As anyone can see who visits the actual Eye on FDA site, there is a great deal of legislation that is being considered by Congress for passage. Some of it involves fundamental changes to the way that the FDA does, or will do business. It is not insignificant legislation, some of which I haven’t even had a chance to toss onto the roll (I promise to get to this).
But, in short, the advent of the 110th Congress has undeniably brought with it a range of new proposals, from proposing a regulatory pathway to consider biotechnology drugs coming off patent to the more rigorous regulation of tobacco.
If, however, you turn to the FDA’s Web site that tracks the agency’s congressional testimony to look at what the newly confirmed FDA Commissioner’s point of view on this would be, you would be hard pressed to find it. In fact, the last testimony provided by the FDA was November 15, 2006. This is in spite of the fact that there has not only been a wealth of legislative proposals, there has been a somewhat aggressive hearing schedule being run by the newly-in-charge Democratic majority.
This leads one to three possible conclusions. First, the Web master at FDA is asleep on the job. Or, second, that Dr. von Eschenbach prefers to keep his opinion to himself. Or, thirdly, that the Democratic chairs do not feel that they need to ask the FDA Commissioner his point of view, presumably because they already know it. I hope no one in Washington would be that jaded.
As recently cited by several former FDA Commissioners, one thing desperately needed by the FDA today is good leadership. Under this Administration, it has gone without that for more time than not. Now that there is finally a commissioner in place, it is time to let him speak his piece about a vision, and there is no more suitable place for him – or for us who want to hear him- than offering testimony on these many bills at these many hearings.