THOREAU- Thorough High Objectivity Review Ends Are Us
Thoreau-FDA.com is composed of and/or descriptive of current and ex-US Food and Drug Administration (US FDA) staff who have succeeded, in resisting their upper management’s wrongful directives and requests that put public health at avoidable risk. When unchecked, these wrongful directives/requests cause drug review outcomes to be misrepresented as carefully considered objective "science based" assessments, when they are, in fact, pre-determined. Click here to read Articles. These wrongful requests or directives by the US FDA’s upper managers are specifically called, undocumented top-down approve directives or requests. Some US FDA staff resist such wrongful directives and requests by disobeying them. This is called Civil Servant Disobedience.
Thoreau-FDA.com also presents the ordeals of some US FDA staff, who alerted the public about harmful FDA regulated products. In the course of doing their jobs, these US FDA staff were subjected to retaliation by US FDA upper management. Click here for accounts of ordeals.
These pre-approval review and post approval regulatory flaws have global implications because US FDA is often cited as an international "gold standard", a regulatory benchmark; Therefore, these flaws, if uncorrected, can affect the public health on an international scale, since it is possible other countries will replicate the US FDA upper management’s actions and policies.
The problem’s globalization should not be underestimated, especially in light of recent talk to locate permanent outposts of FDA regulatory operations abroad. The threat of internationalizing the problem only underscores the urgency to correct matters now. We hope that remediation will occur before US FDA upper managers attempt to establish any outposts on foreign soil. Furthermore, we strongly recommend that the contemplated FDA outposts be augmented with similar reciprocal arrangements in the US, in the spirit of regulatory harmonization and cooperative education.
Thoreau-FDA.com also provides an opportunity for public participation. We invite anyone to join us in our efforts to motivate US FDA Commissioner Von Eschenbach to ensure an end to what amounts to “professional oppression” of journeyman field/review/compliance staff by higher level FDA management. To help us, please go to LETTER TO U.S. FDA COMMISSIONER. (Here you can sign and send a letter to him, or modify the letter, then sign and send it.) In our letter, we ask Commissioner von Eschenbach about implementation of his “Values and Vision” program. This is in keeping with our goal to intensify public scrutiny of FDA upper management’s efforts at ensuring public health protection in an increasingly complex global marketplace. And we want to ensure that his current program corrects preapproval review and regulatory flaws now firmly embedded in the US FDA’s culture. (See Purpose and Philosophy) We believe effective preapproval review and regulatory oversight is crucial to ensuring US and global public health safety.
