If any of you could possibly have missed it, the New York Times just published an outstanding piece examining counterfeit pharmaceutical intermediates---from China to Panama and around the world. The problem: insufficient QA and QC at manufacturing companies which relied on data from suppliers to verify identity and safety of the glycerine. For more on that, click here. Also visit FDA's web site.
The cough syrup tragedy in Haiti in the 1990s has been followed by many others, globally, and the article also provides a glimpse into the life of one perpetrator: the tailor-turned-chemicals-broker, Wang Guiping, who sold industrial grade polyethylene glycol to drug manufacturers, generating a toxic chain that we'd touched on briefly last summer. He'd tasted the solvent before selling it, and when he failed to get sick, assumed that it would be safe to sell. He didn't set out to poison people, but his case illustrates the dangerous combination of ignorance and desire for profit that is fueling many exporters today. (An aside: The ill-gotten gains reportedly fueled Wang G.'s gambling habit, rather than supporting his family, suggesting that China's tremendous economic growth and the pressure for profit may be exacting a large toll in other ways, too.)
Where this had been a subject of much concern and hand wringing, it hasn't really been an issue for the U.S. since the old glycerine cases in the past---the effects of glycol-contaminated cough syrup sales was, after all, a key event in FDA's history. But if anyone thought that the U.S. was exempt from such problems, the melamine and petfood story brought the issue again to the headlines, re-emphasizing the risks of importing ingredients from nations that have not yet established a strong safety infrastructure.
As the government paves the way for importation of safe finished pharmaceuticals into the U.S., one hopes that it will also provide more funding for FDA and other agencies for ensuring the integrity of drugs and their precursors. One also hopes that drug manufacturing plants around the world will invest in the analytical systems required to ensure the identity and quality of imported intermediates.
Pharma blogger and Pembroke Consulting Group principal Adam Fein, an expert in pharma supply chain security, is sure to have some interesting comments on his blog on this subject.
