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

[Guest guest]

February 3, 2008

Editorial

The New York Times

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

 

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.

 

Copyright 2008 The New York Times Company