While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own agenda” over dissenting science or how its own advisory boards vote on 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, because the FDA violated its own rules in running the hearing. FWL filed a March 9, 2012, citizen’s petition challenging the FDA’s proposed classification of CES devices as high-risk or Class III devices.
Kelly Roman, FWL’s vice president, 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 FWL’s desire to have its CES keep its Class I designation.
But Fisher worries that this kind of FDA activity is stifling medical innovation, especially for smaller companies that 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 says. Specifically, he criticized a faction at the FDA for “picking apart” and using aspects of research to prove the 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 from the agency. “We appreciate that the FDA is a big slow-moving ship,” he notes.
For a glimpse at some of the February hearing that troubled FWL, click here.
This article first appeared in the April 11, 2012, edition of the AssurX blog.