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Physician calls for more rigorous standards for drugs up for FDA approval
Date:3/9/2010

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 B. 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.

"When new medications have been compared only to placebo, not to drugs already on the market, it's very difficult to know whether and how we should prescribe them to patients," O'Connor said. "For example, if a new medication to treat depression is approved based only on placebo comparisons, it's very difficult to know how the new drug compares with the dozens of medications already approved for depression. Faced with the extensive and very successful marketing undertaken by the drug manufacturer, oftentimes physicians will assume that the newer drug is more effective or has important advantages over older treatments, even though there may be no evidence showing that to be so."

"The current system makes it very difficult to evaluate a new, more expensive treatment against an established, less expensive option," added O'Connor. "We should consider a differe
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Contact: Tom Rickey
tom_rickey@urmc.rochester.edu
585-275-7954
University of Rochester Medical Center
Source:Eurekalert

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