fda guidelines for social media in pharma
DESCRIPTION
A review of the recent updates to the FDA Guidelines for how pharma companies can use social mediaTRANSCRIPT
FDA Guidelines for Social Media
Rich Westelman, SVP-Sales & Client Services February, 2012
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• Draft Guidance published December 2011; not intended to be comprehensive; not the definitive ‘10 Commandments’ of what’s allowed in social media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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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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What is Covered?
SOLICITED
UNSOLICITED
PUBLIC PRIVATE
Not covered by this guidance
An unsolicited request for off-label information directed privately to a pharma company using a one-to-one communication approach (phone call, e-mail, written letter, etc.)
An unsolicited request for off-label information made in a public forum, whether directed to a pharma company itself or to a forum at large. Includes “emerging electronic media.”
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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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Private Requests: Responses PUBLIC PRIVATE
• 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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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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Public Requests: Responses PUBLIC PRIVATE
• 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
• Published on the Public Forum • Only reference that the question
pertains to unapproved/ uncleared use
• Encourage requestor to contact the firm, and provide medical/scientific rep contact information
• Disclose identity and role of the person providing the response
• Provide link to FDA-approved labeling
• No promotional info or link to any promotional sources
• If/when the requestor then contacts the firm, follow the recommendations as provided for under Private Unsolicited requests
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Sermo Products: Physician & Client Posts
SOLICITED
UNSOLICITED
PUBLIC PRIVATE
Not covered by this guidance
Sermo considers requests for off-label info made in both Physician Posts (organic Sermo traffic) and as comments within Client Posts to be examples of Public Unsolicited requests
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Sermo Makes Compliance Easy
This comment/question pertains to an unapproved use of _____. Please contact Rebecca Jones in Medical Affairs at PharmaCo,
Inc. at (561) 443-8510 or [email protected] to request additional information
• 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
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Suggested Responses: Flowchart
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Rich Westelman SVP-Sales & Client Services Sermo 215 First Street Cambridge, MA 02142 [email protected] 617-229-5199
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