Editor’s Note: It is only appropriate that CRE restate its concern that the FDA in its entirety should be concerned about the safety of imported products and continues to challenge the failure of the FDA to addess the adverse health effects of counterfeit tobacco products.
New report presents FDA’s focus on global cooperation for product safety
The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report1,” detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.
The report describes the steps the agency is taking to ensure that 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,” said FDA Commissioner Margaret A. Hamburg, M.D.
Global production of FDA-regulated goods and materials has exploded over the last decade and continues to grow. FDA-regulated 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. 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 engagement strategies the FDA is using 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, and 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 Quality2, released last year.
To access the Global Engagement Report3, and learn more about the FDA global work please visit the agency’s web page dedicated to its work on globalization: www.fda.gov/global4. Also available are videotaped remarks from Dr. Margaret Chan, Director General of the World Health Organization: http://terrance.who.int/mediacentre/messages/MSG_FDA_CHANm_13APR2012.wmv5 6.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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