FDA Slow In Banning Fraudulent Drug Researchers

Greg Webb

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In a report scheduled for release on Thursday, Congressional investigators say the Food and Drug Administration (FDA) pays little attention to its duty to ban investigators that are convicted of fraud; it is so disorganized that it takes an average of four years to complete its actions. For example, Delfina Hernandez helped to implement one of the most audacious drug research frauds in American history. Hernandez was a study coordinator at the Southern California Research Institute, a drug testing operation in Whittier, California that federal agents raided in 1997. The institute conducted more than 170 drug studies for almost every major drug manufacturer in the world and regularly falsified patient records and data while doing so. Hernandez plead guilty to fraud, thus requiring the FDA to ban her from participating in further drug research. The agency had five years after her conviction to act, however, because regulators sent her a legal notice years late and to the wrong address, she can legally continue to conduct research. When the agency finally learned of its mistake, it was too late for the ban to take affect.

In a review of eighteen proceedings, investigators from the Government Accountability Office ("GAO") found it took anywhere between one to eleven years to complete its ban on fraudulent researchers. This means the researchers were able to conduct experiments for years following their supposed ban. The FDA has claimed it has corrected this problem with increased staffing and centralized coordination. House Representative Joe Barton, the senior Republican on the House Energy and Commerce Committee, criticized the FDA’s slowness in banning fraudulent investigators and has promised to introduce legislation to give the agency more power to ban researchers convicted of fraud from later participating in any kind of human research.

Congress needs to act quickly and decisively to correct this "loophole". This type of governmental oversight is unacceptable.