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Back to Pharmacology Articles
Friday, 5th November 2004
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The FDA was widely criticized for apparent shortcomings of its internal
appeals process for scientists that wish to challenge regulatory decisions.
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In the wake of recent high-profile safety concerns about widely used
drugs, including antidepressants (related
article) and Vioxx (related
article), Dr. Lester M. Crawford, Acting FDA Commissioner, today
announced that they will launch a review of the agency's drug monitoring
policies.
The FDA was widely criticized for apparent shortcomings of
its internal appeals process for scientists that wish to challenge
regulatory decisions. In the case of Vioxx, FDA scientist David Graham
reportedly complained to lawmakers that he was intimidated when he
attempted to have the agency disclose his research suggesting the drug
was potentially unsafe. In the antidepressants case, Andrew D. Musholder,
MD, complained he was barred from informing an advisory panel about
safety concerns with antidepressants because of suicide risk.
The new procedure will allow FDA's Center for Drug
Evaluation and Research (CDER) to formally address concerns over
safety decisions to a three-member panel that includes outside experts.
The panel would then have 30 days to review all relevant materials and
recommend to the Center Director an appropriate course of action.
The CDER will also conduct a national search to fill the
currently vacant position of Director of the Office of Drug Safety,
which is responsible for overseeing the post-marketing safety program
for all drugs.
By the end of this year, FDA intends to publish final
versions of three guidances that have been developed by our agency to
help pharmaceutical firms manage risks involving drugs and biological
products. These guidances should assist pharmaceutical firms in
identifying and assessing potential safety risks before a drug reaches
the market and also after a drug is already on the market using good
pharmacovigilance practices and pharmacoepidemiologic assessment.
Source: Food and Drug Administration
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