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Physician Calls for More Rigorous Standards for Drugs Up for FDA Approval

Posted Mar 10 2010 4:07pm

A hospitalist at the University of Rochester Medical Center calls for more stringent Federal guidelines governing the approval of potential new drugs, in a commentary in the March 10 issue of the Journal of the American Medical Association.

Alec O’Connor, M.D., M.P.H., associate professor in the Hospital Medicine Division of the Department of Medicine, says that while the U.S. Food and Drug Administration does an “incredible job, considering its long list of responsibilities and budget constraints,” the agency should be empowered to demand more detailed data when a new drug is being considered for approval.

O’Connor’s main point is that the FDA 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.

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