FDA cites Sanofi for shoddy study oversight.

U.S. regulators have reprimanded Sanofi-Aventis for poor oversight of investigators doing a clinical study of its antibiotic drug Ketek, said a letter released by FDA Oct. 24, Reuters reported.

According to an 11-page warning letter to the company, FDA said Sanofi failed to oversee investigators who may have falsified study documents, among other violations, during one of the company's clinical trials of the drug.

The agency chided the French company for failing to properly discipline study investigators, including one who eventually pleaded guilty to mail fraud in connection with a fictitious subject and was sentenced to 57 months in federal prison.

FDA investigators found evidence of possible fabrication of data and study subjects.

Sanofi-Aventis also failed to follow up on problems with informed consent from study participants, lack of proper diagnosis for patients and faulty recording of side effects experienced by subject-patients, FDA said.

Sanofi-Aventis spokeswoman Emmy Tsui said the company intends to provide a detailed response to the letter.

The letter, which cited "multiple and significant violations of FDA regulations," was sent from the Office of Human Research Protections (OHRP), which monitors the safety of human subjects in clinical research to ensure their rights are protected.

The company and FDA both noted the letter addresses a time period before the acquisition of Aventis by Sanofi-Synthelabo.

Ketek suffered several setbacks this year, largely stemming from reports of severe liver damage and death in some patients that sparked a debate about the drug's safety and the process leading up to its approval.