FDALawyers 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:
- 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 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.