FDA medtech approval slowdown hits surgical devices hardest

The medtech industry’s main grievance with the FDA in recent years has centred on approval times: device makers contend that the agency used to be faster and slicker, whereas in the past few years the process has become more arduous.

And they are absolutely right. An analysis of data compiled by EvaluateMedTech on approval turnaround times shows that between 2004 and 2008 the agency took an average of 16.9 months to grant a first-time premarket approval – the route taken by the most innovative or dangerous devices – but from 2009 to the present day it took an average of 19.5 months for the same process (see table below).

And this slowdown is thrown into sharper relief by the fact that the FDA greenlighted fewer products in the last five years than in the previous five – 156 compared with 176.

Slowdown at the FDA: how approval times have changed
Time period Number of PMAs Average review time (mths)
January 2004 – December 2008 176 16.9
January 2009 – July 2014 156 19.5
January 2004 – July 2014 332 18.1

This analysis is only concerned with first-time PMAs, as opposed to PMA supplements or 510(k) approvals, which are awarded in vast numbers and have more uniform timescales, thus making patterns hard to discern.

The wooden spoon goes to C. R. Bard’s Progel surgical sealant, approved in 2010 to seal pleural air leaks incurred during pulmonary surgery. The FDA took 100 months – more than eight years – to grant the product’s PMA. But this is not really an outlier; over the past decade eight products have undergone approval processes lasting more than five years, and Allergan’s Natrelle silicone breast implants also took more than eight years to make it through.

Heart rate speeds up

A look at the therapy areas that saw most approvals over the decade shows how the agency views technologies for different applications. The analysis is limited to the more popular areas to provide a large enough sample size from which to draw conclusions.

In both five-year periods the top therapy areas were the same, led by cardiology and in vitro diagnostics (see table below). These two areas have seen cuts in average review time in recent years, 22% for cardio and 18% for IVDs.

Diagnostics would be expected to have relatively rapid turnaround times; they tend to pose less of a risk to patients – they do not emit radiation or require surgical implantation, for example – and therefore ought to require less stringent examination. That the FDA granted more IVD approvals in the last five years compared with the previous five years is another indication of this.

Cardiology products, however, tend to require minimally invasive vascular implantation at least, and often chest-cracking open surgery. The speeding up of approvals in this case is perhaps less natural.

Some cardio products have benefited from the FDA trying to meet medical needs, and have been rushed through. The third fastest, for example, was Medtronic’s CoreValve, which received its PMA six months earlier than anyone, including Medtronic, had expected.

Surgical drag

In the other three leading areas, though, lengthening timelines are clearly delineated – and again, fewer products made it to market. Devices designed for ophthalmic and surgical applications have seen a 33% and 98% increase in review time respectively, but approvals of orthopaedic products have seen the greatest change, with review times increasing by a remarkable 138%.

The reason for this is simple: Poly Implant Prothèse. In 2010, the French company was found to have used illegal industrial-grade silicone in the breast implants it manufactured, sparking calls for regulators to investigate these products far more carefully.

All three surgical products in this analysis that the FDA took more than five years to review were breast implants approved after the PIP finding.

There is still cause for hope. An analysis of PMA approval rates and speed in the first half of this year indicates that the FDA’s initiatives to speed review times and rubber-stamp more products than before may be bearing fruit (FDA grants twice as many device approvals in half the time, July 25, 2014).

Meanwhile, medtech executives who had complained of the FDA being harsher than in the past may be reassured that they were not imagining things. The agency has had a strict period, and now appears to be adopting a stance more sympathetic to business. The eight-year approval is hopefully a thing of the past.

The most popular therapy areas
2004-2008 2009-2014
Therapy area Number of PMAs Avg review time (mths) Number of PMAs Avg review time (mths)
Cardiology 54 16.0 48 12.5
In vitro diagnostics  44 15.6 48 12.8
Orthopaedics 22 19.2 14 38.1
Surgery 15 19.4 8 46.1
Ophthalmics 13 14.7 8 19.5

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizEPVantage on Twitter

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