There is a proverb that an accusation that goes unanswered is an accusation that is admitted. In other words, if the FDA doesn’t act to counter the environment, the environment will define the FDA.
It isn’t clear that that the agency is a fan of old proverbs. Not only did the series of events over the past few years tarnish their image, but legislation has been proposed to "reform" the FDA and Congressional critics use extreme hyperbole when discussing FDA actions or in-actions. If the public continues to hear such hyperbole in connection with the agency, that will begin to mold the perception of the agency in the eyes of the public. Yet, the agency has been hobbled by the silence of the bully pulpit of a permanent commissioner.
Dr. Andrew C. von Eschenbach was appointed as Acting Commissioner of the FDA in September of 2005. But with the exception of one instance of Congressional testimony given recently, any other speeches or public pronouncements from FDA officials have been made by Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs. And the topics of those speeches have not been, in nature, ones that could begin to do the job needed. This has been the pattern since the departure of Dr. Lester Crawford. Dr. Gottlieb is a highly capable individual, imminently smart and a snappy dresser to boot. But he is not the Commissioner. There has been no voice of a leader from the FDA, to address the tarnished image of the agency.
This leads to a conundrum. While it is perhaps not a good idea to muddy the waters before one is confirmed in one’s job, the fact remains that until the waters are un-muddied, confirmation of a new Commissioner may be extremely difficult. If Dr. von Eschenbach can vocally offer a very tantalizing vision for the rehabilitation of the FDA, that at least can provide vision of what his leadership would entail.
Bear in mind that the image of the agency in turn affects the image of the pharmaceutical industry. The silence of the office of the (acting) commissioner has a negative impact. The FDA has lost its voice, and needs to find it.
At the very least, the FDA needs to enunciate a plan of action that is proactive, rather than reactive, when it comes to its own image. Without it, the environment will continue to shape that image.