On Nov. 2, 2021, The BMJ broke the story of Brook Jackson, the regional director who blew the whistle on data integrity issues in Pfizer’s pivotal COVID-19 vaccine trial. Weeks later, documents were leaked supporting Jackson’s complaint about “falsified data.”
Among the leaked documents was an email, authored by a former federal agent in the FDA’s Office of Criminal Investigations (OCI), claiming Pfizer knowingly submitted fraudulent data to the FDA, and the agency responded by turning a blind eye.
To grasp the gravity of what is written in the email, it’s important to understand the role of OCI.
What Is OCI?
OCI is the FDA’s criminal law enforcement arm. Much like a police force, it conducts criminal investigations of illegal activities involving FDA-regulated products and brings them before the Department of Justice for prosecution.
OCI consists of about 200 federal agents, hired from the US Secret Service, the FBI, or the Internal Revenue Service Criminal investigations unit. The agents are stationed throughout the US, as well as attachés in overseas posts, and have the same type of arrest authority as other federal law enforcement agents.
The unit was established by former FDA Commissioner David Kessler, off the back of the generic drug scandal in the late 80s. Kessler was determined to crack down on fraud after FDA employees were found guilty of accepting bribes from generic drug makers.
“What I care about most is restoring the credibility and the integrity of the Food and Drug Administration,” said Kessler at the time,” and the only way to do that is to focus on strong enforcement. We are going to enforce the law.”
Read More: FDA ‘Turned a Blind Eye’ to ‘Submission of Fraudulent Data’ on COVID Vaccine, Says Former Criminal Investigator