FDA Crack Down on Cargo Thefts
April 3rd, 2012 // 12:17 pm @ jmpickett
As last month drew to a close, the FDA issued a new standard operating procedure for dealing with cargo thefts, yet another point in the pharmaceutical supply chain that has generated concern. In recent years, hijacked trucks and spectacular break-ins have highlighted an area of weakness that has prompted drugmakers to energize an industry coalition that works toward beefing up security.
Now, though, the FDA wants to make sure that drugmakers do more than bolster internal operations. In a new standard operating procedure, the agency wants the pharmaceutical industry to know that there are various obligations when a theft occurs and this includes alerting regulators and the public. What happens if a drugmaker fails to do so? Read this..
“If a firm is non-responsive to FDA’s request for information related to the cargo theft or if the firm’s action plan is inadequate, or if the firm is unwilling or reluctant to alert the public to the cargo theft, the CTRT will consider the option of providing the public with the relevant facts about the cargo theft and to address the public health risk associated with that theft,†the FDA writes in its SOP.
Specifically, a failure to provide the FDA with an action plan for alerting the public, including the possibility of any recall, may prompt the agency to issue a consumer alert. The CTRT is the FDA’s Cargo Theft Response Team, by the way. Why push drugmakers to release info publicly? Well, the sad reality is that stolen meds can easily become adulterated if not stored properly .
Of course, this may cause a little friction. For one, no drugmaker likes to publicly acknowledge a breach, however difficult it may be to avoid a theft. Remember when thieves cut a whole two years ago in a Connecticut warehouse run by Eli Lilly? The brazen crime underscored the wider problem, but embarrassed the drugmaker (see here).
Moreover, drugmakers may be reluctant to release info that may tarnish a particular brand, even if only specific lot numbers are involved in a theft. Nonetheless, this is another step in the arduous process the FDA must undertake to secure the supply chain. Last year, there were 36 pharmaceutical thefts last year, a drop from 49 the year before, according to FreightWatch International, which tracks cargo thefts across various industries. That’s a big drop, but the problem will not disappear.
