The latest broadside against the FDA is by Congressman Waxman who argues the FDA is doing a lousy job by not prosecuting and attacking companies who are producing inferior products, engaging in mislabeling or selling suspicious goods. This is the sort of after fact enforcement activity that pols love since it gives them something to hold hearing about. I call it regulation by body count since it requires people to die or be harmed in order for a regulatory or enforcement act to take place. In contrast, since Mark McClellan became commissioner in 2003, the FDA has sought to improve overall product quality through manufacturing efficiencies, risk management programs and other quality improvement efforts that are not politically sexy and often take years and millions of dollars to implement. (Not to mention cooperation. ) Indeed manufacturing is part of the Critical Path lest anyone forgets.
Of course, the drive by media ignores all of this. And the FDA has not done enough to get the message out about these important initiatives. One more thing: Why does Gardiner Harris refer to the ‘conservative’ American Enterprise Institute and the ‘watchdog’ Public Citizen? Public Citizen is nothing but ‘liberal’ and as for watchdog, that is a matter of opinion, not absolute truth. Even a Rockefeller can figure that one out.
