Not quite as good as expected, but not too shabby. The FDA approved 33 innovative devices in 2014, a 43% increase on the number it greenlit the year before. When EP Vantage looked at the sector at the half-year point, we forecast 34 approvals by the year end, so this is very nearly as expected; however, the number is still down compared with 2011 and 2012 (see graph below).
The good news is that approval times are speeding up. Last year, it took an average of just 17.6 months to get a medical device through the FDA’s most stringent regulatory pathway – a first-time premarket approval (PMA) – compared with nearly twice as long the year before. With the FDA’s efforts to lighten the regulatory burden just beginning to take effect, this could get even faster in future.
The FDA has already signalled its willingness to speed up the approval process. Initiatives such as bringing in an expedited device approval pathway and streamlining the de novo approval process will soon bear fruit (The FDA's latest push to speed medtech approvals, August 28, 2014).
But neither of these are responsible for the change so far. The expedited route is not yet in force, and de novo approvals are not counted in this analysis. It seems that the FDA has simply made general efforts to hasten approvals.
Still, it should be noted that these sample sizes are small, and that the approval numbers and speed can fluctuate from year to year depending on the complexity of the products that happen to be submitted, and the quality of those submissions.
|First-time PMAs by therapy area, 2013 and 2014|
|EvaluateMedTech classification - L1||First PMAs in 2013||Avg review time in 2013||First PMAs in 2014||Avg review time in 2014|
|Anesthesia & Respiratory||1||61.3||1||12.0|
|Ear, nose & throat||-||-||1||9.5|
|General & plastic surgery||3||68.2||1||28.7|
|In vitro diagnostics||4||8.6||8||13.4|
|NB: this analysis does not include HDE approvals as not all data are yet available|
Whatever the reasons, device companies are surely not complaining. At the half-year point, it took the agency an average of 18.4 months to grant 17 PMAs (FDA grants twice as many device approvals in half the time, July 25, 2014). Looking at the second half, only 12 devices gained PMAs, but they did so in an average of just 15 months.
One company that made a strong showing in the last six months is Medtronic, which as of today is the largest medtech company in the world. The approval of the IN.PACT Admiral drug-eluting balloon in atherosclerosis could in fact leave the company somewhat deflated; despite beating C. R. Bard’s rival Lutonix device to the European market by two years, Medtronic’s balloon was pipped to the US post when Lutonix was approved three months earlier than expected.
It is almost a surprise to see Myriad Genetics grace the table. For years the company sold its BRACAnalysis breast cancer gene assay in the US as a homebrew test, unregulated by the FDA, and enforced a monopoly by claiming to have patented the BRCA genes rather than the diagnostic.
A succession of legal defeats combined with forthcoming changes to the way the FDA will regulate diagnostics essentially forced the company to seek a PMA for BRACAnalysis as a companion diagnostic for AstraZeneca’s ovarian cancer drug Lynparza (Astra’s Lynparza becomes first Parp inhibitor, December 22, 2014). Achieving FDA approval is always a good move, but Myriad and its investors might feel somewhat disappointed.
Glut of HDEs
Looking at the FDA approvals in the last six months of 2014, perhaps the most interesting aspect is how few of them are traditional PMAs. Three of the 16 innovative devices approved in the second half carry BP codes, indicating that they were approved by the FDA’s Center for Biologics Evaluation and Research rather than its Center for Devices and Radiological Health, which grants approvals with P codes.
BP code approvals are still PMAs, however. Arguably more interesting is the sudden glut of humanitarian device exemptions (HDEs), a different kind of approval for innovative devices. These once-rare designations are the rough equivalent of orphan drug approvals in biopharma, and permit a slightly lower burden of proof when it comes to efficacy.
The FDA granted four HDEs in 2014, all in the second half of the year – indeed some are so recent that the agency has not yet released full data on them. Perhaps more HDE applications are being submitted, and the medtech industry beginning to target rare diseases with the same enthusiasm as the biopharma sector. Or perhaps the uptick in HDEs is another result of a more relaxed attitude at the FDA.