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.
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FDA Guidelines on Responding to Unsolicited Requests for Off-Label Information
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.
Notes de l'éditeur
Non-public unsolicited request: phone call or e-mail, arguably a DM, post to pharma’s FB profile, pre-screened comment on FB or blogSolicited request: FDA gives 11 examples
Reason being, if a firm publicly responds to someone’s unsolicited request, anyone else seeing it would make that firm’s comments available to those who didn’t request that information.