The F.D.A. in Crisis: It Needs More Money and Talent

This story was reported by me here at Newsvine on December 14, 2007 along with a link to the FDA Confidential Report. It's linked below just so you know the news does get here first!!

The Food and Drug Administration is supposed to be Americans' main line of defense against tainted food, drugs, medical devices and other products — in a world abounding with tainted goods. So it was especially chilling last week to hear the agency's former chief counsel, Peter Barton Hutt, tell a Congressional panel that the F.D.A. was "barely hanging on by its fingertips."

That warning was supported by several equally grim authoritative reports and other expert testimony that made clear that the agency does not have enough money or enough skilled scientists to do its job.

In a hearing before a House Energy and Commerce subcommittee, members of the agency's own scientific advisory board outlined the F.D.A.'s many weaknesses. It lacks scientists who understand rapidly emerging technologies — including genomics and nanotechnology — relevant to product safety. The agency is further hobbled by a high turnover rate of scientists, a decrepit information technology system, a weak organizational structure, and a shrinking inspection force.

The Government Accountability Office, meanwhile, warns that at a time when imports are pouring in from all over the globe, the agency does not have enough staff or adequate computer systems to conduct timely inspections of foreign plants that make drugs, medical devices and food products. That is especially worrisome in China, the source of so many dangerous goods. At its current pace, the agency would take 13 years to inspect every foreign drug plant exporting to the United States, 27 years to check every foreign medical device plant and 1,900 years to inspect every foreign food plant.