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October 22, 2009

F.D.A. Lags in Banning Researchers After Fraud


WASHINGTON — Delfina Hernandez helped to carry out one of the most audacious drug research frauds in American history, but because federal drug regulators sent a legal notice years late and to the wrong address, she can legally continue to conduct research.

Ms. Hernandez was a study coordinator at the Southern California Research Institute, a drug testing operation in Whittier, Calif., that federal agents raided in 1997. The institute, which was led by Dr. Robert Fiddes, helped conduct more than 170 drug studies for nearly every major drug maker in the world and routinely falsified data and patient records while doing so.

Ms. Hernandez pleaded guilty to fraud, and federal law required the Food and Drug Administration to ban her from participating in further drug research. The agency had five years after her conviction in which to act.

But in a report scheduled for release on Thursday, Congressional investigators say the agency pays so little attention to its responsibilities to ban investigators convicted of fraud and is so disorganized about carrying them out that its actions take an average of four years to complete.

The agency did not send a notice to Ms. Hernandez until more than four years had passed, and then it went to the wrong address. When the agency realized its mistake, the ban against Ms. Hernandez could not take effect because time had run out.

Ms. Hernandez could not be reached for comment.

In a review of 18 proceedings, investigators for the Government Accountability Office found that the F.D.A. took from 1 to 11 years to complete its process to ban researchers. This means many who were convicted of fraud remained eligible to conduct experiments for years.

Anticipating the office’s findings, the drug agency released a statement saying it had improved the process with increased staffing and centralized coordination.

“The F.D.A. views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,” said Norris Alderson, the agency’s associate commissioner for science. “We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.”

Representative Joe L. Barton of Texas, the senior Republican on the House Energy and Commerce Committee, criticized the drug agency’s slowness in banning fraudulent investigators. Mr. Barton noted the example of Dr. Anne Kirkman-Campbell, an Alabama doctor who participated in trials of Ketek, an antibiotic that has been linked to liver failure.

Dr. Kirkman-Campbell was among several Ketek investigators whose data were found to be fraudulent. She was prosecuted for mail fraud and pleaded guilty in 2003, but the F.D.A. did not ban her from taking part in drug tests until Sept. 2, 2008.

Dr. Kirkman-Campbell could not be reached for comment.

Mr. Barton said he would introduce legislation to give the agency more power to ban researchers convicted of fraud from later participating in any kind of human research.

“The problems at F.D.A. are daunting,” he said, “but I think that a little common sense and some modest legislating can ensure that American families will be safe.”