FDA Accepts Researcher’s Response to Warning Letter

The FDA has agreed to a corrective action plan submitted by clinical investigator David Vesole in response to a warning letter that cited him for twice waiting more than a month before reporting patient deaths to the institutional review board (IRB).

Vesole said his corrective action plan addressed each of the deficiencies cited in the May 30 warning letter, which cited him for violations in drug studies he conducted while at the Medical College of Wisconsin in Milwaukee.

Among other things, the warning letter said he had failed to promptly report three other serious adverse events apart from the deaths to the IRB and the sponsor.

He also was cited for failures in informed consent, patient enrollment and reports to the IRB, as a result of which its approval of the study expired. In addition, the warning letter said Vesole did not perform required study procedures nor maintain records of the disposition of the investigational drug.

The warning letter to Vesole can be accessed at www.fda.gov/foi/warning_letters/s6407c.pdf.