FDA ISSUES WARNING LETTER FOR LISTERIA AND SALMONELLA VACCINE STUDIES

The FDA sent a warning letter to Elizabeth Hohmann of Massachusetts General Hospital in Boston for studies of vaccines for listeria and salmonella for which she served as sponsor and clinical investigator.

The warning letter, issued July 10 and made public Aug. 1, cites Hohmann for failing to submit an investigational new drug application in the listeria trial, in the course of which she " administered an unapproved attenuated strain of listeria vaccine to at least 20 subjects" between October 1999 and December 2001, and continued the study until Aug. 2, 2004. In her reply to the warning letter, she wrote, "I acknowledge and accept responsibility for this violation. All studies I have undertaken since December 2001 involving investigational organisms have been submitted to the FDA for review."

The warning letter also states that Hohmann failed to obtain proper informed consent for eight of the 20 subjects in this study because she used a consent form that had not been approved by the study's institutional review board (IRB). In Hohmann's response letter, she acknowledged the mistake in the informed consent forms and offered proof that she had fixed the problem. The letter also said that Hohmann did not maintain adequate and accurate case histories in this trial, a mistake she said was apparently the result of a typographical error.

The warning letter further states that although the agency had placed the salmonella vaccine study on clinical hold on Sept. 25, 2003, and sent her a letter to that effect on Oct. 17, 2003, Hohmann did not notify the IRB until Jan. 2, 2004. "I apologize for and accept responsibility for this violation, which was not intended to deceive, delay or otherwise obfuscate the review of this study by the IRB or other oversight body," she replied.

Also in the salmonella study, the letter states that Hohmann "failed to promptly report the unexpected adverse events experienced by the study subjects to the IRB," such as an increase in transaminases experienced by one subject, about which the letter says Hohmann notified the IRB "nearly six weeks after the adverse event occurred." In her reply, Hohmann asserted that "the IRB was notified within the time frame specified by institutional policy (30 days)," with proof supplied in attachments.

Hohmann said she had fixed all the problems identified by the FDA and that no one had been harmed.