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Bush Administration Doesn't Turn Over FDA Documents
Yahoo News/Bloomberg
Justin Blum
February 12, 2008

Feb. 12 (Bloomberg) -- The Bush administration failed to comply with a congressional subpoena seeking documents related to Sanofi-Aventis SA's antibiotic Ketek.

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

The subcommittee last year began investigating whether von Eschenbach gave misleading testimony on Ketek at the hearing. The commissioner and the 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 today 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," said officials of the FDA and its parent agency, 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 J. Ventimiglia Jr. of the health department and Susan C. Winckler of the 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.

`Evidence of Perjury?'

Representative John D. Dingell, a Michigan Democrat who is chairman of the Energy and Commerce panel, said at today's hearing that he supports holding the health 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?"

The panel has been investigating the FDA's 2004 approval of Ketek. Lawmakers have said the drug made by Paris-based Sanofi is an example of the FDA's weak oversight. The agency approved the product even after certain data suggested safety risks and agency scientists expressed concern.

The 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.

Accuracy of Testimony

During the March 22 hearing before the investigative subcommittee, lawmakers questioned the accuracy of von Eschenbach's written testimony about Ketek.

People with first-hand knowledge of the 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 Representative Bart Stupak, a Democrat from Michigan, 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 the FDA knew about a falsified clinical trial and what information regulators took into account when approving the drug.

Clinical Trial

Today's hearing focused on whether Aventis, a predecessor company to Sanofi, knew when it submitted data from a Ketek clinical trial to the FDA that a researcher's results were falsified. The researcher, Maria "Anne" Kirkman-Campbell, later pleaded guilty to mail fraud in the case and was sent to prison.

The company should have detected "red flags" about the bogus data before it submitted results to the FDA, said Douglas Loveland, an FDA investigator, at the hearing.

"They were loud signals," Loveland said. "They were bright signals."

Loveland said the evidence wasn't strong enough to make a legal case because he couldn't prove "beyond a reasonable doubt" what was known to the company.

While Aventis knew of deficiencies in Kirkman-Campbell's research, the company didn't know there was fraud, said Paul Herbert Chew, president of U.S. research and development for Sanofi, at the hearing.

"Aventis was unable to confirm actual fraud at the Kirkman- Campbell site," Chew said.

The company regrets it didn't detect the fraud and has since changed its procedures, Chew said.

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

To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net .

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