PSM2012 – John Roth, Director of the FDA’s Office of Criminal Investigations

John Roth, Director of the U.S. Food and Drug Administration's Office of Criminal Investigations was the luncheon speaker at the Interchange, introduced by Partnership for Safe Medicine's Executive Director Scott LaGanga.

Roth spoke on the FDA’s criminal priority areas, its recent experience (and challenges) with combatting counterfeiters, and more broadly about how criminal enforcement fits in with the broader FDA regulatory strategy. 

FDA has had successful campaigns on other area of health-related campaigns.  Notably, there has been a ten-fold reduction in the number of cargo thefts in comparison to ten years ago.  

What role does criminal enforcement play in the FDA? These are the main areas that apply to counterfeit drugs: regulated space, significants risks to public health and false data.

Regulated space: individuals backed by Russian organized crime that set up fake online pharmacies purporting to be from safe sources, but instead the medicines are coming from unknown sources and the manufacturing techniques are unapproved.  The money is then laundered through bank accounts in Crete.  No amount of regulation is going to fix this problem – this is a crime.  It can only be addressed by criminal prosecution.

Roth referred to the Tom Zhou case, who counterfeited the weight-loss medication Alli, and is now serving more than 5 years in US prison. Undercover agents interviewed him and found out about his sophisticated methods – he had boxes, bottles, and printing – and he explained the entire process of international commerce he engaged in in order to get the medicines into the U.S.  His testing procedure for safety the counterfeit as described to agents: "I made this guy eat an entire bottle of the medicine, and he didn't die."  

Risks to the public health: The appropriate remedy is only prosecution in order to address the concern for the public health.  For example, James R. Newcomb, whose crime of selling counterfeited cancer medication impacted patients across the United States.  

Science based and data driven information:  When people submit false information and impact the public safety those cases must be prosecuted.

The FDA-OCI has only around 200 agents, but they collected $1 billion in fines and restitution or about $5 million per agent last year, said Roth.  And they often work with the Homeland Security Investigations and also the Postal Inspection Services.