As many might have guessed, the second target date set by FDA’s DDMAC for the issuance of a Draft Guidance on Social Media and the Internet is about to pass, apparently without any new developments. Slated for the end of 2010 and then for the end of the first quarter, there is no longer any goal being enunciated on timing.
A statement that is circulating purportedly from FDA says the following (though this could not be confirmed by time of this posting):
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. (emphasis added)
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.
The failure to produce a document to which the public could respond, and the lack of transparency regarding the thought process or information on how the draft is being developed and the length of time that the task has taken is disheartening, to say the least. Why can’t the agency be transparent? Why can’t DDMAC be timely? Why is this task so hard? One can only ask – the agency is not producing any answers.
It would appear from the first sentence of this statement that FDA is blaming their own Good Guidance Practices. Those practices are not new, so it is unclear as to why at this late stage they are being sited as a reason for the failure to produce a draft guidance. There is a difference between a reason for a delay and an excuse for a delay. If FDA’s own process is too onerous to produce important guidance on a timely basis, change the process. The process should not stand in the way.
The task at hand is not that difficult and requires an understanding of the Internet, social media and how patients are using both to get information. FDA is trying to apply old paradigms to a new technology. Perhaps the approach would be more timely, and smoother, if the focus were less on merely preserving principles from print and broadcast guidelines to assessing what the public health concerns are that need to be addressed on the Internet and in social media. In other words, it is time that FDA’s approach shift from a focus on what FDA does, to why FDA does it in the first place.