FDA will increase postmarketing surveillance of drugs
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《英国医生杂志》
After controversies about the possible increased risk of suicide in children taking antidepressants and the increase in heart attacks and strokes in patients taking rofecoxib (Vioxx, MSD), the US Food and Drug Administration has announced plans to strengthen its surveillance of drugs on the market.
Dr Lester Crawford
Credit: ALEX WONG/GETTY IMAGES
The acting FDA commissioner, Lester Crawford, said, "The full magnitude of some potential risks not always emerged during the mandatory clinical trials conducted before approval that evaluate these products for safety and effectiveness. Occasionally, serious adverse effects are identified after approval either in postmarketing clinical trials or through spontaneous reporting of adverse effects."
The agency's Center for Drug Evaluation and Research will hire the Institute of Medicine to assemble a committee to review the effectiveness of the US drug safety system with emphasis on the FDA's postmarketing surveillance.
Steven Galson, acting director of the centre, said, "Our current drug approval system has demonstrated that we don't always understand the full magnitude of drug risks prior to approval of drug products."
The centre will also set up a programme to adjudicate differences of opinion within the agency. For the antidepressant and rofecoxib situations, the FDA suppressed the views of staff members who warned of risks with the drugs. In future, such internal disagreements will be referred to an ad hoc panel of outside experts and FDA members who were not directly involved in the decision.(Janice Hopkins Tanne)
Dr Lester Crawford
Credit: ALEX WONG/GETTY IMAGES
The acting FDA commissioner, Lester Crawford, said, "The full magnitude of some potential risks not always emerged during the mandatory clinical trials conducted before approval that evaluate these products for safety and effectiveness. Occasionally, serious adverse effects are identified after approval either in postmarketing clinical trials or through spontaneous reporting of adverse effects."
The agency's Center for Drug Evaluation and Research will hire the Institute of Medicine to assemble a committee to review the effectiveness of the US drug safety system with emphasis on the FDA's postmarketing surveillance.
Steven Galson, acting director of the centre, said, "Our current drug approval system has demonstrated that we don't always understand the full magnitude of drug risks prior to approval of drug products."
The centre will also set up a programme to adjudicate differences of opinion within the agency. For the antidepressant and rofecoxib situations, the FDA suppressed the views of staff members who warned of risks with the drugs. In future, such internal disagreements will be referred to an ad hoc panel of outside experts and FDA members who were not directly involved in the decision.(Janice Hopkins Tanne)