Think tank calls for US FDA to forgo approval of drugs cleared by European regulator

30 July 2010

A new report from the US free-market think tank Pacific Research Institute argues that American patients would benefit if the Food and Drug Administration did not have a monopoly on regulations.

Instead, the think tank believes that 'allowing American patients to access medicines that have already been approved in Europe would increase regulatory competition, enable more patient choice, and potentially save the lives of those suffering life-threatening illnesses and who currently have no treatment options.'

The report shows that, of 39 new medicines approved by the FDA and the European Medicines Agency (EMEA) in 2008 and 2009, 11 were approved only by the EMEA. In addition, the approval time was 97 days faster on average in the European Union for the 13 medicines approved by both regulators.

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