Device industry body Eucomed has launched a clever campaign intended to head off at the pass moves to bring in regulations that replicate the FDA’s regime. Its rather pointedly critical “Don’t lose the 3” campaign, in case you haven’t figured it out, refers to the average three year gap between product reaching the market in Europe compared with the United States.
Find more on the campaign here. And expect plenty of tugging at the heart strings.
The underpinning argument for retention of a regulatory set-up somewhat like the one that already exists is that there is no evidence it works less well than the U.S approval routes, especially the PMA process, which Eucomed implies keeps life-saving products from needy patients for an undue period.
The counter-argument of course is that by having a lower burden of clinical data required, patients are being put at risk by new product hitting the market before they have a body of supporting evidence behind them.
This, of course, is true. Picking one very current example demonstrates both sides of the argument quite nicely. Abbott’s MitraClip device is a heart valve gizmo, inserted via catheter and designed to attach to valve leaflets and in so doing impart a degree of functionality in the patient with a failing valve and too sick to withstand conventional surgery. It gained CE mark approval back in 2008, subsequent to which Abbott has undertaken two major studies, Everest and Everest II. Both are suggestive of efficacy, yet FDA is still wanting more. It’s holding out for data from a study tagged COAPT and another European “pivotal” study, its argument being a lack of comparative data between MitraClip and current standard of care for these critically ill patients. When you think about it, there’s logic in that, but also when you employ the “reasonableness” filter, you wonder whether that’s really quite as relevant as the scientist in you might accept. What the heck is it being compared with and how is the definition of inoperable being controlled? Too many (and too difficult to pin down) variables, all of which leave it looking a bit intractable from a regulatory perspective. So Abbott spends five long years wading through treacle, while in Europe clinicians have worked it out for themselves and are using the device very selectively on patients they consider appropriate in terms of disease state.
The basic problem with the European approach as it stands is that the general public wants and needs technologies quickly (tick), but also wants them to have evidential support. The answer thus far has been the notified body, an entity which is at the very heart of proposed EU reforms, because these “companies” are numerous, variable and opaque. What that means is we have no clue what evidence was used by Abbott’s notified body to satisfy it that the device was fit for market. The fact that a bunch of subsequent, and really good, studies have not yet satisfied FDA suggests in itself that original data was so thin as to be virtually non existent.
And yet the device hit the streets and has not been problematic… well, we don’t think it has. To be honest we don’t know, other than the fact that it’s not been recalled or had bad data published.
So, at the end of the day, you pays your money, you takes your choice. Eucomed is clearly supportive of its industry to the extent that it believes the regulations, while they need tweaking, kinda work. But “kinda work” is not a position you could back down to if you already had a higher level of required evidence. We end up with problems both sides of the pond. FDA too slow and too high a bar (in some cases). EU too quick, too low a bar and therefore too risky.
Except that logic would dictate we’d be able to find evidence of device problems in the EU if it really was too risky. Pointing at the PIP shenanigans is tempting, but a giant red-herring when it comes to regulatory fundamentals. The bar was high enough, just the enforcement was lacking.