Today the Food & Drug Administration announced that they are going to wait until at least the first quarter of 2011 to give the world official guidance on social media. Mark Senak’s blog post gives us a glimpse into what the FDA is thinking with the delay and the official statement from the FDA:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:
- Fulfilling regulatory requirements when using tools associated with space limitations
- Fulfilling post-marketing submission requirements
- On-line communications for which manufacturers, packers, or distributors are accountable
- Use of links on the Internet
- Correcting misinformation
Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.
I understand the FDA wants to ‘get it right’ but what the industry really needs now is strong guidance and a sense of direction. I can’t tell you how many times I have spoken with clients who are looking for the right answer but know in the current market there isn’t one.
