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Advances in Preventive Medicine
Volume 2012 (2012), Article ID 507571, 11 pages
http://dx.doi.org/10.1155/2012/507571
Review Article

FDA Experience with Medical Countermeasures under the Animal Rule

Global Regulatory Affairs, Quintiles, Inc., 1801 Rockville Pike, Rockville, MD 20852, USA

Received 4 May 2011; Revised 14 July 2011; Accepted 21 July 2011

Academic Editor: Kelly T. McKee

Copyright © 2012 Paul Aebersold. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The Food and Drug Administration issued a final rule in May 2002 to permit the Agency to approve drugs or license biological products on the basis of animal efficacy studies for use in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances. Only two drugs were approved in the first nine years of the “Animal Rule” despite massive investment by the federal government since 2001 to stimulate development of medical countermeasures to biological threats. This article therefore examines the Food and Drug Administration reviews made public after approval of those two drugs and the public discussion at the Agency's Anti-Infective Drugs Advisory Committee of one biological product under development under the Animal Rule. Despite the paucity of approved drugs or licensed biological products as medical countermeasures, several investigational drugs have been placed in the National Strategic Stockpile for use as medical countermeasures, if needed.