These are the invisible victims of FDA policy. In the 1974 words of FDA commissioner Alexander M. Schmidt: "In all of FDA's history, I am unable to find a single instance where a congressional committee investigated the failure of FDA to approve a new drug. But, the times when hearings have been held to criticize our approval of new drugs have been so frequent that we aren't able to count them. ... The message to FDA staff could not be clearer."
That message is to always err on the side of overcaution where FDA's victims are invisible and the agency is held blameless.
Kazman's day job is general counsel for the Washington, D.C.-based Competitive Enterprise Institute that's done surveys of physicians and their views of the FDA. On approval speed, 61 to 77 percent of physicians surveyed say the FDA approval process is too slow. Seventy-eight percent believe the FDA has hurt their ability to give patients the best care.
But so what? Physicians carry far less weight with the FDA than "public interest" advocates and politicians.
When the FDA announces its approval of a new drug or device, the question that needs to be asked is: If this drug will start saving lives tomorrow, how many people died yesterday waiting for the FDA to act?