As we at medlatest scour the globe for relevant, informative and interesting information pertaining to the world of medical devices, we repeatedly come across situations that provoke us to shine a light on the way things get done. Mostly these are regulatory issues, and most often are far more interesting to the medical devices community than they are to the clinician who’s more interested in treating patients and assumes that products he’s presented with are safe and effective for his use. Sometimes regulatory issues can be really quite illuminating for the medical device user and specifier too.
The recent press release from Flexible Stenting Solutions Inc, reported this very day on medlatest among other sites, contains some interesting language which is not at all unfamiliar to us. The release details how the company has just enjoyed the first two patient implants of its device in a formal, US clinical study, the intent of which “is to demonstrate that the FlexStent(R) Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease”.
Further down the release, and indeed from Flexible Stenting Solutions’ information, the device in question “has already received CE Mark authorization for peripheral vascular use”.
So the questions this raise are perhaps obvious but worth a moments reflection. Firstly, is the FDA’s regulatory bar so much higher than that required to gain market access to the Eu, to the extent that a 227 patient study across 40 US sites is necessary? Secondly what information did the company submit to its notified body in order to gain CE marking? Previous information placed in the public domain suggests there have been two studies commenced in 2008, one completed in New Zealand, involved 15 patients, the other in Leipzig, Germany, of 20 patients, which isn’t complete or at least hasn’t been made public to our knowledge. Our presumption is that in both cases the studies required local approval from the institutions’ own R&D or ethics committees. They would have no doubt examined all the usual parameters proposed in the study protocols and come to the conclusion they were happy to permit the studies under the appropriate monitoring regimes.
Despite this rigour, the plain fact is that for whatever reason, the regulatory barriers to commencing a trial in humans are lower outside USA and not centrally controlled by any governmental authority. In USA, the FDA would have examined preclinical and non-US clinical data before agreeing to allowing any patient use and even then only under Investigational Device Exemption (IDE) conditions. The study itself would have to be approved by FDA, so comparative/non comparative, randomised/non randomised, number of sites, number of patients, duration of study, time points, end points, monitoring, etc etc would all have been formally reviewed by a panel of experts including clinicians, company, regulatory consultants and FDA staff. It’s incredibly convenient for US companies therefore to have comparatively easier access to patient data from non US markets, which form part of a submission to FDA. You can hear it now; “Our international study sites reported such and such results, which supports our proposal for such and such a study in USA”.
What’s doubly convenient is that the company can gain revenue earlier in its commercialisation phase by starting outside USA.
Don’t misunderstand our position on this however. The FlexStent device is no doubt a brilliant product that will bring major benefits for patients with peripheral vascular disease across the world. We’re using it only as an example, to draw a picture for clinicians of how the regulatory world (and we do mean world) works. It’s always going to be the case that unless there is one global regulatory standard or approach, there will be products on the market in some countries that have no chance of getting to market in others, and that this very situation might encourage companies to go to the “softer” markets with their earlier stage devices and iron out the wrinkles while building clinical experience to aid US market entry in the process.
And who’s right? Eu regulators for allowing fantastic new technologies to get to market more quickly or US regulators for adopting a much more cautious, wait and see approach until companies can collect so much good non US data that a US study requirement shrinks to manageable (and indeed affordable) proportions.
So, should clinicians in non US markets only use FDA approved products? We’d say no because we love Medical Device Technologies and don’t fundamentally believe many bad products get to market. We might however counsel decision makers to ask why products are not yet FDA approved and then decide whether the argument sounds reasonable. If a small company has a product which falls into the category of requiring Pre-Market Approval (in other words what we’re talking about here), the usual reason is cost. Millions of currency units seeking approval from an FDA which is increasingly cautious and therefore demanding, may simply not be worth the investment.
Add to the mix the widely reported conundrum that is the 510(k) approval process for products of a slightly lower regulatory classification, under which a product can be commercialised more easily in USA if it can be demonstrated that it is substantially equivalent to something else that’s already on the market (in USA). Let’s save that for the next thrilling instalment.
Source: medlatest staff