Bayer pinned its failure to tell the FDA about a study regarding heart surgery drug Trasylol on an error by two unnamed individuals, as it hired outside counsel to investigate the matter.
On Sept. 27, the FDA issued an advisory alerting the public that Bayer had failed to tell it about an examination of hospital records by 67,000 patients who had used Trasylol, even though Bayer scientists had appeared at an FDA advisory committee meeting just six days prior. The examination had suggested a risk of serious renal and cardiovascular toxicity with the drug. The FDA learned of the Trasylol study from a researcher involved in it -- Alexander Walker, a professor at Harvard’s School of Public Health.
Dr. Roland Hartwig, Bayer AG general counsel, said in a statement that the omission was due to “a serious error in judgment by two individuals,” adding that they have been suspended. He said that Bayer has retained Fred Fielding, from the law firm Wiley Rein & Fielding, in Washington, DC, to investigate the matter and to advise it regarding a subsequent course of action. Fielding’s findings on how and why the error occurred, and how to ensure that such errors are not repeated, will be published when they are complete, the statement added.
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