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Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate? Maryanne Demasi investigates Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate. In 1992, the US Congress passed the Prescription Drug User Fee Act (PDUFA), allowing industry to fund the US Food and Drug Administration (FDA) directly through “user fees” intended to support the cost of swiftly reviewing drug applications. With the act, the FDA moved from a fully taxpayer funded entity to one supplemented by industry money. Net PDUFA fees collected have increased 30 fold from around $29m in 1993 to $884m in 2016.1 In Europe, industry fees funded 20% of the new EU-wide regulator, the European Medicines Agency (EMA), in 1995. By 2010 that had risen to 75%; today it is

New jerseyUnited statesUnited kingdomCity ofSmithkline beechamPhilip krauseMaryanne demasiJoel lexchinIan hudsonCourtney davisStephen hahnRobert califfAaron kesselheimDevices agencyMelinda gates foundationPublic health