Seeking (social media) Guidance

The FDA will not be issuing a guidance on social media any time soon on any of the following:

• Responding to unsolicited requests
• 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

The FDA goes on to say:

Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed.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.

My colleague Peter Pitts has written smartly on the subject of social media. If you read between the lines of the non-issuance,  Peter's prior observation that there is a lot that the FDA will and cannot regulate suggests that any guidance will be a non-event.

Beside,  as I point out in my book tabloidmedicine,  most of what defines the risk and benefits of a medicine on line is a result of what others are saying or spreading in ways that will always be unregulated by the FDA.   So what's a company to do? 

1.Fill the void with tools that give consumers information and the ability to determine in partnership with their physicians what's best. 
2. Ask people to volunteer participating in certain social networks,  only ask and enter when invited. 
3.  Respond quickly and proactively to scaremongering,  counterfeiting scams and hype. 

If companies wait for the FDA to define the online environment it will already be too late. Guidance should come from within (and not just from the legal department!).