Cost for QD employees to rent an apartment in Chico, CA. $1,200/month. Please turn off your ad blocker in Quality Digest
Our landlords thank you.
Michael Causey
Published: Wednesday, April 18, 2012 - 10:16 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. Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.Medical Device CEO Laments ‘Anti-Industry’ FDA Culture
Is the agency stifling medical innovation?
Our PROMISE: Quality Digest only displays static ads that never overlay or cover up content. They never get in your way. They are there for you to read, or not.
Quality Digest Discuss
About The Author
Michael Causey
© 2023 Quality Digest. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
“Quality Digest" is a trademark owned by Quality Circle Institute, Inc.