The document discusses regulatory compliance for sponsors in social media, outlining responsibilities such as the need for 2253 filings and corrective messaging. It highlights the FDA's draft guidance for online communications, including what promotional materials must be submitted and how user-generated content is treated. The document also addresses open questions regarding the definition of publicly accessible content and the implications for companies and their employees in social media interactions.

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.

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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.

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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.

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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.

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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.