Precision medicine: drowning in a regulatory soup?

As US President Barack Obama noted in his 2015 State of the Union address, precision medicine promises to deliver ‘the right treatments, at the right time, every time to the right person’ which ‘gives us one of the greatest opportunities for new medical breakthroughs that we have ever seen’. These comments were a prelude to a $215 million funding commitment by the President to his Precision Medicine Initiative, the aim of which is to ‘pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients’. The objectives include an undertaking to modernize the current regulatory landscape.