FDA unveils strategy to ensure safety of imports

The Food and Drug Administration warned Monday that the explosion of products, manufacturers and countries involved in FDA-regulated markets has created a "perfect storm" for the agency and called for a "dramatic change in strategy."

To ensure the safety of both foreign-made final products as well as the imported materials and ingredients U.S. manufacturers rely on, the FDA unveiled a "Pathway to Global Product Safety and Quality."  It focuses on four key elements: 

• Promoting international partnerships to create global coalitions of regulators;

• Sharing data and regulatory resources across world markets;

• Focusing on risk analytics and information technology; and 

• Leveraging the efforts of the public and private sectors and allocating FDA resources based on risk.

"Global production of FDA-regulated goods has exploded over the past ten years," FDA Commissioner Margaret Hamburg said in a statement. "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."

The new strategy will require upfront investments in money, human resources and time, Hamburg acknowledged in a press call, but she said it would be worth it.

"This is really a way of leveraging [international] resources in some important new ways, sharing information as well as sharing effective strategies," Hamburg said, "so that I think at the end of the day this approach will enable us to use fewer resources to achieve an important and shared set of goals."

She went on to caution that the 2012 agriculture spending bill passed by the House last week was "enormously worrisome" because it cut spending of food safety by about $87 million below current levels.

"The reality is we'll do the very best job we can for the American people with the resources that we have," Hamburg said, "but we're facing a situation where we're being asked to do more with less and we really feel that this is of enormous concern."

Finally, FDA officials said they needed updated authority from Congress so the agency can modernize its registrations and listings, track trade and increase penalties and shift its focus from domestic to global exchanges. While the food safety act signed earlier this year makes some of those changes for food, the agency is requesting similar powers for medicines and medical devices.

This post was updated at 1 p.m. with comments from FDA officials

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