Study Says FDA Has ‘Flexible Standards’ For Drug Approvals

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Clik here to view.A study this week in the Journal of the American Medical Association says the FDA has “flexible standards” for approving new drug therapies. Drawing on data in  the FDA drug database, researchers said three-quarters of the 188 novel therapies  approved between 2005 and 2012 had only one or two clinical trials. The authors of the article reported wide variation in the duration, size and completion rates of the clinical studies. Comparative-effectiveness data was available for less than half of the indications. One of the study authors, Dr. Joseph Ross, assistant professor of general internal medicine at Yale University School of Medicine, said regulatory flexibility allows the FDA to approve potentially effective therapies for life-threatening diseases and those for which there is no existing, effective treatment. ModernHealthcare