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
Low performance of antigen tests makes it difficult to evaluate the real scale of Omicron spread in schools Rapid Covid-19 tests have demonstrated low effectiveness in detecting the virus in children, a team of British and German researchers has.