Comments on: House And Senate Agree On FDA Reform http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/ News, Comment and Conversation Fri, 10 Feb 2012 19:34:06 +0000 http://wordpress.org/?v=2.6.2 By: Hank http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-20045 Hank Thu, 20 Sep 2007 23:14:58 +0000 http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-20045 I'm still trying to figure out where this leaves us re: preemption. The House version that have a more "anti" preemption clause. The Senate version was, by my reading, more equivocal. Can anyone clarify this? I’m still trying to figure out where this leaves us re: preemption. The House version that have a more “anti” preemption clause. The Senate version was, by my reading, more equivocal. Can anyone clarify this?

]]> By: Your Cancer: Your Choice » Blog Archive » My thoughts on the FDA bill –Part 1: Drug safety monitoring missing its other half http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-20034 Your Cancer: Your Choice » Blog Archive » My thoughts on the FDA bill –Part 1: Drug safety monitoring missing its other half Thu, 20 Sep 2007 20:41:07 +0000 http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-20034 [...] Pharmalot [...] [...] Pharmalot [...]

]]> By: Lisa http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19987 Lisa Thu, 20 Sep 2007 12:28:24 +0000 http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19987 Jason, I have no problem with the Pediatric Exclusivity "Per se". The problem is that when a Company like GSK,who conducted clinical trials of Paxil in children,knew their drug caused suicide,hostility(HOSTILITY IN THE CONTEXT OF A CLINICAL TRIAL IS HOMICIDE")and had demonstrated "No Efficacy" and withheld this "vital,life threatening information from the Public.Parents lost their children,while GSK reaped millions in Profits!!! The lives of Our Nation's Children Is "PRICELESS" Reality, FDA,can of worms...That was mildly put... Jason,
I have no problem with the Pediatric Exclusivity “Per se”.
The problem is that when a Company like GSK,who conducted clinical trials of Paxil in children,knew their drug caused suicide,hostility(HOSTILITY IN THE CONTEXT OF A CLINICAL TRIAL IS HOMICIDE”)and had demonstrated “No Efficacy” and withheld this “vital,life threatening information from the Public.Parents lost their children,while GSK reaped millions in Profits!!!

The lives of Our Nation’s Children Is “PRICELESS”

Reality,
FDA,can of worms…That was mildly put…

]]> By: jason http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19947 jason Thu, 20 Sep 2007 02:54:28 +0000 http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19947 I have absolutely NO problem with the pediatric exclusion staying put. Honestly having a med branded for an additional 6 months is a small price to pay for ped data. Otherwise those peds/FP/GP would be begging NIH to perform those trials for us. It might not be perfect, but those in the trenches need those results. I have absolutely NO problem with the pediatric exclusion staying put. Honestly having a med branded for an additional 6 months is a small price to pay for ped data. Otherwise those peds/FP/GP would be begging NIH to perform those trials for us. It might not be perfect, but those in the trenches need those results.

]]> By: Reality http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19942 Reality Thu, 20 Sep 2007 01:25:39 +0000 http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19942 For those who missed it, for the last 3 years Pharma (and PhRMA) have already been posting trial results of hypothesis-testing studies within 1 year of study end if the report has not been submitted to a journal for publication. www.clinicalstudyresults.org. I'm not really inclined to read the details of the bill tonight (plus legal writing makes my eyes glaze over) but I would be curious to see how the proposed FDA database will differ. Ed, if you can shed any light on this, it would be appreciated. I'll be even more curious to see how the FDA decides what's biased lay reporting and what's not. That's a can of worms right there....one person's nonsignificant trend is another person's bias. For those who missed it, for the last 3 years Pharma (and PhRMA) have already been posting trial results of hypothesis-testing studies within 1 year of study end if the report has not been submitted to a journal for publication.

http://www.clinicalstudyresults.org.

I’m not really inclined to read the details of the bill tonight (plus legal writing makes my eyes glaze over) but I would be curious to see how the proposed FDA database will differ. Ed, if you can shed any light on this, it would be appreciated.

I’ll be even more curious to see how the FDA decides what’s biased lay reporting and what’s not. That’s a can of worms right there….one person’s nonsignificant trend is another person’s bias.

]]> By: Joe Lookout http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19919 Joe Lookout Wed, 19 Sep 2007 20:59:21 +0000 http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19919 "- Conflicts of Interest: Over five years, the number of FDA advisory panel members with conflicts of interests will be reduced by 25 percent. This falls short of the complete ban FDA critics sought, given that waivers are offered regularly." What a joke - completely unenforceable since it seems right now there is no penalty for not disclosing conflicts of interest (e.g. Howard Scher re: Provenge). LookoutJoe “- Conflicts of Interest: Over five years, the number of FDA advisory panel members with conflicts of interests will be reduced by 25 percent. This falls short of the complete ban FDA critics sought, given that waivers are offered regularly.”

What a joke - completely unenforceable since it seems right now there is no penalty for not disclosing conflicts of interest (e.g. Howard Scher re: Provenge).

LookoutJoe

]]> By: Lisa http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19915 Lisa Wed, 19 Sep 2007 20:10:43 +0000 http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19915 Its a shame that the Pediatric 6th month exclusivity remains... Its a shame that the Pediatric 6th month exclusivity remains…

]]> By: phil_vardena (Pharm. D.) http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19913 phil_vardena (Pharm. D.) Wed, 19 Sep 2007 19:57:50 +0000 http://www.pharmalot.com/2007/09/house-and-senate-agree-on-fda-reform/#comment-19913 Hi dear Ed Silverman, you are doing a great job. Conflicted advisory committee members are seriously damaging the people. Thank you for you effort. Regards, Hi dear Ed Silverman,
you are doing a great job.
Conflicted advisory committee members are seriously damaging the people.
Thank you for you effort.
Regards,

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