Oh boy, more forms and more signatures and more questions. Just what we need or not? I’m all for open communications and 100% visibility for adverse event reporting, but what exactly is the issue?

The FDA is now questioning the scope of AE reporting and claims that almost all submissions are incomplete. Personally, I’ve read the entire redwood forest of safety reports and have never been wanting for more information.

Granted, I’m not an FDA suit, but I’m on the front lines everyday taking the AE report from the patient. I can tell you, first hand, that even patient reported post nasal drip is hours of paperwork, followed by a dozen queries, medical monitor questions, request for updated medical records, terminology changes and a whole host of other crazy questioning. I’m serious!

With tens of thousands of Study Coordinators, around the world, fighting 24/7 to get on top of the paper tsunami, how many of them do you think actually report a runny nose? Do you really think the average Study Coordinator reports an SAE because the subject fell of the curb, busted their face and was admitted to the Hospital? We train to report everything, even if the AE is a minor increase in harsh language usage; but, it is an industry wide known fact that many sites  pick and choose what to report.

Just lovely

SMZ

Fierce Pharma: Today’s headline:

FDA study spanks drugmakers for poor adverse events reporting,

and

Roche, Genentech overlook 80,000 adverse reaction complaints