For more than six years, FDA’s Office of Criminal Investigations (OCI) has been beset by a series of troubling allegations regarding its leadership. These issues have once again percolated to the surface, this time in a January 10th Food Safety News article. While I wholeheartedly support the need to vigorously root out mismanagement and misconduct at the highest levels of OCI, this process has surely taken its toll on OCI’s employees who strive each day to fulfill that organization’s invaluable mission. I had a front-row seat to this debacle before my retirement from OCI headquarters in early 2013 and can attest to the deleterious impact it had on my colleagues, many of whom, like me, chose to leave OCI in their prime. Undoubtedly, morale within OCI’s ranks has been undermined in a serious way. You can expect that OCI’s performance has also suffered. It will likely take years to undo this mess and establish OCI as a vibrant and well-tuned criminal investigative body that provides an irreplaceable arrow in FDA’s enforcement quiver. Now, however, OCI will be facing yet another round of revolving temporary directors after current director George Karavetsos departs on January 20th under the latest cloud of controversy. How many more blows can OCI take and still be expected to function at a high level? Hopefully, FDA leadership, facing a transition of its own, is committed to quickly addressing a withering OCI before it’s too late.
- THE UNSETTLING SHORTAGE DRUG DILEMMA FACING HOSPITALS AND MEDICAL CLINICS December 1, 2018
- A POTENTIAL SHIFT IN FDA’S APPROACH TO TAINTED DIETARY SUPPLEMENTS November 29, 2018
- FDA ALERTS THE PUBLIC TO WESTMINSTER PHARMACEUTICALS, LLC DRUG RECALL August 20, 2018
- SENTENCING ANNOUNCED IN ILLEGAL FOREIGN-SOURCED DRUG CAPER August 2, 2018
- DECEPTIVE, UNETHICAL, AND POTENTIALLY CRIMINAL SHORTAGE DRUG DIVERSION SCHEMES CONTINUE TO THREATEN PATIENTS AND OUR HEALTH CARE SYSTEM July 13, 2018
- FDA’S LATEST STATEMENT ON DRUG SHORTAGES SIDESTEPS THE ROLE OF DIVERSION-AGAIN June 1, 2018