If you read the detailed reports relating how DuPont has been knowingly contaminating consumers’ blood by deliberately selling toxic products that contact foods, you would know that the FDA doesn’t exactly come up smelling like roses. Of course the worst of that saga may have been committed by FDA officials of 20 and more years ago. So is the FDA squeaky clean now?
Only the profoundly naive or completely stupid could believe so. A certain amount of built-in "error" is part of every organization. Consider it the human factor, representing or reflecting the darker side of human nature that always surfaces in any organizational setting. It isn’t simple or innocent incompetence, it reflects personal political machinations, quite deliberate and calculated manipulation of due process for some form of personal gain or aggrandizement.
Let’s just consider a more recent review of the FDA. It was performed by no less that the Government Accountability Office (GAO).
There is a drug commonly called Plan B, a so-called morning-after pill used to avoid pregnancy after unprotected sex. The drug has been available in the U.S. with a prescription since 1999. In December 2003, an FDA advisory committee voted 23 to 4 to recommend that availability of the drug be changed to over the counter (OTC). But according to the GAO report, two top officials at the FDA told staff members that the application would be rejected before the completion of a scientific review of the application.
The report described this sort of involvement by top officials as "very, very rare," and characterized the choice to ignore both the advisory committee recommendation and the scientific review as "unprecedented."
Over the past decade, the FDA has reviewed 23 applications to change a drug’s availability from prescription to OTC. The FDA decided against the advisory committee’s recommendation only once: in the case of Plan B.
Whatever the clinical, wider social and health and even moral arguments for or against this drug mat be, there is a very important issue here that purely relates to the FDA official’s behavior. Their extraordinary willingness to tamper with a drug’s approval process should be viewed with some concern, i fnot alarm.
If political pressures can overrule science and due process, do friendships within the drug industry achieve the same? Do drug company contributions to political campaigns also play a role in the process? There are many questions to pose. Important ones are, just who watches the watchdog, and do they have sufficient powers to deal with corruption when it is found?