FDA “hanging on by its fingertips” according to its former head!


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

Published: February 3, 2008

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.

The reason for the agency’s woes is simple. Congress has repeatedly piled new burdens on the F.D.A. ”” more than 100 statutes have added new responsibilities over the past 20 years ”” without providing enough money and personnel to carry out the tasks. To make things worse, the increasing complexity of modern medical products and the flood of food and drug ingredients from abroad have overwhelmed the agency’s ability to keep up.

User fees from industry have helped the F.D.A. review applications to market new drugs and medical devices in this country, but the agency’s underlying scientific core is eroding. The two units that regulate food are in “a state of crisis,” according to the science board, and dietary supplements and cosmetics get short shrift.

The near unanimity about the agency’s weaknesses ”” among Congressional Democrats and Republicans, industry and consumer groups, and authoritative independent analysts ”” is striking. But hand wringing is not enough. The F.D.A. desperately needs an infusion of money and talent. To make up for decades of neglect, Mr. Hutt proposes that its appropriation be doubled and its staff increased by 50 percent over the next two years.

SOURCE   http://www.nytimes.com/2008/02/03/opinion/03sun1.html?_r=1&oref=slogin

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