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

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Page 1: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

Insight from the FDA Office of

Criminal Investigations

FDA Office of Criminal Investigations

Counterterrorism Section

George F. Hughes

Senior Advisor

Counterterrorism and Intelligence

Page 2: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

Boston

New York

Metro Washington

OCI Headquarters

Atlanta

Miami Austin

Kansas City

Chicago

Los Angeles

San Francisco

OCI Field and Resident Offices

.

.

Houston

San Juan

Nashville

Buffalo

Headquarters

Field Offices

Resident Offices

Domicile Offices

New Orleans

Seattle

Denver

Phoenix

Minneapolis

Dallas Tampa

Philadelphia

San Antonio

Norfolk

Syracuse

Cincinnati

Birmingham

Raleigh

Detroit

Page 3: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

INVESTIGATIVE

RESPONSIBILITIES

Federal Food, Drug, and Cosmetic Act (FDCA)

Title 21, United States Code,

& related Acts

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

Federal Anti-Tampering Act

Title 18, United States Code § 1365

Page 4: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

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.

Page 5: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

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

Page 6: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

•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

General Areas of Enforcement

Page 7: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

OTHER OCI CT ACTIVITY

OCI Agent assigned to

INTERPOL

National Central Bureau

Washington, DC

Page 8: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

OCI

Federal

Law Enforcement

Agencies

U.S.

Attorney’s

State/Local

Law Enforcement

Agencies

U.S.

Intelligence

Community

Private

Industry

FDA

Foreign

Law Enforcement

Agencies

Federal/State

Health

Authority

Page 9: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

OCI FCC

ORA

HQ

OLA ORA

Field

Office of

Public

Affairs

OCC Centers

Federal

Law Enforcement

Agencies

U.S.

Attorney’s

State/Local

Law Enforcement

Agencies

U.S.

Intelligence

Community

Private

Industry

FDA

Foreign

Law Enforcement

Agencies

Federal/State

Health

Authority

Page 10: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

JOINT

INVESTIGATIONS

Page 11: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

COUNTERFEIT PRODUCTS AND

TERROR

Page 12: Insight from the FDA Office of Criminal Investigationsindy.afdo.org/uploads/1/5/9/4/15948626/ddc-1030... · Phoenix Minneapolis Dallas Tampa Philadelphia San Antonio Norfolk Syracuse

George F. Hughes

OCI

Headquarters

(240) 276-9456 [email protected]