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U.S. Department of Health and Human Services

Animal & Veterinary

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A PERSPECTIVE ON FDA FIELD WORK

by Frederick D. Doddy, V.M.D., M.S.
FDA Veterinarian Newsletter May/June 1998 Volume XIII, No III

The author recently joined the Office of Surveillance and Compliance at the Center for Veterinary Medicine as a Veterinary Medical Officer. He began his Food and Drug Administration (FDA) career with the Office of Regulatory Affairs (ORA) as an FDA Field investigator (or consumer safety officer) in the Chicago District Office.

FDA Field investigators are employed by the Office of Regulatory Affairs (ORA) throughout the country and play a vital role in FDA serving as the primary "eyes and ears" of the Agency. ORA has approximately 160 Field offices located throughout the country. This is an essential part of the FDA surveillance and enforcement network which is responsible for protecting the public health and ensuring that products comply with the laws and regulations enforced by FDA.

The ORA Field organization is divided into five Regional Offices, which are managed by Regional Food and Drug Directors. Each Regional Office controls several District Offices. The structure of a District Office is not universal throughout the Agency. The Chicago District Office, which is part of the Central Region, is headed by a District Director. The District Director is supported by a Director of Investigations Branch, a Director of Compliance, a Public Affairs Specialist, Compliance Officers, Supervisory Investigators (or First-Line Managers), Investigators, Engineers, Inspectors, aides, and clerical support. The Chicago District Office has geographical responsibility for the entire State of Illinois. Consequently, it is necessary to have extensions of the District Office throughout the State. These strategically located extensions are called Resident Posts, which cover specific geographical areas or operations. For example, Chicago District has seven Resident Posts: Gurnee; Hinsdale; Mount Vernon; O'Hare (for import operations); Peoria; Rockford; and Springfield. This provides easy and rapid access to FDA-regulated industries throughout the State. Some Resident Posts are managed by supervisors; some by a Resident-in-Charge. Because there are only 21 Districts, some Districts are responsible for more than one State. Also, some Districts are affiliated with an FDA laboratory. In addition to Chicago, Illinois, there are District Offices located in the following cities: Atlanta, Georgia; Baltimore, Maryland; Buffalo, New York; Cincinnati, Ohio; Dallas, Texas; Denver, Colorado; Detroit, Michigan; Maitland, Florida; Lenexa, Kansas; Irvine, California; Minneapolis, Minnesota; Nashville, Tennessee; Stoneham, Massachusetts; New Orleans, Louisiana; Parsippany, New Jersey; Brooklyn, New York; Philadelphia, Pennsylvania; Alameda, California; San Juan, Puerto Rico; and Seattle, Washington.

The Investigations Branch in Chicago is organized into six teams under the following program areas: biologics; devices/radiological health; drugs (and cosmetics); foods; imports; and veterinary medicine (e.g., drugs, devices and feeds). (Veterinary biologics fall under the jurisdiction of the USDA.) The Branch's mission is to ensure industry compliance and maximize consumer protection. ORA work plans (or Field assignments) are developed on an annual basis with guidance provided by FDA headquarters and programs from each product-oriented Center, and are allocated to Districts commensurate to staffing. The product-oriented Centers are: 1) Center for Drug Evaluation and Research (CDER); 2) Center for Biologics Evaluation and Research (CBER); 3) Center for Food Safety and Applied Nutrition (CFSAN); 4) Center for Devices and Radiological Health (CDRH); and 5) Center for Veterinary Medicine (CVM). Additionally, Field assignments may originate from other Districts, special requests from headquarters, trade and consumer complaints, court orders, surveillance reports, or emergencies. These assignments consist of: 1) conducting domestic and foreign inspections of FDA-regulated industries; 2) conducting special investigations such as foodborne illnesses and adverse drug reactions; 3) collecting surveillance samples; 4) monitoring product recalls; 5) evaluating/assessing new product applications; 6) reviewing/examining/sampling imported products; 7) administering the Government-Wide Quality Assurance Program to assure safety of medical products purchased by the government; 8) providing training to industry representatives, consumer groups, and cooperating officials; 9) coordinating/cooperating with other regulatory agencies; and 10) enforcing the interstate Sanitation Travel Regulations. The work of the Field investigator is guided chiefly by the Federal Food, Drug, and Cosmetic Act (the Act)and Title 21 of the Code of Federal Regulations. The Public Health Service Act, Compliance Program Guidance Manuals, investigational guidance documents, and specific Center guidance are also used.

The scope of work for the Field investigator can be very broad, and varies from District to District. This is determined by the type and number of FDA-regulated industries in the District. Therefore, investigators are encouraged to select the program area(s) in which they have primary interest and would like to concentrate their efforts. For example, engineers generally select device team work; I focused on drug and veterinary assignments. The majority of my work assignments involved the Bioresearch Monitoring (BIMO) Program which includes clinical investigators, sponsors/monitors, good laboratory practices (GLPs), institutional review boards (IRBs), and contract research organizations. The commodities covered in the BIMO Program include human drugs, animal drugs, human biologics, devices, and food additives. The main objectives of the BIMO Program are: 1) to assure the integrity of scientific test data submitted to FDA to support approval of products; and 2) to determine that the welfare of human and animal research subjects are adequately protected. This permits FDA to make sound judgments regarding the safety and effectiveness of FDA-regulated products requiring premarket approval.

BIMO assignments originate from the product-oriented Centers and are forwarded to the District BIMO monitor who is responsible for the coordination and distribution of these assignments to appropriate District personnel. An inspection assignment is either announced (i.e., notification is given to the firm prior to the start of an inspection) or unannounced (i.e., notification is not given prior to the start of an inspection) depending on the type of BIMO, and the specific guidance provided in the assignment from the Center. An inspection can last from one or two days to several weeks, depending on its purpose and scope. While conducting assignments issued by a Center, the Field investigator may find it necessary to consult with Center personnel to resolve issues raised while conducting the Field assignment. Occasionally, Headquarters may send Center experts to the Field to assist in an inspection. The findings during inspection are documented accurately and factually in narrative form in reports called Establishment Inspection Reports (EIRs). Significant deviations (or deficiencies) from the Federal regulations observed during an inspection are also recorded on an FDA-483 (Inspectional Observations Form). FDA-483's are immediately releasable under the Freedom of Information Act. The EIRs provide historical information and are used to make administrative decisions. EIRs receive one of three classifications by a Field supervisor: 1) no action is indicated (NAI); 2) voluntary action is indicated (VAI); and 3) official action is indicated (OAI). Once endorsed by the District, a copy of the EIR is forwarded to the respective Center reviewer for a final endorsement. The original remains in District files.

Regardless of the type of assignment originating from a product-oriented Center, the coordination between the Center and the Field is generally similar. The coordinated efforts ensure that FDA-regulated products are safe and effective for their intended use(s).