On Friday, GlaxoSmithKline (GSK) made a depressing announcement: “A small number of Advair Diskus inhalers stolen from a GlaxoSmithKline distribution warehouse in 2009 have been found in some pharmacies.”Yikes! I guess the gray market is still alive and well.
This news should be a wake-up call to pharmaceutical manufacturers that are investing money in serialization. As I point out in Reality Check on Supply Chain Security, pedigree laws and track-and-trace technologies only work if pharmacy buyers refuse to buy outside legitimate channels and agree to authenticate (scan) an electronic tag.
Many executives at drug companies spend a lot of time worrying about technology implementation and standards, but forget to worry if anyone will actually read their bar code or RFID tag. Today's supply chain security investments will only have value if gray market buyers play by the rules.
Here are the official announcements from GSK and the FDA:
- GSK: Update to 2009 Notification of Stolen Advair Diskus Inhalers
- FDA: FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers
So far, there is no public information about who sold the stolen inhalers to pharmacies, how many pharmacies purchased them, or whether pedigree was involved. We should all be very worried if the inhalers were purchased by pharmacies operating in states with rigorous pedigree laws.
I’m in favor of a national system for tracking and tracing pharmaceuticals to replace today’s crazy patchwork of inconsistent regulations. However, I’m also skeptical enough to worry that "Don't ask, don't tell" is the mantra of people who buy diverted products from unsavory resellers.
On the bright side, there is no truth to the rumors that a thief named Cobb snuck into the dreams of GSK CEO Andrew Witty to access the warehouse security codes.
Please feel free to refudiate me if I am mistaken.
