Dilip Shah

Executive Summary

Former Quad President requests debarment hearing through a Dec. 4 letter to FDA by the Washington, D.C. law firm Zuckerman, Spaeder, Goldstein, Taylor & Kolker. The letter requests a hearing to contest FDA's Nov. 5 proposal to debar Shah permanently from "providing services in any capacity to a [company] that has an approved or pending drug product application" ("The Pink Sheet" Dec. 14, In Brief). The law firm argues that Shah's "conduct does not fall within the conduct encompassed" by the section on mandatory debarment of individuals but instead falls within the section on permissive debarment of individuals. The firm also said that the debarment provisions "do not apply to convictions that predate enactment of the statute, as in the case with Dr. Shah's conviction".