Traditionally, the US Food and Drug Administration (FDA) and the European CE mark have been at opposite ends of the approval spectrum. While the FDA approval process has typically been long, stringent, and expensive, CE marking is much easier to obtain (on a relative scale, of course!). The implications of these very different approval processes have been notable in the medtech industry. One prominent example is transcatheter heart valves the first of these devices became available in Europe in 2007, while approval in the US had not been granted as of September 2011. Realistically, this has meant that for four years, patients in Europe have been able to have their ailing heart valves replaced using a small catheter and a tiny incision in their leg or chest, while physicians and patients in the US have faced the choice of medical therapy which has limited effectiveness in treating heart valve disease or open-heart surgery which some patients are not eligible for. Given the severity of the condition and the fact that many of the people suffering from heart valve disease are elderly and thus not suitable candidates for open-heart surgery this was not an ideal scenario.
Another example is autologous chondrocyte implantation (ACI)one of the more recent knee cartilage repair innovations. While a number of companies sell ACI products throughout Europe, manufacturers have struggled to receive approval in the US, with only one product available as of 2011. This product is also barely used because of its extremely high price the lack of competition and pushback from insurers for reimbursement has left this as a very expensive option. Physicians interviewed by MRG commented that the stifling of innovation in this market in the US is at least partially due to the stringent FDA approval process.
Obviously all the blame can't be placed on the FDA in this case it is no doubt in their best interest to ensure that the devices that can be used in the US are safe. Industry experts have, however, noted that this process may cause companies to drive innovation in the European or Asia Pacific markets, causing the US to fall behind in terms of offering the most advanced health care. In fact, industry sources have noted that the earlier commercial launch in Europe is often used to fund expensive FDA trials.
On the flip side, European regulatory bodies have been tightening the guidelines for granting CE mark approval in an effort to ensure the devices offered to European patients are safe. Doctors in Europe tend to look toward FDA trials anyway to judge a device's effectiveness, so there has been some pressure to bring the two systems more in line.
All of this leaves us to wonder if there is a happy middle ground.