Ketek Hearing Wrap-up

Numerous highlights came out of yesterday’s hearing on Ketek (see previous post for background info).

An FDA criminal investigator testified that drug maker Sanofi-Aventis should have known fraud was present, calling the episode a “catastrophic failure.”

What has greater continuity, however, is that Michigan Democrats Bark Stupak and John Dingell are threatening to hold Health and Human Services Secretary Michael Leavitt in contempt for failing to turn over subpoenaed material. Those documents relate to whether FDA officials knew about fraudulent trial data before approving Ketek.

Specifically, the documents are briefing papers that FDA Commissioner Andrew von Eschenbach utilized when preparing for House testimony regarding Ketek last year. But Dingell is hinting at a perjury charge. From the AP:   

Von Eschenbach testified the FDA did not use the flawed safety study to approve Ketek. Dingell and other Democrats say that statement may be untrue.

"What is in those briefing books that he does not want either my Republican colleagues or our side to see? Is there evidence of perjury?" asked Dingell.

We’ll keep you updated.

-- Dylan Blaylock