House Members Question Von Eschenbach's Ketek Testimony

Two leading House lawmakers are investigating FDA Commissioner Andrew von Eschenbach's recent testimony on Ketek over concerns that he may have "intentionally misled" a subcommittee about the drug's approval process.

House Committee on Energy and Commerce Chairman John Dingell (D-Mich.) and House Subcommittee on Oversight and Investigations Chairman Bart Stupak (D-Mich.) sent a letter to HHS Secretary Mike Leavitt requesting all the documents used to prepare von Eschenbach's testimony before the subcommittee. In addition, the representatives requested that all senior staff and counsels who helped prepare the testimony arrange interviews with House committee staff.

At the actual subcommittee hearing, Stupak said whoever prepared von Eschenbach's testimony was trying to deceive the committee. The commissioner provided the committee with a detailed summary of the FDA's approval of the antibiotic Ketek, as well as copies of internal emails related to the approval process.

Von Eschenbach told the committee that an FDA advisory committee had not used data from a fraudulent clinical trial in its decision to approve Ketek. However, Stupak said the contents of some agency emails indicated the FDA had used the data. The commissioner's testimony also contradicted other information from the agency, he added.

Dingell and Stupak attached former FDA employee David Ross' critique of the commissioner's testimony to the letter. Ross, who was the primary safety reviewer on Ketek, accused von Eschenbach of making 11 false statements during the subcommittee hearing.

Following the most recent subcommittee hearing, Ross said von Eschenbach's testimony was "remarkably short on details." Previously, Ross told the subcommittee that FDA officials did nothing despite knowing the safety concerns with Ketek.

HHS did not respond to a request for comment.

( http://www.fdanews.com/did/6_66/ )