FDA Strengthens Global Safety Efforts

Targeted News Service

April 25, 2012

U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D., released the agency’s “Global Engagement Report” detailing the many activities and strategies the agency is using to transform from a domestic to a global public-health agency.

The report describes the steps the agency is taking to ensure imported food, drugs, medical devices and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically.

“As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public-health safety net for consumers around the world,” Hamburg said.

Global production of FDA-regulated goods and materials has exploded over the last decade and continues to grow. Products regulated by the agency originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities.

Each year from 2005-2011, food imports have grown by an average of 10%, while imports of pharmaceutical products have increased at nearly 13% and device imports have grown more than 10%. Approximately 50% of fresh fruits and 20% of fresh vegetables, as well as 80% of the seafood consumed in America, come from abroad. Similarly, more than 80% of the active pharmaceutical ingredients used to make medicines are imported.

The report outlines a variety of engagement strategies the FDA uses in partnership with other agencies, organizations and coalitions around the world to strengthen global, regulatory capacity-building efforts; develop and harmonize science-based regulatory standards; increase awareness about the importance of regulatory systems; and share information and data globally to facilitate rapid identification of and response to public health emergencies.

Through its international offices in Africa, Asia, Europe, Latin America and the Middle East, the FDA is increasing its knowledge base about local regulatory systems and landscapes. The agency is also increasing the understanding of foreign governments and industry of FDA regulations and standards for products destined for U.S. consumers.

The agency also is collaborating to strengthen regulatory science and evidenced-based approaches to product safety and quality. All of this furthers the FDA’s implementation of its global strategy, set forth in the agency’s special report, “Pathway to Global Product Safety and Quality,” released last year.

To access the Global Engagement Report and learn more about the FDA’s global efforts, visit the agency’s webpage dedicated to its work on globalization: www.fda.gov/global.