Writing on his blog, The counterfactual, Clive Bates says that the US Food and Drug Administration’s deeming rule, which came into force on Monday, spells the end of innovation.
‘In essence, FDA requires an enormously burdensome Pre-Market Application (PMTA) to be filed and accepted by FDA for any new product from now on,’ he wrote.
‘So that’s the end of innovation, including pro-health and pro-safety innovation.
‘For all products currently on the market, a PMTA has to be filed within two years, with a further year for FDA to review – that will wipe out most products and most smaller firms and open way to black market.’
Bates is one of 16 people who have filed an amici curiae brief in the Nicopure Labs et al versus FDA legal case (http://www.clivebates.com/documents/THRamicibriefpublic.pdf).
His blog is at: http://www.clivebates.com/?p=4278.