Suddenly, out of almost nowhere it seems, a document emerged from the FDA entitled "FDA's Strategic Plan for Risk Communication" and was simply dated "Fall, 2009". In it, the agency lays out its thinking with respect to risk communications, particularly in light of the fact that there are new media to consider. The language and acknowledgment of that fact were nothing short of astonishing:
"In the past, FDA's communication efforts were largely restricted to overseeing the key vehicle for communicating risk information to the public – the labeling of FDA regulated products. The process of negotiating with product manufacturers about changes to labeling or decisions to recall a product was often lengthy. Now, as the Internet and emerging technologies both enable and feed the public's demand for greater transparency and communication frequency, these protracted waiting periods are giving way to communication in real time. Thus, designing a contemporary risk communication strategy is critical to FDA's efforts to realize its potential for effective protection and promotion of health, enabled by 21st century knowledge and technology." (emphasis added)
The statement is surprising from more than a few angles. First, the FDA is finally acknowledging that it needs to move and move quickly given digital media. That is progress. Second, the statement seems to reflect the belief that the Internet was just invented by Al Gore this year, when in fact, the FDA is dismally behind understanding the Internet and how people use to fulfill their health care needs. Second, despite the fact that there is some urgency to a need for further clarification around communications on the Internet from a regulatory point of view due to rapidly emerging developments (e.g., Sidewiki), this strategic plan is in no hurry and has laid out a plan of action that will span years. But the other reality signaled by this plan, and this statement, is that FDA is acknowledging that the responsibilities of the agency extend way beyond the physical labeling of a product. That seems new, at least to me, and opens up some unchartered terrain.
In any case, this plan should be required reading for all who plan to attend the November Part 15 meeting being held by the FDA to discuss the regulation of social media. It is important to get as much information as possible on what the FDA's perceptions of digital media are, where their thinking is, and what processes (albeit lengthy) they are thinking about employing before the meeting so that suggestions offered by stakeholders in the meeting are more relevant.
What processes does the plan have in store and what are the implications.? Tune in tomorrow for FDA's Strategic Plan for Risk Communication, Part 2.
“But the other reality signaled by this plan, and this statement, is that FDA is acknowledging that the responsibilities of the agency extend way beyond the physical labeling of a product. That seems new, at least to me, and opens up some unchartered terrain.”
I’m not sure what you mean here — doesn’t the FDA already oversee pretty much all communication from pharma companies about their products? For example, verifying claims of magazine/television ads?
This is interesting, but I have to wonder — seriously, does the FDA have the capacity to move at the speed required in our networked era? By the time they develop a strategy for sidewiki and twitter, the online world will have long moved on to something else even more disruptive.
Hiya Pierce – what I meant was that i think that fda views all those promotional things they regulate as extensions of the label. by stating that they are realizing they need to go beyond that to me is a signal of something new. or i could just be (and am) very tired today. 🙂