The FDA is now undertaking a glacially paced effort at examining the regulation of social media and the Internet. And slowly the agency has been increasingly using social media and emerging media tools to get word out, particularly during recalls, about products. Most notably, the agency was quite effective in using a widget that was regularly updated during the peanut recall to identify products associated with the recall.
But maybe it is time for a bolder course from the agency, which is still trying to regain its footing and golden image of yesteryear. Maybe it is time for a Wiki.
The Department of Defense (DOD) is all over social media. In January 2009, they launched a Webcast series called "Armed with Science" and one year later, began a blog along the same lines. The efforts come out of DOD's "Defense Media Activity" (DMA) initiative. The mission of the DMA "is to provide a broad range of high quality multimedia products and services to inform, educate, and entertain DOD audiences around the world." Further, the stated vision for DMA is "to be a world-class multimedia organization that skillfully uses and teaches state-of-the-art communications tools and methods…" Wow.
You have to figure, with the huge volumes of people turning to the Internet each day for health care information upon which they will make treatment decisions, someone should be doing something similar in health care in general, and medical products in particular. That would certainly protect and promote the public health.
This week, the Armed with Science blog carried a story about a Wiki begun by DOD for the purpose of increasing scientific collaboration called Techipedia.
Techipedia allows for a much more rapid exchange of information about various topics. As the blog post on the topic states, waiting for people to publish information and ideas in journals just takes too much time. The wiki was begun in 2008 and has over 11,000 entries. It provides a secure means of enhancing scientific collaboration along a whole range of topics.
FDA, take notes. Go visit DOD. Because the system you have in place to provide guidances is just too slow and cumbersome to get the job done in today's environment and you are not keeping up. Case on point – developing a guidance for social media – a process that will take months in response to a situation that demands quicker action. It is not the only example. The FDA and its role are too important for the agency to challenge its own long-term relevance by slow action.
Development of a Wiki to allow an informational exchange of ideas, proposals and developments among regulators, academics, practitioners and medical product manufacturers, should result in faster guidances, greater innovation, much more transparency and would demonstrate that FDA is using the newest tools to respond to the ever-changing environment. The interchange that results on Wiki could result in a much more robust and realistic process for developing REMS programs, for example, than is the current practice of letting companies file NDA's and going through the entire approval process, only to receive a Complete Response Letter asking for a REMS. Why not do this beforehand? Patients would get their meds more quickly, and the public health enhanced by a better REMS program than under the current system.