Improving the Safety Infrastructure
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In recent years, there have been numerous calls for a major revision of the FDA’s safety division originating from the professional and lay press.
IMPROVING THE SAFETY
INFRASTRUCTURE
In
recent years, there have been numerous calls for a major revision of the FDA’s
safety division originating from the professional (Ray and Stein, 2006; Wood,
Stein and Woosley, 1998; Avorn, 2005a) and lay press. Many critics fail to see
the rationale for continued primary reliance on the MedWatch system as a safety
warning system. Its limitations include limited voluntary reporting, incomplete
data and lack of a reliable patient-based denominator from which to assess
rates of AEs. Moreover, the absence of regular national reporting of medication
exposure data from administrative claims or electronic clinical records is
puzzling in view of the opportunity such data would provide to generate
exposure data for potential safety studies at minimal costs.
AE
reporting in psychotropic drug clinical trials for children has been severely
criticized as inade-quate (Greenhill et
al., 2001). Mainly, there is no consistency in terminology, method of
elicitation of unwanted effects and reporting in published trials of AEs.
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