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There is reason to be afraid.
< Congress Told of FDA's Lax Inspection of Foreign Drug Makers -- Again
The Government Accountability Office (GAO) recently told Congress that the U.S. Food and Drug Administration (FDA) inspects an estimated seven percent of foreign drug manufacturing facilities. GAO can only provide an estimate because FDA doesn't know how many foreign facilities are subject to inspection due to inaccurate and uncoordinated databases that have vastly different estimates of the number of drug makers subject to the foreign drug inspection program. At this inspection rate, it would take FDA more than 13 years to inspect all existing facilities one time, assuming no additional facilities were added to the list.>
An email friend (and retired FDA employee) writes:
Just received the following from a former colleague, now retired:"I know you saw in the news where FDA, etc are being given new powers to do wonders with all these bad imports. This also includes sending FDAers to sanction plants overseas. But, interestingly, no money has been allocated, according to what I read. So it seems we are back at square one. It is the same old story about FDA--give them more responsibilities, but not the money or personnel. Oh, and by the way, let's close a few labs while we are at it. Don't these people in Washington ever get it?"
In June the Washington Post wrote: http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR2007061601295.html <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.
….Eager to meet Americans' demand for lower-cost medicines, {China has} expanded rapidly. Last year, they sold more than $675 million in pharmaceutical ingredients and products in the U.S. market.>
This outsourcing game is both dangerous and expensive. In fact we have absolutely no idea if we are getting what we are pay for, and the FDA doesn’t know either. It’s nearly certain they don’t want to know.
