November 5, 2014
After years of decline, the speed of FDA device approvals has finally begun to hit the gas pedal a bit, says an interesting new report from the California Healthcare Institute (CHI) and Boston Consulting Group (BCG).
In hindsight, it appears FDA hit a bottom in 2010 when approval times averaged a staggering four years longer in the US than Europe. Those delays, the report argues, kept proven, life-saving technologies from American patients unless they traveled abroad. Worse, there’s no evidence the FDA’s snail-like approach to approvals made products used in the US any more effective or safe.
Congress and the FDA came together in 2012 to try and find ways to implement, and fund, new policies designed to improve regulatory clarity, consistency, and predictability. The industry agreed to pay significantly higher users fees to help make it happen. The new approach was collected in the Medical Device User Fee Amendments of 2012 (MDUFA III).
The verdict? “Real improvements are evident, yet there are still areas of concern.”
It’s worth noting that CHI and BCG applaud the Center for Devices and Radiological Health (CDRH) for working hard to “get processes, internally and with industry, back on track.”
There’s some good evidence out there to support industry optimism. Report data suggest that, after a 2010 nadir, the PMA classes of 2011 and 2012 will show the best overall review-time performance of the device user fee era. Early returns for 2013 show even further improvement, though the study cautions that there are simply too many products awaiting a decision to make rock-solid claims just yet.
If PMA is part of the good news, the weather report in 510(k) land is far less sunny. Review times in 2012 were 60 percent longer than 2000, say CHI and BCG. But unlike the relative success with PMAs, today’s 510(k) review times “continue to remain far higher, and processes are still viewed as less predictable, than during the pre-device user fee era,” according to the report, Taking the Pulse of Medical Device Regulation & Innovation.
Another disheartening finding: The lag between FDA approval and faster action in Europe hasn’t changed much so far. Europe’s regulatory environment continues to lure US medical technology business away. “Only time will tell if recent improvements at the FDA ultimately have any impact on this gap,” the report summarizes.
Back in my elementary school days, most teachers took great pains to encourage a student who was genuinely trying — even if the results were not always so great. Maybe we should give the FDA a hearty pat on the back instead of a kick in the rear. It just might work.
