This article will discuss the history of the present regulatory regime regarding pharmaceutical wholesaling and will demonstrate the deficiencies of the present system. Next, the article will show that the failings of the present regime are caused by a lack of regulatory diligence and fortitude and that one existing tool, namely, the paper pedigree, if properly used, could curb most of the deficiencies in the system. The article will conclude with concrete recommendations to regulators and the pharmaceutical industry that will make the drug supply safe again.
Written Statement of James A.Dahl submitted to the Committee on Government Reform, Subcommittee on Criminal Justice, Drug Policy, and Human Resources, United States House of Representatives. November 1, 2005.
2.
US Food and Drug Administration. Draft Compliance Policy Guide 160.900. June 2006.
