"A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama's transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law. The nine scientists, whose names have been provided to the transition team and to some members of Congress, say the FDA is a "fundamentally broken" agency and describe it as place where honest employees committed to integrity can't act without fear of reprisal." Mundy: FDA Scientis request FDA overhaul

Lawyers who want to sue drug companies will be drooling over the news that the FDA has “certified” a 2009 letter sent anonymously by FDA staff to President Obama describing “systemic corruption and wrongdoing that permeates all levels of FDA.”

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. According to Doug Kreis, who sues drug companies, “Consumers have been given a slight fighting chance now against [the] ‘FDA Defense,’ based on this certification.”