VCs Take Their Case For FDA Reform To Capitol Hill

Timothy Hay | The Wall Street Journal | October 6, 2011

Venture capitalists are beginning to steer their investment dollars away from fledgling pharmaceutical and medical device companies, a phenomenon that will drive jobs and promising treatments overseas, according to a new survey of life sciences investors.

The chief reason, according to most of the 156 venture firms surveyed, is dysfunction at the Food and Drug Administration, an agency investors say is so unpredictable and risk-averse that young companies are now inclined to merely give up on trying to get on the market in the U.S. These are the results of a survey done this summer by the Medical Innovation and Competitiveness Coalition, a partner organization to the National Venture Capital Association that is made up of medical-technology investors...

...Seidenberg responded by saying investors are pleased that the FDA is listening to their concerns, especially a new initiative to “open source” a good deal of FDA clinical data, which will make it available for analysis, and hence make FDA decisions more transparent. But they were also disappointed that in their eyes few of the initiatives put forward are new...