• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Development of OCI's International Investigative Unit

Description: FDA’s commitment for protecting the public health does not stop at the borders of the United States. The FDA/Office of Criminal Investigations (OCI) is also committed to continuing our mission to build and foster strong working relationships with foreign law enforcement agencies in countries throughout the world. OCI’s role and responsibilities for the FDA is to identify and prosecute violators who import counterfeit, misbranded and/or adulterated FDA-regulated products that threaten the health and safety of the American public. The objective of this project is to coordinate with other FDA components to develop an outreach training and presentation curriculum program to continue building international relations. The training and presentation curriculum program will enhance relations with foreign law enforcement and regulatory counterparts regarding OCI’s role and responsibilities for conducting criminal investigations.

Information is current as of February 18, 2015

Accomplishment: OCI is coordinating with FDA and FDA’s Office of International Programs (OIP) to develop an OCI international investigative unit that will provide liaison activities and instruction to foreign law enforcement, regulatory and FDA relative to OCI’s international investigative role and responsibilities. The training and presentation curriculum program will enhance relations with foreign law enforcement and regulatory counterparts regarding OCI’s role and responsibilities for conducting criminal investigations.

In January 2014, OCI sent a seasoned manager to work with and provide training to the FDA India Office on a 30-day TDY. Our agent advised the India Office on matters relating to data integrity and foreign unapproved drugs. Further, on a bi-monthly basis, OCI provides updates on criminal investigations directly to OIP via teleconference.

In September, 2014, OCI agents provided a briefing to Turkish law enforcement in Ankara, Turkey. In May 2014, OCI provided training on multiple topics including drug counterfeiting and cybercrime investigations to foreign law enforcement at the conference of the Permanent Forum on International Pharmaceutical Crime in Utrecht, Netherlands. Finally, in March 2014, OCI provided training to International law enforcement personnel on cybercrime investigative techniques at Interpol in Lyon, France.

On October 1, 2014, OCI conducted a day-long seminar for Industry security personnel on FDA’s criminal investigations. In addition, OCI provided training and outreach on drug diversion, counterfeiting and cybercrime to international industry personnel in Ankara, Turkey on September 24 and 25, 2014.

OCI continues on-going investigative dialogue with a number of foreign law enforcement agencies. In October 2014, OCI met with the RCMP to discuss cross-border investigations and a follow-up meeting was held in Ottawa in January 2015. Joint criminal investigations have been conducted via OCI’s representative in Europol with Switzerland, Germany and the United Kingdom. OCI as an active participant in the Permanent Forum on International Pharmaceutical Crime and entered into a Memorandum of Understanding with the French National Gendarmerie on combatting counterfeit drugs. OCI is also seeking assignment of a special agent to the Interpol Global Complex for Innovation in Singapore this coming year. Finally, OCI as a major participant in INTERPOL’s yearly Operation Pangea which targets pharmaceutical trafficking on multiple levels and involves transnational coordination.

Briefing Status: Completed

Prior Briefing Status: Delayed

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Develop an outreach and presentation curriculum for OIP personnel relative to OCI’s roles and responsibilities for international related investigations.

3/30/2013

Completed 3/30/2013

2. Develop an outreach and training curriculum for foreign law enforcement entities relative to OCI's international investigative role and responsibilities.

6/30/2013

12/30/2013

Completed Sept 2014

3. Develop an outreach curriculum for industry relative to OCI's international investigative role and responsibilities.

6/30/2013

12/30/2013

Completed 10/1/2014

4. Enhance OCI’s liaison activities with foreign law enforcement entities.

9/30/2013

12/30/2013

Completed Ongoing

Footnotes

  • The dates in italics are modified milestone due dates that have been updated due to real-time delays. The milestone status reflects the current reporting quarter’s status. If a milestone is missed, the milestone will remain delayed until the milestone is completed.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.