Observations THE WEEK IN MEDICINE

FDA tightens its grip on drug regulation

BMJ 2007; 334 doi: http://dx.doi.org/10.1136/bmj.39119.546181.59 (Published 08 February 2007) Cite this as: BMJ 2007;334:290
  1. Rebecca Coombes, journalist, London ([email protected])

    Criticised for being too close to the drug industry, the US drug regulator is trying to fix its image as the guardian of drug safety

    What's happened?

    Dogged by controversy in recent years, the US Food and Drug Administration has announced moves to tighten up regulations on the safety of drugs—including reviewing the safety of new drugs after 18 months on the market.

    The FDA has a growing reputation for weakness, and in particular it faced flak over the withdrawal in 2004 of the painkiller rofecoxib (Vioxx). Two months after Merck withdrew the previously approved drug when it was shown that the drug increased the risk of heart attack, a member of the agency's drug safety team told the US Senate that the agency was “virtually defenceless” against another “tragedy and a profound regulatory failure” like that concerning rofecoxib.

    In September 2006 the Institute of Medicine issued a report decrying the big imbalance between pre-marketing and post-marketing drug surveillance. The report made 25 recommendations for strengthening the agency.

    Last week the FDA finally announced several initiatives designed to improve the safety of prescription drugs, including more monitoring of adverse events after drugs have been approved and put on …

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