The FDA's Sept 6 warning letter to Epipen manufacturer Meridian (a division of Pfizer) condemns the company for knowingly shipping out defective products that led to the death of the customers who paid hyper-inflated prices for the devices, which Meridian manufactured for notorious pharma profiteers Mylan.
According to the FDA, the company received hundreds of complaints about defective auto-injectors and failed to act on them, despite the obvious culprit — a "deformed" component.
Regulators like the FDA and FTC typically have to warn a company before assessing penalties against it, operating on a kind of two-strikes-and-you're-out basis. This letter itself carries no penalties apart from public shaming, but it does set up the companies for massive fines.
The agency went on to note that, during an inspection earlier this year, Meridian employees said that they did not disassemble the "vast majority" of failed devices customers sent back to them. Meridian received 171 such "complaint samples" between 2014 and 2017. But employees said they were only allowed to take devices apart if it was "approved by management." Yet Meridian noted that disassembly was the only way to determine why a device failed.
Days after the inspection, Mylan recalled tens of thousands of injectors.
FDA slams EpiPen maker for doing nothing while hundreds failed, people died
[Beth Mole/Ars Technica]
(Image: Greg Friese, CC-BY)