November 5, 2014
After years of decline, the speed of FDA device approvals has finally begun to hit the gas pedal a bit. This is according to an interesting new report from the California Healthcare Institute (CHI) and Boston Consulting Group (BCG).
FDA Approval Delays Reached Their Peak in 2010
In hindsight, it appears that the FDA hit a low point in 2010. At that time, approval times averaged four years longer in the US than in Europe. Those delays, the report argues, kept proven, life-saving technologies from American patients unless they traveled abroad. Worse, there’s no evidence that the FDA’s snail-like approach to approvals made products used in the US any more effective or safe.
MDUFA III: New Policies to Improve FDA Device Reviews
Congress and the FDA collaborated in 2012 to implement and fund new policies. These were aimed at enhancing regulatory clarity, consistency, and predictability. The industry agreed to pay significantly higher user fees to facilitate this. The new approach was collected in the Medical Device User Fee Amendments of 2012 (MDUFA III).
Signs of Progress in FDA Review Performance
The verdict? “Real improvements are evident, yet there are still areas of concern.”
It’s worth noting that CHI and BCG commend the Center for Devices and Radiological Health (CDRH) for its efforts. Their work to “get processes, internally and with industry, back on track” has been recognized.
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. This is within 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.
510(k) Review Times Remain a Challenge
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 in 2000, say CHI and BCG. However, 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 attract the US medical technology business. “Only time will tell if recent improvements at the FDA ultimately have any impact on this gap,” the report summarizes.
Europe’s Faster Approvals Continue to Challenge FDA
Back in my elementary school days, most teachers took great pains to encourage students who were 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.
