Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Character-Space-Limited Online Prescription Drug Communications, 32842-32846 [2017-15002]
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
person for this jurisdiction; the
jurisdictions Web site address and if the
jurisdiction is willing to serve as an
auditor for another jurisdiction. Part 2
requires information about enrollment,
whether this jurisdiction is a new
enrollee and the date of enrollment;
indication whether this jurisdiction
would like to be removed from the
jurisdiction listing; indication of
requires permission to publish
information on FDA’s Web site by
checking the appropriate box(es) to
indicate what information FDA may
publish on the Web site.
FDA estimates the reporting burden
for this collection of information as
follows:
updated findings to the self-assessment
or verification audit. Part 3 requires
information about self-assessment
findings and verification audit findings;
dates when self-assessment was
completed; which standards have been
met as determined by the selfassessment; which standards have been
met as verified by a verification audit
including the completion dates. Part 4
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(hours)
Activity
FDA form
Total hours
Submission of ‘‘Voluntary
National Retail Food Regulatory Program Standards FDA National Registry Report’’.
Request for documentation
of successful completion
of staff training.
3,958 ..................................
500
1
500
* 0.1
50
Conference for Food Protection Training Plan and
Log.
500
3
1,500
* 0.1
150
Total .............................
.............................................
........................
........................
........................
........................
200
1 There
sradovich on DSK3GMQ082PROD with NOTICES
*6
are no capital costs or operating and maintenance costs associated with this collection of information.
minutes
FDA bases its estimates of the number
of respondents and the hours per
response on its experience with the
Program Standards. As explained
previously, FDA estimates that no more
than 500 regulatory jurisdictions will
participate in the Program Standards in
any given year. FDA estimates a total of
6 minutes annually for each enrolled
jurisdiction to complete the form. FDA
bases its estimate on the small number
of data elements on the form and the
ease of availability of the information.
FDA estimates that, annually, 500
regulatory jurisdictions will submit one
Form FDA 3958 for a total of 500 annual
responses. Each submission is estimated
to take 0.1 hour (or 6 minutes) per
response for a total of 50 hours. In
addition, FDA estimates that, annually,
500 regulatory jurisdictions will submit
three requests for documentation of
successful completion of staff training
using the CFP Training Plan and Log for
a total of 1,500 annual responses. Each
submission is estimated to take 0.1 hour
(or 6 minutes) per response for a total
of 150 hours. The total reporting burden
for this information collection is 200
hours.
Thus, the total hourly burden for this
information collection is 47,345 hours
(47,145 recordkeeping hours and 200
reporting hours).
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Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–14994 Filed 7–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3585]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Character-SpaceLimited Online Prescription Drug
Communications
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.
DATES: Fax written comments on the
collection of information by August 17,
2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
SUMMARY:
PO 00000
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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 ‘‘Character-Space-Limited Online
Prescription Drug Communications.’’
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, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Character Space-Limited Online
Prescription Drug Communications
OMB Control Number 0910—NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (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
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
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 section
502(a) and (n), 201(n) of the FD&C Act
(21 U.S.C. 352(a) and (n), 321(n)); see
also 21 CFR 202.1).
Prescription drug regulations require
a fair balance of the content and
prominence of risk and benefit
information in prescription drug
product claim promotion. The rise of
Internet communications that have
character space limitations, such as
sponsored link promotion and
microblog messaging, has led to
questions about how to use these
communications for prescription drug
promotion while complying with the
fair balance requirements. In 2014, FDA
released a draft guidance entitled,
‘‘Guidance for Industry Internet/Social
Media Platforms with Character Space
Limitations—Presenting Risk and
Benefit Information for Prescription
Drugs and Medical Devices,’’ (Ref. 1)
which states:
Regardless of character space constraints
that may be present on certain Internet/social
media platforms, if a firm chooses to make
a product benefit claim, the firm should also
incorporate risk information within the same
character-space-limited communication. The
firm should also provide a mechanism to
allow direct access to a more complete
discussion of the risks associated with its
product.
The concept of linking to risk
information by providing substantive
product risk information on a landing
page (‘‘link to the risk information’’),
rather than presenting substantive risk
information together with product
benefit information within the
character-space-limited communication,
has been the subject of legislation and
has been discussed as an option by
some in industry and media (for
example, Refs. 2–5).
The studies are designed to address
the question of whether substantive risk
information in the character-space-
limited communications is effective in
communicating risks when benefit
claims are made, or whether a link to
the risk information is sufficient. Within
each study, we will manipulate whether
or not substantive risk information
appears in the character-space-limited
communication.
Another factor to consider is that
when consumers turn to the Internet for
information, they are driven by different
goals. These goals can affect what
information they pay attention to and
what kind of information they find
(Refs. 6–8). Therefore, we will also
manipulate whether participants are
instructed to browse the information or
to search for specific information.
Two pretests will be conducted to test
the goal instructions, stimuli,
questionnaire, and procedure. In studies
1–4, participants will be randomly
assigned to one experimental condition
and will view the corresponding study
materials (tables 1–4). Across all
studies, we will examine two different
character-space-limited formats and two
medical conditions. For pretest 1 and
study 1, the study materials will be a
character-space-limited communication
about a fictional weight loss drug,
embedded in a Google search page about
weight loss. The study 2 materials will
be a character-space-limited
communication about a fictional drug to
treat migraine, embedded in a Google
search page about migraine. The study
3 materials will be a character-spacelimited communication about a fictional
weight loss drug, embedded in a Twitter
search page about weight loss. The
pretest 2 and study 4 materials will be
a character-space-limited
communication about a fictional drug to
treat migraine, embedded in a Twitter
search page about migraine.
All study materials will allow for
scrolling and clicking on any links. The
study materials will be accessible by
participants only. After viewing the
study materials, participants will
complete a questionnaire that assesses
participants’ retention of the risk
information and their perceptions of the
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drug’s risks and benefits. We will also
measure covariates such as
demographics and health literacy. The
questionnaires are available upon
request.
We hypothesize that participants who
see substantive risk information in the
character-space-limited communication,
compared with link-only participants,
will have greater retention of the risk
included in the communication and
higher perceived risk. We will explore
whether including substantive risk
information in the character-spacelimited communication affects the
likelihood that participants notice the
communication or click the link to the
risk information. We hypothesize that
participants with a search goal,
compared with a browse goal, will have
greater retention of the benefit and risk
information and higher perceived risk
because they will be more likely to
notice the character-space-limited
communication and to click the link to
the risk information. We will test these
hypotheses in studies 1–4 to determine
whether these effects hold across
different medical conditions and
different character-space-limited
platforms. To test these hypotheses, we
will conduct inferential statistical tests
such as logistic regression and analysis
of variance.
All participants will be 18 years of age
or older. We will exclude individuals
who work in healthcare or marketing.
Half of the studies will have a sample
of participants who self-report needing
to lose 30 pounds or more; the other half
will have a sample of participants who
self-report suffering from migraines. We
selected these samples to increase the
likelihood that participants will be
interested in the fictitious study drugs
and therefore motivated to pay attention
during the study. The studies will be
conducted with an Internet panel. With
the sample sizes described in the tables,
we will have sufficient power to detect
small-sized effects in studies 1–4 (table
5).
TABLE 1—STUDY 1: GOOGLE SPONSORED LINK, WEIGHT LOSS
Motivation
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General search
Risk only
landing page
Mobile ............................
Risk Location
Desktop/Laptop ..............
Risk Location
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Learn about treatments
Risk and
benefit
landing page
In character space-limited
communication.
On linked Web page only.
In character space-limited
communication.
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Risk only
landing page
Risk and
benefit
landing page
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TABLE 1—STUDY 1: GOOGLE SPONSORED LINK, WEIGHT LOSS—Continued
Motivation
General search
Risk only
landing page
Learn about treatments
Risk and
benefit
landing page
Risk only
landing page
Risk and
benefit
landing page
On linked Web page only
TABLE 2—STUDY 2: GOOGLE SPONSORED LINK, MIGRAINE
Motivation
General search
Risk only
landing page
Mobile ............................
Risk Location
Desktop/Laptop ..............
Risk Location
Learn about treatments
Risk and
benefit
landing page
Risk only
landing page
Risk and
benefit
landing page
In character space-limited
communication.
On linked Web page only.
In character space-limited
communication.
On linked Web page only.
TABLE 3—STUDY 3: TWITTER, WEIGHT LOSS
Motivation
General search
Risk only
landing page
Mobile ............................
Risk Location
Desktop/Laptop ..............
Risk Location
Learn about treatments
Risk and
benefit
landing page
Risk only
landing page
Risk and
benefit
landing page
In character space-limited
communication.
On linked Web page only.
In character space-limited
communication.
On linked Web page only.
TABLE 4—STUDY 4: TWITTER, MIGRAINE
Motivation
General search
Risk only
landing page
Risk Location
Desktop/Laptop ..............
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Mobile ............................
Risk Location
Learn about treatments
Risk and
benefit
landing page
Risk only
landing page
Risk and
benefit
landing page
In character space-limited
communication.
On linked Web page only.
In character space-limited
communication.
On linked Web page only.
FDA estimates the burden of this
collection of information as follows:
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Pretest 1 screener ................................................
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Number of
responses per
respondent
464
Frm 00060
Fmt 4703
1
Sfmt 4703
Total annual
responses
Average burden
per response
1
E:\FR\FM\18JYN1.SGM
0.08 (5 minutes) ...........
18JYN1
Total hours
39
Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
32845
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Pretest 2 screener ................................................
Study 1 screener ..................................................
Study 2 screener ..................................................
Study 3 screener ..................................................
Study 4 screener ..................................................
Pretest 1 ...............................................................
Pretest 2 ...............................................................
Study 1 ..................................................................
Study 2 ..................................................................
Study 3 ..................................................................
Study 4 ..................................................................
464
786
786
786
786
277
277
469
469
469
469
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Total ...............................................................
6,502
........................
........................
1 There
(5 minutes) ...........
(5 minutes) ...........
(5 minutes) ...........
(5 minutes) ...........
(5 minutes) ...........
(20 minutes) .........
(20 minutes) .........
(20 minutes) .........
(20 minutes) .........
(20 minutes) .........
(20 minutes) .........
39
66
66
66
66
93
93
157
157
157
157
.......................................
1,156
are no capital costs or operating and maintenance costs associated with this collection of information.
In the Federal Register of November
7, 2016 (81 FR 78163), FDA published
a 60-day notice requesting public
comment on the proposed extension of
this collection of information. Eleven
comments were received. Two
comments did not address any of the
information collection topics solicited
and therefore we do not discuss them in
this document (they called for a ban on
prescription drug character-spacelimited communications). No comments
addressed Topic 2—Accuracy of Our
Estimate.
Topic 1—Practical Utility
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0.08
0.08
0.08
0.08
0.08
0.33
0.33
0.33
0.33
0.33
0.33
Total hours
Four comments addressed topic 1
with respect to the practical utility of
the study stimuli and real-world
application. FDA’s goal is always to
regulate prescription drug promotion in
support of our public health mission.
We are not aware of any studies, to date,
that specifically assess the general
question of whether a link to
prescription drug information can
effectively convey the risks associated
with a drug when benefit claims about
that drug are made within characterspace-limited communications. This
concept has been suggested in various
ways by our stakeholders, and we feel
that it is important to gain further
insight into this potential practice. We
appreciate the considerations these
comments have put forth; however, we
feel that the current objective is
important and will maintain it for this
project.
One comment stated that a balance of
risk and benefit is not needed in a
character-space-limited communication.
The proposed research is designed to
test this question.
One comment encouraged
dissemination of our results and
requested we indicate a subsequent use
for this information collection. We plan
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to disseminate our results via our Web
site and peer-reviewed publication. FDA
will use the information from this study
to inform its understanding and
regulation of prescription drug
promotion. Results from studies we
conduct are evaluated within the
broader context of research and findings
from other sources.
Topic 3—Ways To Enhance Quality,
Clarity, Utility
Comments Related to Study Design
Several comments suggested ways to
enhance the study design. Four
comments suggested alternate study
objectives, such as testing risk icons,
testing different kinds of characterspace-limited communications, and
testing direct-to-consumer promotion in
the presence of misinformation about
the product. We appreciate these
suggestions for future studies. However,
we feel the current objectives are
important and will maintain them for
this project.
Two comments recommended
including mobile displays. We agree
and will recruit an equal number of
participants who are using mobile and
non-mobile devices. This will not
change the study burden.
One comment suggested manipulating
whether the landing page includes only
risk information or whether it includes
risk and benefit information. We have
taken this suggestion and revised the
study design. This does not change the
study burden.
One comment suggested evaluating
participant engagement with the
stimuli. We plan to measure engagement
variables such as clicking links and
scrolling.
One comment suggested that the issue
we should be studying is whether
consumers know that drugs generally
have risks rather than whether
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consumers know the specifics risks
associated with a drug. We believe the
purpose of communicating the drug’s
specific risk information is so
consumers can make informed decisions
based on both the drug’s benefits and
risks.
One comment suggested FDA conduct
background research before conducting
the proposed research. We appreciate
these suggestions, and note that FDA
has undertaken a content analysis of
mobile prescription drug promotion
(https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofMedicalProducts
andTobacco/CDER/ucm090276.htm).
For this proposed research, FDA wishes
to use its resources more pointedly
toward the research questions proposed
in this notice.
One comment suggested explicitly
telling participants to search for drug
risk information. We will use random
assignment to instruct participants
either to search or browse for
information. However, we will not
instruct participants to search for risk
information, specifically, because we
are interested in how individuals
respond to character-space-limited
communications with and without risk
information rather than whether
participants can find risk information
when they are instructed to search for
it.
One comment suggested that the
browse/search goal construct was not
relevant because approximately half of
U.S. Internet users have searched for
medical information online and because
this construct hasn’t been studied in the
realm of prescription drug information
before. The comment asserts that
consumers are unlikely to browse health
information online. This comment
assumes that only consumers actively
searching for prescription drug
information will be exposed to
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
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communications about these products.
We disagree. Consumers who view
information about a topic more
generally (such as weight loss) may not
be actively searching for prescription
drug information but may come across
it anyway. Our conditions are meant to
simulate a search of ‘‘migraine’’ or
‘‘weight loss’’ that contains prescription
drug information, for which consumers
either will or will not specifically be
looking.
One comment suggested adding a
general population sample. We chose to
recruit individuals with the medical
condition being advertised to increase
the likelihood that participants will be
engaged with the browse and search
tasks. Weight concerns and migraine
affect large segments of the population.
To reduce burden, we do not plan to
add a general population sample.
One comment suggested that we
change the ‘‘browse2’’ instruction so
that it discusses browsing information
in general rather than referring to a
topic. We made this change.
Comments Related to Study Stimuli
Several comments suggested ways to
enhance the study stimuli. Four
comments suggested testing Twitter
cards or photos embedded in tweets that
would expand the space available to
communicate risk information.
Sponsors are permitted to promote their
products on platforms using additional
multimedia components, and we
appreciate these suggestions for future
studies. However, the current study
aims to address the more general
question of whether a link to
prescription drug risk information can
effectively convey the risks associated
with a drug when benefit claims about
that drug are made within characterspace-limited communications used in
prescription drug promotion.
One comment addressed the content
surrounding the character-space-limited
communication. The other links and
tweets will replicate real-world
searches, including links to general
health information Web sites and links
to Web sites for other (non-prescription)
treatments. The surrounding content
will not differ across condition for
experimental control.
One comment suggested using highvisibility techniques to communicate
risks. We appreciate this suggestion but
we intend to make the prominence of
the risk and benefit information
comparable in these studies.
One comment suggested formatting
the landing page to optimize readability
(e.g., easy-to-read font size) and
ensuring participants know they can
click the links. We will take these
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suggestions when we create the landing
pages and study instructions. Another
comment suggested specific tools to use
to create our stimuli. We are employing
a professional firm to create realistic
stimuli.
One comment suggested using
‘‘decoy’’ links/tweets and suggested
randomizing the order of the links/
tweets to decrease bias. We will have
nine other links or tweets, for a total of
ten to simulate one search page. To
make the stimuli as close to real-world
online searches as possible, the
sponsored link will always appear at the
top of the search results. To keep the
stimuli similar across studies, the tweet
will also appear at the top of the page.
The order will remain constant across
conditions in all studies.
One comment suggested changing
‘‘Important Risk Information’’ to ‘‘See
Important Risk Information’’ to include
a ‘‘call to action.’’ We have made this
change.
Comments Related to the Questionnaire
Several comments had suggestions for
how we ask our questions. Two
comments suggested changes to our
medical condition screening questions.
These questions come from the National
Health Interview Survey and the
National Health and Nutrition
Examination Survey. We plan to keep
these questions ‘‘as is’’ so we can
compare our samples to these national
samples. We will change the description
of our samples to match these questions.
Two comments suggested adding a
‘‘don’t know’’ option or letting some
participants opt out of the first series of
questions. We added a ‘‘don’t know’’
option to these questions. We will use
cognitive interviews and pretests to
assess whether we need to make
additional changes, including other
minor wording changes suggested in the
comments.
Two comments suggested moving,
editing, or deleting specific questions
(such as perceptions and intentions).
We moved the items as suggested, and
will flag these items for potential editing
or removal based on cognitive interview
and pretest results.
One comment suggested screening out
participants who had never used Google
or Twitter and participants with low
health literacy. We added a screening
question regarding Internet usage. We
do not plan to screen based on literacy,
but rather we will examine whether
literacy moderates any effects.
One comment suggested defining
‘‘serious side effect’’ for consumers;
however, previous FDA research found
that consumers were able to understand
this concept (Ref. 9).
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Topic 4—Ways To Minimize Burden
One comment addressed topic 4. This
comment suggested conducting 20 hourlong qualitative interviews per study
rather than conducting pretests. To
clarify, we will conduct nine hour-long
qualitative interviews to cognitively test
the study stimuli and materials. We will
use the pretests to test and select the
browse and search goal instructions for
the main studies and to pilot the main
studies.
II. References
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. ‘‘Guidance for Industry: Internet/Social
Media Platforms with Character Space
Limitations—Presenting Risk and Benefit
Information for Prescription Drugs and
Medical Devices,’’ available at: https://
www.fda.gov/downloads/drugs/guidance
complianceregulatoryinformation/
guidances/ucm401087.pdf.
2. https://www.congress.gov/bill/114thcongress/house-bill/2479/text.
3. https://www.fda.gov/AboutFDA/Centers
Offices/OfficeofMedicalProductsand
Tobacco/CDER/ucm184250.htm.
4. https://www.politico.com/story/2015/06/atthe-fda-drugs-and-tweets-dont-mix118693.
5. https://www.dtcperspectives.com/is-oneclick-in-the-cards/.
6. Detlor, B., S. Sproule, and C. Gupta, ‘‘PrePurchase Online Information Seeking:
Search Versus Browse.’’ Journal of
Electronic Commerce Research, vol. 4,
pp. 72–84, 2003.
7. Pieters, R. and M. Wedel, ‘‘Goal Control of
Attention to Advertising: The Yarbus
Implication.’’ Journal of Consumer
Research, vol. 34, pp. 224–233, 2007.
8. Schlosser, A.E., ‘‘Experiencing Products in
the Virtual World: The Role of Goal and
Imagery in Influencing Attitudes Versus
Purchase Intentions.’’ Journal of
Consumer Research, vol. 30, pp. 184–
198, 2003, https://dx.doi.org/10.1086/
376807.
9. FDA. ‘‘Toll-Free Number for Reporting
Adverse Events on Labeling for Human
Drug Products; Final Rule.’’ 73 FR 63886
to 6389. Available at https://
www.regulations.gov/document?D=FDA2003-N-0313-0008, 2008.
Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15002 Filed 7–17–17; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32842-32846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15002]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-3585]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Character-Space-
Limited Online Prescription Drug Communications
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.
DATES: Fax written comments on the collection of information by August
17, 2017.
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 ``Character-Space-Limited Online Prescription Drug
Communications.'' 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, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Character Space-Limited Online Prescription Drug Communications
OMB Control Number 0910--NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (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
[[Page 32843]]
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 section 502(a) and (n), 201(n) of the FD&C Act (21 U.S.C.
352(a) and (n), 321(n)); see also 21 CFR 202.1).
Prescription drug regulations require a fair balance of the content
and prominence of risk and benefit information in prescription drug
product claim promotion. The rise of Internet communications that have
character space limitations, such as sponsored link promotion and
microblog messaging, has led to questions about how to use these
communications for prescription drug promotion while complying with the
fair balance requirements. In 2014, FDA released a draft guidance
entitled, ``Guidance for Industry Internet/Social Media Platforms with
Character Space Limitations--Presenting Risk and Benefit Information
for Prescription Drugs and Medical Devices,'' (Ref. 1) which states:
Regardless of character space constraints that may be present on
certain Internet/social media platforms, if a firm chooses to make a
product benefit claim, the firm should also incorporate risk
information within the same character-space-limited communication.
The firm should also provide a mechanism to allow direct access to a
more complete discussion of the risks associated with its product.
The concept of linking to risk information by providing substantive
product risk information on a landing page (``link to the risk
information''), rather than presenting substantive risk information
together with product benefit information within the character-space-
limited communication, has been the subject of legislation and has been
discussed as an option by some in industry and media (for example,
Refs. 2-5).
The studies are designed to address the question of whether
substantive risk information in the character-space-limited
communications is effective in communicating risks when benefit claims
are made, or whether a link to the risk information is sufficient.
Within each study, we will manipulate whether or not substantive risk
information appears in the character-space-limited communication.
Another factor to consider is that when consumers turn to the
Internet for information, they are driven by different goals. These
goals can affect what information they pay attention to and what kind
of information they find (Refs. 6-8). Therefore, we will also
manipulate whether participants are instructed to browse the
information or to search for specific information.
Two pretests will be conducted to test the goal instructions,
stimuli, questionnaire, and procedure. In studies 1-4, participants
will be randomly assigned to one experimental condition and will view
the corresponding study materials (tables 1-4). Across all studies, we
will examine two different character-space-limited formats and two
medical conditions. For pretest 1 and study 1, the study materials will
be a character-space-limited communication about a fictional weight
loss drug, embedded in a Google search page about weight loss. The
study 2 materials will be a character-space-limited communication about
a fictional drug to treat migraine, embedded in a Google search page
about migraine. The study 3 materials will be a character-space-limited
communication about a fictional weight loss drug, embedded in a Twitter
search page about weight loss. The pretest 2 and study 4 materials will
be a character-space-limited communication about a fictional drug to
treat migraine, embedded in a Twitter search page about migraine.
All study materials will allow for scrolling and clicking on any
links. The study materials will be accessible by participants only.
After viewing the study materials, participants will complete a
questionnaire that assesses participants' retention of the risk
information and their perceptions of the drug's risks and benefits. We
will also measure covariates such as demographics and health literacy.
The questionnaires are available upon request.
We hypothesize that participants who see substantive risk
information in the character-space-limited communication, compared with
link-only participants, will have greater retention of the risk
included in the communication and higher perceived risk. We will
explore whether including substantive risk information in the
character-space-limited communication affects the likelihood that
participants notice the communication or click the link to the risk
information. We hypothesize that participants with a search goal,
compared with a browse goal, will have greater retention of the benefit
and risk information and higher perceived risk because they will be
more likely to notice the character-space-limited communication and to
click the link to the risk information. We will test these hypotheses
in studies 1-4 to determine whether these effects hold across different
medical conditions and different character-space-limited platforms. To
test these hypotheses, we will conduct inferential statistical tests
such as logistic regression and analysis of variance.
All participants will be 18 years of age or older. We will exclude
individuals who work in healthcare or marketing. Half of the studies
will have a sample of participants who self-report needing to lose 30
pounds or more; the other half will have a sample of participants who
self-report suffering from migraines. We selected these samples to
increase the likelihood that participants will be interested in the
fictitious study drugs and therefore motivated to pay attention during
the study. The studies will be conducted with an Internet panel. With
the sample sizes described in the tables, we will have sufficient power
to detect small-sized effects in studies 1-4 (table 5).
Table 1--Study 1: Google Sponsored Link, Weight Loss
--------------------------------------------------------------------------------------------------------------------------------------------------------
Motivation
---------------------------------------------------------------
General search Learn about treatments
---------------------------------------------------------------
Risk and Risk and
Risk only benefit Risk only benefit
landing page landing page landing page landing page
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mobile............................. Risk Location......... In character space-limited
communication.
On linked Web page only.
Desktop/Laptop..................... Risk Location......... In character space-limited
communication.
[[Page 32844]]
On linked Web page only
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2--Study 2: Google Sponsored Link, Migraine
--------------------------------------------------------------------------------------------------------------------------------------------------------
Motivation
---------------------------------------------------------------
General search Learn about treatments
---------------------------------------------------------------
Risk and Risk and
Risk only benefit Risk only benefit
landing page landing page landing page landing page
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mobile............................. Risk Location......... In character space-limited
communication.
On linked Web page only.
Desktop/Laptop..................... Risk Location......... In character space-limited
communication.
On linked Web page only.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 3--Study 3: Twitter, Weight Loss
--------------------------------------------------------------------------------------------------------------------------------------------------------
Motivation
---------------------------------------------------------------
General search Learn about treatments
---------------------------------------------------------------
Risk and Risk and
Risk only benefit Risk only benefit
landing page landing page landing page landing page
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mobile............................. Risk Location......... In character space-limited
communication.
On linked Web page only.
Desktop/Laptop..................... Risk Location......... In character space-limited
communication.
On linked Web page only.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 4--Study 4: Twitter, Migraine
--------------------------------------------------------------------------------------------------------------------------------------------------------
Motivation
---------------------------------------------------------------
General search Learn about treatments
---------------------------------------------------------------
Risk and Risk and
Risk only benefit Risk only benefit
landing page landing page landing page landing page
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mobile............................. Risk Location......... In character space-limited
communication.
On linked Web page only.
Desktop/Laptop..................... Risk Location......... In character space-limited
communication.
On linked Web page only.
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA estimates the burden of this collection of information as
follows:
Table 5--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pretest 1 screener............ 464 1 1 0.08 (5 minutes) 39
[[Page 32845]]
Pretest 2 screener............ 464 1 1 0.08 (5 minutes) 39
Study 1 screener.............. 786 1 1 0.08 (5 minutes) 66
Study 2 screener.............. 786 1 1 0.08 (5 minutes) 66
Study 3 screener.............. 786 1 1 0.08 (5 minutes) 66
Study 4 screener.............. 786 1 1 0.08 (5 minutes) 66
Pretest 1..................... 277 1 1 0.33 (20 93
minutes).
Pretest 2..................... 277 1 1 0.33 (20 93
minutes).
Study 1....................... 469 1 1 0.33 (20 157
minutes).
Study 2....................... 469 1 1 0.33 (20 157
minutes).
Study 3....................... 469 1 1 0.33 (20 157
minutes).
Study 4....................... 469 1 1 0.33 (20 157
minutes).
---------------------------------------------------------------------------------
Total..................... 6,502 .............. .............. ................ 1,156
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
In the Federal Register of November 7, 2016 (81 FR 78163), FDA
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. Eleven comments were
received. Two comments did not address any of the information
collection topics solicited and therefore we do not discuss them in
this document (they called for a ban on prescription drug character-
space-limited communications). No comments addressed Topic 2--Accuracy
of Our Estimate.
Topic 1--Practical Utility
Four comments addressed topic 1 with respect to the practical
utility of the study stimuli and real-world application. FDA's goal is
always to regulate prescription drug promotion in support of our public
health mission. We are not aware of any studies, to date, that
specifically assess the general question of whether a link to
prescription drug information can effectively convey the risks
associated with a drug when benefit claims about that drug are made
within character-space-limited communications. This concept has been
suggested in various ways by our stakeholders, and we feel that it is
important to gain further insight into this potential practice. We
appreciate the considerations these comments have put forth; however,
we feel that the current objective is important and will maintain it
for this project.
One comment stated that a balance of risk and benefit is not needed
in a character-space-limited communication. The proposed research is
designed to test this question.
One comment encouraged dissemination of our results and requested
we indicate a subsequent use for this information collection. We plan
to disseminate our results via our Web site and peer-reviewed
publication. FDA will use the information from this study to inform its
understanding and regulation of prescription drug promotion. Results
from studies we conduct are evaluated within the broader context of
research and findings from other sources.
Topic 3--Ways To Enhance Quality, Clarity, Utility
Comments Related to Study Design
Several comments suggested ways to enhance the study design. Four
comments suggested alternate study objectives, such as testing risk
icons, testing different kinds of character-space-limited
communications, and testing direct-to-consumer promotion in the
presence of misinformation about the product. We appreciate these
suggestions for future studies. However, we feel the current objectives
are important and will maintain them for this project.
Two comments recommended including mobile displays. We agree and
will recruit an equal number of participants who are using mobile and
non-mobile devices. This will not change the study burden.
One comment suggested manipulating whether the landing page
includes only risk information or whether it includes risk and benefit
information. We have taken this suggestion and revised the study
design. This does not change the study burden.
One comment suggested evaluating participant engagement with the
stimuli. We plan to measure engagement variables such as clicking links
and scrolling.
One comment suggested that the issue we should be studying is
whether consumers know that drugs generally have risks rather than
whether consumers know the specifics risks associated with a drug. We
believe the purpose of communicating the drug's specific risk
information is so consumers can make informed decisions based on both
the drug's benefits and risks.
One comment suggested FDA conduct background research before
conducting the proposed research. We appreciate these suggestions, and
note that FDA has undertaken a content analysis of mobile prescription
drug promotion (https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm). For this
proposed research, FDA wishes to use its resources more pointedly
toward the research questions proposed in this notice.
One comment suggested explicitly telling participants to search for
drug risk information. We will use random assignment to instruct
participants either to search or browse for information. However, we
will not instruct participants to search for risk information,
specifically, because we are interested in how individuals respond to
character-space-limited communications with and without risk
information rather than whether participants can find risk information
when they are instructed to search for it.
One comment suggested that the browse/search goal construct was not
relevant because approximately half of U.S. Internet users have
searched for medical information online and because this construct
hasn't been studied in the realm of prescription drug information
before. The comment asserts that consumers are unlikely to browse
health information online. This comment assumes that only consumers
actively searching for prescription drug information will be exposed to
[[Page 32846]]
communications about these products. We disagree. Consumers who view
information about a topic more generally (such as weight loss) may not
be actively searching for prescription drug information but may come
across it anyway. Our conditions are meant to simulate a search of
``migraine'' or ``weight loss'' that contains prescription drug
information, for which consumers either will or will not specifically
be looking.
One comment suggested adding a general population sample. We chose
to recruit individuals with the medical condition being advertised to
increase the likelihood that participants will be engaged with the
browse and search tasks. Weight concerns and migraine affect large
segments of the population. To reduce burden, we do not plan to add a
general population sample.
One comment suggested that we change the ``browse2'' instruction so
that it discusses browsing information in general rather than referring
to a topic. We made this change.
Comments Related to Study Stimuli
Several comments suggested ways to enhance the study stimuli. Four
comments suggested testing Twitter cards or photos embedded in tweets
that would expand the space available to communicate risk information.
Sponsors are permitted to promote their products on platforms using
additional multimedia components, and we appreciate these suggestions
for future studies. However, the current study aims to address the more
general question of whether a link to prescription drug risk
information can effectively convey the risks associated with a drug
when benefit claims about that drug are made within character-space-
limited communications used in prescription drug promotion.
One comment addressed the content surrounding the character-space-
limited communication. The other links and tweets will replicate real-
world searches, including links to general health information Web sites
and links to Web sites for other (non-prescription) treatments. The
surrounding content will not differ across condition for experimental
control.
One comment suggested using high-visibility techniques to
communicate risks. We appreciate this suggestion but we intend to make
the prominence of the risk and benefit information comparable in these
studies.
One comment suggested formatting the landing page to optimize
readability (e.g., easy-to-read font size) and ensuring participants
know they can click the links. We will take these suggestions when we
create the landing pages and study instructions. Another comment
suggested specific tools to use to create our stimuli. We are employing
a professional firm to create realistic stimuli.
One comment suggested using ``decoy'' links/tweets and suggested
randomizing the order of the links/tweets to decrease bias. We will
have nine other links or tweets, for a total of ten to simulate one
search page. To make the stimuli as close to real-world online searches
as possible, the sponsored link will always appear at the top of the
search results. To keep the stimuli similar across studies, the tweet
will also appear at the top of the page. The order will remain constant
across conditions in all studies.
One comment suggested changing ``Important Risk Information'' to
``See Important Risk Information'' to include a ``call to action.'' We
have made this change.
Comments Related to the Questionnaire
Several comments had suggestions for how we ask our questions. Two
comments suggested changes to our medical condition screening
questions. These questions come from the National Health Interview
Survey and the National Health and Nutrition Examination Survey. We
plan to keep these questions ``as is'' so we can compare our samples to
these national samples. We will change the description of our samples
to match these questions.
Two comments suggested adding a ``don't know'' option or letting
some participants opt out of the first series of questions. We added a
``don't know'' option to these questions. We will use cognitive
interviews and pretests to assess whether we need to make additional
changes, including other minor wording changes suggested in the
comments.
Two comments suggested moving, editing, or deleting specific
questions (such as perceptions and intentions). We moved the items as
suggested, and will flag these items for potential editing or removal
based on cognitive interview and pretest results.
One comment suggested screening out participants who had never used
Google or Twitter and participants with low health literacy. We added a
screening question regarding Internet usage. We do not plan to screen
based on literacy, but rather we will examine whether literacy
moderates any effects.
One comment suggested defining ``serious side effect'' for
consumers; however, previous FDA research found that consumers were
able to understand this concept (Ref. 9).
Topic 4--Ways To Minimize Burden
One comment addressed topic 4. This comment suggested conducting 20
hour-long qualitative interviews per study rather than conducting
pretests. To clarify, we will conduct nine hour-long qualitative
interviews to cognitively test the study stimuli and materials. We will
use the pretests to test and select the browse and search goal
instructions for the main studies and to pilot the main studies.
II. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. ``Guidance for Industry: Internet/Social Media Platforms with
Character Space Limitations--Presenting Risk and Benefit Information
for Prescription Drugs and Medical Devices,'' available at: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm401087.pdf.
2. https://www.congress.gov/bill/114th-congress/house-bill/2479/text.
3. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htm.
4. https://www.politico.com/story/2015/06/at-the-fda-drugs-and-tweets-dont-mix-118693.
5. https://www.dtcperspectives.com/is-one-click-in-the-cards/.
6. Detlor, B., S. Sproule, and C. Gupta, ``Pre-Purchase Online
Information Seeking: Search Versus Browse.'' Journal of Electronic
Commerce Research, vol. 4, pp. 72-84, 2003.
7. Pieters, R. and M. Wedel, ``Goal Control of Attention to
Advertising: The Yarbus Implication.'' Journal of Consumer Research,
vol. 34, pp. 224-233, 2007.
8. Schlosser, A.E., ``Experiencing Products in the Virtual World:
The Role of Goal and Imagery in Influencing Attitudes Versus
Purchase Intentions.'' Journal of Consumer Research, vol. 30, pp.
184-198, 2003, https://dx.doi.org/10.1086/376807.
9. FDA. ``Toll-Free Number for Reporting Adverse Events on Labeling
for Human Drug Products; Final Rule.'' 73 FR 63886 to 6389.
Available at https://www.regulations.gov/document?D=FDA-2003-N-0313-0008, 2008.
Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15002 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P
