Fda On The Brink

A prominent biotech executive says the report is "spot-on" but declines to say so on the record because his company has drug approvals pending at the F.D.A. "I hope it gives a proper sense of urgency," he adds. "Things at F.D.A. have deteriorated badly even in last 12 months."

A few details that caught my eye:

• Email systems are so unstable that they sometimes break down, "most recently during an E. coli food contamination investigation," according to the study.


• In recent years, food inspections have dropped 78 percent at a time of rapid expansion in the food industry and as food imports have increased exponentially.


• User fees charged to drug companies have helped with funding for premarket reviews and approvals for drugs but are not enough to counter systemic deficiencies.


• The turnover rate of key scientific personnel is twice that of other agencies, as the F.D.A. fails to keep up with the latest developments in science and technology.

This last point is especially critical for an agency faced with regulating some of the most advanced science in the world, from the latest food additives and novel drug mechanisms to robotics, systems biology, and nanotechnology.

"The public is understandably confused by the growing disconnect between the promises of cutting-edge science and the reality of clinical benefit," the report says.

An illustration of this is a steep decline in F.D.A. approval of new drugs in recent years. There are several reasons for this, but a lack of funds and inadequate oversight of some products and companies—which has led to errors and, as a result, a bunker mentality among some officials who are afraid of making additional mistakes—contribute to the problem.

The report calls for a 50 percent increase in personnel and a doubling of the F.D.A.'s budget over the next two years, and adequate increases thereafter.

So far, committees in Congress have proposed increases of 8 to 12 percent for 2008, but even these modest boosts may encounter trouble from the Bush administration, which has been unwilling to raise funding for regulatory agencies or for similar initiatives.

For my part, I'd pay an extra buck or two a year to make sure my spinach isn't tainted and that the pharmaceuticals used by me or my family are safe and effective. How about you?

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