Executive Summary

FDA CYTOKINE BIOLOGY DIVISION IN BIOLOGICS CENTER STAFFING will total 40 scientists, according to a proposed organizational chart for the new division. Of the 40 scientists, 25 are switching from the Division of Virology and 15 will be "new hires." It is projected that at least some of the newly hired employees will actually be transfers from FDA's Division of Blood and Blood Products. The division scientific staff will include nine fellows. FDA announced the official establishment of the Cytokine Division in an Aug. 30 "Talk Paper." The formation of the division and the appointment of Kathryn Zoon, PhD, to director from Acting Director Division of Virology had originally been signaled at a Food Drug Law Institute annual meeting by FDA Commissioner Young in December 1987 ("The Pink Sheet" Dec. 21, 1987, p. 30). Former head of the Pediatric, Enteric and Neurologic Diseases Lab, Paul Albrecht, MD, replaces Zoon as Acting Director Division of Virology. FDA is also planning to set up another separate division as a successor to the current Lab of Retrovirology in an organizational response to the influx of AIDS and antiviral products. The new Cytokine Division is an offshoot of the Division of Virology. It will specialize in AIDS products joining four other divisions under the Office of Biologics Research: the Division of Biochemistry and Biophysics; the Division of Virology; the Division of Blood and Blood Products; and the Division of Bacterial Products. According to the Center for Biologics and Research staff manual guide, the duties of the new division will be to conduct research on "lymphokine, interferon, cell biology, and cellular and molecular immunology to obtain data bearing on the safety, purity, potency and effectiveness of cytokines and cellular immunotherapeutics produced using cytokines." The Cytokine Division will also review applications and serve "as a source of information within the agency on cytokine biology products."