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FDA Guidelines for Social Media in Pharma
 

FDA Guidelines for Social Media in Pharma

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A review of the recent updates to the FDA Guidelines for how pharma companies can use social media

A review of the recent updates to the FDA Guidelines for how pharma companies can use social media

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    FDA Guidelines for Social Media in Pharma FDA Guidelines for Social Media in Pharma Presentation Transcript

    • FDA Guidelines for Social MediaRich Westelman, SVP-Sales & Client ServicesFebruary, 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    • The New Draft Guidelines: Sources•  Draft Guidance published December 2011; not intended to be comprehensive; not the definitive ‘10 Commandments’ of what’s allowed in social media•  Focus: Responding to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-answered2 2012 Confidential
    • 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? COVERED3 2012 Confidential
    • 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, whetherUNSOLICITED 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 guidance4 2012 Confidential
    • 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”5 2012 Confidential
    • 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 request6 2012 Confidential
    • 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)7 2012 Confidential
    • 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 request8 2012 Confidential
    • Sermo Products: Physician & Client Posts PRIVATE PUBLIC Sermo considers requests for off-label info made in both Physician PostsUNSOLICITED (organic Sermo traffic) and as comments within Client Posts to be examples of Public Unsolicited requestsSOLICITED Not covered by this guidance9 2012 Confidential
    • 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 information10 2012 Confidential
    • Suggested Responses: Flowchart11 2012 Confidential
    • Rich Westelman SVP-Sales & Client Services Sermo 215 First Street Cambridge, MA 02142 rwestelman@sermo.com 617-229-519912 2012 Confidential
    • 13 2012 Confidential