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FDA ENFORCEMENT/SURVEILLANCE ACTIVITIES TOP OPINION POLL

Executive Summary

FDA ENFORCEMENT/SURVEILLANCE ACTIVITIES TOP OPINION POLL of state officials, small businesses, trade associations, health professionals, consumer groups and former FDA officials conducted by the agency. Of 644 respondents to the latest annual agency survey, 79% said enforcement/surveillance activities were among the top three priorities of FDA. The survey was mailed in December to 3,000 potential participants. Results of the poll were presented to FDA Commissioner Kessler and his senior staff in April. Enforcement was defined on the poll as "monitoring [of] clinical investigators and product sponsors prior to marketing, as well as inspecting products and manufacturers once products are on the market." Surveillance efforts include "adverse reaction and product defect reporting systems in drugs, biologics, devices and foods." Application review came in a close second as an FDA priority, with 75% of respondents casting first, second, or third votes in favor of that choice. FDA defined application review as both "reviewing applications" and "play[ing] an active role in the entire network of sponsor activities that lies between fundamental research and the market place." Labeling and information -- which involves providing information to consumers and health professionals "that will reduce health risks and promote good health through the proper use of FDA-regulated products" -- was selected by the 56% of survey respondents as the most important priority for the agency in the next fiscal year. The other two choices -- regulatory science and management/leadership/support -- were named among the three top priorities by 42% of those responding to the survey. FDA defined regulatory science as: "assessing risks associated with FDA- regulated products; setting standards that manage risk; testing products against those standards; developing new methods for more accurate risk assessment; and sample analysis and detection of chemicals and biological substances." Management/leadership/support was characterized as "maintaining FDA's integrity in the minds of the public and setting priorities that are responsive to health and safety concerns," as well as "developing effective program plans; organizing resources to carry out the plans;..... maintaining state-of-the-art facilities and scientific equipment; upgrading information management and communication systems; and recruiting and retaining a highly motivated and capable work force." The annual survey asked participants to rank which three of the five functions were the most important priorities for the agency in fiscal 1993 and which should be emphasized first by FDA. Of the 644 respondents, 93 were state officials, 19 small businesses, 24 trade associations, 219 health professionals, 267 represented consumer groups and 22 were former FDA officials ("policy board alumni"). Bucking the overall survey trend, 67% of trade association respondents chose management/leadership/support as the category to which FDA should assign highest priority in FY 1993, followed by enforcement/surveillance and labeling and information. Application review received the lowest ranking from trade association respondents.
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