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Drug approvals being rushed

The US Food and Drug Administration may be missing important drug side effects by rushing through approvals in order to meet legislated deadlines
The US Food and Drug Administration (FDA) may be missing important drug side effects by rushing through approvals in order to meet legislated deadlines.

Findings of a recent study revealed that rushed approvals meant unanticipated safety problems that do not present themselves until drugs are in clinical use.

The study was conducted by a research team at Harvard University in the UD and was published in The New England Journal of Medicine on March 27.

Deadlines for drug approvals are stipulated by legislation found in the Prescription Drug User Fee Act (PDUFA) enacted in 1992.

Professor of government at Harvard University, Daniel Carpenter, author of the study, said: "We found that while these deadlines speed up the approval process, many drugs are approved right up against the deadline, which might lead to unintended consequences with regard to drug safety.

"This suggests that drug safety might improve under an FDA approval protocol that is more flexible and less driven by deadline pressures and more by stable growth in FDA resources."

28th March 2008

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