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Introduction to the FDASM: Campus Forum, February 16, 2010


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The introduction and context setting portion of the FDASM Public Forum held at the University of Michigan on February 16th, 2010.

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Introduction to the FDASM: Campus Forum, February 16, 2010

  1. 1. Introduction to the FDASM PF Anderson Emerging Technologies Librarian for the Health Sciences University of Michigan
  2. 2. What is #FDASM?
  3. 4. FDA’s Stated Purpose <ul><li>This hearing is intended to provide an opportunity for broad public participation and comment concerning Internet promotion of FDA-regulated medical products, including human and animal prescription drugs and biologics and medical devices. Please note that this hearing does not address nonprescription drug promotion. FDA is particularly interested in hearing views from the public as to how expanding Web 2.0 technologies may be used to promote medical products to both health care professionals and consumers in a truthful, nonmisleading, and balanced manner. In addition, FDA is seeking public comment on Internet adverse event reporting. </li></ul>
  4. 5. FDA’s Purpose: Main Points <ul><li>Internet promotion of FDA-regulated medical products </li></ul><ul><ul><li>Human/animal prescription drugs </li></ul></ul><ul><ul><li>Biologics </li></ul></ul><ul><ul><li>Does NOT address non-prescription drugs </li></ul></ul><ul><li>Web 2.0 use to promote medical products </li></ul><ul><ul><li>To both consumers and health care professionals </li></ul></ul><ul><ul><li>In a truthful, non-misleading, and balanced manner </li></ul></ul><ul><li>Internet adverse event reporting </li></ul>
  5. 6. Questions
  6. 7. The FDA’s Questions <ul><li>1. Accountability </li></ul><ul><li>2. Regulatory requirements best practices </li></ul><ul><li>3. Corrective information </li></ul><ul><li>4. Links </li></ul><ul><li>5. Adverse event reporting </li></ul>
  7. 8. Simplified <ul><li>Who </li></ul><ul><li>is allowed to say What </li></ul><ul><li>to Whom </li></ul><ul><li>regarding health information </li></ul><ul><li>Where in online spaces and social media? </li></ul><ul><li>Are Why & When & How part of the question/answer? </li></ul>
  8. 9. FDA #1 <ul><li>1. For what online communications are manufacturers, packers, or distributors accountable? </li></ul><ul><ul><li>FROM: Federal Register Notice of Public Hearing: </li></ul></ul>
  9. 10. FDA #2 <ul><li>2. How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)? </li></ul><ul><ul><li>FROM: Federal Register Notice of Public Hearing: </li></ul></ul>
  10. 11. FDA #3 <ul><li>3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties? </li></ul><ul><ul><li>FROM: Federal Register Notice of Public Hearing: </li></ul></ul>
  11. 12. FDA #4 & #5 <ul><li>4. When is the use of links appropriate? </li></ul><ul><li>5. Questions specific to Internet adverse event reporting </li></ul><ul><ul><li>FROM: Federal Register Notice of Public Hearing: </li></ul></ul>
  12. 13. Context: Social Media Use Examples
  13. 14. Insurers Pay FB Funny Money to Oppose HC Reform
  14. 15. Oncology on Canvas
  15. 16. Social Media Use in Healthcare Communities
  16. 17. Highlights from November Forum
  17. 18. Wordle from Transcripts
  18. 19. 1. Outbound Links <ul><li>Who is responsible if the target link changes content or location? </li></ul><ul><li>Who should be required to use in-between page warning consumer they are leaving the site? What about groups that don’t have the skills or resources necessary to do so? </li></ul>
  19. 20. 2. Semi-private conversations <ul><li>Social media allows conversations (questions & answers) between private individuals in public spaces. </li></ul>
  20. 21. 3. Spurious content <ul><li>Who decides what is good and what is not? </li></ul><ul><li>Who should be held accountable for the quality of the information provided? </li></ul><ul><li>What should be asked of those who provide questionable content? </li></ul>
  21. 23. 4. Off-Label Use <ul><li>When is emerging research beneficial or dangerous to a healthcare consumer? </li></ul><ul><li>Who decides? </li></ul><ul><li>Should conversations on off-label use be supported, discouraged or managed? </li></ul>
  22. 24. 5. European Precedents <ul><li>Title VIII, Advertising, Article 86 (Denmark) </li></ul><ul><ul><li>” Directive 2001/83/EC on the Community code relating to medicinal products for human use” in conflict with “The European Convention for the protection of human rights and fundamental freedoms” </li></ul></ul><ul><ul><li>The European Court of Justice:  Third-party statements about medicines may be advertising: </li></ul></ul><ul><li>Digital Economy Bill (in progress, UK) </li></ul><ul><ul><li>Clause 11 </li></ul></ul>
  23. 25. <ul><li>Maybe, instead of banning all kinds of opinions on a particular product, one should think of a better way to distinguish independent journalism from mere marketing strategies. The question is how? </li></ul>
  24. 27. Comments
  25. 28. <ul><li>Think about your concerns and hopes for the forthcoming guidelines. Register your comments NOW. </li></ul><ul><li>FDA will have a second 90-day comment period after the initial guidelines are proposed. </li></ul>
  26. 29. Closing Thoughts <ul><li>“ The FDA needs to find a narrow winding road up a steep mountain that leads to real evidence based medicine. </li></ul><ul><li>Too much regulation creates an atmosphere of fear, government distrust and reactionary thinking. </li></ul><ul><li>Too little regulation leads to graft, greed, corruption and disinformation. </li></ul><ul><li>Evidence based medicine means doing the right things for the right reasons.” </li></ul><ul><ul><li>Dr. Ren Stonecutter, at the Second Life Public Forum on the FDASM, January 30, 2010. </li></ul></ul>
  27. 30. What do YOU want the FDA to do?