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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
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Food and medical product safety is crucial for public health. The food and medical products regulatory system (hereafter, the regulatory system) is a key piece of the public health system. In the United States, the Food and Drug Administration (FDA) protects consumers from unsafe food and drugs, an ever more complicated task as increasingly food and medical products travel through complex international supply chains. The past 10 years have seen contaminated heparin and pet food reach the American market from foreign factories. Thousands of Americans die every year from food poisoning and, although much of it is home-grown, foodborne epidemics are increasingly international. This is small compared to the product safety calamities in developing countries, where fake drugs and poisoned excipients kill tens of thousands against a constant background of aflatoxin poisoning and foodborne disease. Product safety in the United States depends on systems in faraway places. The FDA estimates that more than 80 percent of active pharmaceuti- cal ingredients and 40 percent of finished drugs come from abroad, as does 85 percent of seafood. Congress has reacted to these trends by requiring that the FDA inspect more producers. Meeting Congress’s new inspection targets will be a great effort for the FDA. More importantly, Congress’s most ambitious inspection plan still monitors only a small fraction of foreign manufacturers.
Jim E. Riviere and Gillian J. Buckley - Personal Name
978-0-309-22408-6
NONE
Healthcare Management
English
2012
1-367
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