A report by the Government Accountability Office indicates that the Food and Drug Administration has made little progress in addressing the problem of infrequent and insufficient inspections of foreign drug manufacturing facilities.
Many of the drugs that Americans now consume are manufactured in plants in China, India and other foreign countries. The Food and Drug Administration has devoted precious few resources to inspecting these plants. The biggest scandal related to spurious drugs manufactured in foreign plants was Baxter’s heparin scandal of 2008. Contaminated heparin manufactured at a plant in China was linked to several deaths
The GAO released a report in 2009, recommending that the Food and Drug Administration step up its inspections of foreign drug manufacturing facilities, and specifically, prioritize foreign plant inspections with inspections of domestic plants with similar problems. That however hasn’t happened. According to the GAO report, the Food and Drug Administration has invested $41 million in foreign plant inspections in 2009. However, it inspected just 424 foreign plants in 2009. That was an increase over the previous years, but it is still much lower than the 1,000 + domestic plants that the FDA inspected in 2009. About 11% of the total number of foreign plants on the FDA’s priority list were inspected in 2009.
The GAO report doesn’t suggest that the FDA focus on equal numbers of inspections for both foreign and domestic plants. However, it wants the agency to prioritize inspections of those plants where drugs manufactured under low standards would gravely endanger public health, regardless of whether those plants are located on US soil or abroad.
Vuk Vujasinovic is a Houston product liability lawyer, representing victims who have been injured from the use of defective products in Texas and nationwide.
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Vuk Vujasinovic is a Board Certified Houston personal injury attorney who practices Houston auto accident and other personal injury cases.
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