Counterfeiting, says Johnson & Johnson’s Ron Guido, is a form of flattery. “If you don’t have counterfeits in your business, chances are you don’t have a good brand,” said Guido, J&J’s VP for global brand protection, speaking at the ISPE annual meeting in Dallas last week. In other words, a successful product/brand (Gucci, let's say) is the apple of a counterfeiter's eye.

One could say that supply chain security is the most critical issue facing drug manufacturers today—and perhaps facing our healthcare system as well. The supply chain is at the heart of healthcare’s greatest problems—drug counterfeiting and adulteration, shortages of key medicines, and of course escalating medical costs. Without security of supply, none of these challenges can be addressed.

FDA has signaled this past summer that it will toughen its stance on the degree to which drug manufacturers must oversee and audit the activity of their vendor partners.

Last week, FDA released its anticipated final guidance, “Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages.” The aim of the guidance is to lend support to industry efforts to establish end-to-end supply chain security and realize the benefits of the myriad track and trace technologies currently available. This guidance is just a start, the Agency indicates.

At the USP science meeting in Toronto, I met Janeen Skutnik of Pfizer, currently chair of IPEC Americas, and former IPEC chair, Colorcon's David Schonecker. (Also met incoming chair,  William Dale Carter of JM Huber, who will start his new role next year).

I spent the first part of this week in Toronto, Canada (light years away from the staid, dull town I remember visiting as a kid----with rush hours that easily rival New York’s.  I almost missed my flight home!) to attend USP’s annual science meeting.

A key theme was protecting the pharmaceutical supply chain.  A number of scientists discussed the analytical tools that are being developed to help law enforcement specialists identify fakes.  Quite a few of these presentations focused on handheld Raman, but more on that, and the conference, later.

Are we about to hear of a new veterinary supply chain scare involving animal feeds----or vitamins or supplements, now under the cGMP compliance umbrella at FDA?  Or all three?

Some of those in favor of relaxed reimportation often argue that the drug industry is fear mongering when it points to potential safety problems with drugs or ingredients sourced from abroad. "Be afraid, be very afraid. "  Well, recent events have shown that there is reason for fear....or at least for extreme caution when ensuring the pedigree of any raw materials  sourced from abroad.