Research By FDA Scientists Faces Fiscal Setback

Agreement on industry user fees may force the agency to scale back its intramural program, which critics say is fragmented.

Intramural research at the United States Food and Drug Administration (FDA) is coming under increasing financial pressure and criticism. In discussions with FDA officials, pharmaceutical manufacturers have won an agreement that the user fees they pay will soon no longer help fund the agency's research. Since 1992, approximately $10 million annually from industry user fees has gone into FDA's research coffers. The decision to end this practice will result in the loss of dozens of research positions. And while a recent report by an external committee expressed strong support for FDA science, it was also highly critical of the fragmentation and uneven quality of the agency's research effort.

CORPORATE BENEFIT: FDA’s Bernard A. Schwetz contends that the agency’s research program provides direct advantages to industry.

FDA's intramural program, compared with...