Speaker Abstract: S-06
Development of Medical Countermeasures for Threat Agents When Ethics Prohibit the Use of Human Subjects: The Case of Plague
Lewis K. Schrager, M.D., M.A., Division of Counter-Terrorism, Center for Drug Evaluation & Research/FDA
The increased risk of terrorist attacks has engendered a critical need to develop medical countermeasures to threat agents. As it would be unethical to intentionally expose human volunteers to extremely toxic agents, and because naturally occurring exposures to such threats are rare, it is infeasible to conduct clinical studies using such agents. For this reason, the FDA in 2002 promulgated a new regulation, 21 CFR 314 Subpart I (for drugs); 21 CFR 601 Subpart H (for biologics), commonly called the "Animal Rule." Under this rule, animal data may be accepted by the FDA as evidence of the likely efficacy of a medical countermeasure in humans if specific scientific criteria are met. Yersinia pestis, the etiologic agent of pneumonic plague, is a CDC Category A threat agent that could not ethically be administered to human volunteers for clinical studies. The FDA, in collaboration with the National Institute of Allergy and Infectious Diseases, NIH and the US Army Medical Research Institute of Infectious Diseases, is conducting studies of antibiotic efficacy for treatment of pneumonic plague in an African green monkey (AGM) model of the disease. This presentation will discuss the design of the studies to determine gentamicin efficacy in pneumonic plague, with emphasis on those aspects of the studies designed specifically to comply with the scientific criteria set forth in the Animal Rule. Additionally, results of these studies, including the plague natural history study, the gentamicin pharmacokinetic and toxicology studies, and the gentamicin pneumonic plague efficacy study in AGMs will be presented.
2004 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA
Last updated on 2004-MAY-28 by frf