Baseball91's Weblog

July 21, 2009


The Government Accountability Office reported yesterday that while funding of the Food and Drug Administration has increased since 2004, so has the agency’s responsibilities. In a previous report 20 years ago, the GAO first raised concerns about FDA’s inability to determine how much money it really needs to do its job. According to the report, the Food and Drug Administration isn’t able to reliably determine how much money it needs to regulate medical products because FDA staff can’t track all the adverse-event reports it handles. The New York Times did a magazine piece on October 31, 2008 about the FDA and the uphill battles they are up against as they attempt to oversee an industry that over the last 30 years has moved to China, in which the FDA maintains two separate data base which indicate either 3,000 foreign drug plants exporting to the United States or as many as 6,800. In the age of diversity, the Chinese do not use many different names and it is hard to distinguish what constitutes a separate plant. And you thought identity theft was a problem here?

When it comes to quality control, when asked, the Generic Pharmaceutical Association was “largely silent on the issue of the difficulty of regulating factories across several times zones, 6,000 miles, and a vast linguistic and cultural divide.” And the unregulated drug industry now in China would result in death through toxicity, in places that the FDA regulated, based on American law.

In China, in the wake of the melamine-tainted baby formula scandal. In China, where thousands of drug manufacturers sell products in the local markets, where profit margins are razor thin. In China, where contamination and counterfeiting are common, with the Pharmaceutical Association estimating that as much as 8 percent of over-the-counter drugs sold in China were counterfeit in 2002. In an age of moral relativism, what was the cost to the United States imposing FDA standards in China? In China, where the American government was trying to account for things way beyond the mandate of the constitution? We had become the policeman of the world, in China with how many people? And now Congressional lawmakers from both parties have raised concerns about FDA’s inability to determine how much money it really needs to do its job. To police the world. Like in Iran. Like in Afghanistan.

It was not about whether the FDA has enough money to oversee an increasingly complex array of medical products. It was about the use and abuse of power, in the age of globalization.


1 Comment »

  1. Comment by baseball91 — November 14, 2011 @ 6:19 PM | Reply

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