1. Promotion & Enforcement FDA’s Social Media Guidance

2. Basic Regulatory Concepts Content provided in online and social media forums are subject to the same regulatory framework as traditional media. –Could be “labeling” subject to FDA’s jurisdiction “Intended use” standard still applies –Likely to be “advertising” per the FTC’s jurisdiction Stationary and mobile environments also subject to same standards relative to claims and disclosures

3. How do third-parties factor in?

4. FDA’s Draft Guidance

5. FDA on User Generated Content

7. Section 230 “No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.”* Effectively, in many circumstances, this section immunizes both ISPs and Internet users from liability for torts committed by others using their website or online forum. * Myers, Ken S. (Fall 2006), Wikimmunity: Fitting the Communications Decency Act to Wikipedia, Harvard Journal of Law & Technology 20 : 163, SSRN 916529Harvard Journal of Law & TechnologySSRN916529

8. What about other products?

11. Back to Zarbee’s

12. Where does this leave us? If UGC posted on a company site is truly independent, the company is not liable for it (probably) Notwithstanding, a company can be held liable if it endorses, highlights, or actively solicits non-compliant comments

13. OPDP 2014 Enforcement Lessons

14. Enforcement Activity Declining

15. Social Media Enforcement 22% of OPDP letters were social media/space-limited 15

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17. The Violations Omission of risk information Omission of material facts 17

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20. The Violations Omission of risk information Inadequate presentation of established name Lack of adequate directions for use Failure to submit 2253 20

21. The 2009 Violations Omission of risk information Failure to use established name Inadequate communication of indication Overstatement of efficacy 21

22. Lessons from 2014 Activity Promulgate your policies Regularly monitor prominent platforms Control your “agents” 22

23. FDA & Social Media: A Case Study of Open Issues Joy Liu Ropes & Gray LLP

24. Case Study Facts Rando Pharma markets XYRIKASE (rivocrinogrel) XYRIKASE is approved in patients with a history of myocardial infarction (MI) for the reduction of the thrombotic cardiovascular events of cardiovascular death, MI, and urgent coronary revascularization. –Contraindicated in patients with active pathological bleeding or a history of stroke –Label includes warning of increased risk of bleeding –Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. –Discontinue 7 days before planned surgery 24

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27. UGC General Rules Company is not responsible for “truly independent” user generated content (“UGC”) –UGC not produced by Company –UGC not produced on behalf of Company –UGC not prompted by Company Company is not responsible for UGC when –User has no affiliation with company AND –Company had no influence on the UGC

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34. Take Away Your company policy should: –Specify that only authorized employees are permitted to engage in social media on behalf of the company –Identify the parameters of employees’ personal use of social media

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39. Take Away Your internal review process should evaluate not only the proposed language of the company’s post, but also the potential responses to the post

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42. Take Away Establish objective criteria that help dictate when your company will correct misinformation Be prepared to re-evaluate those criteria periodically in light of the UGC specific to your company’s social media activity