FDA Says It Needs New Approach on Imports

FDA Says It Needs New Approach on Imports

June 21st, 2011 // 12:11 pm @

Border and port inspections alone aren’t sufficient to make sure the imported food and drugs consumed by U.S. residents are safe.

That’s the word from the FDA, which today laid out a plan to monitor the rising tide of goods from abroad. It includes planned partnerships with counterpart regulators in other countries and better data-sharing between those regulators.

The scope and scale of food and drug imports has increased dramatically, growing to 24 million shipments to the U.S. this year from 6 million shipments a decade ago, the report says. Imports of FDA-regulated products are growing at an estimated 15% annual rate.

The agency has stepped up overseas inspections — there are now three FDA locations in China, for example — formed some alliances with other regulators and received new powers under the food-safety law enacted this year. But it lacks resources to inspect drug and food production sites overseas, it says.

The report says the “safety of America’s food and medical products remains under serious threat,” citing melamine-tainted pet food that killed animals in the U.S., milk also contaminated by melamine that killed children in China, contaminated heparin, and outbreaks of food-borne diseases. “Many of the crises were due to, or exacerbated by, the regulatory challenges of globalization,” the report says.

FDA head Margaret Hamburg told reporters on a conference call that it will likely take many years to implement its new approach, which also includes building up its IT capabilities to try to identify risks in the food and drug supplies before they pose serious harm and using public and private third parties to conduct audits and inspections on the agency’s behalf.

Hamburg said that the new approach “will require some up-front investments in terms of dollar resources, human resources and time,” she expects better sharing of data and strategies between regulators in different countries will eventually mean using fewer resources to achieve the same end.

“All of us are confronting the same set of challenges,” said John Taylor, acting principal deputy commissioner of food and drugs.

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