News

The IPR Center Report

Partners in Action

Volume 1: No. 1 • November 2008

FDA Law Enforcers Protect Consumers’ Health

The investigators of the Food and Drug Administration (FDA) Office of Criminal Investigations (OCI) protect consumers from companies and individuals who pose a danger to the public’s health. OCI agents target criminals whose illegal acts involve pharmaceuticals, foods and other products regulated by the FDA. OCI focuses on criminal violations of Title 18 of the United States Code, the Federal Food, Drug and Cosmetic Act and the Federal Anti-Tampering Act.

Founded in 1992, OCI has six field offices and six resident offices located throughout the U.S. and Puerto Rico. Field offices are located in New York; Washington, D.C.; Miami; Kansas City, Kan.; Chicago; and Los Angeles. Resident offices are located in San Francisco; Austin, Texas; New Orleans; San Juan, P.R.; Atlanta; and Boston.

OCI Special Agents investigate many types of FDA-related crimes including counterfeit, unapproved, or illegally diverted drugs; consumer product tampering and product substitution; fraudulent health treatments; and allegations of fraud in new drug applications and clinical trials.

Many times when OCI initiates an investigation, other federal law enforcement agencies with a jurisdictional interest will join the investigation. As many OCI cases have an international aspect, the OCI has developed good working relationships with many foreign law enforcement counterparts which aid in bringing criminals outside the U.S. to justice.

Field investigations are enhanced by OCI’s skilled investigative analysts and technical specialists. In addition, the FDA’s Forensic Chemistry Center in Cincinnati, OH, provides valuable forensic laboratory support by performing many different laboratory tests related to suspect products involved in OCI investigations.

On average, 200 criminal suspects are convicted each year as the result of OCI investigations. From 1993 to present, the OCI has made 4,593 arrests resulting in 3,546 convictions and more than $5.7 billion in fines and restitutions.