Democrats Question Accuracy Of FDA Chief's Testimony

Friday, March 30th 2007, 7:03 pm

By: News On 6

WASHINGTON (AP) _ House Democrats are investigating whether FDA Commissioner Andrew von Eschenbach lied under oath about the antibiotic Ketek, which has long been under scrutiny by Congress.

The seriousness of the inquiry was outlined in a letter sent Thursday to Health and Human Services Secretary Mike Leavitt. The letter requested that the department make available by the close of business Wednesday all documents used to prepare von Eschenbach for his testimony. Also, the lawmakers asked Leavitt to make available all senior staff and counsel who participated in preparing him for his testimony.

The employees who assisted von Eschenbach will be allowed to have personal attorneys with them at the questioning, but no other employees of the department will be allowed to participate in the interviews.

The letter was signed by Reps. John Dingell, chairman of the House Energy and Commerce Committee, and Bart Stupak, chairman of the committee's oversight and investigations subcommittee. Both lawmakers are Democrats. No Republicans signed the letter.

Bill Hall, a spokesman for the Health and Human Services Department, said officials were still reviewing the letter on Friday and will determine in a timely fashion what the appropriate response will be. Neither Hall nor an FDA spokesman had further comment.

The Food and Drug Administration approved Ketek in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. However, in February, the agency restricted the drug's use only to treat pneumonia and not the less-serious illnesses.

The agency said it and manufacturer Sanofi-Aventis SA also created a guide for patients outlining the drug's risks and its safe use.

At a hearing by his subcommittee on March 22, Stupak aggressively questioned von Eschenbach about a questionable study of the drug before it was approved. The study was marred by fraud involving one of the 1,800 sites that enrolled patients given the drug.

But Von Eschenbach said the study was not used as part of the decision to approve Ketek.

``That is false,'' Stupak said during the hearing.

The congressman said he believed the doctor was being forthright. ``But whoever is doing your work is trying to lead this committee down the wrong path. We know these issues. We are on top of these issues, so when you come and give us testimony that isn't accurate, we are going to call you on it,'' Stupak said.