The FDA Needs an Overhaul

Today's Wall Street Journal had a scathing criticism of the Food & Drug Administration on the editorial page, including a juicy quote it harvested from the Science Board, an independent advisory panel :

The Science Board's most important, and distressing, finding is that the FDA bureaucracy “cannot even keep up with the advances in science”—and not solely due to a lack of funding. While “the world of drug discovery and development has undergone revolutionary change,” the authors write, the FDA's “evaluation methods have remained largely unchanged over the last half-century.” (Our emphasis.)
Think about that: We live amid a revolution in biology, but the FDA still thinks like it did when Sputnik launched.

Having had a glimpse of the FDA approval process when I worked on my Capstone project for my MS degree from OGI, I can only imagine how painful it is to improve the FDA. We were bringing to market a non-invasive product that could revolutionize disease testing, but the expense to do so was crushing to a start-up. Survive 7 years on limited revenues with your investors hounding you? Ouch!

Josh Poulson

Posted Wednesday, Feb 6 2008 10:27 AM

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