For many years now, there has been a long wait after a public hearing held in 1996 on some form of guidance from the FDA that would provide communications guidelines for this new medium. Fifteen years have passed and those who were waiting still are.
In November 2009 FDA’s DDMAC held another public meeting about the Internet, adding to it the subject matter of social media. Many sought FDA guidance on this issue too, particularly after the quirky pattern of enforcement by the agency that resulted in the New York Times – “FDA Rules on Drug Ads Sow Confusion As Applied to the Web“.
The target for a new Draft Guidance was December 31, 2010, though it was made clear that the deadline could be missed. It was. On December 21, 2010, the FDA issued a statement, re-issued yesterday in response to inquiry, that broadly addressed the issue of what people could expect and when by saying it could involve any one of a number of topics and could be released at any time. The agency has given the public no indication of the area in which they are concentrating – nor has any public input been sought other than through the public meeting and the subsequent docket. Otherwise, the lengthy process has remained arcane.
Also in 2009, the FDA went to great lengths to launch a Transparency Initiative. There is a blog and periodically the indexes by which the agency measures its progress are published. The process for DDMAC’s draft guidance machinations however, are apparently not part of the Transparency Initiative. When one inquires about progress, one gets the same statement over and over – one that is designed to be non-informative. Why can’t the process be more collaborative and open? The end product would surely be improved and take less time if it were.
The wait for some inkling of guidance after all this time would merely be inconvenient but for the fact that health information seeking is one of the primary reasons people utilize the Internet, and increasingly there are social media applications being utilized. But there are many, many open questions that require guidance so that the integrity of that information is reinforced. Without integrity, access to inaccurate information is a public health risk – probably one greater than contained in a whole handful of Notice of Violation letters periodically sent out by DDMAC. For example, medical product manufacturers are not clear if misinformation contained in a posting on a public site can be corrected by the company or not?
How can such a simple question require so much time for a reasonable answer? Some think we will get an answer soon. Some anticipate disappointment. Whatever the answer is to that question, one thing is clear – there has to be a better way.
