FacultyFaculty/Author Profile

Kelsey A Schaefer

United States Food and Drug Administration
Associate Chief Counsel for Enforcement
Silver Spring, MD, USA


Kelsey Schaefer is an Associate Chief Counsel for Enforcement at the Food and Drug Administration (FDA).  Ms. Schaefer works with FDA's Office of Criminal Investigations (OCI) and the Department of Justice in investigating and prosecuting criminal violations of the FDCA and other related health care fraud statutes.  Ms. Schaefer has been appointed as a Special Assistant United States Attorney by the Department of Justice, and assisted in the indictment and successful prosecution of misdemeanor and felony cases under the FDCA.  She also manages False Claims Act investigations involving FDA regulated products, serving as a liaison between FDA and other federal agencies.  She has served as lead agency counsel on civil enforcement matters, and provided legal counsel and advice to FDA personnel on matters concerning interpretation, application, and enforcement of the laws, rules, and regulations administered by the agency.  Prior to joining FDA, Ms. Schaefer worked for twelve years at a top 100 law firm working on a variety of cases involving FDCA issues.  She also worked with the Manatee County Public Defender's Office on a pro bono basis, successfully defending several felony cases at trial.  She graduated cum laude from the Boston University School of Law, and received her undergraduate degree from William Smith College.  Ms. Schaefer is a regular speaker and panelist at industry conferences.
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