FDA Drug Approval Should Be More Rigorous, Physician Argues

Writing in the latest issue of JAMA, Alec B. O'Connor, associate professor at the University of Rochester Medical Center, says the federal guidelines governing the approval of potential new drugs should be much more stringent. The FDA, according to the commentary, should require studies comparing the effectiveness and safety of a new drug to an established first-line drug when considering a drug for approval. Currently the agency does not require such studies, known as "active comparator trials," though some large studies of new drugs do include them. In many cases, to gain approval, the main criterion besides safety is that a new drug must be shown to be more effective than placebo. read more

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