FDA’s Damning Of EU Regulations: Fair Comment?

In short

It’s a rather tired argument for anyone involved in the medical device industry. FDA wants to be held up as the protector of the people and the world’s best regulator, while in Europe patients often gain access to winning new technologies mush earlier than their US counterparts, but according to FDA at a risk level that the US agency finds unacceptable.

In an article published in US online news sheet the Star Tribune, the arguments for and against are played out. Well, not the arguments, more the positions of the arguers.

FDA report damns EU regs

The article has been published following receipt an internal report, either leaked or otherwise acquired by the press, which details FDA’s own analysis of what it claims are 12 classes of “malfunctioning or needlessly invasive” devices approved for sale in Europe but not USA.

The report’s title speaks for itself:  “Unsafe and ineffective devices approved in the E.U. that were not approved in the U.S.”

So why now, and what’s this all about? Is there a subplot?

The Star Tribune seems to think so. In fact it goes so far as to claim that the timing of this report represents FDA’s defence of its practices at a critical time, while industry groups, patient advocates and some in Congress propose changes in the way the agency does business. There is no doubt that the medical device industry lobby has had the agency in its cross hairs for a while as it bemoans the cost, complication and time required to get to market in the US, compared with the relative ease with which the same process occurs in Europe. Obviously that’s a gross simplification, but in essence it just about captures the scene. There is no doubt the process in Europe is less stringent and usually far less demanding of clinical evidence, which is paradoxically the thing that healthcare providers and medical professionals value more than anything else as they select treatments for their patients.

Good device= good for patients. Bad device= bad for patients. Good device not available=?

In an obvious attempt to justify the existence of this report Dr. Willam Maisel, FDA’s deputy director for science said; “If a device gets on the market somewhere else first [and] it’s a good device, good for them; if it’s a bad device, bad for them,”

“The only way to know that is to look at some of the devices and see how they played out.”

Well that’s all true of course, except we haven’t actually seen the list of 12 device classes to which the report refers.  And Dr Maisel’s blunt assessment fails to consider the argument: If a device doesn’t get on the market, despite being a good device, it’s bad regulation.

Will the arguments ever end?

Anyway, the entire Star Tribune piece can be found here, and in it the arguments are well played out, so we’ll not repeat them here. Suffice it to say that the sensible option, after all the posturing has settled down, might be an FDA which retains its current level of discipline while softening its stance enough to allow the good stuff through the door using the Humanitarian Device Exemption route  more readily. And that may be on the cards.

When it comes to regulation though, who decides how tough is too tough? Companies, Governments, Regulatory Agencies, Consumer Groups, the Media… or even the medical profession?

We’re not pretending we have the answer. What’s clear is that history is the main determinant of future structure. FDA is not about to relax its grip because it has a historical reputation and responsibility which it considers is cast in stone. Is EU regulation, by being more relaxed, a pragmatic response to the burgeoning number of devices and technologies hitting our pages every day?

What is true is that even we, as Europeans, sometimes feel uncomfortable with new technologies that pop up with CE mark approval based on what looks like the flimsiest of evidence. We feel even more uncomfortable when a year or more later, after real clinical evidence has been collected as part of the FDA approval process, the agency then knocks it back.

Is it any surprise we find ourselves not knowing where to pitch our tent?

Source: Star Tribune, medlatest staff