Author Affiliation: Division of Clinical Pharmacology, Vanderbilt University, Nashville, Tenn.
The article in this
issue of The Journal by Friedman and colleagues1 at the US Food and Drug Administration (FDA) explores the important question:
"Has the number of drug withdrawals increased since the passage of
the Prescription Drug User Fee Act?" This question was stimulated by
an apparent spate of recent removals—5 drugs in 1 year. However, when
the data were analyzed, not by the year of drug removal but by the year
of drug entry into the market, the clustering of cases was not
apparent. This finding is reassuring as it does not support previous
criticism of the changes that followed the passage of the legislation.
The rejection of 1 hypothesis should be viewed as a challenge to the
scientific community and the FDA to enter into a public discussion to
define what can be learned from the removal of these drugs and can be
used to prevent, or more realistically, minimize the risk of future
unnecessary exposure of patients to adverse drug events. Information on
the 5 drugs withdrawn given in Table 7 of the article by Friedman et
al1 suggests that such a discussion would be productive.
Wood AJJ. The Safety of New MedicinesThe Importance of Asking the Right Questions. JAMA. 1999;281(18):1753-1754. doi:10.1001/jama.281.18.1753