Thursday, November 12, 2009

Gray Market: I'm Not Dead Yet

Secondary market appears to be alive and well. Whether or not patients remain alive and well is a whole different question.

Check out Profiteers peddling flu vaccine from newspapah-of-recahd The Cape Cod Times, which notes:
The seasonal flu vaccine is in short supply, but licensed pharmacists and medical professionals can purchase it on a so-called "gray market" — for as much as eight times the manufacturers' original price.
Unfortunately, the illegitimate secondary market will exist as long as there are willing buyers for products with questionable heritage.

History has shown us that wild west secondary trading markets create a wide open gateway for counterfeit drugs to enter the legitimate drug distribution system. Read Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination of America's Drug Supply, an expose of drug diversion by essentially unregulated drug wholesalers in Florida. The book will show you why Florida passed a pedigree law.

Even Cardinal Health (NYSE:CAH) was forced to promise good ol’ Eliot Spitzer that the company would back away from secondary markets. See Cardinal's Sins.

Inventory Management Agreements (IMAs) and Fee-for-Service agreements dramatically reduced secondary market activity in the U.S. wholesale channel. This has limited product leakage into the grey market and closed a significant entry point for counterfeit drugs.

But we still need to be vigilant because even legitimate pharmacists will be tempted to purchase in the secondary market. A 2004 study found that two-thirds of hospital pharmacy directors use secondary wholesalers as a resource to obtain needed supplies during a product shortage. (Source) If there are willing sellers of dubious H1N1 vaccine, I’m sure there are buyers out there.

Pedigree is one possible solution, although we have no national standards as I point out in my 2008 op-ed Securing America’s Pharmaceutical Supply Chain. I haven’t written a lot about pedigree since the California law was pushed off to 2015, dashing the hopes of many tech companies. See CA E-Pedigree: Hasta La Vista, 2011 and Federal Pedigree Sand Trap for background on the general topic.

BTW, the CCT article references a lawsuit by RxUSA regarding pedigree. As reported in Pharmaceutical Commerce, RxUSA’s lawsuit against wholesaler and manufacturers was thrown out in late September. But as far as I know, the FDA is still enjoined from implementing the pedigree requirements of the 1987 (!) Prescription Drug Marketing Act as I discussed way back in No PDMA for You! in December 2006.

Bonus tip: In addition to potentially-counterfeit flu vaccine, you can also find some wicked good licka stohars down theyah on the Cape.