Monday, June 10, 2013

The FDA's Law Enforcement Arm: The OCI

I'm excited to host Bette Lamb today as she blogs about her latest medical thriller, The Bone Pit. Sounds right up my alley. Plus, she shares about the law enforcement arm of the FDA. Did you know about them? Let the conspiracy theories begin.

Welcome back, Bette!

At some point in your life you might find yourself at odds or in some kind of trouble with the police. And a real nightmare? Getting involved with the FBI. Maybe the CIA.

Very scary stuff! If you’re a movie buff, as I am, there are too many scenarios to paste yourself into once you get your imagination going in that direction

But the OCI? Who the heck are they? And what do they have to do with you, or me?

When I was digging out information about fraudulent clinical drug trials for our latest medical thriller, Bone Pit, I discovered that the Food and Drug Administration (FDA) has its own law enforcement unit: the Office of Criminal Investigations (OCI).

Maybe you’ve heard of them, but I hadn’t.

OCI began operating a little more than twenty years ago; it was tailored to enforce the FDA’s many areas of responsibilities. Since opening six field offices in 1993, OCI has become operational throughout the US and Puerto Rico. It hires experienced agents from the FBI, Immigration and Customs Enforcement, the Secret Service, and other law enforcement agencies – real, tough lawmen and women who bring prior experience in traditional law enforcement methods and investigative techniques. These are not necessarily sit-in-the-office types -- they obtain and execute arrest and search warrants, carry firearms, and gather evidence to support prosecutions through the federal and state court systems.

They are not people to mess with, because if you do—if  you break the law—they will hunt you down and bring you before the Department of Justice for prosecution.

In other words, OCI is the FDA’s teeth. And they will bite anyone who tampers with food or over-the-counter drugs, importation of unapproved drugs or devices, biological products (such as blood supplies), new drug application fraud, and fraudulent schemes involving AIDS, cancer, and Alzheimer’s.

They also oversee clinical investigator fraud – something that drew my interest. For example: An investigation by OCI and the Veterans Affairs (VA) resulted in a conviction of a VA physician who falsified documentation of a clinical drug study and enrolled patients who did not qualify under the study protocol. The physician’s criminal negligence caused the death of one patient by falsely documenting the results of a blood chemistry analysis. The guilty physician was prosecuted and sentenced to 71 months in the federal slammer.

Each year, OCI investigates about 1,200 criminal cases that result in the arrests of some 300 criminal suspects. From 1993 through November 2010, agents made 5,702 arrests that resulted in 4,748 convictions and more than $11 billion in fines and restitutions. Significantly, OCI agents are charged with protecting $1 trillion worth of food, drugs, cosmetics, and other FDA-regulated products from theft, counterfeiting, fraud, tampering, and false advertising, as spelled out in federal laws covering the United States and Puerto Rico. That means the FDA regulates approximately 25 cents of every dollar spent annually by American consumers.

The latest in scientific methodology sits smack in OCI’s corner supporting their investigations: an experienced staff of investigative analysts, technical equipment specialists, polygraph examiners, and specialists in computer forensics are just some of their tools they have to catch the bad guys.

Police, FBI, CIA, and now OCI.

I don’t think I’ll mess with any of them. 

Bette Golden Lamb is unmistakably from the Bronx – probably why she loves to write dark and gritty novels. Being an RN explains her intense interest in medical thrillers. Sisters in Silence, is about a female serial killer on a noble mission to save barren women from a life of despair. The RN Gina Mazzio series, Bone Dry and Sin & Bone, and the new release, Bone Pit, feature a gutsy nurse who can’t ignore life-threatening situations. In another direction, Heir Today, starts out as a treasure hunt and takes you on a suspense/adventure romp.

All four books were co-authored with husband J.J. Lamb.


  1. Thanks for all of this interesting info, Bette. Sounds like an OCI investigator might make a good new series sleuth for you and your partner in crime, J.J. Lamb. Or maybe not, since RN Gina Mazzio, who stars in your "Bone" series, does such excellent detective work on her own.

    1. Thanks for stopping by, Peggy.
      You know, it is a good idea for another series. I wonder who's going to do it?:)

  2. That is so interesting, Bette. It makes sense that the FDA would need its own enforcement unit. I would imagine it will continue to grow with the proliferation of new drugs for all of us baby boomers. I can't wait to start on the BONE PIT!

  3. Thanks, Cindy. It was interesting finding out about this group of law enforcers. I'd never heard of them before but they fit right into BONE PIT.

  4. I agree with the other commenters - sounds like an ideal job for your next heroine.

  5. Thanks Maddy.
    Who knows what kind of trouble Gina Mazzio RN will get into next. (Well, I do, but my lips are sealed for now:)

  6. Who knew? The FDA is scary enough with all their 7 yrs of trials but now to know they have a branch of enforcers. Pretty cool. Loved Bone Pit!

  7. Dear Mythlover,
    Glad you liked the blog and especially happy you liked Bone Pit!

  8. I really like the plot idea of having an OCI officer doing an investigation into some product tampering (Tylenol, anyone?) that leads to a discovery of a terrorist plot... BTW, the postal service has their own law enforcement branch, too.

  9. It's amazing how ignorant we can be about all the things we pay taxes for. Now I can add the postal service's law enforcement to the long list. Think of all the spinoffs we can dive into:) Thanks for dropping by, Eileen.

  10. Very informative article. The more I research and read, the dumber I feel. I haven't started reading Bone Pit yet, but will soon.

  11. This blog is fascinating and I wouldn't have found it if it weren't for Bette's informative article. I'm just betting something in this post, or another, will spark some inspiration in my work! Thanks everyone.