Document ID: FDA-2016-N-3585-0014
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Character-Space-
Limited Online Prescription Drug Communications
Posted Date: 2017-07-18T04:00Z

[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]

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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 (http://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: http://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. http://www.politico.com/story/2015/06/at-the-fda-drugs-and-tweets-dont-mix-118693.
5. http://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