Guest guest Posted March 15, 2010 Report Share Posted March 15, 2010 >Mon, 15 Mar 2010 07:23:48 -0400 (EDT) >Kay Ness <kyness >Kay Ness <kyness >Kay Ness <kyness >FDA " Corruption " Letter Authenticated > >VITAL FDA " Corruption " Letter Authenticated: Lawyers, Start Your Engines > > Sun Mar 14, 2010 12:26 pm ((PDT)) > >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-l\ awyers-start-your-engines/>http://industry.bnet.com/pharma/10007170/fda-corrupti\ on-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 ><http://i.bnet.com/blogs/cert-fda-letter-to-the-president-4-2-09-and-trans-team\ -1-7-09.pdf> >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 > ><http://online.wsj.com/article/SB123142562104564381.html> >it was sent last year to John Podesta ><http://online.wsj.com/article/SB123142562104564381.html> >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 ><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. Quote Link to comment Share on other sites More sharing options...
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