Yesterday, the U.S. Food and Drug Administration put out a statement explaining why a draft guidance on social media — expected to be released this week — was being delayed a second time (a guidance was originally slated for year-end 2010). Here is the full text of the statement, per an email from FDA:
Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities. Despite our limited resources and increasing workload, we remain committed to this area in terms of both time and human resources.
It is difficult to provide a timeframe for the issuance of our guidances due to the extensive work and review process, or “Good Guidance Practices” (GGPs), which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA’s current thinking on a topic.
Taking into consideration the input from within and outside FDA, including testimony and comments from the Part 15 hearing, we have identified the following issues that are important to address:
- 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
We are developing multiple draft guidances to address these topics to benefit industry and the public by ensuring that these draft guidances are meaningful and well thought out when they are issued.
There will be a temptation to see the failure of the FDA to act as a sign that the agency has put the issue on the back burner. That gives the FDA too little credit. In their statement, the agency says the draft guidance is “among our highest priorities.” There are already a set of FDA marketing principles in place, and the agency has made at least two significant moves to apply those principles to online, branded promotion. There is no doubt that attention is being paid.
At WCG, we’ll continue to push ahead with the safe and thoughtful use of social media, guidance or no guidance, and we look forward to sharing additional insights as the process continues.
For additional perspective, please see my colleague Chris Iafolla’s post today: No Social Media FDA Guidance for Pharma, No Problem.