FDA And A New ‘Global Strategy’ For Imports

FDA And A New ‘Global Strategy’ For Imports

June 21st, 2011 // 12:21 pm @

Beset by an inability to thoroughly monitor pharmaceutical ingredients and production around the world, the FDA has declared a new ‘global strategy’ to cope with the fast-paced industry changes that are straining its resources. And in issuing a 37-page report on the topic, the agency says the step reflects a lack of “resources to adequately keep pace with the pressures of globalization.”

To illustrate the point, the FDA says that imports of pharmaceutical products have grown rapidly, at approximately 13 percent annually over the past seven years and accounted for more than 350,000 import lines in 2009. This volume accounted for approximately 30 percent by value of pharma products used annually. And the rise in imports has contributed to a growing trade deficit in pharma products.

In 2000, the US imported $1.7 billion more in pharma products than exported, and by 2008, that gap grew 10-fold to $18 billion. Meanwhile, about 80 percent of active pharmaceutical ingredients found in meds in the US came from overseas, growing from $2.8 billion in 2000 to nearly $4.6 billion in 2007. And the number of device import lines rose an average of 10 percent annualy between 1998 and 2008, and now stands at 7.1 million lines per year. Today, imports represent more than 35 percent of the US medical equipment market. Overall, the FDA expects the proportion of imports to continue rising.

Meanwhile, the average cost of a domestic inspection is $23,000, but the cost is $52,000 for a foreign inspection. And 54 percent of foreign drugmaking facilities went uninspected 2002 and 2007. For devices, 70 percent of the foreign plants went uninspected during that time.

And so, the agency says it will partner with regulators in other countries “to create global coalitions” in hopes of ensuring safety and quality. [This pertains to food, not just drugs, of course.] And these coalitions are supposed to develop international information systems and networks, and step up data sharing and resources.

The FDA, itself, plans to build additional “information gathering and analysis capabilities” that will have an increased focus on “risk analytics and information technology.” And as part of this effort, the agency says it will “leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.”

“In order to cope with the fundamental global shifts on the horizon, the FDA will have to substantially and fundamentally revise our approach to global product safety. We can no longer rely on historical tools, activities and approaches,” acting principal FDA deputy commish John Taylor says in a statement. “Implementing this strategy is vital to the public health”


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