US panel OKs subpoenas in Sanofi antibiotic probe
WASHINGTON, Jan 29 (Reuters) - A U.S. House of Representatives panel voted on Tuesday to subpoena documents from a member of President George W. Bush's cabinet for a February hearing on the Ketek antibiotic made by Sanofi-Aventis (SASY.PA).
The panel has been investigating how France's biggest pharmaceutical company and the FDA handled Ketek, which the agency approved in 2004 despite finding that a key safety study, known as Study 3014, was tainted by fraud.
The House Energy and Commerce oversight and investigations subcommittee voted 12-0 to issue a subpoena to Health and Human Services (HHS) Secretary Michael Leavitt, asking him to produce unredacted records prepared for the FDA commissioner's appearance at a March 2007 hearing on Ketek. Leavitt's department oversees the FDA.
The FDA and HHS have refused to provide those documents, said Rep. Bart Stupak, a Michigan Democrat and the subcommittee chairman.
The panel also approved subpoenas for two current FDA investigators, one former FDA investigator and a former employee of a company that monitored the controversial study.
Stupak said congressional investigators had interviewed most of those witnesses but needed subpoenas to compel their testimony at a hearing scheduled for Feb. 12.
The panel wants to question the witnesses about "their knowledge of whether Aventis was aware of substantial data integrity problems in Study 3014 at the time of submission to FDA," Stupak said. Aventis was bought by Sanofi-Synthelabo and merged to form Sanofi-Aventis.
Reports of severe liver damage and death in some Ketek users emerged in 2006. The FDA withdrew Ketek's approval for sinusitis and bronchitis in 2007 after deciding the drug was too risky for treating those relatively mild infections. Sanofi still sells Ketek to treat pneumonia.
FDA spokeswoman Karen Riley said the agency had provided more than 80,000 pages of Ketek information to House investigators and would continue to cooperate with the probe.
"We also have made staff available who have met with the committee, and we have made every effort to be responsive to the committee's requests," she added.
HHS spokeswoman Christina Pearson said the health department had "worked hard to be responsive to congressional requests related to Ketek" for the past two years.
"We will continue to work with the House toward a solution that is responsive but will not compromise investigations or the ability of senior officials to obtain accurate information and frank advice from their staffs," she said.
Sanofi-Aventis spokeswoman Julissa Viana repeated earlier comments saying Aventis was not aware of the fraud in Study 3014 until after it was submitted to the FDA.
"We have critically reviewed the record of the clinical study being reviewed and have identified important lessons learned to improve policies and procedures," she said.
(Reporting by Lisa Richwine, editing by Richard Chang)
