Panel may issue subpoenas related to FDA drug approval

The House Energy and Commerce Oversight and Investigations Subcommittee will vote Tuesday on subpoenaing Food and Drug Administration criminal investigators and documents related to a potentially deadly drug the FDA approved despite receiving fabricated data, according to a subcommittee memo obtained by CongressDaily.

The subpoenas may be part of the panel's investigation into whether pharmaceutical company Sanofi-aventis knew of critical integrity problems in clinical trial data it submitted to FDA on the antibiotic Ketek. Sanofi-aventis's lead researcher on the largest Ketek clinical trial, Anne Kirkman-Campbell, pleaded guilty to mail fraud in 2004 in connection with accusations she enrolled weight-loss patients and others in the trial who did not suffer from the respiratory illnesses Ketek treats.

The panel might subpoena FDA investigators Robert West and Douglas Loveland and former investigator Robert Ekey as well as Ann Marie Cisneros, who was a contractor who oversaw the Kirkman-Campbell study and said she reported problems to Sanofi-aventis to no avail, according to the subcommittee memo sent Friday. The subcommittee also is after a document that is expected to reveal investigators recommended that Sanofi-aventis deserved prosecution, not just Kirkman-Campbell, for knowingly submitting false trial data. FDA handed over the note to the subcommittee but redacted the entire document.

Senate Finance ranking member Charles Grassley, R-Iowa, who first looked into Ketek as chairman of the committee, and Energy and Commerce Committee leaders have questioned whether FDA conspired to approve Ketek despite knowing about the false trial results. FDA has maintained it largely excluded Kirkman-Campbell's study data and relied mostly on European data.

The subcommittee also wants FDA Commissioner Andrew von Eschenbach's briefing book from a March 22 subcommittee hearing where he was accused of making false statements regarding Ketek's approval. Lawmakers want to know whether the commissioner was deliberately misled in preparation for the hearing. They have tried requesting the briefing documents, but HHS has denied the request. FDA approved Ketek in 2004 and just a year ago pulled approval of the drug for two of the more minor illnesses it treated, chronic bronchitis and acute bacterial sinusitis.

FDA agreed with its expert advisory panel that determined in December 2006 that Ketek had not proved beneficial to treat the respiratory illnesses in light of its risk. Ketek remains approved to treat pneumonia. In addition to the Ketek subpoenas, the subcommittee also will vote whether to subpoena documents related to its investigations into generous bonuses FDA distributed, particularly $5,000 bonuses given to its civilian physician employees.