FOOD-AND-DRUG-ADMINISTRATION WORKSHOP ON INDIRECT MECHANISMS OF CARCINOGENESIS

A workshop sponsored by the Food and Drug Administration (FDA) was hel d on March 4-5, 1996, at the Lister Hill Auditorium of the National In stitutes of Health (NIH) Campus in Bethesda, Maryland. The workshop co nsidered both the scientific aspects and the regulatory implications o f indirect-acting carcinogens. A wide variety of agents and of prospec tive mechanisms was discussed. The organizing committee for the worksh op consisted of Drs. James Farrelly and Joseph DeGeorge of the Center for Drug Evaluation and Research (CDER), Ronald J. Lorentzen and Sidne y Green of the Center for Food Safety and Applied Nutrition (CFSAN), M artin D. Green of the Center for Biologics, Evaluation and Research (C BER), C. Darnell Jackson and Lionel A. Poirier of the National Center for Toxicological Research (NCTR), Rosalie K. Elespuru of the Center f or Devices and Radiological Health (CDRH), and David G. Longfellow of the National Cancer Institute (NCI). Following an introduction by Dr. Poirier, who provided a description of indirect carcinogens, the major talks were grouped into three formal sessions: indirect-acting compou nds and agents of FDA interest, biological and biochemical endpoints c ommonly seen with indirect agents, and specific problems associated wi th the indirect-acting compounds. A panel discussion followed and the concluding remarks were made by Dr. Bernard A. Schwetz, Associate Comm issioner for Science, FDA.