Blood is in the water and the sharks are beginning to circle.  Things have gone from bad to worse for FDA’s Office of Criminal Investigations. And now it appears that OCI has drawn the ire of Congress. According to Reuters, Congress is accusing FDA of “failing to hand over documents that would show whether its criminal office is fulfilling the critical mission of protecting public health.” Does OCI have a death wish or something?  This story is shaping up to have a bad ending. But there is more to this building controversy that needs to be told.

In its most recent article, Reuters highlights once again that OCI agents were being forced to “pursue often toothless cases involving mislabeled foreign-imported injectable drugs, at the expense of cases with more potential to protect the public health.” Reuters added, OCI agents “said they had become the ‘Botox Police’ and were spending hours chasing down doctors who purchased authentic versions of Allergan’s popular anti-wrinkle drug that were labeled for use in other countries.”  Reuters found these concerns “came at a time when the office was seeing more than half its opened cases ultimately get closed without action.”

However, the series of Reuters articles fails to place these cases in the proper context.  Perhaps a wider lens would have shown that OCI’s relentless pursuit of such investigations has been a noble and worthy effort, albeit a strategically lacking one.  Perhaps some emphasis should have been placed on how OCI and its regulatory colleagues in FDA have applied novel techniques to enhance supply chain security and patient safety in an ever-threatening, post-counterfeit Avastin and Altuzan environment.  Well, that’s where I come in.

Fraudulent Botox cases matter! In November 2004, four people became paralyzed following purported Botox injections they received from a Florida medical clinic. OCI investigations ensued and over 200 health care professionals were targeted in response to this unapproved botulinum toxin incident.  In October 2009, FDA lauded OCI’s efforts that resulted in 31 arrests, and 29 convictions of individuals “who purposely injected an unapproved, cheaper substitute toxin for FDA-approved Botox Cosmetic into nearly 1,000 unknowing patients.”  I find it interesting that no one seemed to question OCI’s efforts back then. FDA even chose to title its article, “FDA Law Enforcers Crack Down of Illegal Botox Scammers.”  Funny how times change.

Corrupt health care professionals who exploit vulnerable patients seeking legitimate Botox treatments should remain a top OCI and FDA priority when those schemes involve counterfeit, unapproved, or misbranded drug products.

While OCI’s efforts back in 2004 were valiant, they failed because of a strategy that over-emphasized felony prosecutions.  OCI missed out on a golden opportunity.  Presenting individual cases like these for felony prosecutions has always been a challenge.  Assistant U.S. Attorneys typically have bigger fish to fry.  A far better solution would have been to pursue less sexy misdemeanor cases against the offending doctors under a single, nationwide operation in coordination with DOJ’s Office of Consumer Litigation (now the Consumer Protection Branch).  The beauty of this approach is that once a defendant has been convicted of a misdemeanor offense under the Federal Food, Drug and Cosmetic Act, a second violation of the Act can lead to felony penalties without the need to prove intent to defraud or mislead by the defendant. However, a longstanding turf war between OCI and OCL prevented any such operation from ever being considered.

Shunning misdemeanor prosecutions in collaboration with OCL was a strategic failure by OCI leadership. While building a reputation for successfully investigating challenging felony cases is understandable, it also meant that OCI payed far less attention to its role as a complimentary enforcement agency designed to enhance FDA’s public health and safety mission. The possibility of contributing to over 200 successful prosecutions of health care professionals on misdemeanor charges under the Act would would have done more to boost FDA’s overall mission than 29 felony convictions that received little, if any, attention in the media and were barely a blip on the radar.

More recently, a counterfeit Botox incident involving an unlicensed supplier led FDA to issue over 1,300 letters to medical practices throughout the country that purchased unapproved prescription drugs and/or injectable devices from a company called TC Medical.  FDA’s March 2016 letters stated, “Prescription drugs and/or injectable devices (products) distributed by TC Medical may be counterfeit (not manufactured or distributed by the company indicated on the label) and/or may be from foreign or unknown sources and are not approved for distribution in the United States. These products may have unknown ingredients, or may not have been manufactured, transported, or stored under proper conditions as required by U.S. law, regulations, and standards.”

Greedy health care professionals who obtain illegal foreign-sourced drugs and devices from illegitimate suppliers, like TC Medical, exploit vulnerable patients and should face criminal prosecution for their callous actions.  But if OCI does not investigate such cases, who will?  The attitude displayed by OCI agents who scoff at being dubbed the “Botox Police” is troublesome.  From my perspective, the lack of an effective strategy by OCI, not the investigations themselves, is the issue. The solution is not to for OCI to abandon such cases, it’s to consider a different approach.  Waves of successful misdemeanors prosecutions of health care professionals coordinated through DOJ’s Consumer Protection Branch may ultimately do far more to advance FDA’s public health and safety mission than a handful of felony convictions.  OCI must evolve or it may cease to exist under the current political climate and the mountain of controversy it now faces.  A strategy in which OCI finally begins to place the needs of FDA above its own is good place to start.