Meet the FDA Agent Who Busts Bad Docs

by Adam Marcus

When most people imagine inspections from the US Food and Drug Administration (FDA), they might think of bureaucrats with clipboards scouring baby formula factories for unkempt equipment and rat droppings. But they probably don’t know that the FDA has another group of investigators who carry firearms and have the authority to arrest.

Meet the Office of Criminal Investigations (OCI) — or, if you’re a physician or other healthcare worker on the wrong side of the law, perhaps you’d rather skip the introduction.

The OCI has some 200 agents stationed throughout the United States, as well as attachés in outposts in the United Kingdom and The Hague, Netherlands, who serve as respective liaisons with the U.S. Embassy in London and with EUROPOL, providing assistance with international investigations in which illicit products that fall under the FDA’s regulatory umbrella are being smuggled into the United States.

Most OCI agents arrive at the unit having served for about a decade in another law enforcement agency — IRS Criminal Investigations, Homeland Security, and the Secret Service are frequent stepping-stones to the OCI.

Most cases OCI agents pursue involve drug-related crimes — the distribution of counterfeit or unapproved medications, large-scale and organized diversion, and fraudulent activity with drugs and medical devices. The office took part in the case against Elizabeth Holmes, the founder of Theranos, who was convicted on fraud charges and is awaiting sentencing.

Agents have also pursued inquiries against researchers, such as a posthumous investigation into William Halford, who was accused of having injected people with an unapproved vaccine for herpes for which he’d not received FDA approval to study.

Based in Rockville, Maryland, FDA Special Agent Justin Green is OCI’s deputy director. Green came to the FDA in 2008 from the IRS Criminal Investigations unit and has been deputy director of the office since 2020.