the presumption that they are deceptive.
(Response) Our reference to the
Federal Trade Commission’s (FTC)
definition of the term ‘‘deceptive’’ was
offered as a point of clarification for our
use of the same term as shorthand
within the FRN for the longer phrase
‘‘false or misleading.’’ In other words,
by using ‘‘deceptive’’ as a term of art in
this narrow context, we are not evoking
the specific meaning and interpretation
of the same term used by the FTC.
We disagree with the suggestion that
participants need to have access to the
training and resources of an FDA
reviewer before FDA can evaluate their
ability to identify deceptive promotion.
As further explained below, FDA is not
asking participants to determine
whether nuanced text meets the
regulatory standards for deceptive
promotion; instead, we are presenting
material that meets both the regulatory
standard for a deceptive promotion and
could be identified as such by
consumers or healthcare providers with
no prior experience with the
regulations.
We agree with the second point about
the need to validate that the study
stimuli are deceptive, and we are doing
this in several ways for this study. For
example, some of the specific claims
used in our experimental manipulations
are established as being factually
incorrect because the promoted drug is
a member of a class of drugs for which
the claim could not be true (e.g.,
describing a serotonin-norepinephrine
reuptake inhibitor (SNRI), which is
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required to have a black box safety
warning for suicide risk, as lacking in
significant safety concerns). Other
claims or presentations in the stimuli
are based on similar claims cited as
violative in past warning letters or that
unambiguously fail to follow the law
(e.g., minimizing presentation of
important safety information, such as a
black box warning, by setting it in small,
low contrast type). For one manipulated
claim, we provided participants with
access to the background information
needed to identify the presentation as
deceptive in the form of a footnote. In
the case of Study 2, where a crucial
aspect of the experimental design is to
test an implicitly misleading claim in
relation to an explicitly false claim and
against a nonviolative control, we tested
candidate claims in cognitive interviews
to verify that the audience tended to
interpret the implicit claims as
intended.
Further, it is important to note that we
included a control condition in both
studies, which will enable us to
compare responses to a website that has
no violations. The control conditions
serve as a baseline for perceived
deception, which will also allow us to
examine how consumers and providers
perceive websites with no violations.
g. Media. The Agency proposes using
websites as the only stimuli. FDA
should consider testing additional nonelectronic media, including DTC and
HCP print promotional materials. The
Agency should also base the
promotional stimuli on realistic ‘‘mock’’
package insert (PI) documents. The
commenter requests that FDA make
available for public comment these
materials.
(Response) Previous research on DTC
and HCP-directed prescription drug
promotional materials has, to varying
extents, included all available media
formats, and assessment of outcomes
using these formats has proven useful.
We agree that investigating recognition
of misleading prescription drug
information in multiple formats—
including print, television, web, and
other modes—would be valuable.
However, we also recognize that no
single study can effectively examine all
promotional formats or presentations,
and we chose to focus on branded drug
websites for several reasons. First,
websites, while not necessarily more or
less useful than any other format, are
arguably quite prevalent and important
in today’s technological age where a
large segment of the consumer
population is connected to the internet
and known to seek information
regarding prescription drugs using the
internet. For example, online promotion
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is the fastest growing category of DTC
drug marketing, and branded websites
account for the largest share of this
category (Ref. 11). Second, almost all
print and television ads for prescription
drugs encourage viewers to visit
branded websites for more information,
making these sites an important
extension of promotion in other formats
(Ref. 12). Third, FDA has issued
multiple warning and notice of violation
letters for branded drug websites that
incorrectly communicate information to
visitors, suggesting that there may be a
problem with a proportion of such sites
presenting misleading information.
Fourth, websites serve as a fairly newer
format for promotion relative to
television and print promotion, and by
consequence warrant further study.
There has been significantly less
research on consumer and provider
interpretation of branded drug websites
than other promotional formats (Ref.
13), and the extant research suggests
that some websites still do not present
a fair balance of risk and benefit
information (Ref. 14).
Based on these considerations, we
believe that focusing this study on
branded drug websites will be the most
effective use of FDA’s limited resources.
The fictitious websites included in this
study were modeled on real products
(including the package insert) to ensure
realism and relevance.
In response to the request to share
stimuli, we generally do not share
stimuli before the study has been
conducted to avoid possible inadvertent
publication and therefore contamination
of the subject pool, which would
compromise the research.
h. Disease States. The Agency’s two
studies propose testing stimuli
concerning chronic pain or obesity. The
commenter suggests that FDA instead
consider testing stimuli featuring a
fictitious product for a disease state
which involves more complex safety
information. Such stimuli would be
more reflective of the current healthcare
environment, where product labeling is
increasingly complex.
(Response) The fictitious websites
used in this research do include
complex safety information, which
reflect the risks for real chronic pain
and obesity products in the
marketplace. For example, one of the
fictitious products includes a black box
warning, and the other includes severe
and complex safety information, such as
potential drug interactions and
contraindications.
i. Study 1 Stimuli. In Study 1, the
‘‘degree of deception will be
manipulated over three levels by
altering the number of deceptive claims
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(none, fewer, more).’’ FDA states that
the deceptive claims will include
‘‘various types of violations.’’ Under the
potential design, the most egregious
deceptive claim(s) might only be
contained in the ‘‘more’’ level. This
could potentially skew study results, as
subjects would be more likely to
identify such egregious claims. FDA
should develop a scale that is used to
determine the egregiousness of the
deception. The scale should include
specific examples of egregiousness by
category.
(Response) Although some claims do
not overlap between the ‘‘fewer
violations’’ and ‘‘more violations’’
conditions, we strategically
manipulated the stimuli so that one of
the more ‘‘egregiously’’ deceptive claims
(which appears in a callout bubble) is
present in both conditions. There is also
overlap in those two conditions for
another manipulated element, where we
minimized the prominence of the
Important Safety Information.
Additionally, we included an item
(Q30) that would provide participants
the opportunity to click on anything
they think may be inaccurate. Using this
question, we would expect that the
more egregious claims will be chosen
more often. In this way, this item would
serve as a proxy measure of
egregiousness. Further, our various
questions that ask about perceived
deceptiveness of the websites will
provide an initial assessment of the
degree of deception—with higher scores
representing greater perceived
deception. Because of space constraints
on the survey, we are unable to ask
participants to rate the egregiousness of
the violative claims. Although we
appreciate the value that developing a
scale to determine the egregiousness of
each of the deceptive claims would add,
adopting this suggestion in the present
research would be outside of the scope
of this study and would have an impact
on overall cost considerations.
j. FDA proposes that the HCP samples
for both studies will only include
physician subjects. The commenter
believes the samples should include
other types of HCPs, including nurse
practitioners, physician assistants, and
pharmacists. As the Agency’s recent
research showed, ‘‘Nurse practitioners
and physician assistants tended to see
the [Bad Ad] program as more useful
than [PCPs] and specialists. They also
reported a greater likelihood of
reporting false or misleading advertising
in the future.’’ Given these findings, it
would be helpful also to investigate the
ability of other HCPs independently to
identify false or misleading promotion.
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Additionally, during the recruiting
process, FDA should ensure enrollment
of a diversity of subjects across
demographic categories. Previous
research indicates that certain
demographic groups respond to drug
promotion in different manners. Uneven
representation within certain categories
could potentially skew study results.
(Response) FDA acknowledges and
agrees with the assertion that including
other types of HCPs in this research
would provide value. Yet, sampling
from these additional groups requires
funding that may not be justified in this
initial investigation of the topic area.
Nonetheless, we do intend to strive for
diversity in both our HCP and consumer
samples. HCPs and consumers will vary
in terms of age, race, and ethnicity, and
consumers will additionally vary in
terms of their education level.
k. Leading Questions. The overall
format of the questionnaires is quite
leading. As previously mentioned,
questions asking whether sample
advertisements are ‘‘deceptive,’’
‘‘misleading,’’ ‘‘bad,’’ and ‘‘not
believable’’ could easily pollute data
from later questions inquiring whether a
subject would potentially report such
promotion to FDA. The Agency should
state all questions in an objective
manner.
(Response) Leading questions are
those that ‘‘suggest a possible answer or
make some responses seem more
acceptable than others’’ (Ref. 15). In
keeping with standard practice for
balancing the valence of attitudinal
questions, we have included a mix of
positive and negative statements in the
questionnaire. In fact, there are
presently more positively framed items
than negatively framed items. Moreover,
the slider questions referenced by the
commenter are semantic differentials,
which show both a negatively framed
word and its positive counterpart on
opposite ends of the response scale (e.g.,
‘‘deceptive/truthful,’’ ‘‘misleading/
accurate,’’ ‘‘not believable/believable’’).
We do not see how these items could be
construed as leading because both the
positive and negative frames are
presented. Finally, as stated in our
response to Comment 3d, we have
evidence to suggest that we successfully
masked the true focus of the
questionnaire, so the deception-focused
items should not bias subsequent
responses.
l. Recall Questions. Certain questions
(e.g., Q1–Q3 of Study 1, Q4 of Study 2)
ask test subjects to recall specific risks
and side effects of the featured drug
products. Such questions are not valid
instruments to assess whether a subject
perceives a stimulus to be false or
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misleading. Recall is likely influenced
by the presentation of the content (e.g.,
size, visual display), not by the content
itself. This research, however, is not
material to the stated purpose of the
studies. The recall questions should be
omitted from the questionnaires.
(Response) Q1–Q2 of Study 1 measure
risk recall and risk recognition. These
are important outcome measures for our
study because we vary how the risks are
presented in the different experimental
conditions, minimizing them (in terms
of size and format) in the violative
conditions. Including these risk recall
and recognition measures allow us to
test whether minimizing the risks
influences participants’ ability to
remember them. Further, because
minimization of risk is a misleading
violation in its own right, reduced risk
recall or recognition among participants
in the violative conditions would
provide relevant context for interpreting
more direct measures of deception. Q4
of Study 2 will enable us to determine
if participants can recall seeing the
disclosure statements in the websites.
This is relevant to the question of
whether participants identify false or
misleading content because the
disclosure statement provides
information that would help
participants assess the truth of the
headline claim. None of these items are
intended to be direct measures of
whether the stimuli are misleading;
instead, they are outcomes that may be
affected by misleading content.
m. Repetitive Questions. The
questionnaires are repetitive in nature.
For example, in Q4–Q11 of Study 1,
subjects are asked a series of eight
questions to measure ‘‘Perceived
Website Deception.’’ The questions are
redundant (e.g., Believable/Not
believable, Truthful/Deceptive, Factual/
Distorted, Accurate/Misleading). This
duplication may cause the subject to
believe the promotional material is
actually false or misleading.
(Response) The use of multiple items
to tap into a singular construct is
considered a best practice in social
science research, particularly when
assessing complex psychological
constructs like those in this survey. Our
intent is to combine responses to these
items into a single composite score. Our
cognitive interviewing of these items
suggests that they have slightly different
meanings for many participants and
thus are not viewed as completely
redundant. Further, there is no evidence
to suggest that the use of multiple items
to assess this construct led participants
to believe that the promotional material
was actually false or misleading or that
this series of questions was designed to
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capture whether they thought the
website was misleading. Consequently,
we successfully masked the true intent
of this item by including other bipolar
response options unrelated to
misleadingness.
We dropped Q21 to reduce
redundancy across items.
n. Definitions and Terms. The
questionnaires do not define certain key
terms (e.g., effectiveness, risk,
misleading). Subjects, especially
consumers, may interpret these terms
based on different standards. FDA might
consider providing user-friendly
definitions for the consumer subjects.
The Agency should also utilize patientfriendly medical terms, rather than
complex terminology (e.g., glaucoma,
hepatic failure, SNRI).
(Response) Sophisticated medical
terminology will only be used in the
HCP survey. To use the example of
‘‘hepatic failure,’’ consumers will
instead see ‘‘decreased liver function.’’
We have verified in cognitive interviews
that preceded this study (and in our
previous scale development efforts) that
the terminology used is generally well
understood by our participant sample.
o. Sliding Scale Format. FDA should
consider replacing the sliding scale
format with a ‘‘Yes-No-I Don’t Know’’
scheme. The sliding-scale format is at
times confusing in form and could
potentially introduce error.
Alternatively, the Agency should
consider changing the sliding scale to an
odd number system to permit a
‘‘neutral’’ response and/or use a
variation of the Likert scale.
(Response) Use of a sliding scale
allows for greater precision and
variation in response, as opposed to a
‘‘Yes-No-Don’t Know’’ format. Research
suggests that scales with five to seven
points are more valid and reliable than
those with only two to three categories
(Ref. 16). Additionally, we tested the
sliding-scale format in previous
cognitive interviews and found that it
worked well; participants had little
difficulty understanding this format.
Further, as noted in the response to
Comment 2c, we want to avoid leading
participants to choose a ‘‘Don’t know’’
response; providing this option may cue
participants to select this response and
avoid deeper thinking on the topic.
Regarding the use of an even numbered
scale rather than odd numbered scale,
please see our response to Comment 2c.
p. An ‘‘FDA employee’’ category
should be added to Question S2
[Consumer] of Study 1. These
individuals should also be terminated
from the study.
(Response) Consistent with previous
surveys, we added a category to exclude
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employees of the Department of Health
and Human Services, which includes
employees of FDA.
q. Question S3 [Consumer] of Study 1
should be rewritten as follows: ‘‘Have
you ever been diagnosed with chronic or
long-lasting pain (more than aches and
pains that go away quickly or are
minor)?’’ (emphasis added). This change
aligns the question with the description
of the study in the PRA Notice: ‘‘Study
1 will sample consumers with
diagnosed chronic pain that has lasted
at least 3 months.’’
(Response) We did not restrict people
to be diagnosed with chronic pain
because the prevalence was too small,
which would increase the costs of the
study. Using our current screening
questions, we achieve an 11 percent
prevalence rate (Ref. 6). The objective of
our sampling plan is to target people
that would be in the audience for the
ads; being diagnosed is not a criterion.
r. Question S5 [Consumer] of Study 1
should be eliminated. Whether a subject
still has chronic pain has no bearing on
the study’s purpose. Also, consider
eliminating Question Q12 of Study 1.
This question would only apply to those
consumers currently being treated for
chronic pain, not those who previously
had the condition.
(Response) Assessing whether
participants currently experience
chronic pain helps to ensure a
motivated sample for which the
fictitious medication would potentially
be of interest. Originally, we included
participants that reported suffering from
chronic pain in the past, but we did not
require that they are currently suffering
from chronic pain (although we had an
item that asked ‘‘Do you still have this
chronic or long-lasting pain?’’). After
further consideration, we opted to revise
the screener so that participants remain
eligible if (a) they say ‘‘Yes’’ I still have
chronic pain, or (b) they say ‘‘No’’ (or
remain silent) about still having chronic
pain and they are currently taking a
prescription drug for chronic pain. This
would also make the inclusion criteria
for Study 1 consistent with the
inclusion criteria for Study 2, which
requires that a person currently suffers
from the medical condition of interest.
Consequently, Q12 of Study 1 will be
relevant for all consumers completing
the questionnaire.
s. Consider revising Question S5
[PCP] of Study 1 to inquire: (1) What
percentage of the PCP’s patients has
each condition, and (2) how long the
PCP has treated patients with each
condition. A PCP’s familiarity and
experience with the treatment of the
particular condition provides context
and serves as a reference for detecting
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any potential deception in promotional
materials.
(Response) We appreciate how these
additional questions could provide
valuable context and propose adding
new items to our pretest survey (see
below). We have found, in past work,
that HCPs often have difficulty recalling
precise information about their practice.
Consequently, our approach is to assess
this information more generally.
However, to include some additional
context, we included two additional
items:
• Rate your current knowledge about
prescription drugs for [weight loss/
chronic pain] on a scale of 0 to 10,
where 0 means knowing nothing and 10
means knowing everything you could
possibly know about the topic.
• [If ‘‘chronic pain’’] Approximately
what proportion of your current patients
do you treat for chronic pain? (None or
very few have chronic pain; a small
proportion have chronic pain; about
one-half have chronic pain; a large
proportion have chronic pain; almost all
have chronic pain).
t. Question Q2 of Study 1 should have
a third answer choice: ‘‘Don’t
remember.’’
(Response) In cognitive interviews,
very few people chose this response
option. Moreover, in previous research,
because so few people chose this
response option, we often end up
collapsing this response option with the
response indicating that the referent was
not mentioned in the website.
u. Questions Q5 and Q7 of Study 1
should be deleted. Whether a subject
considers the website to be ‘‘Bad/Good’’
or ‘‘Boring/Interesting’’ has no relevance
to FDA’s study goals.
(Response) These items help to mask
the overall intent of the other items in
this series (e.g., to assess whether the
website is misleading). Also, they
provide useful information about
personal relevance and attitude toward
the website, which we can use as
potential covariates.
v. The commenter recommends
revising Question Q17 of Study 1: ‘‘How
likely are you to ask your doctor about
[Drug]?’’
(Response) The intent of this item is
to assess information-seeking more
broadly, which can include, but is not
limited to, asking one’s doctor about a
drug. While assessing how consumers
access information from various sources
(doctor, family members, etc.) is of
interest, our survey does not have room
to ask about each source individually.
Given that there are multiple sources of
information a consumer might consult
for more information on a drug, we
decided to address information-seeking
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more broadly with one question, rather
than attempting to list all possible
options.
w. Questions Q19 and Q21 of Study
1 should be removed. These questions
require participants to guess whether
the material would mislead people or
‘‘takes advantage of less experienced’’
consumers/providers. FDA should only
ask participants about individual
perception. Additionally, it is unclear
what the Agency means by ‘‘takes
advantage of less experienced’’
consumers/providers.
(Response) To avoid redundancy, we
dropped Q21. We retained Q19 to
ensure assessment of a critical
construct. Because deception is a
complicated construct to measure, we
included a variety of items to capture
the various dimensions of this
construct. Based on a review of the
literature, we recommend using a
variety of relatively sensitive measures
of ability to detect misleading
advertisements to ensure we capture
potentially meaningful variance. The
inclusion of Q19 and Q21 were based on
findings from the literature review that
included measures that tapped into
third-person perception (Ref. 17)—
which is among the most widely
replicated phenomena across media
contents (Ref. 18), such as DTC
prescription drug advertising (Ref. 19).
By including an item that taps into
third-person effects, we will be able to
explore if consumers are more likely to
think that others will be misled, even if
they do not think they are susceptible to
being misled by the website.
x. Question Q24 of Study 1 should be
one of the first questions of the survey.
A subject will likely answer this
question most accurately immediately
after reviewing the website and before
answering other questions that could
influence this answer.
(Response) To avoid bias, the most
critical questions should appear as up
front as possible in the surveys.
Although current question ordering may
bias responses to the attention item, this
outcome is less consequential and we
chose instead to prioritize the key
dependent variables (putting those
measures that rely on memory at the
start of the survey). Consequently, we
intend to retain the current order of
questions in the survey.
y. The box for Question Q30 of Study
1 prompts the subject to respond, even
if the individual did not select anything
in the website as false or misleading.
FDA should consider using a tiered
response:
Q30a: Did you notice anything on the
website that is false or misleading?
1. Yes (go to question 30b).
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2. No (go to question 31).
Q30b: What information was false or
misleading? [open box comment]
(Response) A programming note was
missing in the original survey draft. The
current survey programming reflects the
approach suggested by the commenter.
z. The commenter recommends
revising Question Q32 of Study 1 to: ‘‘If
there was a way to report misleading
prescription drug websites or ads to the
Food and Drug Administration (FDA) by
sending an email or calling a toll-free
phone number, how likely would you
report misleading material?’’
(Response) We have adopted this
recommendation in the revised survey.
aa. As previously stated in footnote
21, Questions Q34, Q41, and Q42 of
Study 1 should be deleted.
Footnote 21 reads: For example, FDA
completed a HCP study incorporating
information asked at Q34, Q41, and Q42
of Study 1. It is not clear why the
Agency is undertaking another study
focusing on such questions. These
questions should be eliminated.
(Response) Please see our response to
Comment 3d.
bb. Question S1 of Study 2 should be
rewritten as follows: ‘‘Have you ever
been diagnosed with obesity, defined as
body mass index greater than or equal
to 30?’’ This change aligns the question
with the description of the study in the
PRA Notice: ‘‘Study 2 will sample
consumers diagnosed with
obesity. . . .’’
(Response) For this study, our intent
was to target people that would be in
the audience for these ads, and being
diagnosed is not a requirement for
personal relevance. The target audience
is consumers with a body mass index
greater than or equal to 30.
cc. The ‘‘Debriefing’’ does not
accurately portray the purpose of the
studies. The purpose of the studies is
not ‘‘to learn about how people feel
about information provided in
prescription drug websites aimed at
consumers/providers and how people
use this information to understand how
well prescription drugs work.’’ The
commenter recommends that the
‘‘Debriefing’’ read: ‘‘The purpose of this
study is to investigate the ability of
consumers/providers to identify false or
misleading prescription drug promotion
and how likely consumers/providers are
to report false or misleading
prescription drug promotion to
regulatory authorities.’’
(Response) We have adopted this
recommendation.
(Comment 4) regulations.gov tracking
number 1k1–8v3r–jacf (summarized for
brevity):
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a. The commenter expressed concern
about the practical utility of the
consumer-oriented arms of the research.
Namely, if consumers are unfamiliar
with the prescribing information for the
product, it is unclear on which basis
they can determine a claim to be
deceptive.
(Response) Please see our response to
Comment 3f, which addresses a similar
theme and may provide useful context.
The concern addressed by the
commenter is framed as a limitation of
the study and appears to question the
relevance of examining consumers’
ability to detect deception in
prescription drug promotion. We
believe the opposite is correct: The
merit of conducting the study is
reinforced by the observation that it is
unclear how consumers can determine a
claim to be deceptive if they lack
relevant background information or
knowledge about an advertised drug.
While prescription drug promotions are
required to present truthful and nonmisleading information, some
prescription drug promotion
nevertheless includes false or
misleading claims, images, or
presentations. DTC prescription drug
promotion can help provide consumers
with truthful information about drugs.
When it does so, it can help consumers
to make well-informed decisions when
determining whether to explore
treatment options and when making
ultimate treatment choices, and it can
provide useful and actionable
information about a product’s efficacy
and risks to consumers already on
treatment, among other outcomes. Yet,
because the information in prescription
drug promotion is not always truthful,
consumers must make judgments about
whether it is true, misleading, or false.
And the same background knowledge
that a consumer might rely on to
identify a claim as deceptive would also
be used to decide that a claim is true.
As the commenter points out, this
background information may be
incomplete or inadequate for the task,
and yet some presume that consumers
(and, for that matter, healthcare
providers) are typically able to
distinguish between true claims and
those that are false or misleading.
Concerns like the one voiced here and
the empirical literature on the topic
suggest there is reason to doubt this
presumption, thus warranting the
proposed study.
b. The commenter expressed concern
that the varied causes of obesity will
result in a heterogeneous population
which could potentially confound the
results of the study.
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(Response) We consider diversity
within this illness population to be an
asset. Also, random assignment will
help to control extraneous influences
because it will create groups that, on
average, are probabilistically similar to
each other. Because randomization
eliminates most other sources of
systematic variation, researchers can be
reasonably confident that any effect that
is found is the result of the intervention
and not some preexisting differences
between the groups (Ref. 20).
Consequently, the varied causes of
obesity should not impact the results.
The primary intention of the research is
to empirically examine consumer and
HCP ability to detect and report
deceptive prescription drug promotion,
but we have to choose stimuli (and by
extension, an illness population) in
order to empirically test our research
questions. By choosing illness
conditions with diverse patient
populations, we can better grasp how
consumers and HCPs from all walks of
life react to deceptive prescription drug
promotion. Also see response to
comment 3j.
(Comment 5) regulations.gov tracking
number 1k1–8v3v–v60p (verbatim with
header and footer language,
introductory language, and supporting
references removed):
We strongly support FDA’s proposed
project as part of the Agency’s broader
research efforts to better understand the
impact of prescription drug promotion
and direct-to-consumer advertising
(DTC). Research regarding deceptive
advertising is becoming increasingly
important as DTC continues to grow at
unprecedented rates. One analysis
estimated DTC spending in 2015 at $5.2
billion—a growth of over 60 percent in
just 4 years. Five drugs—HUMIRA,
LYRICA, ELIQUIS, CIALIS, and
XELJANZ—accounted for one-quarter of
this $5.2 billion. Importantly, these
figures are an underestimate, as they do
not account for spending on digital ads
and social media.
The risks and benefits of DTC have
been well noted and debated. DTC may
promote patient dialogue with
healthcare providers and remove the
stigma associated with certain diseases.
However, there are also significant
concerns that DTC may be misleading,
overemphasize a drug’s benefits as
compared to risks, and lead to
inappropriate prescribing and
overutilization.
Again, we applaud the FDA’s efforts
in this important area. The need to
better understand the ability of
consumers and healthcare professionals
to detect and report misleading DTC is
critical as the use of DTC continues to
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
grow. Thank you for the opportunity to
provide these comments.
(Response) FDA appreciates this
support.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of respondents
Pilot study screener completes
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
1
600
0.33 (20 minutes) .............
200
1
1,500
0.33 (20 minutes) .............
500
........................
........................
...........................................
1,355
5,612 total
Main study screener completes.
10,714 (chronic pain) ..............
1,786 (obesity)
1,531 (HCP)
14,031 total
Pilot study completes ..............
150 (chronic pain) ...................
150 (obesity)
300 (HCP)
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.
III. References
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The following references are on
display in the Dockets Management
Staff (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 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. 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, 29(1): 110–118, 2014.
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, 17: 433–437,
2014.
3. Mitra, A., M.A. Raymond, and C.D.
Hopkins. ‘‘Can Consumers Recognize
Misleading Advertising Content in a
Media Rich Online Environment?’’
Psychology & Marketing, 25(7): 655–674,
2008.
4. Hastak, M. and M.B. Mazis. ‘‘Deception by
Implication: A Typology of Truthful but
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Misleading Advertising and Labeling
Claims.’’ Journal of Public Policy &
Marketing, 30(2): 157–167, 2011.
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, 20: 1330–1336,
2015.
6. Nahin, R.L. ‘‘Estimates of Pain Prevalence
and Severity in Adults: United States,
2012.’’ Journal of Pain, 16(8): 769–780,
2015.
7. U.S. Department of Health and Human
Services, Centers for Disease Control and
Prevention, National Center for Health
Statistics. ‘‘Healthy Weight, Overweight,
and Obesity Among Adults Aged 20 and
Over, by Selected Characteristics: United
States, Selected Years 1988–1994
Through 2009–2012 [Table].’’ In Health,
United States, 2014 with special feature
on adults aged 55–64 (pp. 214220; DHHS
Publication No. 2015–1232). Retrieved
from https://www.cdc.gov/nchs/data/hus/
hus14.pdf.
8. Krosnick, J.A. and S. Presser. ‘‘Question
and Questionnaire Design.’’ In:
Handbook of Survey Research (pp. 263–
314). Bingley, United Kingdom: Emerald
Group Publishing Limited, 2010.
9. Converse, J.M. and, S. Presser. Survey
Questions: Handcrafting the
Standardized Questionnaire (No. 63).
Thousand Oaks, CA: SAGE Publications,
1986.
10. DeVellis, R.F. Scale Development: Theory
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and Applications (Vol. 26). Thousand
Oaks, CA: SAGE Publications, 2016.
11. Sullivan, H.W., K.J. Aikin, E. ChungDavies, and M. Wade. ‘‘Prescription Drug
Promotion from 2001–2014: Data from
the U.S. Food and Drug Administration.’’
PLoS ONE, https://dx.doi.org/10.1371/
journal.pone.0155035, 2016.
12. Liang, B.A. and T.K. Mackey. ‘‘Prevalence
and Global Health Implications of Social
Media in Direct-to-Consumer Drug
Advertising.’’ Journal of Medical Internet
Research, 13(3), e64, 2011.
13. Southwell, B.G. and D.J. Rupert. ‘‘Future
Challenges and Opportunities in Online
Prescription Drug Promotion Research.’’
International Journal of Health Policy
and Management, 5(3), 211–213, 2016.
14. Davis, J.J., E. Cross, and J. Crowley.
‘‘Pharmaceutical Web Sites and the
Communication of Risk Information.’’
Journal of Health Communication, 12,
29–39, 2007.
15. Singleton, Jr., R.A., B.C. Straits, and M.M.
Straits. Approaches to Social Research.
Oxford, United Kingdom: Oxford
University Press, 1993.
16. Aday, L.A. and L.J. Cornelius. Designing
and Conducting Health Surveys: A
Comprehensive Guide. Hoboken, NJ:
John Wiley & Sons, 2006.
17. Xie, G.X. ‘‘Deceptive Advertising and
Third-Person Perception: The Interplay
of Generalized and Specific Suspicion.’’
Journal of Marketing Communications,
22(5), 494–512. doi:10.1080/
13527266.2014.918051, 2014.
18. Sun, Y., Z. Pan, and L. Shen.
‘‘Understanding the Third-Person
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Perception: Evidence from a MetaAnalysis.’’ Journal of Communication,
58(2), 280–300, 2008.
19. DeLorme, D.E., J. Huh, and L.N. Reid.
‘‘Perceived Effects of Direct-ToConsumer (DTC) Prescription Drug
Advertising on Self and Others.’’ Journal
of Advertising, 35(3), 47–65, 2006.
20. Fisher, R.A. The Design of Experiments.
Edinburgh, United Kingdom: Oliver and
Boyd, 1937.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26704 Filed 12–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–2659]
Determination That NOROXIN
(Norfloxacin) Tablets, 400 Milligrams,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that NOROXIN (norfloxacin)
tablets, 400 milligrams (mg), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for norfloxacin
tablets, 400 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Darren Eicken, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206,
Silver Spring, MD 20993–0002, 240–
402–0978.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
ethrower on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:03 Dec 11, 2017
Jkt 244001
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
NOROXIN (norfloxacin) tablets, 400
mg, is the subject of NDA 019384, held
by Merck & Company, Inc. (Merck), and
initially approved on October 31, 1986.
NOROXIN is indicated for the treatment
of adults with the following infections
caused by susceptible strains of certain
designated microorganisms:
Uncomplicated urinary tract infections
(including cystitis), uncomplicated
urethral and cervical gonorrhea, and
prostatitis.
In a letter dated October 13, 2015,
Merck notified FDA that NOROXIN
(norfloxacin) tablets, 400 mg, was being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. In the Federal Register of October
4, 2016 (81 FR 68427), FDA announced
that it was withdrawing approval of
NDA 019384, effective November 3,
2016.
Jubilant Generics Ltd. submitted a
citizen petition dated April 27, 2017
(Docket No. FDA–2017–P–2659), under
21 CFR 10.30, requesting that the
Agency determine whether NOROXIN
(norfloxacin) tablets, 400 mg, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that NOROXIN (norfloxacin)
tablets, 400 mg, was not withdrawn for
reasons of safety or effectiveness. The
PO 00000
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58421
petitioner has identified no data or other
information suggesting that NOROXIN
(norfloxacin) tablets, 400 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of NOROXIN
(norfloxacin) tablets, 400 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NOROXIN (norfloxacin)
tablets, 400 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to NOROXIN
(norfloxacin) tablets, 400 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised,
the Agency will advise ANDA
applicants to submit such labeling.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26693 Filed 12–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–4079]
Product Name Placement, Size, and
Prominence in Promotional Labeling
and Advertisements; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Product
Name Placement, Size, and Prominence
in Promotional Labeling and
Advertisements.’’ The guidance clarifies
the requirements for product name
placement, size, prominence, and
frequency in promotional labeling and
advertisements for human prescription
drugs, including prescription biological
products, and for animal prescription
SUMMARY:
E:\FR\FM\12DEN1.SGM
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Agencies
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58411-58421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26704]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4487]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).
DATES: Fax written comments on the collection of information by January
11, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910--New and
title ``Consumer and Healthcare Professional Identification of and
Responses to Deceptive Prescription Drug Promotion.'' Also include the
FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
[[Page 58412]]
Consumer and Healthcare Professional Identification of and Responses to
Deceptive Prescription Drug Promotion
OMB Control Number 0910--NEW
I. Background
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act. Under the FD&C Act and
implementing regulations, promotional labeling and advertising about
prescription drugs are generally required to be truthful, non-
misleading, and to reveal facts material to the presentations made
about the product being promoted (see FD&C Act sections 201(n) and
502(a) and (n) (21 U.S.C. 321(n) and 352(a) and (n)); see also 21 CFR
202.1).
Prescription drug promotion sometimes includes false or misleading
(collectively, 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 (Refs. 1 and
2) and other products (Refs. 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.
---------------------------------------------------------------------------
\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 used in this document, this term refers
to presentations that are considered false or misleading within the
context of prescription drug promotion.
---------------------------------------------------------------------------
The ability of consumers and HCPs to identify deceptive
prescription drug 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 who are unable to identify deceptive promotion may
prescribe specific drugs that they would not otherwise prescribe. On
the other hand, if consumers and HCPs are able to identify deceptive
promotion, they may appropriately discount or disregard such
information in their medication decisions, and perhaps even report
deceptive promotion to appropriate government regulators who can take
corrective action.
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 review everything. 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.
The mission of the Office of Prescription Drug Promotion (OPDP)
within FDA is to protect the public health by helping to ensure that
prescription drug promotion is truthful, balanced, and accurately
communicated, and to guard against deceptive promotion through
comprehensive surveillance, enforcement, and educational programs. As
part of this mission, it is critical that OPDP adequately understand
the capacity of consumers and HCPs to detect false and misleading
claims as well as these populations' processing of such claims. This
understanding will help OPDP to identify best practices for addressing
false and misleading claims in prescription drug promotion. The
research described here will provide evidence to inform consideration
of the approaches best suited to fulfill OPDP's mission to protect the
public from deceptive promotion.
The proposed project involves two studies examining volunteer
participants' ability to detect and report deceptive 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 websites
targeted toward physicians and consumers will view mock consumer-
targeted pharmaceutical websites. The goal will be to keep the HCP and
consumer-targeted websites as similar as possible, but to include
content that is appropriate for the target audience. For example, HCP
websites may contain medical terminology, whereas the consumer websites
would utilize consumer friendly language. A professional firm will
create all mock websites such that they are generally indistinguishable
from currently available prescription drug websites.
II. Study 1 and 2
Study 1 and 2 sample. Study 1 will sample consumers who self-report
chronic pain that has lasted at least 3 months and HCPs 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. Chronic pain has an incidence rate of roughly 11 percent (Ref. 6)
in the population. Study 2 will sample consumers who self-report
obesity, defined as body mass index greater than or equal to 30 (35
percent incidence; Ref. 7) and include the same types of HCPs as study
1. 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 websites are
understandable, viewable, and delivering intended messages; (2)
identify and eliminate any challenges to embedding the mock websites
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 websites, 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.
[[Page 58413]]
Study 1--Degree of Deception Based on the Number of Deceptive Claims
----------------------------------------------------------------------------------------------------------------
Experimental condition
---------------------------------------------------------------
Population None Fewer More
(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
----------------------------------------------------------------------------------------------------------------
The purpose of Study 1 is to assess consumer and HCP response to
promotional websites 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 websites will contain various types of violations. The
website with fewer violations will contain a subset of the deceptive
claims, imagery, or other presentations included in the website with
more violations. For example, if the fewer-violations website includes
two violations, then the more-violations website 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 focuses 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 (Refs. 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 website: (1) An explicitly false
website, (2) a factually true but implicitly misleading website, or (3)
a website 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 website targeted toward the
relevant experimental population, obese consumers or HCPs who treat
obese patients. As with study 1, 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 website 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 website contributed to that belief. We will also include
indirect measures that identify whether participants believed the
website expressed particular claims (e.g., claim recognition) as well
as participants' beliefs about the veracity of any deceptive claims
(e.g., claim
[[Page 58414]]
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.
In the Federal Register of January 4, 2017 (82 FR 855), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Comments received along with our responses
to the comments are provided below. Comments that are not PRA-relevant
or do not relate to the proposed study are not included. For brevity,
some public comments are paraphrased and therefore may not reflect the
exact language used by the commenter. We assure commenters that the
entirety of their comments was considered even if not fully captured by
our paraphrasing. Question numbering here (e.g., Q30) reflects
numbering from the original draft questionnaire, shared by request at
the time of the 60-day notice. The following acronyms are used here:
FRN = Federal Register Notice; DTC = direct-to-consumer; HCP =
healthcare professional; FDA and ``The Agency'' = Food and Drug
Administration; OPDP = FDA's Office of Prescription Drug Promotion.
(Comment 1) regulations.gov tracking number 1k1-8ubr-t0de (verbatim
with header and footer language removed):
We are supportive of the study, but have the following
recommendations.
We propose that additional study arms be included that explore
various scenarios/websites which test both the number of deceptive
claims in conjunction with the degree of deception. Currently, the
study is structured to measure the impact of the number of deceptions
in a promotional website (Study 1) separately from the degree of the
deception (explicit vs implicit, in Study 2). However, it would also be
beneficial to measure other combinations to see which factor or
combination of factors had the greatest impact on HCPs and Consumers'
overall perception of the website. For example, a single explicit lie
may be more impactful than 15 implied deceptions. The current study
will not be able to draw any conclusions regarding that scenario.
Testing additional combinations of the number of deceptions in a
website along with deceptive claims of varying severity would enable a
better comparison and understanding of what ultimately drives HCPs and
Consumers' perception of deceptive prescription promotion.
(Response) We thank the commenter for their support and for this
suggestion. While certainly a viable research idea, cost implications
of creating and testing additional stimuli for this purpose bar us from
pursuing it. We encourage researchers to pursue this idea in future
research.
(Comment 2) regulations.gov tracking number 1k1-8v15-11b6 (some
comments summarized for brevity; others provided verbatim):
a. Given the stated purpose of the pretests, sample size can be
substantially reduced, and revised to a qualitative approach.
(Response) In addition to the quantitative pretest, we have already
conducted a qualitative test of stimuli and questionnaire materials via
cognitive interviews. Changes based on cognitive interviews are
reflected in our updated survey materials. In regard to sample size,
the number of pretest participants per experimental condition (n = 50)
was chosen based on a power analysis, and is considered to be the
minimum effective size to allow for assessment of the quantitative
outcomes specified in the 60-day FRN. Examples of quantitative outcomes
include assessment of response rates and timing of the survey.
b. To reduce bias, add a screening question to exclude respondents
who are opposed to taking prescription medicines.
(Response) The survey length does not allow for a full exploration
of attitudes toward prescription drug use. However, to assess
opposition to prescription drug use more generally, we added one item
to the survey that has been used successfully in previous FDA surveys.
This item will be used in the pretest survey as a potential covariate
and may or may not be retained in the main study survey depending on
its performance.
The item reads: ``In what situations would you consider taking
prescription drugs?''
I would never take them.
I would take them only for serious health conditions.
I would take them for moderate and serious health
conditions.
I would take them for most health conditions, including
minor problems.
c. Consider revising item scales to include a mid-point to allow
respondents to express neutral views (unless objective is to force a
selection).
(Response) Given the focus of the questions, we believe that
offering a neutral response option is not necessary to measure opinions
and attitudes accurately. Consequently, our objective is to force a
selection and have participants make at least a weak commitment in
either a positive or negative direction. Of concern is that offering a
neutral midpoint could potentially encourage ``satisficing''--cuing
participants to choose a neutral response because it is offered (Ref.
8). Additionally, providing a midpoint leads to the loss of information
regarding the direction in which people lean (Ref. 9). Research has
found that neither format (either with or without a neutral point) is
necessarily better or produces more valid or reliable results (Ref.
10). Instead, it should be left to the researcher to determine the
goals of the study. During cognitive testing, a majority of
participants were satisfied with the response options and all
participants felt comfortable choosing a response in the absence of a
midpoint. Use of a midpoint is an issue we have examined in previous
studies and we determined that we achieve valid and reliable responses
without a midpoint. To increase consistency with measures used in
previous studies, and in support of the arguments presented above, we
are opting to exclude a midpoint. Finally, if a participant does not
feel that they can choose a response because of a lack of a neutral
option, they will be able to skip the question.
d. In Study 1, remove Q21 and Q30 due to potentially leading nature
of items.
(Response) To avoid redundancy, we dropped Q21. In Q30, we ask
participants to click on anything they think is misleading, and we note
that if they do not think anything is misleading, they can click
``none.'' Consequently, we are not strongly presupposing there are
misleading claims. To address some of the wording concerns for this
item, we changed the question to ask about inaccurate information
instead of misleading information and we moved the ``None'' response to
be more prominent above the image.
(Comment 3) regulations.gov tracking number 1k1-8v3z-nzst
(summarized for brevity):
The commenter expresses concern about the practical utility of the
research, reasons for which are covered by comments 3a through 3e. In
the case that FDA continues with the research, the commenter makes
several recommendations which are covered by comments 3f through 3cc.
Comments 3f through 3h concern the study stimuli, comment 3i pertains
to subject recruitment, and comments 3j through 3cc concern the study
questionnaires.
a. The identification of deceptive promotion is FDA's assigned
[[Page 58415]]
responsibility, not the duty of HCPs and consumers.
(Response) As discussed above, the mission of OPDP within FDA is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated, and to
guard against false and misleading promotion through comprehensive
surveillance, enforcement, and educational programs. As part of this
mission, it is critical that OPDP adequately understand the capacity of
consumers and HCPs to detect false and misleading claims as well as
these populations' processing of such claims. This understanding will
help FDA/OPDP to identify best practices for addressing deceptive
claims in prescription drug promotion. Moreover, we note that sponsors
are not generally required to submit promotional pieces to FDA prior to
dissemination, and limited resources prevent OPDP from reviewing all
promotional materials in the marketplace. Voluntary HCP and consumer
reporting of false and misleading promotional pieces contribute to the
accomplishment of FDA/OPDP's mission.
b. Deceptive drug promotion is not a prevalent issue that requires
further studying.
(Response) Numerous studies have examined the prevalence of false
or misleading claims and presentations in DTC advertising, and FDA
frequently issues compliance letters addressing false and misleading
claims and presentations (Refs. 1 and 2). Consequently, FDA disagrees
with this assertion.
c. FDA's proposed studies fail to acknowledge the role of the HCP
as the ``learned intermediary.''
(Response) The present research takes into consideration both
consumer and HCP responses to false or misleading promotion. Consumers
often wish to participate in shared decision making with HCPs when
selecting prescription drugs and may request specific prescription
drugs from their HCPs based on promotions they have seen in the
marketplace. Because information consumers receive through DTC
prescription drug promotion can impact these requests, it is important
to investigate consumers' ability to assess prescription drug product
efficacy and risks as conveyed in promotional pieces. And although HCPs
have medical training and clinical expertise, we are not aware of
research that investigates whether such training and expertise
translates into an ability to detect false or misleading promotion in
the marketplace. Consequently, the present research investigates both
consumer and HCP ability to identify and discount deceptive
prescription drug promotion.
d. The proposed studies are duplicative of recent FDA research
concerning HCP willingness to report deceptive promotion.
The commenter suggests that if FDA wishes to investigate consumer
reporting, the Agency should create two separate studies. The first
should gauge consumer aptitude in identifying false or misleading
prescription drug promotion. Depending on the results of the first
study, the Agency could potentially undertake a second study, surveying
subject willingness to report false or misleading drug promotion. This
approach would avoid potential error associated with influence of
earlier questions regarding deception on later questions regarding
reporting.
(Response) FDA conducted a survey of HCPs in 2013 in which
respondents were asked about their familiarity with the Bad Ad program
and willingness to report misleading advertising (Ref. 5). The current
study is quite different in scope from the previous research. The
current study consists of an experimental design that will enable us to
determine whether HCPs can detect misleading advertising, not just
whether they are willing to report it. We do include questions at the
end of the survey asking similar questions as those in the 2013 survey,
but the purpose here is in connection to HCP ability to detect
misleading advertising. Moreover, our use of similar questions here
reflects a well-established technique in scientific research, used to
determine whether previous findings can be replicated or not.
In response to the second comment recommending division of this
project into two separate studies, we believe that proposal to be an
inefficient use of resources. Regarding concerns about the order of
questions affecting subsequent responses, we chose to distribute
deception-related items throughout the survey, rather than ask all
deception items first and then other outcome measures second. Also, we
include ``masking'' items on the same screen as deception-related items
to mask the intent of the questions. The results from cognitive
interviews confirm that this approach was successful. Consequently, we
have no evidence to suggest that earlier questions related to deception
will influence subsequent questions related to reporting.
e. FDA already has created and implemented consumer programs to
report deceptive promotion.
(Response) The proposed research can inform program needs at
present, whether such needs involve reevaluation of past programs such
as EthicAd, or extensions of existing programs such as the Bad Ad
program or other actions.
f. Validating Stimuli. It is not clear how the Agency will
determine that a study stimulus is deceptive. FDA notes in the PRA
Notice that 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.'' It seems unrealistic for FDA to conduct research with
primary care physicians (PCPs) and consumers who do not understand the
Agency's standards or have access to the training and resources of an
FDA reviewer.
Further, except for literal falsity, whether a particular
communication is false or misleading must be based on empirical
evidence. Promotional pieces do not exist in a vacuum. These
communications interact with the overall health information ecosystem,
including the internet. FDA needs to first validate that the study
stimuli are indeed deceptive before including the stimuli in either
proposed study with the presumption that they are deceptive.
(Response) Our reference to the Federal Trade Commission's (FTC)
definition of the term ``deceptive'' was offered as a point of
clarification for our use of the same term as shorthand within the FRN
for the longer phrase ``false or misleading.'' In other words, by using
``deceptive'' as a term of art in this narrow context, we are not
evoking the specific meaning and interpretation of the same term used
by the FTC.
We disagree with the suggestion that participants need to have
access to the training and resources of an FDA reviewer before FDA can
evaluate their ability to identify deceptive promotion. As further
explained below, FDA is not asking participants to determine whether
nuanced text meets the regulatory standards for deceptive promotion;
instead, we are presenting material that meets both the regulatory
standard for a deceptive promotion and could be identified as such by
consumers or healthcare providers with no prior experience with the
regulations.
We agree with the second point about the need to validate that the
study stimuli are deceptive, and we are doing this in several ways for
this study. For example, some of the specific claims used in our
experimental manipulations are established as being factually incorrect
because the promoted drug is a member of a class of drugs for which the
claim could not be true (e.g., describing a serotonin-norepinephrine
reuptake inhibitor (SNRI), which is
[[Page 58416]]
required to have a black box safety warning for suicide risk, as
lacking in significant safety concerns). Other claims or presentations
in the stimuli are based on similar claims cited as violative in past
warning letters or that unambiguously fail to follow the law (e.g.,
minimizing presentation of important safety information, such as a
black box warning, by setting it in small, low contrast type). For one
manipulated claim, we provided participants with access to the
background information needed to identify the presentation as deceptive
in the form of a footnote. In the case of Study 2, where a crucial
aspect of the experimental design is to test an implicitly misleading
claim in relation to an explicitly false claim and against a
nonviolative control, we tested candidate claims in cognitive
interviews to verify that the audience tended to interpret the implicit
claims as intended.
Further, it is important to note that we included a control
condition in both studies, which will enable us to compare responses to
a website that has no violations. The control conditions serve as a
baseline for perceived deception, which will also allow us to examine
how consumers and providers perceive websites with no violations.
g. Media. The Agency proposes using websites as the only stimuli.
FDA should consider testing additional non-electronic media, including
DTC and HCP print promotional materials. The Agency should also base
the promotional stimuli on realistic ``mock'' package insert (PI)
documents. The commenter requests that FDA make available for public
comment these materials.
(Response) Previous research on DTC and HCP-directed prescription
drug promotional materials has, to varying extents, included all
available media formats, and assessment of outcomes using these formats
has proven useful. We agree that investigating recognition of
misleading prescription drug information in multiple formats--including
print, television, web, and other modes--would be valuable. However, we
also recognize that no single study can effectively examine all
promotional formats or presentations, and we chose to focus on branded
drug websites for several reasons. First, websites, while not
necessarily more or less useful than any other format, are arguably
quite prevalent and important in today's technological age where a
large segment of the consumer population is connected to the internet
and known to seek information regarding prescription drugs using the
internet. For example, online promotion is the fastest growing category
of DTC drug marketing, and branded websites account for the largest
share of this category (Ref. 11). Second, almost all print and
television ads for prescription drugs encourage viewers to visit
branded websites for more information, making these sites an important
extension of promotion in other formats (Ref. 12). Third, FDA has
issued multiple warning and notice of violation letters for branded
drug websites that incorrectly communicate information to visitors,
suggesting that there may be a problem with a proportion of such sites
presenting misleading information. Fourth, websites serve as a fairly
newer format for promotion relative to television and print promotion,
and by consequence warrant further study. There has been significantly
less research on consumer and provider interpretation of branded drug
websites than other promotional formats (Ref. 13), and the extant
research suggests that some websites still do not present a fair
balance of risk and benefit information (Ref. 14).
Based on these considerations, we believe that focusing this study
on branded drug websites will be the most effective use of FDA's
limited resources. The fictitious websites included in this study were
modeled on real products (including the package insert) to ensure
realism and relevance.
In response to the request to share stimuli, we generally do not
share stimuli before the study has been conducted to avoid possible
inadvertent publication and therefore contamination of the subject
pool, which would compromise the research.
h. Disease States. The Agency's two studies propose testing stimuli
concerning chronic pain or obesity. The commenter suggests that FDA
instead consider testing stimuli featuring a fictitious product for a
disease state which involves more complex safety information. Such
stimuli would be more reflective of the current healthcare environment,
where product labeling is increasingly complex.
(Response) The fictitious websites used in this research do include
complex safety information, which reflect the risks for real chronic
pain and obesity products in the marketplace. For example, one of the
fictitious products includes a black box warning, and the other
includes severe and complex safety information, such as potential drug
interactions and contraindications.
i. Study 1 Stimuli. In Study 1, the ``degree of deception will be
manipulated over three levels by altering the number of deceptive
claims (none, fewer, more).'' FDA states that the deceptive claims will
include ``various types of violations.'' Under the potential design,
the most egregious deceptive claim(s) might only be contained in the
``more'' level. This could potentially skew study results, as subjects
would be more likely to identify such egregious claims. FDA should
develop a scale that is used to determine the egregiousness of the
deception. The scale should include specific examples of egregiousness
by category.
(Response) Although some claims do not overlap between the ``fewer
violations'' and ``more violations'' conditions, we strategically
manipulated the stimuli so that one of the more ``egregiously''
deceptive claims (which appears in a callout bubble) is present in both
conditions. There is also overlap in those two conditions for another
manipulated element, where we minimized the prominence of the Important
Safety Information. Additionally, we included an item (Q30) that would
provide participants the opportunity to click on anything they think
may be inaccurate. Using this question, we would expect that the more
egregious claims will be chosen more often. In this way, this item
would serve as a proxy measure of egregiousness. Further, our various
questions that ask about perceived deceptiveness of the websites will
provide an initial assessment of the degree of deception--with higher
scores representing greater perceived deception. Because of space
constraints on the survey, we are unable to ask participants to rate
the egregiousness of the violative claims. Although we appreciate the
value that developing a scale to determine the egregiousness of each of
the deceptive claims would add, adopting this suggestion in the present
research would be outside of the scope of this study and would have an
impact on overall cost considerations.
j. FDA proposes that the HCP samples for both studies will only
include physician subjects. The commenter believes the samples should
include other types of HCPs, including nurse practitioners, physician
assistants, and pharmacists. As the Agency's recent research showed,
``Nurse practitioners and physician assistants tended to see the [Bad
Ad] program as more useful than [PCPs] and specialists. They also
reported a greater likelihood of reporting false or misleading
advertising in the future.'' Given these findings, it would be helpful
also to investigate the ability of other HCPs independently to identify
false or misleading promotion.
[[Page 58417]]
Additionally, during the recruiting process, FDA should ensure
enrollment of a diversity of subjects across demographic categories.
Previous research indicates that certain demographic groups respond to
drug promotion in different manners. Uneven representation within
certain categories could potentially skew study results.
(Response) FDA acknowledges and agrees with the assertion that
including other types of HCPs in this research would provide value.
Yet, sampling from these additional groups requires funding that may
not be justified in this initial investigation of the topic area.
Nonetheless, we do intend to strive for diversity in both our HCP and
consumer samples. HCPs and consumers will vary in terms of age, race,
and ethnicity, and consumers will additionally vary in terms of their
education level.
k. Leading Questions. The overall format of the questionnaires is
quite leading. As previously mentioned, questions asking whether sample
advertisements are ``deceptive,'' ``misleading,'' ``bad,'' and ``not
believable'' could easily pollute data from later questions inquiring
whether a subject would potentially report such promotion to FDA. The
Agency should state all questions in an objective manner.
(Response) Leading questions are those that ``suggest a possible
answer or make some responses seem more acceptable than others'' (Ref.
15). In keeping with standard practice for balancing the valence of
attitudinal questions, we have included a mix of positive and negative
statements in the questionnaire. In fact, there are presently more
positively framed items than negatively framed items. Moreover, the
slider questions referenced by the commenter are semantic
differentials, which show both a negatively framed word and its
positive counterpart on opposite ends of the response scale (e.g.,
``deceptive/truthful,'' ``misleading/accurate,'' ``not believable/
believable''). We do not see how these items could be construed as
leading because both the positive and negative frames are presented.
Finally, as stated in our response to Comment 3d, we have evidence to
suggest that we successfully masked the true focus of the
questionnaire, so the deception-focused items should not bias
subsequent responses.
l. Recall Questions. Certain questions (e.g., Q1-Q3 of Study 1, Q4
of Study 2) ask test subjects to recall specific risks and side effects
of the featured drug products. Such questions are not valid instruments
to assess whether a subject perceives a stimulus to be false or
misleading. Recall is likely influenced by the presentation of the
content (e.g., size, visual display), not by the content itself. This
research, however, is not material to the stated purpose of the
studies. The recall questions should be omitted from the
questionnaires.
(Response) Q1-Q2 of Study 1 measure risk recall and risk
recognition. These are important outcome measures for our study because
we vary how the risks are presented in the different experimental
conditions, minimizing them (in terms of size and format) in the
violative conditions. Including these risk recall and recognition
measures allow us to test whether minimizing the risks influences
participants' ability to remember them. Further, because minimization
of risk is a misleading violation in its own right, reduced risk recall
or recognition among participants in the violative conditions would
provide relevant context for interpreting more direct measures of
deception. Q4 of Study 2 will enable us to determine if participants
can recall seeing the disclosure statements in the websites. This is
relevant to the question of whether participants identify false or
misleading content because the disclosure statement provides
information that would help participants assess the truth of the
headline claim. None of these items are intended to be direct measures
of whether the stimuli are misleading; instead, they are outcomes that
may be affected by misleading content.
m. Repetitive Questions. The questionnaires are repetitive in
nature. For example, in Q4-Q11 of Study 1, subjects are asked a series
of eight questions to measure ``Perceived Website Deception.'' The
questions are redundant (e.g., Believable/Not believable, Truthful/
Deceptive, Factual/Distorted, Accurate/Misleading). This duplication
may cause the subject to believe the promotional material is actually
false or misleading.
(Response) The use of multiple items to tap into a singular
construct is considered a best practice in social science research,
particularly when assessing complex psychological constructs like those
in this survey. Our intent is to combine responses to these items into
a single composite score. Our cognitive interviewing of these items
suggests that they have slightly different meanings for many
participants and thus are not viewed as completely redundant. Further,
there is no evidence to suggest that the use of multiple items to
assess this construct led participants to believe that the promotional
material was actually false or misleading or that this series of
questions was designed to capture whether they thought the website was
misleading. Consequently, we successfully masked the true intent of
this item by including other bipolar response options unrelated to
misleadingness.
We dropped Q21 to reduce redundancy across items.
n. Definitions and Terms. The questionnaires do not define certain
key terms (e.g., effectiveness, risk, misleading). Subjects, especially
consumers, may interpret these terms based on different standards. FDA
might consider providing user-friendly definitions for the consumer
subjects. The Agency should also utilize patient-friendly medical
terms, rather than complex terminology (e.g., glaucoma, hepatic
failure, SNRI).
(Response) Sophisticated medical terminology will only be used in
the HCP survey. To use the example of ``hepatic failure,'' consumers
will instead see ``decreased liver function.'' We have verified in
cognitive interviews that preceded this study (and in our previous
scale development efforts) that the terminology used is generally well
understood by our participant sample.
o. Sliding Scale Format. FDA should consider replacing the sliding
scale format with a ``Yes-No-I Don't Know'' scheme. The sliding-scale
format is at times confusing in form and could potentially introduce
error. Alternatively, the Agency should consider changing the sliding
scale to an odd number system to permit a ``neutral'' response and/or
use a variation of the Likert scale.
(Response) Use of a sliding scale allows for greater precision and
variation in response, as opposed to a ``Yes-No-Don't Know'' format.
Research suggests that scales with five to seven points are more valid
and reliable than those with only two to three categories (Ref. 16).
Additionally, we tested the sliding-scale format in previous cognitive
interviews and found that it worked well; participants had little
difficulty understanding this format. Further, as noted in the response
to Comment 2c, we want to avoid leading participants to choose a
``Don't know'' response; providing this option may cue participants to
select this response and avoid deeper thinking on the topic. Regarding
the use of an even numbered scale rather than odd numbered scale,
please see our response to Comment 2c.
p. An ``FDA employee'' category should be added to Question S2
[Consumer] of Study 1. These individuals should also be terminated from
the study.
(Response) Consistent with previous surveys, we added a category to
exclude
[[Page 58418]]
employees of the Department of Health and Human Services, which
includes employees of FDA.
q. Question S3 [Consumer] of Study 1 should be rewritten as
follows: ``Have you ever been diagnosed with chronic or long-lasting
pain (more than aches and pains that go away quickly or are minor)?''
(emphasis added). This change aligns the question with the description
of the study in the PRA Notice: ``Study 1 will sample consumers with
diagnosed chronic pain that has lasted at least 3 months.''
(Response) We did not restrict people to be diagnosed with chronic
pain because the prevalence was too small, which would increase the
costs of the study. Using our current screening questions, we achieve
an 11 percent prevalence rate (Ref. 6). The objective of our sampling
plan is to target people that would be in the audience for the ads;
being diagnosed is not a criterion.
r. Question S5 [Consumer] of Study 1 should be eliminated. Whether
a subject still has chronic pain has no bearing on the study's purpose.
Also, consider eliminating Question Q12 of Study 1. This question would
only apply to those consumers currently being treated for chronic pain,
not those who previously had the condition.
(Response) Assessing whether participants currently experience
chronic pain helps to ensure a motivated sample for which the
fictitious medication would potentially be of interest. Originally, we
included participants that reported suffering from chronic pain in the
past, but we did not require that they are currently suffering from
chronic pain (although we had an item that asked ``Do you still have
this chronic or long-lasting pain?''). After further consideration, we
opted to revise the screener so that participants remain eligible if
(a) they say ``Yes'' I still have chronic pain, or (b) they say ``No''
(or remain silent) about still having chronic pain and they are
currently taking a prescription drug for chronic pain. This would also
make the inclusion criteria for Study 1 consistent with the inclusion
criteria for Study 2, which requires that a person currently suffers
from the medical condition of interest. Consequently, Q12 of Study 1
will be relevant for all consumers completing the questionnaire.
s. Consider revising Question S5 [PCP] of Study 1 to inquire: (1)
What percentage of the PCP's patients has each condition, and (2) how
long the PCP has treated patients with each condition. A PCP's
familiarity and experience with the treatment of the particular
condition provides context and serves as a reference for detecting any
potential deception in promotional materials.
(Response) We appreciate how these additional questions could
provide valuable context and propose adding new items to our pretest
survey (see below). We have found, in past work, that HCPs often have
difficulty recalling precise information about their practice.
Consequently, our approach is to assess this information more
generally. However, to include some additional context, we included two
additional items:
Rate your current knowledge about prescription drugs for
[weight loss/chronic pain] on a scale of 0 to 10, where 0 means knowing
nothing and 10 means knowing everything you could possibly know about
the topic.
[If ``chronic pain''] Approximately what proportion of
your current patients do you treat for chronic pain? (None or very few
have chronic pain; a small proportion have chronic pain; about one-half
have chronic pain; a large proportion have chronic pain; almost all
have chronic pain).
t. Question Q2 of Study 1 should have a third answer choice:
``Don't remember.''
(Response) In cognitive interviews, very few people chose this
response option. Moreover, in previous research, because so few people
chose this response option, we often end up collapsing this response
option with the response indicating that the referent was not mentioned
in the website.
u. Questions Q5 and Q7 of Study 1 should be deleted. Whether a
subject considers the website to be ``Bad/Good'' or ``Boring/
Interesting'' has no relevance to FDA's study goals.
(Response) These items help to mask the overall intent of the other
items in this series (e.g., to assess whether the website is
misleading). Also, they provide useful information about personal
relevance and attitude toward the website, which we can use as
potential covariates.
v. The commenter recommends revising Question Q17 of Study 1: ``How
likely are you to ask your doctor about [Drug]?''
(Response) The intent of this item is to assess information-seeking
more broadly, which can include, but is not limited to, asking one's
doctor about a drug. While assessing how consumers access information
from various sources (doctor, family members, etc.) is of interest, our
survey does not have room to ask about each source individually. Given
that there are multiple sources of information a consumer might consult
for more information on a drug, we decided to address information-
seeking more broadly with one question, rather than attempting to list
all possible options.
w. Questions Q19 and Q21 of Study 1 should be removed. These
questions require participants to guess whether the material would
mislead people or ``takes advantage of less experienced'' consumers/
providers. FDA should only ask participants about individual
perception. Additionally, it is unclear what the Agency means by
``takes advantage of less experienced'' consumers/providers.
(Response) To avoid redundancy, we dropped Q21. We retained Q19 to
ensure assessment of a critical construct. Because deception is a
complicated construct to measure, we included a variety of items to
capture the various dimensions of this construct. Based on a review of
the literature, we recommend using a variety of relatively sensitive
measures of ability to detect misleading advertisements to ensure we
capture potentially meaningful variance. The inclusion of Q19 and Q21
were based on findings from the literature review that included
measures that tapped into third-person perception (Ref. 17)--which is
among the most widely replicated phenomena across media contents (Ref.
18), such as DTC prescription drug advertising (Ref. 19). By including
an item that taps into third-person effects, we will be able to explore
if consumers are more likely to think that others will be misled, even
if they do not think they are susceptible to being misled by the
website.
x. Question Q24 of Study 1 should be one of the first questions of
the survey. A subject will likely answer this question most accurately
immediately after reviewing the website and before answering other
questions that could influence this answer.
(Response) To avoid bias, the most critical questions should appear
as up front as possible in the surveys. Although current question
ordering may bias responses to the attention item, this outcome is less
consequential and we chose instead to prioritize the key dependent
variables (putting those measures that rely on memory at the start of
the survey). Consequently, we intend to retain the current order of
questions in the survey.
y. The box for Question Q30 of Study 1 prompts the subject to
respond, even if the individual did not select anything in the website
as false or misleading. FDA should consider using a tiered response:
Q30a: Did you notice anything on the website that is false or
misleading?
1. Yes (go to question 30b).
[[Page 58419]]
2. No (go to question 31).
Q30b: What information was false or misleading? [open box comment]
(Response) A programming note was missing in the original survey
draft. The current survey programming reflects the approach suggested
by the commenter.
z. The commenter recommends revising Question Q32 of Study 1 to:
``If there was a way to report misleading prescription drug websites or
ads to the Food and Drug Administration (FDA) by sending an email or
calling a toll-free phone number, how likely would you report
misleading material?''
(Response) We have adopted this recommendation in the revised
survey.
aa. As previously stated in footnote 21, Questions Q34, Q41, and
Q42 of Study 1 should be deleted.
Footnote 21 reads: For example, FDA completed a HCP study
incorporating information asked at Q34, Q41, and Q42 of Study 1. It is
not clear why the Agency is undertaking another study focusing on such
questions. These questions should be eliminated.
(Response) Please see our response to Comment 3d.
bb. Question S1 of Study 2 should be rewritten as follows: ``Have
you ever been diagnosed with obesity, defined as body mass index
greater than or equal to 30?'' This change aligns the question with the
description of the study in the PRA Notice: ``Study 2 will sample
consumers diagnosed with obesity. . . .''
(Response) For this study, our intent was to target people that
would be in the audience for these ads, and being diagnosed is not a
requirement for personal relevance. The target audience is consumers
with a body mass index greater than or equal to 30.
cc. The ``Debriefing'' does not accurately portray the purpose of
the studies. The purpose of the studies is not ``to learn about how
people feel about information provided in prescription drug websites
aimed at consumers/providers and how people use this information to
understand how well prescription drugs work.'' The commenter recommends
that the ``Debriefing'' read: ``The purpose of this study is to
investigate the ability of consumers/providers to identify false or
misleading prescription drug promotion and how likely consumers/
providers are to report false or misleading prescription drug promotion
to regulatory authorities.''
(Response) We have adopted this recommendation.
(Comment 4) regulations.gov tracking number 1k1-8v3r-jacf
(summarized for brevity):
a. The commenter expressed concern about the practical utility of
the consumer-oriented arms of the research. Namely, if consumers are
unfamiliar with the prescribing information for the product, it is
unclear on which basis they can determine a claim to be deceptive.
(Response) Please see our response to Comment 3f, which addresses a
similar theme and may provide useful context. The concern addressed by
the commenter is framed as a limitation of the study and appears to
question the relevance of examining consumers' ability to detect
deception in prescription drug promotion. We believe the opposite is
correct: The merit of conducting the study is reinforced by the
observation that it is unclear how consumers can determine a claim to
be deceptive if they lack relevant background information or knowledge
about an advertised drug. While prescription drug promotions are
required to present truthful and non-misleading information, some
prescription drug promotion nevertheless includes false or misleading
claims, images, or presentations. DTC prescription drug promotion can
help provide consumers with truthful information about drugs. When it
does so, it can help consumers to make well-informed decisions when
determining whether to explore treatment options and when making
ultimate treatment choices, and it can provide useful and actionable
information about a product's efficacy and risks to consumers already
on treatment, among other outcomes. Yet, because the information in
prescription drug promotion is not always truthful, consumers must make
judgments about whether it is true, misleading, or false. And the same
background knowledge that a consumer might rely on to identify a claim
as deceptive would also be used to decide that a claim is true. As the
commenter points out, this background information may be incomplete or
inadequate for the task, and yet some presume that consumers (and, for
that matter, healthcare providers) are typically able to distinguish
between true claims and those that are false or misleading. Concerns
like the one voiced here and the empirical literature on the topic
suggest there is reason to doubt this presumption, thus warranting the
proposed study.
b. The commenter expressed concern that the varied causes of
obesity will result in a heterogeneous population which could
potentially confound the results of the study.
(Response) We consider diversity within this illness population to
be an asset. Also, random assignment will help to control extraneous
influences because it will create groups that, on average, are
probabilistically similar to each other. Because randomization
eliminates most other sources of systematic variation, researchers can
be reasonably confident that any effect that is found is the result of
the intervention and not some preexisting differences between the
groups (Ref. 20). Consequently, the varied causes of obesity should not
impact the results. The primary intention of the research is to
empirically examine consumer and HCP ability to detect and report
deceptive prescription drug promotion, but we have to choose stimuli
(and by extension, an illness population) in order to empirically test
our research questions. By choosing illness conditions with diverse
patient populations, we can better grasp how consumers and HCPs from
all walks of life react to deceptive prescription drug promotion. Also
see response to comment 3j.
(Comment 5) regulations.gov tracking number 1k1-8v3v-v60p (verbatim
with header and footer language, introductory language, and supporting
references removed):
We strongly support FDA's proposed project as part of the Agency's
broader research efforts to better understand the impact of
prescription drug promotion and direct-to-consumer advertising (DTC).
Research regarding deceptive advertising is becoming increasingly
important as DTC continues to grow at unprecedented rates. One analysis
estimated DTC spending in 2015 at $5.2 billion--a growth of over 60
percent in just 4 years. Five drugs--HUMIRA, LYRICA, ELIQUIS, CIALIS,
and XELJANZ--accounted for one-quarter of this $5.2 billion.
Importantly, these figures are an underestimate, as they do not account
for spending on digital ads and social media.
The risks and benefits of DTC have been well noted and debated. DTC
may promote patient dialogue with healthcare providers and remove the
stigma associated with certain diseases. However, there are also
significant concerns that DTC may be misleading, overemphasize a drug's
benefits as compared to risks, and lead to inappropriate prescribing
and overutilization.
Again, we applaud the FDA's efforts in this important area. The
need to better understand the ability of consumers and healthcare
professionals to detect and report misleading DTC is critical as the
use of DTC continues to
[[Page 58420]]
grow. Thank you for the opportunity to provide these comments.
(Response) FDA appreciates this support.
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)
-------------------------
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.
III. References
The following references are on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 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. 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,
29(1): 110-118, 2014.
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, 17: 433-437, 2014.
3. Mitra, A., M.A. Raymond, and C.D. Hopkins. ``Can Consumers
Recognize Misleading Advertising Content in a Media Rich Online
Environment?'' Psychology & Marketing, 25(7): 655-674, 2008.
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, 30(2): 157-167, 2011.
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, 20:
1330-1336, 2015.
6. Nahin, R.L. ``Estimates of Pain Prevalence and Severity in
Adults: United States, 2012.'' Journal of Pain, 16(8): 769-780,
2015.
7. U.S. Department of Health and Human Services, Centers for Disease
Control and Prevention, National Center for Health Statistics.
``Healthy Weight, Overweight, and Obesity Among Adults Aged 20 and
Over, by Selected Characteristics: United States, Selected Years
1988-1994 Through 2009-2012 [Table].'' In Health, United States,
2014 with special feature on adults aged 55-64 (pp. 214220; DHHS
Publication No. 2015-1232). Retrieved from https://www.cdc.gov/nchs/data/hus/hus14.pdf.
8. Krosnick, J.A. and S. Presser. ``Question and Questionnaire
Design.'' In: Handbook of Survey Research (pp. 263-314). Bingley,
United Kingdom: Emerald Group Publishing Limited, 2010.
9. Converse, J.M. and, S. Presser. Survey Questions: Handcrafting
the Standardized Questionnaire (No. 63). Thousand Oaks, CA: SAGE
Publications, 1986.
10. DeVellis, R.F. Scale Development: Theory and Applications (Vol.
26). Thousand Oaks, CA: SAGE Publications, 2016.
11. Sullivan, H.W., K.J. Aikin, E. Chung-Davies, and M. Wade.
``Prescription Drug Promotion from 2001-2014: Data from the U.S.
Food and Drug Administration.'' PLoS ONE, https://dx.doi.org/10.1371/journal.pone.0155035, 2016.
12. Liang, B.A. and T.K. Mackey. ``Prevalence and Global Health
Implications of Social Media in Direct-to-Consumer Drug
Advertising.'' Journal of Medical Internet Research, 13(3), e64,
2011.
13. Southwell, B.G. and D.J. Rupert. ``Future Challenges and
Opportunities in Online Prescription Drug Promotion Research.''
International Journal of Health Policy and Management, 5(3), 211-
213, 2016.
14. Davis, J.J., E. Cross, and J. Crowley. ``Pharmaceutical Web
Sites and the Communication of Risk Information.'' Journal of Health
Communication, 12, 29-39, 2007.
15. Singleton, Jr., R.A., B.C. Straits, and M.M. Straits. Approaches
to Social Research. Oxford, United Kingdom: Oxford University Press,
1993.
16. Aday, L.A. and L.J. Cornelius. Designing and Conducting Health
Surveys: A Comprehensive Guide. Hoboken, NJ: John Wiley & Sons,
2006.
17. Xie, G.X. ``Deceptive Advertising and Third-Person Perception:
The Interplay of Generalized and Specific Suspicion.'' Journal of
Marketing Communications, 22(5), 494-512. doi:10.1080/
13527266.2014.918051, 2014.
18. Sun, Y., Z. Pan, and L. Shen. ``Understanding the Third-Person
[[Page 58421]]
Perception: Evidence from a Meta-Analysis.'' Journal of
Communication, 58(2), 280-300, 2008.
19. DeLorme, D.E., J. Huh, and L.N. Reid. ``Perceived Effects of
Direct-To-Consumer (DTC) Prescription Drug Advertising on Self and
Others.'' Journal of Advertising, 35(3), 47-65, 2006.
20. Fisher, R.A. The Design of Experiments. Edinburgh, United
Kingdom: Oliver and Boyd, 1937.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26704 Filed 12-11-17; 8:45 am]
BILLING CODE 4164-01-P