F.D.A. to Require Suicide Studies in Drug Trials [View All]

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Source: NYTimes

After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials.

The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.

The drug industry, however, is keenly aware of the change. Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials.

In recent months, the agency has sent letters — it would not say how many — to drug makers requiring that they use such a scale. Merck, Sanofi-Aventis and Eli Lilly are all using a detailed suicide assessment in clinical trials being conducted now.

Read more: http://www.nytimes.com/2008/01/24/washington/24fda.html?hp=&adxnnl=1&adxnnlx=1201151345-kTnB6TbW96qNXGt8wqh/Rg