Challenges ahead

FDA is facing an onslaught of new technologies, changing demographic situations and new social agendas of increasingly sophisticated consumers. Technological innovation is challenging all sectors of FDA. While reviewers in the FDA centres must accommodate breakthroughs in genetic engineering of foods, drugs and biological products, FDA must also deal with consumer acceptance of these products, consumer understanding of science and consumer participation in development of regulatory policy. Consumer organizations have become better organized, more politically adept and more effective in campaigns to influence consumers, FDA must therefore maintain effective dialogue that will promote mutual understanding of the reasoning behind its actions as well as the limits to its purview.

The need is to balance scientific technology with improved communications technology and improved methods of responding to consumers. FDA must ensure that current information on agency issues is provided expeditiously to consumers. International agreements on product approval standards, testing and manufacturing methodologies, safety and quality assessments are reshaping regulatory strategies as well as consumer strategies.

FDA has provided a forum and the mechanism for consumers to raise their voice in public policy and regulatory decisions. It has broadened the base for education and information that supports federal regulatory actions. A major barrier is the need for additional resources to continue to support expectations and expand public participation opportunities. These are the challenges awaiting the United States Food and Drug Administration as we move into the twenty-first century.