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FDA Guidelines on Responding to Unsolicited Requests for Off-Label Information


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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. 1. Webinar on New FDA Guidelines Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices January 13, 2012
  2. 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. 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. 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 representativesContents are proprietary and confidential.
  5. 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 usageContents are proprietary and confidential.
  6. 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. 7. 5 Key Takeaways#3 Responses must betruthful, 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 marketingContents are proprietary and confidential.
  8. 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. 9. 5 Key Takeaways#5 Responses should contain:1. contact information for the medical affairs department2. reference to the persons request being off-label3. disclosure of the responders affiliation with the company4. URL link to the products labeling informationContents are proprietary and confidential.
  10. 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. 11. Q&A Matthew Snodgrass @mattsnod Brian Reid @brianreidContents are proprietary and confidential.
  12. 12. Thank you blog.wcgworld.comContents are proprietary and confidential.