Is A Regulatory Goldilocks Zone Attainable?

Too lax or too rigid…that is the question… but is there an answer?

The ongoing heated debate between those lobbying for a speeding up of the FDA approval process and those arguing that to do so would place undue risk on the patient population rages on. Already this week we’ve seen FDA issuing scathing attacks on EU regulatory rules with its listing of devices which passed muster in Europe, but not in USA, and have reportedly subsequently suffered problems of one form or another.

Then we’ve had the Eurocrats getting involved with the issuance of a report from the European Parliament suggesting that EU medical device regulations should include components which almost mimic FDA’s lengthy PMA process.

In the middle of all this we see a great example of how a lifesaving product that has been on the market in Europe for a while is only now getting within range of the US with the news that Cameron Health’s S-ICD implantable cardioverter defibrillator got the nod from FDA’s expert panel… it may still be a year from market remember.

And now, with a wonderful sense of timing, US news vehicle the Star Tribune has tugged at our heart strings with a piece about how a young girl with a septal defect benefitted from the use of an Amplatzer device which, although approved in USA had already been available in Europe prior to its FDA clearance.

The story is being used to illustrate the benefits brought to patients by new medical technologies and could almost have been written by a medical device company like for example St.Jude Medical, purveyor of the aforementioned device,  if it wanted to benefit from the emotional angle.

Of course, while the argument is ostensibly about speed to market, what that really means is red tape, the reduction of which implies an approval process barrier which would be lower than it is at the present time.

Lobbyists, especially from the industry side, are keen to see this and indeed supported by vocal congressmen including the oft quoted Sen Erik Paulsen who is co-chairman of the House Medical Technology Caucus as well as representative of the Twin Cities district, a major medical device industry hub. He’s been a driving force behind efforts to reduce red tape and is now expecting positive results in the current regulatory legislative review. What these measures will amount to remains to be seen, but they are likely to include increasing use of the Humanitarian Device Exemption(HDE) rule, which could in theory have brought the Amplatzer device to market sooner. Other streamlining measures are also in the works.

So what happens next?

Will consumer groups pop up with more examples of how what they see as regulatory laxity has ended badly? It’s an interesting watch and there’s almost a pattern emerging with these serial releases from industry, FDA, consumer lobbyists and pretty much any other interested party. The thing is, there’s no right answer is there? Finding the Goldilocks Zone would be easy if medical devices weren’t so many and varied, so coming up with a one-size-fits-all rule book isn’t likely to work. Consequently extending the HDE rules, as is likely, seems like the most pragmatic way forward.

EU’s Knee Jerk risk

In the meantime EU might just be heading the other way as the PIP scandal seems to be the driving force behind EU legislators determined to “never let this happen again”. Thank goodness the regulatory agencies themselves seem to be adopting a rather more pragmatic stance.

Source: medlatest staff, Star Tribune Health