The FDA's official recognition of the letter means that lawyers who want to use it to demonstrate that the FDA isn't perfect won't have to go through weeks of tedious discovery demands to find someone at the FDA who can officially say, "Yup, we sent that." That's going to be a headache for drug companies who often defend their drugs in court by saying, "Hey, the FDA said this product was fine and we did everything they asked -- so it's not fair to hold us responsible."
Plaintiffs' lawyers can now hold up the letter in court and argue that drug companies have been on notice that the FDA is riddled with politics, conflicts of interest and outright corruption, and is, as the letter says, "fundamentally broken."
The letter made headlines when it was sent last year to John Podesta of Obama's transition team. Written by a group of scientists on FDA letter head -- but with their names blacked out for fear of retaliation -- the letter describes a nightmare of bungling and self-dealing among higher-ups at the drug safety agency. It begs Obama to step in and reform the shop:
... many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place.The letter cites three dark chapters in FDA history:
- Former chief Andrew von Eschenbach's interference with the approval of a knee device.
- The approval of a breast cancer detection device by director of the Office of Device Evaluation Donna-Bea Tillman even though all FDA experts voted against it, following a phone call from Connecticut congressman Christopher Shays.
- And the approval by Daniel Schultz of a medical device that prevents tissue scarring against the unanimous opinion of his scientific staff.
Still unanswered: Who wrote the thing.
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