The document summarizes new FDA draft guidelines for responding to unsolicited requests for off-label information on social media. It outlines that the guidelines cover unsolicited requests for off-label uses of approved products, but not requests about approved uses or pre-launch products. It also defines solicited vs. unsolicited requests and provides recommendations for how companies can respond to private vs. public unsolicited requests in a truthful, non-promotional manner according to the guidelines.

1. FDA Guidelines for Social Media
Rich Westelman, SVP-Sales & Client Services
February, 2012

2. The New Draft Guidelines: Sources
• Draft Guidance published December 2011; not intended to be
comprehensive; not the definitive ‘10 Commandments’ of
what’s allowed in social media
• Focus: Responding to Unsolicited Requests for Off-Label
Information
• Access the full document here:
– http://www.fda.gov/downloads/Drugs/Guidance
• Here are some other helpful blogs sites
– http://www.doseofdigital.com/2012/01/
– http://www.policymed.com/2012/01/fda-guidance
– http://www.pharmacompliancemonitor.com/asked-answered
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3. The New Draft Guidelines: What is Covered?
• Requests for information about approved, cleared
indications/conditions of use for an approved FDA-
regulated product?
NOT COVERED
• Requests for information about products not yet
approved for any uses (i.e., pre-launch)?
NOT COVERED
• Requests for information about off-label uses of a
product currently on the market?
COVERED
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4. What is Covered?
PRIVATE PUBLIC
An unsolicited request for An unsolicited request for
off-label information directed off-label information made in
privately to a pharma a public forum, whether
UNSOLICITED company using a one-to-one directed to a pharma
communication approach company itself or to a forum
(phone call, e-mail, written at large. Includes “emerging
letter, etc.) electronic media.”
SOLICITED Not covered by this guidance
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5. The New Draft Guidelines: Definitions
• Solicited vs Unsolicited?
– You can’t separate the term “solicited …” from the rest
of the phrase “… request for off-label information”… do
not read solicited and equate with sponsored or paid
for
– The examples of solicited provided in the guidance all
reflect clear intent by the pharma company to
encourage or ask for examples of off-label usage
– Therefore: sponsored, public on-label content
published by pharma companies can yield “unsolicited
requests for off-label information”
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6. Private Requests: Responses
PRIVATE PUBLIC
• To the Individual Only
• Answer only the specific question
• Truthful, non-misleading,
accurate & balanced
• Scientific in nature
• Should come from medical or
scientific personnel not sales or
marketing
• Include the standard materials,
including FDA-approved labeling,
actual indication disclosure, ISI,
references, etc.
• Maintain records re: nature of
request, requestor personal data,
what was provided, dates, etc.
• Nothing published in public, even if
the requesting individual references a
public forum in his private request
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7. Public Requests: Context for Responses
• Pharma companies are the most knowledgeable and best
equipped to respond
– “Because firms usually have robust and current information about their products, it
can be in the best interest of public health for a firm to respond to unsolicited
requests for information about off-label uses of the firm’s products that are made in
public forums, especially since other responders may not provide or have access
to the most accurate and up-to-date medical product information
• Your responses are not to be posted in the public forum
– “Regardless of the fact that the original, unsolicited off-label question may have
been available to a very broad audience, the firm should not make its detailed
response with off-label information publicly available within the same forum.”
• So … responses will have a public reply acknowledging
the request was made and could have a private
component (direct communication with the requestor if he/
she follows up directly)
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8. Public Requests: Responses
PRIVATE PUBLIC
• To the Individual Only • Published on the Public Forum
• Answer only the specific question • Only reference that the question
• Truthful, non-misleading, pertains to unapproved/
accurate & balanced uncleared use
• Scientific in nature • Encourage requestor to contact
• Should come from medical or the firm, and provide medical/
scientific personnel not sales or scientific rep contact information
marketing • Disclose identity and role of the
• Include the standard materials, person providing the response
including FDA-approved labeling, • Provide link to FDA-approved
actual indication disclosure, ISI, labeling
references, etc. • No promotional info or link to any
• Maintain records re: nature of promotional sources
request, requestor personal data, • If/when the requestor then contacts
what was provided, dates, etc. the firm, follow the recommendations
• Nothing published in public, even if as provided for under Private
the requesting individual references a Unsolicited requests
public forum in his private request
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9. Sermo Products: Physician & Client Posts
PRIVATE PUBLIC
Sermo considers requests
for off-label info made in
both Physician Posts
UNSOLICITED (organic Sermo traffic) and
as comments within Client
Posts to be examples of
Public Unsolicited requests
SOLICITED Not covered by this guidance
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10. Sermo Makes Compliance Easy
• For requests for off-label information made in the
comment section of Client Posts, we believe the client is
obligated to respond according to the guidelines
• Sermo provides a customized response that appears
immediately following the request; this remains in place
forever, documenting the mfgr’s proper response
This comment/question pertains to an unapproved use of _____.
Please contact Rebecca Jones in Medical Affairs at PharmaCo,
Inc. at (561) 443-8510 or rjones@medaffairs.pharmaco.com to
request additional information
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11. Suggested Responses: Flowchart
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12. Rich Westelman
SVP-Sales & Client Services
Sermo
215 First Street
Cambridge, MA 02142
rwestelman@sermo.com
617-229-5199
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