The final day at the Society of Interventional Radiology (SIR) 2013 meeting was marked by a series of lively and (mostly) good-spirited debates. The gloves came off as notable members of the interventional radiology community?including several past-presidents?duked it out over assigned topics. In a strange twist, the moderator asked that each debater argue both sides of the issue, forcing the speakers to flip-flop on their points. It was a bit weird, but definitely added to the entertainment value! The organizers made great use of technology by polling interventional radiologists (IRs) in the audience in real time to gauge who ?won? the debate.
While the debate about centers of excellence vs community care and the debate about the need for diagnostic radiologists in the IR profession were thoroughly entertaining and had the crowd in stitches, I particularly enjoyed the subject matter in the FDA vs CE approval debate. I also enjoyed that an American physician and a French physician were chosen as the debaters?very fitting.
The obvious arguments circled around the trade-off between access to devices vs patient safety, but it was definitely a challenge for the presenters to compare such radically different systems. This was especially evident when the debaters ?switched sides? for their final arguments.
The FDA system, while clearly flawed in its approval lag, offers greater transparency and promotes more robust clinical data. The quick access to new devices in the EU doesn?t always mean better public health?it was argued that in some ways, European patients end up being the ?guinea pigs? to the American device industry. Plus, the CE system is marked by for-profit notified bodies? a system that operates more in favor of manufacturers than patients. It's important to keep in mind the different risk profiles in each geography as well ?although the slow FDA approvals can be a pain for physicians, they?re much better protected from litigation under the FDA system, which is necessary in the US environment.
The physician from France stuck to the line ?we can do that here? as he went through a laundry list of procedures and devices not yet available in the US, including peripherally indicated Onyx and drug-coated balloons. ?All you IRs should just come to Europe,? he joked, ?you?d have more fun?. The audience agreed: the poll at the end revealed that 60% of the audience would rather practice under the CE mark regulation.
Despite this practice preference, the audience had a slightly different view on the appropriateness of the CE mark, with 58% of the audience believing that patients are better off under the FDA guidelines, as opposed to the CE mark.
In the end, it's clear that there are negatives and positives to each system, which was reflected in the close polling margins. The FDA has a long way to go to improve access to cutting-edge technology, while the EU needs to make strides in terms of ensuring that regulation is more patient-centric.
[Editor's note: This has been a topic of conversation for a while as the FDA works to shorten approval times while the EU revamps its medical device directives. See previous posts on this topic here.]