FDA’s lack of science ‘puts lives at risk’ - December 04, 2007
Science at the US drug regulator is simply not up to the job of keeping America safe. This is the worrying conclusion of a new report by the Food and Drug Administration’s own science advisory committee (report PDF).
“The wheels are coming off. In fact, I would say they're off. They’re already off,” said report co-author Gail Cassel (ABC).
The FDA Science and Mission at Risk report comes on the back of numerous incidents that have raised questions about the agency’s ability to function. Indeed, the FDA’s own reports have previously warned that without budget increases it would be pushed to do its job. The new report says this is already happening (USA Today).
The report states, “science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities”. Also in the report is this rather important point: “FDA’s inability to keep up with scientific advances means that American lives are at risk.”
For sheer impact it’s hard to beat the key findings:
- The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
- The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
- The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
At the Huffington Post, Doug Bremner thinks he knows what the problem is: “I think it is time we turned the FDA back into what it was supposed to be: an agency that protects you and me from unnecessary risks from food and drugs, not a cheerleader for private industry.”
