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Webinar on New FDA Guidelines




   Responding to Unsolicited Requests for Off-Label Information
         About Prescription Drugs and Medical Devices


                        January 13, 2012
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.
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.
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 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.
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.
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.
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.
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.
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.
Q&A


                                                Matthew Snodgrass
                                             msnodgrass@wcgworld.com
                                                   @mattsnod


                                                    Brian Reid
                                               breid@wcgworld.com
                                                    @brianreid




Contents are proprietary and confidential.
Thank you




                                             blog.wcgworld.com




Contents are proprietary and confidential.

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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.

Notas do Editor

  1. 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
  2. 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.