Bush administration refuses to provide briefing papers on Ketek.

The Bush administration failed to comply with a congressional subpoena seeking documents related to Sanofi-Aventis's antibiotic Ketek, Bloomberg news service reported.

An investigative subcommittee of the House Energy and Commerce Committee sought briefing papers used to prepare FDA Commissioner Andrew von Eschenbach for testimony he gave at a hearing on the drug in March. The administration's response was released by the panel Feb. 12.

The subcommittee last year began investigating whether von Eschenbach gave misleading testimony on Ketek at the hearing. The commissioner and FDA are under scrutiny from lawmakers who say the agency hasn't done enough to ensure the safety of Ketek and other medications. The subcommittee held a hearing Feb. 12 on Ketek, which has been linked to fatal side effects.

"The department has serious concerns about providing the kind of materials the committee has subpoenaed," wrote officials of FDA and the Health and Human Services Department in a letter to the committee.

Providing "such highly confidential and deliberative materials used to prepare witnesses testifying before Congress risks chilling the open exchange of views that is essential to the effective conduct of agency business," wrote Vincent Ventimiglia Jr. of the health department and Susan Winckler of FDA.

The agency offered to brief the committee on issues concerning von Eschenbach's testimony, and the panel hasn't responded, according to the letter.

Rep. John Dingell (D-MI), chairman of the Energy and Commerce Committee, said at the hearing that he supports holding HHS Secretary Michael Leavitt in contempt for failing to comply with the subpoena.

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

FDA prohibited marketing Ketek for sinusitis and bronchitis last year after it was linked to liver damage and death in some patients. The drug remains on the U.S. market for pneumonia.

During the hearing before the investigative subcommittee, lawmakers questioned the accuracy of von Eschenbach's written testimony about Ketek. People with first-hand knowledge of FDA's oversight of Ketek "have also raised questions about whether the commissioner or those who helped prepare his testimony intentionally misled the subcommittee," wrote Dingell and Rep. Bart Stupak (D-MI) in a letter to Leavitt after last year's hearing. Stupak is chairman of the investigative panel.

The letter from the lawmakers included an article quoting David Ross, a former FDA scientist who worked on Ketek, saying von Eschenbach's written testimony contained erroneous comments about the agency's handling of the medication. Ross, who detailed his objections to the testimony to reporters at the hearing, took issue with descriptions of what FDA knew about a falsified clinical trial and what information regulators took into account when approving the drug.

The Feb. 12 hearing focused on whether Aventis, a predecessor company to Sanofi, knew when it submitted data from a Ketek clinical trial to FDA that a researcher's results were falsified.

Aventis failed to supervise properly the researchers in the Ketek trial, FDA said in an October warning letter to Sanofi. The company didn't "adequately investigate" reports that a researcher produced false data and enrolled ineligible patients, the agency said.