The regulatory process for reviewing medical devices in Europe is coming under fire after a controversy over leaking breast implants made in France.
That’s a big deal for U.S. medical device companies, who frequently praise the European regulatory system as faster, less burdensome and more supportive of technological innovation. Many in the device industry would like to see the U.S. Food and Drug Administration overhaul its regulatory process and emulate the Europeans.
The problem for U.S. device companies is the idea of Europe’s superiority in device regulation is now in doubt in light of concerns about the leaking implants and other device recalls.
“All the industry guys in the U.S. say, ‘We should have access to these products much sooner, like in Europe,’ ” Carl Heneghan, an Oxford University physician, told Bloomberg News. “The flip side is, the European people are being used as guinea pigs.”
There are two key differences between U.S. and European devices reviews: First, while both the European Union (EU) and U.S. require device makers to prove their products are safe, only the U.S. requires device companies to prove efficacy of their products.
Second, reviews of European devices aren’t conducted by the EU itself. Rather, reviews are carried out by one of 70 approved for-profit companies that must be accredited by one of the EU’s 27 member nations. In the U.S., the FDA handles medical device reviews.
Critics have complained that the European system creates an inherent conflict of interest in which medical device companies can simply shop around for the least-stringent reviewer, according to Bloomberg.
Of course, it would be an overreaction to point to just one case — the leaking breast implants –and say that an entire system is flawed. But the breast implants, which were never approved in the U.S., certainly aren’t the only recent European device to reach the market too quickly.
Bloomberg notes the same thing happened with a lung sealant from Covidien that was recalled in 2010. Ditto for an implant to treat elbow fractures, according to The New York Times. Neither were approved in the U.S.
The device industry will point to an industry-sponsored study by Boston Consulting Group that found little difference in the number of U.S. and European device recalls. However, that study’s methodology has been heavily criticized by the FDA and its allies, and can hardly be considered conclusive.
So, U.S. medical device companies should be careful what they wish for. With the industry already under heavy scrutiny over recalls of metal-on-metal hip implants and defibrillators, now may not be the time to push for an even less-stringent review process that could end up resulting in more recalls, more bad press for medical device companies and more harm to patients.
[Photo by flickr user Picture Perfect Pose]
By Brandon Glenn MedCity News
Brandon Glenn is the Ohio bureau chief for MedCity News.More posts by Author
I am posting in a private capacity. Is the "guinea pig" accusation valid? Do more Europeans die from products that turn out to be dangerous, than Americans die while waiting for "safe" products to be approved by US FDA that are already available in Europe? Is the European system inherently unsafe? Do we have the data to really know any of this? I don't know anyone that doesn't think there is plenty of room for improvement and reform on both sides of the Atlantic, and indeed there is a lot of good work continuing in that regard (GHTF and its successors etc). But it's a very difficult process, especially given the opposing political pressures from government, industry, patient groups, and clinicians. But there's another factor here. The issue with the PIP implants appears to be less about pre-market approval and more about post-approval fraud. The manufacturer swapped out medical-grade silicone for silicone used to fill mattresses. Combating that kind of behaviour, rare as it is, likely requires a wholly different methodology, and it's wrong to conflate the two issues.
The extension of this logic is to release no products in the US, then any failure will occur only in the EU. Delaying delivery of all innovation to the US by 4 years causes harm, which must be measured against the few (3?) failures in the EU. On another critical issue, companies can select one of 70 reviewers for the lowest barrier in the EU, but those barriers are well defined and regulated. This stands in contrast to arbitrary and ill-defined standards in the US. The result is that companies find little advantage in one EU reviewer over another, while finding great variability in different regions of the US. Brandon, you imply that FDA and its allies have no bias in their argument that the study of recalls was flawed, and that 3 failures in the EU are conclusive evidence. FDA efforts to eliminate the 4 year delay in delivery of innovation to the US, eliminate ex post facto decision making, and eliminate regional arbitrariness would be more compelling than either industry standards or reports of unquantified, sensational failures. Finally, your statement that medical device companies are looking for less stringency is unsubstantiated. Interviews of industry repeatedly reveal that our nation's industry would accept higher standards than in the EU, as long as they include clear standards, predictability, and emphasis on safety (rather than efficacy, in which regulatory agencies have demonstrated no special capabilities). Seeking villainy in the medical device industry is silly. Our industry wants better lives for everyone, reduced costs for new cures, and a healthy, dynamic employment base. We also want excellent regulation. Poorly performing regulation works against all our objectives.