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•  Draft Guidance published December 2011; not intended to be comprehensive; not the definitive ‘10 Commandments’ of what’s allowed in social media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 rjones@medaffairs.pharmaco.com 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 rwestelman@sermo.com 617-229-5199

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