U.S. Food and Drug AdministrationBy B.A. Schwetz and N.L. Wilcox The Food and Drug Administration (FDA) congratulates the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) on its 15th anniversary. The FDA is proud to be actively involved in promoting the CAAT mission, which embodies a scientific approach to the use of alternatives in the development and safety evaluation of products, including those that are FDA-regulated. FDA is a team of dedicated professionals working to protect, promote, and enhance the health of the American people. To that end, FDA is a science-based agency and strives to accurately detect and assess health risks under the highest standards. FDA strongly encourages the search for toxicological testing methods intended to better predict health effects in both humans and animals. As technology for product testing becomes more sophisticated, the potential for targeting specific mechanisms of action in humans and animals increases. As such specificity becomes a reality, we are hopeful that toxicological endpoints will be identified that provide information which transcends traditional risk assessment based upon extrapolation from animals to humans. CAAT is to be commended for providing scientific integrity to an often controversial arena. An example of such credibility is the peer-reviewed Extramural Grant Program which embodies academic excellence while promoting practical application of developing methods. In an era when the term "alternatives" has not always been well received by the scientific community, CAAT has conveyed a consistent approach that imbues high standards of excellence while maintaining communication between all stakeholders. During this tenure, FDA has been actively involved internationally in facilitating research and development of toxicological testing methods. Its consistent goal has been that of assuring state-of-the-art science to support regulatory decision-making. To this end, FDA has worked closely with many organizations, including CAAT, while promoting several alternative-related initiatives. Intramurally, FDA's Research Animal Council (FRAC) has been established to address animal use in testing across the agency. FRAC was instrumental in helping to eliminate the LD50 test from FDA guidances. Extramurally, FDA has had consistently strong leadership on many fronts--they include the International Conference on Harmonization of the Technical Requirements for Registration of Human Pharmaceuticals, the Applied Toxicological Research and Testing Program, the Interagency Regulatory Alternatives Group, the Interagency Coordinating Committee for the Validation of Alternative Methods, and the FDA/European Union Bilateral Talks to mention a few. The FDA values the leadership taken by the CAAT to encourage research, development, and validation of alternative methods. CAAT's scientific approach to excellence facilitates FDA's public health mission. Through the promotion of validated methods for testing therapeutic drugs that are more predictive of health effects compared to current standards, the health and well-being of both humans and animals are better protected. FDA looks forward to a sustained collegial relationship with CAAT and active participation in its various programs. Dr. Schwetz is Associate Commissioner for Science, US Food and Drug Administration. Dr. Wilcox is Senior Science Policy Officer, US Food and Drug Administration. | 
