Comments on: FDA Has Failed To Make Safety Changes: GAO http://www.pharmalot.com/2009/12/fda-has-failed-to-make-safety-changes-gao/ News, Comment and Conversation Fri, 10 Feb 2012 19:50:01 +0000 http://wordpress.org/?v=2.6.2 By: Karen fisher http://www.pharmalot.com/2009/12/fda-has-failed-to-make-safety-changes-gao/#comment-475446 Karen fisher Sat, 06 Mar 2010 11:10:51 +0000 http://www.pharmalot.com/?p=20326#comment-475446 Hair dye chemical manufacture of PPD says to use gloves and a cap but only gloves are included and cancer levels are highest ever. Is the lucrative cancer drug industry at work? Hair dye chemical manufacture of PPD says to
use gloves and a cap but only gloves are included
and cancer levels are highest ever.

Is the lucrative cancer drug industry at work?

]]> By: patrons99 http://www.pharmalot.com/2009/12/fda-has-failed-to-make-safety-changes-gao/#comment-450533 patrons99 Thu, 10 Dec 2009 03:38:36 +0000 http://www.pharmalot.com/?p=20326#comment-450533 FDA has been a pharma-shill. Drug Safety should be taken away from FDA. Drug Safety should be completely independent of both FDA and pharma. FDA has failed miserably at ensuring Drug Safety. FDA has been a pharma-shill. Drug Safety should be taken away from FDA. Drug Safety should be completely independent of both FDA and pharma. FDA has failed miserably at ensuring Drug Safety.

]]> By: Justice in MI http://www.pharmalot.com/2009/12/fda-has-failed-to-make-safety-changes-gao/#comment-450439 Justice in MI Wed, 09 Dec 2009 19:07:29 +0000 http://www.pharmalot.com/?p=20326#comment-450439 The need for an independent Office of Drug Safety (by whatever name) has been recommended by high-level government studies since the 1970s--whether via the NHS, IOM, GAO, etc. The administrative details have differed, but the core proposal has not. What's being discussed here is a very conservative version of the separation. It would all still be inside CDER, but people like David Graham would not still be reporting up the chain to the OND, which calls the ultimate shots. So what others are suggesting up the thread goes far, far beyond anything Grassley has endorsed. The need for an independent Office of Drug Safety (by whatever name) has been recommended by high-level government studies since the 1970s–whether via the NHS, IOM, GAO, etc. The administrative details have differed, but the core proposal has not.

What’s being discussed here is a very conservative version of the separation. It would all still be inside CDER, but people like David Graham would not still be reporting up the chain to the OND, which calls the ultimate shots.

So what others are suggesting up the thread goes far, far beyond anything Grassley has endorsed.

]]> By: Jaynesday http://www.pharmalot.com/2009/12/fda-has-failed-to-make-safety-changes-gao/#comment-450430 Jaynesday Wed, 09 Dec 2009 18:22:22 +0000 http://www.pharmalot.com/?p=20326#comment-450430 A Federally recognized (but unattached) Drug and Device "Consumers Report" with bite is in order. And the bite only needs to be real time, unbiased reporting on the actual safety, cost and performance of products. By and for the consumer only, unattached to industry, politics and big money. Producers will have to fight for a thumbs up or suffer the consequences. May the best company win. A Federally recognized (but unattached) Drug and Device “Consumers Report” with bite is in order. And the bite only needs to be real time, unbiased reporting on the actual safety, cost and performance of products. By and for the consumer only, unattached to industry, politics and big money.

Producers will have to fight for a thumbs up or suffer the consequences. May the best company win.

]]> By: patrons99 http://www.pharmalot.com/2009/12/fda-has-failed-to-make-safety-changes-gao/#comment-450415 patrons99 Wed, 09 Dec 2009 17:22:51 +0000 http://www.pharmalot.com/?p=20326#comment-450415 Yes, Lisa. You've nailed it. That's exactly what the public needs. Whose drug safety is it, anyway? Drug safety belongs to the people, not pharma. Data entry and control over the worldwide drug safety database must be completely independent of pharma and FDA. Anything less than that will be bound to fail. Ever since initial enactment of the PDUFA in 1992, FDA has been a client of pharma, not the public. Yes, Lisa. You’ve nailed it. That’s exactly what the public needs. Whose drug safety is it, anyway? Drug safety belongs to the people, not pharma. Data entry and control over the worldwide drug safety database must be completely independent of pharma and FDA. Anything less than that will be bound to fail. Ever since initial enactment of the PDUFA in 1992, FDA has been a client of pharma, not the public.

]]> By: Lisa Van Syckel http://www.pharmalot.com/2009/12/fda-has-failed-to-make-safety-changes-gao/#comment-450363 Lisa Van Syckel Wed, 09 Dec 2009 14:21:17 +0000 http://www.pharmalot.com/?p=20326#comment-450363 i would like to see Senator Grassley try a second time to get a bill passed that will allow an Independent Office of drug Safety. It appears that the efforts of drug safety through PDUFA ha failed i would like to see Senator Grassley try a second time to get a bill passed that will allow an Independent Office of drug Safety. It appears that the efforts of drug safety through PDUFA ha failed

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