The U.S. Food and Drug Administration has released its Global Engagement Report, detailing the many activities and strategies the agency is currently using to transform itself from a domestic to a global public health agency.
Specifically, the report describes steps FDA is taking to ensure that imports of 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,” said FDA Commissioner Margaret A. Hamburg in a statement.
Global production of FDA-regulated goods and materials has taken off during the past 10 years and continues to increase. According to FDA, these products 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 percent, while imports of pharmaceutical products have increased at nearly 13 percent and device imports have grown more than 10 percent,” FDA said. “Approximately 50 percent of fresh fruits and 20 percent of fresh vegetables, as well as 80 percent of the seafood consumed in America come from abroad. Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported.”
The report outlines a variety of strategies FDA is using in partnership with other agencies, organizations and coalitions worldwide to strengthen 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.
FDA, through its international offices in Africa, Asia, Europe, Latin America, and the Middle East, is increasing its knowledge about local regulatory systems and landscapes. The agency is also increasing understanding by foreign governments and industry of FDA regulations and standards for products destined for U.S. consumers, and collaborating to strengthen regulatory science- and evidenced-based approaches to product safety and quality, the agency said. FDA added these efforts help promote its implementation of a global strategy, outlined in its Pathway to Global Product Safety and Quality program, released last year.
To access the Global Engagement Report, and learn more about FDA’s global activities, see the Web-page
. Also available are videotaped remarks
from Margaret Chan, director general of the World Health Organization.