Your SlideShare is downloading. ×
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Staying Compliant in a Social World
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

Staying Compliant in a Social World

228

Published on

Pharmaceutical companies have often been uncertain about how to meet their regulatory obligations while engaging in the new social media forums favored by consumers and physicians alike. FDA has …

Pharmaceutical companies have often been uncertain about how to meet their regulatory obligations while engaging in the new social media forums favored by consumers and physicians alike. FDA has released its first guidance addressing this topic since its 2009 hearings on the subject. The guidance addresses how sponsors can fulfill their requirement to file all material at the time of first use (the 2253 requirement) while engaging in real-time conversations.
This presentation examines key aspects of the guidance including:
* Status of user-generated content (UGC) and companies' reporting obligation for UGC
* Ability to meet 2253 filing requirements in the context of real-time conversations
* Implications of the guidance for filing online promotional materials other than social media
* Some open questions left unanswered by the guidance

Published in: Healthcare
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
228
On Slideshare
0
From Embeds
0
Number of Embeds
2
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. Staying Compliant in a Social World Presented by Dale Cooke
  • 2. 2 The 14 letters from 2009
  • 3. 3 Nov ’09 Part 15 Hearings & FDASIA Five questions: > What online communications are sponsors responsible for? > How can sponsors fulfill regulatory obligations in social media (2253 filings, fair balance, etc.)? > What should sponsors do about corrective messaging? > When are links appropriate? > How should sponsors deal with AERs? FDASIA mandate to produce guidance by July 2014
  • 4. 4 Social media guidance is here http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM 381352.pdf See also, http://www.scribd.com/doc/199434412/DH-Regulatory-Alert-2253-Filing-Requirements- for-Social-Media Released January 2014
  • 5. 5 Nov ’09 Part 15 Hearings & FDASIA Five questions: > What online communications are sponsors responsible for? > How can sponsors fulfill regulatory obligations in social media (2253 filings, fair balance, etc.)? > What should sponsors do about corrective messaging? > When are links appropriate? > How should sponsors deal with AERs? FDASIA mandate to produce guidance by July 2014
  • 6. 6 Additional guidance to come
  • 7. 7 What is a guidance? “Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.” - From the FDA website
  • 8. 8 But it’s only draft
  • 9. 9 What are postmarketing submissions? All promotional materials must be submitted to FDA at the time of initial dissemination (i.e., the 2253 submission). This guidance addresses two questions about the 2253 submission: 1. Whether to submit materials 2. What to submit
  • 10. 10 User-generated content “a firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular)”* * Postmarketing Guidance, page 5.
  • 11. 11 Determining whether to submit Three sets of circumstances: 1. Sites “owned, controlled, created, influenced, or operated by, or on behalf of the firm…. even if the influence is limited.”* 2. Site pages if the firm “influenced the placement” of promotional materials.** 3. When agents or employees are “acting on behalf of the firm”** * Postmarketing Guidance, page 3. ** Postmarketing Guidance, page 4.
  • 12. 12 Enforcement discretion “If a firm submits interactive promotional media in the manner described in this draft guidance, FDA intends to exercise enforcement discretion regarding the regulatory requirements for postmarketing submissions related to promotional labeling and advertising.”* Enforcement discretion means: 1. FDA has the legal authority to enforce legal and regulatory requirements in that area. 2. FDA will not use that authority. * Postmarketing Guidance, page 5.
  • 13. 13 Applying discretion to social media Firms have a legal obligation to submit all parts of a conversation prior to using them, but FDA will not take enforcement action against companies that fail to do so, IF THEY ABIDE BY THIS GUIDANCE.
  • 14. 14 What to submit 1. For static materials with interactive components, submit static and indicate what changes (e.g., which portion of the website houses an online discussion forum) 2. For third-party sites, submit static elements with first communication (e.g., first Tweet & Twitter profile page). 3. Submit a monthly listing of locations (URLs) with real-time discussion.
  • 15. 15 30-day submissions Publicly accessible discussions > Submit a list of URLs where real-time discussions are happening > Update the list every 30 days (confirming, adding, or removing as necessary) to reflect current involvement > Do NOT submit the actual interactions themselves Not publicly accessible discussions (e.g., behind a log-in) > Submit a list of URLs where real-time discussions are happening > Update the list every 30 days (confirming, adding, or removing as necessary) to reflect current involvement > Submit screenshots or other representations of the actual interactions themselves > Indicate what discussion sponsor owns > Provide enough context for FDA to understand/evaluate the discussion
  • 16. 16 Open questions 1. What constitutes being publicly accessible? a) If you have to “like” a page to view it, is it publicly accessible? 2. Does this open up or limit the activities of employees? a) Do companies now have to submit the URL of every employee who mentions a product on their Twitter, Facebook, Tumblr, Pinterest, etc.? 3. Are companies responsible for sites where they advertise?
  • 17. Questions? Dale Cooke Vice President/Group Director, Regulatory Dale.Cooke@DigitasHealth.com @PhillyCooke on Twitter www.scribd.com/Dale_Cooke
  • 18. 18 Dale Cooke VP/Group Director, Regulatory Dale Cooke is the head of the regulatory department for Digitas Health. He has worked with more than 30 pharmaceutical and medical device clients and with Medical-Legal-Regulatory committees around the world from offices in Philadelphia, New York, Boston, San Francisco, and London. Dale advises clients on FDA enforcement actions and provides recommendations for compliance with FDA regulations, with a focus on issues involving the Internet and emerging technology. His insights have been featured in the Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Alliance for a Stronger FDA, and the Food and Drug Law Institute (FDLI). Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of the FDLI primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and pharmaceutical involvement in social media. Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Analytical Philosophy from the University of Arizona, and studied Epidemiology and Biostatistics at Drexel University’s School of Public Health.

×