FDA Slow To Clear Products When EU Data Lacking

“Guinea Pigs” at the front of the Queue for New Technology?

“…some irony in criticizing the FDA for delayed approval of technology, such as TAVI, in which the effectiveness has been shown only in the studies performed to meet the FDA’s safety and effectiveness requirements.”

Whether you follow the subject on Twitter, Linked-in or the daily news media, you cannot fail to have picked up the angst about medical device regulation in recent weeks and months. If you’re in USA the FDA is restricting your access to the most modern technologies. If you’re a patient in Europe you might as well live in a hutch because you’re a guinea pig, vulnerable to having a Chinese toy used on you or implanted in you. So goes the media frenzy.

Anyway, in this useful paper, published last week in the New England Journal of Medicine, it’s pretty much all spelt out so that even a clinician more used to clinical academia and patient care can see how the devices passed to him/her got there. It also rehearses some nice arguments for and against greater regulation.

So, from the recommendations section the paper “found numerous examples of high-risk devices that were first approved in the European Union but showed no benefit or demonstrated substantial safety risk in subsequent testing.”

It also goes on to point out “some irony in criticizing the FDA for delayed approval of technology, such as TAVI, in which the effectiveness has been shown only in the studies performed to meet the FDA’s safety and effectiveness requirements.”

“One essential question that remains unanswered is whether speedier access to some newer technologies in the European Union has improved public health. Or does the more deliberative posture taken for some high-risk devices by the FDA better serve patients overall?”

Certainly, swifter approval helps generate revenue for manufacturers, and physicians may benefit from having more tools at their disposal. But the primary goal of bringing new devices to market should be to improve the treatment of specific diseases, and no current studies address this outcome.

In conclusion the paper contrasts US and EU regulatory requirements by stating; “Features of both environments require reform, as well as continuing research to assess policy changes”, with which we cannot argue.

Source: New England Journal of Medicine