FDA May Fine Errant Medical ResearchersFDA May Fine Errant Medical Researchers

FDA May Fine Errant Medical Researchers

WASHINGTON--In mid-May, federal health officials proposed fines for scientists whoviolate medical research rules. The government has received criticism that it doesn'tprotect the thousands of patients involved in clinical trials, the most recent uproarinvolving a University of Pennsylvania gene therapy experiment which killed an Arizonateenager last fall. If this proposal passes, the Food and Drug Administration (FDA) couldlevy fines up to $250,000 for scientists and $1 million for universities and hospitalsviolating medical research rules.

Congress would have to pass legislation to enact these fines. In the meantime, the FDAsaid researchers need to improve on informing patients of all research risks andimplementing better day-to-day patient monitoring. For further information, visit www.usfda.gov.