FDA develops strategies for safer food, drugs

FDA develops strategies for safer food, drugs

The Food and Drug Administration released an action plan yesterday to improve public health, including strategies to confront bioterrorism, accelerate the drug approval process, and ensure the safety of food imports and the domestic food supply.

'This strategic action plan is our coordinated effort to respond to some of the most challenging threats and opportunities for public health that we have ever faced," said FDA commissioner Dr. Mark McClellan.

In the past, FDA has viewed IT as a means to accomplish daily work, but it will look to IT as part of its strategy to accomplish policy goals, said the report, 'Protecting and Advancing America's Health: A Strategic Action Plan for the 21st Century.' The agency plans to develop an integrated process to determine and manage its own systems, and others throughout the Health and Human Services Department.

The FDA road map outlines IT capabilities that will contribute to faster review of new drugs and medical devices, rapid targeting of suspicious imports, and earlier identification, analysis and communication of medical errors and suspected problems associated with new medical technologies.

A major FDA task is protecting the nation's food supply from naturally occurring and accidental contaminants as well as the possibility that pathogens could spread through the food chain as a bioterrorist weapon.

'If even a small number of contaminants were intentionally introduced to some part of the food chain, such an incident could seriously damage public confidence in the safety of the nation's food supply,' the report said. FDA also has been involved in creating countermeasures for biological, chemical and radiological attacks and expects new technology to produce antidotes and vaccines that are safer and more efficient than what is available now.

To counter food safety challenges, FDA plans to adopt a risk-based import surveillance system to replace the current import program and focus efforts on the highest security and safety risks to the food supply. FDA is working with the Homeland Security Department to link its systems with Customs entry processes.

FDA is also applying a 'life cycle' approach to assure food safety. For example, instead of getting a security snapshot at the border by examining and sampling a particular shipment, the FDA is trying to get a broader picture that covers the product's history from raw materials through production, transportation to the U.S. manufacturer or producer, storage provider, through to the consumer. This approach is intended to help spot unusual trends.

When drugs are introduced for mass use, FDA wants to increase reporting of safety problems. FDA said direct and secure access to relevant electronic health information is essential to monitoring drugs. Steps such as bar coding medications and implementing automated methods for communicating with health professionals can reduce problems, the report said.

About the Author

Mary Mosquera is a reporter for Federal Computer Week.


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