FDA Gets A Beating Over 5 Year Sapien Approval Gap…But Was CE Mark Right 5 Years Ago?

In short

Last week we contemplated the significance of the five year gap between Edwards Lifesciences’ Sapien transcatheter valve gaining approval for high risk patient use in Europe and USA, in our article here.

We were beginning to think it was “just us”, until we saw this piece published on MD+DI online yesterday on exactly the same subject. What’s interesting is that being humble Europeans our starting point was that maybe FDA’s “considered” progress to approval was suggestive of the fact that the European regulatory set-up is a bit watery and as such allowed a product onto the market before an adequate body of evidence had been collated.

Can EU Regulators and FDA both claim to be putting patients first while being at opposite ends of the spectrum?

The new piece, coming from t’other side of the pond, stridently adopts the opposite position and is really interesting for it. Fundamentally it complains that the FDA’s uber cautious approach was faintly ridiculous, as evidenced by the expert panel’s virtually unanimous vote in favour of the new indication in the face of a litany of hurdles being strewn in its path by the agency’s executive summary.

So yet again we ask which system is right? And yet again we don’t know, because there is no definitive answer. It seems to us that the evidence on which EU regulatory approvals are granted MUST be somehow put in the public domain in order for us to come to any firm conclusions, but the duty of confidentiality implicit in the implementation of the medical devices directive is a sticking point there. Having said which, people power will surely ultimately prevail to the extent that companies will want to show their work because not to do so will imply it’s not up to snuff.

If we don’t trust the agencies, we should leave it to the clinicians

Using this case as an example, we’re left, rightly or wrongly, with the assumption that the evidence was thin in 2007, and that the company’s submission to FDA was comfortably thorough enough for the panel to get behind it, while not being thorough enough for the ultimate gatekeeper, the agency itself, to look a bit more relaxed about it than it did. So maybe the expert panel is the common denominator, because we don’t entirely trust the judgment of either continent’s regulatory agency? FDA is arguably overshooting, while EU perhaps underperforms (clearly current moves to raise the bar suggest this is a common view).

Is EU approval a good enough stick to beat FDA with though? 

Back to the article on MD+DI, it records the sentiments of republican Andrew von Eschenbach who puts it most eloquently:

In Republican von Eschenbach’s view, this innovative device could and should have been saving lives in the U.S. five years ago, when it was admitted to the European market and he strongly implied that it would have been here too, were it not for FDA and its “decades-old regulatory process that is outmoded and needlessly long.”

In posted comments, his readers overwhelmingly agreed with von Eschenbach, a substantial number even going much further, whose comments included: “Scrap FDA!” “Graveyards are littered with people the FDA ‘saved.’ This seems to be a strengthening sentiment among FDA-watchers in the conservative media.

Then again, if the device had been causing problems in its CE indicated use over the past five years, lobbyists in favour of tougher regulation would have been saying “look how well FDA protected us against this”.

Source: MD+DI online