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Investigative Insights from the FDA Office of Criminal Investigations

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Presentation on theme: "Investigative Insights from the FDA Office of Criminal Investigations"— Presentation transcript:

1 Investigative Insights from the FDA Office of Criminal Investigations
Counterterrorism Section George F. Hughes Senior Advisor Counterterrorism and Intelligence

2 OCI Field and Resident Offices
Minneapolis Detroit Seattle Syracuse Boston Buffalo New York Chicago Philadelphia San Francisco OCI Headquarters Cincinnati Metro Washington Norfolk Denver Kansas City Los Angeles Nashville Raleigh Birmingham Atlanta Phoenix Headquarters Tampa Austin Dallas New Orleans Miami Field Offices Houston San Antonio Resident Offices .. San Juan Domicile Offices

3 INVESTIGATIVE RESPONSIBILITIES
Federal Food, Drug, and Cosmetic Act (FDCA) Title 21, United States Code, & related Acts Federal Anti-Tampering Act Title 18, United States Code § 1365 Related violations of Title 18 U.S. Criminal Code Title 18, United States Code § 1001 Title 18, United States Code § 371 Title 18, United States Code § 1341 Title 18, United States Code § 1343

4 Other Title 18 Violations
18 USC Trafficking in CFT Goods 18 USC 2339A – Providing material support to terrorists. 18 USC 2339B – Providing material support or resources to designated foreign terrorist organizations. 18 UCS 2339C – Prohibitions against the financing of terrorism.

5 The OCI “Bottom Line”, we enforce the following:
The Food, Drug and Cosmetic Act, Title 21. Federal Anti-Tampering Act. Title 18 USC 1365. Other Title 18 USC violations

6 General Areas of Enforcement
Manufacture and sale of counterfeit or unapproved drugs Illegal diversion of pharmaceuticals and other regulated products Product substitution crimes Product tampering Health fraud - schemes involving fraudulent treatments/cures/devices New drug application fraud Clinical investigator fraud Crimes affecting the safety/integrity of the nation’s blood supply Crimes involving the adulteration and/or misbranding of food Prescription Drug Marketing Act violations Internet facilitated criminal violations involving FDA regulated products Illegal importation of FDA regulated products Off Label Promotion of Drugs and Devices

7 OTHER OCI CT ACTIVITY OCI Agent assigned to INTERPOL at
National Central Bureau Washington, DC and EUROPOL at the Hague.

8 FDA OCI U.S. Intelligence Community Private Industry Federal
Law Enforcement Agencies OCI Foreign Law Enforcement Agencies U.S. Attorney’s FDA Federal/State Health Authority State/Local Law Enforcement Agencies

9 OCI FDA U.S. Intelligence Community Private Industry Federal
Law Enforcement Agencies OCC Centers FCC Office of Public Affairs OCI Foreign Law Enforcement Agencies U.S. Attorney’s ORA Field OLA ORA HQ FDA Federal/State Health Authority State/Local Law Enforcement Agencies

10 JOINT INVESTIGATIONS

11 COUNTERFEIT PRODUCTS AND TERROR

12 OCI Headquarters George F. Hughes (240) 276-9456


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