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On March 31 2006, the Food and Drug Administration (FDA) charged the Science
Board to evaluate FDA's science-based capacities to meet current and future
public health challenges.
The review was initiated to obtain advice regarding current science-based
capacities and the degree to which they can prepare FDA for anticipated changes
in science, technology and population health needs.
This report was presented and discussed at the December 3, 2007, Science Board
Advisory Committee meeting, where the Science Board decided to obtain comments
from the public on the subcommittee report.
The Subcommittee concluded that 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."
The Subcommittee found that the deficiency has two sources:
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"The demands on the FDA have soared due to the
extraordinary advance of scientific discoveries, the complexity of the new
products and claims submitted to FDA for pre-market review and approval, the
emergence of challenging safety problems, and the globalization of the
industries that FDA regulates."
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"The resources have not increased in proportion to the
demands. The result is that the scientific demands on the Agency far exceed
its capacity to respond. This imbalance is imposing a significant risk to
the integrity of the food, drug, cosmetic and device regulatory system, and
hence the safety of the public."
FDA is now soliciting public comment on the subcommittee report. Comments
received while the docket is open will be forwarded to the Science Board for
their review. Comments will also be discussed at the next Science Board Advisory
Committee meeting.
For more information:
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html
http://www.fda.gov/OHRMS/DOCKETS/98fr/07n-0489-n000001.pdf
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