I too have been following the Telegraph stories that have appeared over the last couple of days and agree with Pads that they have been rather sensationalist and of poor journalistic quality.
It is obvious in all cases that if you want to break the law, dodge the system, generally behave in an unethical manner then it really isn't that difficult to do so. This is not a fault of the regulation it is a fault of people. The law currently gives adequate provision to prevent detect this; it perhaps just needs more resource and a more uniform application across the EU.
There have been two high profile cases in the last few years regarding medical devices - PIP and MoM....From this the press is jumping up and down saying that the system is broken....is it really? two cases? hmmm...how many products have been stopped or improved as a result of NB review and surveillance? How many FSCAs are there to improve the safety and efficacy of devices? Let's have some balance here.
In response to the comments about the FDA system being so much better...are you truly so naive to think that you don't have similar abuses within your system that have slipped through? Although the warning letters are indicative of a functioning monitoring system they also show that there are failings and there are problems.
No regulatory system is perfect. The new MDR is an attempt to improve and correct issues that have been identified since the introduction of the MDD. But it is important to remember that if the industry is over regulated then innovation is stifled, products will take longer to reach market and patients will suffer in the mean time.
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Hi P,
In general I agree with most of your comments. However:
This isn't about "who's better". Of course the FDA and its regulatory system aren't perfect. It's just that in some aspects this system seems to work better, and the real important question is whether or not other systems could learn and improve from such strengths. First off, the FDA seems to present a much less fragmented approach than the EC system. Not sure much can be done about that, due to the very nature of the EC vs. the USA. Second, FDA staff are considered [generalization, I know] law enforcement agents; I don't see the parallel of that in the EC. These are just 2 examples, I'm not here to try a comprehensive comparison; the point is that there ARE significant differences, and anyone interested in improvement should be looking into what can/should be brought over (at least partially), and how.
Regarding legal provisions - yes, there are some in place but my impression is that not enough. Maybe I'm not looking in the right direction, but if you look at the MDD and follow the pointers from it, you end up with nothing close to the FDA's enforcement toolbox. I'm sure some dodgy companies try playing games with the FDA too, but at least there seems to be an active system in place, trying to identify them and hold them accountable. PIP made it to the headlines because it had a high sales-promotion potential for the media, but that doesn't mean there aren't smaller scale parallels going on, on a regular basis.
Last, over-regulation and slowing progress aren't the only alternative to ineffective or lacking postmarket enforcement. The pendulum doesn't have to go all the way to the other end; the trick is to find a good balance. I feel that FDA is very concerned with not overburdening innovators (whether or not they succeed is a different question), yet in general it doesn't imply slack in enforcement. In the EC, my general impression is that there is too little postmarket enforcement (maybe in some member states the situation is better than in others), and I'm not sure this is in the name of innovation and patient good.
Maybe it's all just because the FDA communicates better with the public; I can't tell for sure because I live neither in the USA nor in the EC.
Cheers,
Ronen.