A Contrarian View of FDA: Bloated and Inefficient

John Graham of the conservative California think tank, the Pacific Research Institute, just published a research report, Leviathan's Drug Problem, arguing that FDA is overstaffed, overfunded and unproductive. He traces patient wait times for new medicines as contributing to far more loss of life than food contamination.

Citing examples in the U.K., he alleges that FDA holds "monopoly power" over the industry.  He also recommends that U.S. citizens be able to use new medicines once they have been approved in Europe or elsewhere by an authority comparable to FDA. (Presumably, that would exclude China's SFDA, at least for now) He also backs the ACCESS Act, introduced last year, which would allow patients with serious illnesses to try experimental drugs at an earlier phase of regulatory approval. I'd agree with that, just based on risk vs. benefit.

OK, PRI is a right-leaning organization.  But hasn't FDA evolved in response to serious mistakes in the recent and not-so-recent past, political pressures, and the concept that it should be able to oversee the entire global food and drug industry?   Its critics always argue that FDA stifles competition, until they're drowned out by screams of public and regulator outrage after a Vioxx or heparin recall. 

Still, the report is worth reading.