Comments on: Congressman To FDA Commish: ‘Resign’ http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/ News, Comment and Conversation Mon, 22 Mar 2010 08:50:43 +0000 http://wordpress.org/?v=2.6.2 By: Bless the Truth http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-166180 Bless the Truth Mon, 18 Feb 2008 20:26:25 +0000 http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-166180 Lili, My heart bleeds as I read your comments especially knowing what I know about drug safety and pharma greediness. FDA to me, is either an obsolete organization, corrupt or completely not competent to protect the American people. I am shocked how little or no oversight FDA has over clinical trials, ethics and data integrity. FDA is reactive but not proactive. They approve drugs that should not approved with so call "black label" only to pull them out of the market after innocent people have been killed. It is shameful, that we are in the mess, but FDA is not of any help. Lili,
My heart bleeds as I read your comments especially knowing what I know about drug safety and pharma greediness.
FDA to me, is either an obsolete organization, corrupt or completely not competent to protect the American people. I am shocked how little or no oversight FDA has over clinical trials, ethics and data integrity. FDA is reactive but not proactive. They approve drugs that should not approved with so call “black label” only to pull them out of the market after innocent people have been killed. It is shameful, that we are in the mess, but FDA is not of any help.

]]> By: LILI http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-162438 LILI Sun, 17 Feb 2008 01:00:06 +0000 http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-162438 ALL THIS WRITING IS NOT CHANGING THE PROBLEMS THAT PHARAMCEUTICALS ARE CREATING. AMERICANS NEED ACTION! NOT SPEECHES AND CONVERSATION! UNFORTUNATELY, BECAUSE OF MY AND MY FAMILIES EXPERIENCES WITH DOCTORS AND MEDICATION WE HAVE HAD TO COPE WITH EXTREME TRADGERIES THAT FEDERAL AND STATE REPRESENTATIVE HAVE ALLOWED TO EXIST. AMERICANS MUST SPEAK UP AND AND TAKE CONTROL. ALL THIS WRITING IS NOT CHANGING THE PROBLEMS THAT PHARAMCEUTICALS ARE CREATING. AMERICANS NEED ACTION! NOT SPEECHES AND CONVERSATION! UNFORTUNATELY, BECAUSE OF MY AND MY FAMILIES EXPERIENCES WITH DOCTORS AND MEDICATION WE HAVE HAD TO COPE WITH EXTREME TRADGERIES THAT FEDERAL AND STATE REPRESENTATIVE HAVE ALLOWED TO EXIST. AMERICANS MUST SPEAK UP AND AND TAKE CONTROL.

]]> By: JM http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-159709 JM Fri, 15 Feb 2008 18:22:51 +0000 http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-159709 Perhaps the FDA Commissioner appointment should look more like the Fed Chairman (maybe not that long...) or other executive appointments that do not coincide with political cycles... Perhaps the FDA Commissioner appointment should look more like the Fed Chairman (maybe not that long…) or other executive appointments that do not coincide with political cycles…

]]> By: Chris http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-159629 Chris Fri, 15 Feb 2008 17:56:33 +0000 http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-159629 The FDA is asleep at the switch, period. Congress needs to do a lot more than demand a leadership change. Who cares about that? Another clone will be appointed. This FDA has failed to enforce the laws and regulations entrusted to it, and American patients are paying the price over and over again. The omissions in oversight are so substantial that Congress can no longer pass blame to FDA leaders. Congress holds the ultimate power, the power of money. Congress needs to find ways to withhold funding if substantial changes are not made. While I am certainly no fan of no-child-left-behind (not by a long stretch), if we can find a way to hold the county's teachers accountable then Congress can find a way to hold FDA accountable. Calling for resignations is just political jockeying. How about calling for overhaul with milestones and financial conditions. Now that would be leadership and oversight. I work in industry and have for 20 years and in my personal view FDA is our FEMA. It's a fundamentally failed agency. Of course we all know that a big part of the problem is that it is terribly underfunded and so rather than address that the politicians simply do what they do best -- grandstand for the media -- and that's what we are seeing here. But make no mistake the political and financial situation found at the FDA today leaves it fundamentally unable to fulfill its mission. And I see the terrible downside from an industry perspective in that there is virtually no respect and no risk or concern about enforcement. The pharmaceutical industry today is a quasi-regulated industry. It is regulated in the sense that industry players cannot market products without specific approval. But the regulation pretty much stops there. We should not be surprised when we see the Merck/Schering Vytorin or sanofi KETEK scandals. You get what you pay for. Andy von Eschenbach should not step down he should be forced out as part of a major overhaul. 2008 funding should have been contingent on improvements that could be measured. The U.S. pharmaceutical industry used to be a hallmark of american innovation. But today we find it unproductive and lacking any sense of integrity or respect. FDA and industry leaders share accounability for that. And if you have worked in it and watched all this happen over the last decade or so, you are left simply disgusted. The FDA is asleep at the switch, period. Congress needs to do a lot more than demand a leadership change. Who cares about that? Another clone will be appointed. This FDA has failed to enforce the laws and regulations entrusted to it, and American patients are paying the price over and over again. The omissions in oversight are so substantial that Congress can no longer pass blame to FDA leaders. Congress holds the ultimate power, the power of money. Congress needs to find ways to withhold funding if substantial changes are not made. While I am certainly no fan of no-child-left-behind (not by a long stretch), if we can find a way to hold the county’s teachers accountable then Congress can find a way to hold FDA accountable. Calling for resignations is just political jockeying. How about calling for overhaul with milestones and financial conditions. Now that would be leadership and oversight.

I work in industry and have for 20 years and in my personal view FDA is our FEMA. It’s a fundamentally failed agency. Of course we all know that a big part of the problem is that it is terribly underfunded and so rather than address that the politicians simply do what they do best — grandstand for the media — and that’s what we are seeing here. But make no mistake the political and financial situation found at the FDA today leaves it fundamentally unable to fulfill its mission. And I see the terrible downside from an industry perspective in that there is virtually no respect and no risk or concern about enforcement. The pharmaceutical industry today is a quasi-regulated industry. It is regulated in the sense that industry players cannot market products without specific approval. But the regulation pretty much stops there. We should not be surprised when we see the Merck/Schering Vytorin or sanofi KETEK scandals. You get what you pay for.

Andy von Eschenbach should not step down he should be forced out as part of a major overhaul. 2008 funding should have been contingent on improvements that could be measured. The U.S. pharmaceutical industry used to be a hallmark of american innovation. But today we find it unproductive and lacking any sense of integrity or respect. FDA and industry leaders share accounability for that. And if you have worked in it and watched all this happen over the last decade or so, you are left simply disgusted.

]]> By: Ed Silverman http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-159544 Ed Silverman Fri, 15 Feb 2008 17:26:01 +0000 http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-159544 Hi MA, So you think I was too nice, eh? Perhaps my sarcasm was too obscure. You're correct. I've seen him speak. I've listened to him speak many times. He's smooth, very smooth. But in a way that makes his words sometimes hard to understand. Impenetrable comes to mind. That's a special talent, though. Not everyone can spend a great deal of time saying nothing and still sound eloquent. You'd think he's running for election somewhere. Cheers ed Hi MA,

So you think I was too nice, eh? Perhaps my sarcasm was too obscure. You’re correct. I’ve seen him speak. I’ve listened to him speak many times. He’s smooth, very smooth. But in a way that makes his words sometimes hard to understand. Impenetrable comes to mind. That’s a special talent, though. Not everyone can spend a great deal of time saying nothing and still sound eloquent. You’d think he’s running for election somewhere.

Cheers
ed

]]> By: Matthew Arnold http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-159477 Matthew Arnold Fri, 15 Feb 2008 16:48:55 +0000 http://www.pharmalot.com/2008/02/congressman-to-fda-commish-you-should-resign/#comment-159477 Okay, but "Silver-tongued?" Andy's always struck me as a masterful bloviator of bureaucratese, one of those Washington creatures practiced in the art of speaking at length and saying nothing. I might have gone with "Leaden-tongued." And hey, not to disparage the guy. It's a skill of sorts in that town. They can't all be Barack Obama, and a Sorkinesque "hopemonger" probably wouldn't fare well in the glare of one of Waxman's hearings. Okay, but “Silver-tongued?” Andy’s always struck me as a masterful bloviator of bureaucratese, one of those Washington creatures practiced in the art of speaking at length and saying nothing. I might have gone with “Leaden-tongued.” And hey, not to disparage the guy. It’s a skill of sorts in that town. They can’t all be Barack Obama, and a Sorkinesque “hopemonger” probably wouldn’t fare well in the glare of one of Waxman’s hearings.

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