Comments on: Number Of FDA Warning Letters Has Plunged http://www.pharmalot.com/2008/06/number-of-fda-warning-letters-has-plunged/ News, Comment and Conversation Fri, 10 Feb 2012 21:25:11 +0000 http://wordpress.org/?v=2.6.2 By: Justice in Michigan http://www.pharmalot.com/2008/06/number-of-fda-warning-letters-has-plunged/#comment-358497 Justice in Michigan Sun, 08 Jun 2008 17:25:58 +0000 http://www.pharmalot.com/?p=14004#comment-358497 Doc's observations are confirmed by many othrs. Doc’s observations are confirmed by many othrs.

]]> By: Doc http://www.pharmalot.com/2008/06/number-of-fda-warning-letters-has-plunged/#comment-358332 Doc Sat, 07 Jun 2008 19:39:44 +0000 http://www.pharmalot.com/?p=14004#comment-358332 It seems from my back room perspective in marketing and sales for a big pharma co, that FDA warnings hold little threat to companies. Hand slaps send a message that ignoring the FDA's warnings don't cost that much and the penalties are "just part of doing business today" - to qoute a director at my company. It seems from my back room perspective in marketing and sales for a big pharma co, that FDA warnings hold little threat to companies. Hand slaps send a message that ignoring the FDA’s warnings don’t cost that much and the penalties are “just part of doing business today” - to qoute a director at my company.

]]> By: Justice in Michigan http://www.pharmalot.com/2008/06/number-of-fda-warning-letters-has-plunged/#comment-358315 Justice in Michigan Sat, 07 Jun 2008 17:39:40 +0000 http://www.pharmalot.com/?p=14004#comment-358315 The most dramatic change happened after Dan Troy had all warning letters routed through his office. The majority were never sent. Some were sent when the offending promo material was no longer being used, so they were de facto meaningless. Re: Paul's speculation, I would say there is no data whatsoever that the industry is committing fewer violations. On the contrary, most of what comes out suggests an increase. The most dramatic change happened after Dan Troy had all warning letters routed through his office. The majority were never sent. Some were sent when the offending promo material was no longer being used, so they were de facto meaningless.

Re: Paul’s speculation, I would say there is no data whatsoever that the industry is committing fewer violations. On the contrary, most of what comes out suggests an increase.

]]> By: Jaynesday http://www.pharmalot.com/2008/06/number-of-fda-warning-letters-has-plunged/#comment-358243 Jaynesday Sat, 07 Jun 2008 14:43:51 +0000 http://www.pharmalot.com/?p=14004#comment-358243 Jim, currently the best that the FDA can provide for the public is a false sense of security which is actually the worst thing it can do. I know of a product, a membrane which is absorbed by the body that has caused terrible reactions including death in the patients. In many cases the treating doctor states that the reaction was "definitely" related to the product. The manufacturer’s response to a *majority* of the AEs is that no sample was returned and the QA department will not investigate until a sample is returned. Again the product is absorbed into the body. How can a company get away with this? How can the FDA allow this? It just shows that someone is asleep at the wheel. At most the product should be taken off the market, however that might be too drastic, but at least the company should admit there is a problem, investigate the root cause of the reactions and adjust the product or the process if possible. If it’s not possible stronger warnings should be implemented, but not hid behind a technicality and do nothing. To me this is bold and blatant irresponsibility on the company's part and willfull neglect on the part of the FDA, whose job it is to protect us. Jim, knowing what we know, how comfortable are/would you be in accepting a drug/device prescribed by a doctor now? How has you level of confidence in pharmaceuticals changed given you’re experience. If you’re like me you’re confidence level i.e. fear of a drug/device has skyrocketed. My wife and I are going to the hospital today to visit a friend. I already anticipate that my first question will be, what drugs are they giving him? And then I’ll be back on my computer at the FDA’s site looking up AEs. Sorry folks that my new reality. I’ve said it before but when/if the public’s attention to drugs/devices or their lack of faith in the FDA reaches a tipping point, we will see a huge shift in priorities that will make or break a lot of public and private concerns. i.e. there will be you know what to pay. I know they (companies and FDA) understand this so, “keep things quiet” is the rule of the day. Thanks to preemption that gonna be easy. Jim, currently the best that the FDA can provide for the public is a false sense of security which is actually the worst thing it can do.

I know of a product, a membrane which is absorbed by the body that has caused terrible reactions including death in the patients. In many cases the treating doctor states that the reaction was “definitely” related to the product. The manufacturer’s response to a *majority* of the AEs is that no sample was returned and the QA department will not investigate until a sample is returned. Again the product is absorbed into the body.

How can a company get away with this? How can the FDA allow this? It just shows that someone is asleep at the wheel.
At most the product should be taken off the market, however that might be too drastic, but at least the company should admit there is a problem, investigate the root cause of the reactions and adjust the product or the process if possible. If it’s not possible stronger warnings should be implemented, but not hid behind a technicality and do nothing. To me this is bold and blatant irresponsibility on the company’s part and willfull neglect on the part of the FDA, whose job it is to protect us.

Jim, knowing what we know, how comfortable are/would you be in accepting a drug/device prescribed by a doctor now? How has you level of confidence in pharmaceuticals changed given you’re experience. If you’re like me you’re confidence level i.e. fear of a drug/device has skyrocketed. My wife and I are going to the hospital today to visit a friend. I already anticipate that my first question will be, what drugs are they giving him? And then I’ll be back on my computer at the FDA’s site looking up AEs. Sorry folks that my new reality.

I’ve said it before but when/if the public’s attention to drugs/devices or their lack of faith in the FDA reaches a tipping point, we will see a huge shift in priorities that will make or break a lot of public and private concerns. i.e. there will be you know what to pay.
I know they (companies and FDA) understand this so, “keep things quiet” is the rule of the day. Thanks to preemption that gonna be easy.

]]> By: Jim http://www.pharmalot.com/2008/06/number-of-fda-warning-letters-has-plunged/#comment-358214 Jim Sat, 07 Jun 2008 11:56:25 +0000 http://www.pharmalot.com/?p=14004#comment-358214 The drop in warning letters only enhances the fact that the FDA does not use its maude data base for adverse event complaints as much as the public needs them to. I state from fact that there over over 3000 complaints filed for polypropylene hernia mesh and more for bladder suspension kits made up of the same material as the hernia meshes and the complaints keep climbing. If the FDA were to follow there own protocol, warning letters would have been sent to all manufacturers of the above products and also they would have made a public announcement when this whole mesh debocle began. I am only one, who speaks for many, that feel the FDA does not do enough to ensure public safety. If these letters would have been sent out in 1998 when these meshes began going bad inside people, they would have spared millions of people from suffering and possibly would have been able to make these manufacturers make a more human friendly product, one that does not harden and ball up, one that wont adhere to the bowels, one that would stay in place once it is implanted. The FDA does know that there is a problem now with these products, they have known for three years to my own knowledge, but yet, no warning letters to the manufacturers, doctors, hospitals or a public health notification to warn people of the possible complications of these products. Now there are thousands who are stuck in the pain management cycle of this mess and do not know where or who to turn to. The drop in warning letters only enhances the fact that the FDA does not use its maude data base for adverse event complaints as much as the public needs them to. I state from fact that there over over 3000 complaints filed for polypropylene hernia mesh and more for bladder suspension kits made up of the same material as the hernia meshes and the complaints keep climbing. If the FDA were to follow there own protocol, warning letters would have been sent to all manufacturers of the above products and also they would have made a public announcement when this whole mesh debocle began. I am only one, who speaks for many, that feel the FDA does not do enough to ensure public safety. If these letters would have been sent out in 1998 when these meshes began going bad inside people, they would have spared millions of people from suffering and possibly would have been able to make these manufacturers make a more human friendly product, one that does not harden and ball up, one that wont adhere to the bowels, one that would stay in place once it is implanted. The FDA does know that there is a problem now with these products, they have known for three years to my own knowledge, but yet, no warning letters to the manufacturers, doctors, hospitals or a public health notification to warn people of the possible complications of these products. Now there are thousands who are stuck in the pain management cycle of this mess and do not know where or who to turn to.

]]> By: Paul http://www.pharmalot.com/2008/06/number-of-fda-warning-letters-has-plunged/#comment-358107 Paul Sat, 07 Jun 2008 01:35:52 +0000 http://www.pharmalot.com/?p=14004#comment-358107 Can it possibly mean that there has been quite a bit of tightening and cleaning house by companies therefore resulting in fewer grievances requiring letters? I am not saying all is clean and good, but could these efforts be making a bit of a difference? If everyone in this blog and other critical forums is successful in their criticism and calls for change, then they should be happy that there are fewer violations. Philosophically speaking, if these letters never decline, then the critics have failed and should look for something else to do. In other words, this is a report card on their effectiveness. Can it possibly mean that there has been quite a bit of tightening and cleaning house by companies therefore resulting in fewer grievances requiring letters?

I am not saying all is clean and good, but could these efforts be making a bit of a difference?

If everyone in this blog and other critical forums is successful in their criticism and calls for change, then they should be happy that there are fewer violations.

Philosophically speaking, if these letters never decline, then the critics have failed and should look for something else to do. In other words, this is a report card on their effectiveness.

]]> By: Dan http://www.pharmalot.com/2008/06/number-of-fda-warning-letters-has-plunged/#comment-358102 Dan Fri, 06 Jun 2008 23:13:19 +0000 http://www.pharmalot.com/?p=14004#comment-358102 The warning letters mean nothing. It's as if the FDA is saying to others, "Stop!, or, I'll say stop again". It means nothing to the receivers of such letters, although competitors use these letters to illustrate to customers that they are certainly more ethical than others. The warning letters mean nothing. It’s as if the FDA is saying to others, “Stop!, or, I’ll say stop again”. It means nothing to the receivers of such letters, although competitors use these letters to illustrate to customers that they are certainly more ethical than others.

]]> By: Lisa Van S http://www.pharmalot.com/2008/06/number-of-fda-warning-letters-has-plunged/#comment-358099 Lisa Van S Fri, 06 Jun 2008 22:30:35 +0000 http://www.pharmalot.com/?p=14004#comment-358099 This is old news!!! This is old news!!!

]]> By: CPRIII http://www.pharmalot.com/2008/06/number-of-fda-warning-letters-has-plunged/#comment-358096 CPRIII Fri, 06 Jun 2008 22:04:44 +0000 http://www.pharmalot.com/?p=14004#comment-358096 Like this is surprising. The FDA is asleep at the switch. As with so many of the federal agencies, Bush filled the FDA with industry buddies. They have done absolutely nothing but sit there. It's not only that the enforcement letters are down, but even the ones they have issued have been mostly against smaller companies for actions that are totally over the top. The agency has done little or nothing to genuinely further anyone's understanding of promotional compliance. We used to consider the possibility of FDA action in our risk deliberations. Now the idea doesn't even come into the picture. You think about the OIG, maybe. You think about active US Attorneys offices. You think about the states. But the FDA. No, not an issue. It's a disgrace. But it is not a reflection of the people at the agency. There are good people there. Very good. It's a reflection of the leadership that has put a muzzle on the entire place. And Congress is no better because they sit there and grandstand with one committee hearing after another. Grassley says this, and Waxman says that. But have any of them turned words into action. No. I think they prefer it because it provides a constant source of political argumentation. Fixing it would take work. I am shocked at some of the things I see my own company doing but there is simply no realistic argument against anything at this point. Apart from the drug approval process, in my opinion it's no longer a regulated industry. Like this is surprising. The FDA is asleep at the switch. As with so many of the federal agencies, Bush filled the FDA with industry buddies. They have done absolutely nothing but sit there. It’s not only that the enforcement letters are down, but even the ones they have issued have been mostly against smaller companies for actions that are totally over the top. The agency has done little or nothing to genuinely further anyone’s understanding of promotional compliance. We used to consider the possibility of FDA action in our risk deliberations. Now the idea doesn’t even come into the picture. You think about the OIG, maybe. You think about active US Attorneys offices. You think about the states. But the FDA. No, not an issue. It’s a disgrace.

But it is not a reflection of the people at the agency. There are good people there. Very good. It’s a reflection of the leadership that has put a muzzle on the entire place.

And Congress is no better because they sit there and grandstand with one committee hearing after another. Grassley says this, and Waxman says that. But have any of them turned words into action. No. I think they prefer it because it provides a constant source of political argumentation. Fixing it would take work.

I am shocked at some of the things I see my own company doing but there is simply no realistic argument against anything at this point. Apart from the drug approval process, in my opinion it’s no longer a regulated industry.

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