The mission of the Food and Drug Administration is at risk, according to reports and testimony presented before the House Energy and Commerce Committees Oversight and Investigations Subcommittee. FDAs scientific base has eroded and its scientific organizational structure is weak, testified Gail Cassell, who chaired a special subcommittee of the FDA Science Board that assessed whether the FDAs science and technology could support its mandate to protect the nations food and drug supply.
The FDA Science Board subcommittee concluded that the agencys inability to keep up with scientific advances prevents it from adequately monitoring the development of new medical products and evaluating the safety of existing products.
A separate report presented by the Government Accountability Office found that the FDA has not met biennial requirements to inspect certain types of domestic facilities that produce medical devices, such as pacemakers and hearing aids. Peter Barton Hutt, a consultant to the subcommittee of the FDA Science Board, asserted that Congress should double staffing and funds for the FDA over the next two years to provide the agency with the resources it needs to carry out its statutory mission.
The House subcommittee also voted unanimously to subpoena three FDA criminal investigators, a contractor and documents from FDA Commissioner Andrew von Eschenbach in connection with an ongoing investigation of Sanofi-Aventis antibiotic drug Ketek. Lawmakers have questioned whether the FDA conspired to approve the drug despite receiving fraudulent data from the drugs clinical trial. The subpoenaed FDA officials are scheduled to testify before the subcommittee on Feb. 12. -- by Jennifer Lubell
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