Introduction to the FDASM

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Introduction to the FDASM

  1. 1. Introduction to the FDASM PF Anderson / Perplexity Peccable Emerging Technologies Librarian for the Health Sciences University of Michigan Monday, December 14, 2009
  2. 2. What is #FDASM? Monday, December 14, 2009
  3. 3. Monday, December 14, 2009
  4. 4. Main Questions Addressed Monday, December 14, 2009
  5. 5. Question Topics 1. Accountability 2. Regulatory requirements best practices 3. Corrective information 4. Links 5. Adverse event reporting FROM: Federal Register Notice of Public Hearing: http://edocket.access.gpo.gov/2009/E9-22618.htm Monday, December 14, 2009
  6. 6. FDASM Resources Monday, December 14, 2009
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  11. 11. Wordle from Transcripts Monday, December 14, 2009
  12. 12. Context: General Monday, December 14, 2009
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  16. 16. Context: Recent FDA Warning Letters Monday, December 14, 2009
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  19. 19. Context: Social Media Use Examples Monday, December 14, 2009
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  27. 27. Context: European Precedents Monday, December 14, 2009
  28. 28. In 2003, Danish journalist Frede Damgaard published information on his website about Hyben Total, a product licensed in Denmark as a treatment for a wide range of conditions—including gout, kidney and bladder disorders, sciatica, diarrhea, and diabetes. The national regulator in 1999 refused it a marketing authorization. It is still sold as a medicine in Sweden and Norway.   Mr. Damgaard’s positive description of Hyben Total’s effects on the symptoms of gout and arthritis led to his being prosecuted in the Danish courts on the grounds that it constituted advertising of a medicinal product whose sale was not authorized in Denmark, thus contravening Directive 2001/83/EC. Monday, December 14, 2009
  29. 29. Title VIII, Advertising, Article 86 1. For the purposes of this Title, ‘advertising of medicinal products’ shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular: - the advertising of medicinal products to the general public, - advertising of medicinal products to persons qualified to prescribe or supply them, - visits by medical sales representatives to persons qualified to prescribe medicinal products, Monday, December 14, 2009
  30. 30. Title VIII, Advertising, Article 86 - the supply of samples, - the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal, - sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products, - sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith. Monday, December 14, 2009
  31. 31. Title VIII, Advertising, Article 86 2. The following are not covered by this Title: - the labelling and the accompanying package leaflets, which are subject to the provisions of Title V, - correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product, Monday, December 14, 2009
  32. 32. Title VIII, Advertising, Article 86 - factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims, - information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products. Monday, December 14, 2009
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  35. 35. Context: Role of the Health Care Consumer Monday, December 14, 2009
  36. 36. To start and to put you in the right mood, you should know that this official meeting about social media will take place in an office WITHOUT ANY CELL OR INTERNET ACCESS! Monday, December 14, 2009
  37. 37. DTC is currently illegal DTC is direct- in Europe to-consumer Monday, December 14, 2009
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  40. 40. More Questions: What are Yours? Monday, December 14, 2009
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  43. 43. A Big One for Us Impor tant! Does the FDA plan to proactively reach out to more stakeholders -- patients, public, and physicians in particular -- during the comment period? If so, how will it do that? What can we do to help? Monday, December 14, 2009
  44. 44. Main Questions Addressed Monday, December 14, 2009
  45. 45. 1. Accountability 2. Regulatory requirements best practices 3. Corrective information 4. Links 5. Adverse event reporting Monday, December 14, 2009
  46. 46. 1. For what online communications are manufacturers, packers, or distributors accountable? FROM: Federal Register Notice of Public Hearing: http://edocket.access.gpo.gov/2009/E9-22618.htm Monday, December 14, 2009
  47. 47. 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)? FROM: Federal Register Notice of Public Hearing: http://edocket.access.gpo.gov/2009/E9-22618.htm Monday, December 14, 2009
  48. 48. 3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties? FROM: Federal Register Notice of Public Hearing: http://edocket.access.gpo.gov/2009/E9-22618.htm Monday, December 14, 2009
  49. 49. 4. When is the use of links appropriate? 5. Questions specific to Internet adverse event reporting FROM: Federal Register Notice of Public Hearing: http://edocket.access.gpo.gov/2009/E9-22618.htm Monday, December 14, 2009
  50. 50. Things You Can Do NOW Monday, December 14, 2009
  51. 51. Survey: What Happens Now? Questions About the FDA’s Process for Creating Social Media Guidance: <http://www.surveymonkey.com/s.aspx? sm=cTTi_2bsVngf8aiRcggYywrg_3d_3d> Monday, December 14, 2009
  52. 52. Survey: Predicting the Future of the Drug Industry: 2010 and Beyond: <http://www.surveymonkey.com/s/3YJQ65B> Monday, December 14, 2009
  53. 53. Think about your concerns and hopes for the forthcoming guidelines. Register your comments. Community discussion will be held in January to help with this Monday, December 14, 2009
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  55. 55. Monday, December 14, 2009
  56. 56. What do YOU want the FDA to do? Monday, December 14, 2009

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