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Congressional and FDA Investigations
The recent safety revelations concerning Ketek® have precipitated an FDA criminal investigation into the facts, circumstances and data integrity surrounding the FDA’s approval of Ketek® for sale in the United States. Although Ketek® was denied approval by the FDA prior to 2004, the drug was approved for sale in the U.S. in April 2004. The pending criminal investigation is examining the collection and integrity of safety data that was submitted to the FDA and upon which approval was based. Serious questions have arisen over the accuracy, and some cases validity, of the safety data.
The focus of the investigation is so-called Study 3014 which was submitted to the FDA to demonstrate the safety of Ketek. The FDA’s Office of Criminal Investigation launched an investigation into the fabrication of the results set forth in 3014 and the conduct of its lead researcher, Maria Anne Campbell (a/k/a Anne Kirkman Campbell, M.D.). In August 2003, a federal grand jury handed down a 21 count criminal indictment. In October, 2003, Campbell pled guilty to one count of the indictment – mail fraud. She was sentenced to 57 months in prison. The investigation is continuing.
Of greater concern are recent allegations that the FDA, although it approved Ketek® for sale in 2004, learned of these data integrity problems as early as 2002 during the Ketek® pre-approval period. It is also alleged that the manufacturer of Ketek® was aware of the Study 3014 data integrity problems but failed to disclose these problems to the FDA. These allegations are being investigated by the Government Accountability Project.
Separately, Senator Charles E. Grassley (R-Iowa) has urged a Senate hearing on the approval and safety of Ketek® as well as the process by which the FDA issued its approval of the drug. After conducting Senate hearings on Vioxx®, Senator Grassley is concerned that the safety issues surrounding Ketek® raise serious concerns about the FDA’s drug approval process. He has written two letters to the FDA concerning the FDA’s approval of Ketek and the lack of cooperation he is receiving from FDA in the Senate’s investigation. A copy of Grassley’s December 13, 2006 letter report can be seen by clicking here.
If you or a loved one developed liver disease or failure, or symptoms of liver failure, during or after treatment with Ketek®, please click HERE for information about your potential legal rights.
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