FDA evidence varies
January 23, 2014
A STUDY published in the Journal
of the Medical Association (JAMA)
has said the quality of clinical trial
evidence used by the US Food and
Drug Administration (FDA) as the
basis for approvals of new drugs
varied widely across indications.
The study, ‘Clinical Trial Evidence
Supporting FDA Approval of Novel
Therapeutic Agents, 2005-2012’,
said about one third of new drugs
introduced in the US from 2005 to
2012 were approved on the basis of
a single large clinical trial, the Wall
Street Journal reported.
This variation highlighted the
agency’s “flexible standards for
approval”, the paper said.
This meant a customised
approach for approval, which
meant the agency could rapidly
approve potentially effective
therapies for life-threatening
diseases, or for disease where
there was no existing treatment,
the study said.
However, the Wall Street Journal
reported that the authors said the
variations should be more clearly
communicated to the public.
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