SEN. KASSEBAUM'S FDA REFORM BILL TIGHTENS REVIEW PERFORMANCE DEADLINE TO MID-1998; THIRD-PARTY PREMARKET REVIEW OPTION OPPOSED BY LABOR CMTE. CHAIR
This article was originally published in The Gray Sheet
Executive Summary
FDA reform legislation (S 1477) introduced Dec. 13 by Senate Labor and Human Resources Committee Chair Nancy Kassebaum (R-Kan.) presents the agency with a stiff deadline for meeting review performance goals in order to avoid default to third-party product reviews. However, it is a challenge Kassebaum seems to believe FDA can meet, given the Kansas Republican's preference for allowing the agency to implement its own changes rather than going to third-party review.