NEWS SCAN: FDA strategic plan, West Nile in Europe, ricin threat

Aug 17, 2011

FDA lays out plan for enhancing regulatory science
The US Food and Drug Administration (FDA) today released a "Strategic Plan for Regulatory Science," a 37-page report that includes sections outlining the agency's plans to improve its scientific capabilities for ensuring food safety and evaluating medical countermeasures (MCMs) against biological, chemical, and other unconventional weapons. "As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy. It positions us to foster innovation through better science without compromising our high safety standard," FDA Commissioner Margaret Hamburg said in a press release. The food safety section says the FDA will be guided primarily by the recently enacted Food Safety Modernization Act (FSMA),which emphasizes prevention and risk-based priority setting. The plans for food safety calls for using centralized planning and performance measurement processes, improving internal and external information sharing, maintaining critical science capabilities, and cultivating expert institutional knowledge. On the MCM front, the plan notes that development of countermeasures is hindered by the lack of key scientific information, animal models, and methods for assessing safety and efficacy. The strategic plan enunciates four main goals for fostering MCM improvements: developing animal models for testing MCMs; modernizing tools to evaluate MCM safety, efficacy, and quality; developing biomarkers of diseases and conditions; and enhancing emergency communication.
Aug 17 FDA press release
Full text of FDA plan

WHO issues West Nile alert for Europe
The World Health Organization (WHO) said in a notice yesterday that five European countries reported cases of West Nile virus (WNV) infection from July through Aug 11. Rainfall and high temperatures have been conducive to an increased population of WNV-carrying mosquitoes, the report says. Countries reporting cases are Albania (2), Greece (22), Israel (6), Romania (1), and the Russian Federation (11). The situation is being closely monitored, and the WHO is encouraging member states to undertake relevant public health measures to minimize the potential for and impact of WNV outbreaks.
Aug 16 WHO alert
Aug 16 WNV weekly map from European Centre for Disease Prevention and Control

US officials worried about possible ricin attack by Al Qaida
US officials are increasingly concerned that Al Qaida's branch in Yemen is trying to produce the potent poison ricin so they can pack it with explosives for attacks in the United States, according to a recent New York Times report. A speck of ricin, which is derived from castor beans, can kill if it gets into the lungs or blood stream. Intelligence officials said they have evidence that Al Qaida in the Arabian Peninsula is trying to move castor beans and processing agents to a site in Yemen's Shabwa province, which is under insurgents' control. Officials say the evidence suggests the group is trying to make ricin bombs to detonate in indoor spaces like airports, shopping malls, and subways. But they say there is no sign that an attack is imminent and also note that ricin's utility as a weapon is limited because it loses its potency in dry, sunny conditions and is not absorbed through the skin.
Aug 12 Times story

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