The guidance provides an overview of FDA policy on exchanging off-label drug and medical device information. It acknowledges the importance of social media but does not provide comprehensive guidance on its use. The FDA allows scientific exchange of unapproved use information in response to unsolicited consumer requests, but off-label promotion is illegal. While recognizing the public health value, the guidance notes challenges in ensuring digital responses are not promotional and do not disseminate off-label information more broadly. Companies are advised to limit public responses to contact details and approved labeling links.

1. Off-label Information on Prescription
Drugs and Medical Devices in the
Era of Social Media
January 6, 2011
Jim Mittler, PhD; Medical Director
(jmittler@palio.com; twitter, @jim_mittler)

2. New guidance heralded by some as social media guidelines

3. What the new guidance actually says about the use of
social 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

4. 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

5. 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

6. 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

7. Company response to unsolicited requests for off-label
information
• 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

8. 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)

9. FDA guidance on public responses to unsolicited requests
for 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

10. 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

11. 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