Bush Administration Fails To Comply With Subpoena For Documents On Testimony About FDA Approval Of Ketek

Main Category: Litigation / Medical Malpractice
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 14 Feb 2008 - 5:00 PST

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Members of the House Energy and Commerce Oversight and Investigations Subcommittee on Wednesday said that the Bush administration has failed to comply with a subpoena for documents used to prepare testimony from FDA Commissioner Andrew von Eschenbach about the antibiotic Ketek, manufactured by Sanofi-Aventis, Bloomberg/Philadelphia Inquirer reports (Blum, Bloomberg/Philadelphia Inquirer, 2/13). In response, leaders of the Energy and Commerce Committee might hold HHS Secretary Mike Leavitt in contempt (Edney, CongressDaily, 2/12).

During a hearing held by the subcommittee in March 2007, von Eschenbach testified about issues related to FDA approval of Ketek, which reports have linked with a number of serious side effects (Bloomberg/Philadelphia Inquirer, 2/13). The committee "has tried to pry the briefing book from FDA since shortly after the hearing, in which von Eschenbach was accused of misleading lawmakers on more than a dozen points concerning the agency's approval" of Ketek, CongressDaily reports. The committee issued a subpoena for the documents earlier this month (CongressDaily, 2/12).

In letter to Energy and Commerce Committee Chair John Dingell (D-Mich.), HHS officials characterized the subpoena as "overly broad" and said the release of the documents would limit the ability of the department to have an "open exchange of views that is essential to the conduct of agency business," CQ Today reports (Armstrong, CQ Today, 2/12). Vincent Ventimiglia, HHS assistant secretary for legislation, and Susan Winckler, FDA chief of staff, said that the agency has responded to all of the questions from the committee about the testimony from von Eschenbach.

Dingell on Tuesday said that the committee should hold Leavitt in contempt for failure to comply with the subpoena. However, subcommittee Chair Bart Stupak (D-Mich.) said that he, Dingell, committee ranking member Joe Barton (R-Texas) and subcommittee ranking member John Shimkus (R-Ill.) will discuss their options. Stupak said, "What is in those briefing books that (Leavitt) does not want either my Republican colleagues or our side to see? Is there evidence of perjury? Are there statements embarrassing to the administration?" (CongressDaily, 2/12).

Subcommittee Hearing, Sanofi-Aventis Response
In related news, Stupak on Wednesday during a hearing held by the subcommittee said that he plans to shift an investigation of Sanofi-Aventis related to Ketek to the Department of Justice, CongressDaily reports. The subcommittee has begun an investigation into whether Sanofi-Aventis intentionally submitted to FDA inaccurate data from clinical trials of Ketek.

According to Paul Herbert Chew, president of the U.S. research and development division at Sanofi-Aventis, an internal review found significant problems at 10 sites that conducted the trials but no evidence of fraud. He said that Sanofi-Aventis did not report the problems when the company submitted the data to FDA but corrected them through documentation (Edney, CongressDaily, 2/13). Lawmakers "asserted that findings from investigations" into Ketek "show that the integrity of the entire drug approval process is in doubt," CQ HealthBeat reports (Reichard, CQ HealthBeat, 2/12).

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