FDA Guidelines for Social Media in Pharma

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The New Draft Guidelines: Sources•  Draft Guidance published December 2011; not intended to be comprehensive; not the definitive ‘10 Commandments’ of what’s allowed in social media•  Focus: Responding to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

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FDA Guidelines for Social Media in Pharma

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