WASHINGTON, Oct 24 (Reuters) - U.S. regulators have reprimanded Sanofi-Aventis SASY.PA for shoddy oversight of investigators doing a clinical study of its antibiotic drug Ketek, said a letter released by the government on Wednesday.
The Food and Drug Administration, in an 11-page warning letter to the company, said Sanofi failed to oversee renegade investigators who may have falsified study documents, among other violations, during one of the company’s clinical trials of the drug.
The FDA 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.
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, the FDA said.
Sanofi-Aventis spokeswoman Emmy Tsui said the company intends to provide a detailed response to the letter.
She said the study was conducted in good faith, but has been the subject of much discussion. Sanofi has acknowledged that “various deviations occurred, including investigator fraud, and FDA did not rely upon this study in approving Ketek,” she added.
The letter, which cited “multiple and significant violations of FDA regulations,” was sent from an arm of the agency that 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.
The FDA issues dozens of warning letters each year and many resolve themselves without further action. In rare cases, a warning can lead to product seizures or hold up approval of new products.
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