FDA Seeks Comments on Science Board Report

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

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.

Federal Register notice