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Controversial FDA Official Tom Laughren Retires


12/7/2012 7:36:23 AM

One of the more controversial figures at the FDA over the past decade quietly retired late last month. Tom Laughren, who was the director of the Division of Psychiatry Products in the Office of New Drugs in the Center for Drug Evaluation and Research, departed the FDA after spending nearly 20 years at the agency, an FDA spokeswoman confirms. A board certified psychiatrist who co-authored numerous medical papers, he oversaw FDA approval, labeling decisions and guidance documents that influenced the fate some of the best-known psychiatric drugs marketed in the US and helped make him one of the more notable figures in the field of psychiatry. Laughren, who began his FDA career as a clinical reviewer in the former Division of Neuropharmacological Drug Products in 1986, also played a pivotal role several years ago in the agency handling of a pair of long-running controversies over the safety and use of antidepressants and antipyschotics in young children. At the time, many antipsychotics were not approved for children, although prescribing was widespread, despite the risks of such side effects as weight gain and diabetes. Meanwhile, there was growing public pressure to increase warnings about the risk of suicide in youngsters who were treated with antidepressants. For these reasons, Laughren was often on the hot seat at FDA advisory committee meetings and at Congressional hearings, where he was a lightning rod for critics who complained the agency was failing to protect public health by not moving faster to warn physicians and patients of the inherent risks of the medicines.

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