FDA Reacts to Report Accusing the Authority of Serious Deficiencies

GMP News
24 January 2008

FDA Reacts to Report Accusing the Authority of Serious Deficiencies

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:

  • "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."

  • "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:

Learn more about the FDA and its regulations and how to prepare for inspections - in the following ECA courses:

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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