Federal investigators have reported that the Bush-era FDA routinely allowed drug researchers previously convicted of fraud to continue drug experiments despite federal law banning them. The GAO found that in one case the FDA waited four years before initiating a research ban on one researcher convicted of falsifying patient records during drug studies. The overall time period for the FDA to complete the process to ban a convicted researcher was between one to eleven years. For example, in 2003, Dr. Anne Kirkman-Campbell used fraudulent data in the clinical trials of Ketek, the antibiotic linked to liver failure. She pled guilty to mail fraud in 2003 but was not banned by the FDA until September 2008.
Why should we be concerned? Because when the FDA fails to act promptly, convicted researchers are allowed to continue work on important testing of drugs that eventually become available to the average consumer. The FDA must be held to the highest standards in the development of drugs and medical devices that can be a threat to patient safety.
Even the senior Republican on the House Commerce Committee, Rep. Joe Barton, criticized the ineptness of the Bush administration FDA. The current administration says it has improved the process of vetting researchers with increased staffing and centralized coordination. As Rep. Barton said, “The problems at FDA are daunting but with a little common sense and modest legislation the American public can be ensured of their safety when consuming FDA-approved drugs and devices.
Richard J. Arsenault, 2011
