It is safe to say that the FDA has not been exactly an innovative thinker when it comes to the Internet. The agency has done some nice work with widgets (peanut recall, e.g.,) and has begun its own Twitter feeds and even its own transparency blog. (Though it is interesting to note that if the agency twitters mentioning a specific drug name, if the company would re-tweet that tweet, under FDA's current point of view, the FDA might see that as promotion and in violation of fair balance rules and could theoretically result in a notice of violation letter to the company that re-tweeted the FDA's original tweet. Make sense?)
It is not that the agency lacks technical savvy, but DDMAC has been so focused on the rules, it has at times lost sight of the vision for the whole – promoting good public health – hence the 14 Notice of Violation letters sent out in the Spring of 2009. Those letters provided abundant evidence of the fact that the agency was more bent on enforcing a rule, than in considering how the violation of the rule by the pharmaceutical industry represented a sea change in the way people use the Internet.
In any case, the Internet and the people who use it are changing, and changing much more rapidly than the ability of the agency that regulates it – FDA and DDMAC – to keep up. The anachronistic process for developing a guidance after the public hearing is going to provide too little, too late.
An example of how quickly things are changing is with search. In Saturday's rare posting, it was pointed out how real time search by Google transforms crisis communications. Today's is about how, theoretically at least, real time search could transform pharmoacovigilance.
Google has already demonstrated its prowess in the ability of search to impact public health. Look at Google Flu Trends. Google Flu Trends looks for particular search terms that people use to find information about the flu which allows nearly real time tracking of flu trends by geography – which are not only accurate but run at least two weeks ahead of the published reports by the Centers for Disease Control.
If that can be done for flu, why can't it be done for the top twenty or so prescribed drugs to look for trends in issues? The agency could track in real time searches about the compound and determine if a safety signal is showing itself. It would be far more timely than the current system of waiting for a physician or a patient to file a report with the FDA and have it processed. It might be reasonably, if not absolutely accurate, if done right.
In fact, there might even be a role for Google search trends in risk management. What if you could discover the existence of search terms that indicated misuse of opioid based pain killers? You might not only be able to discover the existence of a problem, but see the emergence of a problem geographically or demographically. Or perhaps not, but it is certainly worth exploring.
Come on FDA, connect the dots here. Think strategically. Huddle down with Google and see if you can make this happen. It could save lives. It could go a long way to restoring the agency's battered image as a protector the public's health. And it would demonstrate that the agency finally "gets it" in understanding how people use the Internet for health information.