Advertisement

If you have an ACS member number, please enter it here so we can link this account to your membership. (optional)

ACS values your privacy. By submitting your information, you are gaining access to C&EN and subscribing to our weekly newsletter. We use the information you provide to make your reading experience better, and we will never sell your data to third party members.

ENJOY UNLIMITED ACCES TO C&EN

Policy

FDA 'In Crisis'

Serious deficiencies in funding and science support at the agency endanger lives

by Bette Hileman
December 10, 2007 | A version of this story appeared in Volume 85, Issue 50

[+]Enlarge
Credit: FDA History Office
Scientific research at FDA is in a precarious position because of poor funding and understaffing.
Credit: FDA History Office
Scientific research at FDA is in a precarious position because of poor funding and understaffing.

The Food & Drug Administration is so understaffed and underfunded that it puts lives at risk, concludes a scathing report from the Science & Technology Subcommittee of FDA's own Science Board.

The panel, which includes 33 industry, academic, and government leaders with a wide range of scientific expertise, was convened by FDA Commissioner Andrew C. von Eschenbach and chaired by Gail H. Cassell, Eli Lilly & Co.'s vice president for scientific affairs. "It is the second time in history that an external committee has reviewed the agency as a whole, focusing on science," Cassell says.

Because of rapid scientific advances and more than 100 new statutes passed during the past two decades, the "demands on FDA have soared," the report says. But the agency's resources and number of scientists have remained essentially stagnant. With the possible exception of some drug and medical device review offices supported by industry user fees, the report says, there are "substantial weaknesses across the agency."

The subcommittee is "extremely disturbed" about FDA's information technology infrastructure. For example, the panel says, agency inspectors are not given computers, so their reports are handwritten and cannot be rapidly analyzed. Much critical data, including clinical trial data, reside in warehouses in piles of paper documents with no backup. "You have to have modern informatics and IT resources in order to do your job, and FDA scientists definitely do not have that," Cassell says.

Another major deficiency, according to the panel, is that FDA has 600 fewer food inspectors now than it had four years ago, putting the food supply at risk. "When I came to FDA in the early 1970s, we performed 35,000 food inspections per year, but now the agency does only about 6,000," says former FDA associate commissioner William K. Hubbard.

The impacts of deficiencies in funding, personnel, and IT "are profound precisely because science is at the heart of everything the agency does," Cassell observes. Although previous reviews of FDA warned that crises would result unless major changes were made, "our findings indicate that some of those crises are now realities and American lives are at risk," she says.

Advertisement

Article:

This article has been sent to the following recipient:

0 /1 FREE ARTICLES LEFT THIS MONTH Remaining
Chemistry matters. Join us to get the news you need.