Subject: *

Letter: * (You are welcome to edit the letter prior to sending.)
I understand from articles written by current and ex-US FDA civil servants and posted on Thoreau-FDA.com: There is evidence presented to the US Congress that shows some instances of Undocumented Top Down “Approve” Directives or Requests, by FDA upper managers that interfere with the independent decisions of lower level drug reviewers. Writers on Thoreau-FDA.com assert that reviewer independence is necessary to ensure objective science based outcomes, accountability, transparency and legitimate risk versus benefit decisions throughout any line of drug product review at US FDA. I ask that you ensure the independent decisions of drug reviewers at each level in the US FDA. This will ensure that drug pre-approval reviews are free from biased manipulation by US FDA upper managers, who sometimes direct lower level drug approval decisions via undocumented top down directives or requests. And, Thoreau-FDA.com presents news reports where some US FDA upper managers retaliated against subordinate staff who attempted to carry out the US FDA’s mission to protect the public health safety. These subordinate staff’s ordeals occurred when they brought to public awareness, dangerous and deadly products that had made it to market. In summary, it seems that some US FDA upper managers have resisted staff alerts intended to mitigate, by label revisions or marketplace removal, the effects of harmful and deadly products. The pre- and post-approval drug review processes are under your control. Please do all you can to stop : · Instances of undocumented top down approve directives and requests by US FDA upper managers, in the drug approval program at US FDA · Any change in any lower level regulatory action decision, that fails to document the name of the higher level US FDA manager, who actually directs the change in the lower level decision. · US FDA upper managers from hiding behind their subordinates, when those managers direct them to alter their decisions, so that professional disagreements are not recorded in the public record. · Retaliation by US FDA upper managers against FDA staff who alert the public to dangerous and deadly products already on the market. Please answer the below question about your Values and Vision program and how it will stop what amounts to FDA management oppression of professionals and the suppression of truth. Future questions will be submitted to you periodically by Thoreau-FDA.com for your answers. Please answer those questions starting with the following – How does your Values and Vision effort, as initially announced to US FDA staff in the September 19, 2007 Webcast and subsequent March 2008 updates, prevent future Undocumented Top Down Approve Directives or Requests and more retaliation against US FDA staff who publicly expose deadly human and veterinary products?

Sincerely,

[Your Name]
[Your Address]
[City, State ZIP]

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