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Adv Prev Med. 2012; 2012: 507571.
Published online Sep 20, 2011. doi:  10.1155/2012/507571
PMCID: PMC3177089
FDA Experience with Medical Countermeasures under the Animal Rule
Paul Aebersold *
Global Regulatory Affairs, Quintiles, Inc., 1801 Rockville Pike, Rockville, MD 20852, USA
*Paul Aebersold: paul.aebersold/at/quintiles.com
Academic Editor: Kelly T. McKee
Received May 4, 2011; Revised July 14, 2011; Accepted July 21, 2011.
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.
Articles from Advances in Preventive Medicine are provided here courtesy of
Hindawi Publishing Corporation