Overview

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Justice (DOJ) have recently increased their emphasis on bringing strict-liability criminal prosecutions under the Park Doctrine against companies and individual corporate officers for FDA-related violations. Our experience in FDA-related criminal defense work long pre-dates this recent trend, and allows us to effectively represent companies and individuals in FDA criminal enforcement actions. We have represented parties in criminal investigations involving such allegations as falsification of data; failure to properly file adverse reaction reports; improper promotion or advertising of off-label uses; product adulteration, including failure to follow Good Manufacturing Practices (GMPs); and providing illegal gratuities to FDA officials.

Contact Us

Ralph J. Caccia
202.719.7242 | rcaccia@wiley.law 

Ann M. Begley
202.719.4585 | abegley@wiley.law

View all practice area professionals >

Necessary Cookies

Necessary cookies enable core functionality such as security, network management, and accessibility. You may disable these by changing your browser settings, but this may affect how the website functions.

Analytical Cookies

Analytical cookies help us improve our website by collecting and reporting information on its usage. We access and process information from these cookies at an aggregate level.