Wednesday 15 August 2012

Shocking Story Reveals How the FDA Is Recklessly Abandoning Drug Safety


From marginalizing safety reports to not reading them at all―and then going ahead and approving the drugs in question―the FDA once more stands accused of being little more than a rubber-stamping agency for Big Pharma.

There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees. 

"On one occasion, the company even told me they were going to call upper management to get a clear requirement for approval that they did not want to fulfill eliminated, which I then saw happen. On another occasion a company clearly stated in a meeting that they had "paid for an approval," Kavanagh says.

We Now Know What Domestic Surveillance of Whistleblowers Looks Like

The following video features attorney, Stephen Kohn, executive director of the National Whistleblowers Center and attorney for the FDA whistleblowers in the recently revealed FDA spy operation against them2.
 "For the first time, we now have a glimpse into what domestic surveillance of whistleblowers looks like in this country with the modern technological developments," Kohn says. "The agency [sought] to destroy the reputation of these whistleblowers forever."


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