Ketek Fraudulent Clinical Trials Prove FDA Not Doing Its Job, Congress Says
June 11th, 2008 amy
Congress is once again questioning whether the FDA knows how to do its job, and the fraudulent Ketek clinical trials are being used as a prime example of the lack of proper action taken by the FDA’s Office of Criminal Investigations (OCI) branch. Members of Congress are questioning the management and priorities of OCI in the context of the FDA budget problems.
The Wall Street Journal reports that Sen. Chuck Grassley of Iowa has asked the Government Accountability Office (GAO), to review whether OCI dropped some cases because of direction from other FDA officials. The Senator’s request follows questions raised by Democrats on the House Energy and Commerce Committee in February during a hearing on Ketek, a dangerous antibiotic made by Sanofi-Aventis. OCI agents testified about their unsuccessful efforts to initiate a task force on Ketek that would have looked at whether Sanofi’s executives knew that an outside contractor had used fraudulent data in a clinical trial of the drug. The WSJ also reports that Rep. Bart Stupak (D., Mich.), who leads the Ketek investigation in the House, wrote in a release that “OCI management did not follow through on the line agents’ work, and recommendations to expand fraud investigations were ignored.”
The company says it acted in good faith and didn’t know the clinical-trial data were fake. An outside researcher went to federal prison. FDA officials say they acted appropriately. In November, a year after Mr. Grassley began an investigation into Ketek, the FDA sent a warning letter to Sanofi about its lax oversight of that study.
Rep. Joe Barton of Texas, the ranking Republican on the House Energy and Commerce Committee, is rightly concerned that OCI may be too focused on abuse of drugs such as Oxycontin or ingredients for methamphetamine, where the FDA agency’s efforts may duplicate those of the Drug Enforcement Administration, FBI and local police, a spokeswoman for Mr. Barton says. Mr. Barton wants the OCI to say how many cases it started on its own, she said.
