- 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-l
etter-authenticated-lawyers-start-your-engines/
-
- 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)
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
- (http://online.wsj.com/article/SB123142562104564381.html)
of Obama's transition team.
-
- Written by a group of scientists on FDA letter head Â-
but with their names blacked out for fear of retaliation Â- 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
-
- http://www.awkolaw.com/drugs.html
-
- 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.
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