FDA Funding and Drug Safety: New Report from GWU

When I first downloaded this report from the Rapid Public Health Policy Response Project at George Washington University in DC, I was taken aback to see the Pfizer logo on the first page; but the content, though partly supported by Pfizer's "Public Health and Policy Group," seems reasonably balanced.

The report summarizes existing law on the Prescription Drug User Fee Act (PDUFA) and the current debate over whether this law promotes adequate attention to drug safety, as opposed merely to speedier approval reviews to keep the industry happy.

In HOOKED, I argue that PDUFA should be repealed and the FDA supported fully from congressional appropriations, not industry user fees. So I was pleased to read in the report the line-up of those who argue that this is the case:

Four former FDA commissioners
The Institute of Medicine report on the FDA
Consumer groups
Twenty-two experts in drug safety and regulation, including 3 former editors of the New England Journal

The report can be obtained at:
http://www.gwumc.edu/sphhs/about/rapidresponse/download/RapidResponse_PDUFA.pdf