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

1. The following presentation was delivered at e-Patient Connections 2010 Join the community at http://KruResearch.com/subscribe

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. DDMAC’s Mission
To protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.
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.
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm

4. 21 CFR 202.1
Must not be false or misleading
Must have balance between efficacy and risk information
Must be consistent with the approved product labeling or package insert (PI)
Must be supported by substantial evidence

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. Final Promotional Pieces Submitted on Form FDA 2253 (1997 – 8/1/10)

7. DDMAC Enforcement Letters (2002 – 8/31/10)

8. History
Public Meeting on Promotion of FDA-Regulated Medical Products on the Internet (October 1996)
Investigational product information
Chatrooms and newsgroups
Website links
International issues
Additional regulatory issues
Federal Register Notice – September 16, 1996
Vol. 61, No. 180 [Docket No. 96N-0309]

9. History
Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools (November 12-13, 2009)
Accountability of information
Fulfilling regulatory requirements
Posting of corrective information on 3 rd -party sites
Use of links
Internet adverse event reporting
Federal Register Notice – September 21, 2009
Vol. 74, No. 181 [Docket No. FDA-2009-N-0441]

10. Question 1
For what online communications are manufacturers, packers, or distributors accountable?

11. Question 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)?

12. Question 3
What parameters should apply to the posting of corrective information on websites controlled by third parties?

13. Question 4
When is the use of links appropriate?

14. Question 5
Questions specific to Internet adverse event reporting

15. Part 15 Hearing
12 FDA panelists
59 speakers
77 presentations
54 on Questions 1-4
23 on Question 5

16. Part 15 Hearing

17. Part 15 Hearing

18. Part 15 Comments
Deadline to submit comments to the docket was February 28, 2010
We received 72 comments to the docket, in addition to the 77 presentations
Search docket “FDA-2009-N-0441-0001” on www.regulations.gov to view comments

21. Part 15 Total

22. Part 15 Total

23. Guidance Process
FDA is committed to Good Guidance Practices (GGPs) [21 CFR 10.115]
Hold a Part 15 public hearing [21 CFR 15]
Review comments submitted to the docket
Prepare a draft guidance document
Review comments on the draft guidance
Revise the draft guidance based on comments, if appropriate
Issue a final guidance document

24. Future Direction
CDER Guidance Agenda for 2010
DDMAC Social Media Working Group

25. How Does DDMAC Regulate?
Voluntary Compliance
Advisory comments
Guidance documents
Educational efforts
Comprehensive surveillance and enforcement program

26. Advice to Industry
Provide advisory comments on draft promotional materials
Product launches
Professional promotional materials
Direct-to-consumer materials (DTC)
Non-launches
Usually voluntary submission; pre-submission required for certain drugs (e.g., Subpart H “accelerated approval”)

27. Submission Requirement
Pre-submission required for certain drugs (e.g., Subpart H “accelerated approval”)
Materials to be used in first 120 days after approval must be submitted before approval
Materials to be used after first 120 days must be submitted 30 days before time of first use

28. Enforcement Actions
Untitled letters/Notice of Violation (NOV)
Warning letters (WL)
Injunction/Consent decree
Seizures/Criminal action
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm

29. DDMAC Contact Information
Web address
Mailing Address
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Drug Marketing, Advertising, and Communications
5901-B Ammendale Road
Beltsville, MD 20705

30. DDMAC Contact Information
Telephone
(301) 796-1200
Fax
(301) 847-8444
(301) 847-8445

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