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Evidence shows that the FDA has been increasingly driven by critics and Congress towards ever more risk averse behavior. The danger here is that bureaucratic timidity kills. A 2005 study by economists at the University of Chicago calculated that the speed-up in FDA drug approvals that occurred after 1992 may have been responsible for saving the equivalent of 180,000 to 310,000 life-years (the sum of the years of life that would have been lost had the new drugs not been available). Over the same period, about 56,000 life-years—at worst—were lost to drugs that were eventually withdrawn for safety reasons.
Perhaps Hamburg and Sharfstein will buck this trend toward excessive caution and help speed up the process of getting new medicines to patients. Unfortunately, the preliminary signs are not good.
Ronald Bailey is Reason magazine's science correspondent. His book Liberation Biology: The Scientific and Moral Case for the Biotech Revolution is now available from Prometheus Books.
Disclosure: I am an adjunct scholar at the Competitive Enterprise Institute.