THIRD-PARTY REVIEW PROVISIONS OF S 1477 REMAIN CONCERN, KENNEDY STAFFER SAYS;FDA COMMISSIONER TERM LIMITS LIKELY WILL TARGET KESSLER, STAFFER PREDICTS
Executive Summary
Third-party review mandates in Sen. Kassebaum's (R-Kan.) FDA reform bill (S 1477) are "more worrisome" than the bill's provision for expedited approval for drugs cleared in the European Union, said Pearl O'Rourke, MD, Robert Wood Johnson fellow to Sen. Kennedy (D-Mass.) on the Labor & Human Resources Committee. She made her remarks at the University of North Carolina-Chapel Hill's Center for Pharmaceutical Outcomes Research conference March 31.