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FDA is going easy on China. In the heparin case, it concluded its investigation without ever suggesting the source of the problem:

The Food and Drug Administration failed to pursue several ’specific and credible leads’ that might have identified culprits in China during the 2008 crisis involving contaminated imported heparin, according to a congressional investigation.

Meanwhile, following a “consultation” with the FDA, McNeil has been pressured into issuing a voluntary recall of over 40 medications affecting children. The recall sounds serious, but we have been told that there is no real danger to the public. As someone who has worked in manufacturing, I would have preferred details on just how far “out of spec” the products were.

FDA is playing politics. That’s my working hypothesis. After setting up offices in China — an unprecedented move — the agency learned only that additional scandals out of China are inevitable, and that the biggest quality failures are yet to come. And, unable to prevent disaster, FDA’s next best move was to build the case that, “America has problems, too.”

I don’t think issues at home will do anything to diminish the actual challenge out of China. The most insidious kinds of quality failures involve game-playing, and Chinese versions of quality failure are quite often not the same. Some may miss the difference between “process errors” and “willful shenanigans,” and the distinction must be put on the table when discussing quality issues. Even though the McNeil recall affects children — this is actually a theme with a lot of recalls of US-made products (e.g., cookie dough, peanut butter) — it is by no means like the heparin case, which involved elaborate counterfeiting and which led to many deaths.

I hope I’m wrong about politics playing a part in these cases involving FDA.

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