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Journal calls for new system to monitor post-marketing drug safety

BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7477.1258-g (Published 25 November 2004) Cite this as: BMJ 2004;329:1258
  1. Scott Gottlieb
  1. New York

    The editors of JAMA have called for a “major restructuring” of the way that US drug regulators respond to concerns over the safety of drugs after they go on the market.

    The call comes after a group of doctors uncovered delays in issuing warnings about the cholesterol lowering drug cerivastatin despite the fact that the manufacturer, Bayer, had evidence of its adverse effects for more than 18 months.

    The doctors' review study and the accompanying article by the editors of JAMA have been published online ahead of the print publication because of their relevance to the current debate over drug safety (http://jama.ama-assn.org/). The JAMA editors …

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