Other Neglected Areas in the FDA Approval Process

the FDA does not require the drug company to show that any patients actually recover from their psychiatric disorders as a result 

Fourth, for a drug to be approved, there is no requirement that the patients rate themselves improved as a result of it. Checklist ratings by outside observers, that is, drug company-paid researchers, are sufficient evidence for FDA approval, even if the patients rate themselves no more improved on the drug than on placebo. In many instances, psychiatric drugs are approved despite the fact that patient self-ratings do not indicate improvement. 

---