Re:The EpiPen, a Case Study in Health System Dysfunction
by ende on Sunday August 28, 2016 @10:02PM
(#12379533)
> Auvi-Q was voluntarily recalled because it didn't reliably dispense an accurate dose
In 26 unconfirmed cases. Auvi-Q wasn't recalled because of device failure, but because of -potential- device failure. EpiPen is not immune to device failure either: http://adc.bmj.com/content/98/Suppl_1/A42.3
The FDA needs to be maintaining a standard in device quality, but it also needs to make those assessments free of any potential bias and it also needs to be held responsible for denying a fair competitive market to consumers.
In 26 unconfirmed cases. Auvi-Q wasn't recalled because of device failure, but because of -potential- device failure. EpiPen is not immune to device failure either: http://adc.bmj.com/content/98/Suppl_1/A42.3
The FDA needs to be maintaining a standard in device quality, but it also needs to make those assessments free of any potential bias and it also needs to be held responsible for denying a fair competitive market to consumers.