Map of life expectancy at birth from Global Education Project.

Monday, April 28, 2008

Catching up on my weekly reading

You probably haven't noticed, but Thursday is the day I normally read NEJM and JAMA and give you the straight dope on whatever is in there. Last week I was locked in a recording studio all day so I just got a round tuit.

Alastair Wood doesn't want us to blame the FDA for disasters like the contaminated Chinese heparin because a) the manufacturer has to be held responsible for insuring the quality of its products, they went to the Chinese suppliers purely because they were the cheapest, and why don't they do their own damn inspections? and b) Over the past 20 years Congress has piled more and more responsibility on the FDA without giving it enough funding. I'm not sure which of these he actually thinks is the problem -- the arguments contradict each other if you really think about it -- but he's half right anyway in both cases.

Here's what I think. First of all, you might want to know that nowadays, only 10% of active drug ingredients are made in the U.S. or Europe. I haven't been able to find quantitative info on where they are manufactured, but China and India are among the most important countries engaged in this business, along with other developing countries such as Mexico and Brazil. Given that we know so far of only a single example of a fake or contaminated ingredient making its way from a foreign supplier into a prescription drug sold in the U.S. (this is leaving aside the question of drug counterfeiting, which is a different matter altogether), the record actually doesn't seem that appalling.

However, I do agree that we can't just leave it to the manufacturer to assure the quality of purchased ingredients -- they're always going to be tempted by the lowest price. You could have a model similar to that in the airline industry, where they are required to conduct inspections according to federally mandated protocols and document those inspections, with spot checks by the FDA, as opposed to having the FDA do it directly, but that's really an administrative question. The government, one way or another, has to make sure that short-term commercial considerations don't trump safety.

On the other hand, why should the U.S. taxpayers and consumers pay to make sure that foreign suppliers are properly regulated? Shouldn't the Chinese be doing that themselves? Ultimately, it seems to me, this is a matter for trade policy. We should not buy Active Pharmaceutical Ingredients from countries that don't have their own, adequate regulatory regimes, along with labor and environmental standards that are acceptable to Americans. Put it in the trade treaty.

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