Comments on: FDA Fails To Follow-Up On Questionable Drugs http://www.pharmalot.com/2009/10/fda-fails-to-follow-up-on-questionable-drugs-gao/ News, Comment and Conversation Fri, 10 Feb 2012 21:08:03 +0000 http://wordpress.org/?v=2.6.2 By: JaT http://www.pharmalot.com/2009/10/fda-fails-to-follow-up-on-questionable-drugs-gao/#comment-442236 JaT Tue, 27 Oct 2009 22:52:00 +0000 http://www.pharmalot.com/?p=19291#comment-442236 Maybe ANDAs will be considered too at some point. Particularly ANDAs or sANDAs (supplemental Abbreviated New Drug Applications- which exist but don't exist?) submitted by the current holder of an innovator product, after they change the recipe. Some of those evidently aren't reviewed at all before approval. Nothing quite like taking your usual medication only to find yourself in the ER and in serious trouble because it is no longer effective for you. _________ What is more dangerous... Finding that a new drug is hazardous to your health? Or trusting a product you have safely been on for over a decade- only to find that NOW it is hazardous to your health- and knowing that by some stretch- the warning label still applies. __________ After the second scenario can you ever trust pharmaceuticals again? Anyway- Go Grassley! Maybe ANDAs will be considered too at some point.
Particularly ANDAs or sANDAs (supplemental Abbreviated New Drug Applications- which exist but don’t exist?) submitted by the current holder of an innovator product, after they change the recipe.

Some of those evidently aren’t reviewed at all before approval.

Nothing quite like taking your usual medication only to find yourself in the ER and in serious trouble because it is no longer effective for you.
_________
What is more dangerous…

Finding that a new drug is hazardous to your health?

Or trusting a product you have safely been on for over a decade- only to find that NOW it is hazardous to your health- and knowing that by some stretch- the warning label still applies.
__________
After the second scenario can you ever trust pharmaceuticals again?

Anyway- Go Grassley!

]]> By: Marilyn Mann http://www.pharmalot.com/2009/10/fda-fails-to-follow-up-on-questionable-drugs-gao/#comment-442020 Marilyn Mann Mon, 26 Oct 2009 18:03:56 +0000 http://www.pharmalot.com/?p=19291#comment-442020 Ed You mean the Government Accountability Office. Marilyn Ed

You mean the Government Accountability Office.

Marilyn

]]> By: Jaynesday http://www.pharmalot.com/2009/10/fda-fails-to-follow-up-on-questionable-drugs-gao/#comment-441974 Jaynesday Mon, 26 Oct 2009 16:50:34 +0000 http://www.pharmalot.com/?p=19291#comment-441974 Fast tracking products without care for the viability of the product or the satisfaction of the consumer. Commonly known as puppy mills or as we know them now The FDA Drug Mill. Sorry, I know, way to smarmy. Fast tracking products without care for the viability of the product or the satisfaction of the consumer.
Commonly known as puppy mills or as we know them now The FDA Drug Mill.

Sorry, I know, way to smarmy.

]]> By: Matthew Holford http://www.pharmalot.com/2009/10/fda-fails-to-follow-up-on-questionable-drugs-gao/#comment-441941 Matthew Holford Mon, 26 Oct 2009 15:40:24 +0000 http://www.pharmalot.com/?p=19291#comment-441941 Jeez, Grassley must be reeeaaaally pissed, by now. Matt Jeez, Grassley must be reeeaaaally pissed, by now.

Matt

]]> By: Larry Sasich http://www.pharmalot.com/2009/10/fda-fails-to-follow-up-on-questionable-drugs-gao/#comment-441927 Larry Sasich Mon, 26 Oct 2009 13:15:25 +0000 http://www.pharmalot.com/?p=19291#comment-441927 Hi Ed, Would you like a copy of the Markey Report on this topic? Best, Larry Hi Ed,

Would you like a copy of the Markey Report on this topic?

Best,

Larry

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