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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Another case of the FDA not being on the ball – how many people died because of this sort of lax enforcement?

Posted in FDA Regulation

Please give me one good reason why it should take years for the FDA to ban researchers who commit 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.

Source: Agency Finds F.D.A. Can Take Years to Ban Researchers for Fraud – NYTimes.com