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U.S. Department of Health and Human Services

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Ann Simoneau, JD, MBA, Director, Office of Compliance and Enforcement

Ann Simoneau, JD, MBA, Director, Office of Compliance and EnforcementAnn Simoneau, JD, MBA, Director, Office of Compliance and Enforcement

Ann Simoneau is currently the Director of the Office of Compliance and Enforcement at the Center for Tobacco Products (CTP) of the Food and Drug Administration  (FDA).  When the Office was created in July 2009, Ms. Simoneau was named its Acting Director and in January 2011 she was appointed the permanent Director.  The Office of Compliance and Enforcement at CTP is responsible for a wide-range of compliance and  enforcement efforts required for tobacco product regulation, including compliance education, surveillance, inspections, investigations, and enforcement activities to ensure compliance of the law by regulated industry.  Ms. Simoneau has led the design, development and implementation of CTP’s compliance and enforcement programs, including the development of a state enforcement program under which FDA awards contracts to states and territories to assist with inspections of tobacco retail establishments.

Ms. Simoneau joined the agency in 2001 and has worked in FDA's New England District Office, the Center for Drug Evaluation and Research’s (CDER) Division of Drug Marketing, Advertising, and Communications, and the Center for Devices and Radiological Health’s (CDRH) Office of Compliance.  Ms. Simoneau has served in a variety of capacities in FDA and has acquired compliance experience relating to many FDA-regulated products, including drugs, biologics, medical devices, foods, and dietary supplements.  Her FDA regulatory experience includes enforcement and recall matters, importation, promotion and labeling issues, health fraud, regulatory and manufacturing requirements and product quality assessments.  Prior to working for FDA, Ms. Simoneau was a litigation attorney at Sloane and Walsh, P.C. in Boston, MA.  

Ms. Simoneau received a B.S. degree in pharmacy from Massachusetts College of Pharmacy in 1986, a J.D. degree from Boston University School of Law in 1989, and a MBA from Suffolk University, Sawyer Business School in 2001.