Justinian Lane

Current and Former FDA employees launch blog critical of FDA’s safety policy

I wonder why there isn’t an FDA “insider” blog complaining that the agency is overly cautious?   Hmmm…

new web site called Thoreau-FDA.com has emerged that is highly critical of the agency and, in particular, FDA commish Andy von Eschenbach, who is accused of oppressing FDA employees and preventing them from doing their jobs. The site, which is anonmyously crafted, is allegedly the brainchild of an unknown number of current and former agency employees.

Their goal: “to intensify public scrutiny of FDA upper management’s efforts at ensuring public health protection in an increasingly complex global marketplace…and engage (Andy), his successors and FDA upper managers in a public question and answer dialog … to end the entrenched process flaws in FDA’s pre-approval drug review and post-approval regulatory enforcement systems.

“Among the flaws that need to cease,” it continues, “is the abuse of FDA staff, who do their jobs by making publicly known, the existence of harmful and deadly products already approved for, and in, the market.”

Why Thoreau? Thoreau-FDA stands for Thorough – High – Objectivity – Review – Ends – Are – Us – FDA. And the site goes on to say that “wrongful directives/requests” from FDA upper management “cause drug review outcomes to be misrepresented as carefully considered objective ’science based’ assessments, when they are, in fact, pre-determined.”

Source: Civil Servant Disobedience: A Critical FDA Site // Pharmalot

This ought to be an interesting blog to watch.

Posted at 3:44 PM, Jul 18, 2008 in FDA | Permalink | Comments (1) | TrackBack (0)