Dear FDA, Be Reasonable And Define The Word 'Reasonable'

In response to increasing recalcitrance when staffers inspect manufacturing facilities, the FDA last July issued a draft guidance to spell out the circumstances when a drugmaker can expect to run into trouble. This may occur when facilities or documents are not made available or an inspector is prevented from accessing certain rooms or the premises altogether. After all, no one likes to get the bum’s rush (back story with link to the draft guidance). The draft guidance received attention quickly because the FDA noted that inspection delays can cause a drug made at the given facility to be considered adulterated. Not surprisingly, several drugmakers and industry trade groups have since responded to the missive with various concerns about how the FDA may proceed once its document becomes finalized. For instance, some expressed anxiety about inspectors who take pictures. The Healthcare Distribution Management Association, which represents wholesalers, wrote that, “given the tens of thousands of high-value pharmaceuticals stored within warehouses, the inadvertent publication… of highly confidential security systems, alarms and cameras could seriously compromise a warehouse’s security" (more here). Security is a relative notion, but who can forget that the thieves who swiped some $70 million in medicines from an Eli Lilly (LLY) warehouse were able to do so because they had access to the location of security systems? No, the burglars did not have photos or video taken by an...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs