Executive Summary

Firm is amending its process for reviewing drug studies in light of conclusions by an independent reviewer that its current procedures were partly to blame for Bayer's failure to disclose Trasylol data to FDA prior to a September 2006 advisory committee meeting. Bayer's Protocol Review Committee oversight will be extended to company-sponsored or co-development studies in six categories, including pharmacoepidemiological studies such as the i3 Drug Safety study of Trasylol, company says in an Aug. 17 press release. Bayer came under fire last year when it was revealed two employees knew of preliminary results of the i3 study but did not disclose them before the agency's Cardiovascular and Renal Drugs Advisory Committee meeting, which was convened to review Trasylol's safety. Overall, the report by William Taylor, a partner with Zuckerman Spaeder, exonerates Bayer staff and blames the issue on operational factors and "human error"...