The nation is at risk if FDA science is at risk. In recognition of this threat, in December 2006, FDA Commissioner Andrew von Eschenbach, MD requested that the Science Board, which is the Advisory Board to the Commissioner, form a Subcommittee to assess whether science and technology at the FDA can support current and future regulatory needs. This report is the product of that assessment. 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 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. FDA does not have the capacity to ensure the safety of food for the nation. The FDA science agenda lacks a structure and vision, as well as effective coordination. The FDA has an inadequate and ineffective program for scientist performance. Recommendations of excellent FDA reviews are seldom followed.
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