A Fox Rothschild litigation team led by Patrick J. Egan and Saverio S. Romeo has won the dismissal of all criminal charges against a pharmaceutical executive who was accused of violating the federal Food, Drug and Cosmetic Act (FDCA).
After a pair of victories before the U.S. District Court in Philadelphia and in the 3rd Circuit Court of Appeals, Egan and Romeo argued that prosecutors took an “overexpansive” view of the FDCA when they indicted Ashvin Panchal, an executive at KVK Tech Inc., a generic drug manufacturer in Newtown, Pa.
The 2021 indictment alleged that KVK manufactured hydroxyzine, an anxiety drug, and that Panchal and another executive had improperly sourced the active ingredient for the drug from a lab in Mexico that was not included in the approvals they obtained from the FDA. But Egan and Romeo successfully argued that there was nothing criminal in Panchal’s conduct.
In a brief court proceeding on April 1, 2024, Judge Harvey Bartle formally dismissed all charges against Panchal and another executive. As part of a global resolution of the case, KVK-Tech Inc. agreed to enter into a deferred prosecution agreement and its affiliate, KVK Research, agreed to plead guilty to two misdemeanor counts of distributing adulterated drugs.
Original source can be found here.