Subject: *

Letter: * (You are welcome to edit the letter prior to sending.)
Dr. Hamburg, I understand from articles written by current and ex-US FDA civil servants and posted on Thoreau-FDA.com in July of 2008 that: Evidence presented to the US Congress shows a [practice] of Undocumented Top Down “Approve” directives or requests, by US FDA upper managers that threaten public health safety and cloud accountability. The topsiders interfered with independent decisions of lower level drug reviewers. Contributors to 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 review line of products regulated by the US FDA. It is our hope that you agree with the importance of independent reviews. Therefore, I ask that you ensure the independent decisions of drug, medical device and other FDA reviewers at each level in the US FDA. Thoreau-FDA personnel assert that this will ensure pre-approval product reviews within FDA that are free from biased manipulation by US FDA upper managers, some of whom have lapsed into the practice of directing FDA product approvals by undocumented top down approve directives. In addition, Thoreau-FDA.com presents news reports that explain how some US FDA upper managers retaliated against subordinate staff who attempted to carry out the US FDA’s mission to protect the public health and safety. These retaliations occured when FDA Reviewers brought to public awareness, dangerous and deadly products that made it to market. In summary, it seems that some US FDA upper managers resist staff alerts intended to mitigate, by label revisions or marketplace removal, the effects of harmful and deadly products. Unsuccessful efforts were made by ex-Commissioner Von Eschenbach to correct these abuses by some FDA upper managers. For example, in September of 2007 and in a 2008 update, he launched an FDA Values and Vision program he claimed would end upper management’s wrongdoing and maximize FDA’s public health safety mission. Current and ex-FDA civil servants launched the web site Thoreau-FDA.com, to ensure follow through by ex-Commissioner Von Eschenbach. That site posted a letter for citizens to send to him and forty-four letters were sent. The letters asked that he stop FDA management top-down wrongdoings and end retaliation against lower level staff. However, these letters failed to bring about any response. Most importantly, recent evidence indicates that FDA management wrongdoings continue. An April 2nd 2009 letter to President Barack Obama from US FDA staff presents more examples of upper management wrongdoings that have persisted since our July 2008 postings on Thoreau-fda.com. The April 2009 letter to President Obama underscores that the Values and Vision program failed. Public health remains in jeopardy and our citizens are still placed at great risk and mortal harm by the very agency charged with public health protection. Dr. Hamburg, The pre- and post-approval drug, medical device and other FDA regulated product reviews are now under your control. Please do all you can to stop : * The FDA management practice of undocumented top down approve directives and requests by US FDA managers; * Changes to any lower level regulatory action decisions that fail to document who countermanded the decisions; * FDA upper managers from hiding behind their subordinates, when those managers direct them to alter their decisions, so that professional disagreements are not documented in the public record. * Retaliation by FDA upper managers against FDA staff who alert the public to dangerous and deadly products already on the market.

Sincerely,

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

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