Food and Drug Administration

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The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. The 21st and current Commissioner is Dr. Margaret A. Hamburg. She has served as Commissioner since February 2009.

The FDA has its headquarters at White Oak, Maryland.The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

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Organization

The FDA comprises several offices and centers. There are

Office of the Commissioner

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health (CDRH)
Office of the Center Director
Office of Communication, Education, and Radiation Programs
Office of Compliance
Office of Device Evaluation
Office of In Vitro Diagnostic Device Evaluation and Safety
Office of Management Operations
Office of Science and Engineering Laboratories
Office of Surveillance and Biometrics

Center for Drug Evaluation and Research (CDER)
Office of the Center Director
Advisory Committee Staff
Controlled Substance Staff
Office of Compliance
Division of Compliance Risk Management and Surveillance
Division of Manufacturing and Product Quality
Division of New Drugs and Labeling Compliance
Division of Scientific Investigations
Office of Medical Policy
Division of Drug Marketing, Advertising and Communications8
Office of New Drugs
Office of Nonprescription Products
Office of Oncology Drug Products
Radioactive Drug Research Committee (RDRC) Program
Office of Pharmaceutical Science
Office of Biotechnology Products
Office of Generic Drugs
Office of New Drugs Quality Assessment
Office of Testing and Research
Division of Applied Pharmacology Research
Division of Pharmaceutical Analysis
Division of Product Quality Research
Informatics and Computational Safety Analysis Staff (ICSAS)
Office of Surveillance and Epidemiology (formerly Office of Drug Safety)
Office of Translational Sciences
Office of Biostatistics
Office of Clinical Pharmacology
Pharmacometrics Staff
Division of Drug Information
FDA Pharmacy Student Experiential Program
Botanical Review Team
Maternal Health Team

Center for Food Safety and Applied Nutrition
Center for Tobacco Products
Center for Veterinary Medicine
National Center for Toxicological Research
Office of Regulatory Affairs

In recent years, the agency began undertaking a large-scale effort to consolidate its operations in the Washington Metropolitan Area from its main headquarters in Rockville and several fragmented office buildings in the vicinity to the former site of the Naval Ordnance Laboratory in the White Oak area of Silver Spring, Maryland. When the FDA arrived, the site was renamed from the White Oak Naval Surface Warfare Center to the Federal Research Center at White Oak. The first building, the Life Sciences Laboratory, was dedicated and opened with 104 employees on the campus in December 2003. The project is slated to be completed by 2013.
While most of the Centers are located around the Washington, D.C., area as part of the Headquarters divisions, two offices - the Office of Regulatory Affairs (ORA) and the Office of Criminal Investigations (OCI) - are primarily field offices with a workforce spread across the country.
The Office of Regulatory Affairs is considered the "eyes and ears" of the agency, conducting the vast majority of the FDA's work in the field. Consumer Safety Officers, more commonly called Investigators, are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 13 districts. Districts are based roughly on the geographic divisions of the federal court system. Each district comprises a main district office, and a number of Resident Posts, which are FDA offices located away from the district office to serve a particular geographic area. ORA also includes the Agency's network of laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices.
The Office of Criminal Investigations was established in 1991 to investigate criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and are not focused on the technical aspects of the regulated industries. OCI agents pursue and develop cases where criminal actions have occurred, such as fraudulent claims, or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI will pursue cases where Title 18 violations have occurred (e.g. conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and work closely with the Federal Bureau of Investigation, Assistant Attorney General, and even Interpol. OCI will receive cases from a variety of sources, including ORA, local agencies, and the FBI, and will work with ORA investigators to help develop the technical and science-based aspects of a case. OCI is a smaller branch, comprising about 200 agents nationwide.
The FDA frequently works in conjunction with other federal agencies including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection, and Consumer Product Safety Commission. Often local and state government agencies also work in cooperation with the FDA to provide regulatory inspections and enforcement action.

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Scope and funding

The FDA regulates more than $1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of the expenditures is for goods imported into the United States; the FDA is responsible for monitoring a third of all imports.

The FDA's federal budget request for fiscal year (FY) 2008 (October 2007 through September 2008) totaled $2.1 billion, a $105.8 million increase from what it received for fiscal year 2007. In February 2008, the FDA announced that the Bush Administration's FY 2009 budget request for the agency was just under $2.4 billion: $1.77 billion in budget authority (federal funding) and $628 million in user fees. The requested budget authority was an increase of $50.7 million more than the FY 2008 funding - about a three percent increase. In June 2008, Congress gave the agency an emergency appropriation of $150 million for FY 2008 and another $150 million.

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