FDA releases imported goods strategy, calls for more international regulation
The Food and Drug Administration says it could use an international helping hand in testing the influx of imported drugs and food.
Acknowledging the monitoring difficulties inherent in a global economy, the agency said in an announcement Monday that it needs to transform the way it protects the nation’s food and drug supply, teaming up with other agencies around the world to ensure quality and safety of the products it regulates.
“Global production of FDA-regulated goods has exploded over the past ten years. 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,” Commissioner of Food and Drugs Margaret A. Hamburg said in the announcement.
“There has been a perfect storm — more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”
To handle the rise in imports, the agency outlined four major changes in its report Pathway to Global Product Safety and Quality: First, the agency needs to expand its relationships with regulators in other countries. Next, such partnerships need to share data systems. The FDA will have to modernize its own technology tools and hire analytics experts. And the FDA will focus its resources on the problems that pose the greatest threat to consumers, while relying more on third parties for oversight and accreditation.
After all, a summary of the report begins, nearly two-thirds of fruits and vegetables, half of all medical devices, and 80% of the active ingredients in medications sold in the U.S. come from outside its borders. About 24 million shipments of FDA-regulated goods will enter the country this year, up from 6 million a decade ago.
And like everyone else, the agency is working under a budget, the summary says:
“As the agency looks to the future, it can no longer rely on the historical tools, activities and strategies to regulate products. The reality facing FDA is that its mission will become ever more difficult to fulfill given the breadth and complexity of industries that it regulates during a time of constrained federal resources.”
There’s much to be said for cooperation.
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