Medical Device CEO Laments ‘Anti-Industry’ FDA Culture

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While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the FDA culture is an attempt to “force its own agenda” over dissenting science or how its own advisory boards vote on regarding medical device classification is just part of a broader “systemic” problem with some at the agency.

As reported earlier in Medical Device Daily and elsewhere, an FDA advisory committee hearing in February for cranial electrotherapy stimulator (CES) medical devices was flawed, in part FWL alleges, the FDA violated its own rules in running the hearing.  FWL filed a March 9 citizens petition challenging FDA’s proposed classification of CES devices as high-risk or class III devices.

FWL VP Kelly Roman said he’s “heartened,” however, that the FDA has said publicly that it will discuss the situation directly with FWL.  “The fact that they responded at all” is unusual for the agency in a case like this, and Roman believes it bodes well for their desire to have their CES keep its class I designation.

But CEO Fisher worries that this kind of FDA culture is stifling medical innovation, especially for smaller companies who may not be able to afford a long and drawn out battle like this with the agency.

“I think there’s a growing culture of anti-industry” at the FDA, Fisher told us April 10. Specifically, he criticized a faction at FDA for “picking apart” and using aspects of research to prove it point it wanted to prove, but not always considering the full body of research that might support another position.

Roman doesn’t expect to hear from the FDA for many months, and has gotten no official timetable for the agency. “We appreciate that the FDA is a big slow moving ship,” he noted.

For a glimpse at some of the February hearing that troubled FWL click here.

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