“Welcome to Thoreau-FDA.com, a website launched and operated by current and former US Food and Drug Administration staff who believe public health is being put at unnecessary risk. These concerned civil servants and ex-civil servants have either experienced or are aware of wrongful directives by US FDA upper management – directives that put public health at avoidable risk. Thoreau-FDA stands for Thorough – High – Objectivity – Review – Ends – Are – Us – FDA. Here at Thoreau-FDA.com, you will find articles by its members that describe their efforts to protect all of us and our pets from harmful drugs and other medical products. And there are also reports of ordeals of other US FDCA staff, who are not involved in setting up this web site.
You can join others in discussion about the US FDA’s broken system by clicking on the link to FDA-blog.com. Or submit articles that will be considered for publication on our site by going to ‘Contact Us.’ Finally, we ask for your help. Read as much content on the site and related links as you need to convince yourself of the truth. Then, join an effort to effect real change at US FDA by sending a letter to the Commissioner of the US Food and Drug Administration. A sample letter is already prepared – but you can edit the letter to reflect your perspective. It prompts answers from the US FDA Commissioner about the effectiveness of the FDA’s ‘Values and Vision’ effort – a program that is supposed to correct many of US FDA’s problems that have persistently gotten worse over the last few years.”
(Thoreau-FDA.com. h/t: Pharma Law Blog)
July 22, 2008 at 12:02 pm
Interesting post. I was just reading an article in The Washington Post about a lawsuit which is questioning the constitutionality of the Sarbanes-Oxley Act, which requires publicly traded organizations to establish a process to manage whistleblower complaints. According to the Post, it seems likely that the Public company Accounting Oversight Board, who created the act, will lose their case. This could have an interesting affect on federal whistleblowing regulations and technologies, so it should be an interesting story to keep your eye on.
December 28, 2010 at 5:52 pm
I spent 23 years in Pharmaceutical (Pfizer) sales, and 2009 was downsized in a huge restructuring move. The funny thing was just two weeks before I was at a Masters (Senior Level)rep meeting and was told that very few if any reps would be laid off (mostly just a restructuring) of course (this is not illegal, but unethical) this was not the case and thousands of reps were laid off! the funny thing was that the V.P. lied to the whole group to a direct questions concerning this topic. In my 23 years I have witnessed some very shady activity by management, concerning Pharma guidelines breaches from management conduct concerning all kinds of issues. I am wondering if or how one would go about reporting some of the activities that I witnessed and are still ongoing within Pfizer. You may think that I am just sewing sour grapes, but I have actuality bettered my situation with Pfizer (Great Bio-med company), but still see the same people who ruined the careers of friends and good employees to protect themselves against FDA and Pfizer retaliation. If anyone has any Ideas or have been through this (submission to the FDA or Industry) before, please feel free to respond to this email and give me guidance on how to proceed, or if it is even worth the effort at this time now some two years removed from the madness? Thanks! John Email: dehaas@ymail.com
April 1, 2011 at 6:18 pm
Just wanted you to be aware that Salix Pharm gave a dinner on March 18th at the Captial Grill in Los Angeles.
The rep hosted the dinner for Cedars-Sinai Group and she invited spouses and friends.
This is strictly against the Pharma Guidelines, and she stayed at he entire dinner
How do you report this issue???
October 4, 2011 at 8:24 pm
If you know about alleged fraud, is there anything that can happen to you if you fail to bring it forward? Thanks for any input.