EP Vantage’s half-year report looked at all medical devices approved by FDA through it’s Premarket Approval (PMA) pathway and its Humanitarian Device Exemption (HDE) pathway, both used almost exclusively by entirely new devices, and not just new iterations [typically approved through the 510(k) pathway]. The report notes that with FDA’s plans to soon regulate Lab Developed Tests (LDTs), “the agency (FDA) will have to pick up the pace of approvals” if it is to accommodate its increased workload without letting approval times slip. Luckily, the report notes, “There are signs that it is already doing just that.”
In the first half of 2014, FDA managed to approve seventeen (17) PMAs, up substantially from the nine (9) it approved in the first half of 2013. Additionally, devices were approved in just 18.4 months on average, down substantially from the 35.9 months each PMA approved in 2013 took to approve on average. However, even with the pace of approvals up in the first half, it’s not yet certain that FDA will have a record year, or even just a good one. While FDA approved just twenty-three (23) PMAs and HDEs in 2013, it approved nearly twice as many in 2011 (43) and 2012 (41). For FDA to match those standards, it will have to approve even more PMAs/HDEs in the second half of 2014. And while the Agency has been trying to do more in recent years to bring down PMA approval times and boost (appropriate) first-round approvals, it is ultimately beholden to filings from industry for its approvals. In other words, the agency can’t approve 40+ PMAs if it hasn’t received that many in a given period.
Approvals, Fast and Slow
EP Vantage’s report also has a number of other interesting data. For example, Medtronic’s Corevalve, a transcatheter aortic valve, was approved in just 5.8 months—more quickly than any other device this year. “The approval came six months earlier than even the company itself had expected,” the report said, and far more quickly than a rival device manufactured by Edwards Lifesciences, whose Sapien XT aortic valve, was approved in June 2014 after a 13.5-month review by FDA. Boston Scientific’s Rebel coronary stent and Qiagen’s Artus diagnostic kit also experienced rapid reviews, obtaining approval in just 5.9 months each.
On the opposite end of the approvals spectrum, Anika Therapeutics’ Monovisc, a hyaluronate-based osteoarthritis therapy device, had the longest time between filling and approval at more than four years. The drug had twice been rejected by FDA before obtaining approval.
The report called FDA’s recent trend in approvals “increasingly industry-friendly,” and likely to become even more so in the future. “If the planned expedited review program comes into force this year, the second half could see even more approvals and even shorter submission-to-approval timelines,” its authors hypothesized.
REFERENCE: RAPS; 20 AUG 2014; Alexander Gaffney, RAC