White House rejects subpoena

BLOOMBERG

02/13/2008 - The Bush administration has declined to comply with a congressional subpoena for documents related to Sanofi-Aventis' antibiotic Ketek.

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

The subcommittee last year began investigating whether von Eschenbach gave misleading testimony on Ketek at the hearing. The subcommittee held a hearing yesterday on Ketek, which has been linked to fatal side effects.

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," officials of the FDA and its parent, the Health and Human Services Department, said in a letter to the committee.

The agency offered to brief the committee on issues concerning von Eschenbach's testimony, and the panel has not responded, the letter said.

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

Yesterday's hearing focused on whether Aventis, a predecessor to Sanofi, which has operations in Malvern, knew when it submitted data from a Ketek clinical trial to the FDA that a researcher's results were falsified. The researcher, Maria 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, Douglas Loveland, an FDA investigator, said at the hearing.

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

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