FDA is once again banging the drum on drug shortages. In a statement yesterday, Commissioner Gottlieb announced the agency is focused on doing all it can to mitigate existing shortages. But is that really the case? For some unknown reason, FDA has continued to sidestep the massive influence of unethical and potentially criminal diversion activity when discussing its response to our nation’s ongoing drug shortage crisis. According to the Commissioner, drug shortages have significant costs to our overall health care system. While this is clearly the case, the agency’s apparent aversion to addressing the insidious role of shortage drug diversion schemes is both perplexing and frustrating. I’m betting that most hospitals feel the same way.
In a November 2017 post on this topic, I shared some compelling sections from the July 2012 Congressional report on drug shortages, titled Shining Light on the “Gray Market.” I added, “FDA should look inward at its role in perpetuating the type of shortage drug diversion activity that Congress described in its groundbreaking report more than five years ago. The truth is the agency has done little, if anything, to mitigate this despicable activity.”
FDA claims to be doing all it can to address drug shortages. I’ll believe that once the agency begins to tackle the shortage drug diversion issue in earnest.