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.
- FDA’S OCTOBER 2017 COUNTERFEIT HARVONI NOTICE UNCOVERED February 7, 2018
- FDA’S OFFICE OF CRIMINAL INVESTIGATIONS FACING AN UNCERTAIN FUTURE February 1, 2018
- COUNTERFEIT PRESCRIPTION DRUGS AND FENTANYL-INTERNATIONAL MAIL VULNERABILITIES EXPOSED January 27, 2018
- FDA DRUG SHORTAGE STATEMENT TARGETS HOARDING BY HEALTHCARE PROVIDERS November 23, 2017
- PHARMACY VP CHARGED IN PA DRUG RECYCLING DIVERSION SCHEME October 12, 2017
- OUR AILING SUPPLY CHAIN NEEDS A PANGEA-STYLE FDA OPERATION OF ITS OWN October 10, 2017