FDA

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.”

http://industry.bnet.com/pharma/10007170/fda-corruption-letter-authenticated-lawyers-start-your-engines/

 

FDA "Corruption" Letter Authenticated: Lawyers, Start Your Engines!

By Jim Edwards | Mar 12, 2010


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 http://i.bnet.com/blogs/cert-fda-letter-to-the-president-4-2-09-and-trans-team-1-7-09.pdf?tag=content;selector-perfector
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. http://online.wsj.com/article/SB123142562104564381.html
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:
According to Doug Kriese, who sues drug companies, “Consumers have been given a slight fighting chance now against [the] ‘FDA Defense,’ based on this certification.”

Still unanswered: Who wrote the thing.