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

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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

Other Title 18 Violations 18 USC 2320 - 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.

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

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

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

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JOINT INVESTIGATIONS

COUNTERFEIT PRODUCTS AND TERROR

OCI Headquarters George F. Hughes (240) 276-9456 george.hughes@oci.fda.gov