Comments on: Solving the FDA Crisis http://www.biotechblog.com/2009/02/05/solving-the-fda-crisis/ Commercial, legal, political, and scientific trends in biotechnology Thu, 09 Feb 2012 15:32:22 +0000 hourly 1 http://wordpress.org/?v=3.3 By: Bob Moore http://www.biotechblog.com/2009/02/05/solving-the-fda-crisis/comment-page-1/#comment-7712 Bob Moore Sun, 15 Feb 2009 00:45:58 +0000 http://www.biotechblog.com/?p=993#comment-7712 Mr. Avellanet has hit on something I have been saying for many years. I manage the quality management system audit program for a medical device company. One of my biggest frustrations is that corrective actions from even our internal audits take forever and often do not get at the root cause of the issue. If the penalty or threat of penalty is not readily apparent or the company does not have a strong quality management leadership, when push comes to shove compliance will lose out.. Mr. Avellanet has hit on something I have been saying for many years. I manage the quality management system audit program for a medical device company. One of my biggest frustrations is that corrective actions from even our internal audits take forever and often do not get at the root cause of the issue.

If the penalty or threat of penalty is not readily apparent or the company does not have a strong quality management leadership, when push comes to shove compliance will lose out..

]]> By: I Am Biotech: Discover. Share. Discuss. http://www.biotechblog.com/2009/02/05/solving-the-fda-crisis/comment-page-1/#comment-7710 I Am Biotech: Discover. Share. Discuss. Fri, 13 Feb 2009 15:10:35 +0000 http://www.biotechblog.com/?p=993#comment-7710 [...] had an interesting guest commentary on how to solve the “FDA crisis” in the wake of the recent salmonella contamination. [...] [...] had an interesting guest commentary on how to solve the “FDA crisis” in the wake of the recent salmonella contamination. [...]

]]> By: Carl W. Rausch http://www.biotechblog.com/2009/02/05/solving-the-fda-crisis/comment-page-1/#comment-7701 Carl W. Rausch Fri, 06 Feb 2009 07:32:01 +0000 http://www.biotechblog.com/?p=993#comment-7701 It is truly unfortunate that Mr. Avellanet appears to be a strong proponent of capital punishment, is indeed in need of a restatement. His premise I feel is so flawed in my opinion that it points to the very sickness that his suggested tactics for correction point to the very reason this country and many of our greed based earnings are causing the down fall of our economic system. The big question is over "intent". The peanut problem one can be sure it was not their intent to distribute bad product but it happened and a error and an oversight because someone had to meet a quota for sales or for a revenue line. To chop someones had off because they stole food...did not stop food stealing. I am sure despite all the regulations and making B. Medoff live in a poor house will not prevent the next great swindle. In fact what will happen with Mr. Avellanets approach is that we will shut off further the pathways to innovation, risk taking and discovery. The more rules and the more punishment we make, it does not stop the bad intent it only reduces the good intent trials. The more rules and the more punishment does create service work for lawyers and inspectors (total drain) non-creative. Systems in this country need to rethink the assumptions (Banking, FDA, Lawyers, etc.) We need to progress not punish, we need to innovate and find ways that are preventive from the peanut problem, or the Medoff scam, not punish. Just consider how the computer hackers have been treated...we make them ply their trade to prevent them happening in the future. This is my approach to life, drug discovery and people. I wish that Mr. Avellanet would rethink his position and us it to innovate and not regulate. That only makes more service jobs, more lawyer suits and higher insurance costs....greater expense with no productivity. All the best and excuse typos and grammar but this was done in a hurry. It is truly unfortunate that Mr. Avellanet appears to be a strong proponent of capital punishment, is indeed in need of a restatement. His premise I feel is so flawed in my opinion that it points to the very sickness that his suggested tactics for correction point to the very reason this country and many of our greed based earnings are causing the down fall of our economic system.

The big question is over “intent”. The peanut problem one can be sure it was not their intent to distribute bad product but it happened and a error and an oversight because someone had to meet a quota for sales or for a revenue line.
To chop someones had off because they stole food…did not stop food stealing.
I am sure despite all the regulations and making B. Medoff live in a poor house will not prevent the next great swindle.
In fact what will happen with Mr. Avellanets approach is that we will shut off further the pathways to innovation, risk taking and discovery. The more rules and the more punishment we make, it does not stop the bad intent it only reduces the good intent trials. The more rules and the more punishment does create service work for lawyers and inspectors (total drain) non-creative. Systems in this country need to rethink the assumptions (Banking, FDA, Lawyers, etc.) We need to progress not punish, we need to innovate and find ways that are preventive from the peanut problem, or the Medoff scam, not punish. Just consider how the computer hackers have been treated…we make them ply their trade to prevent them happening in the future.

This is my approach to life, drug discovery and people. I wish that Mr. Avellanet would rethink his position and us it to innovate and not regulate. That only makes more service jobs, more lawyer suits and higher insurance costs….greater expense with no productivity.

All the best and excuse typos and grammar but this was done in a hurry.

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