Democrats work to subpoena FDA investigators

-The Hill

01/29/2008 - Frustrated House Democrats will try to subpoena several Food and Drug Administration officials Tuesday as part of an investigation into whether FDA criminal investigators sought to prosecute a drug company in connection with a flawed drug that killed several people.

The House Oversight and Investigations Subcommittee is to vote on the subpoenas Tuesday, the latest development in an ongoing probe into FDA’s approval of a  respiratory illness treatment called Ketek.

Democrats on the subcommittee also want to look at the briefing book used by FDA Commissioner Andrew von Eschenbach to determine whether he was misled when he offered testimony last year about the approval process of the drug before Congress. After his testimony, several members raised questions about whether he had misled the subcommittee.

The panel will consider subpoenas of two FDA criminal investigators, one former investigator and a drug researcher who monitored a clinical trial of Ketek, along with several documents.

Committee documents obtained by The Hill indicate that staffers are frustrated that FDA redacted an investigative memorandum from the FDA Office of Criminal Investigations before showing it to the committee. That memorandum is believed to show the scope of FDA’s criminal investigation and may recommend criminal prosecution for submitting fraudulent clinical data.

“A redacted copy was provided to the committee staff, but it provides no information as it was essentially blank,” a committee memo states.

The committee is also irritated that FDA has refused to provide von Eschenbach’s briefing book and related documents, though FDA has not provided any legal justification for the refusal.

FDA officials respond that they have been cooperative with the committee in the investigation.

“FDA has provided more than 80,000 pages of information on Ketek to the committee,” the FDA said in a written statement. “We also have made staff available who have met with the committee, and we have made every effort to be responsive to the committee’s requests.”

The pharmaceutical firm Sanofi-Aventis won FDA approval for Ketek as a treatment for respiratory illnesses in April 2004. Some considered it a “blockbuster drug” for the company. More than 28 million prescriptions have been sold worldwide.

By 2006, physicians were reporting that Ketek was linked to severe and even fatal liver problems. By the end of that year, the drug had been linked to four deaths.

A congressional investigation revealed that the drug was approved by the FDA despite the discovery that one doctor had fabricated data in a clinical trial.

The subcommittee has been investigating Ketek for a year, as has Sen. Chuck Grassley (R-Iowa), who started his investigation when he was chairman of the Senate Finance Committee.

House Oversight and Investigations Chairman Bart Stupak (D-Mich.) has said his investigation into Ketek and another drug, Avandia, are part of a stepped-up oversight effort in Congress.

If you or a loved one have experienced liver damage, liver failure, or Stevens Johnson Syndrome as a result of Ketek side effects contact the Ketek attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and attorneys are standing by to answer any questions you may have regarding Ketek side effects, a possible Ketek class action lawsuit, or any other type of Ketek litigation.