Social Media Draft Guidance
Webinar
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July 10, 2014
Thomas Abrams, Director
Office of Prescription Drug Promotion (OPDP)
Center for Drug Evaluation and Research (CDER)
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Presenters
• Thomas Abrams – Introductory Remarks
• Barbara Chong – Fulfilling Regulatory Requirements for
Postmarketing Submissions of Interactive Promotional Media for
Prescription Human and Animal Drugs and Biologics (Draft
Guidance)
• Jean-Ah Kang – Internet/Social Media Platforms with Character
Space Limitations—Presenting Risk and Benefit Information for
Prescription Drugs and Medical Devices (Draft Guidance)
• Julie Chronis – Internet/Social Media Platforms: Correcting
Independent Third-Party Misinformation About Prescription Drugs
and Medical Devices (Draft Guidance)
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Draft Guidance for Industry:
Fulfilling Regulatory Requirements for
Postmarketing Submissions of Interactive
Promotional Media for Prescription
Human and Animal Drugs and Biologics
Barbara Chong, Pharm.D.
Office of Prescription Drug Promotion
Social Media Draft Guidance Webinar
July 10, 2014
5
Outline
• Describe FDA’s current thinking about how firms can
fulfill the regulatory requirements for postmarketing
submissions of interactive promotional media for their
FDA-approved drug products
• Discuss the factors taken into consideration to determine
if product communications using interactive technologies
are subject to FDA’s postmarketing submission
requirements
• Provide FDA’s recommendations for submitting
interactive promotional materials
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Definitions
• Interactive promotional media includes modern tools
and technologies that often allow for real-time
communications and interactions (e.g., blogs,
microblogs, social networking sites, online communities,
and live podcasts) that firms use to promote their drugs
• Drugs include prescription human and animal drug and
biological products
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Factors in Determining Postmarketing Submission
Requirements for Interactive Promotional Media
• Agency considers whether the firm, or anyone acting on
its behalf, is influencing or controlling the promotional
activity or communication
• A firm is responsible for product promotional
communications on sites that are owned, controlled,
created, influenced, or operated by, or on behalf of, the
firm
• Responsible if the firm collaborates on or has editorial,
preview, or review privilege over the content
Factors in Determining Postmarketing Submission
Requirements for Interactive Promotional Media
• Examples include sites that are under the control or
influence of the firm, such as microblogs (e.g., Twitter),
social networking sites (e.g., Facebook), and blogs
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Factors in Determining Postmarketing Submission
Requirements for Interactive Promotional Media
• Under certain circumstances, a firm is responsible
for promotion on third-party sites
– Responsible if a firm has any control or influence
on the third-party site
– Responsible if a firm collaborates, or has
editorial, preview, or review privilege
– Responsible if a firm influences the placement of
its promotion within the third-party site
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Factors in Determining Postmarketing Submission
Requirements for Interactive Promotional Media
• A firm is not responsible if it only provides
financial support (e.g., through an unrestricted
educational grant) and has no control or
influence on the third-party site
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Factors in Determining Postmarketing
Submission Requirements for Interactive
Promotional Media
• A firm is responsible for the content generated
by an employee or agent who is acting on behalf
of the firm to promote the firm’s product
• FDA’s regulation of prescription drug product
promotion extends both to promotional activities
that are carried out by the firm itself, and to
promotion conducted on the firm’s behalf
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Factors in Determining Postmarketing
Submission Requirements for Interactive
Promotional Media
• A firm generally is not responsible for UGC that is
truly independent of the firm (i.e., is not produced
by, or on behalf of, or prompted by the firm in any
particular)
• FDA will not ordinarily view UGC on firm-owned or
firm-controlled venues as promotional content on
behalf of the firm as long as the user has no
affiliation with the firm and the firm had no influence
on the UGC
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Recommendations
• FDA recommends that a firm be transparent in
disclosing its involvement on a site by clearly
identifying the content and communications of its
employees or agents acting on behalf of the firm
– This could be achieved by inclusion of the
firm's identifier (e.g., name or logo) as part of
the communication
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Submission of Sites for Which a
Firm is Responsible
• At the time of initial display, submit in its entirety
all sites for which a firm is responsible on Form
FDA 2253 or Form FDA 2301
– Submit the comprehensive static product website with
the addition of the interactive or real-time components
• Include annotations to describe the parts that
are interactive and allow for real-time
communications
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Submission of Sites for Which a
Firm is Responsible
• Any subsequent changes should be annotated
and resubmitted at the time of initial display (i.e.,
resubmission)
• Provide a cross-reference by noting the
submission date of the most recent version of
the site in the comments section of the form
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Submission of Sites for Which a
Firm is Responsible
• After the initial submission or resubmission, if the
site is non-restricted and remains unchanged other
than displaying real-time information, the firm can
submit a monthly updated listing of the site that
does not include screenshots or other visual
representations of the actual interactive or real-time
communication
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Submission of Third-Party Sites in Which a
Firm’s Participation is Limited to Interactive
Communications
• Submit the home page of the third-party site,
along with the interactive page within the third-
party site and the firm’s first communication at
the time of initial display
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Submission of Third-Party Sites in Which a
Firm’s Participation is Limited to Interactive
Communications
• After the initial submission, if the firm remains an
active participant on the third-party site, and that
site is non-restricted, the firm can submit a
monthly updated listing of the site that does not
include screenshots or other visual
representations of the actual interactive or real-
time communication
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Recommendations for Monthly
Updates for Non-Restricted Sites
• Once every month, submit an updated listing of
all non-restricted sites for which firm is
responsible or in which it remains an active
participant and that include interactive or real-
time communications
• Multiple sites and the corresponding documents
can be submitted with a single Form FDA 2253
or Form FDA 2301
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Recommendations for Monthly
Updates for Non-Restricted Sites
• Include a separate document for each site
which includes:
– Site name
– URL
– Date range
– Cross-reference to the date of the most recent
submission of the site
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Recommendations for Monthly
Updates for Non-Restricted Sites
• Screenshots or other visual representations of
the actual interactive or real-time
communications need not be submitted with the
monthly updates if the site is non-restricted
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Recommendations for Monthly
Updates for Restricted Sites
• If a site has restricted access (e.g., is password
protected or a subscription is required) submit all
content related to the discussion to adequately
provide context to facilitate the review
• Screenshots or other visual representations of the
actual site, including the interactive or real-time
communications, should be submitted monthly on
Form FDA 2253 or Form FDA 2301
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Draft Guidance for Industry:
Internet/Social Media Platforms with
Character Space Limitations – Presenting
Risk and Benefit Information for
Prescription Drugs and Medical Devices
Jean-Ah Kang, Pharm.D.
Office of Prescription Drug Promotion
Social Media Draft Guidance Webinar
July 10, 2014
Character Space Limitations Draft Guidance
Describes FDA’s current thinking about how firms that choose to present benefit
information should present both benefit and risk information within promotion on
Internet/social media platforms with character space limitations
Within scope of guidance
• Online microblog messaging
(e.g., Twitter)
• Online paid search (e.g.,
Google/Yahoo “sponsored links”)
• Future character-space-limited
Internet/social media platforms
(long-term applicability)
Outside scope of guidance
• Product websites
• Webpages on social media
networking platforms (e.g.,
individual product webpages on
Facebook ,Twitter, YouTube)
• Online web banners
• Responsive web design or other
technology-specific presentations
(e.g., mobile devices, tablets)
Importance of This Draft Guidance
• Responds to stakeholder requests for clarification
– In November 2009, FDA posed this issue as one of five main
discussion topics at the Part 15 public hearing on Internet/social
media promotion
• Advances FDA’s mission in protecting public health
– Regardless of the platform, truthful, accurate, and balanced
product promotion best serves the public
Overview of FDA’s Policy
• 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.
Communication of Benefit Information
1. Benefit information should be accurate and non-misleading and
reveal material facts within each individual character-space-limited
communication (e.g., each individual message or tweet).
2. Benefit information should be accompanied by risk information
within each individual character-space-limited communication.
3. If a firm concludes that adequate benefit and risk information, as
well as other required information, cannot all be communicated
within the same character-space-limited communication, then the
firm should reconsider using that platform for the intended
promotional message as it may not provide meaningful
presentations of both benefit and risk—particularly for products
with complex indications or extensive serious risks.
“Twitter” Example 1A (Benefit Information)
• A firm is considering promotion of its prescription drug NoFocus on
Twitter, which is limited to 140 character spaces per message or
tweet.
• NoFocus is indicated for mild to moderate memory loss.
• Any benefit information that the firm communicates about NoFocus
should be accurate and non-misleading and include material facts
about the use of NoFocus, i.e., that it is indicated for mild to
moderate memory loss.
NoFocus for mild to moderate memory loss [40/140]
“Google” Example 2A (Benefit Information)
• A firm is considering promotion of its prescription drug Headhurtz using
Google’s Sitelink extensions (sponsored link promotion that contains
character space limitations and specific formatting requirements, referred to
as “Sitelinks”).
• Headhurtz is indicated for severe headache associated with traumatic brain
injury.
• If the sponsored link promotion contains benefit information about
Headhurtz, to be accurate and non-misleading, it should convey that
Headhurtz is indicated for severe headache associated with traumatic
brain injury.
Headhurtz [9/25]
www.headhurtz.com [17/35]
For severe headache from traumatic brain injury [47/70]
Communication of Risk Information
1. Risk information should be presented together with benefit
information within each individual character-space-limited
communication (each individual message or tweet).
2. The content of risk information presented within each individual
character-space-limited communication should, at a minimum,
include the most serious risks associated with the product.
Communication of Risk Information (continued)
3. A mechanism, such as a hyperlink, should also be provided
within each individual character-space-limited communication to
allow direct access to a more complete discussion of risk
information about the product.
4. The prominence of risk information should be comparable to the
benefit information within each character-space-limited
communication, taking into consideration any formatting
capabilities available on the specific Internet/social media
platform.
“Twitter” Example 1B (Risk Information)
• There are no boxed or other warnings and no known fatal or life-
threatening risks included in the PI for NoFocus.
• The most serious precaution associated with NoFocus is that it may
cause seizures in patients with a seizure disorder.
• The firm includes a direct hyperlink to the “Important Safety
Information” webpage (within the product website) that is devoted to
providing comprehensive risk information about NoFocus.
NoFocus for mild to moderate memory loss; may cause seizures in patients
with a seizure disorder www.nofocus.com/risk [117/140]
“Google” Example 2B (Risk Information)
• The PI for Headhurtz includes a boxed warning about the potential for brain
swelling and warnings about a potentially fatal drug reaction and a drop in
heart rate that may be life-threatening.
• Sitelinks 1-3 are direct hyperlinks to webpages about the specific risk listed;
Sitelink 4 is a direct hyperlink to the “Important Safety Information” webpage
within the product website.
Headhurtz [9/25]
www.headhurtz.com [17/35]
For severe headache from traumatic brain injury [47/70]
Boxed warning [13/25] Warning [7/25]
Potential for brain swelling [28/35] Potentially fatal drug reaction [31/35]
Warning [7/25] Risk information [16/25]
Life-threatening drop in heart rate [35/35] Important safety information [28/35]
Inclusion of Other Product Information
• FDA does not intend to object to the following:
– Communicating the established name directly to the right of, or
directly below, the proprietary name within the character-space-
limited communication
– Substituting commonly recognized linguistic symbols for words
– Using punctuation marks to help with the presentation of
information
– Denoting a chemical ingredient name with a scientific abbreviation
“Twitter” Example 1C (Other Information)
• The FDA-approved name is NoFocus (rememberine hydrochloride)
Capsules.
• NoFocus is available as 200mg capsules.
• At the top of the landing page, the firm again communicates the
brand and established names together with the dosage form and
quantitative information in direct conjunction as follows:
– NoFocus (rememberine hydrochloride) 200 mg Capsules
NoFocus (rememberine HCl) for mild to moderate memory loss-May cause
seizures in patients with a seizure disorder www.nofocus.com/risk [133/140]
“Google” Example 2C (Other Information)
• The FDA-approved name is Headhurtz (ouchafol) Tablets.
• Headhurtz is available as 200mg tablets.
• At the top of each landing page, the firm again communicates the
brand and established names together with the dosage form and
quantitative information in direct conjunction as follows:
– Headhurtz (ouchafol) 200 mg Tablets
Headhurtz (ouchafol) [20/25]
www.headhurtz.com [17/35]
For severe headache from traumatic brain injury [47/70]
Boxed warning [13/25] Warning [7/25]
Potential for brain swelling [28/35] Potentially fatal drug reaction [31/35]
Warning [7/25] Risk information [16/25]
Life-threatening drop in heart rate [35/35] Important safety information [28/35]
Summary
FDA recommends that firms:
• First carefully consider the complexity of the indication and risk
profiles for each of their products to determine whether a
character-space-limited platform will enable meaningful
presentations of both benefit and risk information.
• Then take the factors, recommendations, and hypothetical
examples outlined in this draft guidance into account when
developing benefit and risk presentations.
Please submit your comments!
• Due date is Tuesday, September 16, 2014
– Submit comments online at www.regulations.gov (docket
#FDA-2014-D-0397)
– Federal Register Notice with direct link for submitting
comments https://federalregister.gov/a/2014-14220
• Link to draft guidance
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegul
atoryInformation/Guidances/UCM401087.pdf
Draft Guidance for Industry:
Internet/Social Media Platforms:
Correcting Independent Third-Party
Misinformation About Prescription Drugs
and Medical Devices
Julie Chronis, J.D.
Office of Prescription Drug Promotion
Social Media Draft Guidance Webinar
July 10, 2014
Correcting Misinformation Draft Guidance
Describes FDA’s current recommendations to drug and device companies that
voluntarily choose to respond to misinformation created or disseminated by
independent third parties related to their FDA-regulated medical products on the
Internet or through social media platforms.
Within scope of guidance
• Communications that a firm is
not responsible for fall within the
scope of the guidance
• Third-party UGC on a third-party
site
• Third-party UGC on a firm’s own
platform
Outside scope of guidance
• A firm’s own advertising or
promotional labeling
• Adverse event reporting
• Corrective messages sent in
response to a Warning Letter (e.g.,
DHCP letters)
Importance of This Draft Guidance
• Responds to stakeholder requests for clarification
– In November 2009, FDA posed this issue as one of five main
discussion topics at the Part 15 public hearing on Internet/social
media promotion
• Advances FDA’s mission in protecting public health
– Information generally available may be improved if firms correct
misinformation
– The public health is best served when information about FDA-
regulated products is accurate, truthful, and not misleading
Overview of FDA’s Policy
• This draft guidance clarifies how firms can respond to
misinformation about their drug or device products that
was created or disseminated by third parties unaffiliated
with the firm
• Misinformation - positive or negative incorrect
representations or implications about a firm’s product
Overview of FDA’s Policy
• The correction of misinformation is a voluntary activity
• If a firm corrects misinformation in a truthful and non-
misleading manner per the guidance, FDA does not
intend to object if appropriate corrective information
does not satisfy otherwise applicable regulatory
requirements regarding labeling or advertising (if any)
Importance of Responsibility
• Firms must not be responsible for the communication
containing the misinformation
– Example: A firm discovers an unaffiliated blogger who is posting
incorrect misinformation about the firm’s product. The firm is not
responsible for the misinformation and may voluntarily correct
the misinformation if it chooses.
“Appropriate corrective information”
• A firm may provide truthful and non-misleading corrective
information
• To constitute appropriate corrective information, a firm’s
communication should:
– Be relevant and responsive to the misinformation;
– Be limited and tailored to the misinformation;
– Be non-promotional in nature, tone, and presentation;
– Be accurate;
– Be consistent with the FDA-required labeling for the product;
– Be supported by sufficient evidence, including substantial evidence, when
appropriate, for prescription drugs;
and…
“Appropriate corrective information” (cont.)
– Either be posted in conjunction with the misinformation in the same area or
forum (if posted directly to the forum by the firm), or should reference the
misinformation and be intended to be posted in conjunction with the
misinformation (if provided to the forum operator or author); and
– Disclose that the person providing the corrective information is affiliated with the
firm that manufactures, packs, or distributes the product.
• Additionally, FDA-required labeling should be included or provided
in a readily accessible format
– (e.g., non-promotional link that goes directly to the FDA-required labeling)
Example of Appropriate Corrective Information
• Example: An independent third party writes an online post stating
that one reason he likes taking a prescription drug (or using a
device) is that it has no food restrictions, which is inconsistent with
information from the required labeling regarding the need to avoid
taking the drug with fatty foods (or to avoid using the device in a
certain way).The firm decides to correct the misinformation
according to this draft guidance. The firm’s representative identifies
herself as being affiliated with the firm and posts the corrective
information from the required labeling. She also includes a direct
link to the FDA-required labeling.
Other Options for Correcting Misinformation
• It might not be possible due to technological limitations
(e.g., a non-interactive webpage) for a firm to directly
correct misinformation.
• Regardless of technological limitations -
– Firms may contact the author of the misinformation and provide the
information to author, request the misinformation be removed, or ask
the author to allow comments to be posted
– Firms may contact the site administrator and request the
misinformation be removed or allow comments to be posted
– Firms are not accountable if a third party declines to post corrective
information or remove misinformation
• Firms may provide contact information for the firm (e.g.
Medical Affairs)
Other Options for Correcting
Misinformation - Examples
• Example: A firm finds a webpage about its product that was written
by an independent third party on an Internet-based, interactive,
collaboratively edited encyclopedia. The firm may choose to contact
the author of the webpage and provide corrective information to the
author.
• Example: An independent third party posts a video on a video
hosting website about a firm’s product. It is not possible for viewers,
such as a firm, to post comments about the video. The firm may
contact the entity that administers the website and ask that entity to
allow comments about the video to be posted so that the firm may
post corrective information.
Correcting a Clearly Defined Portion
of a Forum
• A firm should
– Describe the location or the nature of the information that was
corrected
– Define the portion of the forum it is correcting
– Correct all the misinformation in the clearly defined portion
– Provide a date the correction is made
• A firm should not
– Choose to correct only misinformation that portrays its product in
a negative light
– Define a portion so it only has to respond to negative
misinformation
Correcting a Clearly Defined Portion of a
Forum – Examples
• Example: A firm decides to correct misinformation posted
by an independent third party who has commented on a
blog that allows comments. The firm should correct each
piece of misinformation in the particular comment to which
it is responding. The firm should provide a statement that
it is responding only to one particular comment along with
the date the correction is provided. The firm is not
expected to correct misinformation that appears in other
comments.
Correcting a Clearly Defined Portion of a
Forum – Examples
• Example: A firm decides to correct misinformation posted on a
blog that allows comments. The firm corrects misinformation in
several blog postings that provide incorrect risk information
associated with the product and makes clear it is only
correcting those pieces of misinformation, but the firm does not
address exaggerated efficacy claims in favor of the firm’s
product in other postings that appear to readers between the
postings it is correcting. Even if the firm corrects the
misinformation in the limited posts it chose, the firm’s actions
are not in accord with this guidance because it has intentionally
selected only negative information about its product to correct
while readily accessible and visible positive misinformation was
not corrected.
Communications That Fall Outside the
Scope of This Draft Guidance
• Communications by a firms that are designed to correct
misinformation should not go beyond the correction of misinformation
or the communication will fall outside the scope of the guidance.
• Example: An independent third party downplays a labeled
contraindication on an email distribution list. A firm provides the
corrective information regarding the contraindication, and additionally
provides information unrelated to the contraindication comparing the
safety profile of its product to a competitor’s product. The firm’s
communication goes beyond providing corrective information with
respect to the third party’s statements about the product’s
contraindication and, therefore, is not considered to be a correction of
misinformation within the scope of this draft guidance.
Consequences of Correcting Misinformation
• A firm does not have to continue to monitor a website or
communication once it corrects misinformation.
• Record keeping
– Firms do not have to submit appropriate corrective information to
FDA
– However, FDA recommends firms keep records to assist in
responding to questions the Agency may have
Please submit your comments!
• Due date is Tuesday, September 16, 2014
– Submit comments online at www.regulations.gov (docket
#FDA-2014-D-0447)
– Federal Register Notice with direct link for submitting
comments https://federalregister.gov/a/2014-14221
• Link to draft guidance
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegul
atoryInformation/Guidances/UCM401079.pdf
Questions?
