Lawmakers Offer HHS Secretary Leavitt Compromise To Avoid Contempt Vote Over Ketek Documents

Main Category: Litigation / Medical Malpractice
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 03 Mar 2008 - 7:00 PDT

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House Energy and Commerce Committee leaders offered HHS Secretary Mike Leavitt a compromise to avoid charging him with contempt over documents related to the approval of the antibiotic Ketek: Allow the committee to interview FDA employees involved in preparing materials for a 2007 hearing on the drug's approval, CongressDaily reports. The lawmakers also said the committee staff is willing to review the materials to see if they need copies of any part of the documents (Edney, CongressDaily, 2/28).

The compromise was offered in a letter sent to Leavitt on Wednesday and signed by committee Chair John Dingell (D-Mich.), committee ranking member Joe Barton (R-Texas), Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) and subcommittee ranking member John Shimkus (R-Ill.). The letter says that if Leavitt does not agree to terms of the letter by Friday, the subcommittee will proceed with the contempt vote (Armstrong, CQ Today, 2/28). The lawmakers said they reserve the right to invoke the subpoena if the interview results are unsatisfactory (CongressDaily, 2/28).

The contempt threat stems from Leavitt's refusal to supply documents related to FDA Commissioner Andrew von Eschenbach's testimony in March 2007 for Ketek's approval. A whistleblower group told the subcommittee that the testimony contained errors and misleading statements about the drug. Lawmakers also have questioned whether FDA should have detected problems with Ketek before it approved the drug, which has caused liver damage in some patients. The subcommittee issued a subpoena for the documents on Jan. 29 (Haberkorn, Washington Times, 2/29).

Leavitt said, "We'll work with this, and I feel optimistic we can resolve it," adding, "This is the type of dispute (that) has existed for centuries in our government, and we want to work to resolve it" (CongressDaily, 2/28).

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