Executive Summary

While FDA had hoped to be on the "downhill side" of its enhanced investigations of the industry, Center for Drugs Office of Compliance Director Daniel Michels said Dec. 14, "I would conservatively estimate that we have at least another year of intensive effort on the part of field and our organization [staff] to work our way through all the leads [and] all of the issues have been fully played out." He told the Generic Drugs Advisory Committee that there is "some reasonable probability" the agency "will continue referrals for criminal prosecution, based on the information the field has generated at this time".