I don’t want to become an FDA basher. It just seems like every year it is getting harder to push the medical device rock up the FDA hill. Speaking with peers, their perception has been similar, but last week the speculation was confirmed.
I have never spent the time to actually look up FDA approval data. Last week, however, the Minnesota Congressional delegation published a letter to FDA commissioner Margaret Hamburg asking why Investigational Device Exemption (IDE) approval rates are so poor and quoted data.
In 2000, according to the delegation, 76% of IDE’s were approved on their first review cycle. In 2010, that number had dropped to 32%. Less than half!
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Devices that require clinical trial are by definition the more innovative products. By default, a device that can follow a 510K-approval process (without a clinical trial) has a predicate device on the market since 1976 and/or is low risk with obvious clinical outcomes. In contrast, IDE submissions are for more novel products.
I assume the Minnesota delegation focused on IDE approval rates because they are indicative of the throughput of medical device innovation. A 50% reduction in the rate of efficiently gaining approval to start clinical trials has a tremendous impact on start-up companies gaining venture funding. With less funding, the number of start-ups diminishes and innovation tapers off.
A cynic might say that the FDA is putting more effort upfront so that the backend reviews of clinical studies have fewer surprises and ensure greater product safety. The FDA’s defense is that they have had a 27% increase in submissions without sufficient increase in personnel.
The FDA is definitely under-resourced, especially in experienced and knowledgeable reviewers, and a modest rate drop corresponding to an increased workload might be predictable. None of this, however, explains the absolute product approval numbers of 48 Premarket approvals (PMA) in 2000 and only 19 in 2010 with no evidence of a reduction in recalls on PMA products.
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If the FDA was bringing meaningful and measurable value to medical devices by improving safety, industry would be hard-pressed to complain to congress. Unfortunately, challenges that medical devices have had over the last few years relative to recalls have had little to do with clinical trial design or results, with most recalled products following a lesser regulatory pathway.
Hopefully, the recent pressure that the FDA is feeling from congress, the venture capital lobby, and the medical device industry will help pull the pendulum back to the middle-ground. After all, clearing medical devices is about balancing risk vs. benefits.
Healing Innovation is a resource for clinician innovators. The main site - HealingInnovation.com - provides an overview of the various aspects and issues facing clinician innovators.
