Save the Date! November 12th and 13th in Washington DC, you are cordially invited to attend the FDA's first ever public hearing on "Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools." This is excellent news that many in our industry should welcome. Will anything substantive get done? Always unclear. I have been to these kinds of meetings before and there is much talking and commenting, which is not always followed by action on the part of the Agency. That said, the fact that FDA is finally holding a public forum on the issue of social media means the topic is on the radar and hopefully will result in better guidance from them in the future.
Questions have arisen regarding the application of the prescription drug and device advertising and labeling provisions, regulations, and policies of promotion on the Internet, especially with regard to the use of emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis. This section briefly discusses the issues the agency has identified as most frequently raised by regulated companies and other interested parties...We are specifically interested in data and research on the use of social media tools in promotion, including data from companies on their own experiences, the extent to which health care professionals and consumers are using and are influenced by various social media tools, and the impact of Internet and social media promotion on the public health.
Specific questions to be discussed at the meeting include:
- For what online communications are manufacturers, packers, or distributors accountable?
- 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)?
- What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
- When is the use of links appropriate?
- Questions specific to Internet adverse event reporting
A few quick details (all in this document):
- If attending in person, the session runs from 8-5 each day. It is being held at the NTSB Conference Center
- If you can't make it but would still like to make comments submit them electronically; in fact you can submit until February 28, 2010
- A transcript of the meeting is supposed to be posted here about 30 days after the meeting