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Global production of FDA-regulated products has quadrupled over the last decade and continues to grow. Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities. Fifty percent of fresh fruits, 20 percent of vegetables, and 80 percent of seafood consumed in America comes from abroad. Similarly, 40 percent of finished drugs come from overseas, and 80 percent of active ingredients manufacturers are located outside the US. Further, half of all medical devices are imported. The growth in imports has been rapid and promises to accelerate.
Globalization has fundamentally altered the economic and security landscape and demands a major change in the way FDA fulfills its mission. Over the next decade, FDA will transform from a predominantly domestically-focused agency operating in a globalized economy to a modern public health regulatory agency fully prepared for a complex globalized regulatory environment.
The agency is already working to increase transparency and accountability in the supply chain, developing better enforcement and regulatory tools, encouraging greater responsibility by industry, and enhancing collaboration with international regulatory counterparts and other third parties.
As our world transforms and becomes increasingly globalized, it is vital that we come together as a global community – in new, unprecedented, and even unexpected ways – to build a public health safety net for consumers around the world.
FDA has established international offices and posted staff in strategic locations around the world. They work closely with their national and regional regulatory counterparts, and with other U.S. government agencies stationed abroad, to perform functions essential to FDA’s ability to protect U.S. consumers. Learn more about FDA’s international offices and post.
"Today we recognize that to successfully protect U.S. public health, we must think, act, and engage globally. Our interests must be broader than simply those within our own borders."
—Margaret Hamburg M.D., FDA Commissioner
|Dr. Gerald Dal Pan highlights a recent example of FDA’s efforts to transform from a domestic to a truly global agency.|
|View FDA Commissioner Dr. Margaret A. Hamburg's remarks at the launch of the Global Engagement report.|