Print“Manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete. A dramatic change in strategy must be implemented.”
A growing flood of imported food and drugs produced by complex and often-opaque supply chains threatens America’s public health, says the U.S. Food and Drug Administration.
The agency’s report on the problem, “Pathway to Global Product Safety and Quality,” notes that FDA-regulated imports have quadrupled since 2000, spurring a need for it to adopt an international operating model capable of matching the scope of the industries it regulates.
“Global production of FDA-regulated goods has exploded over the past ten years,” says FDA Commissioner Margaret Hamburg. “In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete. A dramatic change in strategy must be implemented.”
The agency’s new approach, already implemented in certain areas, calls for using four core building blocks to improve the safety of everyday food, drugs, cosmetics, and devices: It advocates creating global coalitions of regulators, improving global data systems to track information about regulated products, expanding market intelligence and risk analysis, and leveraging public-private efforts.
The agency has already increased the number of foreign drug manufacturing inspections by 27 percent between 2007 and 2009 and has opened a series of international offices in key locations, including China and India, where a growing share of generic medicines are being manufactured.
But with as much as 80 percent of active pharmaceutical ingredients used in medications sold in the United States being manufactured in other countries, there’s still much to be done. Economically motivated fraud, adulteration, counterfeiting, and other potential dangers remain among the most serious challenges facing Americans, says the agency. Already contaminated heparin, diverted and counterfeit glucose monitor test strips, glycerin contaminated with diethylene glycol, and low quality titanium implants have raised public health concerns, it notes.
On the inspections front at least, some relief may come from the agency’s recent decision to join an international information-sharing collaboration that will provide it with access to information on pharmaceutical facility inspections conducted by its international counterparts.
However, the report notes, “Global supply chains, international trade, foreign sourcing, and terrorism remind us daily that the rest of the world will not stop and wait for regulators to catch up.”
June 23, 2011
http://www.burrillreport.com/article-fda_surveys_import_risks.html
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