BMJ  2005;330:540 (5 March), doi:10.1136/bmj.330.7490.540

Letter

Europe also needs agency for postmarketing surveillance

The first 150 words of the full text of this article appear below.

EDITOR—With respect to the withdrawal of rofecoxib (Vioxx), several months of debate on drug safety have focused on US policy, but very little has been said about the European situation.¹ Some fundamental questions remain to be answered. For example, why did the manufacturer, and not the regulatory agencies, withdraw rofecoxib?

Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) had concluded, before this decision, that this product—and the other drugs belonging to the cyclo-oxygenase 2 inhibitor class—were essentially safe, and all that was needed was a few changes to the summary of the product characteristics, a document that is seldom read by prescribing doctors. This had happened before, for cerivastatin and other drugs, raising doubts about the regulatory agencies' efficiency in reaching decisions about benefit-risk ratios.

The American government has already decided to create an agency separate from the FDA, the Drug Safety . . . [Full text of this article]

Istituto di Ricerche Farmacologiche "Mario Negri," Via Eritrea, 62, I-20157 Milan garattini@marionegri.it

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