St.Jude On FDA’s Naughty Step Again Over Durata

In short

It’s really not going well for St.Jude right now. Embroiled as it is in the enduring hangover from externalised older generation ICD leads, compounded by supply side issues over the coating technology for its Durata leads, it now faces a very uncomfortable rap on the knuckles from the FDA, which has seen its share price badly hit with a double digit drop.

Background

Leaving aside the history, what’s happened in recent months is that St.Jude has undergone FDA inspections during September and October, the outcome from which has been pretty ugly and, as is the way with these things, well circulated. Any sentence that includes the words “Durata” and “Problems” is guaranteed to hot the headlines as the spotlight is so intensely trained on the device.

So, cutting to the chase, what’s happened now is that the FDA has issued a document detailing (and we do mean “detailing”) the flaws it found in the company’s processes on its recent inspections. You can find the FDA document here, but a few highlights include what look like either omissions or inconsistencies in the design history files, inadequate closing out of corrective/preventive actions (CAPAs), and failure to complete design verification testing according to written protocols. On top of that they said internal auditor training and design control was inadequate. There’s lots more… 11 problem areas in total.

Is this all a storm in a teacup or does the company really have a headache that’s not going away any time soon? Time will tell, but what seems to be at issue here is the impression left by the company’s issuing of what amounted to a hint about FDA warning which somewhat underplayed the extent of the document subsequently issued by the agency.

Source: FDA