Spotlight: FDA

In keeping with the public health theme of our last “Spotlight” piece, we’re taking a look at another of major operating component of the U.S. Department of Health and Human Services (HHS): the Food and Drug Administration (FDA). This agency is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply (excluding meat and poultry), cosmetics and products that emit radiation. It also is responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer and more affordable, as well as by helping the public get accurate, science-based information about food and medicine. In addition, the FDA is responsible for regulating the manufacturing, marketing and distribution of tobacco products. Finally, the agency plays a significant role in the nation’s counterterrorism efforts, by ensuring the security of the food supply and by fostering development of medical products to respond to public health threats. Overall, the FDA regulates more than $1 trillion worth of consumer goods (about one-quarter of all U.S. consumer expenditures) and monitors a third of all imports into the country.

Although it did not get its present name until 1930, the FDA is the federal government’s oldest comprehensive consumer protection agency. It began around 1848 with the appointment of a single chemist in the Patent Office to conduct chemical analyses of agricultural products, a function that the newly created Department of Agriculture took over in 1862. The agency began as the Division of Chemistry, was renamed the Bureau of Chemistry in 1901, became the Food, Drug, and Insecticide Administration in 1927 and, finally, the FDA. It remained a part of the Department of Agriculture until 1940, when it was moved to the new Federal Security Agency before being transferred to the Department of Health, Education, and Welfare (HHS’s predecessor) in 1953. The FDA currently consists of seven centers (the Centers for Biologics Evaluation and Research, Devices and Radiological Health, Drug Evaluation and Research, Food Safety and Applied Nutrition, Tobacco Products, and Veterinary Medicine, plus the National Center for Toxicological Research) and two offices (the Offices of Criminal Investigations and Regulatory Affairs).

The FDA’s presence is spread throughout the country, in more than 200 field offices and laboratories, including five regional offices and 20 district offices. In 2008, the agency began opening field offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.  The agency’s headquarters facilities are in the process of being consolidated onto the federal government–owned White Oak Campus off New Hampshire Ave. in Silver Spring, Md., the former site of the Naval Ordnance Laboratory. Since the beginning of the decade, the FDA and GSA have been working together to construct new, state-of-the-art laboratories, office buildings, and other support facilities on 130 acres of the heavily wooded 662-acre campus. Ten buildings already have been completed; four more are under construction and scheduled to be occupied in 2014; and several more are planned for completion in 2016, if Congress provides adequate funding. The number of FDA employees on the campus has grown from about 100 in 2003 to more than 5,500 today, and is expected to reach more than 8,800 by 2016. A 2004 GSA study concluded that the government would save $10 million annually by moving the FDA from rented facilities to the consolidated campus.

President Obama’s FY 2013 budget request for the FDA is $4.5 billion, a net program increase of $654 million, or 17%, above FY 2012. That budget request includes $62 million for the White Oak headquarters consolidation process, as well as $5 million to pay for necessary repairs and maintenance of FDA-owned facilities nationwide.

White Oak Campus Aerial Rendering