A couple of years ago FDA Device chief Jeffrey Shuren referred to Europeans as Guinea Pigs, in one phrase denouncing the weakness of EU device regulations and defending the strength of the FDA’s position.
And now look what’s happened.
Increased bureaucracy, more costly infrastructure, slower pace to market, questionable improvements in safety: The enormity of changes that are likely to be inflicted on companies bringing their new products to Europe in future is being buried under the news that the US sales tax won’t be repealed any time soon.
Europeans currently enjoy access to the world’s newest technology and there’s not much evidence it has bestowed a legacy of product problems on us. Quite the opposite as US physicians and patients look enviously across the pond as their own FDA rules impose time delay and huge cost on device makers and customers.
We muse on the subject in this week’s View From The Med, which is online now, here.