Office of Criminal Investigations - FDA

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The Office of Criminal Investigations (OCI) is a relatively small but important part of the U.S. Food and Drug Administration. OCI was created in 1992 in response to growing concern over criminal violations of Food Drug and Cosmetics Act such as prescription drug counterfeiting, illicit drug diversion, importation of unapproved drugs, application fraud and violations of the Federal Anti Tampring Act related to FDA regulated products. The agency is directed by Terry Vermillion, a former 23 year veteran of the U.S. Secret Service.

OCI is a traditional criminal investigative agency comprised of special agents recruited from a wide variety of federal law enforcement agencies. The average federal law enforcement experience of an OCI Special Agent is 12 years. In 2007, OCI employed approximately 185 special agents. From fiscal year 2000 to 2004, OCI reported a total of 1,943 arrests and 1,452 convictions.

Since its inception, OCI has been responsible for a number of high profile successful investigations affecting the public health. OCI Special Agents work closely with the DOJ U.S. Attorney's Office. Each year, the FDA publishes "The Enforcement Story" which details some of these investigations http://www.fda.gov/ora/about/enf_story/intro.htm.

Mission of OCI:

1. Advises and assists the Associate Commissioner and other key officials on regulations and criminal matters that affect the Agency.

2. Directs, plans, and develops criminal investigation activities in coordination with other Agency components and with other Federal, State, and local law enforcement agencies.

3. Develops, coordinates, and implements Agency policy related to criminal investigations.

4. Initiates and conducts criminal investigations under all statutes administered by the Food and Drug Administration, through area offices located throughout the United States; coordinates assignments involving undercover and surveillance personnel and activities.

5. Assures coordination of criminal investigation activities with FDA Regional Field Offices and District Offices and adherence to Agency's enforcement priorities; develops and maintains cooperative relationships with field and Headquarters components.

6. Provides recommendations to the Office of Chief Counsel on referrals of criminal cases to the Department of Justice for further investigation and/or prosecution, or directly to the U.S. Attorney when such direct reference is authorized.

7. Develops automated data processing systems to be used for criminal investigations and related enforcement matters.

8. Develops, reviews, and approves training programs for FDA's criminal investigators and related personnel.

9. Participates in Grand Jury investigations and serves as agents of the Grand Jury.

OCI and ORA

OCI does not generally participate in routine inspections or other regulatory operations with FDA's Office of Regulatory Affairs (ORA). ORA Investigators (Consumer Safety Officers) receive some training in law enforcement techniques such as evidence handling and investigative interviewing but are more focused on the technical aspects of the regulated industries.