-March 28, 2008
A new study shows that the strict deadlines that are enforced by the FDA regarding prescription medications could be causing more harm than good.
Harvard researchers noticed a disturbing trend when they began looking at the reasoning behind drugs like Vioxx, Bextra and Rezulin being recalled.
Safety Problems Found with Deadlines
The researchers reportedly found that medicines approved by the deadline set by the FDA were more likely to cause safety problems later on that those that were approved past the deadline.
Congress supposedly set the strict deadlines for the FDA in order to increase the speed of arrival time for new medications in the U.S.
Harvard Research Questions System
The research conducted at Harvard suggests that congress re-evaluate the balance between speed and safety.
“It puts the FDA in a very difficult situation when they’re trying to make complex decisions under these very, very tight deadlines,” says Dr. Steven Nissen, the chief of cardiology at the Cleveland Clinic. “We’ve got to re-examine now whether that’s a good policy.”
Research Found
Daniel Carpenter, the Harvard professor who led the study regarding drug deadlines, found that approval is 3.4 times as likely in the two months leading up to the user-fee deadline as at any time.
Drugs approved before or on the deadline reportedly had a four-to-five-fold higher rate of later being recalled from the market.
(Source: Associated Press)
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