We agree with the recommendations of Furberg et al1 and their observations of the weaknesses in the drug safety process of the FDA. While meetings of FDA advisory panels are public, most other discussions and negotiations that figure prominently into FDA decisions involve only FDA employees and drug industry representatives, with the FDA outmanned and out-financed by industry. A single FDA officer generally has major responsibility for the approval of a drug in a process that involves negotiation with a host of industry physicians, scientists, lawyers, and marketing experts over a number of years. This psychologically, scientifically, and financially imbalanced relationship and the absence of other parties forces the FDA to ration its demands and puts the agency at risk of being captured by the economic interests it regulates.2 We recommend additional measures to prevent regulatory capture and to improve the independent analysis of postmarketing adverse events.
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