Summary: A review was conducted of the Food and Drug Administration's (FDA's) financial disclosure system for special Government employees (SGEs), which is designed to protect against conflicts of interest. Files of 906 SGEs were reviewed to determine whether all confidential statements of employment and financial interests were filed and reviewed in a timely manner and properly filed and adequately reviewed. The evaluation of the financial disclosure system also concerned FDA's: (1) policy for making conflict-of-interest determinations; (2) procedures to prevent SGEs serving on committees from participating in restricted activities; and (3) system to publicly disclose potentially controversial cases.
Some statements were not filed or were untimely filed. FDA officials did not always have required information for making conflict-of-interest determinations and determinations were not always documented. Generally, restrictions placed on the activities of consultants were not applied to the activities of non-product-oriented advisory committee members. In many cases, potential conflict-of-interest situations were not publicly disclosed, and there were inconsistencies in the nature and format of information disclosed in memoranda.
