FDA Fees Must Be Increased to Fund Inspection of Chinese Products.

Implications: One only has to read about the Heparin debacle, which has killed, at least, 81 Americans, to realize that there is a serious issue with the quality of medicines produced in China.  Manufacturing of medical food and consumer goods in China is growing at such a rate, the Chinese government has neither the resources or the will to maintain adequate inspection of quality control.  The only way it's going to be done is if our FDA becomes involved, hence the increase in FDA fees.

Analysis: The base ingredient for the heparin spoken of, above, was produced by a Chinese manufacturer, that had never been inspected during it's seven years of existence.  Sadly, this is just the tip of the iceburg.

The good news is that the increase in fees will be passed onto anyone applying for FDA approval, regardless of location in the world.  An additional silver lining in the cloud is the fact that new business will be created for companies that will be sub-contracted to carry out proxy FDA plant inspections.

I see this an a new business opportunity for American based companies to rise to the occasion and offer their contracted services to the FDA.  I have no doubt that the majority of sub-contractors, should the FDA go in that direction, would be sent to inspect plants in China, as well as India and other emerging nations.