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Apr 23

FDA Publishes Global Engagement Report, Highlighting Efforts Abroad

On April 23, 2012, the U.S. Food and Drug Administration (“FDA”) released its “Global Engagement Report,” a document detailing the various strategies undertaken by the agency to ensure that FDA-regulated products, including foods, medical devices, drugs, etc., are manufactured under the same quality and safety standards as those produced domestically. Found here, the Engagement Report acknowledges the dramatic increase in importation of FDA-regulated products in recent years. For example, according to the Agency, imported foods have nearly doubled since 2002.

The Engagement Report also sets forth the efforts that the FDA is taking to ensure that these products meet federal regulatory requirements. In particular, the FDA notes that it has expanded its presence abroad by establishing several international offices in places like China, India and in Latin America, among others. According to the FDA, the opening of this China office is a critical milestone in the cooperative efforts being made to ensure the safety of the nation’s supply of foods and medical products.

In addition, the Enforcement Report highlights the FDA’s various collaborative efforts between the Agency and its governmental counterparts abroad. According to the FDA, these partnerships are key to utilizing its limited resources in an ever-globalized world. An example of these efforts is the increasing effort towards harmonization of recognized scientific standards. The idea is that instead of differing standards being applied to products in Europe and in the United States, a single recognized standard will ease the burden on producers of FDA-regulated products and the Agency and ultimately increase compliance.

While the Enforcement Report goes on to highlight a variety of other efforts undertaken by the FDA, it is unclear whether the sum of the Agency’s efforts will ultimately be effective. Given the rapidly increasing presence of imported FDA-regulated products, which at the moment shows no signs of slowing, the Agency will undoubtedly have its hands full in the coming years.

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