Generic drum debarments

Executive Summary

Denial of hearings and final debarment orders issued for Charles DiCola, former VP-operations at Bolar Pharmaceutical; Liaquat Hossain, former manager of product development at Superpharm; and Daphne Pai, former VP-regulatory affairs & quality control at American Therapeutics, a Nov. 5 Federal Register notice states. In separate requests for hearings, the plaintiffs argued that debarment violated the ex post facto clause of the U.S. Constitution. FDA maintains that since the intent behind section 306(a) (2) of the FD&C act is remedial, rather than punitive, debarment does not violate the ex post facto clause of the fourth.