The federal government is closed for the fourth straight day. However, it would be more accurate to say: closed in the DC area. A significant part of FDA is open and has been all week….making this a good time for FDA Matters to acknowledge and explore the growth of FDA in places far from the Washington Beltway.
Overseas Offices. FDA’s commitment to creating overseas offices has been widely praised and deservedly so. The ultimate goal is to have FDA employees and offices in every area of the world where there are significant amounts of commerce in FDA-regulated products or their constituent ingredients. If food and drug problems can be identified and fixed near the beginning of the supply chain, then America becomes less dependent on successful inspections of cargoes entering the US.
FDA has created permanent offices in China (Beijing, Shanghai, and Guangzhou) and India (New Delhi and Mumbai) over the last two years. It has also upgraded and formalized its presence in Latin America (Costa Rica, Chile, and Mexico City) and Europe (Brussels and London).
Other areas, such as the Middle-East and Asia/Africa, are still overseen from FDA headquarters, but with an increasing local FDA presence in those areas. Likewise, headquarters handles various treaty arrangements (e.g. with Canada and Mexico) and relationships with international organizations.
Growth in Field Staff. Since 2006, FDA employees assigned to “field activities” has grown from 3450 to 4200. These individuals work for the Office of Regulatory Affairs (ORA) and are involved in inspections and enforcement. ORA personnel represent about 45% of the total FDA staff paid out of the agency’s appropriations (non-user fee) budget.
According to FDA’s website, over 85 percent of ORA’s staff works in 5 Regional Offices, 20 District Offices, 13 Laboratories, and more than 150 Resident Posts and Border Stations. This means more than 3500 FDA staffers in ORA are conducting government business away from headquarters.
National Center for Toxicological Research. NCTR is less well-know, but an important part of FDA. Its 210 employees are located in Jefferson, Arkansas, far from snowy DC. Its webpage was updated yesterday, so we know they are at work.
NCTR defines itself as conducting “FDA mission-critical, peer-reviewed, critical path (translational) research targeted to develop a scientifically sound basis for regulatory decisions and reduce risks associated with FDA-regulated products.”
In plainer language, they are the applied sciences part of FDA, focused on toxicology and toxic effects of food, drugs, packaging materials and so on. As Commissioner Hamburg’s campaign to promote “regulatory science” gains momentum, NCTR will be a key part of the effort.
In total, nearly 4,000 FDA staffers work outside the DC metropolitan area. This is a good thing, since the nation’s food and medical products don’t stop because Washington, DC had back-to-back blizzards.
Steven
For more about FDA’s overseas offices, go to: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm185769.htm
For more information about the Office of Regulatory Affairs, go to: http://www.fda.gov/AboutFDA/CentersOffices/ORA/default.htm
For more information about NCTR, go to: http://www.fda.gov/AboutFDA/CentersOffices/NCTR/WhatWeDo/default.htm