What is an apt literary metaphor for the U.S. Food and Drug Administration?
The Queen of Hearts character from Alice’s Adventures in Wonderland.
The FDA has been called many things: slow, capricious and opaque. But perhaps never before has a critic likened the agency to the villainess of the famous children’s novel. The Queen of Hearts is a tyrant who changes the rules of the game as she pleases and is all-powerful.
At an educational event meant to enlighten the audience about the 510(k) process Thursday, regulatory expert Mark DuVal drew laughs as he co-opted characters from the popular classic and framed them within the world of the FDA. (The event was organized by local trade group LifeScience Alley.)
Using the color-saturated trailer from Johnny Depp’s Alice in Wonderland, DuVal epitomized the innocent and naive Alice as the company seeking a 510(k), reviewers at the Center for Devices and Radiological Health as Tweedle Dee and Tweedle Dum and the U.S. Congress as the ephemeral Cheshire cat, fading in and out with a wide grin.
In the center of that world of course is DuVal himself as the Mad Hatter who must navigate Alice through the topsy-turvy world of product review.
Judging by the tenor of the presentation, there will be no reprieve for the agency as CDRH director Jeffrey Shuren had desired, at least here in Minnesota.
Reserve your seat now for MedCity CONVERGE, to be held July 9-10 in Philadelphia. Discover strategies, solutions and startups in healthcare innovation. Be a part of this gathering where the entire healthcare ecosystem converges.
By Arundhati Parmar
Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.More posts by Author
As noted in the article, today’s workshop focused on the process for submitting 510(k) applications to FDA. While the speakers at LifeScience Alley’s programs are content experts, their personal views do not represent the association's views. LifeScience Alley continues a productive, cooperative dialogue with FDA on key issues affecting the industry.