FDA Criticizes Sanofi-Aventis for Failing to Act on Ketek Trial

An FDA warning letter citing sanofi-aventis for failing to respond to reports of problems with a clinical trial for its antibiotic Ketek and not overseeing the trial’s investigator has rekindled a congressional investigation into the drug’s approval process.

The FDA criticized the company for failing to ensure investigators were in compliance, monitor clinical trials and ensure the trials met protocols.

Ketek (telithromycin) has drawn the ire of FDA critics, including some in Congress who say the agency may have misled lawmakers about the drug’s approval process.

House Energy and Commerce Committee Chairman John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Bart Stupak (D-Mich.) called the letter a vindication of the whistleblowers who testified at a February committee hearing. At the hearing, David Ross, who was the primary safety reviewer for Ketek, named six FDA employees who “did nothing” despite receiving multiple warnings on adverse events with Ketek. Ross left the FDA after the Ketek review.

The committee will now obtain the agency’s entire closed criminal case file and interview agents the FDA has not allowed committee members to talk to, Stupak said. “With this warning letter to sanofi-aventis, FDA’s last excuse for blocking our committee’s investigation has been stripped away,” he said.

Most of the 11-page warning letter focuses around Study 3014, the clinical trial overseen by investigator Anne Kirkman-Campbell that ended in 2002. An agency investigation found that Kirkman-Campbell had falsified case report forms and documentation to prove the existence of a fictional trial subject. She is serving a 57-month prison sentence for fraud. The FDA did not rely on Study 3014 in its decision to approve Ketek, and the company conducted the study in good faith, a sanofi-aventis spokeswoman said. The company will respond to the allegations in the letter.

The warning letter can be seen at www.fda.gov/cder/warn/2007/07-HFD-45-1002.pdf.