Food and Drug Administration - Organization

Organization

The FDA comprises several offices and centers. There is

• 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
      • Uncontrolled regulations
  • 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
  • Office of Prescription Drug Promotion
  • 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.