Monday, February 20, 2012

FDA and Medical Innovation

Andrew Von Eschenbach wrote an interesting article in the Wall Street Journal last Tuesday.
You can view the article here. (Subscription required)
The article addresses the issue that the FDA is, unfortunately, woefully unprepared for the new world of Drug Development.
As Mr. Von Eschenbach writes, even FDA Commissioner Margaret Hamburg:

conceded to Congress in 2010 that 'the FDA is relying on 20th century regulatory science to evaluate 21st century medical products.'

And one of the major problems is that the FDA's inefficiency in evaluating new drugs, devices etc. ultimately leads to significantly higher costs for new drug and device development.

Von Eschenbach goes on to say:

The Tufts Center for the Study of Drug Development has reported that clinical trials from 2003-2006 were nearly 70% longer than those from 1999-2002. Longer (and more complicated) trials have led to skyrocketing drug-development costs. High costs discourage investment in much-needed new therapies for conditions like obesity, diabetes and heart disease.

This is not a critique of the FDA itself.
They are doing what they can with the tools they have.
But the bottom line is that Congress and the Obama Administration need to make modernization of the Agency a priority because not only the health of our economy - but our very own health - is at stake.

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