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Back to Pharmacology Articles

Friday, 5th November 2004

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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Antidepressants may be linked to suicidal behavior (FDA warning)
Bextra, Vioxx, Celebrex and heart disease

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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Article reviewed by:

Dr. Tamer Fouad, M.D.


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