This presentation from December 2014 at the Food and Drug Law Institute's Enforcement and Litigation took at look at enforcement actions from the FDA's Office of Prescription Drug Promotion for use of Internet and social media platforms.

1. OPDP 2014 Enforcement
Lessons

2. Enforcement Activity Declining
139
156
108
75
64
28 25 23 29
22 19 21
41
52
31 28 24
9
0
40
80
120
160
200
1997 2000 2003 2006 2009 2012
OPDP Enforcement Letters

3. Social Media Enforcement
22%of OPDP letters were
social media/space-limited
3

4. 4

5. The Violations
• Omission of risk information
• Omission of material facts
5

6. 6

7. 7

8. The Violations
• Omission of risk information
• Inadequate presentation of
established name
• Lack of adequate directions for use
• Failure to submit 2253
8

9. The 2009 Violations
• Omission of risk information
• Failure to use established name
• Inadequate communication of indication
• Overstatement of efficacy
9

10. Lessons from 2014 Activity
• Promulgate your policies
• Regularly monitor prominent platforms
• Control your “agents”
10