The China FDA is also developing an additional fast track programme for priority review. That programme is directed at clinical priorities (mainly geriatric, paediatric and oncology) but also talks about devices which address unmet clinical needs.
Such a pathways may be coming to Australia too. They were proposed by the Expert Review of Therapeutics Regulations in Australia. But see here for a thoughtful slide set from TGA Head John Skerrit which points out that much can be done within existing regulatory arrangements.
I am more than a little sceptical about Innovative Device programs. Many regulators now have or are intending to implement such programs. In my view they are really about reaction to a general concern about regulations getting in the way of progress. There are two key issues
1. Innovative pathways are likely to be relevant to only a very small number of devices
It’s implicit in these kind of programs that the best new devices come from some kind of breakthrough. The reality is that innovation is a continuing and incremental process. The industry in which we all work has developed an astonishing variety of high technology products, and none of that happened overnight. It was the product of continual effort and countless small steps.
2. They don’t – and in my view should not, lower the regulatory requirements for such devices.
Why should they not lower the bar – well simply, innovative devices are by their very nature less well understood and therefore are more risky. Giving a registration to innovative technology based on a lower requirement is a recipe for a train wreck. Should one of these devices fail badly after a soft review then we will undoubtedly see a backlash. And that’s in nobody’s interest.
Really what’s going on here is the gradual introduction of industry support programmes into the operations of regulators.
In theory, regulatory agencies are charged with protecting the public by regulating the safety and effectiveness of therapeutics – no more, no less. It’s a very clear and unarguable mandate.
But innovative device (and drug) programmes ask the regulators to start playing favourites, giving priority and extra resources to new technologies and in the case of China’s priority pathway, to technologies which are the subject of national industry development goals. There’s a big question about the policy wisdom of such approaches in the first place, and a very big assumption that regulators will have the skill sets to make the right decisions to serve the industry development priorities.
In fact such programs could have perverse effects: focus on the latest Shiny New Toy may be diverting resources away from less exciting but perhaps, in public health terms, more important regulatory reviews of the latest incremental improvements in conventional widely used therapies which will have broad impacts to patient outcomes.
These programs offer additional support and guidance to the manufacturers, who are often smaller companies or start ups. And that’s a good thing. But maybe that’s the issue – should regulators rather than focusing on “Innovative Devices” be putting more into helping smaller “Innovative Companies” understand the regulatory processes? And the regulators themselves may need a helping hand too – to know how to assess these Shiny New Toys. Perhaps a more rational approach is to look at ways of making sure that regulators are equipped to deal with new technologies, to make sure that smaller companies are given an appropriate helping hand. This is a matter of proper regulator training and well planned stakeholder assistance. Not so exciting as shiny new programmes with “Innovative” in their title, but perhaps, quietly, a lot more effective.
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