Bayer has appointed an independent counsel to review the company's actions in regards to disclosure of preliminary results from an observational study on Trasylol® to the USFDA.
Fred F. Fielding Esq., from the law firm Wiley Rein & Fielding LLP has been retained by Bayer and charged with conducting a complete and thorough investigation into the matter and with providing recommendations to Bayer regarding subsequent actions that the company should take.
According to Dr. Roland Hartwig, General Counsel, Bayer AG (NYSE: BAY):
Bayer has acknowledged and regrets the error it made in not sharing with the FDA information regarding this study prior to the September 21st Advisory Committee Meeting on Trasylol(R).
Bayer immediately initiated a full investigation into the matter and based on our investigation so far, we believe this was a serious error in judgment by two individuals. These individuals have been suspended with immediate effect.
We are committed to ascertaining how and why this error occurred, and to ensure that such errors are not repeated we have now retained Mr. Fielding, an attorney of the highest reputation for integrity and independence, to carry on this investigation."
Trasylol® is Bayer’s broad-spectrum proteinase inhibitor that modulates the systemic inflammatory response associated with cardiopulmonary bypass (CPB) in the course of CABG surgery.
Trasylol® has been USFDA approved in 1993 and is the only product indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing CPB in the course of CABG surgery.
Read more at the issue at Bayer’s press release.
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