Keeping Watch: The FDA's New Drug Watch Program, Morgan Lewis on Life Sciences
October/November 2005

In the wake of well-publicized and aggressively litigated claims regarding Cox-2 inhibitors, diet drugs and other pharmaceutical products, the FDA became the target of criticism from the public, industry analysts and elected officials. Among the criticisms were complaints that the FDA had become too close with the manufacturers it regulates and that it did not sufficiently warn the public about certain products’ post-approval adverse events or emerging signs of potential injury. Primarily to address the latter concern, the FDA announced in May 2005 that it would initiate “Drug Watch,” an Internet-based drug safety reporting systems to publicize emerging safety information about drugs. This article discusses (1) the Drug Watch program and how it will work (2) the response to the FDA’s announcement and (3) what pharmaceutical manufacturers can do to monitor and respond to Drug Watch concerns.

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