Remember when the idea of importing drugs from Canada appalled good Republicans everywhere? "How will we know they are safe," they asked. Those crazy Canadians simply could not be trusted.
I can't wait to see how they respond to this:
India and China, countries where the Food and Drug Administration rarely conducts quality-control inspections, have become major suppliers of low-cost drugs and drug ingredients to American consumers. Analysts say their products are becoming pervasive in the generic and over-the-counter marketplace.Over the past seven years, amid explosive growth in imports from India and China, the FDA conducted only about 200 inspections of plants in those countries, and a few were the kind that U.S. firms face regularly to ensure that the drugs they make are of high quality.
The agency, which is responsible for ensuring the safety of drugs for Americans wherever they are manufactured, made 1,222 of these quality-assurance inspections in the United States last year. In India, which has more plants making drugs and drug ingredients for American consumers than any other foreign nation, it conducted a handful.
Companies based in India were bit players in the American drug market 10 years ago, selling just eight generic drugs here. Today, almost 350 varieties and strengths of antidepressants, heart medicines, antibiotics and other drugs purchased by American consumers are made by Indian manufacturers.
Five years ago, Chinese drugmakers exported about $300 million worth of products to the United States. Eager to meet Americans' demand for lower-cost medicines, they, too, have expanded rapidly. Last year, they sold more than $675 million in pharmaceutical ingredients and products in the U.S. market.
More and more every day, I really am beginning to believe that its time for a 21st century version of the progressive movement to emerge, this time based on changes to the global economy rather than the domestic one. With stats like these...
Analysts estimate that as much as 20 percent of finished generic and over-the-counter drugs, and more than 40 percent of the active ingredients for pills made here, come from India and China. Within 15 years, they predict, as much as 80 percent of the key ingredients will come from those countries -- which are quickly becoming attractive to brand-name drugmakers, too.
Big Pharma will of course yell and scream about how increased inspections will increase costs. Until, of course, the negligent homicide lawsuits start pouring in, at which point they scream for federal assistance.
For those who claim that the "free market" will sort all this out on its own, my question is this: how many Americans are you willing to let needlessly die before you are convinced action is necessary? Because unless we impose a much stricter inspection regime, that's the only way the "market" will be able to handle this one. Right now the global market is "free" - free in the sense of free from regulation - just as it once was in the early industrial age.
And last but not least, lest you put any faith whatsoever in Chinese inspection regimes, this should take care of that:
The former head of the Chinese drug and food safety agency, for instance, was recently sentenced to death for taking bribes from companies he regulated
UPDATE: More in today's NYT. This problem is going to be incredibly difficult to solve, if for no other reason than that the global market is incredibly complex. Nevertheless, stepping up inspections of US drug imports seems like an incredibly obvious first step.
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