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Drugs from China? Buyer beware!
February 28, 2008

In a move that will likely draw a wide variety of responses, the China State Food and Drug Administration has taken an official position that importers of pharmaceutical products are ultimately responsible for what they get, not the agency. In other words, don't count on us to do your plant inspections for you. This discussion is summarized in an article in today's Wall Street Journal.

So, drug companies that want to manufacture in China or buy ingredients from the country will have to do their own policing. There is little likelihood that the U.S. FDA will be much help in overseas inspections because the agency is already spread too thin. This may put a damper on Chinese sourcing if U.S. companies have to spend more on doing their own QC over there. It may give a shot in the arm (pun intended) to domestic manufacturers.

Personally I find the whole picture pretty scary. Given that it's virtually impossible for a consumer to tell where a pharmaceutical product has been manufactured, you have no way to know if that pill you're about to take came from an FDA inspected plant in Kalamazoo, MI, or a plant in Changzhou that has never been inspected because it stays under the radar with a classification as a chemical producer rather than pharmaceuticals. Moreover, even if that pill was pressed in Kalamazoo, you don't know where the individual ingredients came from.

U.S. pharmaceutical companies that can account for all their sources and show them all as reliable (meaning non-Chinese) will likely begin broadcasting that fact to make consumers feel better. That is assuming there are any.

Posted by Peter Welander on February 28, 2008 | Comments (0)