BAYER SUSPENDS TWO OVER FAILURE TO SHARE DATA WITH FDA

Bayer suspended two people involved in a failure to disclose study results to the FDA that showed Trasylol could cause serious side effects, the company announced Oct. 13.

The company has also appointed an independent counsel to continue the company's investigation. Fred Fielding, from the law firm Wiley Rein & Fielding, will review how and why the company withheld the results, and will recommend further actions. Bayer will publish his findings when the investigation is complete.

"Based on our investigation so far, we believe this was a serious error in judgment by two individuals," Roland Hartwig, general counsel for Bayer, said. He noted the suspensions are effective immediately.

FDA investigations into the drug began in January after two separate studies linked its use to kidney problems. On Sept. 21, an FDA advisory committee reviewed safety data and voted to recommend Trasylol as safe and effective for patients undergoing coronary artery bypass graft (CABG) surgery.

However, on Sept. 27, Bayer told the agency it had results from another safety study, which it had not shared before the meeting. The preliminary results from the study based on patient observation showed Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. At the time, the company said it had not alerted the FDA to the study because the results were preliminary.