About FDA

Description: Enhance the coordination, communication, and strategy in alignment of the Office of Criminal Investigations (OCI) and other FDA components by implementing the findings and recommendations of the OCI/Center coordination and Alignment Review Committee.

Accomplishment: In completion of the key project, the Office of the Counselor to the Commissioner implemented the findings and recommendations of the Office of Criminal Investigations/Center coordination and Alignment Review Committee. Outcomes of this initiative are as follows:

• Improved procedures for the standardization and coordination of information sharing between OCI and other agency components;
• Established mechanisms to ensure that senior leaders share information and coordinate strategic priorities to align criminal enforcement and regulatory activities;
• Increased appropriate use of misdemeanor prosecutions through greater clarity on the criteria for approving such cases to hold corporate officials accountable; encourage preventive actions; and achieve greater deterrence;
• Enhanced procedures to support development of debarment and disqualification actions, and clarify the circumstances under which such administrative actions may proceed concurrently with pending criminal investigations and prosecutions; and
• Established enhanced procedures to coordinate agency response to cargo theft of FDA regulated products, such as pharmaceuticals and infant formula, to ensure that FDA’s regulatory response to cargo thefts is consistent and fully effective.
• Issued Staff Manual Guide: Sharing Of Information Related To Criminal Violations
• Issued Staff Manual Guide: Enhanced Communications With The Office Of Criminal Investigations (OCI) & Improved Alignment Of Criminal/Regulatory Priorities And Activities