On December 27, 2011, FDA released new guidelines, which, for the first time, addressed online communication. The new guidelines, "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices," are narrowly focused and have limited applicability. This presentation reviews the main points and definitions within the guidelines.

1. Webinar on New FDA Guidelines
Responding to Unsolicited Requests for Off-Label Information
About Prescription Drugs and Medical Devices
January 13, 2012

2. Background
• In Nov 2009, FDA held public meeting on addressing new
media in pharma marketing.
• Late last month, FDA issued this first set of guidelines (of
more to come).
• The new guidelines are narrowly focused to off-label
requests and have limited applicability.
Contents are proprietary and confidential.

3. Of Note …
• These are draft guidelines. You have 90 days (73
days from today) to submit comments and
suggestions to FDA.
• These are guidelines. You can stray from them, as
long as you’re not violating any other existing
regulations.
• But … they say you should follow them, so do.
Contents are proprietary and confidential.

4. Definitions
• Unsolicited request: initiated by persons completely
independent of the relevant firm
(HCPs, HCOs, academia, patients, caregivers)
• Non-public unsolicited request: directed privately to the
firm via 1:1 communication
• Public unsolicited request: via public forum directed to
the firm or a larger forum
• Solicited request: request prompted in any way by
manufacturer or its representatives
Contents are proprietary and confidential.

5. 5 Key Takeaways
#1 Requests for information must be unsolicited.
This excludes:
• Online outreach of off-label information, offering to
answer questions
• Public meetings/conferences mentioning off-label
information with a CTA to “let us know if you have any
questions”
• News announcements on off-label use shared on
microblogging services such as Twitter
• CTA for user-generated videos about usage of a
product, if a consumer’s video response contains a
question about off-label usage
Contents are proprietary and confidential.

6. 5 Key Takeaways
#2 Responses should be handled privately
• Requests for off-label information sent privately (e-mail)
or publicly (discussion forum) should be handled privately
by the firm via 1:1 communication.
• Details of those communications should be archived for
records retention.
Contents are proprietary and confidential.

7. 5 Key Takeaways
#3 Responses must be
truthful, accurate, balanced, and non-misleading
• They must also be narrowly tailored to the question
at hand. Responders should be trained on how to
tailor responses.
• Information should be scientific in nature and be
generated by medical or scientific personnel -- not
sales or marketing
Contents are proprietary and confidential.

8. 5 Key Takeaways
#4 Request must be specific to your product
• Your response is only acceptable if the original request is
specific to a named product of your company.
• You can not answer a question related to a competitor’s
product.
YES: “Can NAMED DRUG be used to lower cholesterol?”
NO: “What drugs can be used to lower cholesterol?”
Contents are proprietary and confidential.

9. 5 Key Takeaways
#5 Responses should contain:
1. contact information for the medical affairs department
2. reference to the person's request being off-label
3. disclosure of the responder's affiliation with the
company
4. URL link to the product's labeling information
Contents are proprietary and confidential.

10. Remaining Questions
• Does “private request” also include DMs, post to
pharma’s FB profile, pre-screened comments on FB or
blog?
• What happens when fair balance articles are behind
pay walls?
• Can bloggers, and by extension reporters, not be
briefed by a company regarding data milestones of an
approved product being studied for a secondary
indication?
Contents are proprietary and confidential.

11. Q&A
Matthew Snodgrass
msnodgrass@wcgworld.com
@mattsnod
Brian Reid
breid@wcgworld.com
@brianreid
Contents are proprietary and confidential.

12. Thank you
blog.wcgworld.com
Contents are proprietary and confidential.