This is the only collection of research on the topic I've seen but if anybody has evidence for a lower number I'd be happy to see it.

http://www.fdareview.org/05_harm.php

Specifically:

[T]he benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties per decade or 10,000 per decade for worst-case scenarios. In comparison, it has been argued above that the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade