The US Food and Drug Administration is soliciting public  comments on the report issued by the Science Board Advisory Committee on  December 3, 2007.

In its report, the Science Board’s Subcommittee on Science  and Technology declared that the FDA is in a “precarious position” and suffers  from “serious scientific deficiencies” as a result of soaring demands being  placed on the agency while resources have not increased in proportion to those  demands.

In its evaluation of the Center for Drug Evaluation and  Research (CDER), which focused on pre-market drug assessments, the subcommittee  found CDER’s current scientific capabilities to have “glaring and troubling  deficiencies.” The report says the Center’s efforts to address these  deficiencies is “admirable, but insufficient” and lacks careful planning and  the strategic focus necessary to support the rapid advances in science that  face CDER staff. It also said the center is typically engaging in a reactive,  fire-fighting approach to problem solving, though it marked a more positive  note in saying that CDER has “commendable experience and success in  transforming itself to respond to new priorities” citing examples of its  response to HIV/AIDS and the accelerated drug approval process.

The subcommittee’s evaluation of the Center for Biologics  Evaluation and Research (CBER), in contrast, was generally positive. The  subcommittee said it was “impressed” with the quality of science, the focused  approach to regulatory science, staff stability, and priority setting within  the Center. The report did express concerns, however, about lack of funding for  the Center and limited ability to provide professional development.

Comments on the report may be submitted until February 4,  2008. 

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The US Food and Drug Administration is soliciting public comments on the report issued by the Science Board Advisory Committee on December 3, 2007.