We have represented international pharmaceutical distributors, international pharmacy companies, company owners, senior executives and directors in investigations and prosecutions spearheaded by FDA’s Office of Criminal Investigations (FDA-OCI). The investigations and prosecutions frequently involve charges of drug misbranding, adulteration, and false statements.
The firm has particularly deep expertise defending clients in FDA-OCI matters. Firm attorneys have successfully represented numerous clients in FDA investigations and prosecutions across the United States. These matters often have international aspects and the firm has advised in associated extradition proceedings. The firm has successfully ended investigations without charges and, where charges have been filed, have been able to resolve the cases on extremely favorable terms for clients. Our extensive experience allows us to offer solutions and strategic advice to those under investigation by the FDA.