FDA Chief Outlines Achievements, Goals

19 December 1994

While the last few years have seen changes in US Food and Drug Administration policies and work, and how that work is accomplished, there have also been changes in the political landscape, FDA Commissioner David Kessler has told the Food and Drug Law Institute's annual education conference.

The FDA is working hard to be as productive and efficient as it can, but more importantly, it is working to ensure the high degree of safety and effectiveness for regulated products that the US public has come to expect. In his tenure, FDA credibility has been rebuilt after the generic scandals by ensuring the integrity of its processes; he praised the six FDA field inspectors who recently reported bribery attempts and helped in the subsequent arrests.

The Centers' Priorities The Center for Drug Evaluation and Research's priorities include meeting or exceeding user fee goals, progressing information technology initiatives, implementing Good Review Practice initiatives and continuing efforts on international harmonization of drug regulation. As well as meeting these goals, the Center for Biologics Evaluation and research seeks to implement tissue regulations and set up a gene therapy register. The Center for Devices and Radiological Health will continue to improve the review and approval process, implement mammography standards and move forward on design controls. The National Center for Toxicological Research will develop better analytical methods to identify microbial and chemical contamination of foods and other products, expand knowledge on the relationship between dietary modulation and susceptibility and the expression of chemical/drug-induced toxicity, and develop new test models to improve the ability to predict and identify toxicity.

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