Industry Brief
Intouch to Weigh In on FDA Research Proposal
on Character-Space-Limited Online Prescription
Drug Communications
Intouch Invites Clients, Industry to Join the Conversation
December 2016
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EXECUTIVE SUMMARY
The US Food and Drug Administration (FDA) has announced its intent to study the use of
character-space-limited online platforms for prescription drug communications — specifically,
Twitter and Google sponsored links. The objective of the research is “to test 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.”
The objective of the research is “to test 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.”
The FDA is soliciting public comment regarding the study design, and Intouch intends to provide
input. We invite our clients to participate in the dialogue, as well. Comments must be submitted
to the FDA by January 6, 2017. Intouch has obtained a copy of the FDA’s annotated study
questionnaire, which we’d be happy to share upon request.
INTRODUCTION
The Federal Food, Drug, and Cosmetic (FD&C) Act, sec. 301(b) prohibits “The adulteration or
misbranding of any food, drug, device or cosmetic in interstate commerce.” The FDA is
entrusted with helping to enforce the Act through a variety of mechanisms, including regulations
and guidances and, if appropriate, through warning and untitled letters.
From time to time, the FDA commissions research on a variety of topics involving promotion —
including direct-to-consumer advertising — to guide the life sciences industry and its service
providers (collectively, the “Industry”). The results of the studies are published, available and
used by the FDA in the development of policy.
CURRENT STANDARDS
The FDA requires “fair balance of the content and prominence of risk and benefit information in
prescription drug product claim promotion.” However, microblogging platforms like Twitter and
sponsored-link promotions (e.g., Google paid advertising) have strict character limitations that
can significantly restrain drug promotion when current fair balance requirements must be met.
In 2014, the FDA released draft guidance to address these concerns, stating, “Regardless of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.” Intouch Solutions provided an overview of the 2014 guidance in this POV.
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These character-space limits have been the subject of legislation and some have
recommended the use of a link to a landing page that contains substantive risk information.
THE FDA STUDY
The FDA plans to analyze the use of “character-space-limited communications” of risk
information with a link to a landing page containing the risk information.
The FDA is now looking to compare (a) inclusion of risk information within a character-limited
post or ad against (b) inclusion of just a link from the post or ad to a landing page containing the
risk information. The goal is to compare the two methods’ abilities to effectively communicate
risks when benefit claims are made. The FDA proposes a series of four studies to include:
 Two platforms: Google and Twitter
 Two fictional drugs – one to treat migraines and one to treat weight loss
 Two user goals – browsing and searching
Fig.1: Simplified summary of proposed study design
The FDA hypothesizes that specific situations will provide greater retention of the risk information and
higher perceived risk by the user, including:
 When users see substantive risk information in the character-space-limited communication
versus only in a link to a landing page
 When a user has a goal of searching versus browsing
Prior to beginning the study, the FDA is inviting feedback on the following:
1. Whether the proposed collection of information is necessary for the proper performance of
the FDA's functions, including whether the information will have practical utility;
2. The accuracy of the FDA's estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used;
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3. Ways to enhance the quality, utility and clarity of the information to be collected; and
4. Ways to minimize the burden of the collection of information on respondents, including
through the use of automated collection techniques, when appropriate, and other forms of
information technology.
WHAT IT COULD MEAN FOR PHARMA
The FDA is examining the standard for displaying risk information in character-space-limited online
communications. Optimistically, this could signal the agency’s willingness to shift its current position
toward a more lenient standard.
Alternatively, if the studies find deficiencies in the proposed risk-information-display format, the
agency would likely conclude that the proposed landing-page format does not adequately provide
fair balance of benefit and risk information.
This study presents an opportunity for the Industry to make the case for the landing-page format,
which would remove some significant roadblocks to engaging with consumers in these spaces.
JOIN US AND BE HEARD
Intouch has been successfully navigating regulatory issues since day one. Together with the Kulkarni
Law Firm — which also has extensive experience with complex regulatory pharmaceutical,
biopharmaceutical, and medical device affairs — we intend to leverage this opportunity to engage
with the FDA on behalf of the Industry.
Among other topics, we plan to respond to the Notice with our comments on the following:
 proposed study, specifically the study hypothesis
 rationale for conditions selected
 planned response-collection techniques and devices
Furthermore, we’d like to incorporate input from our clients, so that our response fairly represents the
Industry viewpoint and gives voice to companies that would prefer not to go on the record as
engaging with the FDA on this issue. We are happy to include your comments as part of our response
either as a joint reply or anonymously, whichever you prefer.
If you’d like to submit comments to us, have a more in-depth discussion about the study and its
potential implications, or receive a copy of the FDA’s survey, please send comments or queries to
[email protected] with the subject line “FDA-2016-N-3585” before December 15,
2016.
Intouch Solutions and Kulkarni Law will submit a response to the FDA prior to the January 6, 2017
deadline and will subsequently publicly release a copy of the response.
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