Changes in FDA Structure

HEHS-96-53R: Published: Dec 8, 1995. Publicly Released: Dec 8, 1995.

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Pursuant to a congressional request, GAO examined changes in the Food and Drug Administration's (FDA) organizational structure since the new commissioner was appointed, focusing on changes in: (1) the number of staff positions in the Office of the Commissioner, staff offices, and product centers; and (2) FDA decisionmaking authority. GAO noted that between 1990 and 1995: (1) FDA increased its total staff by 20 percent; (2) the Office of the Commissioner received 4 percent of the staff increase, while staff offices received 11 percent and product centers received 85 percent of the increase; (3) the number of full-time equivalent (FTE) staff in the commissioner's office increased by 84 percent, while the number of staff reporting directly to the commissioner decreased; (4) FTE in staff offices increased by 21 percent, while FTE in product centers stayed about the same; and (5) there was no change in direction regarding the centralization of FDA decisionmaking authority, but some organizational changes decentralized product approval and centralized functions such as policy development.

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