FDA Part 15 Public Hearing on Internet and Social Media Promotion of FDA-Regulated Medical Products


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Presentation by Barbara Chong, FDA

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FDA Part 15 Public Hearing on Internet and Social Media Promotion of FDA-Regulated Medical Products

  1. 1. The following presentation was delivered at e-Patient Connections 2010 Join the community at http://KruResearch.com/subscribe
  2. 2. FDA Part 15 Public Hearing on Internet and Social Media Promotion of FDA-Regulated Medical Products Barbara Chong, Pharm.D., BCPS Team Leader, Training and Support Division of Drug Marketing, Advertising, and Communications Center for Drug Evaluation and Research Food and Drug Administration
  3. 3. DDMAC’s Mission <ul><li>To protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated. </li></ul><ul><li>This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers. </li></ul><ul><li>http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm </li></ul>
  4. 4. 21 CFR 202.1 <ul><li>Must not be false or misleading </li></ul><ul><li>Must have balance between efficacy and risk information </li></ul><ul><li>Must be consistent with the approved product labeling or package insert (PI) </li></ul><ul><li>Must be supported by substantial evidence </li></ul>
  5. 5. Professional Review Group I Leader Andrew Haffer (acting) Neurology (Quynh-Van Tran) Oncology Biologics (Carole Broadnax) Reproductive, Urology (Janice Maniwang) Psychiatry (Jessica Clerk Derenick) Professional Review Group II Leader Karen Rulli (acting) Oncology Drugs: Solid tumors (Keith Olin) Oncology Drugs: Hematologic Cancers (Adam George, Nisha Patel) Hematology, Medical Imaging (James Dvorsky) Director’s Office Director, Thomas Abrams Deputy Director, vacancy Associate Director, Mark Askine Associate Director of Operations, Marci Kiester Management Advisor, Catherine Gray Management Advisor, Robert Dean Special Assistant, Jean-Ah Kang Program Specialist, Becki Vogt Professional Review Group III Leader Lisa Hubbard Pulmonary, Allergy, Rheumatology (Roberta Szydlo) Analgesics, Anesthetics (Mathilda Fienkeng) Metabolism and Endocrinology (Samuel Skariah) Gastroenterology (Kathleen Klemm) Professional Review Group IV Leader Sheila Ryan Cardiovascular and Renal (Emily Baker) Anti-Infectives, Ophthalmology, Special Pathogens, Transplant (Christine Corser) Antivirals (Lynn Panholzer) Dermatology, Dental (Vacancy) The Division of Drug Marketing, Advertising, and Communications Direct- To-Consumer Review Group I Leader Michael Sauers Reproductive (Carrie Newcomer) Psychiatry (Susannah Hubert) Urology (Osteo, Other), Antivirals, Special Pathogens, Transplant (Michelle Safarik) Dermatology, Dental (Sheetal Patel) Direct- To-Consumer Review Group II Leader Aline Moukhtara (acting) Neurology (Sharon Watson, Beth Carr) Pulmonary, Allergy (Robyn Tyler) Urology (Vacancy) Research Team (Kathryn Aikin, Amie O’Donoghue, Helen Sullivan) Regulatory Counsel Team Leader, Sangeeta Vaswani Regulatory Counsel, Marissa Chaet Brykman Regulatory Counsel, Julie Burger Regulatory Counsel, Bryant Godfrey Regulatory Counsel, Ernest Voyard IT Specialist, Michael Wade Evidence Review & Division Support, Elaine Cunningham Regulatory Project Manager, Wayne Amchin Training & Support, Barbara Chong TIA, Janet Daly TIA, Sharon Smith Direct- To-Consumer Review Group IV Leader Amy Toscano (acting) Cardiovascular and Renal (Zarna Patel) Oncology Drugs ( Stephanie Victor) Hematology, Medical Imaging, Anti-Infectives, Ophthalmology (JuWon Lee) (Vacancy) Direct- To-Consumer Review Group III Leader Shefali Doshi (acting) Anesthetics, Analgesics, Rheumatology (Twyla Thompson) Gastroenterology (Cindy Collins) Oncology Biologics (Vacancy) Metabolism and Endocrinology (Kendra Jones)
  6. 6. Final Promotional Pieces Submitted on Form FDA 2253 (1997 – 8/1/10)
  7. 7. DDMAC Enforcement Letters (2002 – 8/31/10)
  8. 8. History <ul><li>Public Meeting on Promotion of FDA-Regulated Medical Products on the Internet (October 1996) </li></ul><ul><ul><li>Investigational product information </li></ul></ul><ul><ul><li>Chatrooms and newsgroups </li></ul></ul><ul><ul><li>Website links </li></ul></ul><ul><ul><li>International issues </li></ul></ul><ul><ul><li>Additional regulatory issues </li></ul></ul><ul><ul><li>Federal Register Notice – September 16, 1996 </li></ul></ul><ul><ul><li>Vol. 61, No. 180 [Docket No. 96N-0309] </li></ul></ul>
  9. 9. History <ul><li>Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools (November 12-13, 2009) </li></ul><ul><ul><li>Accountability of information </li></ul></ul><ul><ul><li>Fulfilling regulatory requirements </li></ul></ul><ul><ul><li>Posting of corrective information on 3 rd -party sites </li></ul></ul><ul><ul><li>Use of links </li></ul></ul><ul><ul><li>Internet adverse event reporting </li></ul></ul><ul><ul><li>Federal Register Notice – September 21, 2009 </li></ul></ul><ul><ul><li>Vol. 74, No. 181 [Docket No. FDA-2009-N-0441] </li></ul></ul>
  10. 10. Question 1 <ul><li>For what online communications are manufacturers, packers, or distributors accountable? </li></ul>
  11. 11. Question 2 <ul><li>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>
  12. 12. Question 3 <ul><li>What parameters should apply to the posting of corrective information on websites controlled by third parties? </li></ul>
  13. 13. Question 4 <ul><li>When is the use of links appropriate? </li></ul>
  14. 14. Question 5 <ul><li>Questions specific to Internet adverse event reporting </li></ul>
  15. 15. Part 15 Hearing <ul><li>12 FDA panelists </li></ul><ul><li>59 speakers </li></ul><ul><li>77 presentations </li></ul><ul><ul><li>54 on Questions 1-4 </li></ul></ul><ul><ul><li>23 on Question 5 </li></ul></ul><ul><li>http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm </li></ul>
  16. 16. Part 15 Hearing
  17. 17. Part 15 Hearing
  18. 18. Part 15 Comments <ul><li>Deadline to submit comments to the docket was February 28, 2010 </li></ul><ul><li>We received 72 comments to the docket, in addition to the 77 presentations </li></ul><ul><li>Search docket “FDA-2009-N-0441-0001” on www.regulations.gov to view comments </li></ul>
  19. 19. Part 15 Comments
  20. 20. Part 15 Comments
  21. 21. Part 15 Total
  22. 22. Part 15 Total
  23. 23. Guidance Process <ul><li>FDA is committed to Good Guidance Practices (GGPs) [21 CFR 10.115] </li></ul><ul><ul><li>Hold a Part 15 public hearing [21 CFR 15] </li></ul></ul><ul><ul><li>Review comments submitted to the docket </li></ul></ul><ul><ul><li>Prepare a draft guidance document </li></ul></ul><ul><ul><li>Review comments on the draft guidance </li></ul></ul><ul><ul><li>Revise the draft guidance based on comments, if appropriate </li></ul></ul><ul><ul><li>Issue a final guidance document </li></ul></ul>
  24. 24. Future Direction <ul><li>CDER Guidance Agenda for 2010 </li></ul><ul><li>DDMAC Social Media Working Group </li></ul>
  25. 25. How Does DDMAC Regulate? <ul><li>Voluntary Compliance </li></ul><ul><ul><li>Advisory comments </li></ul></ul><ul><ul><li>Guidance documents </li></ul></ul><ul><ul><li>Educational efforts </li></ul></ul><ul><li>Comprehensive surveillance and enforcement program </li></ul>
  26. 26. Advice to Industry <ul><li>Provide advisory comments on draft promotional materials </li></ul><ul><ul><li>Product launches </li></ul></ul><ul><ul><li>Professional promotional materials </li></ul></ul><ul><ul><li>Direct-to-consumer materials (DTC) </li></ul></ul><ul><ul><li>Non-launches </li></ul></ul><ul><li>Usually voluntary submission; pre-submission required for certain drugs (e.g., Subpart H “accelerated approval”) </li></ul>
  27. 27. Submission Requirement <ul><li>Pre-submission required for certain drugs (e.g., Subpart H “accelerated approval”) </li></ul><ul><ul><li>Materials to be used in first 120 days after approval must be submitted before approval </li></ul></ul><ul><ul><li>Materials to be used after first 120 days must be submitted 30 days before time of first use </li></ul></ul>
  28. 28. Enforcement Actions <ul><li>Untitled letters/Notice of Violation (NOV) </li></ul><ul><li>Warning letters (WL) </li></ul><ul><li>Injunction/Consent decree </li></ul><ul><li>Seizures/Criminal action </li></ul><ul><li>http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm </li></ul>
  29. 29. DDMAC Contact Information <ul><li>Web address </li></ul><ul><ul><li>http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm </li></ul></ul><ul><li>Mailing Address </li></ul><ul><ul><li>Food and Drug Administration </li></ul></ul><ul><ul><li>Center for Drug Evaluation and Research </li></ul></ul><ul><ul><li>Division of Drug Marketing, Advertising, and Communications </li></ul></ul><ul><ul><li>5901-B Ammendale Road </li></ul></ul><ul><ul><li>Beltsville, MD 20705 </li></ul></ul>
  30. 30. DDMAC Contact Information <ul><li>Telephone </li></ul><ul><ul><li>(301) 796-1200 </li></ul></ul><ul><li>Fax </li></ul><ul><ul><li>(301) 847-8444 </li></ul></ul><ul><ul><li>(301) 847-8445 </li></ul></ul>