ParfumGigi@aol.com

Associated Press 02.12.08, 6:20 AM ET

WASHINGTON -

Lawmakers are expected to question a Sanofi-Aventis executive Tuesday on whether the company knew data included in a large-scale study of an antibiotic was fraudulent.

The 10 a.m. hearing, titled: "Ketek Clinical Study Fraud: What did Sanofi-Aventis know?" is the House Energy and Commerce Committee's fifth focusing on the antibiotic Ketek. The drug, approved in 2004, received FDA's most serious warning last February after several patients taking it suffered liver failure.

Since then, government investigators revealed that several physicians hired by Sanofi predecessor Aventis falsified data in a 1,800-patient study of Ketek. Sanofi said in a statement Monday it has "learned important lessons" from the study and implemented changes in "policies, practices and personnel," to address the problems.

FDA has previously said the study was not used to approve Ketek. But that hasn't stopped Energy and Commerce Committee Chairman John Dingell from alleging that the agency wrongly cleared the drug despite knowledge of the botched data.

The committee has subpoenaed four FDA staffers who conducted their own probe of the Ketek approval.

Bart Stupak, D-Mich., who chairs the Energy and Commerce Subcommittee for Oversight and Investigations, is expected to question two of those staffers Tuesday. Also scheduled to appear are Sanofi-Aventis Research and Development President Paul Chew, as well as employees from Pharmaceutical Product Development Inc., a research contractor that helped conduct the study of Ketek.