Von Eschenbach Defends Agency Decisions Before House Subcommittee

In his latest appearance before a congressional committee, FDA Commissioner Andrew von Eschenbach once again defended the agency's approval of the controversial antibiotic Ketek.

Von Eschenbach provided the House Subcommittee on Oversight and Investigations with a detailed, step-by-step summary of the FDA's approval of the antibiotic Ketek as well as copies of internal emails related to Ketek's approval process. But much of the discussion focused on whether data from a fraudulent clinical trial, known as Study 3104, was used by an FDA advisory committee in deciding whether to approve Ketek.

While von Eschenbach said that was not the case, subcommittee Chairman Bart Stupak (D-Mich.) said the contents of some of the emails and the FDA's actions indicated the agency had used the data. For instance, Study 3014 is included on the FDA's website of Ketek's approval information, Stupak said, and he asked why von Eschenbach's sworn testimony contradicted other information from the agency. Von Eschenbach replied that the website was incorrect and emphasized the decision to approve Ketek happened after the agency discounted the results of Study 3014.

Former FDA employee David Ross called von Eschenbach's testimony "remarkably short on details" and said that no one has been held accountable for Ketek. The data to approve Ketek's safety "was just not there," according to Ross, who was the drug's primary reviewer. Ross testified at a previous subcommittee hearing on Ketek's review process and the agency's culture.

Ketek was also at the center of criticism of the agency's enforcement activities. Rep. Ed Whitfield (R-Ky.) noted that Anne Kirkman-Campbell, the investigator who oversaw Study 3014, has not been disqualified from conducting future clinical trials, and is still eligible to "receive investigational drugs" even though she is currently serving a 57-month prison sentence for fraud associated with the study. Kirkman-Campbell enrolled patients in the trial on days when the office was closed, enrolled her entire staff in the study and blatantly forged consent documents, according to a witness at a previous committee meeting.

( http://www.fdanews.com/did/6_59/ )