All is not well at the FDA.
Commish Andy had to listen to four hours of "critique".
“I think we’ve had a cascade of serious warning signs that the levies are leaking,” Garret. FitzGerald of the University of Pennsylvania, a member of the agency’s Science Board, tells the paper. “We need to respond to these warnings before the hurricane hits.”
The possibility of dangerous side effects from medications is too strong to continue to ignore. This is the life-saving truth the Food and Drug Administration has finally acknowledged, after years of significant anecdotal evidence.
Drug makers are now being required to follow a specific regimen to determine if patients become suicidal during clinical trials, the ground zero for pre-market testing.
Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and other conditions will be required to perform a comprehensive assessment to determine suicide predictability.
The assessment was developed after top agency officials discounted claims that antidepressants cause some children and teenagers to become suicidal. But a lingering unease developed as cases have grown in recent years. Columbia University's department of psychiatry was commissioned to reanalyze the clinical trials of specific drugs. The possibility of a link was impossible to ignore.
Determining the predictability of the side effects will not only provide a chance to deter their occurrence. It also shifts the costs of averting the problem to manufacturers.
Source
Insider's view: Cheer up Andy. Insider has a plan.
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