Translating the FDA's draft Guidance

Off-label Information on PrescriptionDrugs and Medical Devices in theEra of Social MediaJanuary 6, 2011Jim Mittler, PhD; Medical Director(jmittler@palio.com; twitter, @jim_mittler)

New guidance heralded by some as social media guidelines

What the new guidance actually says about the use ofsocial media is very slim• Draft issued on December 30, 2011 – Open to public comment for 90 days• Provides overview on FDA policy and traditional requests for off-label drug/device information• FDA acknowledges the importance of emerging electronic media, but new guidance is in no way a comprehensive policy on its use

Exchange of off-label information• FDA allows exchange of scientific information for unapproved indications or conditions of use when a question is initiated by the consumer, not the pharma company (an “unsolicited request”) – Response must be scientific in nature, balanced, and include appropriate reference articles (even findings that are unsupportive of the use of a drug/device)• Off-label promotion of this information is illegal – Must be handled by scientific or medical affairs departments• FDA recognizes that it’s in the best interest of public health that pharma companies provide off-label drug information – Companies maintain large body of scientific information – Social media tools can spawn digital content that is published by those not affiliated with pharma company; potentially erroneous or dated information

Requests for off-label information• Nonpublic unsolicited requests – Consumer directly calls or e-mails company – One-on-one response• Public unsolicited requests – Directed at the company in a public forum • Live presentation • Company-controlled Web site – Directed to community at large • Third-party Web site or other digital media tools

Solicited requests show intent to promote off-label use• “Solicited” requests are consumer questions that arise because of a prompt on the part of the company and are violative of FDA policy Traditional examples Digital examples • Rep mentions an unapproved use of a • Company tweets that an off-label use of product and invites doctor to request a product is safe and effective more info • Company Web site that contains a • MSL or paid speaker presents data on standardized response to off-label use of off-label use of a product a product • Business reply card intended for • Company asks users to post YouTube requesting off-label information video, which might result in off-label • Use of other words, phrases, or alpha- testimonial numeric representations of off-label uses • Company sends informational packets to delivered in a promotional manner bloggers and encourages them to write about off-label use

Company response to unsolicited requests for off-labelinformation• Truthful, accurate, balanced, nonmisleading, and nonpromotional scientific or medical information – This viewed as scientific exchange, not intended to promote off-label use – Shouldn’t be a summary document; include applicable data and scientific reprints (even those that have contrary findings), technical literature, etc• Should be generated by scientific and medical personnel independent of sales and marketing• Tailored to answer only the specific question in the unsolicited request• Provided only to the individual who made the unsolicited request as a one-on-one communication – This privatizes the communication stream; opposes the social media tenet of open, transparent, conversation among the masses

What the FDA sees as challenges in the digital environment• Consumers are increasingly using the Web to search for medical information• Unsolicited questions about a drug/device can arise from potentially erroneous and/or dated content not generated by pharma companies• Questions made in a third-party forum might not necessarily be directed at the company (traditional requests are directed at the company)• Posting an online response to an off-label questions disseminates this info to everyone (ie, persons who have not requested it... This is violative off-label promotion)• Enduring nature of digital content can render responses outdated (eg, if new risk information becomes available)

FDA guidance on public responses to unsolicited requestsfor off-label information encountered in the digital space• Company can respond only when the request pertains to its own product – “Can drug X be used to treat condition Y?” Not “What drug can treat condition Y?”• Limit response to company’s contact information – Do not include any off-label information – Can disclose that the question pertains to an unapproved use of the product and to contact medical affairs with a specific request for information• Company representative should clearly disclose themselves as such• Include a mechanism for readily accessing FDA-approved label through a direct hyperlink – Link should not itself be promotional (eg, www.bestcancercure.com) – Should not include links to promotional, corporate, or third-party Web sites

Implications for pharma• Acknowledgement by the FDA that social media is useful and important in the pharma space – But there are inherent challenges to dissemination of online information, particularly to off-label requests• “Business as usual” for off-label requests – Requests must be unsolicited – Off-label information still cannot be openly discussed; only responses via one-on- one communication• Still awaiting guidelines on use of social media channels for drug promotion – Judgment should prevail; if you wouldn’t say it off line, don’t say it online

Implications for healthcare advertising agencies• Nothing tangible until there’s guidance on the use of social media for drug promotion• Unsolicited requests for off-label promotion must be handled by medical affairs personnel

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Translating the FDA's draft Guidance

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Translating the FDA’s draft Guidance — Presentation Transcript