Monday, June 02, 2008

FDA inspections

The recent contamination of products and drugs entering the USA from foreign countries has heightened our awareness of the lack of oversight.

It is pretty clear that the FDA cannot protect us from all the dangers.

Concern about the FDA oversight was highlighted with the recent contaminant in some batches of blood-thinner heparin that were made with raw ingredients from China.

The Government Accountability Office has stated that the FDA increased inspections of foreign manufacturing sites to about 11 percent last year and took other steps in recent months.

This seems like a very small percentage to guarantee safety of drugs especially when the FDA is so stringent about what can be put on the labeling.

A House of Representatives subcommittee is investigating and will question FDA Commissioner Andrew von Eschenbach about foreign drug inspections. His answers I’m sure will be enlightening.

Most people do not realize that more than 80 percent of the active ingredients in U.S. drugs come from foreign countries and about half of these come from India and China alone.

The estimated cost to inspect all suppliers would be between $67 million and $71 million dollars.

So the question remains; how safe are we?

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