There is a thread talking a bit about the call from FDA for people to submit reports of adverse effects of e-cigs and how damaging it may be: http://www.e-cigarette-forum.com/forum/e-cigarette-news/29503-response-dr-siegel.html
But there is another story in the Wall Street Journal from few days ago that indirectly, but without doubt, discredits such FDA efforts:
GAO: FDA Can't Determine Its Funding Needs - WSJ.com
Quote (emphasis mine): "The FDA isn't able to reliably determine how much money it needs to regulate medical products because, among other things, its staff can't track all the adverse-event reports it handles, according to the Government Accountability Office."
I am sorry, but isn't the primary objective of FDA drug safety? Isn't accurate tracking of the problems reported just a little teeny bit important for that? Isn't it important for FDA to accurately track adverse effects to produce a fair and valid review of the drug?
What kind of mess is FDA? Can any reports produced by them be trusted if they can't track data consistently and reliably?
Another quote from the same WSJ article (emphasis mine): "FDA told GAO while they place a priority on reviewing serious adverse-event reports, they receive "substantially" more adverse-event reports than staff can review. The FDA said the adverse-event reporting systems don't allow agency to track whether individual reports have been reviewed."
This must inspire confidence in general public.
Why isn't mass media picking up on this? Isn't this much bigger health hazard than electronic cigarette?
But there is another story in the Wall Street Journal from few days ago that indirectly, but without doubt, discredits such FDA efforts:
GAO: FDA Can't Determine Its Funding Needs - WSJ.com
Quote (emphasis mine): "The FDA isn't able to reliably determine how much money it needs to regulate medical products because, among other things, its staff can't track all the adverse-event reports it handles, according to the Government Accountability Office."
I am sorry, but isn't the primary objective of FDA drug safety? Isn't accurate tracking of the problems reported just a little teeny bit important for that? Isn't it important for FDA to accurately track adverse effects to produce a fair and valid review of the drug?
What kind of mess is FDA? Can any reports produced by them be trusted if they can't track data consistently and reliably?
Another quote from the same WSJ article (emphasis mine): "FDA told GAO while they place a priority on reviewing serious adverse-event reports, they receive "substantially" more adverse-event reports than staff can review. The FDA said the adverse-event reporting systems don't allow agency to track whether individual reports have been reviewed."
This must inspire confidence in general public.
Why isn't mass media picking up on this? Isn't this much bigger health hazard than electronic cigarette?
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