Dangerous Substandard Medicines: An Increasing Global Problem
AEI Health Policy Outlook No. 6
7 Pages Posted: 22 Oct 2013
Date Written: July 6, 2011
Legal but poorly made, or substandard, drugs can be lethal. The problem is most prevalent in emerging markets, where gross flaws in production, especially by domestic producers selling only in local markets, are easily detected by simple quality-control tests. These problems will worsen as more emerging countries, often supported by aid agencies, develop their own manufacturing capabilities. Flaws are rarer and more difficult to detect in developed countries, but they still pose a significant danger to public health. The US Food and Drug Administration (FDA) recently released its "Pathway to Global Product Safety and Quality," a report that candidly explains that the FDA cannot adequately oversee the safety of chemicals manufactured overseas and imported into the United States. Some generic drugs are not equivalent to innovator products, and while they are effective for most patients, they can be fatal for others. Such production flaws will be exacerbated by lower-quality chemical inputs from China, the world's largest chemical supplier. While China's products are always cheap, they are not always high quality; even perfectly formulated products may be lethal if the ingredients are suspect. Drug shortages and adverse health outcomes will increase as a result, even in the United States.
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